TRITON/TRU-TRAC/TX/TRITON DTS TRACTION

K053223 · Chattanooga Group · ITH · Feb 24, 2006 · Physical Medicine

Device Facts

• Record ID: K053223
• Device Name: TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
• Applicant: Chattanooga Group
• Product Code: ITH · Physical Medicine
• Decision Date: Feb 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide traction and mobilization of skeletal structures and skeletal muscles. The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide a treatment in static, intermittent, progressive and cycling distraction forces to relieve pressures on micentifies that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions. The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices with the optional EMG (a.k.a. sEMG) biofeedback feature may be used to relieve peripheral radiation/sciatica and nain associated with: Protruding discs, Spinal root impingement, Bulging discs, Hypomobility, Herniated discs, Degenerative joint disease, Degenerative disc disease, Facet syndrome, Posterior facet syndrome, Compressions fractures, Acute facet problems, Joint pain, Radicular pain, Discogenic pain, Prolapsed discs. EMG (a.k.a. sEMG) Determination of the activation magnitude and timing of muscles for: a) retraining of muscle activation b) coordination of muscle activation Determination of the force produced by muscle for control and maintenance of muscle contractions and Relaxation muscle training Muscle re-education

Device Story

Powered traction device for hospitals, physical therapy, and chiropractic clinics; operated by licensed practitioners. Inputs include clinician-set traction parameters (force, time, cycle patterns) and sEMG signals for biofeedback. Device consists of electric traction unit, display, traction rope, and patient stop switch. Transforms inputs into static, intermittent, progressive, or cyclic distraction forces applied to patient via traction belts. EMG feature detects muscle activation/relaxation; clinician sets threshold via visual display; traction unit adjusts based on these thresholds. Output is mechanical distraction force and visual biofeedback data. Benefits include relief of pressure on skeletal/muscular structures causing pain and facilitation of muscle re-education/coordination.

Clinical Evidence

Bench testing only. Compliance with UL 60601-1 (safety) and IEC 60601-1-2 (electromagnetic compatibility) standards provided. No clinical data included.

Technological Characteristics

Powered traction equipment; electric traction unit with display, rope, and patient stop switch. Includes optional sEMG biofeedback. Standards: UL 60601-1 (2003), IEC 60601-1-2 (2001).

Indications for Use

Indicated for patients requiring traction/mobilization of skeletal structures/muscles to relieve pain of skeletal/muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder) associated with disc issues, spinal impingement, hypomobility, degenerative joint/disc disease, facet syndrome, compression fractures, and radicular/discogenic pain. EMG biofeedback indicated for muscle retraining, coordination, force control, and relaxation training.

Regulatory Classification

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.

Predicate Devices

• Triton/ Tru-Trac/ TX Traction (K051938)
• Eskotek EST Trac 401 Traction (K844385)
• Akron ATP9 (K992733)
• VAX-D Genesis System (K053503)
• SpineRx-LDM (K031862)
• Jilco (K001361)
• SpineMed (K030060)
• EMG Retrainer (K972487)
• MyoTrac (K881416)

Submission Summary (Full Text)

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| 510(k) Summary - K053223 | FEB 2 4 2006 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | Chattanooga Group,<br>A Division of Encore Medical, L.P.<br>4717 Adams Road<br>Hixson, TN 37343 |
| CONTACT PERSON: | Michael Treas<br>Manager of Regulatory Affairs<br>Phone: [phone] ext. 7207<br>Fax: [phone] |
| DATE PREPARED: | February 22, 2006 |
| DEVICE TRADE NAME: | Triton/ Tru-Trac/ TX/ Triton DTS Traction |
| COMMON/ USUAL NAME: | Powered Traction Equipment |
| CLASSIFICATION | Class II (Product Code ITH) |
| PREDICATE DEVICES | K051938 - Triton/ Tru-Trac/ TX Traction,<br>K844385 - Eskotek EST Trac 401 Traction,<br>K992733 - Akron ATP9,<br>K053503 - VAX-D Genesis System,<br>K031862 - SpineRx-LDM,<br>K001361 - Jilco,<br>K030060 - SpineMed,<br>K972487 - EMG Retrainer,<br>K881416 - MyoTrac |

#### DEVICE DESCRIPTION:

The Chattanooga Group powered traction device consists of an electric traction treatment unit, and may be sold with the following: EMG (a.k.a. sEMG) biofeedback feature, Pull-Pattern intermittent traction preset feature, patient traction treatment table device, positioning bolster accessories, patient traction belt accessories, high volt pulsed electrotherapy device and miscellaneous traction devices and/ or accessories. The device is intended to be used in hospitals, physical therapy clinics and chiropractic clinics for treatment in static, intermittent, progressive, regressive and cyclic, distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). The device is restricted to sale by or on the order of a licensed physician or licensed practitioner.

