(232 days)
Cryo-Thermo Compression Device combines cold, heat and compression therapies.
It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated. It is intended to treat post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics and athletic training settings.
Cryo-Thermo Compression Device. Model Number: FGK002. is an AC powered. software-controlled device, designed to be used in rehabilitation facilities, outpatient clinics and athletic training settings and under the direction, prescription, or supervision of a licensed healthcare professional.
Cryo-Thermo Compression Device features iceless cold therapy, heat therapy and intermittent pneumatic compression therapy.
Cryo-Thermo Compression Device provides various inflatable wraps for thermal treatment (heat or cold) of the elbow, shoulder, ankle, hand-wrist or knee. The wraps are reusable for a single patient and can be cleaned if necessary.
Cryo-Thermo Compression Device is controlled by a touch screen interface, allowing the user to manage in the therapy modalities as well as easily adjust treatment temperature, compression level and time settings.
Cryo-Thermo Compression Device consists of a main equipment, wraps and accessories. The main equipment includes a control unit, a hose and a power cable. The drainpipe and the ice stick are accessories which can be ordered upon request. It is approximately 17.641bs (8kg) when reservoir is full of coolant. And, it is recommended to use 10% ethanol with 90% distilled water as the coolant.
The provided document is a 510(k) Pre-Market Notification for a medical device called the "Cryo-Thermo Compression Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical trials with strict acceptance criteria and comparative effectiveness studies as might be found for a PMA (Pre-Market Approval) device or a novel high-risk device.
Therefore, the document does not contain the kind of detailed information typically found in studies designed to prove acceptance criteria for AI/ML-driven diagnostic devices, such as sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or training set details.
The performance data summarized in this document are primarily related to bench testing, electrical safety, software verification, biocompatibility, and skin temperature testing of a physical device. It is not a study proving an algorithm's diagnostic performance against a clinical ground truth.
Given this, I will describe the "acceptance criteria" and "study" as presented in the document for this specific type of device and submission.
Device Name: Cryo-Thermo Compression Device
Device Type: Powered Inflatable Tube Massager (Class II)
This device combines cold, heat, and compression therapies for post-surgical and acute injuries to reduce edema, swelling, and pain.
Acceptance Criteria and Study Details (as per FDA 510(k) Submission)
The "acceptance criteria" in this context are primarily conformance to established performance criteria and safety standards, demonstrating that the device is as safe and effective as its predicate devices, rather than a diagnostic accuracy threshold. The "study" refers to the verification and validation activities conducted.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Test Category | Acceptance Criteria (Implicit from testing purpose) | Reported Device Performance / Outcome |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993 standards for intended use (surface medical device with prolonged intact skin contact). | Overall biological safety conclusion: acceptable based on evaluation per ISO 10993-1, 10993-5 (cytotoxicity), and 10993-10 (irritation and skin sensitization). |
| Electrical Safety | Conformance to IEC 60601-1:2005+AMD1:2012+AMD2:2020 and US National Differences. | Testing results indicated that the device is safe. |
| EMC (Electromagnetic Compatibility) | Conformance to IEC 60601-1-2:2014. | Testing results indicated that the device is safe. |
| Software Verification & Validation | Conformance to FDA guidance "Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304. Software concern level "Moderate" for no new safety/effectiveness issues compared to predicates. | Testing demonstrated that the Cryo-Thermo Compression Device does not raise any new issues of safety and effectiveness as compared to the predicate devices. |
| Bench Performance Testing: | ||
| - Temperature accuracy | Tolerance between wrap temperature and target value. | Conforms to predetermined specifications. |
| - Time to reach target temp. | Time spent to achieve target temperature. | Conforms to predetermined specifications. |
| - Pressure accuracy | Tolerance between wrap pressure and target value. | Conforms to predetermined specifications. |
| - Timing accuracy | Tolerance between duration of treatment/rest and target value. | Conforms to predetermined specifications. |
