The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using an inflatable wrap.

The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.

Device Description

Cold Compression Wrap Pro Device consists of a main unit and wraps which simulates kneading and stroking of tissue with the hands by use of inflatable pressure wraps. It is for temporary increase in circulation of the treated areas and temporary relief of minor muscle aches and pains. By inflating the air chambers and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient.

There are 4 different wraps for Shoulder, elbow/arm, low limbs (Calf and upper leg), ankle/foot. The wrap contains cold pack, and the cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.

When the device is used for 30 minutes (Default time) at the operature (5°C~ 40°C) specified in the user manual, the temperature of the cold pack is (-18°C ~-4℃) (±2℃).

AI/ML Overview

The provided document, K230524, is a 510(k) Premarket Notification for a medical device called "Cold Compression Wrap Pro". This document, issued by the FDA, determines the substantial equivalence of the new device to existing legally marketed predicate devices.

Based on the provided document, here's a breakdown of the acceptance criteria and the study proving the device meets them:

Crucially, this is not a clinical study report for an AI/ML medical device. It's a 510(k) submission for a physical medical device (cold compression wrap) with embedded software. Therefore, many of the typical acceptance criteria and study details for AI/ML performance (like MRMC studies, ground truth establishment by experts, and large training/test sets of medical data) are not applicable or present in this document.

The "study" here refers to the non-clinical performance testing conducted to demonstrate that the device functions as intended and is safe.

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" with quantitative performance metrics for the device's therapeutic effect (e.g., pain reduction scores, circulation improvement). Instead, it focuses on the device's technical specifications and safety parameters, which serve as its de facto acceptance criteria for this type of device.

Here's an attempt to extract the closest equivalents to acceptance criteria and reported performance based on the "510(k) Summary" section, particularly the "Substantial Equivalence Comparison" table and "Summary of Non-clinical Performance Testing":

Acceptance Criteria (Stated or Implied)	Reported Device Performance (Subject Device)	Comments / Basis for Performance Claims
Electrical Safety	Complies with IEC 60601-1:2005, AMDI:2012	Non-clinical testing
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014	Non-clinical testing
Software Validation	Software verification and validation testing conducted; considered "moderate" level of concern.	Non-clinical testing; followed FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Product Appearance and Size	Tested according to internal standards	Non-clinical testing
Wrap Performance	Tested according to internal standards	Non-clinical testing
Function Test	Tested according to internal standards	Non-clinical testing
Intended Use Equivalence	"The Cold Compression Wrap Pro is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using an inflatable wrap. The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable."	Claimed "Identical" to predicate devices (K222669 & K133483).
Operating Temperature of Cold Pack	-18℃ ~ -4℃ (±2℃)	Maintained consistency with predicate (K222669).
Main Unit Operating Temperature Range	5℃ ~ 40℃ (41°F ~ 104°F)	Identical to predicate (K222669).
Pressure Range	0-100 mmHg	Identical to predicate (K222669).
Pressure Levels	20, 40, 60, 80, 100 mmHg	Identical to predicate (K222669).
Pressure Error Range	±15 mmHg	Identical to predicate (K222669).
Noise Level	≤ 55dB	Identical to predicate (K222669).
Biocompatibility	Not conducted due to use of same patient contact material as predicate device with same nature and duration of contact.	Equivalence argument; implied acceptance criteria met by predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document describes non-clinical performance testing (electrical safety, EMC, software validation, product appearance/size, wrap performance, function tests). These tests are typically performed on a small sample of manufactured devices (e.g., a few units, or internal test benches). The specific number is not specified in this summary.
Data Provenance: The tests are "non-clinical" and likely conducted in a lab setting by the manufacturer, Chengdu Cryo-Push Medical Technology Co.,Ltd, which is located in China. The data is prospective, in the sense that the company specifically conducted these tests for the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a physical device, not an AI/ML diagnostic algorithm. Therefore, the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists interpreting images) is not applicable. The "ground truth" for this device's performance is established by engineering measurements and adherence to recognized standards (e.g., IEC 60601-1 for electrical safety). The qualifications of the testing personnel are not disclosed in this summary.

