The Nicel combines cold 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 be used by or on the order of a healthcare professional in hospital, outpatient clinics, athletic training settings, or home settings.

Device Description

Nice1 is a cold and compression therapy device used to aid recovery and reduce pain associated with soft tissue injuries. The device works by circulating cooled water and air through a therapy wrap that is placed on the injured body part. The cooled water circulates through the therapy wrap and provides cold therapy; the air inflates the therapy wrap causing it to compress around the injured body part.

The Nice1 uses thermoelectric technology to chill the water. The Nice1 consists of 3 key components:

The control unit which chills the water and contains the pneumatic system for inflating and deflating the therapy wraps.
The hose assembly which connects to the control unit to the therapy wrap and provides conduits for the flow of water and air to and from the therapy wrap.
The therapy wrap which is placed on the patient and wraps around the injured body part to deliver cold and compression therapy.

The control unit is an electromechanical, software-controlled device housed in a plastic enclosure. The device is approximately 8 x 7.64 x 8" and weighs 10 lbs. Inside the control unit are a thermoelectric heat exchange for cooling the water, a pneumatic system to control the flow of air to/from the therapy wrap to regulate compression, and electronics to control the therapy. Integrated into the plastic enclosure is graphical touch screen that displays outputs and receives inputs from the user. Temperature, compression levels and therapy duration are selected by the user via the graphical touch screen interface and controlled by a microprocessor.

The control unit contains a 300ml reservoir that is filled with water by the user. Water from the reservoir is cooled by passing through the thermoelectric heat exchange; it is then pumped from the control unit through the hose assembly, through the therapy wrap and then returns to the control unit to be re-chilled. Temperature is controlled in five (5) levels ranging in temperature from 59°F to 43°F.

Compression can be set at low, medium and high settings ranging from 0 mmHg to 75 mmHg. The compression cycles from high to low on 2 – 5 minute intervals to achieve Intermittent Pneumatic Compression.

The hose assembly is 6 feet long and consists of a foam rubber outer sheath to provide insulation and 3 urethane tubes that carry water and air to/from the control unit and therapy wrap.

The therapy wraps are comprised of 3 layers of urethane coated nylon that are welded together to make 2 separate air and liquid tight layers for the air and water. The therapy wraps are tailored to fit specific body parts. At the current time the company is only marketing a knee wrap. Therapy wraps use a Velcro closure to allow for customized fitting for different patients.

AI/ML Overview

The provided text describes the Nice1 device, a cold and compression therapy system, and its substantial equivalence to a predicate device, the Game Ready System, as reviewed by the FDA. However, the document does not contain acceptance criteria for the device in the sense of performance thresholds (e.g., minimum accuracy, sensitivity, or specificity values) that need to be met by a medical device.

Instead, the "acceptance criteria" presented are implicitly defined by the demonstration of substantial equivalence to the predicate device through non-clinical performance testing. The study performed is a non-clinical comparative performance testing study.

Here's an analysis based on the information provided, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, there are no explicit "acceptance criteria" with numerical thresholds in the provided document. The criteria are derived from the comparison to the predicate device.

Feature	Acceptance Criteria (Implied by Predicate)	Reported Nice1 Device Performance
Intended Use	To treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. Used by or on order of healthcare professional in various settings. Similar patient population.	Same as predicate. Patient population: Adults, children under 18 under supervision of licensed healthcare practitioner.
Therapy Temperature Range	Cool: 34°-50°F	Cool: 43°-59°F (Note: While the range differs, the document states "The Nicel and Game Ready operate at similar therapeutic temperatures." and earlier, "The main difference demonstrated in non-clinical testing was that the Game Ready reaches cold temperatures quicker than Nicel because it uses ice to cool water. Ice has an almost instantaneous effect while the thermoelectric technology used by Nicel requires a cool-down time of approximately 5 – 10 minutes to reach the target low temperature." The FDA deemed this "Substantially Equivalent.")
Therapy Mode of Operation	Cold / Compression	Cold / Compression
User Interface	Button, dial with display	Touch screen. The different control mechanism does not affect safety and effectiveness. (Deemed "Substantially Equivalent.")
Operating Fluid	Tap Water	Tap Water
Compression Pump Pressure	0-75 mm Hg	0-75 mm Hg
Electrical Safety	UL 60601-1, CAN/CSA C22.2 No. 601.1, IEC 60601-1-2:2001	AAMI ANSI ES60601-1:2005/(R)2012, AI:2012, IEC 60601-1-2:2007 (Deemed "Substantially Equivalent.")
Compression Settings	High (75 mmHg), Medium (50 mmHg), Low (15 mmHg) with specific inflation/deflation times.	Same as predicate for High, Medium, and Low settings and cycle times.
Knee Wrap Fit & Dimensions	One size fits all, Length: 17 3/8", Max Circumference: Top: 32", Bottom: 24"	One size fits all, Length: 17", Max Circumference: Top: 32", Bottom: 24" (Deemed "Substantially Equivalent." The slight length difference of 3/8" is not considered significant).
Power	AC power: 100-240 V~, 50-60 Hz; DC input: 12Vdc, 2.5A	AC power 120V~, 50-60 Hz; DC input: 15Vdc, 12A (Deemed "Substantially Equivalent." The different power specifications are not considered to impact fundamental safety or effectiveness.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The study involved non-clinical performance testing of the device itself, not human subjects. It likely involved a single or small number of Nice1 units and predicate units for direct comparison.
Data Provenance: The data is from non-clinical performance testing conducted on the devices, presumably by Nice Recovery Systems LLC or a contracted lab. There is no mention of country of origin for test data or whether it was retrospective or prospective in the context of human data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Experts: Not applicable. For this type of non-clinical device performance testing, "ground truth" is established through engineering and scientific measurements and specifications, not expert consensus (e.g., radiologists, pathologists). The comparison is against objective performance metrics of a legally marketed predicate device.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no need for expert adjudication, as the "ground truth" was based on direct physical measurements and comparison to the predicate device's documented performance.

