Polar Care Wave

K183702 · Breg, Inc. · IRP · Mar 1, 2019 · Physical Medicine

Device Facts

• Record ID: K183702
• Device Name: Polar Care Wave
• Applicant: Breg, Inc.
• Product Code: IRP · Physical Medicine
• Decision Date: Mar 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polar Care Wave System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

Device Story

Polar Care Wave is an AC-powered, software-controlled system providing cold therapy and intermittent pneumatic compression. Input: user-filled ice and water in an insulated container. Operation: lid-housed water pump circulates cold water through a dual-bladder pad; air pump cyclically inflates/deflates a second bladder for compression. Output: localized cold and compression therapy. Used in hospitals, clinics, or homes; operated by healthcare professionals or patients under prescription. Keypad interface allows manual therapy adjustment. Benefits: reduction of edema, swelling, pain, and potential reduction in post-surgical opioid consumption.

Clinical Evidence

Bench testing only. No clinical data presented. System underwent design verification and validation testing to confirm proper operation, safety, and effectiveness. Labeling was evaluated for usability.

Technological Characteristics

AC-powered, software-controlled system. Components: insulated ice/water container, lid with water/air pumps, keypad, and dual-bladder cold-compression pads. Cold therapy range: 45°F-60°F. Compression: intermittent, two levels (0-25 mmHg, 0-50 mmHg). Electrical safety: IEC 60601 3rd edition, ANSI/AAMI/ES60601, IEC 60601-1-11. EMC: IEC 60601-1-2 4th edition.

Indications for Use

Indicated for post-surgical and acute injury patients 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, or home settings.

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

• Game Ready Classic System (K072620)
• Med4 Elite (K171685)

Submission Summary (Full Text)

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March 1, 2019

Breg Inc. Monique Zamora Manager, Quality Engineering 2885 Locker Ave. East Carlsbad, California 92010

Re: K183702

Trade/Device Name: Polar Care Wave Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILO Dated: December 28, 2018 Received: December 31, 2018

Dear Monique Zamora:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# VivekJ. 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) K183702

Device Name Polar Care Wave

Indications for Use (Describe)

The Polar Care Wave System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.25 3.375L5.75 10.875L2.75 7.875" stroke="currentColor" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="14" rx="3" stroke="currentColor" stroke-width="1.5" width="14" x="1" y="1"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Breg, a company that specializes in orthopedic bracing and rehabilitation products. The logo consists of a stylized orange circle with white lines inside, followed by the word "BREG" in bold, black letters. The logo is simple and modern, and it is easily recognizable.

#### 510(k) Summary

| Date Prepared: | February 27, 2019 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Breg, Inc.<br>2885 Loker Ave., E<br>Carlsbad, CA 92010 |
| Contact person: | Monique Zamora<br>Manager, Quality Engineering<br>Breg, Inc.<br>2885 Loker Ave., E<br>Carlsbad, CA 92010<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

#### DEVICE INFORMATION:

| Proprietary Name: | Polar Care WaveTM |
|-----------------------|------------------------------------------------------------------------------------------------------------|
| Common Name: | Cold and Compression Therapy |
| Regulatory Common: | Powered inflatable tube massager (21 CFR 820.5650)<br>Water circulating hot or cold pack (21 CFR 890.5720) |
| Device Product Code: | IRP, ILO |
| Classification: | Class II (510(k) required) |
| Classification Panel: | Physical Medicine |

#### PREDICATE DEVICE:

| Predicate | 510(k) | Device Name | Company |
|-----------|---------|---------------------------|-------------------|
| Primary | K072620 | Game Ready Classic System | CoolSystems, Inc. |
| Secondary | K171685 | Med4 Elite | CoolSystems, Inc. |

## PRODUCT DESCRIPTION:

The Polar Care Wave system is an AC powered, software controlled, multimodality system. The device is intended for application of external cold therapy and intermittent pneumatic compression therapy to be used by, or on the order of, licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings. The device features a multi-setting cold therapy module and multi-setting compression therapy module which can be run simultaneously or independently.

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The device contains three key parts: A cold-compression pad with connector, an insulated container to hold ice and water, and a lid that contains a water pump and air pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.

The device is intended to be used with Breg Cold-Compression pads only, which are designed for specific application sites. The cold-compression pads are available for the core regions; back, shoulder, hip, and knee and for the extremity region, foot/ankle. The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladders. The dualbladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy.

The insulated container is filled with ice and water by the user. The water circulates through the coldcompression pad to deliver cold therapy to the application site.

The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional.

