(53 days)
Sharpoint® Coated FAST ABSORBING™ PolyGlycolic Acid suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa where only short-term wound support (7-10 days) is required. Coated FAST ABSORBING PolyGlycolic Acid suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Suture is a synthetic absorbable braided, sterile, surgical suture composed of a homopolymer of Glycolic Acid. The suture material is coated with a copolymer of Polycaprolactone and PolyGlycolic Acid. The substances contained in the coating and suture are noncollagenous and nonantigenic.
This document is a 510(k) Summary for a surgical suture, which is a medical device. The information provided heavily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and performance metrics for a diagnostic or AI-driven device.
Therefore, many of the requested categories for AI/diagnostic device studies (like MRMC studies, ground truth establishment for training sets, number of experts for ground truth, adjudication methods) are not applicable or cannot be extracted from this type of regulatory submission. The "study" here is a set of physical and animal tests to show the suture meets performance standards and is biocompatible.
Here's the information that can be extracted and a clear indication of what is not applicable:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Composition | Composed of 100% PolyGlycolic Acid (equivalent to predicate device material). | Composed of 100% PolyGlycolic Acid. |
| Design | Sterile, flexible, coated braided multifilament form (same as predicate device). | Sterile, flexible, coated braided multifilament form. |
| Intended Use | Indicated for superficial general soft tissue approximation of the skin and mucosa where only short-term wound support (7-10 days) is required. Not for ligation, ophthalmic, cardiovascular, or neurological procedures. | Same intended use as the predicate device: indicated for superficial general soft tissue approximation of the skin and mucosa where only short-term wound support (7-10 days) is required. Not for ligation, ophthalmic, cardiovascular, or neurological procedures. |
| Physical Testing | Conformance to USP 24 standards, specifically: - U.S.P. 24, <861> Sutures - Diameter - U.S.P. 24, <871> Sutures - Needle Attachment - U.S.P. 24, <881> Tensile Strength | Physical testing was conducted on the device to USP 24, including <861> Sutures - Diameter, <871> Sutures- Needle Attachment, and <881> Tensile Strength (implies conformance, as this is a 510(k) approval). |
| Biocompatibility | Conformance to ISO 10993 for biocompatibility. | Animal testing was performed for conformance to ISO 10993 for biocompatibility. |
| Implant Performance | Demonstration of rates of tensile strength and mass loss (consistent with absorbable suture expectations). | Animal implant studies were performed to demonstrate rates of tensile strength and mass loss. |
| Substantial Equivalence | Similar in intended use, materials, design, and performance characteristics to the Ethicon VICRYL Rapide Synthetic Absorbable Surgical Suture (K944110). | The FDA concluded the device is substantially equivalent to the Predicate Device. |
Study Details
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a number of "samples" in a traditional diagnostic sense. Instead, "physical testing was conducted" and "animal testing was performed." The number of sutures tested or animals used is not specified.
- Data Provenance: The testing was conducted by the manufacturer, Surgical Specialties Corporation. The location of the animal testing is not specified, but it would have been part of preclinical testing required for regulatory submission. This would be considered prospective testing for the purpose of this submission.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. For a surgical suture, "ground truth" as typically defined for diagnostic or AI devices (e.g., disease diagnosis) is not relevant. The "truth" is established by adherence to physical standards (USP 24) and biological responses (ISO 10993), which are objectively measured.
-
Adjudication Method for the Test Set:
- Not Applicable. There was no human adjudication process involved as the "test set" consists of physical and biological measurements against established standards.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a surgical suture, not a diagnostic or AI-assisted device for human readers.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (suture), not an algorithm or AI system.
-
The Type of Ground Truth Used:
- For physical properties (diameter, needle attachment, tensile strength): Established industry standards and monographs (USP 24).
- For biocompatibility and implant studies: Established international medical device standards (ISO 10993) and biological response measurements (rates of tensile strength and mass loss in animal models).
-
The Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of a physical medical device like a suture, as it does not involve machine learning or pattern recognition.
-
How the Ground Truth for the Training Set was Established:
- Not Applicable. (See point 7).