| - Water flow rate | Flow rate of water circulation under working condition. | Conforms to predetermined specifications. |
| - Water pressure | Pressure of water circulation under working condition. | Conforms to predetermined specifications. |
| - Wrap seam strength | Wrap does not burst or deform when pressure exceeds maximum pressure. | Conforms to predetermined specifications. |
| - Hose function | Hose does not leak under maximum pressure for maximum duration. | Conforms to predetermined specifications. |
| - Failure mode test | Device can release pressure if there is a software failure. | Conforms to predetermined specifications. Overall: "Testing results indicated that Cryo-Thermo Compression Device conforms to its predetermined specifications and operates within safety limits." |
| Skin Temperature Testing | No thermal damage or cold injury to the skin in worst-case use scenario. | Minimum skin temperature: 7.0°C (44.6°F); Maximum skin temperature: 44.2°C (111.6°F). Concluded "didn't cause any thermal damage or cold injury to the skin." These values are included in the Instruction for Use. |
| Cleaning & Expected Life Testing | Validation of cleaning instructions for single-patient reusable wraps. Continued functional performance throughout service life for main equipment (5 years) and wraps (1 year). | Cleaning instructions validated per FDA guidance. Accelerated life test performed for main equipment; fatigue test performed for wraps, accounting for repeated cleaning. Confirmed safe use for expected duration. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of diagnostic performance testing for an AI/ML device. For physical product testing, the "samples" are the device units and their components. The document does not specify the number of units tested for each bench performance test, but it implies a sufficient number were tested to demonstrate conformance to specifications.
- Data Provenance: Not applicable for clinical data in this type of submission. The performance data provenance is from internal lab testing conducted by the manufacturer (Suzhou MicroPort RehabTech (Group) Co., Ltd.) and external accredited testing facilities for safety standards. The skin temperature testing was conducted on "healthy volunteers who provided informed consents" but the number of volunteers or their country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a diagnostic device where expert ground truth is established for a test set of clinical images/data. The "ground truth" for this device's performance relates to established engineering and medical device safety standards and the device's ability to maintain specific physical parameters (temperature, pressure, timing).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human readers or interpretation of clinical data requiring adjudication.
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 is not an AI/ML-driven diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML-driven diagnostic device. Software testing was done, but it was for controlling the physical device's functions and ensuring proper operation, not for diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance verification is based on:
- Established international and national standards for medical device safety and essential performance (e.g., IEC 60601 series, ISO 10993 series).
- Predetermined functional specifications for the device's operational parameters (temperature, pressure, timing, flow rate, seam strength, etc.).
- Physiological safety limits for human tissue regarding temperature exposure, as assessed through skin temperature testing on healthy volunteers.
8. The sample size for the training set
- Not applicable. This device does not use an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning for diagnostic tasks. The software development follows traditional software engineering principles outlined in IEC 62304.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for an AI/ML algorithm in this context.
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March 8, 2023
Suzhou MicroPort RehabTech (Group) Co., Ltd. % Yunfang Sun Senior Specialist, Regulatory Affairs MicroPort Sinica Co., Ltd. No. 1601 ZhangDong Rd, ZJ Hi-Tech Park Shanghai, 201203 China
Re: K222136
Trade/Device Name: Cryo-Thermo Compression Device Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILO Dated: January 13, 2023 Received: January 13, 2023
Dear Yunfang Sun:
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.
Heather L. Dean -S
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
Enclosure
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Indications for Use
510(k) Number (if known) K222136
Device Name Cryo-Thermo Compression Device
Indications for Use (Describe)
Cryo-Thermo Compression Device combines cold, heat and compression therapies.
