Game Ready GRPro 2.1 System

K192114 · Cool Systems, Inc. (Dba Game Ready) · IRP · Oct 29, 2019 · Physical Medicine

Device Facts

• Record ID: K192114
• Device Name: Game Ready GRPro 2.1 System
• Applicant: Cool Systems, Inc. (Dba Game Ready)
• Product Code: IRP · Physical Medicine
• Decision Date: Oct 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Game Ready GRPro 2.1 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 Story

Portable DC-powered system providing cold and compression therapy; utilizes control unit, AC adapter, and anatomical wraps (sleeve + heat exchanger). System circulates chilled water and compressed air through multi-chamber wraps to treat pain/swelling. Operated by healthcare professionals, athletic trainers, or patients (home use) via control panel with LCD and 9 buttons. Features manual and programmed treatment cycles (pressure/time). Provides intermittent compression and cold therapy; helps reduce edema and pain post-surgery or injury. Benefits patient through controlled, localized recovery therapy.

Clinical Evidence

No clinical studies performed. Bench testing conducted per FDA guidance for heating/cooling devices; healthy human subjects used to measure minimum skin temperature (41°F) at lowest setting. System underwent design verification/validation for electrical safety, EMC, software, and biocompatibility (ISO 10993-1).

Technological Characteristics

DC-powered; portable air compressor and ice/water reservoir. Materials: 70 Denier nylon/polyester, elastomeric straps. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-1-2 (4th ed), IEC 62366, IEC 62133. Connectivity: Standalone. Software: Moderate Level of Concern. Sterilization: Non-sterile.

Indications for Use

Indicated for post-surgical and acute injury treatment to reduce edema, swelling, and pain where cold and compression are indicated. For use by or on order of licensed healthcare professionals in hospitals, clinics, athletic training, or home settings.

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

• Game Ready Classic GR2 (K072620)

Submission Summary (Full Text)

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October 29, 2019

CoolSystems®, Inc. (dba Game Ready®) % Natalie J. Kennel Regulatory Affairs Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, California 92129

Re: K192114

Trade/Device Name: Game Ready GRPro 2.1 System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILO Dated: August 5. 2019 Received: August 6, 2019

Dear Natalie Kennel:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Vivek Pinto, Ph.D. Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K192114

Device Name

Game Ready GRPro 2.1 System

Indications for Use (Describe)

The Game Ready GRPro 2.1 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.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> |
|----------------------------------------------|---------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> |

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Image /page/3/Picture/0 description: The image shows the logo for Game Ready. The logo consists of the words "GAME" and "READY" in a simple, sans-serif font, with a stylized "GR" in between. The "GR" is in a dark red color, while the other letters are black. There is a registered trademark symbol after the word READY.

# 510(k) Summary

| Sponsor: | CoolSystems®, Inc. (dba Game Ready®<br>1800 Sutter St. Ste. 500<br>Concord, CA 94520 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Natalie J. Kennel<br>Consultant<br>NJK & Associates, Inc.<br>13721 Via Tres Vista<br>San Diego, CA 92129 USA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

Date Prepared: October 17, 2019

#### DEVICE INFORMATION:

| Proprietary Name: | Game Ready GRPro 2.1 System |
|-----------------------|----------------------------------|
| Common Name: | Powered inflatable tube massager |
| Classification: | II |
| Product Codes: | IRP, ILO |
| Regulations: | 21 CFR 890.5650 |
| Classification Panel: | 89- Physical Medicine |

#### PRODUCT DESCRIPTION:

The Game Ready GRPro 2.1 System and its accessories including Wraps is a medical device that helps athletes and patients recover from post-surgical and acute injuries to reduce edema, swelling, and pain. The Game Ready GRPro 2.1 System provides cold and compression therapy using ice and water in a portable device. The Game Ready GRPro 2.1 System is a DC-powered, software-controlled device that delivers compressed air and chilled water from the Control Unit through tubing to a Wrap that is designed for a specific body part (e.g., shoulder, elbow, knee, ankle, back) to treat pain and swelling from injuries and/or surgical interventions. The Game Ready GRPro 2.1 System is comprised of the following components:

- Control Unit ●
- AC Adapter (to convert line power to DC input power)

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- . Connector Hose (connects Control Unit to the Wrap)
- Optional Carry bag ●
- Optional Battery Pack (Battery and AC charger) ●
- Wrap (Sleeve + Heat Exchanger) ●

## INDICATIONS FOR USE:

The Game Ready GRPro 2.1 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.

## PREDICATE DEVICES:

The selected predicate device, the Game Ready Classic GR2 was cleared on October 31, 2007. CoolSystems® (dba Game Ready) is the owner of the predicate 510(k), K072620.

