ICE COMPRESSION FIRST, DUO, & MOOVE Systems

K193079 · Mks Paris · IRP · Jan 11, 2021 · Physical Medicine

Device Facts

• Record ID: K193079
• Device Name: ICE COMPRESSION FIRST, DUO, & MOOVE Systems
• Applicant: Mks Paris
• Product Code: IRP · Physical Medicine
• Decision Date: Jan 11, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

ICE COMPRESSION FIRST, DUO, & MOOVE Systems provide cold and compression therapy for post-surgical and acute injuries; reduces edema, swelling, and pain. System consists of DC-powered control unit, AC adapter, tubing, and anatomical splints (shoulder, wrist, knee, leg, hip, back). Control unit pumps chilled water and compressed air into splint bladders; water provides cold therapy; air provides intermittent compression. FIRST/MOOVE models support one splint; DUO model supports two splints for one or two patients. Operated by healthcare professionals, athletic trainers, or patients (home use) via LCD touchscreen and buttons. Software monitors temperature and pressure; adjusts water flow rate based on thermosensor feedback. Benefits include localized thermal and pneumatic therapy to aid recovery. Used in hospitals, clinics, and home settings.

Clinical Evidence

No clinical studies performed. Bench testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software verification/validation, and biocompatibility (ISO 10993). Skin temperature testing conducted on healthy volunteers per FDA guidance for heating/cooling devices; minimum skin temperature of 11.7°C (53°F) recorded at lowest setting.

Technological Characteristics

DC-powered control unit; removable ice water tank; pneumatic/fluid pumps. Splints constructed of Nylon 210 and non-woven polyester. Temperature range 41-77°F (5-25°C); pressure range 0-75 mmHg. Connectivity: standalone. Software-controlled flow rate via thermosensor feedback. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-11, IEC 60601-1-2 (4th ed). Non-sterile.

Indications for Use

Indicated for patients with post-surgical or acute injuries requiring cold and compression therapy to reduce edema, swelling, and pain. Intended for use by or on the order of licensed healthcare professionals in hospitals, clinics, athletic training settings, or home environments.

Regulatory Classification

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.

Predicate Devices

• GRPro 2.1 System (K192114)
• Med4Elite (K171685)

Reference Devices

• Therm X (K181149)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <b> X</b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] |
| | Fax: [phone] |
| Contact Person: | Ms. Natalie J. Kennel |
| | Consultant |
| | NJK & Associates, Inc. |
| | 13721 Via Tres Vista |
| | San Diego, CA 92129 USA |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |

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 | Clearance<br>Date | Scope of safety and<br>effectiveness<br>comparison to<br>subject device |
|---------|---------------------|----------------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| K192114 | GRPro 2.1<br>System | CoolSystems® (dba<br>Game Ready) | October 29,<br>2019 | Compared to all<br>aspects of the subject<br>device.<br>Primary Predicate |
| K171685 | Med4Elite | CoolSystems® (dba<br>Game Ready) | September 29,<br>2017 | Compared to the Duo<br>control module's dual<br>output functionality.<br>Compared to the Wrist<br>Splint and the Hip<br>Splint.<br>Secondary Predicate |
| K181149 | Therm X | Zenith Technical<br>Innovations | August 3, 2018 | Compared to the<br>subject device static<br>pressure option.<br>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/<br>Parameters | ICE COMPRESSION<br>FIRST, DUO, & MOOVE<br>Systems<br>(Subject Device) | GameReady GRPro 2.1,<br>K192114<br>(Primary predicate device) | Game Ready Med4Elite,<br>K171685<br>(Secondary predicate<br>device) | Comparison results and<br>reference devices, where<br>applicable |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The ICE COMPRESSION<br>FIRST, DUO, and MOOVE<br>Systems combine cold and<br>compression therapies. They are<br>intended to treat post-surgical<br>and acute injuries to reduce<br>edema, swelling, and pain where<br>cold and compression are<br>indicated. They are intended to<br>be used by or on the order of<br>licensed healthcare professionals<br>in hospital, outpatient clinics,<br>athletic training settings, or<br>home settings. | Game Ready GRPro 2.1 System<br>is intended to treat post-surgical<br>and acute injuries to reduce<br>edema, swelling, and pain where<br>cold and compression are<br>indicated.<br>It is intended to be used by or on<br>the order of licensed healthcare<br>professionals in hospitals,<br>outpatient clinics, athletic<br>training settings, or home<br>settings. | The Med4 Elite™ combines<br>cold, heat, contrast and<br>compression therapies.<br>It is intended to treat post-<br>surgical and acute injuries to<br>reduce edema, swelling and pain<br>for which cold and compression<br>are indicated.<br>It is intended to treat post<br>traumatic and post surgical<br>medical and/or surgical<br>conditions for which localized<br>thermal therapy (hot or cold or<br>contrast) are indicated.<br>It is intended to be used by, or<br>on the order of, licensed<br>healthcare professionals in<br>rehabilitation facilities,<br>outpatient clinics, and athletic<br>training settings. | Substantially equivalent to<br>predicate device; wording differs<br>slightly. Both devices intended<br>to treat the same conditions.<br>Secondary intended use covers<br>the subject device intended use<br>AND additional indications not<br>included in the subject device.<br>Differences between the subject<br>device and the predicate device<br>indications for use do not raise<br>new safety or effectiveness<br>questions. |
| Contraindications<br>and precautions | Provided in Subject Device User<br>Manual | Available in Predicate Device<br>User Manual | Available in Predicate Device<br>User Manual | Similar, minor wording<br>differences only.<br>Secondary predicate includes<br>contraindications for heat, which<br>does not apply to the subject<br>device. |
| Characteristics/<br>Parameters | ICE COMPRESSION<br>FIRST, DUO, & MOOVE<br>Systems<br>(Subject Device) | GameReady GRPro 2.1,<br>K192114<br>(Primary predicate device) | Game Ready Med4Elite,<br>K171685<br>(Secondary predicate<br>device) | Comparison results and<br>reference devices, where<br>applicable |
| Intended Users | Healthcare professionals, athletic<br>trainers, lay users under the<br>direction of a healthcare<br>professional | Healthcare professionals, athletic<br>trainers, lay users under the<br>direction of a healthcare<br>professional | Healthcare professionals only<br>(prescription use) | Substantially equivalent to<br>primary predicate device; differs<br>from secondary predicate device<br>which is restricted to healthcare<br>professionals |
