ULTRA V THERAPEUTIC ULTRASOUND

K001166 · Excel Tech. , Ltd. · IMG · Jul 7, 2000 · Physical Medicine

Device Facts

• Record ID: K001166
• Device Name: ULTRA V THERAPEUTIC ULTRASOUND
• Applicant: Excel Tech. , Ltd.
• Product Code: IMG · Physical Medicine
• Decision Date: Jul 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultra V Therapeutic Ultrasound device provides 1 and 3 MHz ultrasound therapy to provide deep heating effects for the treatment of pain and contractures associated with the chronic and sub-chronic conditions of: Adhesive capsulitis, bursitis, bursitis with slight calcification, and myositis. Soft tissue injuries and shortened tendons due to past injuries and scar tissue. Joint contractures resulting from capsular tightness and scarring.

Device Story

Ultra V Therapeutic Ultrasound delivers 1 and 3 MHz ultrasound energy to generate deep heating effects in tissues; used for treatment of pain and contractures. Device operates as therapeutic stimulator; intended for clinical use by healthcare professionals. Output consists of ultrasound waves applied to patient body to facilitate healing of soft tissue injuries and joint conditions. Device design and function are substantially equivalent to predicate Excel Tech Ultra Max (K944065).

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and functional comparison to the predicate device.

Technological Characteristics

Therapeutic ultrasound device providing 1 and 3 MHz frequencies. Class II device, product code IMG. Design and function are consistent with established therapeutic ultrasound technology.

Indications for Use

Indicated for patients with chronic or sub-chronic pain and contractures, including adhesive capsulitis, bursitis (with/without slight calcification), myositis, soft tissue injuries, shortened tendons from past injury/scarring, and joint contractures from capsular tightness.

Regulatory Classification

Identification

An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.

Predicate Devices

• Excel Tech Ultra Max (K944065)

Reference Devices

• Excel Tech Ultra SX (K923076)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo for "XLTEK" in bold, stylized font. Below the logo, the text "510(k) NOTIFICATION OF A NEW DEVICE" is present, indicating the document's purpose. To the right of the logo is a circular symbol with a triangle inside.

Ultra V Therapeutic Ultrasound APRIL 7, 2000

Section E- 510(k) Summary

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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR § 807.92.

| Name: | Cameron Mahon<br>Director of R & D |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Excel Tech, Ltd.<br>2568 Bristol Circle<br>Oakville, Ontario<br>Canada, L6H 5S1 |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Common Names: | Therapcutic Ultrasound |
| Classification Name: | Stimulator, Ultrasound and Muscle, for use in<br>applying Therapeutic Deep Heat |
| Predicate Devices: | Excel Tech Ultra Max [510(k) K944065,<br>formerly called Ultra SX]. |
| Description: | The XLTek Ultra V is a Therapeutic Ultrasound |
| Substantial Equivalence: | The Ultra V is similar in design and function to<br>the Excel Tech Ultra SX [510(k) K923076, also<br>known as the Ultra Max]. |
| Indications for Use: | The Ultra V Therapeutic Ultrasound device<br>provides 1 and 3 MHz ultrasound therapy to<br>provide deep heating effects for the treatment of<br>pain and contractures associated with the chronic<br>and sub-chronic conditions of: |
| | Adhesive capsulitis, bursitis, bursitis with<br>1.<br>slight calcification, and myositis.<br>Soft tissue injuries and shortened tendons<br>2.<br>due to past injuries and scar tissue<br>Joint contractures resulting from capsular<br>3.<br>tightness and scarring. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

JUL - 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Camerom Mahon, P. Eng., M. H. Sc. Director of R & D Excel Tech, Ltd. 2568 Bristol Circle Oakville, Ontario, Canada L6H 5S1

Re: K001166

Trade Name: Ultra V Therapeutic Ultrasound Regulatory Class: II Product Code: IMG Dated: April 7, 2000 Received: April 10, 2000

Dear Mr. Mahon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the enoredure) to ice ice Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general morelors, marions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remancer ripp. Charge of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to moponently the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Camerom Mahon, P. Eng., M. H. Sc.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

DmnR Vachner.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ultra V Therapeutic Ultrasound APRIL 7, 2000

#### 510(K) NOTIFICATION OF A NE

#### rent of indications Section Destate

### Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

XLTek Ultra V Therapeutic Ultrasound Device Name:

The Ultra V provides 1 and 3 MHz ultrasound therapy to Indications for Use: provide deep heating effects for the treatment of pain and contractures associated with the chronic and subchronic conditions of:

- Adhesive capsulitis, bursitis, bursitis with slight 】. calcification, and myositis.
- 2. Soft tissue injuries and shortened tendons due to past injuries and scar tissue
- Joint contractures resulting from capsular 3. tightness and scarring.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Dmns R. lochner
Division Sign-Off

(Division Sign-Off) · Division of General Restorative Devices >10(k) Number_KUQULLe

Prescription Use
(Per 21§ CFR 801.109)

Over-The Counter Use __ OR

(Optional Format 1-2-96)