(56 days)
The HEALIX ADVANCE Anchor is indicated for use in soft-tissue-to-bone fixation in association with postoperative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
The proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a line extension to the currently marketed HEALIX ADVANCE™ Anchor family. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is available in absorbable BR and non-absorbable PEEK materials. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is provided sterile and is for single use only.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study of acceptance criteria and performance for a novel AI/software device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not present in the provided text. The document describes a traditional medical device (suture anchor) and its non-clinical testing for safety and effectiveness, not a computational device with performance metrics typically found in AI/software submissions.
Specifically, the document states:
- Non-clinical Testing: "Device safety and effectiveness is supported by non-clinical testing performed on the proposed device and / or its predicate. Performance testing included straight and knot tensile strength, suture approximation force, anchor fixation post cyclic loading and sterility."
- Safety and Performance: "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. Based on similarities in the indications for use, technological characteristics, and performance in comparison to the predicate devices, the proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act."
This indicates that the "acceptance criteria" were essentially demonstrating equivalence to existing predicate devices through mechanical performance testing relevant to a physical suture anchor, as opposed to accuracy, sensitivity, or specificity metrics for an AI system.
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June 4, 2020
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Medos International SARL % Elizabeth Messana Regulatory Affairs Specialist II DePuy Synthes Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K200949
Trade/Device Name: HEALIX ADVANCETM Anchor with DYNATAPE™ Suture Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: April 8, 2020 Received: April 9, 2020
Dear Ms. Messana:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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
Jesse Muir, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic 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) K200949
Device Name
HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures
Indications for Use (Describe)
The HEALIX ADVANCE Anchor is indicated for use in soft-tissue-to-bone fixation in association with postoperative immobilization as follows:
| Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular |
|---|
| Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction |
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
| 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
HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures Date Prepared: April 3, 2020
| Submitter'sName andAddress | DePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767On behalf of:Medos International SARLChemin-Blanc 38, Le Locle NeuchatelCH 2400, Switzerland |
|---|---|
| Contact Person | Elizabeth MessanaRegulatory Affairs Specialist IITelephone: 508-828-3150Email: emessan1@its.jnj.comDePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 |
| Name of MedicalDevice | Proprietary Name: HEALIX ADVANCETM Anchor withDYNATAPETM SuturesA) HEALIX ADVANCE™ BR Anchor with DYNATAPE™ SutureB) HEALIX ADVANCE™ PEEK Anchor with DYNATAPE™SutureClassification Name:A) Single/multiple component metallic bone fixation appliances andaccessoriesB) Smooth or threaded metallic bone fixation fastenersProduct Code:A) MAIB) MBICommon Name: Suture Anchor |
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| SubstantialEquivalence | The HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures issubstantially equivalent to:K173859, K183506 - HEALIX ADVANCE™ Anchor with DYNACORD™ Suture Reference Devices: K170639 - HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture K191483 - HEALIX ADVANCE™ Anchor with DYNA+TAPE™ Sutures K021434, K041553- FiberWire® (Arthrex) | ||
|---|---|---|---|
| DeviceClassification | The HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is classified as: | ||
| A) HEALIX ADVANCE BR Anchor with DYNATAPE Suture is classified as: Single/multiple component metallic bone fixation appliances and accessories, classified as Class II, product code MAI, regulated under 21 CFR 888.3030. | |||
| B) HEALIX ADVANCE PEEK Anchor with DYNATAPE Suture is classified as: Smooth or threaded metallic bone fixation fasteners, classified as Class II, product code MBI, regulated under 21 CFR 888.3040. | |||
| Device Panel | Orthopedic Devices | ||
| DeviceDescription | The proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a line extension to the currently marketed HEALIX ADVANCE™ Anchor family. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is available in absorbable BR and non- absorbable PEEK materials. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is provided sterile and is for single use only. | ||
| TechnologicalCharacteristics | The HEALIX ADVANCETM Anchor with DYNATAPETM Sutures isintended for soft-tissue-to-bone fixation in association withpostoperative mobilization. | ||
| When DYNATAPET™ Suture is placed in an aqueous environment, thesalt particles within the silicone core elute out, leaving behind a micro-porous structure within the silicone core. These small voids areconsequently filled with surrounding fluid as the core hydrates,resulting in a radial expansion of the suture. If laxity is present, thisradial expansion of the braid causes an axial shortening of the totalsuture length. The DYNATAPETM Suture is designed to resist laxityand minimize gap formation by maintaining approximation(compression) force. | |||
| Indications forUse | The HEALIX ADVANCE Anchor is indicated for use in soft-tissue-to-bone fixation in association with postoperative immobilization asfollows: | ||
| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP LesionRepair, Biceps Tenodesis, AcromioclavicularSeparation Repair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction | ||
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, AchillesTendon Repair | ||
| Knee: | Medial Collateral Ligament Repair, Lateral CollateralLigament Repair, Posterior Oblique Ligament Repair,Iliotibial Band Tenodesis | ||
| Elbow: | Biceps Tendon Reattachment, Ulnar CollateralLigament Reconstruction, Radial Collateral LigamentReconstruction | ||
| Comparison toPredicateDevices | The proposed HEALIX ADVANCE™ Anchors with DYNATAPE™Sutures is a line extension to the HEALIX ADVANCE™ Anchorfamily, inclusive of the HEALIX ADVANCE™ Anchors withDYNACORD™ Suture (K173859, K183506). The anchors, suturematerials, intended use, packaging and sterilization are identical to thecurrently marketed HEALIX ADVANCE™ Anchors withDYNACORD™ Suture (K173859, K183506). |
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| The inner and outer sheath of the DYNATAPE™ Suture has beenredesigned with thicker fibers and a unique braiding pattern to createthe flattened structure specific to DYNATAPE ™ Suture. The proposedHEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures will bepreloaded with one strand of 2.5 mm DYNATAPE ™ Suture and onestrand of #2 DYNACORD ™ Suture. | |
|---|---|
| Non-clinicalTesting | Device safety and effectiveness is supported by non-clinical testingperformed on the proposed device and / or its predicate. Performancetesting included straight and knot tensile strength, suture approximationforce, anchor fixation post cyclic loading and sterility. In-vitro anchorfixation, torque testing, chemical characterization, biocompatibility, in-vivo testing, packaging and shelf-life of the predicate device wereincluded by reference (K173859, K183506). |
| Ethylene Oxide Sterilization was validated according toANSI/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 therequirements set forth in ANSI/AAMI ST-72:2011, United StatesPharmacopeia (USP), and European Pharmacopeia (EP) using thebacterial endotoxin testing (BET) method. | |
| Safety andPerformance | Results of performance testing have demonstrated that the proposeddevices are suitable for their intended use. Based on similarities in theindications for use, technological characteristics, and performance incomparison to the predicate devices, the proposed HEALIXADVANCE™ Anchor with DYNATAPE™ Sutures has shown to besubstantially equivalent to the predicate devices under the Federal Food,Drug and Cosmetic Act. |
N/A