| Intended use<br>environment | Hospitals, outpatient clinics,<br>athletic training facilities.<br>prescription home use. | Hospitals, outpatient clinics,<br>athletic training facilities.<br>prescription home use. | Intended for indoor use only<br>such as rehabilitation clinics,<br>outpatient clinics, athletic<br>training settings. | Identical to primary predicate.<br>Differs from secondary predicate<br>which excludes the home use<br>environment. |
| Principle of<br>Operation | Pneumatic and fluid pumps and<br>flexible multi-chamber wrap<br>deliver intermittent compression<br>and cold therapy. | Pneumatic and fluid pumps and<br>flexible multi-chamber wrap<br>deliver intermittent compression<br>and cold therapy. | Pneumatic and fluid pumps and<br>flexible multi-chamber wrap<br>deliver intermittent compression,<br>cold therapy and heat therapy. | Substantially equivalent;<br>secondary predicate description<br>includes heat therapy which is<br>not applicable to subject device |
| Cooling Unit/<br>Compressor<br>Description | Small, removable ice water<br>tank(s); no compressor cooling<br>unit. | Small, ice box reservoir; no<br>compressor cooling unit. | Vapor compression cold<br>reservoir unit and resistance<br>heating reservoir unit (1 gallon<br>each). | Similar to primary predicate;<br>ICE COMPRESSION Systems<br>have removable water tank(s).<br>ICE COMPRESSION DUO<br>System has two units in enclosed<br>in one system. Differs from<br>secondary predicate which uses<br>a compressor cooling unit.<br>This does not raise new safety<br>or effectiveness questions. |
| Characteristics/<br>Parameters | ICE COMPRESSION<br>FIRST, DUO, & MOOVE<br>Systems<br>(Subject Device) | GameReady GRPro 2.1,<br>K192114<br>(Primary predicate device) | Game Ready Med4Elite,<br>K171685<br>(Secondary predicate<br>device) | Comparison results and<br>reference devices, where<br>applicable |
| Treatment<br>Temperature Range | 41-77°F (5-25°C) | 34 - 50°F (1- 10°F) | 38 - 60°F (3.33-15.56°C) (cold<br>therapy temperature range) | Substantially equivalent. The<br>subject device has a warmer<br>temperature range that does not<br>raise new issues of safety and<br>effectiveness. Highest<br>temperature is driven by the<br>ambient environment (no heating<br>unit in subject or primary<br>predicate). |
| Water Temperature<br>accuracy | +/-1.8°F (+/-1°C) | +/-4°F (+/-2°C)<br>Per predicate User Manual | +/-4°F (+/-2°C)<br>Per predicate User Manual | Similar. Subject device claims a<br>tighter accuracy than predicate<br>devices; does not raise new<br>issues of safety and<br>effectiveness. |
| Temperature<br>Adjustment<br>Mechanism | Software adjusts the flowrate<br>based on thermosensor feedback. | Patented fluid flow control<br>technology. | Not publicly available. | Different. Physical mechanism<br>for temperature adjustment is<br>different but both the subject<br>device and the primary predicate<br>use adjustment of water flow<br>rate to controlled by software to<br>adjust temperature. Unable to<br>compare to the secondary<br>predicate. No new issues of<br>safety or effectiveness raised. |
| Characteristics/<br>Parameters | ICE COMPRESSION<br>FIRST, DUO, & MOOVE<br>Systems<br>(Subject Device) | GameReady GRPro 2.1,<br>K192114<br>(Primary predicate device) | Game Ready Med4Elite,<br>K171685<br>(Secondary predicate<br>device) | Comparison results and<br>reference devices, where<br>applicable |
| Compression range | 0-75 mmHg | 5-75 mmHg<br>Or 0 mmHg (no pressure) | 5-75 mmHg<br>Or 0 mmHg (no pressure) | Substantially equivalent. Subject<br>device has a lower minimum<br>pressure when oscillating<br>(dynamic mode); Predicate<br>devices can be set to 0 pressure:<br>does not raise different issues of<br>safety and effectiveness. |
