(90 days)
No
The device description and performance studies focus on the physical properties and sterilization of a surgical suture, with no mention of AI or ML.
No
The device is a suture, used for approximation of soft tissue, not for treating a disease or condition itself.
No
Explanation: The device is a surgical suture used for soft-tissue approximation, which is a therapeutic function, not a diagnostic one. It does not provide information about a patient's medical condition.
No
The device description clearly states it is a physical suture made of polyethylene, provided with and without stainless steel needles, and is sterilized via Ethylene Oxide. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "orthopedic procedural use in soft-tissue approximation including use with allograft tissue." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a suture, which is a physical material used to close wounds or hold tissues together during surgery. This is a surgical tool, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
PERMALOOP™ Suture: The PERMALOOP Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue.
PERMATAPE™ Suture: The PERMATAPE Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GAT
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
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.(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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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
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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
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Indications for Use
510(k) Number (if known)
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."
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Indications for Use
510(k) Number (if known)
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."
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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: K162247 PERMATAPE Suture Reference Device: K122374 Arthrex Fiberloop Suture | |
| Device Classification | The PERMATAPE™ Suture and PERMALOOP™ Suture are classified as: | |
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| 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 |