(77 days)
Not Found
No
The description focuses on mechanical and software control of cold and compression therapy, with no mention of AI or ML capabilities for diagnosis, treatment planning, or adaptive therapy based on patient data.
Yes
The device is intended to treat post-surgical acute injuries to reduce edema, swelling, and pain, which are therapeutic actions.
No
The device description indicates it administers cold and compression therapies to reduce edema, swelling, and pain, which are therapeutic functions. There is no mention of it being used to identify or diagnose any medical condition.
No
The device description clearly outlines multiple hardware components including a Control Unit, AC Adapter, Connector Hose, Wrap (Heat Exchanger + Sleeve), Optional Carry Bag, and Optional Battery Pack. While it mentions Control Unit software, the device is fundamentally a hardware system with integrated software for control and safety.
Based on the provided information, the Game Ready System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to treat post-surgical acute injuries by applying cold and compression to reduce edema, swelling, and pain. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details a system that physically applies cold and compression to the body. It does not involve analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples.
- Providing information about a disease, condition, or state of health.
- Using reagents or calibrators.
- Performing laboratory tests.
The Game Ready System is a therapeutic medical device used for physical treatment.
N/A
Intended Use / Indications for 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.
Product codes
IRP, ILO
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 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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, elbow, knee, ankle, back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
No clinical testing data are submitted, referenced, or relied on to determine substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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: 510-868-5378 Fax: 510-984-5330 Email: mbaldwin@gameready.com 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
1
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.
2
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.
3
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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_