It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated. It is intended to treat post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics and athletic training settings.
| 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)
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510(k) Summary
| 510(k) Submitter: | Suzhou MicroPort RehabTech (Group) Co., Ltd.Part of building3#, 112 Fangzhong Street, SuzhouIndustrial Park,201203 Suzhou, PEOPLE'SREPUBLIC OF CHINA |
|---|---|
| Contact Person : | Liang Honghongliang@microport.comPhone: +86-0512-65001777-2257 |
| Date Prepared : | January 11, 2023 |
| Device Name: | Cryo-Thermo Compression Device |
| Device Classification Name: | Powered Inflatable Tube Massager |
| Regulation Number: | 21 CFR 890.5650 |
| Classification Panel: | Physical Medicine |
| Classification Product Code: | IRP, ILO |
| Device Class: | Class II |
1. Substantial Equivalence Claimed To
Cryo-Thermo Compression Device is substantially equivalent to Therm-X cleared under (K193550) and Med4 Elite™ cleared under K171685. The predicate devices are listed in Table 1.
| Comparison Device | Primary Predicate Device | Secondary Predicate Device |
|---|---|---|
| Trade Name: | Therm-X | Med4 Elite™ |
| Common Name: | Massager, Powered Inflatable Tube | Heat and/or Cold and Compression Therapy |
| 510(k) Number: | K193550 | K171685 |
| 510(k) Submitter/Holder: | Zenith Technical Innovations, LLC. | Cool Systems, Inc. |
| Classification: | Class II | Class II |
| Regulation Number: | 21 CFR 890.5650 | 21 CFR 890.5650 |
Table 1 Table of Predicates
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| Classification Panel: | Physical Medicine | Physical Medicine |
|---|---|---|
| Product Code: | IRP, ILO, JOW | IRP, ILO |
2. Indication for Use
Cryo-Thermo Compression Device combines cold, heat and compression therapies.
It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics and athletic training settings.
3. Intended Use Population
Cryo-Thermo Compression Device is intended for adults only (greater than 21 years of age).
4. Device Description
Cryo-Thermo Compression Device. Model Number: FGK002. is an AC powered. software-controlled device, designed to be used in rehabilitation facilities, outpatient clinics and athletic training settings and under the direction, prescription, or supervision of a licensed healthcare professional.
Cryo-Thermo Compression Device features iceless cold therapy, heat therapy and intermittent pneumatic compression therapy.
Cryo-Thermo Compression Device provides various inflatable wraps for thermal treatment (heat or cold) of the elbow, shoulder, ankle, hand-wrist or knee. The wraps are reusable for a single patient and can be cleaned if necessary.
Cryo-Thermo Compression Device is controlled by a touch screen interface, allowing the user to manage in the therapy modalities as well as easily adjust treatment temperature, compression level and time settings.
Cryo-Thermo Compression Device consists of a main equipment, wraps and accessories. The main equipment includes a control unit, a hose and a power cable. The drainpipe and the ice stick are accessories which can be ordered upon request. It is approximately 17.641bs (8kg) when reservoir is full of coolant. And, it is recommended to use 10% ethanol with 90% distilled water as the coolant.
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5. Substantial Equivalence
The subject device, Cryo-Thermo Compression Device, is substantially equivalent to the primary predicate Therm-X (K193550) by Zenith Technical Innovations, LLC. (Zenith) and the secondary predicate Med4 Elite™ (K171685) by Cool Systems, Inc. currently on the market.
The table below provides a detailed comparison of the Cryo-Thermo Compression Device to predicate devices.
