MTD 4000

K091540 · Mettler Electronics Corp. · ITH · Oct 8, 2009 · Physical Medicine

Device Facts

• Record ID: K091540
• Device Name: MTD 4000
• Applicant: Mettler Electronics Corp.
• Product Code: ITH · Physical Medicine
• Decision Date: Oct 8, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MTD 4000 traction device provides traction and mobilization of skeletal structures and skeletal muscles. The MTD 4000 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.

Device Story

MTD 4000 is a powered traction device for cervical or lumbar spine treatment. It applies static or intermittent traction via a high-strength cable to separate vertebrae and draw soft tissue. Device features include user-definable hold/rest times, multiple speed selections, and active displays for treatment progress. Operated by clinicians in a clinical setting, the device incorporates multiple sensors and a patient safety switch to ensure controlled force application. Output consists of mechanical traction force; healthcare providers use this to manage musculoskeletal pain and spinal conditions. Benefits include non-invasive relief of radicular pain and spinal impingement symptoms.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Powered traction device; AC mains supply (110-240V); membrane user interface with control knob; high-strength traction cable; includes patient safety switch. Dimensions: 12.2" x 14.2" x 9.1"; Weight: 32 lbs. CE Class IIa, Type BF.

Indications for Use

Indicated for patients requiring traction and mobilization of skeletal structures and muscles to relieve pain and symptoms associated with disc, joint, and spinal conditions including sciatica, radicular pain, herniated/bulging/prolapsed discs, facet syndrome, and degenerative joint/disc disease.

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/Triton DTS Traction Device (K051938)
• TM-300 (K992545)

Submission Summary (Full Text)

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K091540

OCT - 8 2009

## 510(k) SUMMARY STATEMEMT

## Mettler Traction Device, MTD 4000

Mettler Electronics Corp. Submitter's Name: 1333 South Claudina Street Address: Anaheim, CA 92805

> Telephone: [phone] x324 714-533-3860 Fax:

- Robert E. Fleming Contact: Director, QA/RA
Date Prepared: May 21, 2009

#### Proposed Device Name:

- a. TRADE NAME: MTD 4000
b. CLASSIFICATION NAME: Equipment, Traction, Powered (Sec. 890.5900, Product Code ITH)

- c. COMMON NAME: Powered Traction Device
#### Predicate Devices:

a. TRADE NAME: Triton/Tru-Trac/TX/Triton DTS Traction Device by Chattanooga.

b. 510(k) Number: K053223

- c. TRADE NAME: TM-300 by ITO Co., Ltd.
- d. 510(k) Number: K992545

#### Description of Proposed Device:

The MTD 4000 (Mettler Traction Decompression) system is an easy to use device that offers static and intermittent traction with user definable hold, rest, and treatment times. It gently pulls the cervical spine or lumbar spine in opposite directions to draw the soft tissue around the cervical or lumbar joints and separate the distance between bone sections of the vertebra.

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The MTD 4000 may be used to help relieve peripheral radiation/sciatica and pain associated with: protruding discs, spinal root impingement, bulging discs, hypomobility, herniated discs, degenerative joint disease, degenerative disc disease, facet syndrome, posterior facet syndrome, compressions fracture, acute facet problems, radicular pain, discogenic pain and prolapsed discs.

Some of the features of the MTD 4000 are:

- Easy to use �
- Active displays show all treatment parameters and progress. �
- Multiple sensors and safety controls �
- High strength traction cable �
- Adjustable Hold/Rest times �
- Continuous and Intermittent traction with multiple speed selection �
- Smooth, quiet operation �

#### Proposed Device Intended Use Statement:

The MTD 4000 traction device provides traction and mobilization of skeletal structures and skeletal muscles.

The MTD 4000 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 ◆

#### Comparison of Technological Characteristics Between Proposed and Predicate Devices:

Similarities:

- 1. Indications for use for the MTD 4000, and the aforementioned predicates are essentially the same, all related to powered traction treatment.
- 2. All have similar operating modes.
- 3. Each is provided with similar accessories.

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### Differences:

- 1. Physical shape and size of the enclosure.
- 2. Configuration of user interface controls.
- 3. Display methods.

# Comparison Table

| Feature | MTD 4000 | Triton / Tru-<br>Trac /<br>TX Traction | TM-300 |
|-------------------------------|---------------------------------------|----------------------------------------|-------------------------------------|
| Distributor /<br>Manufacturer | Mettler Electronics | Chattanooga Group | Ito Co., Ltd. |
| 510k | | K051938 | K992545 |
| Mains Supply | AC 110~120 /<br>220~240 V<br>50/60 Hz | 100~240V / 50/60<br>Hz | AC 110~120/220~240<br>V<br>50/60 Hz |
| FDA Class | II | II | II |
| CE Classification | Class IIa, Type BF<br>MDD 93/42/EEC | Class 1, Type B<br>MDD 93 /42 /EEC | Class I, Type B |
| CE Mark | CE 0434 | CE 0413 | CE (MDD) |
| Dimensions (in) | 12.2(W) x 14.2(D)<br>x 9.1(H) | 9.5(W) x 17.5(D) x<br>17.5(H) | 10.2(W) x 13(D) x<br>9.8(H) |
| Weight (pounds) | 32 | 30 | 26 |
| User interface | Membrane, control<br>knob | Touch screen,<br>buttons | Membrane |
| Patient safety<br>switch | Yes | Yes | Yes |
| Treatment Time<br>(min) | 1-99 | 1-99 | 1-99 |
| Hold Time (sec) | 0-99 | 0-99 | 1-99 |
| Hold Force (lbs) | 7-198 | 0-200 | 2-198 |
| Rest Time (sec) | 0-99 | 0-99 | 1-99 |
| Rest Force (lbs) | 0-196 | 0-200 | 0-196 |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mettler Electronics, Corporation % Mr. Robert E. Flemming Director, QA/RA 1333 South Claudina Street Anaheim, California 92805

OCT - 8 2009

Re: K091540

Trade/Device Name: MTD 4000 Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: August 18, 2009 Received: August 19, 2009

Dear Mr. Flemming:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 - Mr. Robert E. Flemming

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/McdicalDcvices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

ely yours,

For

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1b

Page of

510(k) Number (if known):

Device Name:

MTD 4000

The MTD 4000 traction device provides traction and mobilization of skeletal structures and skeletal muscles.

The MTD 4000 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

HARRY M. CLARY FOR M. MELKERSON
Division Signer

(Bivision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091540

Prescription Use × (Per CFR 801 Subpart D) AND/OR

Over the Counter Use (Per 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)

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