(114 days)
K9647991
No
The description focuses on physical therapy modalities (cold, heat, contrast, compression) and a software-controlled interface for managing these therapies. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to treat post-surgical and acute injuries, reduce edema, swelling, and pain, and treat post traumatic and/or surgical medical conditions, which are all therapeutic purposes. Its functionalities (cold, heat, contrast, and compression therapies) are designed to provide therapeutic effects on the body.
No
Explanation: The device is intended for treatment (reducing edema, swelling, and pain, localized thermal therapy) and therapy management, not for diagnosing conditions or diseases.
No
The device description clearly outlines physical components such as water reservoirs, pumps, a cold engine, valves, power supplies, and an enclosure made of plastic and sheet metal. While it is software-controlled, it is not solely software.
Based on the provided information, the Med4 Elite™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Med4 Elite™ Function: The Med4 Elite™ is a therapeutic device that applies physical modalities (cold, heat, contrast, and compression) directly to the body's surface to treat injuries and reduce symptoms. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for treating post-surgical and acute injuries and conditions, not for diagnostic purposes based on analyzing samples.
- Device Description: The description focuses on the physical components and how it delivers therapy, not on analyzing biological materials.
Therefore, the Med4 Elite™ falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Med4 Elite™ combines cold, heat, contrast and compression therapies.
It 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 treat post traumatic and/or surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold or contrast) are indicated.
Product codes
IRP, ILO
Device Description
The Med4 Elite™ (Model Number 650550) is an AC powered, software-controlled multimodality device, designed to be used in a clinical setting, and under the direction and supervision of a licensed healthcare professional in rehabilitation facilities, outpatient clinics and athletic training settings. The device features iceless cold therapy, heat therapy, contrast (alternating heat and cold) therapy, and intermittent pneumatic compression therapy for one or two patients at a time. The device is designed to be compatible with the pre-existing portfolio of ergonomic Game Ready Wraps made for specific body parts (e.g., shoulder, elbow, knee, ankle, back, etc.). The Wraps are flexible water circulating garments that apply to the body to deliver cold, heat, or rapid contrast temperature and/or compression therapy. The wrap is comprised of an inner ATX Series Heat Exchanger and an Outer Sleeve.
The Med4 Elite™ allows for treatment of one or two patients, or two anatomical locations simultaneously. The device is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings.
The physical description of the Med4 Elite™ is a compact unit with four caster wheels and a built-in handle. It has two separate, covered reservoirs - one for holding cold water and the other for holding hot water. The water reservoirs, pumps, cold engine, valves, power supplies and any other electronics are inside a covered enclosure made out of both plastic and sheet metal that can only be accessed with a tool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, elbow, knee, ankle, back, Hip-Groin, Hand-Wrist, Flexed Elbow, Half-leg boot
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 rehabilitation facilities, outpatient clinics, and athletic training 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)
Clinical Data
An IRB approved clinical study was conducted on healthy volunteers who provided in informed consent for the purpose of measuring the maximum and minimum skin temperatures.
Key Results:
Maximum Temperature: Skin temperature measured as high as 111 °F (44 °C) when set to maximum Heat Reservoir set point
Minimum Temperature: Skin temperature measured as low as 44 °F (7 °C) when set to minimum Cold Reservoir set point
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K9647991
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2017
Cool Systems, Inc. (dba Game Ready) % Natalie Kennel Regulatory Affairs Consultant NJK & Associates 13721 Via Tres Vista San Diego, California 92129
Re: K171685
Trade/Device Name: Med4 Elite Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP, ILO Dated: August 25, 2017 Received: August 29, 2017
Dear Natalie Kennel:
This letter corrects our substantially equivalent letter of 9/29/17.
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. 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
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Vivek J. Pinto -S
for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171685
Device Name Med4 Elite™
Indications for Use (Describe)
The Med4 Elite™ combines cold, heat, contrast and compression therapies.
It 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 treat post traumatic and/or surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold or contrast) are indicated.
It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Game Ready. The logo consists of the word "GAME" followed by a stylized "GR" symbol in red, and then the word "READY" with a registered trademark symbol. The text is in a simple, sans-serif font and is horizontally aligned.
