(433 days)
The ICE COMPRESSION FIRST, DUO, and MOOVE Systems combine cold and compression therapies. They are intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. They are intended to be used by or on the order of licensed healthcare professionals in hospital, outpatient clinics, athletic training settings, or home settings.
The ICE COMPRESSION FIRST, DUO, & MOOVE System and its accessories, including the Splints, is designed to treat post-surgical and acute injuries to reduce edema, swelling, and pain when cold and compression are indicated. The ICE COMPRESSION System provides cold and compression therapy using ice and water. The ICE COMPRESSION System is a DC-powered, software-controlled device that delivers compressed air and chilled water from the Control Module through tubing to a Splint that is designed for a specific body part (e.g., shoulder, wrist, knee, leg, hip and ankle, back) to treat pain and swelling from injuries and/or surgical interventions.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of distinct "acceptance criteria" and "reported device performance" for each criterion. Instead, it describes performance characteristics related to safety and effectiveness, and how the subject device compares to predicate devices. The primary "acceptance criterion" demonstrated through testing is achieving a minimum skin temperature within a safe range.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Minimum skin temperature achieved during cold therapy | Minimum skin temperature of 11.7℃ (53°F) |
| Electrical Safety and Electromagnetic Compatibility | Complies with IEC 60601 3.1 edition standards, ANSI/AAMI/ES60601 with U.S. deviations, and 4th edition of collateral standard for EMC. |
| Biocompatibility | Patient contacting components verified as acceptable per ISO 10993-1 (cytotoxicity, primary irritation, skin sensitization). |
| Software Safety and Effectiveness | Verified and validated as safe and effective for intended use (Moderate Level of Concern). |
| Cleaning and Disinfection | Instructions provided in labeling for non-sterile use over intact skin or sterile dressings. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions that the measurement of the lowest skin temperature was "conducted with healthy volunteers." It does not specify the exact number of healthy volunteers used for this test.
- Data Provenance: The document does not explicitly state the country of origin where the skin temperature test was performed. The data is prospective, as it describes tests conducted for the submission. Other tests (electrical safety, EMC, software V&V, biocompatibility) are also described as prospective design verification and validation testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/not stated. The skin temperature measurement was a direct physical measurement, not dependent on expert interpretation for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since the key performance test involved direct measurement (skin temperature), an adjudication method in the context of expert review is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Although clinical studies were not needed to demonstrate substantial equivalence of the ICE COMPRESSION FIRST, DUO, & MOOVE Systems..."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not applicable. This device is a physical system combining cold and compression therapies, not an AI/algorithm-only device. The software controls pressure, displays battery level, and monitors/adjusts temperature, but its performance is integrated into the system's function, not evaluated as a standalone "algorithm only" product in the sense of AI.
7. The Type of Ground Truth Used
- For skin temperature measurement: The ground truth was established by direct physical measurement using sensors to record temperature on healthy volunteers.
- For other safety and performance aspects (Electrical Safety, EMC, Biocompatibility, Software): Ground truth was established through adherence to recognized international standards and regulatory guidance (e.g., IEC 60601, ISO 10993, FDA software guidance for medical devices).
8. The Sample Size for the Training Set
- Not applicable. This device does not involve AI/machine learning that requires a "training set" in the conventional sense for image analysis or diagnostic algorithms. The software's functionality is based on predefined control logic and algorithms for regulating temperature and pressure, not on learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no "training set" for this type of device.
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January 11, 2021
mks paris % Natalie Kennel Quality & Regulatory Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, California 92129
Re: K193079
Trade/Device Name: ICE COMPRESSION FIRST, DUO, & MOOVE Systems Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILO Dated: October 9, 2020 Received: October 13, 2020
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.
