(63 days)
Not Found
Not Found
No
The summary describes a mechanical device (Multi-Pin Clamp) for fracture fixation and does not mention any software, image processing, AI, or ML terms.
Yes
The device is indicated for treating unstable fractures and dislocations, joint fusion, and osteotomies, which are therapeutic interventions.
No
The device, a "TransFx Multi-Pin Clamp," is indicated for treating fractures and joint fusions, which are therapeutic rather than diagnostic applications. It does not mention any function for identifying or analyzing disease or injury.
No
The device description "TransFx Multi-Pin Clamp" clearly indicates a physical hardware device used for fracture fixation, not a software-only medical device.
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 being used for the treatment of fractures and other musculoskeletal conditions. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The device is described as a "TransFx Multi-Pin Clamp," which is consistent with a surgical or orthopedic device used for external fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo (within the body) use or external application to the body for structural support and stabilization.
N/A
Intended Use / Indications for Use
Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary Exation 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
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius, hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures
Indicated Patient Age Range
Not Found
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces left and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Public Health Service
JUL 22 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Roy Bogert Director of R&D and Regulatory Affairs Immedica®, Inc. 100 Passaic Avenue Chatham, New Jersey 07928
Re: K991723 Trade Name: TransFx Multi Pin Clamp Regulatory Class: II Product Code: LXT Dated: May 19, 1999 Received: May 20, 1999
Dear Mr. Roy 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 control provisions of the Act. The general control 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 (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 regulation may result in regulatory 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 laws 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4,99 1723 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: TransFx Multi-Pin Clamp
Indications For Use:
Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary Exation 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)
Division Sign Off)
Division of General Restorative Devices
510(k) Num
Prescription Use
X
(Per 21 CFR 801.109)
:
OR
Over-The-Counter Use (Optional Format 1-2-96)
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