510(k) Summary
CoolSystems®, Inc. (dba Game Ready®) Sponsor: 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: September 29, 2017
DEVICE INFORMATION
| Proprietary Name: | Med4 Elite™ |
|---|---|
| Common Name: | Heat and/or Cold and Compression Therapy |
| Regulatory Common | Powered Inflatable tube massager |
| Classification: | Class II (510(k) required) |
| Device Product Code: | 21 CFR 890.5650 product code IRP, ILO |
| Classification Panel | 89- Physical Medicine |
Predicate Devices
The predicate devices are listed in Table 1. The primary predicate device is the Game Ready® Classic System (GR2) (K072620) and the secondary predicate is the VascuTherm™ (K061866). One other reference device is also listed.
None of the predicates have been subject to design recalls.
4
| 510(k) | Product | 510(k) Holder | Clearance Date | Comment |
|---|---|---|---|---|
| K072620 | Game Ready® Classic | |||
| System (GR 2) | CoolSystems® | |||
| (dba Game | ||||
| Ready) | Oct. 31, 2007 | Primary Predicate | ||
| K061866 | NanoTherm™ and | |||
| VascuTherm™ | ThermoTek, Inc. | August 22, 2006 | Secondary | |
| Predicate(NanoTherm™) | ||||
| K9647991 | Artrotherm | |||
| Cryotherapy | Ormed | August 29, 1997 | Reference device |
Table 1 Table of Predicates
Product Description:
The Med4 Elite™ (Model Number 650550) is an AC powered, software-controlled multimodality device, designed to be used in a clinical setting, and under the direction and supervision of a licensed healthcare professional in rehabilitation facilities, outpatient clinics and athletic training settings. The device features iceless cold therapy, heat therapy, contrast (alternating heat and cold) therapy, and intermittent pneumatic compression therapy for one or two patients at a time. The device is designed to be compatible with the pre-existing portfolio of ergonomic Game Ready Wraps made for specific body parts (e.g., shoulder, elbow, knee, ankle, back, etc.). The Wraps are flexible water circulating garments that apply to the body to deliver cold, heat, or rapid contrast temperature and/or compression therapy. The wrap is comprised of an inner ATX Series Heat Exchanger and an Outer Sleeve.
The Med4 Elite™ allows for treatment of one or two patients, or two anatomical locations simultaneously. The device is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings.
The physical description of the Med4 Elite™ is a compact unit with four caster wheels and a built-in handle. It has two separate, covered reservoirs - one for holding cold water and the other for holding hot water. The water reservoirs, pumps, cold engine, valves, power supplies and any other electronics are inside a covered enclosure made out of both plastic and sheet metal that can only be accessed with a tool.
Indications for Use
The Med4 Elite™ combines cold, heat, contrast, and compression therapies. It 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 treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold or contrast) are indicated. It is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.
4 Now claimed as 510(k) exempt (no compression)
5
omparison to Predicate Device
Table 2 contains a detailed comparison of the Medit in to its main predicated on the Ready® OF 2, and the
Table 2 Substantial Equivalence Table for Med4 Elite™
6
| Characteristic | Med4 Elite™
(this submission) | Game Ready® Classic
System (GR 2)
(K072620) Main predicate | VascuTherm™ (and NanoTherm™)
(K061866) Secondary predicate | Comparisons and reference
device |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Users | Health Care Professionals only
(Prescription use) | Health Care Professionals
and lay users (under
prescription) | Health Care Professionals only
(Prescription use) | All three devices are prescription
use only. Med4 Elite™ and
secondary predicate are only used
by Health Care professionals. |
| Intended Use
Environment | Intended for indoor use only such
as rehabilitation clinics, outpatient
clinics, athletic training settings | Intended for indoor use only | Intended for indoor use only | Substantially equivalent |
| Number of Patients
that can be treated | Two | One | One | Med4 Elite™ was designed to
accommodate 2 patients or 2
anatomical locations on one patient |
| Heat Therapy | Available without and with
compression (Low) | Not available | Available with and without
compression
(Low, Medium, High) | Both devices have same
functionality of heat with and
without compression but. Med4
Elite™ offers only low compression
as additional patient protection.
(See Compression only row for
compression levels) |
| Heat Therapy
Treatment Time | 5 to 30 minutes
Default setting: 15 minutes | Not available | 10 minutes (presumed – not clearly
stated in User Manual) | Med4 Elite™ has more flexibility in
the set up than VascuTherm; thus
providing the clinician more options.
