(61 days)
No
The summary describes a mechanical anchor device made of PEEK material for soft tissue reattachment. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical properties and sterilization.
Yes
The device is indicated for reattachment of soft tissue to bone for specific procedures in the shoulder and knee, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a Tendon Docking Anchor used for reattaching soft tissue to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical anchor made of PEEK material, preloaded on a disposable inserter shaft with a handle, and provided sterile. This indicates a hardware medical device, not a software-only one.
Based on the provided information, the MITEK TIGHT-N™ Tendon Docking Anchor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "reattachment of soft tissue to bone" in surgical procedures. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical anchor made of PEEK material, designed to be implanted to secure soft tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is designed to be implanted within the body for a surgical repair.
N/A
Intended Use / Indications for Use
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
Product codes
MBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification activities were performed on the proposed device and / or its predicates. Biocompatibility, shelf-life, pyrogenicity, endotoxin and performance testing conducted on representative products was presented to support determination of equivalence. Performance testing included assessment of fixation strength and fatigue strength.
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.
Results of performance testing have demonstrated that the proposed devices are suitable for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K201749 Arthrex Biocomposite 3.9mm SwiveLock Anchor
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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July 11, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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'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 | Tatyana Korsunsky
Technical Manager, Regulatory Affairs
DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 | Telephone: 774-284-7014
Email: tkorsuns@its.jnj.com |
| Name of
Medical Device | Proprietary Name: MITEK TIGHT-NT™ Tendon Docking Anchor (also
referred to as TIGHT-NT™ Anchor)
Classification Name:
Fastener, Fixation, Nondegradable, Soft Tissue
Product Code: MBI
Common Name: Suture Anchor | |
| Substantial
Equivalence | The MITEK TIGHT-NT™ Tendon Docking Anchor is substantially
equivalent to:
• K201749 Arthrex Biocomposite 3.9mm SwiveLock Anchor | |
| Device
Classification | 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 | |
| Device
Description | 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. | |
| Technological
Characteristics | The anchor design, principal of operation and intended use on MITEK
TIGHT-NTM Tendon Docking Anchor are similar when compared to the
predicate Arthrex 3.9mm SwiveLock Anchor (K201749). Both devices
are implantable anchors used to secure soft tissue to bone. Suture tails
of a pre-stitched soft tissue graft (suture provided separately) are
threaded through the anchors, thus securing the graft to the anchor.
The proposed MITEK TIGHT-NTM Tendon Docking Anchor is
designed as a suspensory push-in anchor, while the predicate
SwiveLock is designed as an interference thread-in anchor. While there
exists differences in the means of insertion style (thread-in vs. push in)
and mechanism of tissue retention, the proposed and predicate devices
are ultimately securing soft tissue to bone to achieve the device's
therapeutic benefit.
Both predicate and proposed devices are provided with sutures
facilitating placement of the anchor (stay sutures for both the proposed
and the predicate device and an additional axillary suture for the
proposed MITEK TIGHT-NTM Tendon Docking Anchor).
The proposed anchor is constructed from PEEK material, the predicate
Arthrex SwiveLock is composed of both PEEK and PLLA/βTCP
materials. The PEEK material, of the proposed anchor implant, is
identical to the PEEK material of existing Mitek implantable anchors –
Versalok Anchors (K100532)
Any differences between the proposed device and the predicate are
considered non-significant and do not raise different questions of safety
or effectiveness, supported by testing. | |
| Indications for
Use | The MITEK TIGHT-NTM 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 | |
| Non-clinical
Testing | Verification activities were performed on the proposed device and / or
its predicates. Biocompatibility, shelf-life, pyrogenicity, endotoxin and
performance testing conducted on representative products was presented
to support determination of equivalence. Performance testing included
assessment of fixation strength and fatigue strength. | |
| | 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
MITEK TIGHT-NTM Tendon Docking Anchor has shown to be
substantially equivalent to the predicate device under the Federal Food,
Drug and Cosmetic Act. | |
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