(29 days)
The Omni Foot and Ankle Plating System is intended for use in internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.
The Omni Foot and Ankle Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws and 4.0mm solid screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.
The provided text is for a 510(k) premarket notification for a medical device called the "Omni Foot and Ankle Plating System." This document does not describe the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered device. Instead, it details the regulatory process for establishing substantial equivalence to previously cleared devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set specifics for an AI/ML powered device from the provided text.
The document explicitly states: "No clinical testing was performed." and relies on "engineering analysis" for comparison to predicate devices, which is typical for non-AI/ML mechanical devices.
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August 20, 2021
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Extremity Medical, LLC. Brian Smekal Sr. VP, QA/RA and Compliance 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K212297
Trade/Device Name: Omni Foot and Ankle Plating 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, HWC Dated: July 21, 2021 Received: July 22, 2021
Dear Brian Smekal:
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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: Shumaya Ali, MPH 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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Indications for Use
510(k) Number (if known) K212297
Device Name
Omni Foot and Ankle Plating System
Indications for Use (Describe)
The Omni Foot and Ankle Plating System is internal fixation of arthrodesis, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.
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)
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510(k) Summary of Safety and Effectiveness:
| Submitter | Extremity Medical, LLC300 Interpace Parkway, Suite 410Parsippany, NJ 07054 |
|---|---|
| Contact Person | Brian Smekal, MS, RACSr. VP, Quality Assurance, Regulatory Affairs and CompliancePhone: (973) 588-8988Email: bsmekal@extremitymedical.com |
| Date Prepared | July 21, 2021 |
| Trade Name | Omni Foot and Ankle Plating System |
| ClassificationName andNumber | 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances andaccessories (Primary)21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Product Code | HRS (plate, fixation, bone) (Primary)HWC (screw, fixation, bone) |
| PrimaryPredicate | K180808 – Omni Foot Plating System |
| AdditionalPredicates | K170780 - ARIX Foot System (2.3/2.8)K163044 - ORTHOLOC® 3Di Ankle Fracture Plating SystemK181067 – AlignX Ankle Fusion System |
| DeviceDescription | The Omni Foot and Ankle Plating System is a bone fixation system consisting of unalloyedTitanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws,which meet ASTM F67 and ASTM F136, and a set of instruments used for implant sitepreparation and delivery. The plates are available in various configurations, essentiallydiffering by the lengths and number of holes. The plate screws are provided in diameters of2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulatedscrews and 4.0mm solid screws in various lengths to be used as adjunctive fixation. The3.5mm cannulated screw can also be used with a specialized locking screw ("Post") whichcontains a locking feature at the distal end for compression/stabilization. |
| Indications foruse | The Omni Foot and Ankle Plating System is intended for use in internal fixation ofarthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankleincluding the fore-, mid-, and hind foot and ankle applications. |
| Statement ofTechnologicalComparison | The Omni Foot and Ankle Plating System and predicate devices are equivalent in terms ofdesign, material, mechanical properties and indications for use.The subject and predicate are based on the following same technological elements:Implants are used temporarily to generate compression across the joint/bone that isbeing repaired/reconstructed. Devices are made of the same material (Unalloyed Titanium per ASTM F67 and Ti-6Al-4V ELI per F136). |
| Non-clinicalTesting | The new geometries of the Omni Foot and Ankle plates were compared to the Omni FootSystem plates and ARIX System plates by engineering analysis. The 4.0mm solid screwswere compared to the predicate Omni 3.5mm cannulated screws and 4.0mm AlignX solidscrews by engineering analysis. The results of this analysis indicate that the Omi Foot andAnkle Plating System is equivalent to predicate devices. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The Omni Foot and Ankle Plating System is substantially equivalent to its predicate devices.This conclusion is based upon indications for use, principles of operation, design, andengineering analysis. |
Omni Foot and Ankle Plating System
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§ 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.