DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM

K060735 · Axiom Worldwide, Inc. · ITH · May 26, 2006 · Physical Medicine

Device Facts

• Record ID: K060735
• Device Name: DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
• Applicant: Axiom Worldwide, Inc.
• Product Code: ITH · Physical Medicine
• Decision Date: May 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The DRX9000 True Decompression System is designed to relieve pressure on structures that may be causing low back pain and sciatica. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radicular pain. Intervertebral disc decompression is achieved non-surgically through the application of logarithmic distraction tensions applied to the patient according to the Axiom protocol.

Device Story

The DRX9000 is a power traction system for non-surgical spinal decompression. It applies controlled, logarithmic distraction tensions to the lumbar spine to decompress intervertebral disc space. The system consists of a treatment computer, servo-amplifier, servo-motor, load-cell feedback mechanism, two-segment textile patient harness, and a free-floating lower body mattress. The device is operated by healthcare personnel in a clinical setting. The treatment computer modulates cyclic tension (high/low plateaus) via non-linear changes; load-cell feedback continuously monitors and adjusts tensile forces to account for patient posture and external forces. The patient holds a safety switch to immediately pause tension. The system facilitates paraspinal muscle relaxation by allowing the lower body to extend independently of the upper body, which is secured by the harness. This process aims to relieve pressure on spinal structures, potentially reducing pain associated with degenerative or compressive injuries.

Clinical Evidence

No clinical data provided. The device relies on bench testing and the established safety profile of the predicate device, which has been in clinical use since 2002 with no reported injuries.

Technological Characteristics

Power traction equipment (21 CFR 890.5900). Features include servo-motor/servo-amplifier control, continuous load-cell tensile feedback, and a free-floating mattress. Tension is applied via a logarithmic, cyclic, non-linear modulation protocol. Includes a patient-operated safety switch with redundant monitoring systems. Textile patient harness system for upper/lower body stabilization.

Indications for Use

Indicated for patients suffering from incapacitating low back pain and sciatica. Used for management of pain and disability associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, and radicular pain.

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

• DRX3000 - Axiom Worldwide (K022602)
• VAX-D Genesis System - VAX-D Medical Technologies (K053503)

Submission Summary (Full Text)

{0}------------------------------------------------

## MAY 2 6 2006

## SECTION VIII

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

- 1. Sponsor Identification
Axiom Worldwide, Inc. 9423 Corporate Lake Dr Tampa, FL 33634 Telephone: [phone] Facsimile: [phone]

#### 2. Sponsor Establishment Registration Number Establishment Registration Number: 3004378341 Owner / Operator Number: 9044586

- 3. Official Contact Person Jim Gibson
Telephone: [phone] Facsimile: [phone]

#### 4. Device Information

DRX9000 True Non-Surgical Device Trade Name: Spinal Decompression System Common Name: Traction Equipment Classification Name: Power Traction Equipment Class and Reference Class II (21 CFR Section 890.5900) Product Code: 89 ITH Panel Code: 87 ORS

#### ડ. Predicate Devices

- K022602 DRX3000 - Axiom Worldwide K053503 VAX-D Genesis System - VAX-D Medical Technologies
#### 6. Device Description

The DRX9000 True Non-Surgical Spinal Decompression System provides accurately controlled tensions designed to relax and confuse paraspinal muscles and allow distractive forces to decompress intervertebral spinal disc space. The user interface provided by the treatment computer constantly updates a servo-amplifier controlling a servo-motor to immediately and safely apply forces as determined by qualified healthcare personnel. Load-cell feedback is utilized to further verify and adjust tensile forces, allowing for variations in patient posture and outside forces such that continuous and smooth tension is experienced by the patient. The patient safety switch is held by the patient who at anytime and for any reason may quickly

{1}------------------------------------------------

pause any tensile forces. This patient safety switch is monitored and executed by two redundant systems. Integral to effective spinal decompression and included in the device are continuous load-cell tensile feedback into the treatment computer, dedicated and matched servo-amplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), two segment (upper and lower) textile patient harness, patient safety switch, and free-floating lower body mattress. The free-floating lower body mattress allows the interdiscal segments of the lumbar spine to decompress at their own rate. As tension is cycled, the lower body can extend independent of the upper body which is held in place via an upper body textile patient harness. The treatment bed and textile harness allow the patient to relax completely and require no conscious exertion on the part of the patient. Total patient relaxation encourages paraspinal muscle relaxation from both a physical and psychological standpoint and is a key to spinal decompression.

#### 7. Intended Use

The DRX9000 True Decompression System is designed to relieve pressure on structures that may be causing low back pain and sciatica. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radicular pain. Intervertebral disc decompression is achieved non-surgically through the application of logarithmic distraction tensions applied to the patient according to the Axiom protocol.

#### 8. Indications for Use

The DRX9000 True Non-Surgical Spinal Decompression System provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome and sciatica.

#### 9. Technological Characteristics

The Axiom Worldwide DRX9000 True Non-Surgical Spinal Decompression System is essentially the same product as the predicate device (DRX3000). Axiom Worldwide has made some modifications to the appearance and components used in the Axiom Worldwide DRX3000 to provide more accurate application of tension. Each of these changes were evaluated by Axiom Worldwide and found not to impact the safety and effectiveness of this device.

#### 10. Summary of Safety and Effectiveness

The DRX9000 True Non-Surgical Spinal Decompression System provides accurately controlled tensions designed to relax and confuse paraspinal muscles and allow distractive forces to decompress intervertebral spinal disc space. Integral to

{2}------------------------------------------------

effective spinal decompression and included in the device are continuous load-cell tensile feedback into the treatment computer, dedicated and matched servoamplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), two segment (upper and lower) textile patient harness, patient safety switch, and free-floating (apper and is mattress. An important safety feature is that patients hold a patient safety switch to allow at anytime the pausing of any tensile forces. Axiom Worldwide therapy has been in clinical use since 2002 and has been the subject of clinical studies examining its effectiveness. Axiom Worldwide maintains contact with the clinics administering the therapy, and over the past twelve years, not a while the othere of injury has been filed, which reflects the inherent safety of the device.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

MAY 2 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Axiom Worldwide, Inc. % TÜV Rheinland of North America, Inc. Mr. Tamas Borsai Program Manager 12 Commerce Road Newtown, Connecticut 06470

Re: K060735

Trade/Device Name: DRX9000 True Non-Surgical Spinal Decompression System Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: Class II ** Product Code: ITH Dated: May 9, 2006 Received: May 11, 2006

Dear Mr. Borsai:

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 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 - Mr. Tamas Borsai

Enclosure

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter natification. The FDA finding of substantial equivalence of your device to a legally promated 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" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general 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,

\$\mathcal{f}\$

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

{5}------------------------------------------------

Page 3 - Mr. Tamas Borsai

## Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

{6}------------------------------------------------

# Indications for Use

510(k) Number (if known): K060735

Device Name: DRX9000 True Non-Surgical Spinal Decompression System

### INDICATIONS FOR USE

The DRX9000 True Non-Surgical Spinal Decompression System provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome and sciatica.

Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)

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

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

Hebert Lemon
(Division Sign-Off)

പ്പുള്ളും ല്‍ട്ടില്ലെങ്ങില്‍ Bestonation (ODE) Concul and Neurological Devices

**510(k) Number** K060735

Page 1 of

ళ