## INDICATIONS FOR USE:

The Polar Care Wave System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

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# COMPARISON TO PREDICATE:

The following table compares the characteristics of the Polar Care Wave and the predicate devices.

| Feature | Polar Care Wave | Game Ready, K072620 | Med4 Elite, K171685 | Difference / Implication | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Product<br>Code | IRP Powered inflatable tube<br>massager (21 CFR 820.5650) | IRP Powered inflatable tube<br>massager (21 CFR 820.5650) | IRP Powered inflatable tube<br>massager (21 CFR 820.5650) | Substantially Equivalent | |
| Regulation<br>Number | ILO Water circulating hot or cold<br>pack (21 CFR 890.5720) | ILO Water circulating hot or<br>cold pack (21 CFR 890.5720) | ILO Water circulating hot or<br>cold pack (21 CFR 890.5720) | | |
| Regulatory<br>Class | II | II | II | Substantially Equivalent | |
| Intended<br>Use | The Polar Care Wave system is<br>intended to treat post-surgical and<br>acute injuries to help reduce<br>edema, swelling, and pain where<br>cold and compression are<br>indicated. It is intended to be<br>used by or on the order of<br>licensed healthcare professionals<br>in hospitals, outpatient clinics,<br>athletic training settings, or home<br>settings. | The Game Ready Classic<br>System is intended to treat<br>post-surgical and acute injuries<br>to reduce edema, swelling, and<br>pain where cold and<br>compression are indicated. It<br>is intended to be used by or on<br>the order of licensed<br>healthcare professionals in<br>hospitals, outpatient clinics,<br>athletic training settings, or<br>home settings. | The Med4 Elite combines<br>cold, heat, contrast and<br>compression therapies. It is<br>intended to treat post-surgical<br>and acute injuries to reduce<br>edema, swelling, and pain<br>where cold and compression<br>are indicated. It is intended to<br>treat post traumatic and post-<br>surgical medical and/or<br>surgical conditions for which<br>localized thermal therapy (hot<br>or cold or contrast) are<br>indicated. It is intended to be<br>used by or on the order of<br>licensed health care<br>professionals in rehabilitation<br>facilities, outpatient clinics<br>and athletic training settings. | The Polar Care Wave and<br>the primary predicate<br>device (Game Ready<br>Classic System) Intended<br>Use are substantially<br>equivalent.<br><br>The Polar Care Wave and<br>the secondary predicate<br>device (Med4 Elite) have<br>similar intended uses, the<br>difference is that the Polar<br>Care Wave does not<br>provide heat or contrast<br>therapy. | |
| Feature | Polar Care Wave | Game Ready, K072620 | Med4 Elite, K171685 | Difference / Implication | |
| Indications<br>for Use | The Polar Care Wave product is<br>intended for the application of<br>external cold and compression<br>therapy to temporarily reduce<br>pain, swelling, and/or<br>inflammation resulting from<br>injury or surgery. The use of cold<br>and compression therapy has<br>been shown to reduce opioid<br>consumption following surgical<br>procedures. It is intended for use<br>by or on the order of licensed<br>healthcare professionals in<br>hospitals, outpatient clinics,<br>athletic training settings, and/or<br>home settings. | The Game Ready Classic<br>System is intended to treat<br>post-surgical and acute injuries<br>to reduce edema, swelling, and<br>pain where cold and<br>compression are indicated. It<br>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. It is<br>intended to treat post-surgical<br>and acute injuries to reduce<br>edema, swelling, and pain<br>where cold and compression<br>are indicated. It is intended to<br>treat post traumatic and post-<br>surgical medical and/or<br>surgical conditions for which<br>localized thermal therapy (hot<br>or cold or contrast) are<br>indicated. It is intended to be<br>used by or on the order of<br>licensed health care<br>professionals in rehabilitation<br>facilities, outpatient clinics<br>and athletic training settings. | The Polar Care Wave and<br>the primary predicate<br>device (Game Ready<br>Classic System)<br>Indications For Use are<br>substantially equivalent.<br><br>The Polar Care Wave and<br>the secondary predicate<br>device (Med4 Elite) have<br>similar Indications For<br>Use, the difference is that<br>the Polar Care Wave does<br>not provide heat or<br>contrast therapy. | |
| Intended<br>Users | Health Care Professionals and lay<br>users (under prescription). | Health Care Professionals and<br>lay users (under prescription) | Health Care Professionals<br>only (under prescription) | All three devices are<br>prescription only. The<br>secondary predicate is<br>only used by Health Care<br>Professionals. | |
| Intended Use<br>Environment | Intended for indoor use | Intended for indoor use | Intended for indoor use | Substantially Equivalent | |
| Therapy | Cold and Compression<br><br>Work together or independently | Cold and Compression<br><br>Work together or<br>independently | Cold, Heat, Contrast and<br>Compression | All three devices provide<br>cold and compression<br>therapy. The secondary<br>predicate provides heat<br>and contrast therapy. | |
