K Number
K180625
Device Name
Rondek PGA Suture (Beige or Violet)
Date Cleared
2018-05-10

(62 days)

Product Code
Regulation Number
878.4493
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
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.
More Information

Not Found

No
The summary describes a surgical suture and its performance testing, with no mention of AI or ML.

No
The device, a surgical suture, is used for tissue approximation and ligation during surgical procedures, not for treating a disease or condition therapeutically.

No
The device is a surgical suture used for approximation and ligation of soft tissues. It is a therapeutic device, not a diagnostic one, as it does not diagnose medical conditions.

No

The device description clearly indicates it is a physical suture, a hardware component, and the performance studies focus on physical and biological properties of the suture material.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states "general soft tissue approximation and/or ligation". This describes a surgical procedure performed directly on a patient's body.
  • Device Description: The device is a "sterile, absorbable, braided suture". This is a physical material used to close wounds or tie off blood vessels during surgery.
  • Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information. IVDs are designed to perform tests on these types of samples.
  • Performance Studies: The performance studies listed (USP testing, stability, biocompatibility, etc.) are typical for surgical devices, not IVDs. IVD performance studies would focus on metrics like sensitivity, specificity, accuracy in detecting specific analytes, etc.

In summary, the Rondek PGA suture is a surgical device used in vivo (within the living body) for tissue repair, not an IVD used in vitro (outside the living body) for diagnostic purposes.

N/A

Intended Use / 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.

Product codes

GAM

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

K992088

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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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 Corporation
34 Executive Drive, # 1
Danbury, CT 06810 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person:
John Gillespie (Consultant)
Clover Medical LLC
79 Haven St.
Dover, MA 02030
www.CloverMedical.com |
| Date Prepared: | May 8, 2018 |
| Device Trade Name: | Rondek PGA Suture |
| Common Name: | Synthetic Absorbable Suture, PGA Suture |
| Classification: | Class: II
Panel: General and Plastic Surgery
Regulation: 878.4493 Absorbable Poly (Glycolide/L-
Lactide) surgical suture
Product Code: GAM (Suture, Absorbable, Synthetic,
Polyglycolic Acid) |
| Predicate Device: | K992088 Bondek Plus Synthetic Absorbable Surgical
Suture |

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.