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

This is not applicable as there is no human review or adjudication of data points in the way it would occur for AI/ML diagnostic algorithms (e.g., reviewing medical images). The testing involves objective measurements against predefined engineering specifications.

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, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that assist human readers (e.g., radiologists). This product is a physical therapeutic device, not a diagnostic AI.

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

Not applicable in the context of an AI/ML algorithm. The device has "embedded software" which underwent "software validation". This is a test of the embedded software's functionality and safety (e.g., reliably controlling pressure and time settings), not a standalone diagnostic AI performance evaluation. The device itself operates "as is" when used by a patient, meaning the "algorithm" (software) operates in a standalone manner as part of the device's function, but not as a diagnostic tool.

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

The "ground truth" for this device's performance is based on engineering specifications, recognized international safety standards (e.g., IEC 60601 series), and the functional requirements for a cold compression system. For instance, the ground truth for electrical safety is whether the device actually meets the voltage leakage limits of IEC 60601-1. For the cold pack temperature, it's whether the internal temperature sensor actually registers within the specified range after 30 minutes of operation. This is determined by instrumental measurements and adherence to test protocols, not clinical outcomes or expert consensus on medical data.

8. The sample size for the training set

The device is a physical product with embedded software. It is not an AI/ML device that requires a "training set" of data in the common sense (e.g., images for deep learning). The software is likely programmed deterministically or based on engineered control logic, not "trained" on data. Therefore, the concept of a "training set sample size" is not applicable.

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

Since there is no "training set" in the AI/ML sense, this question is not applicable. The "ground truth" for the device's design and software functionality is rooted in engineering requirements, safety standards, and the intended physiological effects of cold compression therapy (which are well-established prior to this device's development).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 19, 2024

Chengdu Cryo-Push Medical Technology Co.,Ltd % Liz Li Counselor Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518000 China

Re: K230524

Trade/Device Name: Cold Compression Wrap Pro Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, IME Dated: October 31, 2023 Received: November 20, 2023

Dear Liz Li:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices

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OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230524

Device Name Cold Compression Wrap Pro

Indications for Use (Describe)

The Cold Compression Wrap Pro is indicated for the temporary relief of minor muscle aches and pains.

The device is indicated for temporary increase in created areas in people who are in good health, and simulates kneading and stroking of tissues using an inflatable wrap.

The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.

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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510(k) Summary K230524

1. Contact Details

1.1 Applicant information

510(k) owner's name	Chengdu Cryo-Push Medical Technology Co.,Ltd
Address	102, 105, Zone 20, Huayin Industrial Port, No.618,
	Kexing Road (West), Wenjiang District, Chengdu 611137
	Sichuan P.R.China
Phone No.	TEL: +86 18086852687
Fax No.	/
Name of contact	Zhang Peiyong
person
Date Prepared	Nov.18th.2023

1.2 Submission Correspondent

卓远天成	Shenzhen Joyantech Consulting Co., Ltd.
	1713A, 17th Floor, Block A, Zhongguan Times Square,
	Liuxian Avenue, Xili Town, Nanshan District, Shenzhen,
	Guangdong Province, China
Phone No.	+86 755-86069197
Contact person	Liz Li
e-mail	liz@cefda.com; grace@cefda.com
Website	http://www.cefda.com

2. Device information

Trade name	Cold Compression Wrap Pro
Classification	II
Classification name	Massager, Powered Inflatable Tube
Product code	IRP; IME
Regulation No.	21 CFR 890.5650

3. Legally Marketed Predicate Device

Trade Name	Cryopush Cold Compression Device
Classification	II
510(k) Number	K222669
Product Code	IRP; IME

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Manufacturer	Chengdu Cryo-Push Medical Technology Co., Ltd
Trade Name	Portable Therapeutix Squid Active Cold Compressiondevice and Cold Pack for OTC Use
510(k) Number	K133483
Product Code	IRP, IME
Manufacturer	MEDIcept, Inc.