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
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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 medical devices and radiation-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,
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193079
Device Name ICE COMPRESSION FIRST, DUO, & MOOVE Systems
Indications for Use (Describe)
The ICE COMPRESSION FIRST, DUO, and MOOVE Systems combine cold and compression therapies. They are intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. They are intended to be used by or on the order of licensed healthcare professionals in hospital, outpatient clinics, athletic training settings, or home 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 is a logo for MKS Paris. The logo is in white text on an orange background. The text reads "MKS Paris" on the top line and "VOTRE BIEN-ETRE NOTRE PARI" on the bottom line. There is a line separating the two lines of text.
510(k) Summary
| Sponsor: | mks paris |
|---|---|
| Zone Ecoparc | |
| 27 Rue Meziere | |
| 34690 Fabregues | |
| France | |
| Phone: 04-99-64-21-05 | |
| Fax: 04-99-64-21-06 | |
| 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: January 11th, 2021
DEVICE INFORMATION:
| Proprietary Name: | ICE COMPRESSION FIRST, DUO, & MOOVE System |
|---|---|
| Common Name: | Powered inflatable tube massager |
| Classification: | II |
| Product Codes: | IRP, ILO |
| Regulations: | 21 CFR 890.5650 |
| Regulation Name: | Powered Inflatable Tube Massager |
| Classification Panel: | 89- Physical Medicine |
PREDICATE DEVICES:
The predicate devices are listed in Table 1. The primary predicate device is the Game Ready GRPro 2.1 System and the secondary predicate is the Game Ready Med4Elite. The Therm X is the reference device. None of the predicate or reference devices have been subject to design recalls.
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Table 1 Table of Predicates
| 510(k) | Product | 510(k) Holder | ClearanceDate | Scope of safety andeffectivenesscomparison tosubject device |
|---|---|---|---|---|
| K192114 | GRPro 2.1System | CoolSystems® (dbaGame Ready) | October 29,2019 | Compared to allaspects of the subjectdevice.Primary Predicate |
| K171685 | Med4Elite | CoolSystems® (dbaGame Ready) | September 29,2017 | Compared to the Duocontrol module's dualoutput functionality.Compared to the WristSplint and the HipSplint.Secondary Predicate |
| K181149 | Therm X | Zenith TechnicalInnovations | August 3, 2018 | Compared to thesubject device staticpressure option.Reference device |
PRODUCT DESCRIPTION:
The ICE COMPRESSION FIRST, DUO, & MOOVE System and its accessories, including the Splints, is designed to treat post-surgical and acute injuries to reduce edema, swelling, and pain when cold and compression are indicated. The ICE COMPRESSION System provides cold and compression therapy using ice and water. The ICE COMPRESSION System is a DC-powered, software-controlled device that delivers compressed air and chilled water from the Control Module through tubing to a Splint that is designed for a specific body part (e.g.,
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shoulder, wrist, knee, leg, hip and ankle, back) to treat pain and swelling from injuries and/or surgical interventions.
The ICE COMPRESSION System is comprised of the following components:
- Control Unit (FIRST, DUO, or MOOVE) ●
- AC Adapter (to convert line power to DC input power) ●
- Water/Air Connectors (connects Splint to the Control Module)
- Instruction Manual
- Splints (Accessories) ●
- Optional Carry Case
The ICE COMPRESSION System Control Unit is available in three variants or models: FIRST, DUO, and MOOVE. The FIRST and the MOOVE models each have only one Splint connection while the DUO has two Splint connectors. The DUO model is essentially the same as the single-splint connection models (FIRST and MOOVE) but with two of the single-splint connection internal models inside one device module. The FIRST and DUO models use the same outside dimensions and different only by whether they contain one or two single-splint connection internal control units. The DUO model can provide therapy to one patient, wearing two splints, or to two patients at the same time. In the DUO model, each of the two singlesplint connection models inside, are separately controlled with their own user interface and tank. All three models each use only one Power Supply. The MOOVE model is a smaller more portable unit.
The Water/Air Hose Connector connects the Splint to the Control Module. Water from the Hose Connector fills the Splint's water bladder to provide cold therapy. Air from the Hose Connector fills the air bladder to provide compression. All Splints have both air and water bladders.
