(232 days)
Not Found
No
The summary describes a software-controlled device for thermal and compression therapy, but there is no mention of AI or ML capabilities in the intended use, device description, or performance studies. The software control appears to be for managing basic parameters like temperature, compression level, and time.
No.
The device's intended use and description clearly state it is for therapeutic treatment (reducing edema, swelling, pain; localized thermal therapy) and not for diagnosing medical conditions.
No
The device description explicitly states it is an "AC powered, software-controlled device" and includes physical components like a main equipment unit, wraps, hoses, and accessories. While it is software-controlled, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for treating post-surgical and acute injuries to reduce edema, swelling, and pain through cold, heat, and compression therapies. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a device that applies physical therapies (cold, heat, compression) to the body using wraps. It does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Lack of IVD-related information: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information. The performance studies focus on the physical performance of the device (temperature, pressure, timing, safety) and its effect on skin temperature, not on diagnostic accuracy.
In summary, the Cryo-Thermo Compression Device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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-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.
Product codes (comma separated list FDA assigned to the subject device)
IRP, ILO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
elbow, shoulder, ankle, hand-wrist or knee.
Indicated Patient Age Range
adults only (greater than 21 years of age).
Intended User / Care Setting
licensed healthcare professionals in rehabilitation facilities, outpatient clinics and athletic training settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Evaluation: The patient contacting components are categorized as surface medical device with prolonged intact skin contact. Information of the safe history of the materials and their manufacturing processes are collected and assessed. Relevant biocompatibility endpoints are identified, and representative components are analyzed and selected to conduct biocompatibility testing. The wrap patient contact materials were verified in accordance with ISO 10993-1, ISO 10993-5, and ISO 10993-10.
Electrical Safety and Electromagnetic Compatibility (EMC): Testing was performed in accordance with IEC 60601-1:2005+ AMD1:2012+AMD2:2020 and IEC 60601-1-2:2014. 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 was considered a "Moderate" level of concern. The testing demonstrated that the device does not raise any new issues of safety and effectiveness.
Bench Performance Testing: Verified device's functional properties through tests including temperature accuracy, time to reach target temperature, pressure accuracy, timing accuracy, water flow rate, water pressure, wrap seam strength, hose function, and failure mode test. Results demonstrated conformance to predetermined specifications and operation within safety limits.
Skin Temperature Testing: Tested on healthy volunteers in worst-case use scenarios. The minimum skin temperature measured was 7.0℃ (44.6℉) and the maximum was 44.2℃ (111.6°F), included in the Instruction for Use. Concluded no thermal damage or cold injury to the skin, thus no safety and effectiveness issues compared to predicates.
Cleaning & Expected life Testing: Cleaning instructions for single-patient use wraps have been validated as per FDA guidance. Main equipment expected life of 5 years confirmed by accelerated life test. Wraps expected life of 1 year verified by fatigue test, accounting for repeated cleaning.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains 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.
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.
1
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
2
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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3
510(k) Summary
| 510(k) Submitter: | Suzhou MicroPort RehabTech (Group) Co., Ltd.
Part of building3#, 112 Fangzhong Street, Suzhou
Industrial Park,201203 Suzhou, PEOPLE'S
REPUBLIC OF CHINA |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person : | Liang Hong
hongliang@microport.com
Phone: +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
4
| 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.
5
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.
6
| Characteristics | Cryo-Thermo
Compression Device
(Subject Device) | Therm-X (K193550)
(Primary Predicate) | Med4 Elite™
(Secondary Predicate) | Comparison |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Cryo-Thermo Compression
Device combines cold, heat
and compression therapies. | Therm-X (Therm-X Home
and Therm-X AT) combines
cold, heat, contrast, and
compression therapy. | The Med4 Elite™
combines cold, heat,
contrast and compression
therapies. | All three devices combine
cold, heat and compression
therapies, the Cryo-Thermo
Compression Device does
not provide contrast therapy
compared to predicate
devices Therm-X and Med4
Elite™. |
| | 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. | Therm-X 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 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 or contrast) are
indicated. | Cryo-Thermo Compression
Device has the same
intended use as the
predicate devices Therm-X
and Med4 Elite™. |
| | It is intended to be used by,
or on the order of, licensed
healthcare professionals in
rehabilitation facilities,
outpatient clinics and | Therm-X Home systems also
provide DVT therapy. Therm-
X Home systems with DVT
therapy are intended to reduce | It is intended to be used
by, or on the order of, | The Cryo-Thermo
Compression Device is not
indicated for decreasing
risk of DVT and not used
in home setting, which is
covered by additional |
| Characteristics | Cryo-Thermo
Compression Device
(Subject Device) | Therm-X (K193550)
(Primary Predicate) | Med4 Elite™
(Secondary Predicate) | Comparison |
| | athletic training settings. | the risk of the formation of
deep venous thrombosis
(DVT) by aiding blood flow
back to the heart via lower
extremity limb compression.