. Clinical skin temperature testing
on healthy subjects for maximum
time limit at the highest temperature
setting did not cause thermal
damage to the skin. (See Table 3);
thus demonstrating no new safety
issues. |
Section 5 – Page 4 of 1
7
| Characteristic | Med4 Elite™
(this submission) | Game Ready® Classic
System (GR 2)
(K072620) Main predicate | VascuTherm™ (and NanoTherm™)
(K061866) Secondary predicate | Comparisons and reference
device |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cold Therapy | Available without and with
compression (Low, Medium-low,
Medium, High) | Available without and with
compression (Low, Medium,
High) | Available without and with
compression (Low, Medium, High) | Same (See compression only entry
for compression levels) |
| Cold Therapy
Treatment Time | 5 to 60 minutes
Default setting: 15 minutes | 5 to 90 minutes
Default treatment time: 15
minutes | 20 minutes (presumed not clearly
stated in User Manual.) | Med4 Elite™ has more flexibility in
the set up than NanoTherm™; thus
providing the clinician more options.
Clinical skin temperature testing on
healthy subjects for the maximum
time at the minimum temperature
setting did not cause thermal
damage to the skin. (See Table 3) |
| Contrast Therapy | Available
Heat: 1 - 10 minutes, default 3
minutes
Cold: 1 - 10 minutes, default 3
minutes
Total treatment 15 - 90 minutes,
default 30 minutes | Not available | Available
Heat: 10 minutes
Cold : 20 minutes | Med4 Elite™ has more flexibility in
the set up of contrast than
NanoTherm™; thus providing the
clinician more options. No new
issues of safety |
| Compression Only | Available in four levels
Low (5 - 15 mm Hg)
Medium-Low (5 - 30 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) | Available in three levels (general)
Low (15 mm Hg)
Medium (30 mm Hg)
High (50 mm Hg)
DVT calf (45 mm Hg)
DVT foot (100 mm Hg) | All three devices have similar
ranges of pressure settings but the
VascuTherm is higher on their DVT
setting which is outside of the Med4
Elite™ indication.
All three devices have no
compression as an option also |
Section 5 – Page 5 of 1
8
| Characteristic | Med4 Elite™
(this submission) | Game Ready® Classic
System (GR 2)
(K072620) Main predicate | VascuTherm™ (and NanoTherm™)
(K061866) Secondary predicate | Comparisons and reference
device |
|-------------------------------------|----------------------------------|------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compression Only | 5 to 60 minutes | Not available | Cycle time
Inflation 20 seconds, Deflation 40 sec | Med4 Elite™ provides more options
to clinician. No new issues of safety |
| Treatment time | 15 minutes default | Not available | 105°F | Med4 Elite™ has a higher
maximum heat reservoir set point
than VascuTherm™. Additional
reference predicate, Artotherm
Cryotherapy has an upper
temperature setting of 122°F.
Additional supporting data from
literature supports use of 120° F for
direct hot water to skin. Clinical skin
temperature testing on healthy
subjects for maximum time limit at
the highest temperature setting did
not cause thermal damage to the
skin. (See Table 3); thus no new
safety issue. |
| Heat Reservoir
Temperature Range | 95 -113°F (35 - 45°C) | Not available | | |
| Cold Reservoir
Temperature Range | 38 - 60°F (3.33 -15.56°C) | 34 - 50°F | 43 - 49°F | Med4 Elite™ has a lower minimum
cold therapy set point than the
secondary predicate but a higher
one than the primary predicate.
The primary predicate (K072620)
uses the same Wrapsso substantial
equivalence demonstrated. |
| "Snooze" Function | Available | Sleep option available | Not Available | Provides an additional user
convenience. No safety impact. |
Section 5 – Page 6 of 1
9
| Characteristic | Med4 Elite™
(this submission) | Game Ready® Classic
System (GR 2)
(K072620) Main predicate | VascuTherm™ (and NanoTherm™)
(K061866) Secondary predicate | Comparisons and reference
device |
|-----------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | 32.5" L x 24.75" W x 43"H (83 cm
L x 63 cm W x 109cm H) | Physical Unit
16.25" L x 7.75" W x 9.25" H
(413 x 197 x 235) mm (not
including carrying case) | 13.2"H x 12.00"D x 6.6"W (335 mm H
x 305 mm D x 167 mm W) | Med4 Elite™ is larger to
accommodate 2 patients (or two
anatomical locations) and larger
fluid reservoir (for user
convenience) |
| Weight | 172 lbs (78 kg) | 7.3 lbs (3.31 kgs) empty
Approximately 18 lbs full of
ice and water | 18.75 lbs (8.5 kgs) | Med4 Elite™ is larger to
accommodate 2 patients (or two
anatomical locations) and larger
fluid reservoir (for user
convenience) |
| Chilling Mechanism | Vapor compression | Ice | Thermoelectric | All three devices generate cold
water for the reservoir. |
| Heating Mechanism | Resistance heaters | Not applicable | Thermoelectric | Both devices generate hot water for
the reservoir. |
| Reservoir Fluid
Capacity | Heat reservoir: 1 gallon (3.8 L)
Cold reservoir: 1 gallon (3.8 L) | Cold reservoir only for ice and
water: 1.25 gallons | 8.5 fl oz (250 mL) | Med4 Elite™ is larger to
accommodate 2 patients (or two
anatomical locations) and larger
fluid reservoir (for user
convenience) Maintaining both
reservoirs in reserve reduces set up
time. |
| User Interface | Touch Screen | No | Touch Screen | No difference between Med4 Elite™
and secondary predicate so
substantially equivalent |
| Recommended
Coolant | Distilled Water | Tap Water and ice | 90% Distilled Water, 10% Isopropyl
Alcohol | Each device is able to attain its
desired performance requirements.
