MODEL D DISC FORCE

K073132 · North American Medical Corp (Nam) · ITH · Apr 3, 2008 · Physical Medicine

Device Facts

• Record ID: K073132
• Device Name: MODEL D DISC FORCE
• Applicant: North American Medical Corp (Nam)
• Product Code: ITH · Physical Medicine
• Decision Date: Apr 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Model D provides a program of treatments for the relief from pain for those patients suffering from low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the Model D and is designed to provide static, intermittent, and cycling distraction forces to relieve pressure on structures that may be causing low back and neck pain. It achieves this through decompression of intervertebral discs - unloading due to distraction and positioning. Conditions which may be treated by this methodology include back and neck pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica.

Device Story

Model D is a powered traction table for clinical use by practitioners. Patient steps onto vertical bed; practitioner uses remote to recline bed to horizontal. Bed features two cushions on low-friction runners; upper torso anchored via chest harness; lower torso secured via pelvic harness. Distraction unit mounted on vertical platform at foot end applies tension (0-27 degree angle). Device provides static, intermittent, or cycling distraction forces (0-200 lbs). Practitioner programs treatment parameters (time, tension) via control panel. System includes patient/emergency interrupt switches for immediate tension release. Safety features: audible warnings, automatic tension return to zero at session end, and manual parameter re-entry required after any interruption. Flat panel monitor provides patient comfort/education. Benefits include pain relief through disc decompression and unloading.

Clinical Evidence

No clinical data. Bench testing only. Safety and effectiveness supported by design characteristics, including electrical safety (24V circuits), mechanical safety (emergency release, tension limits), and historical performance of similar devices over ten years without MDR events.

Technological Characteristics

Powered traction equipment; 24V electric bed actuator and control unit. Features: two-cushion sliding bed, pelvic/chest harness system, vertical movable distraction platform (0-27 degrees). Tension range: 0-200 lbs. Connectivity: control panel for parameter input/monitoring. Safety: patient/emergency interrupt switches, audible alarms, automatic tension release. Sterilization: N/A.

Indications for Use

Indicated for patients suffering from low back and neck pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. Provides static, intermittent, and cycling distraction forces for pain relief via intervertebral disc decompression.

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

• DRS (K981822)
• DRX500 (K023160)
• DRY9000 (K060735)

Submission Summary (Full Text)

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Chirotronics Model D - 510(k) Notification Submission 20 September 2007

K073/32

# 510(k) Summary of Safety and Effectiveness

## Device Description

Device Trade Name:

Common Name: Classification Name: Class: Reference: Product Code: Panel Code:

Model D Disc Force Traction Equipment Powered Traction Equipment Class II 21 CFR 890.5900 ITH 890 - Physical Medicine

APR - 3 2008

# Predicate Devices:

K981822 - DRS K023160 - DRX500 K060735 - DRY9000

# Intended Use:

The Model D provides a program of treatments for the relief from pain for those patients suffering from low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the Model D and is designed to provide static, intermittent, and cycling distraction forces to relieve pressure on structures that may be causing low back and neck pain. It achieves this through decompression of intervertebral discs - unloading due to distraction and positioning. Conditions which may be treated by this methodology include back and neck pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica.

#### Technological Characteristics:

The Model D incorporates various principles and working characteristics of the predicate devices. The incorporation of a traction device with a flat surface type powered bed remains the same, and the new overall appearance of the apparatus has not impacted on or changed the safety and effectiveness of the device.

#### Device Description:

The main parts of the Model D are as follow:

- The bed is a stand on / stand off type of bed that can be tilted to allow the fully し. clothed patient to step onto a footrest while in the vertical position and then be slowly lowered to the horizontal treatment position using a remote control hand held by the practitioner.
- The bed is split into two cushions which slide on low friction runners only in the 2. horizontal plane and which can be locked independently.

