(65 days)
Not Found
Not Found
No
The provided text describes a mechanical traction device with programmable patterns and cycles, but there is no mention of AI or ML technology.
Yes
The device is described as providing treatment and relief for various skeletal and muscular conditions, including pain associated with disc issues and joint problems, which classifies it as having a therapeutic purpose.
No
The device is described as providing traction and mobilization to relieve pain, which are therapeutic actions, not diagnostic ones. It treats conditions rather than identifying or diagnosing them.
No
The description explicitly refers to "traction devices" and their function in applying "distraction forces," which are physical actions requiring hardware components. The summary does not mention any software-only aspect.
Based on the provided information, the Triton/Tru-Trac/TX traction devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that these devices provide traction and mobilization to skeletal structures and muscles directly on the patient's body. They do not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use describes a physical therapy/rehabilitation treatment. The device applies physical forces (traction and distraction) to the body to relieve pain and address musculoskeletal conditions. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
Therefore, the Triton/Tru-Trac/TX traction devices fall under the category of therapeutic medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Triton/Tru-Trac/TX traction devices provide traction and mobilization of skeletal structures and skeletal muscles.
The Triton/Tru-Trac/TX traction devices provide a treatment in static, intermittent, progressive, regressive and cycling distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, knee, etc). This distraction can be applied in a variety of programmable patterns, cycles and functions.
The Triton/Tru-Trac/TX traction devices may be used to relieve peripheral radiation/sciatica and pain associated with:
-
Protruding discs
-
Bulging discs
-
Herniated discs
-
Degenerative disc disease
-
Posterior facet syndrome
-
Acute facet problems
-
Radicular pain
-
Prolapsed discs
-
Spinal root impingement
-
Hypomobility
-
Degenerative joint disease
-
Facet syndrome
-
Compressions fractures
-
Joint pain
-
Discogenic pain
The Triton/Tru-Trac/TX traction devices achieve these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
Product codes
ITH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, thoracic, lumbar, hip, knee
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): 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.
Not Found
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
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle symbol.
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cheryl L. Bagwell Director of Regulatory Chattanooga Group 4717 Adams Road Hixson, TN 37343
Re: K051938
Trade/Device Name: Triton/Tru-Trac/TX Traction Regulation Number: 21 CFR 890.5900 Regulation Name: Powered traction equipment Regulatory Class: Class II Product Code: ITH Dated: July 15, 2005 Received: July 20, 2005
Dear Ms. Bagwell:
We have reviewed your Section 510(k) premarket notification of intent to market the device in indication we nave reviewed your Soctor 9 ro(s) premieries is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosulty to regarly manative profithe Medical Device Ameridments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Device Brya commerce prior to May 20, 1770, the chance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the Act. For and Cosment Act (Act) that do not require special controls provisions of the Act. The You may, merciole, market the do Act include requirements for annual registration, listing of general controls provisions of the rice, 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 If your device is classifica (soc above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major and control lit may be subject to such additional volusions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of a cases of a certains of the requirements of the Act that I DA has made a decemmation administered by other Federal agencies. You must of ally recetal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sets CrK Fatt 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 – Ms. Cheryl Bagwell
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begill marketing your avvalence of your device to a legally
premarket notification. The FDA finding of substantial equipales of the permits vo premarket notification. The FDA inding of substantal. Poplar 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), please
rst lead If you desire specific advice for your do vice of our of the regulation entitled, the regulation entitled, the leavery of the may obtain contact the Office of Compliation at (240) 210 of PR Part 807.97). You may obtain "Misbranding by relerence to prematics notified.com of the Act from the Division of Small other general information on your responsionner Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Prositiation aroved corport/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Sis Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KOS1938
ન્દ્ર
510(k) Number (if known): K Triton/Tru-Trac/TX Traction Device Name:
Indications for Use:
The Triton/Tru-Trac/TX traction devices provide traction and mobilization of skeletal structures and skeletal muscles.
The Triton/Tru-Trac/TX traction devices provide a treatment in static, intermittent, The Trion Fra Tractive and cycling distraction forces to relieve pressures on structures progressive, rogress round of skeletal or muscular origin (cervical, thoracic, lumbar, hip, that may be causing pain of existraction can be applied in a variety of programmable patterns, cycles and functions.
The Triton/Tru-Trac/TX traction devices may be used to relieve peripheral radiation/sciatica and pain associated with:
-
Protruding discs
-
Bulging discs
-
Herniated discs
-
Degenerative disc disease
-
Posterior facet syndrome
-
Acute facet problems
-
Radicular pain
-
Prolapsed discs
-
Spinal root impingement
-
Hypomobility
-
Degenerative joint disease
-
Facet syndrome
-
Compressions fractures
-
Joint pain
-
Discogenic pain
The Triton/Tru-Trac/TX traction devices achieve these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
| Prescription Use | AND/OR | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(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,
and Neurological Devices
| 510(k) Number | K051938 |
|---|---|
| --------------- | --------- |
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