(114 days)
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.
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.
The provided document is a 510(k) premarket notification for a medical device called "Med4 Elite™" by Cool Systems, Inc. (dba Game Ready). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and detailed study results for a new device's performance against specific metrics, particularly in the context of an AI/ML diagnostic device.
Therefore, the information required to fully answer the request, especially regarding acceptance criteria for an AI device (like sensitivity, specificity, AUC), sample size, ground truth establishment for AI training/test sets, expert adjudication, or MRMC studies, is not present in this document. This device is a physical therapy device (a powered inflatable tube massager combining cold, heat, contrast, and compression therapies) and not an AI-powered diagnostic tool.
However, I can extract the information relevant to the performance testing and safety assessment of this specific device as presented in the document.
Here's what can be extracted from the provided text regarding the device's validation:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in the typical sense of quantitative performance metrics (like accuracy, sensitivity) that would be common for diagnostic AI devices. Instead, it describes various performance tests and their outcomes, primarily to demonstrate safety and functional equivalency to predicate devices. The "performance" is more about adherence to safety standards and functional operation within specified ranges.
| Acceptance Criteria (Implied from tests/standards) | Reported Device Performance (Summary of Study Results) |
|---|---|
| Electrical Safety Standards Compliance | Complies with ANSI/AAMI ES60601-1:2005/(R) 2012 and CAN/CSA C22.2 No. 60601-1:2014. |
| Electromagnetic Compatibility (EMC) | Complies with all EMC requirements of IEC 60601 3rd edition standards, including ANSI/AAMI/ES60601 and collateral standard for EMC. |
| Biocompatibility of Patient-Contacting Components | Wraps and outside of connector hoses tested successfully for cytotoxicity, skin irritation, and skin sensitization according to ISO 10993-1, -5, and -10. Found to be biocompatible for intended patient contact duration (limited: ≤ 24 hrs or prolonged: >24 hrs to 30 days). |
| Software Validation (Moderate Level of Concern) | Software (custom-developed and OTS) validated and demonstrated to be safe and effective for its intended use. All required items related to software as required by FDA guidance included. |
| Safety of Thermal Therapies (Skin Temperature) | Maximum Temp: Skin temperature measured as high as 111 °F (44 °C) when set to maximum Heat Reservoir set point. (Supported by reference to Table 3 and finding "no thermal damage to the skin"). |
| Safety of Thermal Therapies (Skin Temperature) | Minimum Temp: Skin temperature measured as low as 44 °F (7 °C) when set to minimum Cold Reservoir set point. (Supported by reference to Table 3 and finding "no thermal damage to the skin"). |
| Cleaning and Disinfection Effectiveness | Cleaning and disinfection instructions for non-patient contacting components (Control Unit, connector hoses, drain hoses) have been validated, including impact of repeated use over expected life. |
| Functional Performance (System/Bench Testing) | Device subjected to design verification and validation testing for system/bench. Tests verified and validated proper operation of the system. |
| Storage and Transport Performance | Device subjected to design verification and validation testing for storage and transport performance. |
| Labeling Clarity | Labeling materials found to be easy to use and understandable to the intended users. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "healthy volunteers" for the clinical study measuring skin temperatures (Table 3), but it does not specify the number of volunteers (sample size).
- Data Provenance: The study was a "clinical study" on "healthy volunteers" which implies it was prospectively collected. The country of origin is not explicitly stated, but as it's an FDA submission for a US company, it's highly likely to be US-based data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This question is not applicable to the Med4 Elite™ device. The device is a therapy device, not a diagnostic device requiring expert interpretation of images or other data to establish "ground truth" in the AI sense. The "ground truth" for the skin temperature study was direct measurement of skin temperature. No experts are mentioned in this context for establishing "ground truth."
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
Not applicable. There was no expert "adjudication" in the sense of reconciling divergent interpretations for a diagnostic test set. The validation involved direct physical measurements and compliance with engineering/safety standards.
5. 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 device is not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance was not performed and is irrelevant to this device type.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm/software-only device. Its "performance" is based on its physical operation and thermal/compression outputs. The software component is described as a "Moderate Level of Concern" for control, not for independent diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the clinical study was direct physical measurement of skin temperature on healthy volunteers using sensors, as well as adherence to established engineering and biocompatibility standards.
8. The sample size for the Training Set:
Not applicable. This device did not involve an AI model requiring a "training set" in the machine learning sense. The device's "training" would be its design and manufacturing process, and its "validation" is through engineering tests and a small clinical safety study.
9. How the ground truth for the Training Set was established:
Not applicable, as there was no AI model training set.
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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
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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
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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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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.