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# Chirotronics Model D - 510(k) Notification Submission

- Distraction tensions are applied to the patient via a pelvic harness while the upper 3. torso is anchored to the locked cephalic cushion via a chest harness. The lower cushion, on which the lower torso of the patient rests, is unlocked and able to slide freely, thus negating any frictional movement between the patient and the bed cushions during the application of distraction forces and ensuring the efficiency of the application of the prescribed force.
- The distraction unit is mounted to a vertical movable platform incorporated into a 4. support tower at the foot end of the bed. This enables the distraction tensions to be applied at differing angles (ranging from 0 to 27 degrees) to the patient.
- The distraction unit is programmable and controlled from a control panel fitted న్. into the tower to provide static or intermittent distraction.
- The minimum and maximum distraction settings are 0 200 pounds. 6.
- Treatment parameters, such as time and tension, are continuously monitored and 7. displayed by the control panel during set up and during treatment.
- At the conclusion of the duration of the treatment session, the tension always 8. returns to zero.
- A flat panel monitor, which is incorporated in a separate section of the control 9. tower, with headphones provides comfort and relaxation to the patient and / or educational opportunities.
- The system incorporates a Patient Interrupt Switch; an Emergency Interrupt 10. Switch; and a Power Switch, which, when selected independently, in tandem, or in unison, results in the immediate release of all tension.
- The Model D will not operate if the Patient Switch is not working properly or has 11. not been tested prior to the commencement of each treatment session.
- If the Patient Interrupt Switch, or the Emergency Interrupt Switch is activated 12. during a session, or power is interrupted, all treatment parameters must be manually re-entered before the treatment session will restart.

# Summary of Safety and Effectiveness:

The Model D has been designed to be safe and effective. The primary characteristics for safety and effectiveness include:

- The bed actuator activation is via a 24-volt electric circuit. 1.
- The control unit of the distraction unit, including the Patient Emergency Switch's 2. power supply is a maximum of 24 volts.
- The patient steps onto the bed while it is in the vertical position and is then 3. reclined into the treatment position under the supervision of the attendant, and does not have to climb onto the treatment bed.
- Adjustable handgrips are fitted for patient support during the reclining of the bed. 4.
- There is an audible warning signal when the unit is first turned on, when the 5. treatment session is complete, when the Patient Interrupt Switch is tested or activated during a treatment session.

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# Chirotronics Model D - 510(k) Notification Submission

- Anytime a session is interrupted, whether as a result of patient input via the 6. Patient Interrupt Switch; attendant input via the Stop Session switch, or Power Switch; or power interruption, there is an instantaneous release of all tensions. In any of these instances, the treatment program has to be manually reentered into the control panel before treatment can re-commence.
- All treatment parameters must be physically inputted each time a session occurs. 7.
- There is limited vertical movement of the traction head. 8.
- There is a permanent visible means of indication of the angle of distraction pull. 9.
- The system defaults to a maximum tension of 200 pounds for lumbar session and 10. 30 pounds for a cervical session if an amount greater than these are inadvertently entered by the physician.
- If a tension amount greater than one-half of the patient's body weight is entered, a 11. warning box must be responded to before the session can start.

Similar types of devices have been successfully manufactured and marketed in this country for over ten years with no evidence of MDR events.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

North American Medical Corp (NAM) % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, MN 55313

APR - 3 2008

Re: K073132

Trade/Device Name: Model D Disc Force Regulation Number: 21 CFR 890.5900 Regulation Names: Power traction equipment Regulatory Class: II Product Code: ITH Dated: March 18, 2008 Received: March 19, 2008

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becternined the device 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 chorosure) to regars the Medical Device Amendments, or to commence provision of May 20, 1976, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that to not require approvine the general controls provisions of the Act. The You may, mercerore, market the act include requirements for annual registration, listing of general controls provisions of the 110 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 classified (500 abor of als. Existing major regulations affecting your device can may be subject to such additional controller and the games 800 to 898. In addition, FDA may oc found in the Oods of Peaching your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hiat I Dri 3 issualled of a backed complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must or any Fecelal statutes and regulations animals. 8 - 3 - 5 - 5 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 comply with an the Act 3 requirements, netwarts, and manufacturing practice requirements as set CFK Part 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.

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#### Page 2 - Mr. Mark Job

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

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

Enclosure

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# Indications for Use

510(k) Number (if known): not known

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Model D -- Disc Force provides a program of traction type treatments for relief from pain for patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the Model D - Disc Force and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of inter-vertebral discs, that is, unloading due to distraction and positioning.

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)

Concurrent of CDRH, Office of Device Evaluation (ODE)

Neithre 22. Gicmkn

Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number_KO73132