INDICATIONS FOR USE:
The ICE COMPRESSION FIRST, DUO, and MOOVE Systems combine cold and compression therapies. They are intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. They are intended to be used by or on the order of licensed healthcare professionals in hospital, outpatient clinics, athletic training settings, or home settings.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
Table 2 is a detailed comparison of the ICE COMPRESSION FIRST, DUO, & MOOVE Systems with its predicates device.
Table 2 Comparison of the ICE COMPRESSION FIRST, DUO, & MOOVE Systems and its predicates
| Characteristics/Parameters | ICE COMPRESSIONFIRST, DUO, & MOOVESystems(Subject Device) | GameReady GRPro 2.1,K192114(Primary predicate device) | Game Ready Med4Elite,K171685(Secondary predicatedevice) | Comparison results andreference devices, whereapplicable |
|---|---|---|---|---|
| Indications for Use | The ICE COMPRESSIONFIRST, DUO, and MOOVESystems combine cold andcompression therapies. They areintended to treat post-surgicaland acute injuries to reduceedema, swelling, and pain wherecold and compression areindicated. They are intended tobe used by or on the order oflicensed healthcare professionalsin hospital, outpatient clinics,athletic training settings, orhome settings. | Game Ready GRPro 2.1 Systemis intended to treat post-surgicaland acute injuries to reduceedema, swelling, and pain wherecold and compression areindicated.It is intended to be used by or onthe order of licensed healthcareprofessionals in hospitals,outpatient clinics, athletictraining settings, or homesettings. | The Med4 Elite™ combinescold, heat, contrast andcompression therapies.It is intended to treat post-surgical and acute injuries toreduce edema, swelling and painfor which cold and compressionare indicated.It is intended to treat posttraumatic and post surgicalmedical and/or surgicalconditions for which localizedthermal therapy (hot or cold orcontrast) are indicated.It is intended to be used by, oron the order of, licensedhealthcare professionals inrehabilitation facilities,outpatient clinics, and athletictraining settings. | Substantially equivalent topredicate device; wording differsslightly. Both devices intendedto treat the same conditions.Secondary intended use coversthe subject device intended useAND additional indications notincluded in the subject device.Differences between the subjectdevice and the predicate deviceindications for use do not raisenew safety or effectivenessquestions. |
| Contraindicationsand precautions | Provided in Subject Device UserManual | Available in Predicate DeviceUser Manual | Available in Predicate DeviceUser Manual | Similar, minor wordingdifferences only.Secondary predicate includescontraindications for heat, whichdoes not apply to the subjectdevice. |
| Characteristics/Parameters | ICE COMPRESSIONFIRST, DUO, & MOOVESystems(Subject Device) | GameReady GRPro 2.1,K192114(Primary predicate device) | Game Ready Med4Elite,K171685(Secondary predicatedevice) | Comparison results andreference devices, whereapplicable |
| Intended Users | Healthcare professionals, athletictrainers, lay users under thedirection of a healthcareprofessional | Healthcare professionals, athletictrainers, lay users under thedirection of a healthcareprofessional | Healthcare professionals only(prescription use) | Substantially equivalent toprimary predicate device; differsfrom secondary predicate devicewhich is restricted to healthcareprofessionals |
| Intended useenvironment | Hospitals, outpatient clinics,athletic training facilities.prescription home use. | Hospitals, outpatient clinics,athletic training facilities.prescription home use. | Intended for indoor use onlysuch as rehabilitation clinics,outpatient clinics, athletictraining settings. | Identical to primary predicate.Differs from secondary predicatewhich excludes the home useenvironment. |