No safety impact from the
difference. |
Section 5 – Page 7 of 1
10
| Characteristic | Med4 Elite™
(this submission) | Game Ready® Classic
System (GR 2)
(K072620) Main predicate | VascuTherm™ (and NanoTherm™)
(K061866) Secondary predicate | Comparisons and reference device |
|-----------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Line Voltage | 100-240 VAC | 100 – 240 VAC | 100-240 VAC | Same |
| Line Frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz | Same |
| Electrical Safety
Standards | ANSI/AAMI ES60601-1:2005/(R) 2012
CAN/CSA C22.2 No. 60601-1:2014 | ANSI/AAMI ES60601-
1:2005/(R) 2012
CAN/CSA C22.2 No. 60601-
1:2014
Type BF | UL 60601
Type B | Substantially equivalent |
| Operating
Temperature | 50°F - 90°F (10°C - 32°C) | 33.8°F - 104°F (1-40°C) | 50°F - 80°F (10°C - 27°C) | Med4 Elite™ works in a higher
temperature environment than
secondary predicate but lower than
main predicate. Med4 Elite™ is
more than adequate for routine
indoor use. |
| Storage Temperature | 33°F - 122°F (1°C to 50 °C) | 33°F - 122°F (1°C to 50 °C) | 32°F - 122°F (0°C to 50 °C) | Substantially equivalent |
| Operating Humidity | 30 to 90%, Non-condensing | 30% to 90% Non-Condensing | 30 to 60%, Non Condensing | Med4 Elite™ works in a wider RH
range environment than secondary
predicate but same as main
predicate and is more than
adequate for routine indoor use. |
| Storage Humidity | 10 to 95%, Non-condensing | 10 to 95%, Non-condensing | 10 to 95%, Non Condensing | Same |
| Operating
Atmospheric Pressure | 0 - 9,842 Ft
(0 – 3,000 m) | 0 – 9,842 Ft
(0 – 3,000 m) | Unknown | Med4 Elite™ has same operating
atmospheric pressure as main
predicate and is a sufficient range
for desired use environments |
Section 5 – Page 8 of 1
11
| omparisons and referent | | Vraps are accessories to the Game eady GR 2.1 and cleared under 072620 or newly cleared with the ed4 Elite as part of this bmission.
ditional Med4 Elite Wraps Toxed elbow, Half-leg burbstillers bere bere beller Indicannel of siles artistics and startes and the prop opins of range viral locations areap ange | led4 Elite™ uses the same Write s the Game Ready GR 2 using lentical materials and process he new Wraps.
