(63 days)
The Rogachefsky Distal Radius Plates are intended for use in internal fixation of fractures of the distal radius.
This submission describes a distal radius plating system including one volar and two dorsal plates ( left and right configurations) with a curved profile designed to fit the contour of the distal radius. It is intended for use in internal fixation of fractures of the distal radius. Plates are a modified T shape and are 1.0 mm thick. The plates are manufactured from titanium alloy , Ti 6Al 4V, which conforms to ASTM specification F136. The Rogachefsky Distal Radius Plates are attached to the underlying bone using bone screws previously cleared in the Leibinger Radius Reconstruction Plate System [RRPS] 510(k) submission K961496. The plates are available in sterile and non-sterile versions.
The provided text is related to a 510(k) submission for Rogachefsky Distal Radius Plates. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
This type of document (510(k) summary) does not typically include detailed studies involving a "device performance" comparison against "acceptance criteria" through clinical trials, expert review, or AI assistance as would be expected for a diagnostic or AI-powered device.
Instead, the core of a 510(k) submission is to demonstrate substantial equivalence to an existing predicate device based on similarities in intended use, material, design, and operational principles. Clinical effectiveness studies with detailed performance metrics, ground truth establishment, and expert adjudication are usually reserved for de novo classifications, PMAs, or when significant new indications or technologies are introduced that render equivalence to existing devices difficult to prove.
Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not present or applicable in this specific 510(k) summary.
However, I can extract the information that is available from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) or report detailed "device performance" data from a study for this device against such criteria. The "acceptance" for this 510(k) is based on demonstrating substantial equivalence to predicate devices.
2. Sample sized used for the test set and the data provenance
Not applicable/Not provided. The document describes a medical device (distal radius plates), not a diagnostic or AI system that would typically undergo testing with a "test set" of patient data. Equivalence is based on design, materials, and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No test set requiring ground truth established by experts is described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided.
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/Not provided. This device is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided.
8. The sample size for the training set
Not applicable/Not provided. This relates to machine learning models, which is not what this document describes.
9. How the ground truth for the training set was established
Not applicable/Not provided.
Summary of what is provided regarding equivalence and regulatory acceptance:
- Device: Rogachefsky Distal Radius Plates (volar and two dorsal plates, 1.0 mm thick, made of titanium alloy Ti 6Al 4V)
- Intended Use: Internal fixation of fractures of the distal radius.
- Predicate Devices:
- Basis of Equivalence: Similarities in intended use, material, design, and operational principle to the predicate devices.
- Regulatory Acceptance: The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to predicate devices marketed prior to May 28, 1976. This determination allows the sponsor to market the device, subject to general controls and GMP regulations.
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JUN 1 0 1998
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510(k) Summary
Rogachefsky Distal Radius Plates
Device:
For information contact:
John Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Tel: (201) 507-7386 Fax: (201) 507-6870
Date Prepared:
April 16, 1998
Summary:
This submission describes a distal radius plating system including one volar and two dorsal plates ( left and right configurations) with a curved profile designed to fit the contour of the distal radius. It is intended for use in internal fixation of fractures of the distal radius. Plates are a modified T shape and are 1.0 mm thick. The plates are manufactured from titanium alloy , Ti 6Al 4V, which conforms to ASTM specification F136. The Rogachefsky Distal Radius Plates are attached to the underlying bone using bone screws previously cleared in the Leibinger Radius Reconstruction Plate System [RRPS] 510(k) submission K961496. The plates are available in sterile and non-sterile versions.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the RRPS Distal Radius Plating System (Howmedica K961496) and the Alta® Tibial/Upper Extremity Plating System Metaphyseal T Plate (Howmedica K885250).
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Image /page/1/Picture/2 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 an abstract symbol of three human profiles facing right, arranged in a stacked formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 1998
Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
Re: K981283 Trade Name: Rogachefsky Distal Radius Plates Regulatory Class: II Product Code: HRS Dated: April 8, 1998 Received: April 8, 1998
Dear Mr. Dichiara:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. John F. Dichiara
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative 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: Rogachefsky Distal Radius Plates
Indications for Use:
The Rogachefsky Distal Radius Plates are intended for use in internal fixation of fractures of the distal radius.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-The-Counter Use __
(Per 21 CFR 801:109) and/or prescription use, and/or over-the-counter use, and/or over-the-counter use (optional format 1-2-96)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices K961203
510(k) Number
. .
§ 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.