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# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

| Characteristics/<br>Parameters | GRPro 2.1<br>(Subject Device) | Game Ready Classic System (GR 2),<br>K072620<br>(Predicate Device) | Comparison results |
|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Game Ready GRPro 2.1 System is<br>intended to treat post-surgical and acute<br>injuries to reduce edema, swelling, and<br>pain where cold and compression are<br>indicated. It is intended to be used by or<br>on the order of licensed healthcare<br>professionals in hospitals, outpatient<br>clinics, athletic training settings, or home<br>settings. | Game Ready Classic System (GR 2) is<br>intended to treat post-surgical and acute<br>injuries to reduce edema, swelling, and<br>pain for which cold and compression are<br>indicated. It is intended to be used by or<br>on the order of licensed healthcare<br>professionals in hospitals, outpatient<br>clinics, athletic training settings, or home<br>settings. | Same; updated to reflect different device<br>name only. |
| Intended Users | Healthcare professionals, athletic<br>trainers, lay users under the direction of a<br>healthcare professional | Healthcare professionals, athletic trainers,<br>lay users under the direction of a<br>healthcare professional | Same |
| Intended use environment | Hospitals, outpatient clinics, athletic<br>training facilities, prescription home use. | Hospitals, outpatient clinics, athletic<br>training facilities, prescription home use. | Identical |
| Principle of Operation | Pneumatic and fluid pumps and flexible<br>multi-chamber wrap deliver intermittent<br>compression and cold therapy. | Pneumatic and fluid pumps and flexible<br>multi-chamber wrap deliver intermittent<br>compression and cold therapy. | Same |
| Functions | | | |
| Cooling Unit/Compressor<br>Description | Small, portable air compressor and ice<br>box packages as one system. | Small, portable air compressor and ice<br>box packages as one system. | Same |
| Treatment Temperature<br>Range | 34 - 50°F | 35-50°F | Substantially equivalent. The predicate<br>device could result in a warmer<br>temperature (closer to room temperature<br>due to temperature control mechanism<br>but this doesn't raise different issues of<br>safety and effectiveness. (Highest<br>temperature is limited to room<br>temperature) |
| Characteristics/<br>Parameters | GRPro 2.1<br>(Subject Device) | Game Ready Classic System (GR 2),<br>K072620<br>(Predicate Device) | Comparison results |
| Temperature Adjustment<br>Mechanism | Patented fluid flow control technology. | Mechanical valve to control fluid<br>temperature. | Different. Physical mechanism for<br>temperature adjustment is different but<br>the difference results better temperature<br>control. No different issues of safety or<br>effectiveness raised. |
| Compression levels | Available in three levels:<br>Low (5-15 mm Hg)<br>Medium (5-50 mm Hg)<br>High (5-75 mm Hg) | Available in three levels:<br>Low (5-15 mm Hg)<br>Medium (5-50 mm Hg)<br>High (5-75 mm Hg) | Same |
| Treatment time<br>adjustment | 15 minutes default, increasing or<br>decreasing in 5-minute increments to a<br>max of 90 min or a min of 5 min. | 15 minutes default, increasing or<br>decreasing in 5-minute increments to a<br>max of 90 min or a min of 5 min. | Same |
| Rest Timer | Sleep option | Sleep option | Same |
| Treatment Cycle | Manual Mode:<br>15 minutes default, increasing or<br>decreasing in 5-minute increments to a<br>max of 90 min or a min of 5 min.<br>Program Mode:<br>Six (6) pre-programmed treatment on-off<br>cycles are 30-30 or 30-60 min. at no<br>pressure, low pressure, or medium<br>pressure. | Manual Mode:<br>15 minutes default, increasing or<br>decreasing in 5-minute increments to a<br>max of 90 min or a min of 5 min.<br>Program Mode:<br>Six (6) pre-programmed treatment on-off<br>cycles are 30-30 or 30-60 min. at no<br>pressure, low pressure, or medium<br>pressure. | Same |
| Software/Software<br>Features | Electronic pressure control and therapy<br>time monitoring. Battery voltage<br>monitoring, | Electronic pressure control, therapy time<br>monitoring, temperature control. Battery<br>voltage monitoring, | Substantially equivalent; subject device<br>uses a different algorithm to adjust water<br>temperature. No different issues of safety<br>or effectiveness raised. |
| User interface (Control<br>unit control panel) | LCD display and 9 buttons | LCD display and 9 buttons | Substantially equivalent; slightly<br>different temperature display<br>information. Subject devices now<br>displays set point temperature |
| Number of patients that<br>can be treated at the same<br>time | One | One | Same |
| Dimensions | Physical Unit | | |
| Dimensions | 16.25" L x 7.75" W x 9.25 H (413 x 197<br>x 235) mm (not including carrying case) | 16.25" L x 7.75" W x 9.25" H (413 x 197<br>x 235) mm (not including carrying case) | Same |
