Rondek PGA Suture (Beige or Violet)

K180625 · Rk Manufacturing Corporation · GAM · May 10, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180625
• Device Name: Rondek PGA Suture (Beige or Violet)
• Applicant: Rk Manufacturing Corporation
• Product Code: GAM · General, Plastic Surgery
• Decision Date: May 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Rondek PGA suture is a sterile, absorbable, braided surgical suture. Composed of a homopolymer of glycolic acid and coated with a copolymer of polycaprolactone and polyglycolic acid. Used by surgeons in clinical settings for soft tissue approximation and ligation. Provides temporary wound support during healing before being absorbed by the body. Device is provided sterile for single use.

Clinical Evidence

Bench testing only. Data includes USP performance testing, stability evaluations, Eto residuals testing, LAL pyrogen testing, material-mediated rabbit pyrogen testing, biocompatibility testing, and physico-chemical analysis.

Technological Characteristics

Synthetic absorbable braided suture. Material: homopolymer of glycolic acid coated with polycaprolactone and polyglycolic acid copolymer. Sterilization: Ethylene oxide (Eto). Meets USP specifications for absorbable surgical sutures.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including ophthalmic procedures. Contraindicated for cardiovascular and neurological procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Bondek Plus Synthetic Absorbable Surgical Suture (K992088)

Submission Summary (Full Text)

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