(119 days)
Not Found
No
The summary describes a mechanical orthopedic implant for fracture fixation and contains no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
No
The device is described as an implantable orthopedic trauma device for fixation of pertrochanteric fractures, which is a supportive and reparative function, not a therapeutic one.
No
Explanation: The device is described as an "implantable orthopedic trauma device" used for the "fixation of pertrochanteric fractures." This indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly states it is an "implantable orthopedic trauma device," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of pertrochanteric fractures." This describes a surgical procedure to stabilize broken bones, not a test performed on samples from the human body to diagnose or monitor a condition.
- Device Description: The device is described as an "implantable orthopedic trauma device." This is consistent with a surgical implant, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the Fixano D.S.S. System is an orthopedic surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HSB, HRS and HRS
Device Description
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 D.S.S. System For Osteosynthesis of Per-Trochanterian 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes System (K954757), 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)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
: -
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