← Product Code [GAT](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT) · K220219 # PERMALOOP Suture, PERMATAPE Suture (K220219) _Medos International SARL · GAT · Apr 26, 2022 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT/K220219 ## Device Facts - **Applicant:** Medos International SARL - **Product Code:** [GAT](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT.md) - **Decision Date:** Apr 26, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.5000 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The PERMALOOP Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue. ## Device Story PERMATAPE and PERMALOOP are non-absorbable, flat-braided polyethylene surgical sutures; used for soft-tissue approximation in orthopedic procedures. PERMATAPE is a 1.3mm wide suture; PERMALOOP is a looped configuration of the same material. Devices are provided sterile via Ethylene Oxide (EO) with or without stainless steel needles. Intended for single-use by surgeons in clinical/OR settings. Sutures provide mechanical fixation of soft tissue; aid in tissue healing/repair. Performance verified via tensile strength and needle attachment testing. ## Clinical Evidence Bench testing only. Performance evaluated per USP Tensile Strength and Needle Attachment Strength standards for surgical sutures. Sterilization validated per ANSI/AAMI/ISO 11135:2014 (SAL 10^-6). EO residuals tested per AAMI/ANSI/ISO 10993-7:2008. Non-pyrogenicity confirmed via bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011. ## Technological Characteristics Material: Non-absorbable polyethylene (dyed/un-dyed with chromium cobalt aluminum oxide <2.0% per 21 CFR 73.1015). Form: 1.3mm wide flat-braided suture. Sterilization: Ethylene Oxide (EO). Connectivity: None. Software: None. ## Regulatory Identification Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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 - PERMATAPE Suture ([K162247](/device/K162247.md)) ## Reference Devices - Arthrex Fiberloop Suture ([K122374](/device/K122374.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 26, 2022 Medos International SARL % Ashley Aromando (Goncalo) Regulatory Affairs Project Manager DePuy Synthes Mitek Sports Medicine 325 Paramount Drive Raynham, Massachusetts 02767 Re: K220219 Trade/Device Name: PERMALOOP Suture, PERMATAPE Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: January 20, 2022 Received: January 26, 2022 Dear Ashley Aromando (Goncalo): 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K220219 Device Name PERMALOOP™ Suture Indications for Use (Describe) The PERMALOOP Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220219 Device Name PERMATAPE™ Suture Indications for Use (Describe) The PERMATAPE Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### 510(K) SUMMARY ### PERMATAPE™ 1.3mm Suture, PERMALOOP™ Suture Date Prepared: 1/21/22 | Submitter's Name and Address | DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767

On behalf of:

Medos International SARL
Chemin-Blanc 38, Le Locle Neuchatel
CH 2400, Switzerland | | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------| | Contact Person | Ashley Aromando
Project Manager, Regulatory Affairs

DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767

| Telephone: 508-977-3907
Email: aaromand@its.jnj.com | | Name of Medical Device | Proprietary Name: PERMATAPE™ Suture, PERMALOOP™ Suture
Classification Name: 21 CFR 878.5000 Nonabsorbable polyethylene surgical suture
Product Code: GAT
Common Name: Suture | | | Substantial Equivalence | The PERMATAPE™ Suture and PERMALOOP™ Suture are substantially equivalent to: Reference Device: | | | Device Classification | The PERMATAPE™ Suture and PERMALOOP™ Suture are classified as: | | {5}------------------------------------------------ | | Nonabsorbable polyethylene surgical suture, classified as Class II, product code GAT, regulated under 21 CFR 878.5000. | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Panel | General & Plastic Surgery | | Device Description | The PERMATAPE™ Suture is a 1.3mm wide, synthetic, sterile, flat
braided suture composed of dyed and un-dyed (chromium cobalt
aluminum oxide <2.0%, 21 CFR 73.1015), non-absorbable
polyethylene. The PERMATAPE Sutures are provided with and
without stainless steel needles. The PERMALOOP™ Suture is a
suture loop constructed from the proposed PERMATAPE 1.3mm
Suture. The PERMALOOP Sutures are offered with a curved,
stainless steel needle attachment configuration or a straight, stainless
steel needle attachment configuration.
Both the PERMATAPE Suture and PERMALOOP suture are sterile
via Ethylene Oxide (EO) sterilization and are for single use only. The
devices are provided packaged in a pack of twelve (12). | | Technological
Characteristics | The design, principal of operation and intended use of the proposed
sutures are nearly identical to that of the predicate PERMATAPE
Suture (K162247). Furthermore, the material of the proposed sutures is
identical to polyethylene material of the predicate PERMATAPE
Suture.
The looped design feature of the PERMALOOP Suture is a
technological characteristic which is found in other general orthopedic
surgical sutures, such as the reference device, Arthrex Fiberloop Suture
(Κ122374).
Any differences between the proposed device and the predicate are
considered non-significant and do not raise different questions of safety
or effectiveness. | | Indications for
Use | The PERMATAPE Suture is indicated for orthopedic procedural use in
soft-tissue approximation including use with allograft tissue.
The PERMALOOP Suture is indicated for orthopedic procedural use
in soft-tissue approximation including use with allograft tissue. | | Non-clinical
Testing | PERMATAPE Suture and PERMALOOP Suture performance was
tested per USP Tensile Strength and Needle Attachment Strength for
Surgical Sutures and follows FDA's Special Controls Guidance | | | document for Surgical Sutures. Identical to the predicate, it does not conform to USP Diameter and size classification due to its flat braiding. | | | Ethylene Oxide Sterilization was validated according to ANSI/AAMI/ISO 11135: 2014 to a SAL of 1 x 10-6. | | | EO residuals were tested per AAMI/ANSI/ISO 10993-7:2008 | | | The proposed device has been determined to be non-pyrogenic per the requirements set forth in ANSI/AAMI ST-72:2011, United States Pharmacopeia (USP), and European Pharmacopeia (EP) using the bacterial endotoxin testing (BET) method. | | Safety and
Performance | Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. | | | Based on similarities in the intended use, technological characteristics, and performance in comparison to the predicate devices, the proposed PERMATAPE Suture and PERMALOOP Suture have shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act. | {6}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT/K220219](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT/K220219) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com