| Characteristics/<br>Parameters | GRPro 2.1<br>(Subject Device) | Game Ready Classic System (GR 2),<br>K072620<br>(Predicate Device) | Comparison results |
| Weight | 7.3 lbs. (3.31 kgs) empty, Approximately<br>18 lbs. full of ice and water but less when<br>filled per instructions for use | 7.3 lbs. (3.31 kgs) empty, Approximately<br>18 lbs. full of ice and water | Substantially equivalent. Slight lower<br>weight when filled per instructions for<br>use |
| Chilling Mechanism | Ice | Ice | Same. |
| Reservoir Water/Ice<br>Capacity | Approximately 5100 mL (5.4 qt) | Approximately 5100 mL (5.4 qt) | Same. |
| Coolant | Tap water and ice | Tap Water and ice | Same. |
| Water flow rate | 275-450 mL/min | 275-450 ml/min adjustable flow | Substantially equivalent. Both systems<br>have flow rates that provide good<br>temperature distribution. Flow rate is<br>driven by temperature control<br>mechanism on subject device.. |
| | | <b>Electrical</b> | |
| Power source | Mains power from medical desktop<br>power supply, optional battery pack | Mains power from medical desktop power<br>supply, optional battery pack | Substantially equivalent, predicate<br>device lists optional battery pack as<br>"under development" Battery is for user<br>convenience only. |
| Battery Type | Lithium, rechargeable | Nickle-Metal Hydride or Lithium,<br>rechargeable | Substantially equivalent Difference does<br>not raise different issues of safety or<br>effectiveness |
| Input power | 12V 2.5A (through AC adapter) | 12V 2.5A (through AC adapter) | Same |
| Line Voltage | 100-240 V AC | 100-240 V AC | Same |
| Line Frequency | 50/60 Hz | 50/60 Hz | Same |
| Electrical Safety and<br>EMC standards met | ANSI/AAMI ES60601 -<br>1:2005/(R) 2012 & A1:2012,<br>C1:2009 (R) 2012, A2:2010/(R)<br>2012- Part 1<br>CAN/CSA - C22.2 No. 60601-<br>1:14 Part 1<br>• IEC 60601-1-6:2010 + A1:2013<br>• IEC 60601-1-11:2015<br>• IEC 60601 - 1-2, Ed. 4.0: 2014<br>• BS EN 60601-1-2:2015<br>• IEC 62366:2007 + A1:2014<br>• IEC 62133:2012 + C1:2013 | ANSI/AAMI ES60601-1:2005/<br>• IEC 60601-1-2<br>EN60601-1-2 compliant (EMC) | Substantially equivalent. Tested subject<br>device meets additional horizontal<br>standards for medical electrical safety<br>and home use; meets 4th edition of EMC<br>standards. |
| Characteristics/<br>Parameters | GRPro 2.1<br>(Subject Device) | Game Ready Classic System (GR 2),<br>K072620<br>(Predicate Device) | Comparison results |
| Environment | | | |
| Operating Temperature | 33.8 - 104 F (1-40 C) | 33.8 F - 104 F (1-40C) | Same. |
| Storage Temperature | 33-122 F (1 C - 50 C) | 33 F - 122 F (1 C - 50 C) | Same. |
| Storage Humidity | 15% - 90% non-condensing | 10% - 95% non-condensing | Substantially equivalent. |
| Operating Altitude | 0-9,843 Ft (3,000 meters) | 0-8,000 Ft (0-2,500 m) | Substantially equivalent; subject device<br>range is wider because testing confirmed<br>use up to 3,000 meters. |
| Wraps (Accessories) | | | |
| Wrap<br>technology/characteristics | Flexible "Wraps"; outer sleeve with inner<br>heat exchanger to deliver compression<br>and cold. 2-chamber heat exchanger<br>(water and air). | Flexible "Wraps"; outer sleeve with inner<br>heat exchanger to deliver compression and<br>cold. 2-chamber heat exchanger (water<br>and air). | Same |
| Wraps Types | Various anatomical wraps in different<br>sizes for:<br>Straight Knee, Straight Elbow, Ankle,<br>Shoulder, Back, Traumatic Amputee,<br>Neck, Lower Limb, Full Leg Boot and<br>Chest | Various anatomical wraps in different<br>sizes for:<br>Straight Knee, Straight Elbow, Ankle,<br>Shoulder, Back | Substantially equivalent. Additional<br>Wraps available since K072620<br>(predicate) clearance. The new Wraps<br>have same intended use and indications<br>for use as the predicate wraps. |
| Primary Patient<br>Contacting Material | 70 Denier nylon & polyester | 70 Denier nylon | Substantially equivalent No different<br>issues of safety and effectiveness |
| Additional materials for<br>straps and trim<br>(incidental or no patient<br>contact) | Elastomeric materials of nylon or<br>polyester with natural or synthetic<br>rubber/latex | Elastomeric materials of nylon or<br>polyester with natural or synthetic<br>rubber/latex | Same (Elastomeric materials present but<br>not mentioned in predicate device<br>submission) |
| Biocompatibility | Primary patient contacting components<br>verified as acceptable according to ISO<br>10993-1 using cytotoxicity, primary<br>irritation and skin sensitization.<br>Additional elastomeric materials were<br>verified as acceptable according to ISO<br>10993-1 using acute systematic toxicity,<br>primary irritation and skin sensitization. | Primary patient contacting components<br>verified as acceptable according to ISO<br>10993-1 using cytotoxicity, primary<br>irritation and skin sensitization. | Substantially equivalent. No mention of<br>elastomeric materials biocompatibility in<br>predicate device submission but these<br>materials were in use. |
| Sterile or Non-sterile | Non-sterile only | Non-sterile only | Same |