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

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical therapy device that does not involve image interpretation or AI assistance for human readers/users.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance: Not applicable in the context of an "algorithm." This device is a physical therapy machine. Its performance was assessed in a standalone manner as a device (e.g., its ability to cool water and generate pressure), but this phrasing typically refers to AI/software performance.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the non-clinical testing was established by the engineering specifications and measured performance of both the Nice1 device and the predicate device (Game Ready System). This includes objective measurements of temperature ranges, compression levels, flow rates, and adherence to electrical safety standards. The predicate device's established safety and effectiveness served as the benchmark.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This document describes the premarket notification (510(k)) for a physical medical device, not a machine learning or AI-based diagnostic/therapeutic algorithm. There is no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 23, 2014

Nice Recovery Systems, LLC c/o Dave Yungvirt, CEO Third Party Review Group 45 Rockefeller Plaza Suite 2000 New York, New York 10111

Re: K143197

Trade/Device Name: Nice1 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILO Dated: December 8, 2014 Received: December 9, 2014

Dear Dave Yungvirt,

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. 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 statutes and regulations administered by other Federal agencies. You must comply

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K143197

Device Name Nice1

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Image /page/4/Picture/0 description: The image contains the logo for NICE Recovery Systems. The word "nice" is written in large, orange, sans-serif font. Below "nice" is the phrase "Recovery Systems" in a smaller, gray, sans-serif font.

Traditional 510(k) Summary as required by Section 21CFR 807.92(c)

Submitter/Owner	Nice Recovery Systems LLC
	CEO: Michael Ross
	1382 Kalmia Avenue
	Boulder, CO 80304
	phone: 1-646-675-7700
	fax: 1-720-302-1262

Contact Person	Michael RossNice Recovery Systems LLC1382 Kalmia AvenueBoulder, CO 80304phone: 646-675-7700fax: 1-720-302-1262mr@nicerecovery.com
----------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------

Date the summary wasprepared	December 5, 2014
----------------------------------	------------------

Name of the Device	Trade Name: Nice1Common Name: Cold/Compression Therapy System
--------------------	-------------------------------------------------------------------

Classification	Classification Name: Cold water circulating pack/Powered
	inflatable tube massager
	Primary Product Code: IRP
	Secondary Product Code: ILO
	Class II
	890.5650
	Physical Medicine

Manufacturing Facility	Sparton Medical Systems Colorado4300 Godding Hollow ParkwayFrederick, CO 80504Establishment Registration Number: 1724385
------------------------	--------------------------------------------------------------------------------------------------------------------------------------

Predicate Device	Game Ready System
	Manufactured by CoolSystems Inc.
	K071050
	Product Code: ILO/IRP
	Class II
	Cold water circulating pack/Powered inflatable tube massager

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Nice Recovery Systems LLC, 1382 Kalmia Ave., Boulder, CO 80304

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Image /page/5/Picture/0 description: The image shows the logo for Nice Recovery Systems. The word "nice" is written in large, orange, sans-serif font. Below the word "nice" is the phrase "Recovery Systems" written in a smaller, gray, sans-serif font. The logo is simple and modern.

