(61 days)
The MITEK TIGHT-N™ Tendon Docking Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures:
• Shoulder: Biceps tenodesis
• Knee: Medial patellofemoral ligament repair/reconstruction (MPFL), posterior oblique ligament repair (POL), medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, anterolateral ligament (ALL) reconstruction, Iliotibial (IT) Band Tenodesis
The MITEK TIGHT-NTM Tendon Docking Anchor is designed to reattach soft tissue to bone when used in conjunction with suture (provided separately). The anchor is preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable "stay suture". The proposed anchor will be offered in three sizes: 5.5 mm, 7.0 mm, and 8.5 mm and is molded from PEEK (Polyetheretherketone) material. The proposed anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.
The provided text describes a medical device's 510(k) submission to the FDA, focusing on establishing substantial equivalence to a predicate device. It details the device's description, technological characteristics, indications for use, and a summary of non-clinical testing. However, it does not contain information about the acceptance criteria and the results of a study as typically outlined for AI/ML device performance.
Specifically, the document focuses on:
- Device Name: MITEK TIGHT-N™ Tendon Docking Anchor
- Regulatory Classification: Class II, Product Code MBI, regulated under 21 CFR 888.3040 (Fastener, Fixation, Nondegradable, Soft Tissue).
- Predicate Device: K201749 Arthrex Biocomposite 3.9mm SwiveLock Anchor.
- Technological Characteristics: The proposed anchor is a suspensory push-in anchor made of PEEK material, while the predicate is an interference thread-in anchor made of PEEK and PLLA/βTCP. Both secure soft tissue to bone.
- Non-clinical Testing:
- Biocompatibility
- Shelf-life
- Pyrogenicity
- Endotoxin testing
- Performance testing (fixation strength and fatigue strength)
- Ethylene Oxide Sterilization validation per ANSI/AAMI/ISO 11135:2014 to a SAL of 1 x 10^-6.
- EO residuals testing per AAMI/ANSI/ISO 10993-7:2008.
- Non-pyrogenic determination per ANSI/AAMI ST-72:2011, USP, and EP using Bacterial Endotoxin Testing (BET).
- Conclusion: "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." And "Based on similarities in the intended use, technological characteristics, and performance in comparison to the predicate devices, the proposed MITEK TIGHT-NTM Tendon Docking Anchor has shown to be substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act."
Missing Information (relevant to AI/ML device studies):
The document does not provide the following information that would be expected for a detailed description of acceptance criteria and the study proving a digital or AI/ML device's performance:
- A table of acceptance criteria and reported device performance: This would typically list metrics like sensitivity, specificity, accuracy, AUC, F1 score, etc., with pre-defined thresholds for acceptance and the observed performance.
- Sample size used for the test set and data provenance: No test set sample size or details about data origin (e.g., country, retrospective/prospective) are mentioned.
- Number of experts used to establish ground truth and their qualifications: Not applicable, as this is a physical medical device.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for this type of device.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: For this physical device, "performance testing" includes mechanical tests like fixation strength and fatigue strength, and biological tests like biocompatibility and sterilization efficacy. These are not "ground truth" in the AI/ML sense.
- Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes the regulatory clearance for a physical medical device (tendon docking anchor) based on substantial equivalence and non-clinical performance testing. It does not contain the characteristics of an AI/ML device study, and therefore, the specific requested details regarding acceptance criteria and performance studies for such devices are not present.
