(98 days)
Not Found
No
The document describes a mechanical suture anchor system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as suture anchors intended for fixation of soft tissue or ligaments to bone, which are orthopedic implants rather than devices that provide therapeutic treatment.
No
The device, Valeris BoneCam Suture Anchors, is an implantable medical device used for fixing soft tissue to bone. Its intended use and description clearly state its function in surgical repair procedures, not in diagnosing conditions or diseases.
No
The device description clearly indicates it is a physical medical device (suture anchors and delivery systems made of titanium or PEEK) and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided text clearly describes a device used for surgical implantation to fix soft tissue to bone within the body. It's a physical anchor used during surgical procedures.
The device's function and application are entirely different from the purpose of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Valeris BoneCam Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acormio-Clavicular Separation Repair Deltoid Repair Capisular Shift or Capsulolabral Reconstruction
Foot/Ankle Lateral stabilization Medial stabilization Achilles tendon repair Metatarsal ligament repair Hallux Valgus reconstruction Digital tendon transfers Mid-foot reconstruction
Knee Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Posterior Oblique Ligament Repair Iliotibial Band Tenodesis Reconstruction Patellar Ligament/Tendon Repair
Hand/Wrist Scapholunate Ligament Reconstruction Carpal Ligament Reconstruction Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers
Elbow Biceps Tendon Reattachment Ulnar or Radial Collateral Ligament Reconstruction
Hip Capsular Repair Acetabular Labral Repair
Product codes
MBI
Device Description
The BoneCam Suture Anchor Delivery Systems are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, hip, and hand/wrist procedures. These anchors consist of anchors with integrated suture attachment. The Anchors are provided loaded on individual inserters with integrated UHMWPE sutures. Sterile, for single use only. Anchor implants are made from either a titanium alloy (6AI4V ELI) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers. Anchors range in size from 2.9mm to 3.3mm in diameter and 6mm to 10mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Axial Pull-Out per ASTM F543-13 testing confirmed that the Subject device performed as intended with #2, 2-0, 3-0, and 4-0 sutures in G20 PU foam and in G40 PU foam for #2 sutures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2015
Valeris Medical % Ms. Chervl Wagoner Principal Consultant Wagoner Consulting LLC P.O. Box 15729 Wilmington, North Carolina 28408
Re: K152255
Trade/Device Name: BoneCam Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: August 18, 2015 Received: August 19, 2015
Dear Ms. Wagoner:
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,
Mark N. Melkerson -S
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
510(k) Number (if known) K152255
Device Name BoneCam Suture Anchor
Indications for Use (Describe)
Valeris BoneCam Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acormio-Clavicular Separation Repair Deltoid Repair Capisular Shift or Capsulolabral Reconstruction
Foot/Ankle Lateral stabilization Medial stabilization Achilles tendon repair Metatarsal ligament repair Hallux Valgus reconstruction Digital tendon transfers Mid-foot reconstruction
Knee Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Posterior Oblique Ligament Repair Iliotibial Band Tenodesis Reconstruction Patellar Ligament/Tendon Repair
Hand/Wrist Scapholunate Ligament Reconstruction Carpal Ligament Reconstruction Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers
Elbow Biceps Tendon Reattachment Ulnar or Radial Collateral Ligament Reconstruction
Hip Capsular Repair Acetabular Labral Repair
3
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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4
510(k) Summary (as required by 21 CFR 807.92)
| (as required by 21 CFR 807.92) | |
|---|---|
| Date Prepared | 11/12/2015 |
| Manufacturer | Valeris Medical |
| Address | 200 Cobb Pkwy N |
| Building 200, Suite 210 | |
| Marietta, GA 30062 | |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| Contact Person | Daniel Lanois |
| President | |
| Address | Valeris Medical |
| 200 Cobb Pkwy N | |
| Building 200, Suite 210 | |
| Marietta, GA 30062 | |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| daniel@valerismedical.com |
| Trade Name | BoneCam Suture Anchor |
|---|---|
| Common Name | Suture Anchor |
| Panel Code | Orthopaedics/87 |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| Class | Class II |
| Regulation Number | 21 CFR 888.3040 |
| Product Code | MBI |
| Name of Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Arthrex SutureTak® Suture | ||
| Anchors | K140855 | Arthrex Inc. |
| Valeris Apollo Suture Anchor | ||
| System and Titan Screws | K142230 | Valeris |
| Description | The BoneCam Suture Anchor Delivery Systems are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, hip, and hand/wrist procedures. These anchors consist of anchors with integrated suture attachment. The Anchors are provided loaded on individual inserters with integrated UHMWPE sutures. Sterile, for single use only.
Anchor implants are made from either a titanium alloy (6AI4V ELI) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers. Anchors range in size from 2.9mm to 3.3mm in diameter and 6mm to 10mm in length. |
| ------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Indications and
Intended Use | Valeris BoneCam Suture Anchors are intended to be used for suture
(soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow,
shoulder, and hip. |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Shoulder |
| | Rotator Cuff Repair |
| | Bankart Repair |
| | SLAP Lesion Repair |
| | Biceps Tenodesis |
5
| Acormio-Clavicular Separation Repair | |
|---|---|
| Deltoid Repair | |
| Capisular Shift or Capsulolabral Reconstruction | |
| Foot/Ankle | |
| Lateral stabilization | |
| Medial stabilization | |
| Achilles tendon repair | |
| Metatarsal ligament repair | |
| Hallux Valgus reconstruction | |
| Digital tendon transfers | |
| Mid-foot reconstruction | |
| Knee | |
| Medial Collateral Ligament Repair | |
| Lateral Collateral Ligament Repair | |
| Posterior Oblique Ligament Repair | |
| Iliotibial Band Tenodesis Reconstruction | |
| Patellar Ligament/Tendon Repair | |
| Hand/Wrist | |
| Scapholunate Ligament Reconstruction | |
| Carpal Ligament Reconstruction | |
| Repair/Reconstruction of collateral ligaments, | |
| Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints | |
| for all digits, | |
| Digital tendon transfers | |
| Elbow | |
| Biceps Tendon Reattachment | |
| Ulnar or Radial Collateral Ligament Reconstruction | |
| Hip | |
| Capsular Repair | |
| Acetabular Labral Repair | |
| Technological | |
| Characteristics and | Documentation was provided to demonstrate that the Subject device, |
| Technological
Characteristics and
Substantial
Equivalence | Documentation was provided to demonstrate that the Subject device, Valeris
BoneCam Suture Anchor is substantially equivalent to the Predicate Arthrex
Suture Tak® Suture Anchors (K140855). The Subject device is substantially
equivalent to the predicate device in intended use, indications for use, materials,
technological characteristics, and labeling. |
| -------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| Performance Data | Axial Pull-Out per ASTM F543-13 testing confirmed that the Subject
device performed as intended with #2, 2-0, 3-0, and 4-0 sutures in G20
PU foam and in G40 PU foam for #2 sutures. |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based on the intended use, indications for use, technological characteristics,
materials, and comparison to predicate devices, the Subject Valeris BoneCa
Suture Anchor (Subject device) has been shown to be substantially equivalent to
legally marketed predicate devices |