Absorbable Sutures 510k

Absorbable Sutures are surgical threads or materials used to sew together tissues or wounds. They are classified based on several factors, including the material used, the size of the suture, the shape of the needle, and the intended use.

Absorbable sutures are degradable stitches that are made of materials that will degrade over time due to the Hydrolysis process in the body. Hydrolysis is a process where water penetrates the strands of the suture resulting in the breakdown of the polymer structure of the filament, and the sutures will degrade over time.

Synthetic absorbable sutures are degraded by the Hydrolysis process, whereas Natural absorbable sutures like Catgut absorb by Enzymatic reaction. They do not require removal, so after the wound is healed.

The type of absorbable synthetic sutures available in the market 

• Polydioxanone
• Polyglactin
• Poly(hydroxybutyrate)

The surgical sutures are intended for general soft tissue approximation and/or ligation, such as use in ophthalmic, cardiovascular, neurological, Orthopedic, and dental procedures.

Polydioxanone sutures: An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.

Polyglactin sutures: An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is a sterile, flexible strand prepared and synthesized from homopolymers of glycolide and copolymers made from 90 per cent glycolide and 10 per cent l-lactide, and is indicated for use in soft tissue approximation. it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved colour additive. Also, the suture may be provided with or without a standard needle attached.

Poly(hydroxybutyrate) Sutures: An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.

• Monofilament sutures/Unbraided: These sutures are made of a single strand of material and are typically smooth, which can make them easier to handle.
• Multifilament sutures/Braided: These sutures are made of multiple strands of material that are twisted or braided together.
• Barbed sutures: These sutures have tiny, backwards-facing barbs along the length of the suture, which help hold tissues together without the need for knots.

They are available in a range of gauge sizes and lengths, attached to stainless steel needles of varying types and sizes suture is available in size range of USP 12-0 to 5.

Surgical sutures must comply with 21 CFR 70.5(c) for colour additives.

Polydioxanone sutures: Flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone). It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.

Polyglactin sutures: They may be monofilament or multifilament (braided) in form; they may be uncoated or coated; and they may be undyed or dyed with an FDA-approved colour additive. Also, the suture may be provided with or without a standard needle attached.

Poly(hydroxybutyrate) sutures: Produced by recombinant DNA technology, braided/unbraided, composed of poly (4-hyd rob butyrate) (P4HB) with cyanoacrylate, available either dyed (D&C Violet No. 2) or un-dyed (natural), with and without pre-attached needles

In both Traditional and Abbreviated 510(k) submissions, the FDA advises including the listed section headings in the recommended sequence. Although certain sections may not apply to your device, maintaining the specified order of headings is suggested by the FDA to facilitate expedited reviews.

1. FDA Medical Device User Fee Cover Sheet
2. FDA Premarket Review Submission Cover Sheet
3. FDA 510k Cover Letter
4. FDA 510(k) Indications for Use Statement
5. FDA 510(k) Summary or FDA 510(k) Statement
6. FDA Truthful and Accuracy Statement
7. FDA Class III Summary and Certification
8. Financial Certification or Disclosure Statement
9. Declarations of FDA Conformity and Summary Reports
10. FDA 510 (k) Executive Summary
11. Medical Device Description
12. FDA 510(k) Substantial Equivalence Discussion
13. Proposed Labeling
14. Sterilization and Shelf Life
15. Biocompatibility
16. Software
17. Electromagnetic Compatibility and Electrical Safety
18. Performance Testing-Bench
19. Performance Testing-Animal
20. Performance Testing-Clinical

Biocompatibility Evaluation should be done according to Use “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.” Contact type and duration for surgical sutures depend on intended use, the following endpoints should be addressed in your biocompatibility evaluation.

• Cytotoxicity
• Sensitization
• Irritation or Intracutaneous Reactivity
• Acute systemic toxicity
• Material-Mediated Pyrogenicity
• Subacute/Subchronic Toxicity
• Genotoxicity
• Clinically relevant implantation
• Chronic Toxicity
• Carcinogenicity
• Hemocompatibility
• Chemical characterization with detailed toxicological risk assessment including clinical evidence with scientific rationale is recommended in case of not performing the toxicity testing (Subacute, Subchronic, chronic, chronic, Genotoxicity, and carcinogenicity) mentioned above.

Note: Two different sutures have to perform the individual biocompatibility testing

If the sutures are with a needle, then the following five Biocompatibility tests need to be performed.

• In Vitro Cytotoxicity
• Skin Sensitization
• Skin Irritation
• Acute Systemic Toxicity
• Material Mediated Pyrogenicity

• Suture Resorption profile (In vitro & In vivo study : should include rate of absorption, time to complete absorption, and residual tensile strength over time)- USP-NF M80190_04_01 Absorbable Surgical Suture- ASTM F1635-16
• Diameter Test -USP-NF M99650_02_01 <861> Sutures – Diameter
• Tensile Strength USP-NF M99670_02_01 <881> Tensile Strength
• Suture-Needle attachment USP-NF M99660_03_01 <871> Sutures – Needle Attachment
• Sutures – Length requirements USP for “Suture Length Requirement” (95% of stated label length)
• Barb Holding Forces (Barb Holding Strength Testing) if the suture is barbed.
• Extractable colour -if suture is dyed (USP monograph)
• Residual solvents (USP monograph)

For devices labelled as sterile, sterilization methods are to be performed as per below mentioned standard;

• ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
• ISO 11135-1 Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
• ISO 11137-1 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.
• ISO 20857 Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices.
• ISO 11607-1 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems.
• ISO 11607-2 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes.

In below following conditions FDA may recommend collecting clinical data for a surgical suture device:

• a formulation dissimilar from formulations previously cleared under a 510(k).
• a new technology, i.e., technology different from that used in legally marketed surgical suture devices; or
• indications for use dissimilar from indications for use of sutures of the same type.

• Real-time stability study
• Accelerated ageing stability study as per -ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices