The Game Ready Classic System 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 licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

Device Description

The Game Ready Classic 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 (under development) .

The Game Ready Classic 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 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. These protections have been carried forward from the original Game Ready to Game Ready Classic.

AI/ML Overview

The provided text is for a 510(k) premarket notification for the "Game Ready Classic System," a cold/compression therapy system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with specific acceptance criteria related to a new technology's performance.

Therefore, the information requested in the prompt, which typically applies to studies evaluating the performance of a diagnostic or AI-driven device against predefined acceptance criteria, is not present in this 510(k) submission.

Here's a breakdown of why the requested information cannot be provided from this document:

No new performance claims: The Game Ready Classic System is presented as substantially equivalent to an existing device (Game Ready System, K071050) already on the market. This means the primary evidence presented is a comparison to the predicate, not a performance study against novel acceptance criteria.
No clinical testing: The document explicitly states: "No clinical testing data are submitted, referenced, or relied on to determine substantial equivalence." This immediately rules out any studies involving human subjects, ground truth establishment, expert review, or MRMC studies.
Bench testing for specifications: The "Non-Clinical Testing" section mentions "Bench testing was performed at the component and system level. The testing showed that the Game Ready Classic System met its requirements. Design Verification Testing showed that the Game Ready Classic System performed according to specification." This refers to engineering and quality assurance testing against internal specifications, not externally defined acceptance criteria for clinical performance that would typically be described in the context of diagnostic accuracy, sensitivity, or specificity.

In summary, based on the provided 510(k) summary, the following information is not available:

A table of acceptance criteria and the reported device performance: No such criteria or performance metrics (like sensitivity, specificity, AUC) are discussed in the context of a clinical study.
Sample size used for the test set and the data provenance: No clinical test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment was conducted as there was no clinical study.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (this is a physical therapy device, not an AI algorithm).
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable (no AI training set).
How the ground truth for the training set was established: Not applicable.

The "study" that proves the device meets "acceptance criteria" in this context is the comparison to the predicate device and the bench testing demonstrating the device meets its own design specifications, indicating substantial equivalence and safety, rather than a clinical performance study against specific acceptance criteria.

Summary

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K072620

510(k) Summary of Safety and Effectiveness

Game Ready Classic System

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:

OC1 3 1 2007

A. Submitter:	CoolSystems, Inc.2201 Dwight WayBerkeley, CA 94704
Phone:	510-868-5378
Fax:	510-984-5330
Email:	mbaldwin@gameready.com
Contact:	Marianne Baldwin, VP, QA/RA/CA
Date Prepared:	September 14th, 2007

B. Device Names:

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

C. Predicate Device:

The Game Ready Classic System is substantially equivalent to the Game Ready System, cleared under 510(k) K071050, and currently legally marketed by CoolSystems, Inc.

D. Device Description:

The Game Ready Classic 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 (under development) .

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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. These protections have been carried forward from the original Game Ready to Game Ready Classic.

E. Intended Use:

F. Comparison with the Predicate Device:

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

G. Non-Clinical Testing

Bench testing was performed at the component and system level. The testing showed that the Game Ready Classic System met its requirements. Design Verification Testing showed that the Game Ready Classic System performed according to specification.

H. Clinical Testing

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

ﻨﮯ Conclusions

There are no significant differences between the Game Ready Classic System and the predicate device that would adversely affect the use of the proposed device or introduce new potential risks or safety concerns. The Game Ready Classic System is substantially equivalent to the predicate device in design, function, and indications for use/intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2007

CoolSystems, Inc % Ms. Marianne Baldwin 2201 Dwight Way Berkeley, CA 94704

Re: K072620

Trade/Device Name: Game Ready Classic System 550550 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: II Product Code: IRP, ILO Dated: September 14, 2007 Received: September 17, 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.

Image /page/2/Picture/11 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is facing to the right and has a sleek, modern design.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sincerely yours,

for Pete,

Mark Melkerson

DEP D. RECTOR
10/31/07

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 (if known):

Game Ready™ Classic System Device Name: _

Indications for Use:

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 IF NEEDED)

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

(Division Sign-Uff) Division of General. Restorative. and Neurological Devic

510/k) Number

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
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.(b)
Classification. Class II (performance standards).