(84 days)
Not Found
No
The document describes a cold and compression therapy device with software control, but there is no mention of AI or ML capabilities in the intended use, device description, or performance studies. The focus is on delivering controlled cold and compression based on pre-set parameters.
Yes.
The device is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain, which are therapeutic applications.
No
The device is intended to treat injuries by reducing edema, swelling, and pain using cold and compression therapy, rather than to diagnose conditions.
No
The device description explicitly lists multiple hardware components including a Control Unit, AC Adapter, Connector Hose, Optional Carry bag, Optional Battery Pack, and Wraps. While it is software-controlled, it is not solely software.
Based on the provided information, the Game Ready GRPro 2.1 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Game Ready GRPro 2.1 System Function: The description clearly states that the Game Ready GRPro 2.1 System is a medical device that provides cold and compression therapy to treat post-surgical and acute injuries. It works by applying chilled water and compressed air externally to the body.
- No Specimen Analysis: There is no mention of the device collecting, preparing, or analyzing any specimens from the human body. Its function is purely external therapeutic application.
Therefore, the Game Ready GRPro 2.1 System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IRP, ILO
Device 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)
- . Connector Hose (connects Control Unit to the Wrap)
- Optional Carry bag ●
- Optional Battery Pack (Battery and AC charger) ●
- Wrap (Sleeve + Heat Exchanger) ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Various anatomical wraps in different sizes for: Straight Knee, Straight Elbow, Ankle, Shoulder, Back, Traumatic Amputee, Neck, Lower Limb, Full Leg Boot and Chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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)
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.
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 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 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) per FDA guidance. All required items related to software as required by FDA guidance for moderate LOC have been included in this submission.
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.
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.
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
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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
2
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. 500
Concord, CA 94520 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Natalie J. Kennel
Consultant
NJK & Associates, Inc.
13721 Via Tres Vista
San Diego, CA 92129 USA
Phone: (858) 705-0350
Fax: (858) 764-9739
Email: 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)
4
- . 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 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. | Game Ready Classic System (GR 2) is
intended to treat post-surgical and acute
injuries to reduce edema, swelling, and
pain for which 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. | Same; updated to reflect different device
name only. |
| Intended Users | Healthcare professionals, athletic
trainers, lay users under the direction of a
healthcare professional | Healthcare professionals, athletic trainers,
lay users under the direction of a
healthcare professional | Same |
| Intended use environment | Hospitals, outpatient clinics, athletic
training facilities, prescription home use. | Hospitals, outpatient clinics, athletic
training facilities, prescription home use. | Identical |
| Principle of Operation | Pneumatic and fluid pumps and flexible
multi-chamber wrap deliver intermittent
compression and cold therapy. | Pneumatic and fluid pumps and flexible
multi-chamber wrap deliver intermittent
compression and cold therapy. | Same |
| Functions | | | |
| Cooling Unit/Compressor
Description | Small, portable air compressor and ice
box packages as one system. | Small, portable air compressor and ice
box packages as one system. | Same |
| Treatment Temperature
Range | 34 - 50°F | 35-50°F | Substantially equivalent. The predicate
device could result in a warmer
temperature (closer to room temperature
due to temperature control mechanism
but this doesn't raise different issues of
safety and effectiveness. (Highest
temperature is limited to room
temperature) |
| Characteristics/
Parameters | GRPro 2.1
(Subject Device) | Game Ready Classic System (GR 2),
K072620
(Predicate Device) | Comparison results |
| Temperature Adjustment
Mechanism | Patented fluid flow control technology. | Mechanical valve to control fluid
temperature. | Different. Physical mechanism for
temperature adjustment is different but
the difference results better temperature
control. No different issues of safety or
effectiveness 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 time
adjustment | 15 minutes default, increasing or
decreasing in 5-minute increments to a
max of 90 min or a min of 5 min. | 15 minutes default, increasing or
decreasing in 5-minute increments to a
max 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 or
decreasing in 5-minute increments to a
max of 90 min or a min of 5 min.
Program Mode:
Six (6) pre-programmed treatment on-off
cycles are 30-30 or 30-60 min. at no
pressure, low pressure, or medium
pressure. | Manual Mode:
15 minutes default, increasing or
decreasing in 5-minute increments to a
max of 90 min or a min of 5 min.