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| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
|---|---|---|---|---|
| Indications for Use | Cryo-Thermo CompressionDevice combines cold, heatand compression therapies. | Therm-X (Therm-X Homeand Therm-X AT) combinescold, heat, contrast, andcompression therapy. | The Med4 Elite™combines cold, heat,contrast and compressiontherapies. | All three devices combinecold, heat and compressiontherapies, the Cryo-ThermoCompression Device doesnot provide contrast therapycompared to predicatedevices Therm-X and Med4Elite™. |
| It is intended to treat post-surgical and acute injuries toreduce edema, swelling andpain for which cold andcompression are indicated. Itis intended to treat posttraumatic and post-surgicalmedical and/or surgicalconditions for whichlocalized thermal therapy(hot or cold) are indicated. | Therm-X is intended to treatpost-surgical and acuteinjuries to reduce edema,swelling, and pain for whichcold and compression areindicated. It is intended totreat post traumatic and post-surgical medical and/orsurgical conditions for whichlocalized thermal therapy (hotor cold) are indicated. | It is intended to treat post-surgical and acute injuriesto reduce edema, swellingand pain for which coldand compression areindicated. It is intended totreat post traumatic andpost-surgical medicaland/or surgical conditionsfor which localizedthermal therapy (hot orcold or contrast) areindicated. | Cryo-Thermo CompressionDevice has the sameintended use as thepredicate devices Therm-Xand Med4 Elite™. | |
| It is intended to be used by,or on the order of, licensedhealthcare professionals inrehabilitation facilities,outpatient clinics and | Therm-X Home systems alsoprovide DVT therapy. Therm-X Home systems with DVTtherapy are intended to reduce | It is intended to be usedby, or on the order of, | The Cryo-ThermoCompression Device is notindicated for decreasingrisk of DVT and not usedin home setting, which iscovered by additional | |
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| athletic training settings. | the risk of the formation ofdeep venous thrombosis(DVT) by aiding blood flowback to the heart via lowerextremity limb compression.Therm-X (Therm-X Homeand Therm-X AT) is intendedto be used by, or on the orderof, licensed health careprofessionals in rehabilitationfacilities, outpatient clinics,athletic training settings, andhome settings. | licensed healthcareprofessionals inrehabilitation facilities,outpatient clinics, andathletic training settings. | indications andfunctionality of the Therm-X Home. | |
| Intended User | Health Care Professionalsonly (Prescription use) | Health Care Professionals andlay users (under prescription) | Health Care Professionalsonly (Prescription use) | All three devices areprescription use only. Cryo-Thermo CompressionDevice and secondarypredicate are only used byhealth care professionals. |
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| Number ofPatients thatcan be treatedat one time | One | One | Two | Both subject device Cryo-Thermo Compression Device and primary predicate Therm-X are designed to treat one patient at a time. |
| Functions | ||||
| Heat Therapy | 38°C (100.4°F) or 40°C(104°F) | Default: 40.5°C ( 105°F ) ,41.6°C ( 107°F ) , 43°C(110°F ) ;Custom: 40.5°C - 43°C(105°F -110°F ) ;Default, continuous:40.5°C (105°F), 41.6°C(107°F ) ;Custom, continuous: 40.5°C-41.6°C (105°F -107°F ); | 35°C - 45°C(95°F -113°F) | The maximum temperature set point for heat therapy of Cryo-Thermo Compression Device is lower compared with the primary predicate Therm-X. Furthermore, the both temperature set points (38°C or 40°C) of Cryo-Thermo's heat therapy are within the temperature range of the secondary predicate Med4 Elite™.There is no new safety and effectiveness issue. |
