(84 days)
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.
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)
- . Connector Hose (connects Control Unit to the Wrap)
- Optional Carry bag ●
- Optional Battery Pack (Battery and AC charger) ●
- Wrap (Sleeve + Heat Exchanger) ●
The provided FDA 510(k) summary for the Game Ready GRPro 2.1 System does not contain any information about an AI/ML-based device or its acceptance criteria and study data.
This document is for a traditional medical device (a powered inflatable tube massager for cold and compression therapy) and focuses on demonstrating substantial equivalence to a predicate device. The performance data section refers to standard medical device testing like electrical safety, electromagnetic compatibility, software verification and validation, biocompatibility, and cleaning/disinfection.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set specifics, as these are not relevant to the device described in this 510(k) summary.
Specifically, to address your numbered points:
- A table of acceptance criteria and the reported device performance: This document does not present acceptance criteria in the context of an AI/ML model's performance (e.g., sensitivity, specificity, AUC). Instead, it discusses the device's adherence to safety and performance standards relevant to a physical medical device (e.g., temperature range, pressure levels, electrical safety, biocompatibility).
- Sample sizes used for the test set and the data provenance: Not applicable. The document mentions "healthy volunteer human subjects" for a skin temperature measurement as required by guidance for heating and cooling devices, but this is a very limited human factors test, not a large-scale data set for model evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood in AI/ML is not relevant to this device.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic or therapeutic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. The "ground truth" for this device would be its physical performance characteristics (e.g., actual temperature output, actual pressure, electrical safety compliance) verified through engineering tests, not expert consensus on medical images or patient outcomes data in an AI context.
- The sample size for the training set: Not applicable. There is no AI/ML model to train.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes a Class II medical device, the Game Ready GRPro 2.1 System, which provides cold and compression therapy. Its clearance is based on demonstrating substantial equivalence to a predicate device through engineering design verification and validation testing, not on the performance of an AI/ML algorithm.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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®1800 Sutter St. Ste. 500Concord, CA 94520 |
|---|---|
| Contact Person: | Ms. Natalie J. KennelConsultantNJK & Associates, Inc.13721 Via Tres VistaSan Diego, CA 92129 USAPhone: (858) 705-0350Fax: (858) 764-9739Email: NKennel@njkconsulting.com |
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/Parameters | GRPro 2.1(Subject Device) | Game Ready Classic System (GR 2),K072620(Predicate Device) | Comparison results |
|---|---|---|---|
| Indications for Use | Game Ready GRPro 2.1 System isintended to treat post-surgical and acuteinjuries to reduce edema, swelling, andpain where cold and compression areindicated. It is intended to be used by oron the order of licensed healthcareprofessionals in hospitals, outpatientclinics, athletic training settings, or homesettings. | Game Ready Classic System (GR 2) isintended to treat post-surgical and acuteinjuries to reduce edema, swelling, andpain for which cold and compression areindicated. It is intended to be used by oron the order of licensed healthcareprofessionals in hospitals, outpatientclinics, athletic training settings, or homesettings. | Same; updated to reflect different devicename only. |
| Intended Users | Healthcare professionals, athletictrainers, lay users under the direction of ahealthcare professional | Healthcare professionals, athletic trainers,lay users under the direction of ahealthcare professional | Same |
| Intended use environment | Hospitals, outpatient clinics, athletictraining facilities, prescription home use. | Hospitals, outpatient clinics, athletictraining facilities, prescription home use. | Identical |
| Principle of Operation | Pneumatic and fluid pumps and flexiblemulti-chamber wrap deliver intermittentcompression and cold therapy. | Pneumatic and fluid pumps and flexiblemulti-chamber wrap deliver intermittentcompression and cold therapy. | Same |
| Functions | |||
| Cooling Unit/CompressorDescription | Small, portable air compressor and icebox packages as one system. | Small, portable air compressor and icebox packages as one system. | Same |
| Treatment TemperatureRange | 34 - 50°F | 35-50°F | Substantially equivalent. The predicatedevice could result in a warmertemperature (closer to room temperaturedue to temperature control mechanismbut this doesn't raise different issues ofsafety and effectiveness. (Highesttemperature is limited to roomtemperature) |
| Characteristics/Parameters | GRPro 2.1(Subject Device) | Game Ready Classic System (GR 2),K072620(Predicate Device) | Comparison results |
| Temperature AdjustmentMechanism | Patented fluid flow control technology. | Mechanical valve to control fluidtemperature. | Different. Physical mechanism fortemperature adjustment is different butthe difference results better temperaturecontrol. No different issues of safety oreffectiveness raised. |
| Compression levels | Available in three levels:Low (5-15 mm Hg)Medium (5-50 mm Hg)High (5-75 mm Hg) | Available in three levels:Low (5-15 mm Hg)Medium (5-50 mm Hg)High (5-75 mm Hg) | Same |