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| 510(k) | Product | 510(k) Holder | Clearance Date | Comment |
|---|---|---|---|---|
| K072620 | Game Ready® ClassicSystem (GR 2) | CoolSystems®(dba GameReady) | Oct. 31, 2007 | Primary Predicate |
| K061866 | NanoTherm™ andVascuTherm™ | ThermoTek, Inc. | August 22, 2006 | SecondaryPredicate(NanoTherm™) |
| K9647991 | ArtrothermCryotherapy | 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)
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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™
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| Characteristic | Med4 Elite™(this submission) | Game Ready® ClassicSystem (GR 2)(K072620) Main predicate | VascuTherm™ (and NanoTherm™)(K061866) Secondary predicate | Comparisons and referencedevice |
|---|---|---|---|---|
| Intended Users | Health Care Professionals only(Prescription use) | Health Care Professionalsand lay users (underprescription) | Health Care Professionals only(Prescription use) | All three devices are prescriptionuse only. Med4 Elite™ andsecondary predicate are only usedby Health Care professionals. |
| Intended UseEnvironment | Intended for indoor use only suchas rehabilitation clinics, outpatientclinics, athletic training settings | Intended for indoor use only | Intended for indoor use only | Substantially equivalent |
| Number of Patientsthat can be treated | Two | One | One | Med4 Elite™ was designed toaccommodate 2 patients or 2anatomical locations on one patient |
| Heat Therapy | Available without and withcompression (Low) | Not available | Available with and withoutcompression(Low, Medium, High) | Both devices have samefunctionality of heat with andwithout compression but. Med4Elite™ offers only low compressionas additional patient protection.(See Compression only row forcompression levels) |
| Heat TherapyTreatment Time | 5 to 30 minutesDefault setting: 15 minutes | Not available | 10 minutes (presumed – not clearlystated in User Manual) | Med4 Elite™ has more flexibility inthe set up than VascuTherm; thusproviding the clinician more options.. Clinical skin temperature testingon healthy subjects for maximumtime limit at the highest temperaturesetting did not cause thermaldamage to the skin. (See Table 3);thus demonstrating no new safetyissues. |
Section 5 – Page 4 of 1
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| Characteristic | Med4 Elite™(this submission) | Game Ready® ClassicSystem (GR 2)(K072620) Main predicate | VascuTherm™ (and NanoTherm™)(K061866) Secondary predicate | Comparisons and referencedevice |
|---|---|---|---|---|
| Cold Therapy | Available without and withcompression (Low, Medium-low,Medium, High) | Available without and withcompression (Low, Medium,High) | Available without and withcompression (Low, Medium, High) | Same (See compression only entryfor compression levels) |
| Cold TherapyTreatment Time | 5 to 60 minutesDefault setting: 15 minutes | 5 to 90 minutesDefault treatment time: 15minutes | 20 minutes (presumed not clearlystated in User Manual.) | Med4 Elite™ has more flexibility inthe set up than NanoTherm™; thusproviding the clinician more options.Clinical skin temperature testing onhealthy subjects for the maximumtime at the minimum temperaturesetting did not cause thermaldamage to the skin. (See Table 3) |
| Contrast Therapy | AvailableHeat: 1 - 10 minutes, default 3minutesCold: 1 - 10 minutes, default 3minutesTotal treatment 15 - 90 minutes,default 30 minutes | Not available | AvailableHeat: 10 minutesCold : 20 minutes | Med4 Elite™ has more flexibility inthe set up of contrast thanNanoTherm™; thus providing theclinician more options. No newissues of safety |
| Compression Only | Available in four levelsLow (5 - 15 mm Hg)Medium-Low (5 - 30 mm Hg)Medium (5 - 50 mm Hg)High (5 - 75 mm Hg) | Available in three levelsLow (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 similarranges of pressure settings but theVascuTherm is higher on their DVTsetting which is outside of the Med4Elite™ indication.All three devices have nocompression as an option also |
Section 5 – Page 5 of 1
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| Characteristic | Med4 Elite™(this submission) | Game Ready® ClassicSystem (GR 2)(K072620) Main predicate | VascuTherm™ (and NanoTherm™)(K061866) Secondary predicate | Comparisons and referencedevice |
|---|---|---|---|---|
| Compression Only | 5 to 60 minutes | Not available | Cycle timeInflation 20 seconds, Deflation 40 sec | Med4 Elite™ provides more optionsto clinician. No new issues of safety |
| Treatment time | 15 minutes default | Not available | 105°F | Med4 Elite™ has a highermaximum heat reservoir set pointthan VascuTherm™. Additionalreference predicate, ArtothermCryotherapy has an uppertemperature setting of 122°F.Additional supporting data fromliterature supports use of 120° F fordirect hot water to skin. Clinical skintemperature testing on healthysubjects for maximum time limit atthe highest temperature setting didnot cause thermal damage to theskin. (See Table 3); thus no newsafety issue. |
