(63 days)
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No
The summary describes a mechanical external fixation system and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is an external fixation system used for stabilizing fractures, which is a structural support/holding function, not a therapeutic treatment.
No
The device is described as an external fixation system used for treating unstable fractures and dislocations, joint fusion, osteotomies, and peri-articular fractures, which involve stabilization and repair, not diagnosis.
No
The device description explicitly lists "External Fixation System" with different sizes, which are hardware components used to stabilize bones. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's application in treating fractures and other musculoskeletal conditions. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as an "External Fixation System," which is a type of surgical implant used to stabilize bones. This is consistent with a therapeutic device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is used in vivo (inside the body) to treat a physical condition.
N/A
Intended Use / Indications for Use
Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary fixation before internal fixation. Fractures and fracture dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures.
Product codes
LXT
Device Description
TransFx Intermediate External Fixation System TransFx Small External Fixation System TransFx Mini External Fixation System
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
distal radius, hand, wrist, forearm, mandible, foot, ankle, long bones
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
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Description of the test set, sample size, data source, and annotation protocol
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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)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 1999
Mr. Roy Bogert Director of R&D and Regulatory Affairs Immedica, Inc. 100 Passaic Avenue Chatham, New Jersey 07928
Re : K990848 TransFx Intermediate External Fixation System TransFx Small External Fixation System TransFx Mini External Fixation System Regulatory Class: II Product Code: LXT March 11, 1999 Dated: March 15, 1999 Received:
Dear Mr. Bogert:
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, Drug, 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 against 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 Regulations, Title 21, Parts 800 to 895. A 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 requlatory 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 !.aws or regulations.
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Page 2 - Mr. Roy Bogert
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,
'Ph.D., M.D. M. Witten, Celi Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
TransFx Small External Fixation System Device Name: TransFx Intermediate External Fixation System TransFx Mini External Fixation System
Indications For Use:
Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary fixation before internal fixation. Fractures and fracture dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
bocella
(Division Sign-Off)
Division of General Restorative Devices K990848
510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
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