4. Device Description

When the device is used for 30 minutes (Default time) at the operature (5°C~ 40°C) specified in the user manual, the temperature of the cold pack is (-18°C ~-4℃) (±2℃).

5. Intended use

The Cold Compression Wrap Pro is indicated for the temporary relief of minor muscle aches and pains.

The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using an inflatable wrap.

The cold wrap is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.

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6. Substantial Equivalence Comparison

Item	Subject device	Predicate device K222669	Predicate device K133483	Comments
Device name	Cold Compression Wrap Pro	Cryopush Cold CompressionDevice	Portable Therapeutix SquidActive Cold Compressiondevice and Cold Pack forOTC Use	/
model	A02-C-006	A02-P-001	not publicly available	/
Regulation number	21 CFR 890.5650,21 CFR 890.5700	21 CFR 890.5650,21 CFR 890.5700	21 CFR 890.5650,21 CFR 890.5700	Identical
Classification	II	II	II	Identical
Product Code	IRP, IME	IRP, IME	IRP, IME	Identical
Intended use	The Cold Compression WrapPro is indicated for thetemporary relief of minormuscle aches and pains.The device is indicated fortemporary increase incirculation of the treatedareas in people who are ingood health, and simulateskneading and stroking oftissues using an inflatablewrap.The cold pack is indicated forlocalized therapy in situationswhere cold temperaturetherapy is necessary ordesirable.	The Cryopush ColdCompression Device isindicated for the temporaryrelief of minor muscle achesand pains.The device is indicated fortemporary increase incirculation of the treatedareas in people who are ingood health, and simulateskneading and stroking oftissues using an inflatablewrap.The cold pack is indicated forlocalized therapy in situationswhere cold temperaturetherapy is necessary ordesirable.	The Squid Active ColdCompression device and ColdPack for OTC use is indicatedfor the temporary relief ofminor muscle aches andpains.The compression device isindicated for temporaryincrease in circulation of thetreated areas in people whoare in good health, andsimulates kneading andstroking of tissues using aninflatable garment.The cold pack is indicated forlocalized therapy in situationswhere cold temperaturetherapy is necessary ordesirable.	Identical
Item	Subject device	Predicate device K222669	Predicate device K133483	Comments
Treatment area/Structure ofSleeves	Shoulder, elbow/arm, lowlimbs (Calf and upper leg),ankle/foot	Low limbs (Calf and upperleg)	Leg, foot, arm, shoulders,lower back, hands	Note
OTC or Rx	OTC	OTC	OTC	Identical
Environment ofUse	Clinics, hospital, athletetraining environments	Clinics, hospital, athletetraining, and homeenvironments	not publicly available	Note
Power source	100-240V~50/60Hz	100-240V~50/60Hz	120V 60 Hz, consumption26W; AC adapter: 120V 60Hz, consumption 36W Lithiumbattery	Identical toK222669
Principle ofoperation/Mechanicalcharacteristics	Intermittent compression 5intensity settings1-20 mmHg2-40 mmHg3-60 mmHg4-80 mmHg5-100 mmHg	Intermittent compression 5intensity settings1-20 mmHg2-40 mmHg3-60 mmHg4-80 mmHg5-100 mmHg	Intermittent compression 4intensity settings1-30 mmHg2-50 mmHg3-70 mmHg4-85 mmHg	Identical toK222669 &Note
Working Time	10min, 20 min, 30 min, 40min, 50 min, 60 min, 70 min,80 min, 90 min, 100 min, 110min, 120 min, default as30min	10min, 20 min, 30 min, 40min, 50 min, 60 min, 70 min,80 min, 90 min, 100 min, 110min, 120 min, default as30min	15min	Identical toK222669
Pressure range	0-100mmHg	0-100mmHg	0-85mmHg	Identical toK222669
