(33 days)
No
The summary describes a mechanical external fixator and makes no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is described as a "wrist fixation device" intended for "reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities" in upper extremity applications, which are therapeutic medical purposes.
No
The device is described as an external fixator used for reduction, alignment, and stabilization of fractures and deformities, which are treatment functions, not diagnostic ones.
No
The device description explicitly states it is a "radiolucent external fixator," which is a physical hardware device used for bone stabilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities" in the upper extremity. This describes a surgical or therapeutic device used directly on the patient's body.
- Device Description: The description as a "radiolucent external fixator" further confirms its role as a physical device used to stabilize bone and tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. The provided information contains no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the Fixano TWIN FIX wrist fixation device is a medical device, specifically an external fixator, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fixano TWIN FIX 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 radiolucent external fixator capable of limited range of motion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity
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)
Danek Wrist Fixator K891066, PF2 (K012062)
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
510(K) SUMMARY
K022771
page 1 of 1
| Manufacturer: | Fixano S.A.
Z.A. Les Bruyeres
01960 Peronnas
France |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Submitted By: | Ferguson Medical
Consultant to Fixano S.A. |
| Classification Name: | Single/multiple component metallic
bone
fixation appliances and accessories. |
| Common/Usual Name: | External fixation device, wrist fixator, and
others. |
| Proprietary Name: | TWIN FIX |
| Classification Number: | 21 CFR 888.3030/Procode 87 KTT |
| Substantial Equivalence: | Danek Wrist Fixator K891066), PF2 (K012062),
and others. |
| Device Description: | The device is a radiolucent external fixator
capable of limited range of motion. |
| Intended Use: | The intended use is similar to that for other
external fixators. |
| Technological Characteristics: | The TWIN FIX device is similar in its intended
use to predicate devices
and
existent
methodologies. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, represented by flowing lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fixano SA c/o Ferguson Medical Frank Ferguson Consultant P. O. Box 12038 La Jolla, California 92039-2038
SEP 2 3 2002
Re: K022771
Trade/Device Name: Twin Fix Regulation Number: 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: August 1, 2002 Received: August 21, 2002
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 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.
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" (21 CFR 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,
Mull n Mullum
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): 《ΟΣΣ 7 7 /
Device Name: TWIN FIX
Indications For Use:
The Fixano TWIN FIX 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 Millkenn
for
(Division Sign-Off) Division of General. Resto and Neurological Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use XX (Per 21 CFR 801.109)
OR
Over-The- Counter Use