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JAN 2 8 2002
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY
Surgical Specialties Corporation Submitter: Address: 100 Dennis Drive Reading, PA 19606 610 404 1000, ext. 2231 Telephone: Elizabeth Lazaro Contact Person: Regulatory Affairs Specialist December 3, 2001 Date Prepared: Sharpoint® Coated FAST ABSORBINGTM Name of Device: PolyGlycolic Acid braided, synthetic absorbable suture, undyed. Common / Usual Suture, Absorbable, Synthetic, PolyGlycolic Acid Classification Name: Predicate Device: Ethicon, Inc. Coated VICRYL RAPIDE (polyglactin 910) braided synthetic absorbable, suture, undyed. Coated FAST ABSORBING PolyGlycolic Acid Device Description Suture is a synthetic absorbable braided, sterile, surgical suture composed of a homopolymer of Glycolic Acid. The suture material is coated with a copolymer of Polycaprolactone and PolyGlycolic Acid. The substances contained in the coating and suture are noncollagenous and nonantigenic.
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Coated FAST ABSORBING PolyGlycolic Acid suture, undyed Surgical Specialties Corporation
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Intended Use: | Coated FAST ABSORBING PolyGlycolic Acidsuture is indicated only for use in superficial generalsoft tissue approximation of the skin and mucosawhere only short-term wound support (7-10 days)is required. |
|---|---|
| Coated FAST ABSORBING PolyGlycolic Acidsuture is not intended for use in ligation,ophthalmic, cardiovascular or neurologicalprocedures. | |
| The coated FAST ABSORBING PolyGlycolic Acidsuture, undyed has the same intended use as thepredicate device. | |
| Technological Characteristics: | Coated FAST ABSORBING PolyGlycolic Acidsuture, undyed is composed of 100% PolyGlycolicAcid, a material equivalent to the materialcomprising the predicate VICRYL Rapide device.The suture has the same design as the VICRYLRapide predicate devices, being a sterile, flexiblesuture available in a coated braided multifilamentform. |
| Performance Data: | Physical testing was conducted on the CoatedFAST ABSORBING PolyGlycolic Acid suture toUSP 24, including <861> Sutures - Diameter,<871> Sutures- Needle Attachment, and <881>Tensile Strength. Animal testing was performed forconformance to ISO 10993 for biocompatibility andimplant studies in animals to demonstrate rates oftensile strength and mass loss. |
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Coated FAST ABSORBING PolyGlycolic Acid suture, undyed Surgical Specialties Corporation
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9
The FAST ABSORBING PolyGlycolic Acid Synthetic Absorbable surgical suture is similar in intended use, materials, design, and performance characteristics to the Ethicon VICRYL Rapide Synthetic Absorbable Surgical Suture (K944110).
The determination of substantial equivalence for this device was based on a detailed device description, physical testing (U.S.P. 24) and animal testing for conformance with performance standards e.g. ISO 10993-1 Biological Evaluation of Medical Devices and the FDA Guidance Document for Surgical Suture 510(k)s issued on August 10, 2000.
Based on the 510(k) summaries (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2002
Ms. Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606
Re: K014021
Trade/Device Name: Sharpoint® Coated FAST ABSORBING™ Polyglycolic Acid Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(glycolide/L-lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: December 05, 2001 Received: December 06, 2001
Dear Ms. Lazaro:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Elizabeth Lazaro
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Of Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Sharpoint® Coated FAST ABSORBING™ PolyGlycolic Acid Device Name: Synthetic
Absorbable Surgical Suture
Indications for Use:
Sharpoint® Coated Fast Absorbing™ PolyGlycolic Acid Suture is indicated only for use in superficial soft tissue approximation of the skin and mucosa where only short term wound support (7 – 10 days) is required. Coated Fast Absorbing™ PolyGlycolic Acid Suture is not intended for use in ligation, ophthalmic cardiovascular or neurological procedures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Muriam C. Provost
(Division Sign-Off) Division of Coneral, Rostorative and Neurological Devices
510(k) Number KO1 402
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” 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 color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.