(129 days)
No
The device description and performance studies focus on the mechanical properties and fixation strength of a physical suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The document describes a suture anchor used in soft tissue reattachment procedures; it is a surgical implant, not a device providing therapy itself.
No
Explanation: The Ventix Suture Anchors are described as a device used in soft tissue reattachment procedures. Their function is to physically secure tissue, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a physical, two-piece suture anchor made of PEEK, preloaded with suture, and loaded onto a disposable inserter. This is a hardware device, 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 describes a surgical implant used for reattaching soft tissue in various joints. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a physical implant made of PEEK with preloaded suture, designed to be inserted into the body.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Ventix Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, knee, and hip. Specific indications are:
Shoulder: Bankart repair, SLAP lesion repair, acromio- clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, pectoralis major repair.
Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow: Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction, Lateral epicondylitis repair
Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair, medial patellofemoral ligament (MPFL) repair or reconstruction, quadriceps tendon repair.
Hip: Proximal hamstring repair
Product codes
MBI
Device Description
The Ventix Suture Anchor is a two-piece design consisting of the vented body and the threaded tip preloaded with suture. The anchor will be offered in three sizes: 3.5mm, 4.75mm, and 5.5mm and is manufactured from polyetheretherketone (PEEK). The Ventix Suture Anchor will be loaded onto a disposable inserter and will be available with #2 MaxBraid or 1.5mm ForceFiber OrthoTape suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, wrist/hand, ankle/foot, elbow, knee, and hip
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 laboratory testing was performed to verify the pull-out strength o of the Ventix Suture Anchors by mechanical pullout testing as compared to the ALLThread PEEK Suture Anchors for substantial equivalence and the JuggerKnot Soft Anchors for use in expanded indications. The test results indicate that the Ventix Suture Anchors provide statistically equivalent or greater fixation strength to the predicate devices and would be functional within the intended use.
Clinical Tests: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2016
Biomet Manufacturing Corporation Adam Cargill Regulatory Affairs Specialist 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581
Re: K153558
Trade/Device Name: Ventix Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 23, 2016 Received: March 24, 2016
Dear Mr. Cargill:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153558
Device Name Ventix Suture Anchor
Indications for Use (Describe)
The Ventix Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are:
Shoulder: Bankart repair, SLAP lesion repair, acromio- clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, pectoralis major repair.
Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow: Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction, Lateral epicondylitis repair
Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair, medial patellofemoral ligament (MPFL) repair or reconstruction, quadriceps tendon repair.
Hip: Proximal hamstring repair
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Ventix Suture Anchor | Traditional 510(k)
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Ventix Suture Anchor 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034
Phone: (574) 267-6639
Fax: (574) 267-8137 |
|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Adam Cargill
Regulatory Affairs Specialist
Biomet Sports Medicine |
| Date: | December 11, 2015 |
| | Subject Device: Trade |
| | Name: Ventix Suture Anchor |
| | Common Name: Soft Tissue Anchor |
| | Classification Name:
• MBI - Fastener, Fixation, Nondegradable, Soft Tissue
(21 CFR 888.3040) |
Legally marketed devices to which substantial equivalence is claimed:
Device Description
The Ventix Suture Anchor is a two-piece design consisting of the vented body and the threaded tip preloaded with suture. The anchor will be offered in three sizes: 3.5mm, 4.75mm, and 5.5mm and is manufactured from polyetheretherketone (PEEK). The Ventix Suture Anchor will be loaded onto a disposable inserter and will be available with #2 MaxBraid or 1.5mm ForceFiber OrthoTape suture.
Intended Use and Indications for Use
The Ventix Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, knee, and hip. Specific indications are:
4
BIOME
Ventix Suture Anchor | Traditional 510(k)
Shoulder: Bankart repair, SLAP lesion repair, acromio- clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, pectoralis major repair.
Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow: Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction, Lateral epicondylitis repair
Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair, medial patellofemoral ligament (MPFL) repair or reconstruction, quadriceps tendon repair.
Hip: Proximal hamstring repair
Summary of Technological Characteristics
The technological characteristics (materials, design, sizing, and indications) of the Ventix Suture Anchors are similar to the predicate devices or other previously cleared devices with the main difference being the Ventix Suture Anchors have a vented implant when compared to the ALLThread PEEK Suture Anchors.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- . Intended Use: The proposed Ventix Suture Anchors are intended for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, knee, and hip which is the same as the predicate devices.
- . Indications for Use: Indications are identical to the predicate devices.
- . Materials: The proposed Ventix Suture Anchor uses the identical implant material as the predicate device.
- . Design Features: The proposed Ventix Suture Anchor incorporates similar design features as the predicate device.
- . Sterilization: The proposed Ventix Suture Anchor is provided sterile via ethylene oxide (EtO), the same sterilization method utilized for the predicate devices.
Summary of Performance Data (Nonclinical and/or Clinical)
- . Non-Clinical Tests
Non-clinical laboratory testing was performed to verify the pull-out strength o of the Ventix Suture Anchors by mechanical pullout testing as compared to the ALLThread PEEK Suture Anchors for substantial equivalence and the JuggerKnot Soft Anchors for use in expanded indications. The test results indicate that the Ventix Suture Anchors provide statistically equivalent or greater fixation
5
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Ventix Suture Anchor | Traditional 510(k)
strength to the predicate devices and would be functional within the intended use.
- . Clinical Tests
- o None provided as a basis for substantial equivalence.
Substantial Equivalence Conclusion
The proposed Ventix Suture Anchor has similar intended use, technological characteristics, and mechanical performance as the predicate devices. The performance testing data identified no new risks and substantial equivalence to the legally marketed predicate devices.