Table 1 Comparison of the Game Ready GRPro 2.1 System and its predicate

## Table 1 is a detailed comparison of the Game Ready GRPro 2.1 System with its predicate device.

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## PERFORMANCE DATA

The Game Ready GRPro 2.1 System with its Wraps has been subjected to design verification and validation testing for electrical safety, electromagnetic compatibility, software V&V, system/bench testing, and storage and transport performance. These tests verified and validated the proper operation of the current version system. All patient contacting components and accessories have been tested to demonstrate appropriate biocompatibility. No part of the system components or accessories are provided sterile or can be sterilized. Cleaning and disinfection instructions have been validated and are included in the labeling for the system and accessories. The Game Ready GRPro 2.1 System with its Wraps has been found to be adequately safe and effective for the intended users, its intended uses, and use environments.

## BIOCOMPATIBILITY

The biocompatibility evaluation was conducted within the risk management framework and in compliance with ISO 10993 standards. This evaluation of each device component accessory, specifically the new Wraps, with patient contact included relevant data sources related to biological safety of testing finished device material by supplier, component material history of safe biological use and testing, and use in previously cleared products accessories for the same intended use. This biocompatibility evaluation established the biological safety of the new patient contacting Wraps of the Game Ready GRPro 2.1

## CLEANING, DISINFECTION & SHELF LIFE TESTING

Cleaning and disinfection instructions for the non-patient contacting components are given in the labeling. The impact of repeated use of these cleaning/disinfecting materials over the expected life of the Game Ready GRPro 2.1 System Control Unit has been validated.

The Game Ready GRPro 2.1 System uses the previously 510(k) cleared Wraps and new Wraps included in this submission. The Wraps which provide the patient contact are intended for use over intact skin or sterile dressings only. They are provided non-sterile and not intended to be user sterilized. Instructions for how to clean and disinfect if needed the sleeve or heat exchangers of the Wraps have been provided in the respective labeling for the Wraps.

Neither the Game Ready GRPro 2.1 System components nor the Wraps have a definitive shelf life based on packaging or time. Expected life is based on frequency of use and continued functional performance.

#### SOFTWARE

The software in the Game Ready GRPro 2.1 System, including both custom-developed firmware and OTS software, has been verified and validated and demonstrated to be safe and effective for its intended use. The software is a Moderate Level of Concern (LOC)

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per FDA guidance. All required items related to software as required by FDA guidance for moderate LOC have been included in this submission.

## ELECTRICAL SAFETY & EMC

The Game Ready GRPro 2.1 System complies with all the medical electrical safety and electromagnetic compatibility requirements of IEC 60601 3.1 edition standards including the ANSI/AAMI/ES60601 with the U.S. deviations, and the 4th edition of collateral standard for EMC. Refer to the list of standards in Table 1.

## ANIMAL STUDIES

No animal studies were performed to support this submission.

## CLINICAL STUDIES

Although clinical studies were not needed to demonstrate substantial equivalence of the Game Ready GRPro 2.1, the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices" (July 26, 1995, reformatted 12/18/1997 requires measure of the lowest skin temperature that the device can generate at its lowest setting. This measurement of the lowest skin temperature had to be conducted with healthy volunteer human subjects.

As required by the FDA guidance for heating and cooling devices, the Game Ready GRPro 2.1 System was used at its lowest setting with the worst case wrap and location on healthy subjects. A minimum skin temperature of 41°F was measured and has been included in the product labeling.

## CONCLUSION

The data and information provided in this submission support the conclusion that the Game Ready GRPro 2.1 System is substantially equivalent to its predicate device with respect to indications for use and technological characteristics.