| Principle ofOperation | Pneumatic and fluid pumps andflexible multi-chamber wrapdeliver intermittent compressionand cold therapy. | Pneumatic and fluid pumps andflexible multi-chamber wrapdeliver intermittent compressionand cold therapy. | Pneumatic and fluid pumps andflexible multi-chamber wrapdeliver intermittent compression,cold therapy and heat therapy. | Substantially equivalent;secondary predicate descriptionincludes heat therapy which isnot applicable to subject device |
| Cooling Unit/CompressorDescription | Small, removable ice watertank(s); no compressor coolingunit. | Small, ice box reservoir; nocompressor cooling unit. | Vapor compression coldreservoir unit and resistanceheating reservoir unit (1 galloneach). | Similar to primary predicate;ICE COMPRESSION Systemshave removable water tank(s).ICE COMPRESSION DUOSystem has two units in enclosedin one system. Differs fromsecondary predicate which usesa compressor cooling unit.This does not raise new safetyor effectiveness questions. |
| Characteristics/Parameters | ICE COMPRESSIONFIRST, DUO, & MOOVESystems(Subject Device) | GameReady GRPro 2.1,K192114(Primary predicate device) | Game Ready Med4Elite,K171685(Secondary predicatedevice) | Comparison results andreference devices, whereapplicable |
| TreatmentTemperature Range | 41-77°F (5-25°C) | 34 - 50°F (1- 10°F) | 38 - 60°F (3.33-15.56°C) (coldtherapy temperature range) | Substantially equivalent. Thesubject device has a warmertemperature range that does notraise new issues of safety andeffectiveness. Highesttemperature is driven by theambient environment (no heatingunit in subject or primarypredicate). |
| Water Temperatureaccuracy | +/-1.8°F (+/-1°C) | +/-4°F (+/-2°C)Per predicate User Manual | +/-4°F (+/-2°C)Per predicate User Manual | Similar. Subject device claims atighter accuracy than predicatedevices; does not raise newissues of safety andeffectiveness. |
| TemperatureAdjustmentMechanism | Software adjusts the flowratebased on thermosensor feedback. | Patented fluid flow controltechnology. | Not publicly available. | Different. Physical mechanismfor temperature adjustment isdifferent but both the subjectdevice and the primary predicateuse adjustment of water flowrate to controlled by software toadjust temperature. Unable tocompare to the secondarypredicate. No new issues ofsafety or effectiveness raised. |
| Characteristics/Parameters | ICE COMPRESSIONFIRST, DUO, & MOOVESystems(Subject Device) | GameReady GRPro 2.1,K192114(Primary predicate device) | Game Ready Med4Elite,K171685(Secondary predicatedevice) | Comparison results andreference devices, whereapplicable |
| Compression range | 0-75 mmHg | 5-75 mmHgOr 0 mmHg (no pressure) | 5-75 mmHgOr 0 mmHg (no pressure) | Substantially equivalent. Subjectdevice has a lower minimumpressure when oscillating(dynamic mode); Predicatedevices can be set to 0 pressure:does not raise different issues ofsafety and effectiveness. |
| PressureApplication time | Dynamic pressure: Adjustablefrom 0-55 seconds of pressurefor cycleStatic pressure: Up to 45 minutescontinuous application ofpressure setting | Dynamic pressure: Cyclicalcompression applied from 5 to90 minutes (total) in three levels:Low (5-15 mmHg) cycled in 5minutesMedium (5-50 mmHg) cycled in3 minutesHigh (5-75 mmHg) cycled in 3minutes(per User Manual)No Static pressure | Dynamic pressure: Cyclicalcompression applied from 5 to60 minutes (total) with default of15 minutes in four levels:Low (5-15 mmHg) cycled in 5minutesMedium-Low (5-30 mmHg)cycled in 3 minutesMedium (5-50 mmHg) cycled in3 minutesHigh (5-75 mmHg) cycled in 3minutes(per User Manual)No Static pressure | Similar for pressure applicationof dynamic pressure on Subjectdevice compared to predicatedevices. Subject device has moreflexibility in the cycling timingof pressure.Predicate devices do not havestatic pressure settings.Reference device K181149Therm X has a static pressuremode like subject device.Differences do not raise newsafety or effectiveness questionsbecause the maximum pressureand range is similar to otherdevices |