| Heat ReservoirTemperature Range | 95 -113°F (35 - 45°C) | Not available | ||
| Cold ReservoirTemperature Range | 38 - 60°F (3.33 -15.56°C) | 34 - 50°F | 43 - 49°F | Med4 Elite™ has a lower minimumcold therapy set point than thesecondary predicate but a higherone than the primary predicate.The primary predicate (K072620)uses the same Wrapsso substantialequivalence demonstrated. |
| "Snooze" Function | Available | Sleep option available | Not Available | Provides an additional userconvenience. No safety impact. |
Section 5 – Page 6 of 1
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| Characteristic | Med4 Elite™(this submission) | Game Ready® ClassicSystem (GR 2)(K072620) Main predicate | VascuTherm™ (and NanoTherm™)(K061866) Secondary predicate | Comparisons and referencedevice |
|---|---|---|---|---|
| Dimensions | 32.5" L x 24.75" W x 43"H (83 cmL x 63 cm W x 109cm H) | Physical Unit16.25" L x 7.75" W x 9.25" H(413 x 197 x 235) mm (notincluding carrying case) | 13.2"H x 12.00"D x 6.6"W (335 mm Hx 305 mm D x 167 mm W) | Med4 Elite™ is larger toaccommodate 2 patients (or twoanatomical locations) and largerfluid reservoir (for userconvenience) |
| Weight | 172 lbs (78 kg) | 7.3 lbs (3.31 kgs) emptyApproximately 18 lbs full ofice and water | 18.75 lbs (8.5 kgs) | Med4 Elite™ is larger toaccommodate 2 patients (or twoanatomical locations) and largerfluid reservoir (for userconvenience) |
| Chilling Mechanism | Vapor compression | Ice | Thermoelectric | All three devices generate coldwater for the reservoir. |
| Heating Mechanism | Resistance heaters | Not applicable | Thermoelectric | Both devices generate hot water forthe reservoir. |
| Reservoir FluidCapacity | Heat reservoir: 1 gallon (3.8 L)Cold reservoir: 1 gallon (3.8 L) | Cold reservoir only for ice andwater: 1.25 gallons | 8.5 fl oz (250 mL) | Med4 Elite™ is larger toaccommodate 2 patients (or twoanatomical locations) and largerfluid reservoir (for userconvenience) Maintaining bothreservoirs in reserve reduces set uptime. |
| User Interface | Touch Screen | No | Touch Screen | No difference between Med4 Elite™and secondary predicate sosubstantially equivalent |
| RecommendedCoolant | Distilled Water | Tap Water and ice | 90% Distilled Water, 10% IsopropylAlcohol | Each device is able to attain itsdesired performance requirements.No safety impact from thedifference. |
Section 5 – Page 7 of 1
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| Characteristic | Med4 Elite™(this submission) | Game Ready® ClassicSystem (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 SafetyStandards | ANSI/AAMI ES60601-1:2005/(R) 2012CAN/CSA C22.2 No. 60601-1:2014 | ANSI/AAMI ES60601-1:2005/(R) 2012CAN/CSA C22.2 No. 60601-1:2014Type BF | UL 60601Type B | Substantially equivalent |
| OperatingTemperature | 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 highertemperature environment thansecondary predicate but lower thanmain predicate. Med4 Elite™ ismore than adequate for routineindoor 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 RHrange environment than secondarypredicate but same as mainpredicate and is more thanadequate for routine indoor use. |
| Storage Humidity | 10 to 95%, Non-condensing | 10 to 95%, Non-condensing | 10 to 95%, Non Condensing | Same |
| OperatingAtmospheric Pressure | 0 - 9,842 Ft(0 – 3,000 m) | 0 – 9,842 Ft(0 – 3,000 m) | Unknown | Med4 Elite™ has same operatingatmospheric pressure as mainpredicate and is a sufficient rangefor desired use environments |
Section 5 – Page 8 of 1
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| 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 NanoTherm61866) 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, Faceious anatomical Wraps in differerzes for: | Denier Nylon Oxf | informatic | Some configurations availat Sterile | |
| 72620) Main prediczame 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 10993-12SO 10993-10SO 10993-510993- | ovided non-sterile |
| nis submission)led4 Elite™ | traight Knee, Articulated Knee, Ibow, Ankle, Shoulder, Back, Hip Groin, Hand-Wrist, Flexed Elbow, Ialf-leg boots inarious anatomical Wrap: ifferent sizes for: | cryn (hose coveDenier nylo | SO 10993-12SO 10993-5SO 10993-1SO 10993- | ovided non-sterile on | |
| aracteris | pes of Wraps | Patient Contactin Material | ocompatibil | Sterility |
Section 5 – Page 9 of
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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
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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.
§ 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).