Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and software control of pumps and temperature, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain, which are therapeutic effects.

Diagnostic

No
The device is described as an external cold therapy and intermittent pneumatic compression system intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain. Its "Intended Use / Indications for Use" section specifies treatment rather than diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a cold-compression pad, insulated container, lid with pumps and electronics, and tubing, indicating it is a hardware-based system with software control, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Polar Care Wave System is an external therapy device that applies cold and compression to the body. It does not analyze any samples taken from the patient.
Intended Use: The intended use is to treat post-surgical and acute injuries by reducing edema, swelling, and pain through external cold and compression. This is a therapeutic function, not a diagnostic one.
Device Description: The description details a system that circulates cold water and air externally to the body. There is no mention of analyzing biological samples.

Therefore, the Polar Care Wave System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

IRP, ILO

Device 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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

back, shoulder, hip, knee, foot/ankle

Indicated Patient Age Range

Not Found

Intended User / Care Setting

licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K072620, K171685

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for 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.
2885 Loker Ave., E
Carlsbad, CA 92010
Contact person:	Monique Zamora
Manager, Quality Engineering
Breg, Inc.
2885 Loker Ave., E
Carlsbad, CA 92010
Phone: (760) 795-5917
Fax: (760) 795-5284
Email: mzamora@breg.com

DEVICE INFORMATION:

Proprietary Name:	Polar Care WaveTM
Common Name:	Cold and Compression Therapy
Regulatory Common:	Powered inflatable tube massager (21 CFR 820.5650)
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
Code	IRP Powered inflatable tube
massager (21 CFR 820.5650)	IRP Powered inflatable tube
massager (21 CFR 820.5650)	IRP Powered inflatable tube
massager (21 CFR 820.5650)	Substantially Equivalent
Regulation
Number	ILO Water circulating hot or cold
pack (21 CFR 890.5720)	ILO Water circulating hot or
cold pack (21 CFR 890.5720)	ILO Water circulating hot or
cold pack (21 CFR 890.5720)
Regulatory
Class	II	II	II	Substantially Equivalent
Intended
Use	The Polar Care Wave system is
intended to treat post-surgical and
acute injuries to help 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.	The Game Ready Classic
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.	The Med4 Elite combines
cold, heat, contrast and
compression therapies. It is
intended to treat post-surgical
and acute injuries to reduce
edema, swelling, and pain
where cold and compression
are indicated. It is intended to
treat post traumatic and post-
surgical medical and/or
surgical conditions for which
localized thermal therapy (hot
or cold or contrast) are
indicated. It is intended to be
used by or on the order of
licensed health care
professionals in rehabilitation
facilities, outpatient clinics
and athletic training settings.	The Polar Care Wave and
the primary predicate
device (Game Ready
Classic System) Intended
Use are substantially
equivalent.

The Polar Care Wave and
the secondary predicate
device (Med4 Elite) have
similar intended uses, the
difference is that the Polar
Care Wave does not
provide heat or contrast
therapy. | |
| Feature | Polar Care Wave | Game Ready, K072620 | Med4 Elite, K171685 | Difference / Implication | |
| Indications
for Use | The Polar Care Wave product is
intended for the application of
external cold and compression
therapy to temporarily reduce
pain, swelling, and/or
inflammation resulting from
injury or surgery. The use of cold
and compression therapy has
been shown to reduce opioid
consumption following surgical
procedures. It is intended for use
by or on the order of licensed
healthcare professionals in
hospitals, outpatient clinics,
athletic training settings, and/or
home settings. | The Game Ready Classic
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. | The Med4 Elite combines
cold, heat, contrast and
compression therapies. It is
intended to treat post-surgical
and acute injuries to reduce
edema, swelling, and pain
where cold and compression
are indicated. It is intended to
treat post traumatic and post-
surgical medical and/or
surgical conditions for which
localized thermal therapy (hot
or cold or contrast) are
indicated. It is intended to be
used by or on the order of
licensed health care
professionals in rehabilitation
facilities, outpatient clinics
and athletic training settings. | The Polar Care Wave and
the primary predicate
device (Game Ready
Classic System)
Indications For Use are
substantially equivalent.

The Polar Care Wave and
the secondary predicate
device (Med4 Elite) have
similar Indications For
Use, the difference is that
the Polar Care Wave does
not provide heat or
contrast therapy. | |
| Intended
Users | Health Care Professionals and lay
users (under prescription). | Health Care Professionals and
lay users (under prescription) | Health Care Professionals
only (under prescription) | All three devices are
prescription only. The
secondary predicate is
only used by Health Care
Professionals. | |
| Intended Use
Environment | Intended for indoor use | Intended for indoor use | Intended for indoor use | Substantially Equivalent | |
| Therapy | Cold and Compression

Work together or independently | Cold and Compression

Work together or
independently | Cold, Heat, Contrast and
Compression | All three devices provide
cold and compression
therapy. The secondary
predicate provides heat
and contrast therapy. | |
| Feature | Polar Care Wave | Game Ready, K072620 | Med4 Elite, K171685 | Difference / Implication | |
| Therapy
sessions | Manual mode – allows the user
to adjust cold and compression
settings as directed by a Health
Care Professional. | Manual mode - allows the user
to adjust treatment time and
pressure settings.

Program mode – allows the
user to choose one of six
treatment programs that
provide therapy for a set time
at a specific pressure setting. | Program mode – allows the
user to choose treatment
programs and therapy times. | The Polar Care Wave and
the primary predicate
contain a manual mode for
temperature and
compression therapies that
are controlled by the user. | |
| Types of Pads | Various anatomical pads:

Knee, Shoulder, Back, Hip,
Universal, Foot/Ankle | Various anatomical pads:

Straight knee, Articulated
Knee, Elbow, Ankle, Shoulder,
Back, Hip-Groin, Hand-Wrist | Various anatomical pads:

Low (0-25 mm Hg)

Regular (0-50 mm Hg) | Available in three levels

Low (5-15 mm Hg)

Medium (5-50 mm Hg)

High (5-75 mm Hg) | Available in four levels

Low (5-15 mm Hg)

Medium-Low (5-30 mm Hg)

Medium (5-50 mm Hg)

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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.