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| Cold Therapy | 6°C -15°C (42.8°F-59°F), | Default: 1.1°C (34°F), 7.2°C(45°F), 12.7°C (55°F);Custom: 1.1°C -12.7°C (34°F-55°F);Default, continuous:4.4°C (40°F), 7.2°C (45°F),10°C (50°F);Custom, continuous:4.4°C - 10°C (40°F - 50°F); | 3.33°C -15.56°C(38°F -60°F) | The minimum andmaximum temperature setpoints for cold therapy ofCryo-Thermo CompressionDevice are highercompared with the primarypredicate Therm-X.Furthermore, thetemperature range for coldtherapy of Cryo-Thermocan be covered by thesecondary predicate Med4Elite™.There is no new safety andeffectiveness issue. |
| Compressionrange | Available in five levels:Off (0mmHg),Low (15mmHg),Medium-Low (30mmHg),Medium-High (50mmHg),High (70mmHg) | Available in four levels:Lite (5 mm Hg),Low (20 mm Hg),Medium (45 mm Hg),High (70 mm Hg)For continuous treatment. | Available in four levels:Low (5 - 15 mm Hg),Medium-Low (5 - 30 mmHg),Medium (5 - 50 mmHg),High (5 - 75 mmHg) | The Cryo-ThermoCompression Device has asame maximumcompression level as theprimary predicate Therm-X, and the pressure valueavailable in each level can |
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| available in three levels:Low (20 mm Hg)Medium (45 mm Hg)High (70 mm Hg) | be covered by thesecondary predicate Med4 Elite™ | |||
| Static orIntermittentPressure | Intermittentavailable | Static and IntermittentPressure | Intermittentavailable | All the three devices can provide intermittentpressure. |
| Treatment TimeSetting(for Heat, Cold andCompression) | Single Treatment time:10 min - 40min | Default: 10 or 20 minutesCustom: 3 - 40 minutes | Heat: 5 to 30 minutes, 15 minutes default;Cold: 5 to 60 minutes, 15 minutes default;Compression Only: 5 to 60 minutes, 15 minutes default | Regard to single treatment:The single treatment time of Cryo-ThermoCompression Device can be covered by primarypredicate Therm-X, which is also within the treatmenttime range for cold or/andcompression therapy of thesecondary predicate Med4 Elite™.For continuous use:The continuous use ofCryo-Thermo CompressionDevice can be covered by |
| Continuous use:Cycle Length: Treatmenttime: 10 min - 40min; Resttime: 30 - 60min.Cycle number: 1-6 cycles | Continuous use:Cycle Length:10 - 40 minutes active, 30 - 60minutes restContinuous Treatment Cycle:Available on Therm-X Home. | "Snooze" Function:Available | ||
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| primary predicate Therm-X, Cryo-Thermo Compression Device provides same cycle length smaller cycle number and shorter total treatment time compared with the primary predicate Therm-X (based on information from the published IFU of Therm-X Home).Compared with the secondary predicate Med4 Elite™ in cold therapy, Cryo-Thermo Compression Device provides shorter cycle length, same cycle number and shorter total treatment time (based on information from the published IFU of Med4 Elite™). | ||||
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| The safety andeffectiveness of Cryo-Thermo's continuous usehave been demonstrated bythe skin temperaturetesting.Thus, there is no newsafety and effectivenessissue. | ||||
| Physical Unit | ||||
| Dimensions | 13.7"L×5.75"W×11.02"H(34.8×14.6×28.0cm) | 15"L×10.5"W×9"H(38.1×26.67×22.86cm) | 32.5"L×24.75"W×43"H(83×63×109cm) | The dimension of CryoThermo CompressionDevice is similar to theprimary predicate Therm X.The cold therapy of thesecondary predicate Med4Elite™ is conducted byvapor compression with a |
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| larger reservoir, thus Med4Elite™'s dimension islarger than the Cryo-Thermo CompressionDevice. | ||||
| Weight | 17.64 lbs (8kg) when full ofcoolant | 15 lbs. when full of coolant | 172 lbs (78 kg) | Cryo-Thermo CompressionDevice is similar in weightwith the primary predicateTherm-X.The cold therapy of thesecondary predicate Med4Elite™ is conducted byvapor compression with alarger reservoir, thus Med4Elite™ is heavier than theCryo-Thermo CompressionDevice. |
| ChillingMechanism | Thermoelectric | Thermoelectric | Vapor compression | The Cryo-ThermoCompression Device hasthe same chillingmechanism with the |
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| HeatingMechanism | Thermoelectric | Thermoelectric | Resistance heaters | The Cryo-ThermoCompression Device hasthe same heatingmechanism with theprimary predicate Therm-X. |