| Air PressureAccuracy | +/- 10mm Hg | +/-10mmHgPer predicate User Manual | +/-10mmHgPer predicate User Manual | Same |
| Characteristics/Parameters | ICE COMPRESSIONFIRST, DUO, & MOOVESystems(Subject Device) | GameReady GRPro 2.1,K192114(Primary predicate device) | Game Ready Med4Elite,K171685(Secondary predicatedevice) | Comparison results andreference devices, whereapplicable |
| Treatment timeadjustment | Adjustable from 0- 45 minutes inincrements of 1 minute | 15 minutes default, increasing ordecreasing in 5-minuteincrements to a max of 90 min ora min of 5 min. | Cold and/or compressiontherapy: 15 minutes default,increasing or decreasing in 5-minute increments to a max of60 min or a min of 5 min. | Similar. Subject devicemaximum treatment time (45minutes) is less than predicatedevice maximum treatment time(90 minutes or 60 minutes).Does not raise any differentissues of safety andeffectiveness. (Cold therapy islimited by use of ice water forsubject device and primarypredicate device) |
| Treatment Cycle | Manual Mode:20 min default,increasing/decreasing in 5-second increments with aminimum of 0 min and amaximum of 45 min. | Manual Mode:15 minutes default, increasing ordecreasing in 5-minuteincrements to a max of 90 min ora min of 5 min.Program Mode:Six (6) pre-programmedtreatment on-off cycles are 30-30 or 30-60 min. at no pressure,low pressure, or mediumpressure. | Cold: 5 to 60 minutes, 1 minuteincrementsDefault 15 minutesCompression: 5 to 60 minutes,15 minutes default | Different: Subject has onlymanual mode that can beadjusted up to 45 minutes:primary predicate devices pre-programmed treatments arecustomizable. Secondarypredicate settings haveadjustable default settings.Differences do not raise newissues of safety or effectivenessraised. |
| Software/ SoftwareFeatures | Software controls pressure,displays battery level, monitorsand adjusts temperature. | Electronic pressure control andtherapy time and temperaturemonitoring. Battery voltagemonitoring. | Electronic pressure control andtherapy time and temperaturemonitoring. | Substantially equivalent; subjectdevice uses a different algorithmto adjust water temperature fromproprietary algorithm inpredicate devices. No differentissues of safety or effectivenessraised. |
| Characteristics/Parameters | ICE COMPRESSIONFIRST, DUO, & MOOVESystems(Subject Device) | GameReady GRPro 2.1,K192114(Primary predicate device) | Game Ready Med4Elite,K171685(Secondary predicatedevice) | Comparison results andreference devices, whereapplicable |
| User interface(Control unit controlpanel) | LCD touchscreen display and 9surrounding button keys | LCD display and 9 buttons | LCD touchscreen displays allelements | Substantially equivalent toprimary predicate; subject deviceprovides users with an option touse the touchscreen or the keys.Secondary predicate uses onlytouchscreen. |
| Number of patientsthat can be treated atthe same time | MOOVE: OneFIRST: OneDUO: Two | One patient | Two patients | Substantially equivalent.Subject FIRST and MOOVEmodels have substantiallyequivalent capabilities to theprimary predicate. Subject DUOmodel is substantially equivalentto capabilities of the secondarypredicate. |
| Dimensions | MOOVE: 11.4" x 9.45" x 15.35"(290 x 240 x 390 mm)FIRST: 12.8" x 18.81" x 15.94"(327 x 478 x 405 mm)DUO: 12.8" x 18.81" x 15.94"(327 x 478 x 405 mm) | 9.25" H x 7.75" W x 16.25" L(413 x 197 x 235) mm (notincluding carrying case) | 32.5" L x 24.75" W x 43"H (83cmL x 63 cm W x 109cm H) | Different. Subject device (allmodels) is larger than theprimary predicate. Both subjectand primary predicate device areportable. Subject MOOVEmodel has a handle likepredicate device. Subject deviceis smaller than the secondarypredicate. Does not raisedifferent questions of safety oreffectiveness. |
