(139 days)
Shoulder
- Rotator Cuff Repair
- · Bankart Repair
- · SLAP Lesion Repair
- · Biceps Tenodesis
- · Acormio-Clavicular Separation Repair
- · Deltoid Repair
- Capsular Shift or Capsulolabral Reconstruction
Hand and 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
Foot and 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
- Illiotibial band tenodesis reconstruction
- Patellar ligament/tendon repair
The BoneCam Suture Anchor Delivery Systems are for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The BoneCam Suture Anchor Delivery System consists of a single anchor with integrated multiple suture attachment. The anchors are provided loaded on individual inserters with integrated sutures with or without needles, sterile (EtO), for single use only. The BoneCam Suture Anchor Delivery Systems have a shelf life of 2 years. Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK (ASTM F2026).
Here's a breakdown of the acceptance criteria and study information for the Valeris Medical Inc. Bonecam Suture Anchor, based on the provided document:
This document is a 510(k) summary for a medical device (Bonecam Suture Anchor), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel AI performance. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable (N/A) for this type of submission.
Acceptance Criteria and Device Performance (Not applicable for AI performance in this document)
This document does not provide specific acceptance criteria or reported performance for an AI-powered device. Instead, it focuses on demonstrating the substantial equivalence of the Bonecam Suture Anchor to a predicate device, K152255, by comparing their technological characteristics and performing bench testing.
| Acceptance Criteria (N/A for AI) | Reported Device Performance (N/A for AI) |
|---|---|
| N/A | N/A |
Study Information
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified for human subject data. For bench testing: "Axial Pull-Out per ASTM F543-17 testing was conducted..." The exact number of samples tested is not provided in this summary but would be detailed in the full test report.
- Data Provenance: N/A for human subject data. For bench testing, it's laboratory testing for mechanical performance characteristics of the device materials.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: N/A (No clinical study involving expert ground truth determination is described).
- Qualifications of Experts: N/A
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A (No clinical study requiring adjudication is described).
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device (suture anchor) submission, not an AI device. Therefore, no MRMC study or AI assistance improvement effect size is mentioned or applicable.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device, not an AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A (No AI algorithm or clinical endpoint requiring ground truth is described). For the mechanical testing, the "ground truth" would be the measured physical properties according to the ASTM standard.
-
The sample size for the training set:
- N/A (No AI algorithm training set is mentioned).
-
How the ground truth for the training set was established:
- N/A (No AI algorithm training set is mentioned).
Summary of Relevant Information from the Document:
- Device Name: Bonecam Suture Anchor
- Purpose of Submission: Demonstrate substantial equivalence to a predicate device (K152255) for approval to market.
- Key Comparisons for Substantial Equivalence:
- Intended Use/Indications for Use: Identical to predicate device.
- Materials: Similar (both Solvay ZENIVA PEEK), with the subject device offering additional configurations (ZA-600, ZA-600 CF30 PEEK) and an additional UHMWPE suture manufacturer.
- Design Features: Same general design as the predicate, with an additional suture port for more options.
- Sterilization and Shelf-Life: Identical (sterile (EtO), 2-year shelf life).
- Biocompatibility: Established according to ISO 10993-1.
- Performance Data: "Axial Pull-Out per ASTM F543-17 testing was conducted to confirm the material additive did not introduce any new risk." This bench test demonstrates mechanical performance, but specific results or acceptance criteria are not detailed in this summary.
- Conclusion: The subject device is considered substantially equivalent to the predicate device, and safe and effective for its intended use, based on the documented comparisons and performance testing.
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March 26, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Valeris Medical Inc. Brendan Thies Medical Device Engineer 200 Cobb Pkwy N, Building 200, Suite 210 Marietta. Georgia 30062
Re: K193108
Trade/Device Name: Bonecam 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: October 21, 2019 Received: November 8, 2019
Dear Mr. Thies:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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.
