(62 days)
Rondek PGA suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
RK's Rondek PGA suture is a sterile, absorbable, braided suture composed of a homopolymer of glycolic acid and coated with a copolymer of Polycaprolactone and Polyglycolic acid.
This document is a 510(k) summary for the Rondek PGA Suture and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and an independent study proving the device meets those criteria.
Therefore, the requested information elements related to acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment cannot be fully provided from this document alone, as it describes a different type of regulatory submission process.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document states that the device meets "relevant USP specifications" and lists several types of performance tests. However, it does not provide a table specifying the exact acceptance criteria for each test or the exact performance results achieved by the Rondek PGA Suture. It only generally states that the tests "support that the Rondek PGA suture meets relevant USP specifications and is equivalent to its predicate."
| Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|
| USP specifications | Meets relevant USP specifications |
| Equivalent to predicate | Equivalent to predicate (Bondek® Plus Synthetic Absorbable Surgical Suture) |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the submission focuses on laboratory and performance testing for a suture, not on diagnostic output requiring expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for this type of device and submission. The performance data listed (e.g., USP testing, Eto Residuals, Biocompatibility) are typically objective laboratory measurements, not subjective evaluations requiring adjudication.
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:
Not applicable. This is a surgical suture, not a diagnostic AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance data would be the established scientific and regulatory standards (e.g., USP monographs for suture properties, recognized standards for biocompatibility, pyrogenicity, and sterilization residuals). These are objective measurements rather than interpretations requiring expert consensus or pathology.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
May 10, 2018
RK Manufacturing Corporation % Mr. John Gillespie Consultant Clover Medical, LLC 79 Haven St. Dover, Massachusetts 02030
Re: K180625
Trade/Device Name: Rondek PGA Suture (Beige or Violet) Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: March 7, 2018 Received: March 9, 2018
Dear Mr. Gillespie:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180625
Device Name Rondek PGA Suture (Beige or Violet)
Indications for Use (Describe)
Rondek PGA suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Submitter: | 510(k) Owner:RK Manufacturing Corporation34 Executive Drive, # 1Danbury, CT 06810 |
|---|---|
| Contact Person:John Gillespie (Consultant)Clover Medical LLC79 Haven St.Dover, MA 02030www.CloverMedical.com | |
| Date Prepared: | May 8, 2018 |
| Device Trade Name: | Rondek PGA Suture |
| Common Name: | Synthetic Absorbable Suture, PGA Suture |
| Classification: | Class: IIPanel: General and Plastic SurgeryRegulation: 878.4493 Absorbable Poly (Glycolide/L-Lactide) surgical sutureProduct Code: GAM (Suture, Absorbable, Synthetic,Polyglycolic Acid) |
| Predicate Device: | K992088 Bondek Plus Synthetic Absorbable SurgicalSuture |
Description of Device:
RK's Rondek PGA suture is a sterile, absorbable, braided suture composed of a homopolymer of glycolic acid and coated with a copolymer of Polycaprolactone and Polyglycolic acid.
Indications For Use:
Rondek PGA suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
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Summary of Technological Characteristics vs. Predicate:
Rondek PGA suture has the same intended use, technology, and functional characteristics as its predicate Bondek® Plus Synthetic Absorbable Surgical Suture (K992088).
Performance Data
Performance data provided includes:
- USP Performance Testing
- Stability Evaluations ●
- Eto Residuals Testing ●
- LAL Pyrogen Testing .
- Material Mediated Rabbit Pyrogen Testing ●
- Biocompatibility Testing ●
- Physico-Chemical Analysis ●
These tests support that the Rondek PGA suture meets relevant USP specifications and is equivalent to its predicate.
Conclusion
Based on the Indication for Use, technological characteristics, test data, and comparison to its predicate device we conclude that the Rondek PGA Suture has been shown to be as safe and effective as the predicate device.
§ 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.