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 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 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 dual-bladder 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 cold-compression 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.

AI/ML Overview

The provided text is a 510(k) Summary for the Breg Polar Care Wave system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with specific acceptance criteria and performance metrics as would be typical for a novel device or a device requiring de novo classification.

The document discusses performance testing in a general sense, stating:

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

However, it does not provide a table of specific acceptance criteria, reported device performance (quantitative metrics like sensitivity, specificity, accuracy, etc.), or details of a clinical study in the way medical AI or diagnostic devices typically require. Instead, the focus is on engineering and safety standards compliance (e.g., IEC 60601) and comparison of features to predicate devices.

Therefore, for the information requested regarding acceptance criteria and a study proving performance, this document does not contain the specific details you've asked for, such as:

A table of acceptance criteria and reported device performance.
Sample size used for a clinical test set or data provenance.
Number of experts or their qualifications for ground truth.
Adjudication method for a test set.
MRMC comparative effectiveness study or human reader improvement data.
Standalone algorithm performance.
Type of ground truth used (clinical outcomes, pathology, expert consensus).
Sample size for training set or how ground truth was established for it.

The primary study detailed here is a comparison to predicate devices, focusing on demonstrating similarities in intended use, technology, and compliance with general safety standards, leading to a conclusion of substantial equivalence.

Based on the provided text, here is what can be inferred or explicitly stated regarding performance, albeit without the detailed clinical study metrics you requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied, not explicitly quantified as typically done for AI/diagnostic devices): The device functions as intended, providing cold and compression therapy safely and effectively within specified ranges, and meets relevant electrical safety and EMC standards. It is "adequately safe and effective" and its labeling is "easy to use and understandable."
Reported Device Performance (Qualitative, not quantitative clinical metrics from the document):
- "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 software in the Polar Care Wave system has been validated and demonstrated to be safe and effective for its intended use."
- Therapy Temperature Range: 45°F-60°F (falls within the range of predicate devices).
- Compression Setting: Low (0-25 mm Hg), Regular (0-50 mm Hg). The high pressure is within the predicate device range, and low pressure being lower is noted as having no safety/effectiveness issues as it represents minimum pressure.
- Compliance: Certified to IEC 60601-3rd edition (medical electrical safety) including ANSI/AAMI/ES60601-1-11, and IEC 60601-1-2 4th edition (EMC).

2. Sample size used for the test set and the data provenance:

Not provided. This document does not describe a clinical test set with a specific sample size of patients or images. The "testing" mentioned refers to design verification and validation, likely internal engineering tests, not a clinical trial on a patient cohort specified by sample size.
Data Provenance: Not applicable in the context of a clinical test set for performance evaluation in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The submission does not detail a clinical study where human experts established ground truth for a test set. The validation is based on engineering and safety standards, and functional verification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set and associated ground truth adjudication described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a physical therapy device (cold and compression), not an AI/diagnostic imaging device. Therefore, MRMC studies and concepts of "human readers improving with AI assistance" are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or AI device. Its performance is inherent to its mechanical and electrical function.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable in the clinical sense. For a device like this, "ground truth" would be the engineering specifications and clinical indications for which cold and compression are generally accepted therapies (e.g., reduction of edema, swelling, and pain). Performance is established by meeting design specifications and safety standards, rather than direct comparison to a "ground truth" diagnosis.

8. The sample size for the training set:

Not applicable. This is not a machine learning/AI device, so there is no training set in that context.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

In summary: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence of a physical therapy device (Polar Care Wave) to existing predicate devices. It relies on engineering verification and validation, compliance with recognized safety and electrical standards (IEC 60601 series), and a comparison of functional features to establish that the device is "adequately safe and effective" for its intended use, rather than presenting a clinical study with quantitative performance metrics (like sensitivity/specificity) against a clinically established ground truth, which would be typical for AI-driven or diagnostic technologies.

Summary

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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 (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)

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., ECarlsbad, CA 92010
Contact person:	Monique ZamoraManager, Quality EngineeringBreg, Inc.2885 Loker Ave., ECarlsbad, CA 92010Phone: (760) 795-5917Fax: (760) 795-5284Email: 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:

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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:

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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
ProductCode	IRP Powered inflatable tubemassager (21 CFR 820.5650)	IRP Powered inflatable tubemassager (21 CFR 820.5650)	IRP Powered inflatable tubemassager (21 CFR 820.5650)	Substantially Equivalent
RegulationNumber	ILO Water circulating hot or coldpack (21 CFR 890.5720)	ILO Water circulating hot orcold pack (21 CFR 890.5720)	ILO Water circulating hot orcold pack (21 CFR 890.5720)
RegulatoryClass	II	II	II	Substantially Equivalent
IntendedUse	The Polar Care Wave system isintended to treat post-surgical andacute injuries to help reduceedema, swelling, and pain wherecold and compression areindicated. It is intended to beused by or on the order oflicensed healthcare professionalsin hospitals, outpatient clinics,athletic training settings, or homesettings.	The Game Ready ClassicSystem is intended to treatpost-surgical and acute injuriesto reduce edema, swelling, andpain where cold andcompression are indicated. Itis intended to be used by or onthe order of licensedhealthcare professionals inhospitals, outpatient clinics,athletic training settings, orhome settings.	The Med4 Elite combinescold, heat, contrast andcompression therapies. It isintended to treat post-surgicaland acute injuries to reduceedema, swelling, and painwhere cold and compressionare indicated. It is intended totreat post traumatic and post-surgical medical and/orsurgical conditions for whichlocalized thermal therapy (hotor cold or contrast) areindicated. It is intended to beused by or on the order oflicensed health careprofessionals in rehabilitationfacilities, outpatient clinicsand athletic training settings.	The Polar Care Wave andthe primary predicatedevice (Game ReadyClassic System) IntendedUse are substantiallyequivalent.The Polar Care Wave andthe secondary predicatedevice (Med4 Elite) havesimilar intended uses, thedifference is that the PolarCare Wave does notprovide heat or contrasttherapy.
Feature	Polar Care Wave	Game Ready, K072620	Med4 Elite, K171685	Difference / Implication
Indicationsfor Use	The Polar Care Wave product isintended for the application ofexternal cold and compressiontherapy to temporarily reducepain, swelling, and/orinflammation resulting frominjury or surgery. The use of coldand compression therapy hasbeen shown to reduce opioidconsumption following surgicalprocedures. It is intended for useby or on the order of licensedhealthcare professionals inhospitals, outpatient clinics,athletic training settings, and/orhome settings.	The Game Ready ClassicSystem is intended to treatpost-surgical and acute injuriesto reduce edema, swelling, andpain where cold andcompression are indicated. Itis 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 isintended to treat post-surgicaland acute injuries to reduceedema, swelling, and painwhere cold and compressionare indicated. It is intended totreat post traumatic and post-surgical medical and/orsurgical conditions for whichlocalized thermal therapy (hotor cold or contrast) areindicated. It is intended to beused by or on the order oflicensed health careprofessionals in rehabilitationfacilities, outpatient clinicsand athletic training settings.	The Polar Care Wave andthe primary predicatedevice (Game ReadyClassic System)Indications For Use aresubstantially equivalent.The Polar Care Wave andthe secondary predicatedevice (Med4 Elite) havesimilar Indications ForUse, the difference is thatthe Polar Care Wave doesnot provide heat orcontrast therapy.
IntendedUsers	Health Care Professionals and layusers (under prescription).	Health Care Professionals andlay users (under prescription)	Health Care Professionalsonly (under prescription)	All three devices areprescription only. Thesecondary predicate isonly used by Health CareProfessionals.
Intended UseEnvironment	Intended for indoor use	Intended for indoor use	Intended for indoor use	Substantially Equivalent
Therapy	Cold and CompressionWork together or independently	Cold and CompressionWork together orindependently	Cold, Heat, Contrast andCompression	All three devices providecold and compressiontherapy. The secondarypredicate provides heatand contrast therapy.
Feature	Polar Care Wave	Game Ready, K072620	Med4 Elite, K171685	Difference / Implication
Therapysessions	Manual mode – allows the userto adjust cold and compressionsettings as directed by a HealthCare Professional.	Manual mode - allows the userto adjust treatment time andpressure settings.Program mode – allows theuser to choose one of sixtreatment programs thatprovide therapy for a set timeat a specific pressure setting.	Program mode – allows theuser to choose treatmentprograms and therapy times.	The Polar Care Wave andthe primary predicatecontain a manual mode fortemperature andcompression therapies thatare controlled by the user.
Types of Pads	Various anatomical pads:Knee, Shoulder, Back, Hip,Universal, Foot/Ankle	Various anatomical pads:Straight knee, ArticulatedKnee, Elbow, Ankle, Shoulder,Back, Hip-Groin, Hand-Wrist	Various anatomical pads:Straight knee, ArticulatedKnee, Elbow, Ankle,Shoulder, Back, Hip-Groin,Hand-Wrist	Substantially Equivalent
CompressionSetting	Available in two levelsLow (0-25 mm Hg)Regular (0-50 mm Hg)	Available in three levelsLow (5-15 mm Hg)Medium (5-50 mm Hg)High (5-75 mm Hg)	Available in four levelsLow (5-15 mm Hg)Medium-Low (5-30 mm Hg)Medium (5-50 mm Hg)High (5-75 mm Hg)	The Polar CareWave and the predicatedevices provideintermittent compressionwith multiple settings. ThePolar Care Wave highpressure is within thepressure range of thepredicate devices. Thelow pressure for the PolarCare Wave is less than thepredicate devices, there isno safety or effectivenessissues since this representsthe minimum pressureduring a deflation cycle.
Feature	Polar Care Wave	Game Ready, K072620	Med4 Elite, K171685	Difference / Implication
ColdTherapy	Available without and withcompression (Low and Regular)	Available without and withcompression (Low, Medium-low, Medium, High)	Available without and withcompression (Low, mediumHigh)	Substantially Equivalent
TherapyTemperatureRange	45°F-60°F	34°F-50°F	38°F-60°F (+/- 4°F accuracy)	The Polar Care Wavetemperature range iswithin the temperaturerange of the secondarypredicate and the low endof the range is within theprimary predicate.
HeatTherapy	Not Available	Not Available	Available without and withcompression (Low)	The Polar Care Wave andthe primary predicate aresubstantially equivalent.The secondary predicateprovides heat therapy.
UserInterface	Keypad with indicator lights	Button, dial with display	Touch Screen	The Polar Care Wave usesa keypad for userinteraction as compared tothe primary predicate dialcontrol and the secondarypredicate touch screen.The different controlmechanisms do not affectsafety and effectiveness.
OperatingFluid	Tap Water	Tap Water	Distilled Water	Substantially Equivalent
Feature	Polar Care Wave	Game Ready, K072620	Med4 Elite, K171685	Difference / Implication
WaterCoolingSource	Ice	Ice	Vapor Compression	Substantially Equivalent
	Single UserColdCompressionPad	Yes	Yes	Yes	Substantially Equivalent
		ColdCompressionPad Sterility	Non-Sterile	Non-Sterile	Non-Sterile
Line Voltage/ Frequency			100-240 VAC50/60 HZ	100-240 VAC50/60 HZ	100-240 VAC50/60 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.

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).