GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM

K071050 · Coolsystems, Inc. · IRP · Jun 29, 2007 · Physical Medicine

Device Facts

• Record ID: K071050
• Device Name: GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM
• Applicant: Coolsystems, Inc.
• Product Code: IRP · Physical Medicine
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Game Ready System combines cold and compression therapies. It is intended to treat post-surgical acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

Device Story

Game Ready System provides intermittent pneumatic compression and cold therapy; utilizes DC-powered control unit, connector hose, and body-specific wraps (heat exchanger + sleeve). Control unit circulates ice water for cooling and pumps air for compression. User adjusts compression, cooling, and treatment duration. Used in hospitals, clinics, athletic settings, or homes; operated by healthcare professionals or patients. System includes safety monitoring: software detects insufficient fluid flow, over-pressure, or under-pressure, triggering alarms or system shutdown to prevent injury. Benefits include reduction of edema, swelling, and pain post-surgery or injury.

Clinical Evidence

No clinical testing data are submitted, referenced, or relied on to determine substantial equivalence. Bench testing was performed at sub-assembly and assembly levels to verify design requirements.

Technological Characteristics

DC-powered system; includes control unit, connector hose, and wraps. Cooling via circulating ice water; compression via intermittent pneumatic pump. Software-controlled safety monitoring for fluid flow and pressure. Available in standard and pre-programmed configurations.

Indications for Use

Indicated for patients with post-surgical or acute injuries requiring cold and compression therapy to reduce edema, swelling, and pain. Suitable for use in clinical, athletic, or home settings under professional guidance.

Regulatory Classification

Identification

A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.

Predicate Devices

• CRYOPress (K951769)
• Polar Care 500 (K961855)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

## Game Ready System

JUN 2 9 2007

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

The assigned 510(k) number is:

- A. Submitter: CoolSystems, Inc. 2201 Dwight Way Berkeley, CA 94704
Phone: [phone] Fax: [phone] Email: [e-mail] Contact: Marianne Baldwin, VP, QA/RA/CA

June 11, 2007 Date Prepared:

## B. Device Names:

| Trade Name: | Game Ready System |
|----------------------|----------------------------------------------------------------|
| Common/usual Name: | Cold/compression therapy system |
| Classification Name: | Cold water circulating pack / Powered inflatable tube massager |

## C. Predicate Device:

The Game Ready System is substantially equivalent to the following predicate devices:

| Device, K# | Manufacturer | Product Code(s) |
|-------------------------|------------------|-----------------|
| CRYOPress, K951769 | Grimm Scientific | ILO/IRP |
| Polar Care 500, K961855 | Breg, Inc. | ILO |

### D. Device Description:

The Game Ready System is comprised of the following components:

- . Control Unit, with AC Adapter (to convert line power to DC input power)
- Connector Hose (connects Control Unit to Wrap) .
- Wrap (Heat Exchanger + Sleeve) ●
- . Optional Carry Bag
- · Optional Battery Pack

The Game Ready System is a DC-powered device that provides intermittent compression and controlled cold therapy by controlling fluid flow and air pressure through a Wrap that is specially designed for a specific body part or location (e.g., shoulder, elbow, knee, ankle, back). A Wrap is comprised of a Sleeve (the outer covering for the Heat Exchanger) and a Heat Exchanger. Cooling is provided by

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circulating ice water from the Control Unit through the Connector Hose to the Wrap. Compression is provided by an intermittent-cycling pneumatic pump that pumps air from the Control Unit through the Connector Hose to the Wrap. The user can adjust the amount of compression, the amount of cooling, and the treatment time. The Control Unit software is designed to protect both the user and the Control Unit from harm by shutting off the system and sounding an alarm if there is insufficient fluid flow or in case of an over-pressure or under-pressure situation. The software detects other. less-serious error conditions and sounds a warning beep to alert the user, so that the error condition can be corrected.

The Game Ready System is available in two configurations: the Game Ready Professional Therapy System (P/N 550100) and the Pre-Programmed Game Ready Professional Therapy System (P/N 550350)

#### E. Intended Use:

The Game Ready System combines cold and compression therapies. It is intended to treat post-surgical acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

#### F. Comparison with the Predicate Device:

The Game Ready System is substantially equivalent to the predicate devices in design, function, and indications for use/intended use.

#### G. Non-Clinical Testing

Bench testing was performed at both the sub-assembly and assembly level. The testing showed that the Game Ready System met its requirements. Design Verification Testing showed that the Game Ready System performed according to specification.

#### H. Clinical Testing

No clinical testing data are submitted, referenced, or relied on to determine substantial equivalence.

#### -Conclusions

There are no significant differences between the Game Ready System and the predicate devices that would adversely affect the use of the proposed device. The Game Ready System is substantially equivalent to the predicate devices in design, function, and indications for use/intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CoolSystems, Inc % Ms. Marianne Baldwin Vice President, RA/QA/CA 2201 Dwight Way Berkeley, California 94704

JUN 2 9 2007

Re: K071050

Trade/Device Name: Game Ready Professional Therapy System, Model 550100, Game Ready Pre-programmed Professional Therapy System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: II Product Code: IRP, ILO Dated: May 30, 2007 Received: May 31, 2007

Dear Ms. Baldwin

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 - Ms. Marianne Baldwin

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 yours,

Mark N. Melkerson

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: | K071050 |
|----------------|---------------------------------|
| Device Name: | Game Ready ^TM System |

#### Indications for Use:

The Game Ready System combines cold and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number_