(49 days)
Not Found
No
The device description and summary of performance studies focus on the mechanical properties and materials of a surgical anchor, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an anchor used for reattaching soft tissue to bone, which functions as an implantable medical device for mechanical support rather than delivering therapy.
No
Explanation: The device, Ventix™ Link Knotless Anchors, is an implantable surgical anchor used for reattaching soft tissue to bone. Its intended use is for surgical repair and reconstruction, not for identifying or diagnosing diseases or conditions.
No
The device description clearly states it is a "sterile, manually operated, single procedure anchor device" made of PEEK and stainless steel, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reattachment of soft tissue to bone" in various anatomical locations (Shoulder, Knee, Foot and Ankle). This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a "sterile, manually operated, single procedure anchor device" made of PEEK, preloaded on an inserter. This is a physical implant and delivery system used during surgery.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a surgical implant.
Therefore, the Ventix™ Link Knotless Anchors are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cayenne Medical, Inc. Ventix™ Link Knotless Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:
Shoulder
- Acromioclavicular separation repairs ●
- Deltoid repairs
- Rotator cuff repairs
- Biceps tenodesis
Knee
- Extra-capsular repairs ●
- o Medial collateral ligament
- o Lateral collateral ligament
- Posterior oblique ligament O
- Patellar realignment and tendon repairs
- Illiotibial band tenodesis ●
- Supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation.
Foot and Ankle
- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Ventix™ Link Knotless Anchor is a sterile, manually operated, single procedure anchor device for reattachment of soft tissue to bone. The anchor is preloaded on a disposable inserter. The Ventix™ Link Knotless Anchor incorporates design features that facilitate anchor placement under arthroscopic, open or limited access conditions in soft tissue to bone reattachment procedures. The Ventix™ Link Knotless Anchor is offered in two sizes, 4.75mm and 5.5mm, and can receive up to six suture ends. The anchor is made out of PolyEtherEtherKetone (PEEK). Zimmer Biomet TRU-LINK™, MaxBraid™ and/or MaxBraid™ BroadBand™ Tape, or Force Fiber® USP #1 or #2 sutures are to be only used with the Ventix™ Link Knotless Anchors.
The disposable inserter has a working shaft length (from handle to distal tip of anchor) of 6.1 in (155 mm) with an outer shaft diameter of 0.1875 in (4.76 mm). The inserter shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic. The inserter facilitates the placement of the implant into a hole prepared in the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Knee, Foot and Ankle
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)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. The results of mechanical testing (pull-out strength), and assessment of biocompatibility, pyrogenicity, shelf-life and MRI safety demonstrated that the functionality and safety of the Ventix™ Link Knotless Anchor are adequate for its intended use and determination of substantial equivalence to the predicate device.
Clinical testing was not used to establish substantial equivalence to predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2018
Cayenne Medical, Inc. Shima Hashemian QA/RA Associate Director 16597 N. 92nd Street, Suite 101 Scottsdale, Arizona 85260
Re: K180274
Trade/Device Name: Ventix™ Link Knotless Anchor with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: January 30, 2018 Received: January 31, 2018
Dear Ms. Hashemian:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Ms. Shima Hashemian
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Device Name: VentixTM Link Knotless Anchor with Inserter
Indications for Use:
The Cayenne Medical, Inc. Ventix™ Link Knotless Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:
Shoulder
- Acromioclavicular separation repairs ●
- Deltoid repairs
- Rotator cuff repairs
- Biceps tenodesis
Knee
- Extra-capsular repairs ●
- o Medial collateral ligament
- o Lateral collateral ligament
- Posterior oblique ligament O
- Patellar realignment and tendon repairs
- Illiotibial band tenodesis ●
- Supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation.
Foot and Ankle
- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary
Cayenne Medical, Inc.
Ventix™ Link Knotless Anchor with Inserter
Administrative Information
| Date of summary: | 03/19/2018 |
|---|---|
| Manufacturer Name: | Cayenne Medical, Inc. |
| 16597 N. 92nd St., Suite 101 | |
| Scottsdale, AZ 85260 | |
| Telephone (480) 458-2196 | |
| FAX (480) 502-3670 | |
| Official Contact: | Shima Hashemian |
| 16597 N. 92nd St., Suite 101 | |
| Scottsdale, AZ 85260 | |
| Shima.Hashemian@zimmerbiomet.com | |
| Telephone (480) 458-2196 | |
| FAX (480) 502-3670 |
Device Name
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
|---|---|
| Trade/Proprietary Name: | Ventix™ Link Knotless Anchor with Inserter |
| Common Name: | Suture Anchor |
Device Classification
FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for Fastener, Fixation, Nondegradable, and Soft Tissue is MBI.
Primary Predicate: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897)
4
Device Description
The Ventix™ Link Knotless Anchor is a sterile, manually operated, single procedure anchor device for reattachment of soft tissue to bone. The anchor is preloaded on a disposable inserter. The Ventix™ Link Knotless Anchor incorporates design features that facilitate anchor placement under arthroscopic, open or limited access conditions in soft tissue to bone reattachment procedures. The Ventix™ Link Knotless Anchor is offered in two sizes, 4.75mm and 5.5mm, and can receive up to six suture ends. The anchor is made out of PolyEtherEtherKetone (PEEK). Zimmer Biomet TRU-LINK™, MaxBraid™ and/or MaxBraid™ BroadBand™ Tape, or Force Fiber® USP #1 or #2 sutures are to be only used with the Ventix™ Link Knotless Anchors.
The disposable inserter has a working shaft length (from handle to distal tip of anchor) of 6.1 in (155 mm) with an outer shaft diameter of 0.1875 in (4.76 mm). The inserter shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic. The inserter facilitates the placement of the implant into a hole prepared in the bone.
Indications for Use
The Cayenne Medical, Inc. Ventix™ Link Knotless Anchor is intended to be used for fixation of soft tissue to bone for the following indications:
5
Shoulder
- Acromioclavicular separation repairs
- Deltoid repairs
- Rotator cuff repairs
- Biceps tenodesis
Knee
- Extra-capsular repairs ●
- Medial collateral ligament O
- Lateral collateral ligament O
- o Posterior oblique ligament
- Patellar realignment and tendon repairs
- Illiotibial band tenodesis
- Supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation.
Foot and Ankle
- Medial or lateral instability repairs/reconstructions ●
- Achilles tendon repairs/reconstructions ●
Technological Differences
The Ventix™ Link Knotless Anchor is similar in its indication for use, intended use, design features, technology, and materials to the predicate device.
The subject Ventix™ Link device has the same intended use and similar indication for use as the predicate device, the Smith & Nephew FOOTPRINT Ultra PK Suture Anchor.
The subject device differs from the predicate device, Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, in terms of design features and the offered sizes.
Non-clinical Testing
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. The results of mechanical testing (pull-out strength), and assessment of biocompatibility, pyrogenicity, shelf-life and MRI safety demonstrated that the functionality and safety of the Ventix™ Link Knotless Anchor are adequate for its intended use and determination of substantial equivalence to the predicate device.
6
Clinical Testing
Clinical testing was not used to establish substantial equivalence to predicate device.
Equivalence to Marketed Product
Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Ventix™ Link Knotless Anchor is substantially equivalent in indication and performance to the legally marketed predicate device, Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897). The substantial equivalence of Ventix™ Link Knotless Anchor is based on similarities in indications for use, intended use, design features, technology, and materials to the predicate device.