| Characteristics/Parameters | ICE COMPRESSIONFIRST, DUO, & MOOVESystems(Subject Device) | GameReady GRPro 2.1,K192114(Primary predicate device) | Game Ready Med4Elite,K171685(Secondary predicatedevice) | Comparison results andreference devices, whereapplicable |
| Weight(empty/filled) | MOOVE: 5.5 / 11 lbs.FIRST: 11 / 15.4 lbs.DUO: 13 / 22 lbs. | 7.3 / 18 lbs. (approx.) | 172 lbs (78 kg) | Similar to the primary predicate;the empty predicate deviceweighs less than 2 of Subjectmodels. When filled, the primarypredicate device weight is inbetween the Subject FIRST andDUO models. The primarypredicate device weighs morewhen full because of slightlyhigher capacity. The weight ofthe secondary predicate isheavier than the subject deviceas secondary predicate is notintended to be portable.Differences do not raise newsafety or effectivenessquestions. |
| Chilling Mechanism | Ice | Ice | Vapor compressor | Same mechanism as primarypredicate. Mechanism differsfrom secondary predicate. |
| Water/Ice Capacity | FIRST & MOOVE: 2,500 mLDUO: 5,000 mL | Approximately 5100 mL (5.4 qt) | 1 gallon (3.8 L)Not applicable as ice is notchilling mechanism. | Similar.: largest subject devicemodel capacity is similar toprimary predicate capacity.Secondary predicate capacity isnot applicable because ice wateris not the chilling mechanism.Differences do not raise newsafety or effectivenessquestions. |
| Characteristics/Parameters | ICE COMPRESSIONFIRST, DUO, & MOOVESystems(Subject Device) | GameReady GRPro 2.1,K192114(Primary predicate device) | Game Ready Med4Elite,K171685(Secondary predicatedevice) | Comparison results andreference devices. whereapplicable |
| Coolant | Tap water and ice | Tap water and ice | Distilled water (cooled by vaporcondenser) | Same as primary predicate.Secondary predicate usescondenser to provide cooling. |
| Water flow rate | 100-350 mL/min | 275-450 mL/min | Not publicly disclosed | Similar. The subject device flowrate is slightly slower than thepredicate. For both, the flow rateis driven by temperature controlmechanism. User doesn't set orcontrol water flow rate. Does notraise different issues of safetyand effectiveness |
| Power source | Battery; power supply connectsbattery to mains to charge. | Mains power from medicaldesktop power supply, optionalbattery pack | Mains power to control unit | Different. All pass electricalsafety; differences do not raisedifferent issues of safety oreffectiveness |
| Battery Type | Nickel-Metal Hydride | Lithium, rechargeable | N/A no battery | Different.Both pass electricalsafety; difference does not raisedifferent issues of safety oreffectiveness |
| Input power | 12V 1A (through AC adapter) | 12V 2.5A (through AC adapter) | 1200 VA | Similar. primary Predicateamperage is slightly higher. Allpass electrical safety; differencesdo not raise different issues ofsafety or effectiveness |
| Line Voltage | 100-240 V AC | 100- 240 V AC | 100-240 VAC | Same |
| Line Frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz | Same |
| Characteristics/Parameters | ICE COMPRESSIONFIRST, DUO, & MOOVESystems(Subject Device) | GameReady GRPro 2.1,K192114(Primary predicate device) | Game Ready Med4Elite,K171685(Secondary predicatedevice) | Comparison results andreference devices, whereapplicable |
| Electrical Safetyand EMC standardsmet | 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 60601-1-11:2015 IEC 60601 – 1-2, Ed.4.0: 2014 | 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 EN60601-1-2:2015 IEC 62366:2007 +A1:2014 IEC 62133:2012 +C1:2013 | ANSI/AAMI ES60601-1:2005/(R)2012 CAN/CSA C22.2 No.60601-1:2014 Type B | Substantially equivalent. Subjectand predicate devices weretested to similar electrical safetyand EMC standards. Secondarypredicate is not for home use soIEC 60601-1-11:2015 is notapplicable. Differences do notraise new safety oreffectiveness questions. |
| OperatingTemperature | 41 – 104 F (5-40 C) | 33.8 – 104 F (1-40 C) | 50°F - 90°F (10°C – 32°C) | Similar. Differences do notraise new safety oreffectiveness questions. |