Therm-X (Therm-X Home
and Therm-X AT) is intended
to be used by, or on the order
of, licensed health care
professionals in rehabilitation
facilities, outpatient clinics,
athletic training settings, and
home settings. | licensed healthcare
professionals in
rehabilitation facilities,
outpatient clinics, and
athletic training settings. | indications and
functionality of the Therm-
X Home. |
| Intended User | Health Care Professionals
only (Prescription use) | Health Care Professionals and
lay users (under prescription) | Health Care Professionals
only (Prescription use) | All three devices are
prescription use only. Cryo-
Thermo Compression
Device and secondary
predicate are only used by
health care professionals. |
| Characteristics | Cryo-Thermo
Compression Device
(Subject Device) | Therm-X (K193550)
(Primary Predicate) | Med4 Elite™
(Secondary Predicate) | Comparison |
| Number of
Patients that
can be treated
at 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-Thermo
Compression 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 and
maximum temperature set
points for cold therapy of
Cryo-Thermo Compression
Device are higher
compared with the primary
predicate Therm-X.
Furthermore, the
temperature range for cold
therapy of Cryo-Thermo
can be covered by the
secondary predicate Med4
Elite™.
There is no new safety and
effectiveness issue. |
| Compression
range | 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 mm
Hg),
Medium (5 - 50 mmHg),
High (5 - 75 mmHg) | The Cryo-Thermo
Compression Device has a
same maximum
compression level as the
primary predicate Therm-
X, and the pressure value
available in each level can |
| Characteristics | Cryo-Thermo
Compression 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 the
secondary predicate Med4 Elite™ |
| Static or
Intermittent
Pressure | Intermittent
available | Static and Intermittent
Pressure | Intermittent
available | All the three devices can provide intermittent
pressure. |
| Treatment Time
Setting
(for Heat, Cold and
Compression) | Single Treatment time:
10 min - 40min | Default: 10 or 20 minutes
Custom: 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-Thermo
Compression Device can be covered by primary
predicate Therm-X, which is also within the treatment
time range for cold or/and
compression therapy of the
secondary predicate Med4 Elite™.
For continuous use:
The continuous use of
Cryo-Thermo Compression
Device can be covered by |
| | Continuous use:
Cycle Length: Treatment
time: 10 min - 40min; Rest
time: 30 - 60min.
Cycle number: 1-6 cycles | Continuous use:
Cycle Length:
10 - 40 minutes active, 30 - 60
minutes rest
Continuous Treatment Cycle:
Available on Therm-X Home. | "Snooze" Function:
Available | |
| Characteristics | Cryo-Thermo
Compression 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-Thermo
Compression Device
(Subject Device) | Therm-X (K193550)
(Primary Predicate) | Med4 Elite™
(Secondary Predicate) | Comparison |
| | | | | The safety and
effectiveness of Cryo-
Thermo's continuous use
have been demonstrated by
the skin temperature
testing.
Thus, there is no new
safety and effectiveness
issue. |
| | 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 Cryo
Thermo Compression
Device is similar to the
primary predicate Therm X.
The cold therapy of the
secondary predicate Med4
Elite™ is conducted by
vapor compression with a |
| Characteristics | Cryo-Thermo
Compression Device
(Subject Device) | Therm-X (K193550)
(Primary Predicate) | Med4 Elite™
(Secondary Predicate) | Comparison |
| | | | | larger reservoir, thus Med4
Elite™'s dimension is
larger than the Cryo-
Thermo Compression
Device. |
| Weight | 17.64 lbs (8kg) when full of
coolant | 15 lbs. when full of coolant | 172 lbs (78 kg) | Cryo-Thermo Compression
Device is similar in weight
with the primary predicate
Therm-X.