| Feature | Polar Care Wave | Game Ready, K072620 | Med4 Elite, K171685 | Difference / Implication | |
| Therapy<br>sessions | Manual mode – allows the user<br>to adjust cold and compression<br>settings as directed by a Health<br>Care Professional. | Manual mode - allows the user<br>to adjust treatment time and<br>pressure settings.<br><br>Program mode – allows the<br>user to choose one of six<br>treatment programs that<br>provide therapy for a set time<br>at a specific pressure setting. | Program mode – allows the<br>user to choose treatment<br>programs and therapy times. | The Polar Care Wave and<br>the primary predicate<br>contain a manual mode for<br>temperature and<br>compression therapies that<br>are controlled by the user. | |
| Types of Pads | Various anatomical pads:<br><br>Knee, Shoulder, Back, Hip,<br>Universal, Foot/Ankle | Various anatomical pads:<br><br>Straight knee, Articulated<br>Knee, Elbow, Ankle, Shoulder,<br>Back, Hip-Groin, Hand-Wrist | Various anatomical pads:<br><br>Straight knee, Articulated<br>Knee, Elbow, Ankle,<br>Shoulder, Back, Hip-Groin,<br>Hand-Wrist | Substantially Equivalent | |
| Compression<br>Setting | Available in two levels<br><br>Low (0-25 mm Hg)<br><br>Regular (0-50 mm Hg) | Available in three levels<br><br>Low (5-15 mm Hg)<br><br>Medium (5-50 mm Hg)<br><br>High (5-75 mm Hg) | Available in four levels<br><br>Low (5-15 mm Hg)<br><br>Medium-Low (5-30 mm Hg)<br><br>Medium (5-50 mm Hg)<br><br>High (5-75 mm Hg) | The Polar Care<br>Wave and the predicate<br>devices provide<br>intermittent compression<br>with multiple settings. The<br>Polar Care Wave high<br>pressure is within the<br>pressure range of the<br>predicate devices. The<br>low pressure for the Polar<br>Care Wave is less than the<br>predicate devices, there is<br>no safety or effectiveness<br>issues since this represents<br>the minimum pressure<br>during a deflation cycle. | |
| Feature | Polar Care Wave | Game Ready, K072620 | Med4 Elite, K171685 | Difference / Implication | |
| Cold<br>Therapy | Available without and with<br>compression (Low and Regular) | Available without and with<br>compression (Low, Medium-<br>low, Medium, High) | Available without and with<br>compression (Low, medium<br>High) | Substantially Equivalent | |
| Therapy<br>Temperature<br>Range | 45°F-60°F | 34°F-50°F | 38°F-60°F (+/- 4°F accuracy) | The Polar Care Wave<br>temperature range is<br>within the temperature<br>range of the secondary<br>predicate and the low end<br>of the range is within the<br>primary predicate. | |
| Heat<br>Therapy | Not Available | Not Available | Available without and with<br>compression (Low) | The Polar Care Wave and<br>the primary predicate are<br>substantially equivalent.<br>The secondary predicate<br>provides heat therapy. | |
| User<br>Interface | Keypad with indicator lights | Button, dial with display | Touch Screen | The Polar Care Wave uses<br>a keypad for user<br>interaction as compared to<br>the primary predicate dial<br>control and the secondary<br>predicate touch screen.<br>The different control<br>mechanisms do not affect<br>safety and effectiveness. | |
| Operating<br>Fluid | Tap Water | Tap Water | Distilled Water | Substantially Equivalent | |
| Feature | Polar Care Wave | Game Ready, K072620 | Med4 Elite, K171685 | Difference / Implication | |
| Water<br>Cooling<br>Source | Ice | Ice | Vapor Compression | Substantially Equivalent | |
| | Single User<br>Cold<br>Compression<br>Pad | Yes | Yes | Yes | Substantially Equivalent |
| | | Cold<br>Compression<br>Pad Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
| Line Voltage<br>/ Frequency | | | 100-240 VAC<br>50/60 HZ | 100-240 VAC<br>50/60 HZ | 100-240 VAC<br>50/60 HZ |

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## Substantial Equivalence

None of the performance or technological differences between the Polar Care Wave and the predicates raise any new issues of safety and effectiveness.

#### Performance Testing

The Polar Care Wave System has been subjected to design verification and validation testing. These tests verified and validated the proper operation of the system. The Polar Care Wave device has been found to be adequately safe and effective for the intended users, its intended uses, and use environment. The labeling materials have been found to be easy to use and understandable to the intended users.

#### Software

The software in the Polar Care Wave system has been validated and demonstrated to be safe and effective for its intended use.

## Electrical Safety and Electromagnetic Compatibility

The Polar Care Wave system is certified to the medical electrical safety standards of IEC 60601 3rd edition, including the ANSI/AAMI/ ES60601 collateral standards, 60601-1-11. The system also complies with the EMC standard, IEC 60601-1-2 4th edition.

#### Conclusion

The data and information provided in this submission, support the conclusion that the Breg Polar Care Wave is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics associated cold and compression.