The primary features of the Triton/ Tru-Trac/ TX/ Triton DTS Traction hardware are the traction unit (a.k.a. traction head), display screen, traction rope, mounting assembly and patient stop treatment switch.

K053223 Summary Page 1 of 3

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K053223

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The EMG biofeedback feature is used to detect muscle activation and relaxation for Frie ENC oferous traction therapy. The treating clinician determines the minimum muscle activation or minimum muscle relaxation threshold set point. This is done by utilizing the visual display. The intermittent traction reacts to these threshold settings and administers prescribed traction treatment. The Pull Pattern feature is a preset of intermittent traction settings, less the setting of traction force, less setting of traction time. Force and time parameters are determined by the treating clinician. STATEMENT OF TECHHICAI. CHARACTERISTICS COMPARISON

A comparison of device features demonstrate that the Triton/ Tru-Trac/ TX/ Triton DTS Traction device is substantially equivalent to the following devices:

| Predicate device name and product code | 510(k) number |
|-------------------------------------------------------------------------------------------|---------------|
| Triton/ Tru-Trac/ TX Traction<br>ITH, Powered Traction Equipment | K051938 |
| Eskotek EST Trac 401 Traction<br>(a.k.a. Tru-Trac 401)<br>ITH, Powered Traction Equipment | K844385 |
| Akron ATP9<br>Traction Device<br>ITH Powered Traction Equipment | K992733 |
| VAX-D Genesis System<br>Traction Device<br>ITH, Powered Traction Equipment | K053503 |
| SpineRx-LDM<br>Traction Device<br>ITH, Powered Traction Equipment | K031862 |
| Jilco<br>Traction Device<br>ITH, Powered Traction Equipment | K001361 |
| SpineMed<br>Traction Device<br>ITH, Powered Traction Equipment | K030060 |
| EMG Retrainer<br>HCC, Biofeedback | K972487 |
| MyoTrac<br>HCC, Biofeedback | K881416 |

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K05322}

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## Declarations of Conformity

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices is in compliance with the following FDA recognized Consensus Standards:

UL 60601-1: 2003, Standards for Medical Equipment Part 1: General Requirements for Safety, 1st Edition

IEC 60601-1-2: 2001, Medical Electrical Equipment Part 1 - 2: General requirements for Safety - Collateral Standard, Electromagnetic Compatibility --Requirements and Tests, 2nd Edition

## Truthful and Accurate Statement

A statement attesting to the truthfulness and accuracy of the information contained in this submission is attached in Section 3.

### Further Information

In the event that additional information is required, please contact:

Michael Treas Manager of Regulatory Affairs Chattanooga Group, A Division of Encore Medical, L.P. 4717 Adams Road Hixson, TN 37377 U.S.A. Telephone: [phone] ext. 7207 Fax: [phone] E-mail: Michael Treas(@ChattGroup.com

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a simplified or stylized version of the official HHS seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2006

Chattanooga Group c/o Mr. Michael Treas Manager of Regulatory Affairs 4717 Adams Road Hixson, Tennessee 37343

Re: K053223

Trade/Device Name: Triton/Tru-Trac/TX/Triton DTS Traction Regulation Number: 21 CFR 890.5900 Regulation Name: Powered traction equipment Regulatory Class: II Product Code: ITH Dated: February 7, 2006 Received: February 9, 2006

Dear Mr. Treas:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nare reveal 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 for ass based in 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 Errth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Treas

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA linding 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
dell

Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K 05 32 23 Device Name:

Indications for Use:

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide traction and mobilization of skeletal structures and skeletal muscles.

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide a treatment in static, intermittent, progressive and cycling distraction forces to relieve pressures on micentifies that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions.

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices with the optional EMG (a.k.a. sEMG) biofeedback feature may be used to relieve peripheral radiation/sciatica and nain associated with:

| ➤ Protruding discs | ➤ Spinal root impingement |
|-----------------------------|------------------------------|
| ➤ Bulging discs | ➤ Hypomobility |
| ➤ Herniated discs | ➤ Degenerative joint disease |
| ➤ Degenerative disc disease | ➤ Facet syndrome |
| ➤ Posterior facet syndrome | ➤ Compressions fractures |
| ➤ Acute facet problems | ➤ Joint pain |
| ➤ Radicular pain | ➤ Discogenic pain |
| ➤ Prolapsed discs | |

EMG (a.k.a. sEMG)

Determination of the activation magnitude and timing of muscles for:

a) retraining of muscle activation

- b) coordination of muscle activation
Determination of the force produced by muscle for control and maintenance of muscle contractions

and the comments of the comments of the comments of the comments of the comments of the comments of

Relaxation muscle training

Muscle re-education

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

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