(119 days)
Osteosynthesis of Per-Trochanterian Fractures is intended for use in the fixation and osteosynthesis of per-trochanterian fractures.
This device is indicated for use in the fixation of pertrochanteric fractures.
The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Per-Trochanterian Fractures is an implantable orthopedic trauma device to be used in procedures.
The provided text is a 510(k) summary for the Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanterian Fractures. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study evaluating specific acceptance criteria and device performance.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies from the provided text.
The document describes the device, its intended use, and technological characteristics, and then directly compares it to pre-existing, legally marketed devices to establish substantial equivalence for regulatory approval. It does not contain information about:
- Acceptance criteria and reported device performance: This document does not specify quantitative acceptance criteria or provide performance data for the Fixano D.S.S. system.
- Sample size and data provenance for a test set: No information regarding a specific test set, its size, or origin is present.
- Number and qualifications of experts for ground truth: There is no mention of experts establishing ground truth.
- Adjudication method for the test set: No test set means no adjudication method is described.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: This type of study is not mentioned.
- Standalone (algorithm-only) performance: As this is a physical medical device (hip screw system), an algorithm-only performance assessment is not applicable.
- Type of ground truth used: No ground truth is described.
- Training set sample size: No training set is mentioned.
- How ground truth for the training set was established: Not applicable, as no training set is described.
The 510(k) summary format is designed for regulatory submission to demonstrate that a new device is as safe and effective as devices already on the market, usually by comparing features and materials, not typically by presenting detailed performance study results against predefined acceptance criteria for a new clinical study.
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Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "F" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The logo is black and white.
Kanoal 016-342-4 FAX: 916-343-4
MAY 2 2 1997
15 January 1997
510(k) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- Screw, fixation, bone, or Classification name: A. nail/plate/blade fixation, appliance, a combination, multiple component.
- Hip screw, hip pin, hip screw Common/Usual name: and plate, etc.
- Fixano D.S.S. (Double Sliding Proprietary name: For Osteosynthesis of Per-Screws) System Trochanterian Fractures.
- Fixano D.S.S. (Double Substantial equivalence: B. Synthes System (K954757), Sliding Screws) Dynamic Hip Screw (DHS) (K791619), Howmedica Compression Hip Screw System Omega Plus -Howmedica Screw and Alta Lag (K955306), " Compression Screw (K900584), Zimmer Versa-Fx (K954555), and others.
- Device description: The Fixano D.S.S. (Double C. System For Osteosynthesis of Sliding Screws) Per-Trochanterian Fractures is an implantable orthopedic trauma used in device to be procedures.
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For D.S.S. System D. Intended The use: Osteosynthesis of Per-Trochanterian Fractures is intended for use in the fixation and osteosynthesis of per-trochanterian fractures.
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al characteristics: The D.S.S. System
Osteosynthesis of Per-Trochanterian Technological characteristics: E. For Fractures is a hip screw mechanism that utilizes the D.S.S. sliding screw in utilizes This allows for maximum stability in the osteosynthesis of most per-trochanterian fractures.
Submitted, FERGUSON MEDICAL FDA Establishment Registration Number 2937794
Frank Enea
Frank Ferguson Official Correspondent
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 symbol that resembles an eagle or a bird in flight. The image is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1997
Frank Ferquson Mr. Official Correspondent Ferquson Medical 3407 Bay Avenue Chico, California 95973
K970257 Re : Fixano Double Sliding Screws (D.D.S.) with Intramedullary Nail K970258 Fixano Double Sliding Screws (D.D.S.) and Mini-Plate K970280 Fixano Double Sliding Screws (D.D.S.) and Sid Plate Requlatory Class: II Product Codes: HSB, HRS and HRS Dated: April 15, 1997 Received: April 21, 1997
Dear Mr. Ferguson:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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, Drug, and Cosmetic Act (Act). You may. therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in
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Page 2 - Mr. Frank Ferguson
Please note: this response to your the Federal Register. 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 regulations.
This letter will allow you to begin marketing your devices as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to 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,
[signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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10(k) Number (If known): K = 7 < 2 25
Fixano DSS (Double Sliding Screw) System For Device Name: Osteosynthesis of Per-Trochanterian Fractures
Indications For Use:
This device is indicated for use in the fixation of pertrochanteric fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTEHR PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. Oeele
h Sign-Off) (Divisid Onvision of General Restorative Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.