MODIFICATION TO POLAR CARE 500

K070402 · Breg, Inc. · ILO · Mar 29, 2007 · Physical Medicine

Device Facts

• Record ID: K070402
• Device Name: MODIFICATION TO POLAR CARE 500
• Applicant: Breg, Inc.
• Product Code: ILO · Physical Medicine
• Decision Date: Mar 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Local anesthetic effect which significantly reduces pain following an injury, surgery or rehabilitative therapy Early use of cold therapy following an injury or surgery will reduce primary bleeding and swelling Temporary decrease in blood circulation, where applied, reduces pain and swelling.

Device Story

Polar Care 500 is a water-circulating cold therapy device. It circulates chilled water through a pad applied to the patient's skin. Used in clinical or home settings under prescription. Provides localized cooling to reduce pain, swelling, and bleeding post-injury or surgery. Operates by circulating water from a reservoir through a cooling pad; provides therapeutic cold to the treatment site. Benefits patient by managing post-operative or post-injury symptoms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Water-circulating cold therapy system. Consists of a reservoir and circulation pump to deliver chilled water to a patient-applied pad. Class II device (21 CFR 890.5720).

Indications for Use

Indicated for patients requiring cold therapy to reduce pain, swelling, and bleeding following injury, surgery, or rehabilitative therapy.

Regulatory Classification

Identification

A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BREG, Inc. % Ms. Kathleen Barber Vice President of Regulatory Affairs 2611 Commerce Wav Vista, California 92083

MAR 2 9 2007

Re: K070402

> Trade/Device Name: Polar Care 500 Regulation Number: 21 CFR §890.5720 Regulation Name: Water circulating hot or cold pack Regulatory Class: II Product Code: ILO Dated: February 11, 2007 Received: February 27, 2007

Dear Ms. Barber:

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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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/industry/support/index.html.

Sincerely vours.

f.2
Mark N. Mcllhonan

Mark N kerson 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: K070402

Polar Care 500 Device Name:

## Indications for Use:

- Local anesthetic effect which significantly reduces pain . following an injury, surgery or rehabilitative therapy
- Early use of cold therapy following an injury or surgery will ● reduce primary bleeding and swelling
- Temporary decrease in blood circulation, where applied, . reduces pain and swelling.

Prescription Use XXXX And/Or Over the Counter Use

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

Division of General. Restorative. and Neurological Devices

*510(k) Number* K070402