Program Mode:
Six (6) pre-programmed treatment on-off
cycles are 30-30 or 30-60 min. at no
pressure, low pressure, or medium
pressure. | Same |
| Software/Software
Features | Electronic pressure control and therapy
time monitoring. Battery voltage
monitoring, | Electronic pressure control, therapy time
monitoring, temperature control. Battery
voltage monitoring, | Substantially equivalent; subject device
uses a different algorithm to adjust water
temperature. No different issues of safety
or effectiveness raised. |
| User interface (Control
unit control panel) | LCD display and 9 buttons | LCD display and 9 buttons | Substantially equivalent; slightly
different temperature display
information. Subject devices now
displays set point temperature |
| Number of patients that
can be treated at the same
time | One | One | Same |
| Dimensions | Physical Unit | | |
| Dimensions | 16.25" L x 7.75" W x 9.25 H (413 x 197
x 235) mm (not including carrying case) | 16.25" L x 7.75" W x 9.25" H (413 x 197
x 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, Approximately
18 lbs. full of ice and water but less when
filled per instructions for use | 7.3 lbs. (3.31 kgs) empty, Approximately
18 lbs. full of ice and water | Substantially equivalent. Slight lower
weight when filled per instructions for
use |
| Chilling Mechanism | Ice | Ice | Same. |
| Reservoir Water/Ice
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
have flow rates that provide good
temperature distribution. Flow rate is
driven by temperature control
mechanism on subject device.. |
| | | Electrical | |
| Power source | Mains power from medical desktop
power supply, optional battery pack | Mains power from medical desktop power
supply, optional battery pack | Substantially equivalent, predicate
device lists optional battery pack as
"under development" Battery is for user
convenience only. |
| Battery Type | Lithium, rechargeable | Nickle-Metal Hydride or Lithium,
rechargeable | Substantially equivalent Difference does
not raise different issues of safety or
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
EMC standards met | ANSI/AAMI ES60601 -
1:2005/(R) 2012 & A1:2012,
C1:2009 (R) 2012, A2:2010/(R)
2012- Part 1
CAN/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 60601-1-2
EN60601-1-2 compliant (EMC) | Substantially equivalent. Tested subject
device meets additional horizontal
standards for medical electrical safety
and home use; meets 4th edition of EMC
standards. |
| 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 device
range is wider because testing confirmed
use up to 3,000 meters. |
| Wraps (Accessories) | | | |
| Wrap
technology/characteristics | Flexible "Wraps"; outer sleeve with inner
heat exchanger to deliver compression
and cold. 2-chamber heat exchanger
(water and air). | Flexible "Wraps"; outer sleeve with inner
heat exchanger to deliver compression and
cold. 2-chamber heat exchanger (water
and air). | Same |
| Wraps Types | Various anatomical wraps in different
sizes for:
Straight Knee, Straight Elbow, Ankle,
Shoulder, Back, Traumatic Amputee,
Neck, Lower Limb, Full Leg Boot and
Chest | Various anatomical wraps in different
sizes for:
Straight Knee, Straight Elbow, Ankle,
Shoulder, Back | Substantially equivalent. Additional
Wraps available since K072620
(predicate) clearance. The new Wraps
have same intended use and indications
for use as the predicate wraps. |
| Primary Patient
Contacting Material | 70 Denier nylon & polyester | 70 Denier nylon | Substantially equivalent No different
issues of safety and effectiveness |
| Additional materials for
straps and trim
(incidental or no patient
contact) | Elastomeric materials of nylon or
polyester with natural or synthetic
rubber/latex | Elastomeric materials of nylon or
polyester with natural or synthetic
rubber/latex | Same (Elastomeric materials present but
not mentioned in predicate device
submission) |
| Biocompatibility | Primary patient contacting components
verified as acceptable according to ISO
10993-1 using cytotoxicity, primary
irritation and skin sensitization.
Additional elastomeric materials were
verified as acceptable according to ISO
10993-1 using acute systematic toxicity,
primary irritation and skin sensitization. | Primary patient contacting components
verified as acceptable according to ISO
10993-1 using cytotoxicity, primary
irritation and skin sensitization. | Substantially equivalent. No mention of
elastomeric materials biocompatibility in
predicate device submission but these
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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7
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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)
10
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.