| Operating Humidity | 15-90%, non-condensing, butnot requiring a water vaporpartial pressure greater than 50hPa | Not stated in User Manual | 30 to 90%, Non-condensing | Subject device has acceptableoperating humidity range forindoor use. Subject device rangesimilar to secondary predicate.Differences do not raise newsafety or effectivenessquestions. |
| Max OperatingAltitude | 6,562 Ft (2,000 meters) | 9,843 Ft (3,000 meters) | 9,842 Ft (3,000 meters) | Similar. Subject device cannotbe used at as high an altitude aspredicate devices. Differencesdo not raise new safety oreffectiveness questions. |
| Characteristics/Parameters | ICE COMPRESSIONFIRST, DUO, & MOOVESystems(Subject Device) | GameReady GRPro 2.1,K192114(Primary predicate device) | Game Ready Med4Elite,K171685(Secondary predicatedevice) | Comparison results andreference devices, whereapplicable |
| Storage Conditions | -13 to 95°F (-25 to 35°C) at arelative humidity up to 90%,non-condensing;>95 - 158°F (>35°C - 70°C) atwater vapor pressure up to 50hPa | 33-122 F (1 C – 50 C)Relative humidity of 15-90%,non-condensing | 33°F - 122°F (1°C to 50°C)Relative humidity of 30 to 90%,Non-condensing | Similar. Subject device storagetemperature range is wider thanthe predicate devices.Differences do not raise newsafety or effectiveness questions. |
| Splint/Wraptechnology/characteristics | Splint outer cover holds a waterbladder and a separate airbladder in place to provide coldand compression therapy. Splintconnects to the water circuit andthe air circuit. | Flexible "Wraps"; outer sleevewith inner heat exchanger todeliver compression and cold. 2-chamber heat exchanger (waterand air). | Flexible "Wraps"; outer sleevewith inner heat exchanger todeliver compression and cold. 2-chamber heat exchanger (waterand air). | Substantially equivalent.Splint/wrap delivers ice waterand air to provide cold andcompression therapy. Primaryand secondary predicates use thesame wrap design. Differencesdo not raise new safety oreffectiveness questions. |
| Splints/WrapsTypes | Various anatomical wraps indifferent sizes for:Ankle, shoulder, back, leg,articulated knee, hip, wrist. | Various anatomical wraps indifferent sizes for:Ankle, Shoulder, Back, StraightKnee, Straight Elbow, TraumaticAmputee, Neck, Lower Limb,Full Leg Boot and Chest | Various anatomical Wraps indifferent sizes for:Straight Knee, Articulated Knee,Elbow, Ankle, Shoulder, Back,Hip-Groin, Hand-Wrist, FlexedElbow, Half-leg boot | Overlapping areas/wraps withprimary predicate: Ankle,shoulder, back, knee(straight/articulated) and lowerlimb/legOverlapping areas/wraps withsecondary predicate: Hip andwrist |
| Primary PatientContacting Material | Nylon 210 & non-wovenpolyester | 70 Denier nylon & polyester | 70 Denier nylon & polyester | Substantially equivalent. Patientcontact materials are same typesof fabric. No different issues ofsafety and effectiveness. |
| Characteristics/Parameters | ICE COMPRESSIONFIRST, DUO, & MOOVESystems(Subject Device) | GameReady GRPro 2.1,K192114(Primary predicate device) | Game Ready Med4Elite,K171685(Secondary predicatedevice) | Comparison results andreference devices, whereapplicable |
| Biocompatibility | Primary patient contactingcomponents verified asacceptable according to ISO10993-1 using cytotoxicity,primary irritation and skinsensitization. | Primary patient contactingcomponents verified asacceptable according to ISO10993-1 using cytotoxicity,primary irritation and skinsensitization. Additionalelastomeric materials wereverified as acceptable accordingto ISO 10993-1 using acutesystematic toxicity, primaryirritation and skin sensitization. | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12 | Substantially equivalent. Subjectdevice does not containelastomeric materials. Nodifferent issues of safety andeffectiveness. |
| Sterile or Non-sterile | Non-sterile only | Non-sterile only | Non-sterile only | Same |
| Control ModuleExpected Lifetime | 5 years | 5 years | 5 years | Same |