| Reservoir FluidCapacity | 600mL | 650 mL | Heat reservoir: 1 gallon(3.8 L)Cold reservoir: 1 gallon(3.8 L) | The reservoir fluid capacityof the Cryo-ThermoCompression Device issimilar to the primarypredicate Therm-X.The secondary predicateMed4 Elite™ has a largerreservoir fluid capacitysince it is designed formaximum two patients at atreatment time, while Cryo-Thermo CompressionDevice and the primarypredicate Therm-X are for |
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| User Interface | Touch Screen | Touch Screen | Touch Screen | Same |
| RecommendedCoolant | 90% Distilled Water, 10%Ethanol | 90% Distilled Water, 10%Isopropyl Alcohol | Distilled Water | Cryo-Thermo CompressionDevice recommends thesimilar coolant to theTherm-X.Each device is able to attaindesired performancerequirements with itsrecommended coolant. |
| Electrical | ||||
| Line Voltage | 100-240 VAC | 100-240 VAC | 100-240 VAC | Same |
| Line Frequency | 60 Hz | 50/60 Hz | 50-60 Hz | Same |
| Electrical SafetyStandards | IEC 60601-1: 2005 + AMD1:2012+AMD2:2020Type BIEC 60601-1-2 | ANSI/AAMI ES60601-1:2005/(R)2012CAN/CSA C22.2 No.60601-1:2014Type BIEC 60601-1-2 | ANSI/AAMI ES60601-1:2005/(R)2012CAN/CSA C22.2 No.60601-1:2014Type B | The subject device wastested per IEC 60601-1:2005 + AMD1:2012+AMD2:2020,moreover, tests to cover theUS national differenceswere supplemented as anattachment to the IEC |
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| 60601-1 report, which wasshown to comply with therequired componentsofANSI/AAMIES60601-1:2005/(R)2012 in supportof substantial equivalence. | ||||
| Environment | ||||
| OperatingTemperature | 41°F - 104°F(5°C - 40°C) | 60°F - 80°F(16°C - 27°C) | 50°F -90°F(10°C - 32°C) | Cryo-Thermo CompressionDevice works in a widertemperatureenvironmentthan Therm-X and Med4EliteTM. |
| StorageTemperature | 32°F – 122°F(0°C - 50°C) | 33°F - 122°F(1°C - 50°C) | 33°F - 122°F(1°C to 50°C) | Cryo-Thermo CompressionDevice has similar StorageTemperature to Therm-Xand Med4 Elite™. |
| OperatingHumidity | 25 to 80% Non-condensing | Below 60% Non-condensing | 30 to 90%Non-condensing | Cryo-Thermo CompressionDevice is defined in a RHrange environment widerthan thefirst predicateTherm-X,butCryo-ThermoCompressionDevice works within the |
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| Storage Humidity | 0 to 95%, Non-condensing | Below 60% Non-condensing | 10 to 95% Non-condensing | RH range environment ofsecondary predicate Med4Elite™.Cryo-Thermo CompressionDevice stores in a widerstorage humidity range thanTherm-X, but has a samemaximum storage humiditywith Med4 Elite™. |
| OperatingAtmosphericPressure | 860hPa - 1060hPa | 700 hPa – 1060 hPa | 700 hPa – 1060 hPa | Cryo-Thermo CompressionDevice works at similaratmospheric pressure as theTherm-X and the Med4Elite™. |
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| Wraps | ||||
| Types of Wraps | Various anatomical wrapsfor:Elbow,Knee,Hand-Wrist,Ankle,Shoulder | Various anatomical thermalgarments for:Back,Elbow,Shoulder,Knee,Ankle,Hip.DVT Garments:Calf and Foot | Various anatomical wrapsin different sizes for:Straight Knee,Articulated Knee,Elbow,Ankle,Shoulder,Back,Hip-Groin,Hand-Wrist,Flexed Elbow,Half-leg boot | Cryo-Thermo has sameanatomical wrap in Elbow,Knee, Ankle and Shouldercompared to the primarypredicate Therm-X.Furthermore, all the fivetypes of wraps of Cryo-Thermo can be covered bythe secondary predicateMed4 Elite™.No new issues of safetyand effectiveness. |
| PatientContactingMaterial | Wrap Envelope : nylon6Wrap and Fixing BandEdge : T/C cloth,Fixing Band Envelope : 427polyester brushed fabric,Connector : ABS plastic | Thermal garment,reusable (multi patient) – 30denier nylon coated inurethane;Thermal garment,disposable (single patient) –200 denier nylon coated inurethane; | 70 Denier nylon,Silcryn (hose covering) | All patient contactingmaterials of Cryo-ThermoCompression Device wrapswere evaluated according toISO 10993, and no newsafety concerns were found. |