Device Description	Nice1 is a cold and compression therapy device used to aidrecovery and reduce pain associated with soft tissue injuries. Thedevice works by circulating cooled water and air through atherapy wrap that is placed on the injured body part. The cooledwater circulates through the therapy wrap and provides coldtherapy; the air inflates the therapy wrap causing it to compressaround the injured body part.
	The Nice1 uses thermoelectric technology to chill the water.The Nice1 consists of 3 key components:1. The control unit which chills the water and contains thepneumatic system for inflating and deflating the therapywraps.2. The hose assembly which connects to the control unit tothe therapy wrap and provides conduits for the flow ofwater and air to and from the therapy wrap.3. The therapy wrap which is placed on the patient andwraps around the injured body part to deliver cold andcompression therapy.
	The control unit is an electromechanical, software-controlleddevice housed in a plastic enclosure. The device is approximately8 x 7.64 x 8" and weighs 10 lbs. Inside the control unit are athermoelectric heat exchange for cooling the water, a pneumaticsystem to control the flow of air to/from the therapy wrap toregulate compression, and electronics to control the therapy.Integrated into the plastic enclosure is graphical touch screen thatdisplays outputs and receives inputs from the user. Temperature,compression levels and therapy duration are selected by the uservia the graphical touch screen interface and controlled by amicroprocessor.
	The control unit contains a 300ml reservoir that is filled withwater by the user. Water from the reservoir is cooled by passingthrough the thermoelectric heat exchange; it is then pumped fromthe control unit through the hose assembly, through the therapywrap and then returns to the control unit to be re-chilled.Temperature is controlled in five (5) levels ranging intemperature from 59°F to 43°F.
	Compression can be set at low, medium and high settings rangingfrom 0 mmHg to 75 mmHg. The compression cycles from highto low on 2 – 5 minute intervals to achieve Intermittent
	Pneumatic Compression.
	The hose assembly is 6 feet long and consists of a foam rubberouter sheath to provide insulation and 3 urethane tubes that carrywater and air to/from the control unit and therapy wrap.
	The therapy wraps are comprised of 3 layers of urethane coatednylon that are welded together to make 2 separate air and liquidtight layers for the air and water. The therapy wraps are tailoredto fit specific body parts. At the current time the company is onlymarketing a knee wrap. Therapy wraps use a Velcro closure toallow for customized fitting for different patients.

Intended Use	The Nice1 combines cold and compression therapies. It isintended to treat post-surgical and acute injuries to reduce edema,

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swelling, and pain where cold and compression are indicated. It

Summary of Technological	Nice1 and Game Ready have substantially equivalent functions:
Characteristics in	-Both devices pump cooled water through a hose and therapy
Comparison to Predicate	wrap that is placed on the injured body part of the patient.
	-Both devices inflate and deflate the therapy wrap and regulate air
	pressure to achieve Intermittent Pneumatic Compression.
	-Both devices use a microprocessor to control water temperature,
	compression levels and therapy duration.
	-Both devices have therapy wraps that correspond to specific
	body parts.
	-Both devices use therapy wraps that are comprised of 3 layers of
	urethane coated nylon that are welded together to make 2 separate
	air and liquid tight layers for the air and water.
	Nice1 differs from Game Ready in only 3 significant aspects:
	Nice1 uses thermoelectric technology to cool the water, so1.
	the patient only needs to add water to the reservoir. Game
	Ready uses ice to cool the water, so the patient must fill
	the reservoir with both ice and water.
	2.Because Nice1 and Game Ready use different methods to
	cool the water (thermoelectric vs. ice) the devices use
	different water flow rates to maintain the same levels of
	cold therapy. The differing flow rates are completely
	transparent to the user as the user is only aware of the cold
	therapy which is identical regardless of the fact that the
	water is flowing at different rates inside of the system.
	3.Nice1 uses a graphical touch screen to display options and