| Parts andAccessoriesExpected Lifetime(includessplints/wraps) | 3-24 months, depending on use | 3-24 months, depending on use | 3-24 months, depending on use | Same |
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PERFORMANCE DATA
The Sponsor subjected the ICE COMPRESSION FIRST, DUO, & MOOVE Systems System to design verification and validation testing for electrical safety, electromagnetic compatibility, software V&V, system/bench testing, and biocompatibility, 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 are justified and are included in the labeling for the system and accessories. Therefore, the ICE COMPRESSION FIRST, DUO, & MOOVE System with its Splints are 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 device evaluation included relevant data sources related to biological safety of finished device testing, component material history of safe biological use and testing, and where applicable, safe previous use in other cleared products. This biocompatibility evaluation establishes the biological safety for the splints of the ICE COMPRESSION SYSTEM.
CLEANING, DISINFECTION & SHELF LIFE TESTING
The Sponsor provides the ICE COMPRESSION FIRST, DUO, & MOOVE Systems and system accessories, including the Splints as non-sterile. The ICE COMPRESSION FIRST, DUO, & MOOVE Systems Control Module and system accessories, excluding the Splints, are not patient contacting and have only incidental patient or user contact at most. The user contacts the Splints when setting up or stopping therapy. The unit is not intended for use in a sterile environment. The Sponsor provides cleaning and disinfection instructions in the Instructions Manual.
The ICE COMPRESSION FIRST, DUO, & MOOVE System Splints contact the patient and are intended for use over intact skin or sterile dressings only. The Splints are provided non-sterile and not intended to be user sterilized. The Sponsor provides cleaning and disinfection instructions in the device Instruction manual and in the respective Splint instruction manual.
The expected service life for the systems and splints expected to be five years and 3-24 months based on frequency of use and continued functional performance.
SOFTWARE
The software in the ICE COMPRESSION FIRST, DUO, & MOOVE Systems, including both custom-developed firmware and OTS software, was verified and validated and demonstrated to be safe and effective for its intended use. The software is a Moderate
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Level of Concern (LOC) per FDA guidance. All required software items required by FDA guidance for moderate LOC are included in this submission.
ELECTRICAL SAFETY & EMC
The ICE COMPRESSION FIRST. DUO. & MOOVE Systems 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 2.
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 ICE COMPRESSION FIRST, DUO, & MOOVE Systems, the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices" (July 26, 1995), reformatted 12/18/97 requires measure of the lowest skin temperature that the device can generate at its lowest setting. This measurement of the lowest skin temperature was conducted with healthy volunteers.
As required by the FDA guidance for heating and cooling devices, the ICE COMPRESSION FIRST, DUO, & MOOVE Systems was used at its lowest setting with the worst-case splint and location. A minimum skin temperature of 11.7℃ (53°F) was measured and has been included in the product labeling.
Further, the ICE COMPRESSION System treatment temperature range and pressure settings are substantially equivalent to the predicate device. The ICE COMPRESSION System Splints have the same anatomical coverage as the predicate and reference devices.
CONCLUSION
The data and information provided in this submission support the conclusion that the ICE COMPRESSION FIRST, DUO, & MOOVE Systems is substantially equivalent to its 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).