VECTRA (INTELECT) EPR ULTRASOUND

K031116 · Chattanooga Group · IMI · Dec 3, 2003 · Physical Medicine

Device Facts

• Record ID: K031116
• Device Name: VECTRA (INTELECT) EPR ULTRASOUND
• Applicant: Chattanooga Group
• Product Code: IMI · Physical Medicine
• Decision Date: Dec 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1. Relief of pain, muscle spasms and joint contractures 2. Relief of pain, muscle spasms and joint contractures that may be associated with: a) Adhesive capsulitis b) Bursitis with slight calcification c) Myositis d) Soft tissue injuries e) Shortened tendons due to past injuries and scar tissues 3. Relief of sub-chronic and chronic pain and joint contractures resulting from: a) Capsular tightness b) Capsular scarring

Device Story

Vectra (Intelect) Genisys Ultrasound is a therapeutic device designed to deliver deep heat to body tissues. It operates as an ultrasonic diathermy system, utilizing high-frequency sound waves to generate thermal effects in soft tissues. The device is intended for use by healthcare professionals in clinical settings to manage pain, muscle spasms, and joint contractures associated with various musculoskeletal conditions. By applying ultrasound energy, the device facilitates tissue heating, which can help alleviate symptoms and improve joint mobility. The clinician selects appropriate parameters based on the patient's condition to achieve the desired therapeutic outcome.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Ultrasonic diathermy device; operates under 21 CFR 890.5300; Class II; Product Code IMI. Utilizes ultrasonic energy for deep tissue heating.

Indications for Use

Indicated for patients requiring therapeutic deep heat for sub-chronic and chronic conditions including pain, muscle spasms, joint contractures, adhesive capsulitis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons, capsular tightness, and capsular scarring.

Regulatory Classification

Identification

An ultrasonic diathermy 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.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2003

Mr. Mick Davis Regulatory Analyst Chattanooga Group A Division of Encore Medical 4717 Adams Road P.O. Box 489 Hixson, Tennessee 37343-0489

Re: K031116

Trade Name: Vectra (Intelect) Genisys Ultrasound Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: II Product Code: IMI Dated: September 9, 2003 Received: September 10, 2003

Dear Mr. Davis:

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 10 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 adultcration.

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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Mr. Mick Davis

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse organ finding of substantial equivalence of your device to a legally premaince hotmeation "The elassification 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 If you dosire specific acreoliance 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 other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.hunl

Sincerely yours,

Sincerely yours,

Mark N Wilkerson

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

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

510(k) Number (if known): K031116

Vectra (Intelect) Genisys Ultrasound Device Name:

## For Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

1. Relief of pain, muscle spasms and joint contractures

2. Relief of pain, muscle spasms and joint contractures that may be associated with:

a) Adhesive capsulitis

b) Bursitis with slight calcification

c) Myositis

d) Soft tissue injuries

c) Shortened tendons due to past injuries and scar tissues

3. Relief of sub-chronic and chronic pain and joint contractures resulting from:

a) Capsular tightness

b) Capsular scarring

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) (? {{}, f(DB D = {{ } = } = } = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Usc ાર (Per 21 CFR 801.109) (Optional Format 1-2-96) Con Sign-Off; meral Restorative ... sal ! ..