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| Biocompatibility | Cytotoxicity testing per ISO 10993-5Sensitization testing per ISO 10993-10Irritation testing per ISO 10993-10 | Cytotoxicity testing per ISO 10993-5Sensitization testing per ISO 10993-10Irritation testing per ISO 10993-10 | Cytotoxicity testing per ISO 10993-5Sensitization testing per ISO 10993-10Irritation testing per ISO 10993-10 | Same |
| Sterile/Non-Sterile | Non-sterile only | Non-sterile onlyDVT – 200 deniernylon coated in urethane | Non-sterile only | Same |
| Reusable Wraps | Yes, Single-Patient usereusable wraps | Yes, Multi-Patient usereusable wraps | Yes, Multi-Patient usereusable wraps | The reusable wraps of Cryo-Thermo are only used for single patient and can be cleaned if necessary according to the cleaning instructions in IFU. |
| Expected Life ofreusable wraps | One year, based on frequency of use and continued functional performance. | Based on frequency of use and continued functional performance. | Based on frequency of use and continued functional performance. | The expected life of Cryo-Thermo's single-patient reused wraps has been verified. |
| Characteristics | Cryo-ThermoCompression Device(Subject Device) | Therm-X (K193550)(Primary Predicate) | Med4 Elite™(Secondary Predicate) | Comparison |
| Validation ofcleaning or/anddisinfection forreusable wraps | Yes. | Yes - for Multi-Patient usereusable wraps. | Yes | The effectiveness of thecleaning method of Cryo-Thermo's single-patientreused wraps has beenvalidated. |
Table 2 Detailed Comparison of the Subject and Predicate Device
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Attachment 31 510(k) Summary
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The rationale for the substantial equivalence of the subject device and the predicate devices is based on the same technical principles of providing cold or heat therapy combined with intermittent pneumatic compression as well as on comparable performances for the same intended use. Although, there are differences in the setting range of treatment parameters between the Cryo-Thermo and the predicate devices, the maximum limits of all Cryo-Thermo treatment parameters are equal to or less than the maximum values of corresponding treatment parameters of both predicate devices.
The subject device and predicate devices have the same intended use and similar technological characteristics with the exception that the patient contacting materials of the subject device differ from the predicate devices. All the patient contacting materials of Cryo-Thermo Compression Device wrap were evaluated according to ISO 10993, and no new safety and effectiveness concerns were found.
In summary, any differences between the subject device and the predicate devices do not raise new issues of safety and effectiveness. The subject device Cryo-Thermo Compression Device is as safe, as effective, and performs comparably to predicate devices Therm-X and Med4 Elite™ for the same intended use.
6. Summary of Performance Data
Cryo-Thermo Compression Device and the software were verified and validated in accordance with documented testing plans to ensure conformance with established performance criteria. See below for the tests performed.
● Biocompatibility Evaluation
The biocompatibility evaluation for Cryo-Thermo Compression Device is conducted based on the FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The patient contacting components are categorized as surface medical device with prolonged intact skin contact. Then, information of the safe history of the materials and their manufacturing processes are collected and assessed. In addition, relevant biocompatibility endpoints are identified, and representative components are analyzed and selected to conduct biocompatibility testing. The wrap patient contact materials of Cryo-Thermo Compression Device were verified in accordance with the following standards:
• ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
· ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
· ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization.
In conclusion, the overall biological safety conclusion can be drawn that the biocompatibility risk of Cryo-Thermo Compression Device is acceptable.