| Treatment timeadjustment | 15 minutes default, increasing ordecreasing in 5-minute increments to amax of 90 min or a min of 5 min. | 15 minutes default, increasing ordecreasing in 5-minute increments to amax of 90 min or a min of 5 min. | Same |
| Rest Timer | Sleep option | Sleep option | Same |
| Treatment Cycle | Manual Mode:15 minutes default, increasing ordecreasing in 5-minute increments to amax of 90 min or a min of 5 min.Program Mode:Six (6) pre-programmed treatment on-offcycles are 30-30 or 30-60 min. at nopressure, low pressure, or mediumpressure. | Manual Mode:15 minutes default, increasing ordecreasing in 5-minute increments to amax of 90 min or a min of 5 min.Program Mode:Six (6) pre-programmed treatment on-offcycles are 30-30 or 30-60 min. at nopressure, low pressure, or mediumpressure. | Same |
| Software/SoftwareFeatures | Electronic pressure control and therapytime monitoring. Battery voltagemonitoring, | Electronic pressure control, therapy timemonitoring, temperature control. Batteryvoltage monitoring, | Substantially equivalent; subject deviceuses a different algorithm to adjust watertemperature. No different issues of safetyor effectiveness raised. |
| User interface (Controlunit control panel) | LCD display and 9 buttons | LCD display and 9 buttons | Substantially equivalent; slightlydifferent temperature displayinformation. Subject devices nowdisplays set point temperature |
| Number of patients thatcan be treated at the sametime | One | One | Same |
| Dimensions | Physical Unit | ||
| Dimensions | 16.25" L x 7.75" W x 9.25 H (413 x 197x 235) mm (not including carrying case) | 16.25" L x 7.75" W x 9.25" H (413 x 197x 235) mm (not including carrying case) | Same |
| Characteristics/Parameters | GRPro 2.1(Subject Device) | Game Ready Classic System (GR 2),K072620(Predicate Device) | Comparison results |
| Weight | 7.3 lbs. (3.31 kgs) empty, Approximately18 lbs. full of ice and water but less whenfilled per instructions for use | 7.3 lbs. (3.31 kgs) empty, Approximately18 lbs. full of ice and water | Substantially equivalent. Slight lowerweight when filled per instructions foruse |
| Chilling Mechanism | Ice | Ice | Same. |
| Reservoir Water/IceCapacity | 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 systemshave flow rates that provide goodtemperature distribution. Flow rate isdriven by temperature controlmechanism on subject device.. |
| Electrical | |||
| Power source | Mains power from medical desktoppower supply, optional battery pack | Mains power from medical desktop powersupply, optional battery pack | Substantially equivalent, predicatedevice lists optional battery pack as"under development" Battery is for userconvenience only. |
| Battery Type | Lithium, rechargeable | Nickle-Metal Hydride or Lithium,rechargeable | Substantially equivalent Difference doesnot raise different issues of safety oreffectiveness |
| 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 andEMC standards met | ANSI/AAMI ES60601 -1:2005/(R) 2012 & A1:2012,C1:2009 (R) 2012, A2:2010/(R)2012- Part 1CAN/CSA - C22.2 No. 60601-1:14 Part 1• IEC 60601-1-6:2010 + A1:2013• IEC 60601-1-11:2015• IEC 60601 - 1-2, Ed. 4.0: 2014• BS EN 60601-1-2:2015• IEC 62366:2007 + A1:2014• IEC 62133:2012 + C1:2013 | ANSI/AAMI ES60601-1:2005/• IEC 60601-1-2EN60601-1-2 compliant (EMC) | Substantially equivalent. Tested subjectdevice meets additional horizontalstandards for medical electrical safetyand home use; meets 4th edition of EMCstandards. |
| Characteristics/Parameters | GRPro 2.1(Subject Device) | Game Ready Classic System (GR 2),K072620(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 devicerange is wider because testing confirmeduse up to 3,000 meters. |
| Wraps (Accessories) | |||
| Wraptechnology/characteristics | Flexible "Wraps"; outer sleeve with innerheat exchanger to deliver compressionand cold. 2-chamber heat exchanger(water and air). | Flexible "Wraps"; outer sleeve with innerheat exchanger to deliver compression andcold. 2-chamber heat exchanger (waterand air). | Same |
| Wraps Types | Various anatomical wraps in differentsizes for:Straight Knee, Straight Elbow, Ankle,Shoulder, Back, Traumatic Amputee,Neck, Lower Limb, Full Leg Boot andChest | Various anatomical wraps in differentsizes for:Straight Knee, Straight Elbow, Ankle,Shoulder, Back | Substantially equivalent. AdditionalWraps available since K072620(predicate) clearance. The new Wrapshave same intended use and indicationsfor use as the predicate wraps. |
| Primary PatientContacting Material | 70 Denier nylon & polyester | 70 Denier nylon | Substantially equivalent No differentissues of safety and effectiveness |
| Additional materials forstraps and trim(incidental or no patientcontact) | Elastomeric materials of nylon orpolyester with natural or syntheticrubber/latex | Elastomeric materials of nylon orpolyester with natural or syntheticrubber/latex | Same (Elastomeric materials present butnot mentioned in predicate devicesubmission) |
| Biocompatibility | Primary patient contacting componentsverified as acceptable according to ISO10993-1 using cytotoxicity, primaryirritation and skin sensitization.Additional elastomeric materials wereverified as acceptable according to ISO10993-1 using acute systematic toxicity,primary irritation and skin sensitization. | Primary patient contacting componentsverified as acceptable according to ISO10993-1 using cytotoxicity, primaryirritation and skin sensitization. | Substantially equivalent. No mention ofelastomeric materials biocompatibility inpredicate device submission but thesematerials 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.
§ 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).