ibstantial equivalenc | ed4 Elite™ Wraps (as well a ain predicate, GR 2) have >monstrated biocomingatility >monstrated biocomingatility ese applicable standards. | d4 Elite™ Wraps are applied ectly to intact skin or over a rile bandage |
|----------------------------------------------------------|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| ascuTherm™ (and NanoTherm
61866) Secondary predic | | ull leg, Knee segmental & ROM, Hz m, Foot/Ankle, Shoulder w/ practs, rm, Foot/Ankle, Shoulder w/ praces, ex w/ & w/o brists, Howd, Arm, Haef g knee, Head, Face
ious anatomical Wraps in differer
zes for: | Denier Nylon Oxf | informatic | Some configurations availat Sterile |
| 72620) Main predicz
ame Ready® Class System (GR 2) | ccessories (Wra | arious anatomical Wraps fferent sizes for:
traight Knee, Articulational nee, Elbow, Ankle, nee, Elbow, Ankle, Choulder, Back, Hip-Gr and-Wrist | Denier nylo | SO 10993-12
SO 10993-10
SO 10993-5
10993- | ovided non-sterile |
| nis submission)
led4 Elite™ | | traight Knee, Articulated Knee, Ibow, Ankle, Shoulder, Back, Hip Groin, Hand-Wrist, Flexed Elbow, Ialf-leg boot
s in
arious anatomical Wrap: ifferent sizes for: | cryn (hose cove
Denier nylo | SO 10993-12
SO 10993-5
SO 10993-1
SO 10993- | ovided non-sterile on |
| aracteris | | pes of Wraps | Patient Contactin Material | ocompatibil | Sterility |
Section 5 – Page 9 of
12
Substantial Equivalence
None of the performance or technological differences between the Med4 Elite™ and its predicates raises any new issues of safety and effectiveness.
Performance Testing
The Med4 Elite™ System has been subjected to design verification and validation testing for electrical safety, electromagnetic compatibility, software V&V, system/bench testing, clinical testing, and storage and transport performance. These tests verified and validated the proper operation of the 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 Med4 Elite™ device has been found to be adequately safe and effective for the intended users. its intended uses, and use environments. The labeling materials have been found to be easy to use and understandable to the intended users.
Sterilization/Shelf Life/Cleaning &Disinfection
The Game Ready Med4 Elite™ components (Control Unit, connector hoses, drain hoses) are provided non- sterile and do not need and cannot be sterilized. These components are not patient contacting. They are only contacted by the health care professional for setting up therapy. The unit is not intended for use in a sterile environment. Cleaning and disinfection instructions for the non-patient contacting components are given in the User Manual. The impact of repeated use of these cleaning/disinfecting materials over the expected life of the Med4 Elite™ Control Unit has been validated.
The Game Ready Med4 Elite™ device uses the previously 510(k) cleared Wraps that also work with the Game Ready GR 2.1 or new Wraps cleared 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. The Wraps can be cleaned with mild detergent or antibacterial soap and cold water between uses.
Neither the Med4 Elite™ device components nor the Wraps have a definitive shelf life based on packaging. Expected life is based on frequency of use and continued functional performance.
Biocompatibility
The Game Ready Med4 Elite Control Unit is not patient contacting. Only the wraps and the outside of the connector hoses are patient contacting. The accessories with patient contact are all surface devices with either intact skin contact or over sterile dressings. The duration of the patient contact is considered either limited (≤ 24 hours) or prolonged (>24 hrs to 30 days due to repeated treatments).
All of the wraps and the outside of the connector hoses have been tested for cytotoxicity, skin irritation and skin sensitization according to ISO 10993-1, -5 and -10 and found to be biocompatible for this patient contact and duration.
Software
The software in the Game Ready Med4 Elite System including both custom-developed and OTS software has been validated and demonstrated to be safe and effective for its
13
intended use. The software is a Moderate Level of Concern as per FDA guidance. All required items related to software as required by FDA guidance have been included in this submission.
Electrical Safety and Electromagnetic Compatibility
The Game Ready Med4 Elite™ System complies with all of the medical electrical safety and electromagnetic compatibility requirements of IEC 60601 3th edition standards including the ANSI/AAMI/ ES60601 with the U.S. deviations, and the collateral standard for EMC. The requested information from FDA guidance to support a claim of EMC of electrically powered medical devices has been provided.
Animal Data
No animal studies were necessary for Game Ready Med4 Elite™ System.
Clinical Data
An IRB approved clinical study was conducted on healthy volunteers who provided in informed consent for the purpose of measuring the maximum and minimum skin temperatures. The results are summarized in Table 3.
| Table 3 Measure Skin Temperature | |
|---|---|
| Maximum Temperature | Skin temperature measured as high as 111 °F (44
°C) when set to maximum Heat Reservoir set point |
|---------------------|-----------------------------------------------------------------------------------------------------|
| Minimum Temperature | Skin temperature measured as low as 44 °F (7 °C)
when set to minimum Cold Reservoir set point |
These data support the safety and effectiveness of the Med4 Elite™.
Conclusion
The data and information provided in this submission support the conclusion that the Game Ready Med4 Elite™ is substantially equivalent to its primary and secondary predicate devices with respect to indications for use and technological characteristics.