(90 days)
A02-P-001:
The Cryopush Cold Compression Device 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 by an inflatable wrap.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
A02-P-002:
The Cryopush A02-P-002 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 by an inflatable wrap.
Cryopush Cold Compression 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. The device includes two models A02- P-001 and A02- P-002. The A02- P-001 has one chamber, and A02- P-002 has 2 chambers. The A02- P-001 contains cold pack, and the cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
When the A02- P-001 is used for 30 minutes (Default time) at the operating temperature (5°C~ 40°C) specified in the user manual, the temperature of the cold pack is (-18℃~-4℃) (±2℃).
The provided document is a 510(k) summary for the "Cryopush Cold Compression Device" (K222669). It details the device's characteristics and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the sense of clinical performance or diagnostic accuracy.
Instead, the document focuses on demonstrating substantial equivalence through non-clinical testing and comparison of technological characteristics. The "acceptance criteria" discussed are related to manufacturing standards, electrical safety, electromagnetic compatibility, and basic functional performance, not clinical efficacy or diagnostic accuracy.
Therefore, many of the requested points about "acceptance criteria" for performance, sample size, ground truth, experts, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it outlines a regulatory submission based on substantial equivalence to a predicate device rather than a de novo clinical trial demonstrating novel performance against defined criteria.
Here's the information that can be extracted based on the provided text, with notes for items not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Internal Standards based on Predicate) | Reported Device Performance/Characteristics |
|---|---|
| Electrical Safety, EMC | Device complies with IEC 60601-1:2005, AMDI:2012, IEC 60601-1-11:2015, IEC 60601-1-2:2014 |
| Software Validation | Software document determined according to FDA guidance (May 11, 2005) for software in medical devices |
| Pressure Range | A02-P-001: 0-100mmHg; A02-P-002: 0-215mmHg (Predicate: 0-240 mmHg) |
| Pressure Levels | A02-P-001: 20, 40, 60, 80, 100 mmHg; A02-P-002: 100, 160, 215 mmHg (Predicate: 150, 185, 215 mmHg) |
| Pressure Error Range | A02-P-001: ±15mmHg; A02-P-002: ±20mmHg (Predicate: ±25mmHg) |
| Cold Pack Temperature (A02-P-001) | -18℃ to -4℃ (±2℃) within 30 minutes of operation at 5°C-40°C operating temperature |
| Noise Level | ≤ 55dB (Predicate: ≤ 65dB) |
| Working Time | A02-P-001: 10-120 min (default 30 min); A02-P-002: 10-60 min (default 30 min) (Predicate: 20 minutes) |
| Keep time (Pressure hold time) | 10s (Predicate: 1-5s) |
| Deflation time | 20s (Predicate: 1-5s) |
| Product Appearance and Size, Wrap Performance, Function Test (Internal Standards) | Tested according to internal standards; specific metrics or results are not provided in this summary. |
| No adverse impact on safety and effectiveness compared to predicate despite differences | Concluded that differences in cold pack (A02-P-001) and treatment time do not raise adverse impact on safety and effectiveness. |
| Overall substantial equivalence to predicate device (K193354) | Concluded based on comparison of intended use, technological characteristics, and performances. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable. The document describes non-clinical engineering and performance testing against standards, not a clinical test set with human subjects for performance evaluation.
- Data provenance: Not applicable. The testing is described as internal testing by the manufacturer ("Chengdu Cryo-Push Medical Technology Co., Ltd") to conform to engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of expert consensus, is not relevant for the type of engineering and performance testing described. The "ground truth" here is adherence to specified engineering standards and internal performance metrics.
4. Adjudication method for the test set
- Not applicable. No expert adjudication process is described for this type of non-clinical testing.
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
- Not applicable. This device is a physical medical device (cold compression device), not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and "human readers improving with AI" are irrelevant 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-based device.
7. The type of ground truth used
- For engineering and performance tests: The ground truth implicitly refers to the specifications defined by relevant standards (e.g., IEC 60601 series for electrical safety, internal product specifications for pressure, noise, temperature) and the characteristics of the predicate device for comparison of substantial equivalence. There is no "expert consensus," "pathology," or "outcomes data" ground truth established for this type of submission.
8. The sample size for the training set
- Not applicable. There is no software or algorithm that would require a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned or implied.