	messages as well as receive inputs from the user. Game Ready uses physical dials, buttons and a liquid crystal display to display options and messages as well as receive inputs from the user. Both products have substantially equivalent functions and provide equivalent therapies.
Non-clinical Testing	Nice1 complies with AAMI ANSI ES60601-1:2005/(R)2012, AI:2012 general requirements for electrical safety and IEC 60601-1-2:2007 electromagnetic compatibility.Substantial equivalence with the predicate device is supported by Performance testing. Performance data demonstrates comparable results for cold therapy and compression therapy. A summary of the testing results follows:
	1. Cold Therapy: The Nicel and Game Ready operate at similar therapeutic temperatures. The coldest temperature for the Nice1 is 43 degrees F while the coldest temperature for Game Ready is 37 degrees F.
	The main difference demonstrated in non-clinical testing was that the Game Ready reaches cold temperatures quicker than Nicel because it uses ice to cool water. Ice has an almost instantaneous effect while the thermoelectric technology used by Nicel requires a cool-down time of approximately 5 – 10 minutes to reach the target low temperature.
	2. Compression Therapy: Compression Therapy: The Nicel and Game Ready devices both operate at the same compression levels and cycle times.
	At the High setting: the Nicel inflated to 75 mmHg for 2.5 minutes and then deflated to 5 mmHg for 1 minute. The Game Ready inflated to 75 mmHg for 2.5 minutes and deflated to 5 mmHg for 1 minute.
	At the Medium setting: the Nicel inflated to 50 mmHg for 2.5 minutes and then deflated to 5 mmHg for 1 minute. The Game Ready inflated to 50 mmHg for 2.5 minutes and deflated to 5 mmHg for 1 minute.
	At the Low setting: the Nicel inflated to 15 mmHg for 4.5 minutes and then deflated to 5 mmHg for 1 minute. The
	Game Ready inflated to 15 mmHg for 4.5 minutes anddeflated to 5 mmHg for 1 minute.
Conclusions from Non-Clinical Testing	Testing demonstrates that the Nice1 is as safe, as effective, and performs as well as the Game Ready device.
Clinical Testing	No clinical testing data are submitted, referenced or relied on to determine substantial equivalence.

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Substantial Equivalence	The Nice1 is substantially equivalent to the Game Ready System,CoolSystems Inc., K071050, Product Code ILO/IRP for coolingand compression based on intended use, design, energy delivered,performance, safety and bench testing.
-------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Feature	Nice1	Game Ready, K071050(predicate)	Difference/Implication
Indication for Use	The Nice1 combines coldand compression therapies.It is intended to treat post-surgical and acute injuries toreduce edema, swelling, andpain where cold andcompression are indicated.It is intended to be used byor on the order of ahealthcare professional inhospital, outpatient clinics,athletic training settings, orhome settings.Patient population: Nice1can be used by adults. Andchildren under 18 can usethe device only under thesupervision of a licensedhealthcare practitioner.	The Game Ready Systemcombines cold andcompression therapies. Itis intended to treat post-surgical and acute injuriesto reduce edema, swelling, andpain where cold andcompression are indicated.It is intended to be used byor on the order of ahealthcare professional inhospitals, outpatientclinics, athletic trainingsettings, or home settings.Patient population:Athletes and active peopleand surgery patients.Children under 18 can usethe device only undersupervision of a licensedhealthcare practitioner.	Substantially Equivalent
TherapyTemperatureRange	Cool: 43°-59°F	Cool: 34°-50°F	Substantially Equivalent
TherapyMode of	Cold / Compression	Cold / Compression	Substantially Equivalent
	Touch screen. The different	Button, dial with display	The Nice1 uses a touch
Operation	control mechanism does notaffect safety andeffectiveness.	screen for userinteraction as comparedto the Game Readymechanical controls.
Operating FluidCompressionPump Pressure	Tap Water0-75 mm Hg	Tap Water0-75 mm Hg	Substantially Equivalent
Electrical Safety	AAMI ANSI ES60601-1Electrical SafetyIEC 60601-1-2 EMC	UL 60601-1CAN/CSA C22.2 No.601.1IEC 60601-1-2:2001	Substantially Equivalent
CompressionSetting	Compression Off Intermittent Compression:-High (5 to 75 mmHg).Approximately 2 to 3minutes of inflation and1 minute of deflation. -Medium (5 to 50 mmHg).Approximately 2 to 3minutes of inflation and1 minute of deflation. -Low (5 to 15 mmHg).Approximately 4 to 5minutes of inflation and 1minute of deflation.	Compression Off Intermittent Compression:-High (5 to 75mmHg).Approximately 2 to 3minutes of inflationand 1 minute ofdeflation. -Medium (5 to 50mmHg).Approximately 2 to 3minutes of inflationand 1 minute ofdeflation. -Low (5 to 15 mmHg).Approximately 4 to 5minutes of inflation and 1minute of deflation.	Substantially Equivalent.
Knee Wrap Fitand Dimensions	One size fits allLength: 17"Maximum Circumference:Top: 32"Bottom: 24"	One size fits allLength: 17 3/8"Maximum Circumference:Top: 32"Bottom: 24"	Substantially Equivalent.
Power	AC power 120V~, 50-60 HzDC input: 15Vdc, 12A	AC power: 100-240 V~,50-60 HzDC input: 12Vdc, 2.5A	Substantially Equivalent.

Nice Recovery Systems LLC, 1382 Kalmia Ave., Boulder, CO 80304

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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).