(90 days)
The PERMALOOP Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue.
The PERMATAPE Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue.
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).
This document describes the FDA's 510(k) clearance for the PERMALOOP Suture and PERMATAPE Suture, which are non-absorbable polyethylene surgical sutures. The information provided focuses on the substantial equivalence to predicate devices rather than a standalone clinical study with detailed acceptance criteria and performance metrics for a specific algorithm or AI.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable as this isn't a submission for an AI-powered diagnostic device but a traditional medical device (surgical suture).
However, I can extract the available information regarding testing and performance for the sutures.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like sutures, the "acceptance criteria" are typically defined by recognized standards and guidelines, and "device performance" is demonstrated through compliance with these standards.
| Acceptance Criteria / Test Standard | Reported Device Performance |
|---|---|
| USP Tensile Strength for Surgical Sutures | Performance demonstrated as suitable for intended use. |
| USP Needle Attachment Strength for Surgical Sutures | Performance demonstrated as suitable for intended use. |
| USP Diameter and Size Classification | Does not conform due to flat braiding (identified as non-significant difference from predicate). |
| Ethylene Oxide Sterilization (ANSI/AAMI/ISO 11135: 2014) | Validated to a SAL of 1 x 10^-6. |
| EO Residuals (AAMI/ANSI/ISO 10993-7:2008) | Tested and compliant. |
| Non-pyrogenicity (ANSI/AAMI ST-72:2011, USP, EP using BET method) | Determined to be non-pyrogenic. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes for each physical and chemical test mentioned (e.g., how many sutures were tested for tensile strength or how many batches for sterilization validation).
- Data Provenance: The studies were non-clinical (laboratory testing) performed by the manufacturer, Medos International SARL / DePuy Synthes Mitek Sports Medicine.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. For physical device testing, "ground truth" is established by adherence to recognized engineering and material science standards, not by expert consensus in the same way as, for example, image interpretation.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically relevant for human-in-the-loop studies or ground truth establishment based on expert disagreement, which is not the case here.
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 not an AI-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance testing described is "standalone" for the device, meaning it evaluates the physical and chemical properties of the suture itself. However, this is not an algorithm, so the term doesn't apply in the common AI/algorithm context.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing of the PERMALOOP and PERMATAPE Suture is established by:
- Performance Standards: Adherence to established standards such as USP (United States Pharmacopeia) for tensile strength and needle attachment strength.
- Sterilization Standards: Compliance with international standards like ANSI/AAMI/ISO 11135 for Ethylene Oxide Sterilization.
- Biocompatibility/Safety Standards: Compliance with standards for EO residuals (AAMI/ANSI/ISO 10993-7) and non-pyrogenicity (ANSI/AAMI ST-72, USP, EP).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. The design, materials, and manufacturing processes are based on established engineering principles and prior validated devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is not an AI/machine learning device.
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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)
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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 Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 On behalf of: Medos International SARLChemin-Blanc 38, Le Locle NeuchatelCH 2400, Switzerland | |
|---|---|---|
| Contact Person | Ashley AromandoProject Manager, Regulatory Affairs DePuy Synthes Mitek Sports Medicine a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 | Telephone: 508-977-3907Email: aaromand@its.jnj.com |
| Name of Medical Device | Proprietary Name: PERMATAPE™ Suture, PERMALOOP™ SutureClassification Name: 21 CFR 878.5000 Nonabsorbable polyethylene surgical sutureProduct Code: GATCommon 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, flatbraided suture composed of dyed and un-dyed (chromium cobaltaluminum oxide <2.0%, 21 CFR 73.1015), non-absorbablepolyethylene. The PERMATAPE Sutures are provided with andwithout stainless steel needles. The PERMALOOP™ Suture is asuture loop constructed from the proposed PERMATAPE 1.3mmSuture. The PERMALOOP Sutures are offered with a curved,stainless steel needle attachment configuration or a straight, stainlesssteel needle attachment configuration.Both the PERMATAPE Suture and PERMALOOP suture are sterilevia Ethylene Oxide (EO) sterilization and are for single use only. Thedevices are provided packaged in a pack of twelve (12). |
| TechnologicalCharacteristics | The design, principal of operation and intended use of the proposedsutures are nearly identical to that of the predicate PERMATAPESuture (K162247). Furthermore, the material of the proposed sutures isidentical to polyethylene material of the predicate PERMATAPESuture.The looped design feature of the PERMALOOP Suture is atechnological characteristic which is found in other general orthopedicsurgical sutures, such as the reference device, Arthrex Fiberloop Suture(Κ122374).Any differences between the proposed device and the predicate areconsidered non-significant and do not raise different questions of safetyor effectiveness. |
| Indications forUse | The PERMATAPE Suture is indicated for orthopedic procedural use insoft-tissue approximation including use with allograft tissue.The PERMALOOP Suture is indicated for orthopedic procedural usein soft-tissue approximation including use with allograft tissue. |
| Non-clinicalTesting | PERMATAPE Suture and PERMALOOP Suture performance wastested per USP Tensile Strength and Needle Attachment Strength forSurgical 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 andPerformance | 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. |
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§ 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.