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July 11, 2022
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Medos International SARL % Ashley Aromando (Goncalo) Regulatory Affairs Project Manager DePuy Synthes Mitek Sports Medicine 325 Paramount Drive Raynham, Massachusetts 02767
Re: K221364
Trade/Device Name: MITEK TIGHT-N™ Tendon Docking Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 5, 2022 Received: May 12, 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 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
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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 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,
Laura C. Rose, Ph.D. 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) K221364
Device Name MITEK TIGHT-N™ Tendon Docking Anchor
Indications for Use (Describe)
The MITEK TIGHT-N™ Tendon Docking Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures:
· Shoulder: Biceps tenodesis
· Knee: Medial patellofemoral ligament repair/reconstruction (MPFL), posterior oblique ligament repair (POL), medial collateral ligament (MCL) repair, lateral ligament (LCL) repair, anterolateral ligament (ALL) reconstruction, Iliotibial (IT) Band Tenodesis
Type of Use (Select one or both, as applicable)
| ☑ Remediation Under PA STR 301-Subject Site | ☐ One-Time Correction (No STR 301-Subject Site) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- |
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
MITEK TIGHT-N™ Tendon Docking Anchor
Date Prepared: 07/08/2022
| 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 | Tatyana KorsunskyTechnical Manager, Regulatory AffairsDePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 | Telephone: 774-284-7014Email: tkorsuns@its.jnj.com |
| Name ofMedical Device | Proprietary Name: MITEK TIGHT-NT™ Tendon Docking Anchor (alsoreferred to as TIGHT-NT™ Anchor)Classification Name:Fastener, Fixation, Nondegradable, Soft TissueProduct Code: MBICommon Name: Suture Anchor | |
| SubstantialEquivalence | The MITEK TIGHT-NT™ Tendon Docking Anchor is substantiallyequivalent to:• K201749 Arthrex Biocomposite 3.9mm SwiveLock Anchor | |
| DeviceClassification | The MITEK TIGHT-NTM Tendon Docking Anchor is classified as:Fastener, Fixation, Nondegradable, Soft Tissue, classified as Class II,product code MBI, regulated under 21 CFR 888.3040. | |
| Device Panel | Orthopedic Devices | |
| DeviceDescription | The MITEK TIGHT-NTM Tendon Docking Anchor is designed toreattach soft tissue to bone when used in conjunction with suture(provided separately). The anchor is preloaded on a disposable insertershaft with handle, held in place by a non-absorbable "stay suture". Theproposed anchor will be offered in three sizes: 5.5 mm, 7.0 mm, and 8.5mm and is molded from PEEK (Polyetheretherketone) material. Theproposed anchor is provided sterile via Ethylene Oxide (EO)sterilization and is for single use only. | |
| TechnologicalCharacteristics | The anchor design, principal of operation and intended use on MITEKTIGHT-NTM Tendon Docking Anchor are similar when compared to thepredicate Arthrex 3.9mm SwiveLock Anchor (K201749). Both devicesare implantable anchors used to secure soft tissue to bone. Suture tailsof a pre-stitched soft tissue graft (suture provided separately) arethreaded through the anchors, thus securing the graft to the anchor.The proposed MITEK TIGHT-NTM Tendon Docking Anchor isdesigned as a suspensory push-in anchor, while the predicateSwiveLock is designed as an interference thread-in anchor. While thereexists differences in the means of insertion style (thread-in vs. push in)and mechanism of tissue retention, the proposed and predicate devicesare ultimately securing soft tissue to bone to achieve the device'stherapeutic benefit.Both predicate and proposed devices are provided with suturesfacilitating placement of the anchor (stay sutures for both the proposedand the predicate device and an additional axillary suture for theproposed MITEK TIGHT-NTM Tendon Docking Anchor).The proposed anchor is constructed from PEEK material, the predicateArthrex SwiveLock is composed of both PEEK and PLLA/βTCPmaterials. The PEEK material, of the proposed anchor implant, isidentical to the PEEK material of existing Mitek implantable anchors –Versalok Anchors (K100532)Any differences between the proposed device and the predicate areconsidered non-significant and do not raise different questions of safetyor effectiveness, supported by testing. | |
| Indications forUse | The MITEK TIGHT-NTM Tendon Docking Anchor is indicated for usefor reattachment of soft tissue to bone for the following procedures:Shoulder: Biceps tenodesis Knee: Medial patellofemoral ligament repair/reconstruction(MPFL), posterior oblique ligament repair (POL), medial collateralligament (MCL) repair, lateral collateral ligament (LCL) repair,anterolateral ligament (ALL) reconstruction, Iliotibial (IT) BandTenodesis | |
| Non-clinicalTesting | Verification activities were performed on the proposed device and / orits predicates. Biocompatibility, shelf-life, pyrogenicity, endotoxin andperformance testing conducted on representative products was presentedto support determination of equivalence. Performance testing includedassessment of fixation strength and fatigue strength. | |
| 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 the intended use, technological characteristics,and performance in comparison to the predicate devices, the proposedMITEK TIGHT-NTM Tendon Docking Anchor has shown to besubstantially equivalent to the predicate device under the Federal Food,Drug and Cosmetic Act. |
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.