(90 days)
DEXON® Rapid (DEXON "R") sutures are indicated for use in the surgical closure of skin and mucosa where only short-term wound support is required and where rapid degradation of the suture material is considered desirable. It is not intended for use in ligation, ophthalmic, cardiovascular or neural tissue.
The Dexon® "R" Polyglycolic Acid Suture is an Absorbable Suture composed of a homopolymer of glycolic acid and coated with Polycaprolate, a copolymer of glycolide and epsilon-caprolactone. The polycaprolate coating system is inert, noncollagenous, nonantigenic and nonpyrogenic. The Dexon "R" sutures are sterile, inert, noncollagenous, nonantigenic and nonpyrogenic and are available in various colors.
The provided text describes a 510(k) submission for a surgical suture, not a device that relies on an algorithm or AI. Therefore, most of the questions regarding acceptance criteria and study design for an AI/algorithm-based device are not applicable to this document. The document focuses on the substantial equivalence of the suture to predicate devices and results from standard biocompatibility and strength retention tests.
Here's an attempt to answer the relevant questions based on the provided text, while explicitly stating when information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility | These are standard tests for medical devices to ensure they are safe for use in the body. | |
| Cytoxicity (elution test) | Deemed acceptable | Passed standard cytotoxicity tests. |
| Systemic Injection | Deemed acceptable | Passed systemic injection tests. |
| Pyrogenicity | Deemed acceptable | Passed pyrogenicity tests. |
| Intracutaneous Injection | Deemed acceptable | Passed intracutaneous injection tests. |
| Physical Performance | These likely pertain to the mechanical integrity and absorption properties of the suture. | |
| Strength Retention | Deemed acceptable | Passed strength retention tests, implying it meets predefined mechanical performance over time. |
| Material Composition | Homopolymer of glycolic acid, coated with Polycaprolate (copolymer of glycolide and epsilon-caprolactone) | This is a description of the material, not a performance criterion per se, but it must match the predicate. |
| Sterility | Sterile | A fundamental requirement for surgical sutures. |
| Non-collagenous, Non-antigenic, Non-pyrogenic | Stated to be inert, non-collagenous, non-antigenic, non-pyrogenic | These are characteristics that contribute to biocompatibility and were likely confirmed through testing. |
| Intended Use | For use in surgical closure of skin and mucosa where short-term wound support is required and where rapid degradation is desirable. Not for ligation, ophthalmic, cardiovascular, or neural tissue. | This is the defined scope of safe and effective use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "a battery of tests were performed" but does not specify sample sizes for these tests, nor the data provenance (e.g., whether the tests were conducted in a specific country or were retrospective/prospective observations).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as the device is a surgical suture, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device would be established through laboratory testing and potentially in vivo animal or human studies (though no human study details are given here).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reason as above. Adjudication methods are typically used when subjective interpretations (e.g., image readings) are involved in establishing ground truth.
5. 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
This question is not applicable as the device is a surgical suture, not an AI-assisted diagnostic or interpretive system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a surgical suture, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this device, the "ground truth" for its performance and safety would be established through:
- Laboratory testing: Measuring physical properties like strength retention, absorption rates, and material composition.
- Biocompatibility testing: In vitro (e.g., cytotoxicity) and in vivo (e.g., systemic injection, pyrogenicity, intracutaneous injection) tests to assess biological response.
- Comparison to predicate devices: The primary method for proving substantial equivalence, relying on the established safety and effectiveness of previously approved devices.
8. The sample size for the training set
This question is not applicable as the device is a surgical suture and does not involve a "training set" in the context of machine learning or algorithms.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
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MAY 1 8 1998
510k SUMMARY OF SAFETY AND EFFECTIVENESS
DEXON® "R" Polyglycolic Acid, Synthetic Absorbable Surgical Suture
Sherwood-Davis & Geck Submitted by: 444 McDonnell Blvd. Hazelwood, MO 63042-2516
Vanada Johnson Contact: Sr. Regulatory Affairs Specialist
February 12, 1998 Date of Summary:
The Dexon® "R" Polyglycolic Acid Suture is an Absorbable Suture composed of a homopolymer of glycolic acid and coated with Polycaprolate, a copolymer of glycolide and epsilon-caprolactone. The Dexon "R" Suture is a Class II device, per 21 CFR Section 878,4493. Product code 73GAM. Performance standards have not been pulmogated for this device, as of this date ..
The polycaprolate coating system is inert, noncollagenous, nonantigenic and nonpyrogenic. The Dexon "R" sutures are sterile, inert, noncollagenous, nonantigenic and nonpyrogenic and are available in various colors.
The Dexon® "R" Sutures are indicated for use in the surgical closure of skin and mucosa where short-term wound support is required and where rapid degradation of the suture material is considered desirable. It is not intended for use in ligation, ophthalmic, cardiovascular or neural tissue.
The following battery of tests were performed in accordance to respective guidelines and deemed acceptable: Cytoxicity (elution test), Systemic Injection, Pyrogenicity, Intracutaneous Injection and Strength Retention.
Dexon® "R" Polyglycolic Acid. Synthetic Absorbable Surgical Suture is substantially equivalent in design and composition to Vicryl Rapide (Ethicon, Inc.). Both are synthetic polyglycolic acid absorbable sutures. The intended use for Dexon "R" and Vicryl Rapide are very similar. Both are available sterile, undyed and in various lengths, diameters and quantities w/surgical needles. Sherwood-Davis & Geck considers the DEXON® "R" Polyglycolic Acid, Synthetic Absorbable Surgical Suture to be substantially equivalent to the DEXON family of predicate devices: DEXON II covered under 510(k) K900198, DEXON Violet covered under 510(k) K972566, Vicryl Rapide Suture covered under 510(k) K944110.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | 8 |998
Ms. Vanada Johnson Senior Regulatory Affairs Specialist Sherwood Davis and Geck 444 McDonnell Boulevard Hazelwood, Missouri 63042-2516
Re: K980610 Dexon R® Polyglycolic Acid Synthetic Absorbable Suture Regulatory Class: II Product Code: GAM Dated: February 12, 1998 Received: February 17, 1998
Dear Ms. Johnson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Tuesday, October 26, 1993 (Vol. 58, No. 205, Pages 57557 and 57558). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at (800) 638-2041 or (301) 443-6597. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
-
- The Dexon R® Polyglycolic Acid Synthetic Absorbable Suture is indicated for use in the surgical closure of skin and mucosa where only short-term wound support is required and where rapid degradation of the suture material is considered desirable. It is not intended for use in ligation, ophthalmic, cardiovascular, or neural tissues.
-
- This device may not be manufactured from any material other than homopolymers and copolymers glycolide and/or L-lactide. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the Dexon R® Polyglycolic Acid Synthetic Absorbable Suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.
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Page 2 - Ms. Johnson
The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.
Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control Provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4595. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597, or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours.
'oeele
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known)_ K980610
Device Name: Sherwood-Davis & Geck DEXON® Rapid Polyglycolic Acid, Synthetic Absorbable Surgical Suture
DEXON® Rapid (DEXON "R") sutures are indicated for use in the Indications for Use: surgical closure of skin and mucosa where only short-term wound support is required and where rapid degradation of the suture material is considered desirable. It is not intended for use in ligation, ophthalmic, cardiovascular or neural tissue.
(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrenc of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the-Counter Use ... . . . (Per 21 CFR 801.109) 3 (Division Sign-off)
510(k) Number _ K9 806/0
Sherwood-Davis & Geck DEXON® Rapid Polyglycolic Acid, Synthetic Absorbable Surgical Suture Premarket Notification
§ 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.