for
Jesse Muir, Ph.D. Acting 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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known) K193108
Device Name Bonecam Suture Anchor
Indications for Use (Describe)
Shoulder
- Rotator Cuff Repair
- · Bankart Repair
- · SLAP Lesion Repair
- · Biceps Tenodesis
- · Acormio-Clavicular Separation Repair
- · Deltoid Repair
- Capsular Shift or Capsulolabral Reconstruction
Hand and 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
Foot and 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
- Illiotibial band tenodesis reconstruction
- Patellar ligament/tendon repair
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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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510(k) Summary
(as required by 21 CFR 807.92)
| Date Prepared | March 24, 2020 |
|---|---|
| Manufacturer | Valeris Medical |
| Address | 200 Cobb Pkwy NBuilding 200, Suite 210Marietta, GA 30062 |
| Telephone | 888-404-3980 Ext 105 |
| Fax | 770-575-4052 |
| Contact Person | Brendan ThiesMedical Device Engineer |
| Address | Valeris Medical200 Cobb Pkwy NBuilding 200, Suite 210Marietta, GA 30062 |
| Telephone | 888-404-3980 Ext 105 |
| Fax | 770-575-4052 |
| Brendan@Valerismedical.com |
| Trade Name | Bonecam Suture Anchor | |
|---|---|---|
| Common Name | Screw, Fixation, Bone | |
| Panel Code | Orthopaedics/87 | |
| Classification Name | Fastener, Fixation, Nondegradable, Soft Tissue | |
| Class | Class II | |
| Regulation Number | 21 CFR 888.3040 | |
| Product Code | MBI | |
| Name of Predicate Device | 510(k) # | Manufacturer |
| Bonecam Suture Anchor | K152255 | Valeris Medical |
| Reference Predicate Device | 510(k) # | Manufacturer |
| Riverpoint HS Fiber Suture | K100006K190817 | Riverpoint Medical |
| Description | The BoneCam Suture Anchor Delivery Systems are for use in fixation ofligament, tendon, bone, or soft tissue to bone in knee, shoulder,foot/ankle, elbow, and hand/wrist procedures. The BoneCam SutureAnchor Delivery System consists of a single anchor with integratedmultiple suture attachment. The anchors are provided loaded onindividual inserters with integrated sutures with or without needles, sterile(EtO), for single use only. The BoneCam Suture Anchor DeliverySystems have a shelf life of 2 years.Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600CF30 PEEK (ASTM F2026). |
|---|---|
| Modifications forFDA 510(k) Review | •Add a set of Bonecam anchors made from ZA-600 CF30 (same MAFfile as filed in predicate device)•Add a configuration that allows surgeons to load additional suture intothe device•Add a set of Bonecam anchors made from ZA-600 PEEK•Add an additional Suture manufacture for UHMWPE suture and tapeproducts |
| Indications andIntended Use | Shoulder- Rotator Cuff Repair |
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| • Bankart Repair• SLAP Lesion Repair• Biceps Tenodesis• Acormio-Clavicular Separation Repair• Deltoid Repair• Capsular Shift or Capsulolabral Reconstruction | |
|---|---|
| Hand and 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 | |
| Foot and 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• Illiotibial band tenodesis reconstruction• Patellar ligament/tendon repair | |
| Technological | Documentation was provided to demonstrate that the Subject device. |
| Technological Characteristics and Substantial Equivalence | Documentation was provided to demonstrate that the Subject device, Bonecam Suture Anchor is substantially equivalent to the Predicate Bonecam Suture Anchor (K152255). The Subject device is substantially equivalent to the predicate device in intended use, indications for use, materials, technological characteristics, performance and labeling. |
|---|---|
| Materials: The subject device is very similar to the predicate device in that they are both fabricated from Solvay ZENIVA PEEK; the subject device will offer additional configurations Solvay Zeniva PEEK (ZA-600 and ZA-600 CF). An additional suture manufacturer is being proposed that will provide UHMWPE sutures that are substantially equivalent to those used in the predicate device. | |
| Design Features: The additional configuration of the subject device anchor is the same design as the predicate with an additional suture port to provide additional options for the type of suture used with the anchor. | |
| Sterilization and Shelf-Life: The subject and predicate devices are offered sterile (EtO), and have a shelf-life of 2 years. |
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| Biocompatibility: Biocompatibility was established according to ISO 10993-1.Bacterial endotoxins for the implantable components are determined using LALtesting to meet endotoxin limit specifications.Additional instrument modifications include change of material for the Obturator(stainless steel, Drill Guide (stainless steel), and the Instrument Handle (Radel).There were also design modifications to the Small Joint Inserter Handle toincorporate the suture and needles within the handle. | |
|---|---|
| The subject device is substantially equivalent to the predicate device in thatthey are comprised of similar materials, share the same fundamentaltechnology, are intended for the same indications and utilize similar designs.They are capable of achieving fixation in the same way. | |
| Performance Data | Axial Pull-Out per ASTM F543-17 testing was conducted to confirm thematerial additive did not introduce any new risk. |
| Conclusion | Based on the intended use, indications for use, technologicalcharacteristics, and comparison to the predicate device, the Subjectdevice has been shown to be substantially equivalent to the legallymarketed predicate device and is safe and effective for the intended use. |
§ 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.