| Pressure<br>Application time | Dynamic pressure: Adjustable<br>from 0-55 seconds of pressure<br>for cycle<br>Static pressure: Up to 45 minutes<br>continuous application of<br>pressure setting | Dynamic pressure: Cyclical<br>compression applied from 5 to<br>90 minutes (total) in three levels:<br>Low (5-15 mmHg) cycled in 5<br>minutes<br>Medium (5-50 mmHg) cycled in<br>3 minutes<br>High (5-75 mmHg) cycled in 3<br>minutes<br>(per User Manual)<br>No Static pressure | Dynamic pressure: Cyclical<br>compression applied from 5 to<br>60 minutes (total) with default of<br>15 minutes in four levels:<br>Low (5-15 mmHg) cycled in 5<br>minutes<br>Medium-Low (5-30 mmHg)<br>cycled in 3 minutes<br>Medium (5-50 mmHg) cycled in<br>3 minutes<br>High (5-75 mmHg) cycled in 3<br>minutes<br>(per User Manual)<br>No Static pressure | Similar for pressure application<br>of dynamic pressure on Subject<br>device compared to predicate<br>devices. Subject device has more<br>flexibility in the cycling timing<br>of pressure.<br>Predicate devices do not have<br>static pressure settings.<br>Reference device K181149<br>Therm X has a static pressure<br>mode like subject device.<br>Differences do not raise new<br>safety or effectiveness questions<br>because the maximum pressure<br>and range is similar to other<br>devices |
| Air Pressure<br>Accuracy | +/- 10mm Hg | +/-10mmHg<br>Per predicate User Manual | +/-10mmHg<br>Per predicate User Manual | Same |
| Characteristics/<br>Parameters | ICE COMPRESSION<br>FIRST, DUO, & MOOVE<br>Systems<br>(Subject Device) | GameReady GRPro 2.1,<br>K192114<br>(Primary predicate device) | Game Ready Med4Elite,<br>K171685<br>(Secondary predicate<br>device) | Comparison results and<br>reference devices, where<br>applicable |
| Treatment time<br>adjustment | Adjustable from 0- 45 minutes in<br>increments of 1 minute | 15 minutes default, increasing or<br>decreasing in 5-minute<br>increments to a max of 90 min or<br>a min of 5 min. | Cold and/or compression<br>therapy: 15 minutes default,<br>increasing or decreasing in 5-<br>minute increments to a max of<br>60 min or a min of 5 min. | Similar. Subject device<br>maximum treatment time (45<br>minutes) is less than predicate<br>device maximum treatment time<br>(90 minutes or 60 minutes).<br>Does not raise any different<br>issues of safety and<br>effectiveness. (Cold therapy is<br>limited by use of ice water for<br>subject device and primary<br>predicate device) |
| Treatment Cycle | Manual Mode:<br>20 min default,<br>increasing/decreasing in 5-<br>second increments with a<br>minimum of 0 min and a<br>maximum of 45 min. | Manual Mode:<br>15 minutes default, increasing or<br>decreasing in 5-minute<br>increments to a max of 90 min or<br>a min of 5 min.<br>Program Mode:<br>Six (6) pre-programmed<br>treatment on-off cycles are 30-<br>30 or 30-60 min. at no pressure,<br>low pressure, or medium<br>pressure. | Cold: 5 to 60 minutes, 1 minute<br>increments<br>Default 15 minutes<br>Compression: 5 to 60 minutes,<br>15 minutes default | Different: Subject has only<br>manual mode that can be<br>adjusted up to 45 minutes:<br>primary predicate devices pre-<br>programmed treatments are<br>customizable. Secondary<br>predicate settings have<br>adjustable default settings.<br>Differences do not raise new<br>issues of safety or effectiveness<br>raised. |
| Software/ Software<br>Features | Software controls pressure,<br>displays battery level, monitors<br>and adjusts temperature. | Electronic pressure control and<br>therapy time and temperature<br>monitoring. Battery voltage<br>monitoring. | Electronic pressure control and<br>therapy time and temperature<br>monitoring. | Substantially equivalent; subject<br>device uses a different algorithm<br>to adjust water temperature from<br>proprietary algorithm in<br>predicate devices. No different<br>issues of safety or effectiveness<br>raised. |
| Characteristics/<br>Parameters | ICE COMPRESSION<br>FIRST, DUO, & MOOVE<br>Systems<br>(Subject Device) | GameReady GRPro 2.1,<br>K192114<br>(Primary predicate device) | Game Ready Med4Elite,<br>K171685<br>(Secondary predicate<br>device) | Comparison results and<br>reference devices, where<br>applicable |