Pressure levels	20mmHg,40 mmHg,60mmHg,80 mmHg,100 mmHg.	20mmHg,40 mmHg,60mmHg,80 mmHg,100 mmHg.	30mmHg,40 mmHg,70mmHg,85 mmHg	Identical toK222669
Pressure errorrange	±15mmHg	±15mmHg	not publicly available	Identical toK222669
Keep time	5s	10s	not publicly available	Substantial
Deflation time	6s	20s	not publicly available	Equivalence
Item	Subject device	Predicate device K222669	Predicate device K133483	Comments
Noise level	≤ 55dB	≤ 55dB	not publicly available	Identical toK222669
Wrap Material	Nylon with a PVC laminate	Nylon with a PVC laminate	Nylon with TPU backingwrap-yes	Identical toK222669
Patient contact	Non-conductive attachments	Non-conductive attachments	not publicly available	Identical toK222669
Single Wrapweight	low limbs (Calf and upperleg):480g;Ankle/foot: 338g;Shoulder: 388g;elbow/arm: 308g;	480g	not publicly available
Wrap Size	low limbs (Calf and upperleg): 330610mm;Ankle/foot: 830420mm;Shoulder: 1080430mm;elbow/arm: 620440mm;	330*610mm	not publicly available	SubstantialEquivalence
Cold pack weight	low limbs (Calf and upperleg):1030g;Ankle/foot: 1282g;Shoulder: 932g;elbow/arm: 632g;	1030g (±10%)	not publicly available
Cold pack Size	low limbs (Calf and upperleg):570300mm;Ankle/foot: 595260mm;Shoulder: 520360mm;elbow/arm: 440370mm;	300*570mm	not publicly available
Cold packOperatingtemperature	-18℃~-4°C (±2°C)	-18℃~-4℃ (±2℃)	not publicly available	Identical toK222669
Operatingenvironment	Temperature:5℃~ 40℃ (41°F ~ 104°F)Relative humidity:	Temperature:5℃~ 40℃(41°F ~ 104°F)Relative humidity:	not publicly available	Identical toK222669
Item	Subject device	Predicate device K222669	Predicate device K133483	Comments
Transportation &Storageenvironment	10% ~ 90%Atmospheric pressure:700~1060hpa	10% ~ 90%Atmospheric pressure:700~1060hpa
	Temperature:	Temperature:
	-25℃~~55℃ (-13°F~~131°F)	-25℃~~55℃ (-13°F~~131°F )
	Relative humidity:10% ~ 90%Atmospheric pressure:700~1060hpa	Relative humidity:10% ~ 90%Atmospheric pressure:700~1060hpa	not publicly available	Identical toK222669

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Product: Cold Compression Wrap Pro

Chengdu Cryo-Push Medical Technology Co., Ltd

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The subject device, Cold Compression Wrap Pro, is substantially equivalent to the predicate device K222669 and K133483. This conclusion is based upon comparison on intended use, principle of operation and technological characteristics, etc.

7. Summary of Non-clinical Performance Testing

The following data were provided in support of the substantial equivalence determination:

Electrical Safety, Electromagnetic Compatibility 1)
-IEC 60601-1:2005, AMDI:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
1. Software validation

The subject device contains an embedded software system. Software verification and validation testing were conducted as recommended by FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", and the software for this device was considered as a "moderate" level of concern.

1. Performance
  There are no FDA recognized consensus standards for this device. We tested the following items according to our internal standards,
-Product Appearance and Size
-Wrap Performance
-Function Test
1. Biocompatibility test

The subject device and the predicated device use the same patient contact material, and has the same nature of body contact and contact duration. Therefore, no biocompatibility test was conducted.

8. Clinical testing

N/A

9. Conclusions

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).