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 5, 2022
Chengdu Cryo-Push Medical Technology Co., Ltd % Liz Li Counselor Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A. Zhonhhuan Times Square Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518000 China
Re: K222669
Trade/Device Name: Cryopush Cold Compression Device Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, IME Dated: September 6, 2022 Received: September 6, 2022
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 (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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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 Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K222669
Device Name Cryopush Cold Compression Device
Indications for Use (Describe)
A02-P-001:
The Cryopush Cold Compression Device 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 by an inflatable wrap.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
A02-P-002:
The Cryopush A02-P-002 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 by an inflatable wrap.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. Contact Details
1.1 Applicant information
| Applicant Name | Chengdu Cryo-Push Medical Technology Co.,Ltd |
|---|---|
| Address | 102, 105, Zone 20, Huayin Industrial Port, No.618, KexingRoad (West), Wenjiang District, Chengdu 611137 SichuanP.R.China |
| Phone No. | TEL: +86 18086852687 |
| Contact person | Zhang Peiyong |
| Date Prepared | Aug.10.2022 |
1.2 Submission Correspondent
| Shenzhen Joyantech Consulting Co., Ltd. | |
|---|---|
| 1713A, 17th Floor, Block A, Zhongguan Times Square,Liuxian Avenue, Xili Town, Nanshan District, Shenzhen,Guangdong Province, China | |
| 卓远天成 | |
| Phone No. | +86 755-86069197 |
| Contact person | Liz Li |
| Contact person's e-mail | liz@cefda.com; grace@cefda.com |
| Website | http://www.cefda.com |
2. Device information
| Trade name | Cryopush Cold Compression Device |
|---|---|
| Classification | II |
| Classification name | Massager, Powered Inflatable Tube |
| Product code | IRPIME |
| Regulation No. | 21 CFR 890.565021 CFR 890.5700 |
3. Legally Marketed Predicate Device
| Trade Name | Air Compression Therapy Device |
|---|---|
| 510(k) Number | K193354 |
| Product Code | IRP |
| Manufacturer | Shenzhen Dongjilian Electronics Co., Ltd |
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4. Device Description
Cryopush Cold Compression 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. The device includes two models A02- P-001 and A02- P-002. The A02- P-001 has one chamber, and A02- P-002 has 2 chambers. The A02- P-001 contains cold pack, and the cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
When the A02- P-001 is used for 30 minutes (Default time) at the operating temperature (5°C~ 40°C) specified in the user manual, the temperature of the cold pack is (-18℃~-4℃) (±2℃).
5. Intended use
A02-P-001:
The Cryopush Cold Compression Device 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 by an inflatable wrap.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
A02-P-002:
The Cryopush A02-P-002 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 by an inflatable wrap.
6. Substantial Equivalence Comparison
| Item | Proposed Device:(K222669) | Predicate Device:(K193354) | Comments | |
|---|---|---|---|---|
| Regulationnumber | 890.5650 | 890.5650 | Same | |
| Classification | II | II | Same | |
| Model | A02-P-001 | A02-P-002 | S9019 | Same |
| Product Code | IRP, IME | IRP | ||
| Intendeduse/Indicationsfor use | The Cryopush ColdCompression Deviceis indicated for thetemporary relief ofminor muscle achesand pains.The device is | The CryopushA02-P-002 isindicated for thetemporary relief ofminor muscle achesand pains.The device is | The Air CompressionTherapy Device isindicated for thetemporary relief of minormuscle aches and painsand for temporaryincrease in circulation tothe treated areas in | SubstantialEquivalence |
| Item | Proposed Device:(K222669) | Predicate Device:(K193354) | Comments | |
| indicated fortemporary increase incirculation of thetreated areas inpeople who are ingood health, andsimulates kneadingand stroking oftissues using by aninflatable wrap.The cold pack isindicated for localizedtherapy in situationswhere coldtemperature therapyis necessary ordesirable. | indicated fortemporary increasein circulation of thetreated areas inpeople who are ingood health, andsimulates kneadingand stroking oftissues using by aninflatable wrap. | people who are in goodhealth. The AirCompression TherapyDevice simulateskneading and stroking oftissues by using aninflatable garment. | ||
| Treatmentarea/Structure ofSleeves | Low limbs (Calf and upper leg) | Low limbs (Foot, calf andupper leg) | Similar | |
| OTC or Rx | OTC | OTC | Same | |
| Environment ofUse | Clinics, hospital, athlete training, and homeenvironments | Clinics, hospital, athletetraining, and homeenvironments | Same | |
| Power source | 100-240V~50/60Hz | 100~240V 50/60Hz | Same | |