| User interface<br>(Control unit control<br>panel) | LCD touchscreen display and 9<br>surrounding button keys | LCD display and 9 buttons | LCD touchscreen displays all<br>elements | Substantially equivalent to<br>primary predicate; subject device<br>provides users with an option to<br>use the touchscreen or the keys.<br>Secondary predicate uses only<br>touchscreen. |
| Number of patients<br>that can be treated at<br>the same time | MOOVE: One<br>FIRST: One<br>DUO: Two | One patient | Two patients | Substantially equivalent.<br>Subject FIRST and MOOVE<br>models have substantially<br>equivalent capabilities to the<br>primary predicate. Subject DUO<br>model is substantially equivalent<br>to capabilities of the secondary<br>predicate. |
| Dimensions | MOOVE: 11.4" x 9.45" x 15.35"<br>(290 x 240 x 390 mm)<br>FIRST: 12.8" x 18.81" x 15.94"<br>(327 x 478 x 405 mm)<br>DUO: 12.8" x 18.81" x 15.94"<br>(327 x 478 x 405 mm) | 9.25" H x 7.75" W x 16.25" L<br>(413 x 197 x 235) mm (not<br>including carrying case) | 32.5" L x 24.75" W x 43"H (83<br>cm<br>L x 63 cm W x 109cm H) | Different. Subject device (all<br>models) is larger than the<br>primary predicate. Both subject<br>and primary predicate device are<br>portable. Subject MOOVE<br>model has a handle like<br>predicate device. Subject device<br>is smaller than the secondary<br>predicate. Does not raise<br>different questions of safety or<br>effectiveness. |
| Characteristics/<br>Parameters | ICE COMPRESSION<br>FIRST, DUO, & MOOVE<br>Systems<br>(Subject Device) | GameReady GRPro 2.1,<br>K192114<br>(Primary predicate device) | Game Ready Med4Elite,<br>K171685<br>(Secondary predicate<br>device) | Comparison results and<br>reference devices, where<br>applicable |
| Weight<br>(empty/filled) | MOOVE: 5.5 / 11 lbs.<br>FIRST: 11 / 15.4 lbs.<br>DUO: 13 / 22 lbs. | 7.3 / 18 lbs. (approx.) | 172 lbs (78 kg) | Similar to the primary predicate;<br>the empty predicate device<br>weighs less than 2 of Subject<br>models. When filled, the primary<br>predicate device weight is in<br>between the Subject FIRST and<br>DUO models. The primary<br>predicate device weighs more<br>when full because of slightly<br>higher capacity. The weight of<br>the secondary predicate is<br>heavier than the subject device<br>as secondary predicate is not<br>intended to be portable.<br>Differences do not raise new<br>safety or effectiveness<br>questions. |
| Chilling Mechanism | Ice | Ice | Vapor compressor | Same mechanism as primary<br>predicate. Mechanism differs<br>from secondary predicate. |
| Water/Ice Capacity | FIRST & MOOVE: 2,500 mL<br>DUO: 5,000 mL | Approximately 5100 mL (5.4 qt) | 1 gallon (3.8 L)<br>Not applicable as ice is not<br>chilling mechanism. | Similar.: largest subject device<br>model capacity is similar to<br>primary predicate capacity.<br>Secondary predicate capacity is<br>not applicable because ice water<br>is not the chilling mechanism.<br>Differences do not raise new<br>safety or effectiveness<br>questions. |
| Characteristics/<br>Parameters | ICE COMPRESSION<br>FIRST, DUO, & MOOVE<br>Systems<br>(Subject Device) | GameReady GRPro 2.1,<br>K192114<br>(Primary predicate device) | Game Ready Med4Elite,<br>K171685<br>(Secondary predicate<br>device) | Comparison results and<br>reference devices. where<br>applicable |
| Coolant | Tap water and ice | Tap water and ice | Distilled water (cooled by vapor<br>condenser) | Same as primary predicate.<br>Secondary predicate uses<br>condenser to provide cooling. |
| Water flow rate | 100-350 mL/min | 275-450 mL/min | Not publicly disclosed | Similar. The subject device flow<br>rate is slightly slower than the<br>predicate. For both, the flow rate<br>is driven by temperature control<br>mechanism. User doesn't set or<br>control water flow rate. Does not<br>raise different issues of safety<br>and effectiveness |
| Power source | Battery; power supply connects<br>battery to mains to charge. | Mains power from medical<br>desktop power supply, optional<br>battery pack | Mains power to control unit | Different. All pass electrical<br>safety; differences do not raise<br>different issues of safety or<br>effectiveness |
| Battery Type | Nickel-Metal Hydride…