(87 days)
No
The summary describes a mechanical external fixator and does not mention any software, image processing, AI, or ML capabilities.
Yes
The device is described as an external fixator intended for the reduction, alignment, and stabilization of fractures and soft tissue deformities, which are therapeutic medical interventions.
No
The device description indicates it is an external fixator used for the "reduction, alignment and stabilization" of fractures and deformities, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "balljoint-hinged external fixator," which is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Fixano PF2 wrist fixation device is an external fixator. It is a physical device used to stabilize bones and soft tissues externally.
- Intended Use: The intended use is for the reduction, alignment, and stabilization of fractures and deformities in the upper extremity. This is a surgical/orthopedic application, not a diagnostic test performed on a sample.
The information provided clearly describes a medical device used for treatment and stabilization, not for diagnosing a condition using a biological sample.
N/A
Intended Use / Indications for Use
The Fixano PF2 wrist fixation device is intended for use in upper extremity applications for the reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
Product codes
KTT
Device Description
The device is a balljoint-hinged external fixator capable of rotation and anqulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity (specifically wrist)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SEP 2 7 2001
KO12062
510(K) SUMMARY
Manufacturer:
Fixano S.A. Z.A. Les Bruyeres 01960 Peronnas France
Submitted By:
Ferquson Medical Consultant to Fixano S.A.
Single/multiple component metallic bone Classification Name: fixation appliances and accessories.
External others.
PF2
Common/Usual Name:
Proprietary Name:
21 CFR 888.3030/Procode 87 KTT Classification Number:
Substantial Equivalence:
Device Description:
Intended Use:
Technological Characteristics:
others.
EBI XFIX DFS Wristfix System (K993649) and
fixation device, wrist fixator, and
The device is a balljoint-hinged external fixator capable of rotation and anqulation.
The intended use is similar to that for other external fixators.
The PF2 device is similar in its intended use to predicate devices and existent methodologies.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three profiles of human faces.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 2001
Mr. Frank Ferguson C/o Fixano S.A. Ferguson Medical P.O. Box 12038 La Jolla, California 92039-2038
Re: K012062 Trade/Device Name: PF2 Regulation Number: 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: II Product Code: KTT Dated: May 25, 2001 Received: July 2, 2001
Dear Mr. Ferguson:
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 ror answer 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 11 Jour artise 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.
2
Page 2 – Mr. Frank Ferguson
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Marke n Millken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (If known): KV / 2062
Device Name: PF2
Indications For Use:
The Fixano PF2 wrist fixation device is intended for use in upper extremity applications for the reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Mulkeen
(Division Sign-Off) (Division Sign of General, Restorative Division ological Devices KOI 2062
510(k) Number --
Prescription Use _ XX (Per 21 CFR 801.109)
OR OR ..
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________