(61 days)
The Profyle® System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
This submission is a line extension to the Profyle® Hand and Small Fragment System to add alternate styles of plates and screws. Also, locking plates and locking screws are being added to the system.
This 510(k) summary (K062498) describes the Profyle® System, which consists of bone plates and screws. This is a traditional device submission and not one for AI/ML software. Therefore, the requested information, which pertains to AI/ML device performance studies, is not applicable or available in the provided text.
Here's a breakdown of why this information isn't present in this type of submission:
- Acceptance Criteria/Device Performance: For a traditional device like bone plates and screws, "acceptance criteria" and "reported device performance" are typically related to mechanical testing (e.g., tensile strength, fatigue life, biocompatibility) and clinical data if applicable (though often not required for 510(k) if substantial equivalence can be shown). The provided document only details the device description, indications for use, and a comparison to predicate devices, which is typical for a 510(k) summary demonstrating substantial equivalence. Mechanical testing results are usually in a separate part of the 510(k) submission, not the summary.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These terms are specific to the evaluation of AI/ML algorithms, particularly in medical imaging or diagnostic contexts. They refer to the methodologies used to train, validate, and test AI models against a human-established ground truth. Since the Profyle® System is a physical medical device (bone plates and screws) and not an AI/ML algorithm, these concepts do not apply.
Conclusion:
The provided document (K062498) is a 510(k) summary for a physical medical device (bone plates and screws). The questions posed are designed for the evaluation of AI/ML-driven medical devices. Therefore, none of the specific information requested in the prompt can be extracted from this document, as it is not relevant to the type of device or regulatory submission described.
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OCT 25 2006
510(k) Summary of Safety and Effectiveness Profyle® System
| Proprietary Name: | Profyle® System |
|---|---|
| Common Name: | Bone plates and screws |
| Classification Name/Reference: | Single/multiple component metallic bone fixationappliances and accessories, 21 CFR §888.3030 |
| Device Product Code: | 87 HRS |
| Proposed Regulatory Class: | Class II |
| For Information contact: | Vivian Kelly, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581 Fax: (201) 831-6038 |
| Date Summary Prepared: | August 24, 2006 |
Description
This submission is a line extension to the Profyle® Hand and Small Fragment System to add alternate styles of plates and screws. Also, locking plates and locking screws are being added to the system.
Indications:
The Profyle® System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
Substantial Equivalence:
The subject Profyle® System is substantially equivalent to other plating systems in regards to intended use, design, materials, and operational principles as internal fixation components such as the Profyle® Hand and Small Fragment System (K961497 and K980364), Stryker® Leibinger Universal Distal Radius System (K040022), and Aptus® Titanium Osteosynthesis System, Medartis, Inc. (K051567.)
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Image /page/1/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design that resembles an eagle or other bird-like figure. The design is composed of several curved lines that come together to form the shape of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corporation % Vivian Kelly, RAC Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
OCT 2 5 2006
Re: K062498
Trade/Device Name: Profyle® 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: August 24, 2006 Received: August 25, 2006
Dear Ms. Kelly:
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 such 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); 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.
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Page 2 - Vivian Kelly, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 acidress http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Toubaya bichem
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): ____________________________________________________________________________________________________________________________________________________
Device Name: Profyle® System
Indications for Use:
The Profyle® System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
Prescription Use Over-The-Counter Use >> AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Barbara Buckner
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062498
б
§ 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.