The cold therapy of the
secondary predicate Med4
Elite™ is conducted by
vapor compression with a
larger reservoir, thus Med4
Elite™ is heavier than the
Cryo-Thermo Compression
Device. |
| Chilling
Mechanism | Thermoelectric | Thermoelectric | Vapor compression | The Cryo-Thermo
Compression Device has
the same chilling
mechanism with the |
| Characteristics | Cryo-Thermo
Compression Device
(Subject Device) | Therm-X (K193550)
(Primary Predicate) | Med4 Elite™
(Secondary Predicate) | Comparison |
| Heating
Mechanism | Thermoelectric | Thermoelectric | Resistance heaters | The Cryo-Thermo
Compression Device has
the same heating
mechanism with the
primary predicate Therm-X. |
| Reservoir Fluid
Capacity | 600mL | 650 mL | Heat reservoir: 1 gallon
(3.8 L)
Cold reservoir: 1 gallon
(3.8 L) | The reservoir fluid capacity
of the Cryo-Thermo
Compression Device is
similar to the primary
predicate Therm-X.
The secondary predicate
Med4 Elite™ has a larger
reservoir fluid capacity
since it is designed for
maximum two patients at a
treatment time, while Cryo-
Thermo Compression
Device and the primary
predicate Therm-X are for |
| Characteristics | Cryo-Thermo
Compression Device
(Subject Device) | Therm-X (K193550)
(Primary Predicate) | Med4 Elite™
(Secondary Predicate) | Comparison |
| User Interface | Touch Screen | Touch Screen | Touch Screen | Same |
| Recommended
Coolant | 90% Distilled Water, 10%
Ethanol | 90% Distilled Water, 10%
Isopropyl Alcohol | Distilled Water | Cryo-Thermo Compression
Device recommends the
similar coolant to the
Therm-X.
Each device is able to attain
desired performance
requirements with its
recommended 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 Safety
Standards | IEC 60601-1: 2005 + AMD
1:2012+AMD2:2020
Type B
IEC 60601-1-2 | ANSI/AAMI ES60601-
1:2005/(R)2012
CAN/CSA C22.2 No.60601-
1:2014
Type B
IEC 60601-1-2 | ANSI/AAMI ES60601-
1:2005/(R)2012
CAN/CSA C22.2 No.
60601-1:2014
Type B | The subject device was
tested per IEC 60601-
1:2005 + AMD
1:2012+AMD2:2020,
moreover, tests to cover the
US national differences
were supplemented as an
attachment to the IEC |
| Characteristics | Cryo-Thermo
Compression Device
(Subject Device) | Therm-X (K193550)
(Primary Predicate) | Med4 Elite™
(Secondary Predicate) | Comparison |
| | | | | 60601-1 report, which was
shown to comply with the
required components
of
ANSI/AAMI
ES60601-
1:2005/(R)2012 in support
of substantial equivalence. |
| | | Environment | | |
| Operating
Temperature | 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 Compression
Device works in a wider
temperature
environment
than Therm-X and Med4
EliteTM. |
| Storage
Temperature | 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 Compression
Device has similar Storage
Temperature to Therm-X
and Med4 Elite™. |
| Operating
Humidity | 25 to 80% Non-condensing | Below 60% Non-condensing | 30 to 90%
Non-
condensing | Cryo-Thermo Compression
Device is defined in a RH
range environment wider
than the
first predicate
Therm-X,
but
Cryo-
Thermo
Compression
Device works within the |
| Characteristics | Cryo-Thermo
Compression 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 of
secondary predicate Med4
Elite™.
