(204 days)
The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints
The EXTREMITY MEDICAL Midfoot Screw System
The provided 510(k) summary for the EXTREMITY MEDICAL Midfoot Screw System (K082934) does not contain information about acceptance criteria or a study demonstrating device performance against such criteria for AI/ML device functionalities.
The document describes a medical implant system, which are physical devices used for fixation and arthrodesis of foot joints, not an AI/ML-driven device. Therefore, the requested information points, which are primarily relevant to AI/ML device validation, are not applicable or available within this 510(k) submission.
Specifically:
- 1. A table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence to predicate devices based on design, materials, indications for use, and mechanical properties.
- 2. Sample sized used for the test set and the data provenance: Not applicable. No test set for AI/ML performance is mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for AI/ML is mentioned.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The document indicates that the device's substantial equivalence was based on:
- Indications for use: Same as predicate devices.
- Materials: Similar to predicate devices.
- Design: Similar to predicate devices.
- Test data: Implies mechanical testing data, but specific acceptance criteria and detailed results are not provided in this summary.
- Principles of operation: Similar to predicate devices.
This 510(k) establishes substantial equivalence for a conventional medical device, not an AI/ML product.
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K082934 1/1
EXTREMITY
APR 2 3 2009
510k Summary of Safety and Effectiveness
Extremity Medical Implant System
| Submitter: | EXTREMITY MEDICAL LLC300 Interpace ParkwaySuite 410Parsippany, NJ 07054 |
|---|---|
| Contact Person | Jamy GannoePresidentPhone: (973) 588-8980Email: jgannoe@extremitymedical.com |
| Date Prepared | April 13, 2009 |
| Trade Name | EXTREMITY MEDICAL Midfoot Screw System |
| Classification Name andNumber | Smooth or threaded metallic bone fixation fastener21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Devices | 1. 3.5 Fully Threaded Screw , Synthes K0506832. EXTREMITY MEDICAL Compression Screw K0819343. Pioneer Medical, Stayfuse K0227264. 6.5 Midfoot Fusion Bolt, Synthes K081071 |
| Device Description | The EXTREMITY MEDICAL Midfoot Screw System |
| Indications for use | The Extremity Medical Midfoot Screw System is intended for fixationarthrodesis of the metatarsal-cuneiform, navicular-cuneiform,metatarsal-cuboid, talonavicular, and calcaneocuboid joints. |
| Statement ofTechnologicalComparison | The EXTREMITY MEDICAL Midfoot Screw System and its predicatedevices have the same indications for use; have a similar design; aremade of similar materials, and have equivalent mechanicalproperties. |
| Conclusion | The EXTREMITY MEDICAL Midfoot Screw System is substantiallyequivalent to its predicate devices. This conclusion is based uponindications for use, materials, design, test data and principles ofoperation. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2009
EXTREMITY MEDICAL LLC % Mr. Jamy Gannoe 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054
Re: K082934
Trade/Device Name: EXTREMITY MEDICAL Midfoot Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 13, 2009 Received: April 14, 2009
Dear Mr. Gannoe:
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at
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Page 2 - Mr. Jamy Gannoe
(240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours, A
Yor Dhol
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Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082934
Device Name:
EXTREMITY MEDICAL Midfoot Screw System
Indications for Use:
"The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsalcuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints"
Over-the-counter Prescription Use X AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) (Division Digit of General, Restorative, Division - Problem Devices
510(k) Number L682934
б
§ 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.