| Working Time | 10min, 20 min, 30min, 40 min, 50 min,60 min, 70 min, 80min, 90 min, 100 min,110 min, 120 min,default as 30min | 10min, 20 min, 30min, 40 min, 50 min,60 min, default as30min | 20 minutes | SubstantialEquivalence |
| Pressure range | 0-100mmHg | 0~215 mmHg | 0~240 mmHg | |
| Pressure levels | 20mmHg,40mmHg,60 mmHg,80mmHg,100 mmHg. | 100mmHg, 160mmHg, 215mmHg; | 150mmHg; 185mmHg;215mmHg | SubstantialEquivalence |
| Pressure errorrange | ±15mmHg | ±20mmHg | ±25mmHg | |
| Keep time | 10s | 1-5s | Substantial | |
| Deflation time | 20s | 1-5s | Equivalence | |
| Working process | The pressure of thechamber graduallyrises to thepre-determined airpressure level, thendecompresses andthe air pressure | Starting with thelower chamber andprogressing up theupper chamber,each sectioncompresses and thepressure graduallyrise to thepre-determined air | Mode 1:Starting with thefoot chamber andprogressing up the thighchamber, each sectioncompresses and thepressure gradually risesto the pre-determined airpressure level, thendecompresses and the | Similar |
| Item | Proposed Device:(K222669) | Predicate Device:(K193354) | Comments | |
| drops. The cyclebegins again. | air pressure drops. Oncethe thigh sectiondecompresses, the cyclebegins again.Mode 2:Starting with thefoot chamber andprogressing up the thigh,each section compressesand the pressuregradually rises to thepre-determined airpressure level, holds theair until the entiregarment is compressed.All three sections thendecompresssimultaneously and theair pressure drops, thencycle begins again.Mode 3:include twostages, stage1: it worksaccording to the methodof mode 1, after the stage1 is completed, it goes tostage 2(workingaccording to the methodof mode 2) withoutinterruption time untilfinish the stage 2, thenenter next cycle withoutinterruption.Mode1⇌Mode2The pressure sequenceof mode 3 combinesmode 1 and mode 2 | |||
| Noise level | ≤ 55dB | ≤ 65dB | Similar | |
| Wrap Material | Nylon with a PVC laminate | Nylon with aPolyurethane laminate | Different | |
| Patient contact | Non-conductive attachments | Non-conductiveattachments | Same | |
| Appearance | Image: wrap with controller | Image: wrap with controller | Different | |
| Single Wrapweight | 480g | 210g | 4.6 pounds (2023g) | |
| Wrap Size | 330x610mm | 615x255mm | 72*26cm | |
| Item | Proposed Device:(K222669) | Predicate Device:(K193354) | Comments | |
| Cold packweight | 1030g (±10%) | NA | Different | |
| Cold packSize | 300 x 570mm | NA | ||
| Operatingenvironment | Temperature: 5℃~ 40℃ (41°F ~ 104°F)Relative humidity: 10% ~ 90%Atmospheric pressure: 700~1060hpa | Temperature: 5°C- 40°C,Humidity: 5%- 90%non-condensing | ||
| Transportation &Storageenvironment | Temperature: -25°C | Temperature: - 20 °C~55℃;Humidity:5%-90%non-condensingAtmosphericPressure:75kPa-106kPa | Similar |
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The subject device sequentially inflates and deflation inflatable chambers to simulate kneading and stroking of tissues for the temporary relief of minor muscle aches and pains. Prolonged use will not cause circulation issues.
The cold pack of A02-P-001 provides cold therapy for body surfaces, which can make capillaries constrict, reduce local congestion, can make nerve endings less sensitive and reduce pain. Within 30 minutes of operation, the temperature of the cold pack will be from -18℃ to -4℃, which will not bring potential harm to the patient. Its code is IME and the submission type is 510(K) Exempt. So, the difference of cold pack would not raise adversely impact on safety and effectiveness.
Although the treatment time range of subject device is 0 to 120mins, which seems to be larger than the predicate devices, but the default value is 30min which is suitable for daily use. In the process of use, the user can start or stop at any time by the power button on the hand controller, so the difference of Treatment time would not raise adversely impact on safety and effectiveness.
The subject device, Cryopush Cold Compression Device, is substantially equivalent to the predicate device (K193354). This conclusion is based upon comparison on intended use, technological characteristics and performances. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.
7. Non-clinical Testing
The following data were provided in support of the substantial equivalence determination:
- Electrical Safety, Electromagnetic Compatibility
IEC 60601-1:2005, AMDI:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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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
- Software validation
The software document of the subject device was determined according to Guidance for Industry and FDA Staff- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005
- 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
8. Clinical testing
N/A
9. Other information (such as required by FDA guidance/Test)
N/A
10. Conclusions
The subject device is substantially equivalent to the legally marketed predicate device Air Compression Therapy Device (K193354).
§ 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).