(159 days)
The osteo-WEDGE II ® Open Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
The osteo-WEDGE II® Open Wedge Bone Locking Plate System consists of plates and screws and incorporates a screw-to-plate locking mechanism. The plate is attached to a prepared surface of the involved bone(s) of the foot using six (6) screws for fixation. The fully threaded screws are available in 2 diameters, with numerous lengths and previously cleared under K111326.
The provided text describes the 510(k) premarket notification for the "OsteoWedge II Open Wedge Bone Locking Plate System." This document primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance testing. It does not describe an AI/ML-based medical device. Therefore, many of the requested categories related to AI/ML device evaluation (like sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this submission.
Here's a summary of the information that is available in the provided text, structured to address the relevant points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Demonstrate substantial equivalence to predicate devices | Non-clinical testing was performed to demonstrate the change of the plate geometry is substantially equivalent to other predicate devices. OsteoWedge II Open Wedge Bone Locking Plate System is shown to be substantially equivalent to legally marketed predicate devices. |
| Static and dynamic four-point bending testing per ASTM F382-99(2008) | Testing was performed as specified. (Specific quantitative results or pass/fail thresholds against acceptance criteria are not provided in this summary document, but the conclusion is that it demonstrated substantial equivalence). |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission details non-clinical, mechanical testing of a medical implant, not an AI/ML device that uses patient data as a test set. The testing involved mechanical components (plates and screws).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of expert review, is not relevant for the mechanical performance testing described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication is not relevant for the mechanical performance testing described.
5. 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 not an AI/ML device; therefore, no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The "ground truth" for this device's performance would be the physical properties and mechanical behavior of the materials and design, evaluated against engineering standards (like ASTM F382-99(2008)), rather than clinical outcomes or expert labels.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device; there is no "training set."
Study that proves the device meets the acceptance criteria:
The study that proves the device meets the acceptance criteria is termed "Non-Clinical Performance Testing" in the document.
- Description: "Non-clinical testing was performed to demonstrate the change of the plate geometry is substantially equivalent to other predicate devices."
- Specific Tests Performed: "Static and dynamic four-point bending testing per ASTM F382-99(2008)."
- Conclusion: Based on this testing, the "OsteoWedge II Open Wedge Bone Locking Plate System is shown to be substantially equivalent to legally marketed predicate devices."
The provided text is a 510(k) clearance letter and an associated summary for a Class II metallic bone fixation appliance. It explicitly details that the submission is based on demonstrating "substantial equivalence" through non-clinical, mechanical performance testing to legally marketed predicate devices, not through clinical trials or AI/ML algorithm evaluation.
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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 a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Graham Medical Technologies, L.L.C. dba GraMedica January 10, 2017 % Linda Braddon President/CEO Secure Biomed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K162179 Trade/Device Name: Osteowedge II Open Wedge Bone Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS Dated: December 2, 2016 Received: December 5, 2016
Dear Ms. Braddon:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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" (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.
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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K162179
Device Name
OsteoWedge™ II Open Wedge Bone Locking Plate System
Indications for Use (Describe)
The osteo-WEDGE II ® Open Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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In accordance with 21 CFR 807.87 (h) and 21 CFR 807.92, the 510(k) summary for the GraMedica osteo-WEDGE® Opening Wedge Bone Locking Plate System is provided below.
| Date Summary Prepared | August 3, 2016 |
|---|---|
| Sponsor | GraMedica |
| 16137 Leone Drive | |
| Macomb, MI 48042 | |
| 586-677-9600 (office) | |
| 586-677-9615 (fax) | |
| ARecchia@GraMedica.com (email) | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 (direct) | |
| 855-MED-DEV1 (office) | |
| LGB@SecureBME.com | |
| Trade Name | osteo-WEDGE II® Open Wedge Bone Locking Plate System |
| Common Name | Plate, Fixation, Bone |
| Code -Classification | HRS 21 CFR 888.3030 : Class II |
| Predicate Devices | K111326 Graham Medical Technologies LLC (dba GraMedica) osteo-WEDGE® Opening |
| Wedge Bone Locking Plate System | |
| Additional PredicateDevices | K061808 DARCO Locking Bone Plate System |
| Device Description | The osteo-WEDGE II® Open Wedge Bone Locking Plate System consists of plates |
| and screws and incorporates a screw-to-plate locking mechanism. The plate is | |
| attached to a prepared surface of the involved bone(s) of the foot using six (6) | |
| screws for fixation. The fully threaded screws are available in 2 diameters, with | |
| numerous lengths and previously cleared under K111326. | |
| Intended Use | The osteo-WEDGE II® Open Wedge Bone Locking Plate System is used for adult and |
| transitional adolescent (18 to 21 years old) patients for the purpose of stabilization | |
| and/or correction of angular deviations within an individual bone or in between | |
| two adjacent bones in the foot, such as opening wedge osteotomy for first | |
| metatarsal cuneiform joint deviations. | |
| Technological | The osteo-WEDGE II® Open Wedge Bone Locking Plate System is of similar sizes, |
| Characteristics | material choices and configurations as compared to the predicate. |
| Non-ClinicalPerformance TestingConclusion | Non-clinical testing was performed to demonstrate the change of the plate |
| geometry is substantially equivalent to other predicate devices. The following | |
| tests were performed: | |
| ● Static and dynamic four-point bending testing per ASTM F382-99(2008) | |
| Substantial EquivalenceSummary (Conclusion) | Based on the indications for use, technological characteristics, and comparison to |
| predicate devices, the osteo-WEDGE II® Open Wedge Bone Locking Plate System is | |
| shown to be substantially equivalent to legally marketed predicate devices. |
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.