TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)

K050428 · Advanced Spinal Technologies, Inc. · LXM · Jun 14, 2005 · PM

Device Facts

• Record ID: K050428
• Device Name: TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)
• Applicant: Advanced Spinal Technologies, Inc.
• Product Code: LXM · PM
• Decision Date: Jun 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

Adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine by a licensed health care professional.

Device Story

ASMI is a handheld electromechanical instrument for spinal joint mobilization/manipulation. Operated by licensed healthcare professionals in a clinical setting. System includes a handset with internal pistons and solenoid valves connected to a console containing a filter/regulator and PCB. Device requires external compressed air source. Operates in three modes: introductory (acclimatization), mobilization (transmits practitioner-applied force via air-cushioned pistons), and recovery (light paraspinal massage, 50N peak force). Silicone pads provide patient contact. Failsafe design ceases operation if malfunction occurs. Output assists practitioners in delivering controlled force to spinal joints, potentially benefiting patients through therapeutic mobilization.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Handheld electromechanical instrument. Materials: silicone rubber (patient contact), metal body. Energy: compressed air (pneumatic), 12V transformer power supply. Features: dual solenoid-operated valves, proportional valve, PCB control. Failsafe operation. Dimensions: handheld handset with console unit.

Indications for Use

Indicated for adjustment, mobilization, or manipulation of musculoskeletal spinal joints by licensed healthcare professionals. For external use only.

Predicate Devices

• Impulse™ Adjusting Instrument (K023462)
• Full Spectrum Activator® III (K003185)
• Frye Adjusting Instrument (K021238)
• Smart Adjuster Adjusting or Joint Mobilization (K962239)

Submission Summary (Full Text)

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K050428

# Advanced Spinal Technologies, Inc.

. #

433 Plaza Real. Suite 255 Boca Raton, Florida 33432 Phone: [phone] • Facsimile: [phone]

'JUN 1 4 2005

### 510(k) Summary Advanced Spinal Mobilization Instrument (ASMI)

| Date of Preparation: | February 14, 2005 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Advanced Spinal Technologies, Inc.<br>433 Plaza Real, Suite 255<br>Boca Raton, Florida 33432 |
| Contact: | Jeffrey R. Perelman, M.D.<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Specification developer: | Alteristic Instruments Limited<br>66 Lemon Street<br>Truro, Cornwall TR1 2PN<br>United Kingdom |
| Contract manufacturer: | SMC Pneumatics (UK) Ltd.<br>Vincent Avenue<br>Crownhill, Milton Keynes MK8 OAN<br>United Kingdom |
| Trade Name: | Advanced Spinal Mobilization Instrument (ASMI) |
| Common Name: | Adjusting or Joint Mobilization Instrument |
| Classification Name: | Plunger-Like Joint Manipulator |
| Intended Use: | Adjustment, mobilization, or manipulation of the musculoskeletal<br>joints of the spine by a licensed health care professional. |
| Predicate Devices: | K023462 – Impulse™ Adjusting Instrument<br>K003185 – Full Spectrum Activator® III<br>K021238 - Frye Adjusting Instrument<br>K962239 - Smart Adjuster Adjusting or Joint Mobilization |

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| Establishment<br>Registration Number: | 3005096823 |
|---------------------------------------|------------------------|
| Regulatory Class: | Unclassified |
| Product Code: | LXM |
| Panel: | Physical Medicine |
| Performance Standards: | None known established |

### Device Description & Specifications:

The Advanced Spinal Mobilization Instrument (ASMI) is a handheld electromechanical The Advanced Spinal Hoomobilize, or manipulate the musculoskeletal joints of the spine. The motions assure assure as a licensed health care professional. Because manual spinal device is intended for ass of the ASMI gives the licensed health care professional the moontanton is diffreent spinal mobilization with a handheld electromechanical device.

The device operates in three distinct modes. The introductory mode initiates a therapy session The device operated in the touch and feel of the instrument. The mobilization mode is and accrimatizes the patient to me actions of a physical therapist's hands performing spinal mobilization. The recovery mode is used between the mobilization treatments to lightly massage the paraspinal area and promote a soothing feeling of well-being.

The system incorporates a handset connected to a console. The handset consists of a metal body The system moorporates a ing pistons and two five-port solenoid-operated valves. The console consists of a filter/regulator/filter (FRF) and a metal case which contains a proportional valve and printed circuit board (PCB). The pads, the only patient contact part, are made of silicon and printThe system is designed for standard connection to a compressed air source.

The equipment is manufactured to the highest possible standards and is failsafe, i.e., if it r no oquipment is malling the seases to operate. The power supply is via a transformer with an output of 1.7 A at 12V. In recovery mode, the ASMI transmits a peak force of 50N. In mobilization mode, the pistons act as air springs or cushions and therefore primarily transmit the mobilizing effort applied by the practitioner.

#### Substantial Equivalence Comparison:

The Advanced Spinal Mobilization Instrument (ASMI) is substantially equivalent to other FDA listed and 510(k) cleared hand-held chiropractic adjusting/mobilization instruments. Specifically, the ASMI has the same intended use and similar technological characteristics as the above-listed devices. All of these devices are used by licensed professionals to impart or transmit controlled force to musculoskeletal joints as part of the practice of physical therapy, chiropractic medicine, and related professional fields. While substantially equivalent to the identified predicate devices in their totality, the ASMI is similar to, for example, the Impulse

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(K023462) fitted with the dual stylus attachments. The Smart Adjuster (K962239) is also available with a dual prong attachment. Additionally, while all means of activating the impact force are substantially equivalent, the Frye Adjusting Instrument (K021238) is, like the ASMI device, activated pneumatically.

A comparison of the technological characteristics of the current device and the predicate devices is set forth in the chart below.

#### Comparison Chart:

| Feature | ASMI | Impulse | Activator III | Smart<br>Adjuster | Frye |
|------------------------------------------------------------------|------|---------|---------------|-------------------|------|
| Indicated for<br>adjustment and<br>mobilization of<br>the spine? | Yes | Yes | Yes | Yes | Yes |
| Hand held<br>adjusting<br>device? | Yes | Yes | Yes | Yes | Yes |
| Adjustable<br>impact force? | Yes | Yes | Yes | Yes | Yes |
| Silicone rubber<br>body contact<br>member? | Yes | Yes | Yes | N/A | Yes |
| Activated<br>pneumatically? | Yes | No | No | N/A | Yes |
| More than one<br>body contact<br>member<br>available? | Yes | Yes | No | Yes | No |

N/A = information not available

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, representing the department's focus on people and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 4 2005

Jeffrey R. Perelman, M.D. President Advanced Spinal Technologies, Inc. 433 Plaza Real, Suite 255 Boca Raton, Florida 33432

Re: K050428

Trade/Device Name: Advanced Spinal Mobilization Instrument (ASMI) Regulatory Class: Unclassified Product Code: LXM Dated: June 9, 2005 Received: June 10, 2005

Dear Dr. Perelman:

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.

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Page 2 -- Jeffrey R. Perelman, M.D.

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 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Hup E. Elurde
Miriam C. Provost, Ph.D.

Miriam C. Provost. Acting 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: K050428

Device Name: Advanced Spinal Mobilization Instrument (ASMI)

The Advanced Spinal Mobilization Instrument (ASMI) is for adjustment, Indications for Use: mobilization, or manipulation of the musculoskeletal joints of the spine by a licensed health care professional. The device is for external use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

. I

Concurrence of

Atut. Qurlis

(Division Sign-Of Division of General, Restorative, and Neurological Devices

**510(k) Number** K050428

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