Cryo-Thermo Compression Device
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● Electrical Safety and Electromagnetic Compatibility(EMC)
Electrical safety and electromagnetic compatibility testing were performed in accordance with following standards:
- a) IEC 60601-1:2005+ AMD1:2012+AMD2:2020 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance. In addition, the US National Differences are tested as a supplement to the IEC 60601-1 testing.
- b) 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.
Testing results indicated that the device is safe.
● Software Verification and Validation Testing
Software tests were conducted to satisfy the requirements of the FDA guidance on Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 Medical Device Software- Software Life Cycle Processes. The software contained in Cryo-Thermo Compression Device was considered a "Moderate" level of concern. The testing demonstrated that Cryo-Thermo Compression Device does not raise any new issues of safety and effectiveness as compared to the predicate devices.
● Bench Performance Testing
The device performances were tested to verify the device's functional properties. The following performance tests were completed.
| 1 | Temperature accuracy | To verify the tolerance between the wrap temperatureand the target value set on the device. |
|---|---|---|
| 2 | The time required toreach the targettemperature | To verify the time spent to achieve the targettemperature set on the device. |
| 3 | Pressure accuracy | To verify the tolerance between the wrap pressure andthe target value set on the device. |
| 4 | Timing accuracy | To verify the tolerance between the duration oftreatment/rest and the target value set on the device. |
| 5 | Water flow rate | To verify the flow rate of water circulation under theworking condition. |
| 6 | Water pressure | To verify the pressure of water circulation under theworking condition. |
| 7 | Wrap seam strength | To verify the wrap does not burst or deform when thepressure exceeds the maximum pressure. |
| 8 | Hose function | To verify the hose does not leak while undermaximum pressure for the maximum duration of use. |
| 9 | Failure mode test | To verify the device can release the pressure if there isa software failure. |
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Testing results indicated that Cryo-Thermo Compression Device conforms to its predetermined specifications and operates within safety limits.
● Skin Temperature Testing
As required by the FDA guidance document "Guidance Document for the Preparation of Premarket Notification (510(k) Applications for Heating and Cooling Devices", the Cryo-Thermo Compression Device was tested for skin temperatures in the worstcase use scenario on healthy volunteers who provided informed consents. The skin temperature change within 5 minutes' time window and the temperature range at the skin surface where the device is applied were measured in the skin temperature testing. The minimum skin temperature measured can achieve as 1ow as 7.0℃ (44.6℃) and the maximum temperature can arrive as high as 44.2℃ (111.6°F), and these skin temperatures are included on the Instruction for Use.
Based on these results, it was concluded that Cryo-Thermo Compression Device didn't cause any thermal damage or cold injury to the skin. The studies demonstrated that there are no safety and effectiveness issues created by the device and that Cryo-Thermo Compression Device is as safe and effective as the predicate devices.
● Cleaning & Expected life Testing
Cryo-Thermo Compression Device wraps are intended for single-patient use and can be cleaned if necessary. Instructions for how to clean the wrap are provided in the IFU. Such cleaning instructions have been validated as per FDA guidance document "Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling' issued on March 17, 2015.
Expected life is estimated based on the frequency of use and is verified by continued functional performance throughout service life. The main equipment is expected for a use life of 5 years, and the accelerated life test has been performed to confirm the safe use for the duration of the expected life. The use life of the wraps is expected for 1 year, and fatigue test is adopted to verify the expected life of the wraps, and the test accounts for the effect of repeated cleaning of the wraps.
7. Conclusion
The non-clinical testing data demonstrate the technological characteristics of the subject device are equivalent to the predicate devices and provide evidence that the Cryo-Thermo Compression Device performs as intended in the specified use conditions. Any differences between the subject device and the predicate devices do not raise new questions of safety and effectiveness, hence the subject device Cryo-Thermo Compression Device is as safe, as effective, and performs comparably to the predicate devices for the same intended use.
§ 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).