Cryo-Thermo Compression
Device stores in a wider
storage humidity range than
Therm-X, but has a same
maximum storage humidity
with Med4 Elite™. |
| Operating
Atmospheric
Pressure | 860hPa - 1060hPa | 700 hPa – 1060 hPa | 700 hPa – 1060 hPa | Cryo-Thermo Compression
Device works at similar
atmospheric pressure as the
Therm-X and the Med4
Elite™. |
| Characteristics | Cryo-Thermo
Compression Device
(Subject Device) | Therm-X (K193550)
(Primary Predicate) | Med4 Elite™
(Secondary Predicate) | Comparison |
| Wraps | | | | |
| Types of Wraps | Various anatomical wraps
for:
Elbow,
Knee,
Hand-Wrist,
Ankle,
Shoulder | Various anatomical thermal
garments for:
Back,
Elbow,
Shoulder,
Knee,
Ankle,
Hip.
DVT Garments:
Calf and Foot | Various anatomical wraps
in different sizes for:
Straight Knee,
Articulated Knee,
Elbow,
Ankle,
Shoulder,
Back,
Hip-Groin,
Hand-Wrist,
Flexed Elbow,
Half-leg boot | Cryo-Thermo has same
anatomical wrap in Elbow,
Knee, Ankle and Shoulder
compared to the primary
predicate Therm-X.
Furthermore, all the five
types of wraps of Cryo-
Thermo can be covered by
the secondary predicate
Med4 Elite™.
No new issues of safety
and effectiveness. |
| Patient
Contacting
Material | Wrap Envelope : nylon6
Wrap and Fixing Band
Edge : T/C cloth,
Fixing Band Envelope : 427
polyester brushed fabric,
Connector : ABS plastic | Thermal garment,
reusable (multi patient) – 30
denier nylon coated in
urethane;
Thermal garment,
disposable (single patient) –
200 denier nylon coated in
urethane; | 70 Denier nylon,
Silcryn (hose covering) | All patient contacting
materials of Cryo-Thermo
Compression Device wraps
were evaluated according to
ISO 10993, and no new
safety concerns were found. |
| Characteristics | Cryo-Thermo
Compression Device
(Subject Device) | Therm-X (K193550)
(Primary Predicate) | Med4 Elite™
(Secondary Predicate) | Comparison |
| Biocompatibility | Cytotoxicity testing per ISO 10993-5
Sensitization testing per ISO 10993-10
Irritation testing per ISO 10993-10 | Cytotoxicity testing per ISO 10993-5
Sensitization testing per ISO 10993-10
Irritation testing per ISO 10993-10 | Cytotoxicity testing per ISO 10993-5
Sensitization testing per ISO 10993-10
Irritation testing per ISO 10993-10 | Same |
| Sterile
/Non-Sterile | Non-sterile only | Non-sterile only
DVT – 200 denier
nylon coated in urethane | Non-sterile only | Same |
| Reusable Wraps | Yes, Single-Patient use
reusable wraps | Yes, Multi-Patient use
reusable wraps | Yes, Multi-Patient use
reusable 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 of
reusable 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-Thermo
Compression Device
(Subject Device) | Therm-X (K193550)
(Primary Predicate) | Med4 Elite™
(Secondary Predicate) | Comparison |
| Validation of
cleaning or/and
disinfection for
reusable wraps | Yes. | Yes - for Multi-Patient use
reusable wraps. | Yes | The effectiveness of the
cleaning method of Cryo-
Thermo's single-patient
reused wraps has been
validated. |
Table 2 Detailed Comparison of the Subject and Predicate Device
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9
10
11
12
13
14
15
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Attachment 31 510(k) Summary
17
18
19
20
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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 temperature
and the target value set on the device. |
|---|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| 2 | The time required to
reach the target
temperature | To verify the time spent to achieve the target
temperature set on the device. |
| 3 | Pressure accuracy | To verify the tolerance between the wrap pressure and
the target value set on the device. |
| 4 | Timing accuracy | To verify the tolerance between the duration of
treatment/rest and the target value set on the device. |
| 5 | Water flow rate | To verify the flow rate of water circulation under the
working condition. |
| 6 | Water pressure | To verify the pressure of water circulation under the
working condition. |
| 7 | Wrap seam strength | To verify the wrap does not burst or deform when the
pressure exceeds the maximum pressure. |
| 8 | Hose function | To verify the hose does not leak while under
maximum pressure for the maximum duration of use. |
| 9 | Failure mode test | To verify the device can release the pressure if there is
a 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.