(28 days)
Not Found
No
The summary describes a software-controlled device with a touch screen interface for managing therapy settings. There is no mention of AI, ML, or any capabilities that would suggest the use of such technologies for diagnosis, treatment planning, or adaptive therapy. The software validation and performance studies focus on basic device functionality, safety, and effectiveness compared to predicate devices.
Yes
The device combines cold, heat, contrast, and compression therapy to treat various conditions like post-surgical and acute injuries, reducing edema, swelling, and pain, and to reduce the risk of deep venous thrombosis (DVT), which are all therapeutic indications.
No
The device is described as a multimodality therapy device that combines cold, heat, contrast, and compression therapy to treat various conditions, reduce pain, swelling, and the risk of DVT. It is used for treatment and prophylaxis, not for identifying or diagnosing a condition.
No
The device description explicitly states it is an "AC powered, software-controlled multimodality device" and details various hardware components like a coolant reservoir, pumps, fans, circuit board, and reusable/single-use garments. While software is a key component, it controls physical hardware to deliver therapy.
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 Therm-X is for treating post-surgical and acute injuries, reducing edema, swelling, and pain, and providing localized thermal therapy and DVT prophylaxis. These are all therapeutic and physical treatment applications.
- Device Description: The device description details a system that applies cold, heat, contrast, and compression therapy using wraps and pneumatic compression. This aligns with physical therapy and medical treatment devices, not devices used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro testing, or providing diagnostic information based on laboratory analysis.
Therefore, Therm-X is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. 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-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce 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.
Product codes (comma separated list FDA assigned to the subject device)
IRP, ILO, JOW
Device Description
Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.
Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.
Therm-X consists of various reusable inflatable wraps for thermal treatment of the back, elbow, hand/wrist, shoulder, ankle, hip, lower leg, or knee and DVT prophylactic treatment applied to the foot or calf. Multi-patient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the back, hand/wrist, shoulder, neck, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with or without pneumatic compression. The foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.
Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings. Therm-X AT and Therm-X Home models provide an optional password protection feature that allows for a user to use only stored cycles, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first. The Therm-X device also allows users to change treatment pressure and temperatures to less extreme therapies (e.g. changing a warm cycle to a lower warm temperature or changing a cold cycle to a higher cold temperature).
The Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Back, elbow, hand/wrist, shoulder, ankle, hip, lower leg, knee, foot, calf, neck.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home 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)
Performance - Bench: Therm-X has been tested for performance to verify the proper operation of the system with the new thermal garments. Test and verification results indicate that Therm-X conforms to its predetermined specifications and operates within safety limits.
Electromagnetic Compatibility / Electrical Safety: Testing performed in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11. Verification results indicated that the device is safe.
Biocompatibility: Testing performed in accordance with ISO 10993-1, ISO 10993-5, and ISO 10993-10. Verification results indicated that the materials comply with the standard.
Cleaning, Disinfection & Shelf Life Testing: Cleaning and disinfection instructions for multi-patient use garments have been validated. Durability accelerated aging test has been performed and has confirmed the safe use and disinfection of a Therm-X garment for the duration of the garment's life without evidence of deterioration.
Software Validation: Software validation testing confirmed that Therm-X software meets its performance requirements and specifications. Validation completed according to an established Validation procedure and FDA Guidance documents and Industry Standards including General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 2002; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005; and Guidance for the Content of Premarket Submissions for Device Software Functions, 2023. Software classified as an Enhanced Document Level per the new 2023 guidance.
Clinical Testing: IRB approved studies performed on healthy volunteer human subjects who provided informed consent to measure the lowest skin temperature the Therm-X device can generate. A minimum skin temperature of 40°F was measured and included in product labeling. The studies demonstrated no safety issues created by the device and that Therm-X is as safe and effective as the predicate devices.
Human Factors / Usability: Assessments performed in a simulated use environment. Found to be adequately safe and effective for the intended users, uses, and use environments. Results demonstrated that users can operate Therm-X as safely and effectively as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum skin temperature of 40°F was measured during clinical testing.
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.
July 27, 2023
Zenith Technical Innovations % Rita King Chief Executive Officer MethodSense. Inc. 1 Copley Parkway, Suite 130 Morrisville, North Carolina 27560
Re: K231912
Trade/Device Name: Therm-X Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP. ILO. JOW Dated: June 28, 2023 Received: June 29, 2023
Dear Rita King:
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.
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
1
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231912
Device Name Therm-X
Indications for Use (Describe)
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. 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-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Zenith Technical Innovations K231912
This 510(k) Summary is in conformance with 21 CFR 807.92
| Submitter: | Zenith Technical Innovations, LLC. (Zenith)
1396 St. Paul Ave.
Gurnee, IL 60031
Phone: (847) 672-7481
Fax: (847) 672-8721 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961 |
| Company Contact: | Greg Binversie
Chief Technical Officer |
- Date Prepared: June 28, 2023
Device Name and Classification
| Trade Name: | Therm-X |
|---|---|
| Common Name: | Massage, Powered Inflatable Tube |
| Classification: | Class II |
| Regulation Number: | 21 CFR 890.5650, Powered inflatable tube massage |
| Classification Panel: | Physical Medicine |
| Product Code: | IRP, ILO, JOW |
Predicate Device
| Trade Name: | Therm-X |
|---|---|
| Common Name: | Heat and/or Cold and Compression Therapy |
| 510(k) Submitter / Holder: | Zenith Technical Innovations, LLC. (Zenith) |
| 510(k) Number: | K193550 |
| Classification: | Class II |
| Requlation Number: | 890.5650, Powered Inflatable tube massager |
| Classification Panel: | Physical Medicine |
| Product Code: | IRP, ILO, JOW |
The predicate device has not been subject to a design-related recall.
4
Device Description
Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.
Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.
Therm-X consists of various reusable inflatable wraps for thermal treatment of the back, elbow, hand/wrist, shoulder, ankle, hip, lower leg, or knee and DVT prophylactic treatment applied to the foot or calf. Multi-patient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the back, hand/wrist, shoulder, neck, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with or without pneumatic compression. The foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.
Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings. Therm-X AT and Therm-X Home models provide an optional password protection feature that allows for a user to use only stored cycles, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first. The Therm-X device also allows users to change treatment pressure and temperatures to less extreme therapies (e.g. changing a warm cycle to a lower warm temperature or changing a cold cycle to a higher cold temperature).
The Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.
Indications for Use
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. 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 surqical conditions for which localized thermal therapy (hot or cold) are indicated.
5
Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce 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.
Risk Analysis Method
The Therm-X was assessed to determine the risks to health associated with the device modifications and evaluate risks related to safety, effectiveness, and usability. A risk analysis was conducted in accordance with ISO 14971:2019, Medical devices -- Application of risk manaqement to medical devices. No additional risks were associated with the release of the four new thermal garments for this submission.
Substantial Equivalence
Therm-X is substantially equivalent to Therm-X (K193550) by Zenith Technical Innovations, LLC. (Zenith).
Therm-X has the same intended use and indications for use as the predicate device and uses equivalent overall design and operating principals as the predicate device.
The table below provides a detailed comparison of Therm-X to the predicate device:
6
Detailed Comparison of the Subject and Predicate Device
| Characteristic | Therm-X | Therm-X (K193550) | Comparison |
|---|---|---|---|
| Indications for Use | Subject Device | ||
| Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. 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. |
Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce 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. | Primary Predicate
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. 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.
Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce 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. | The indications for use of the Therm-X (subject device) are identical to the Therm-X (K193550). |
| Characteristic | Therm-X | Therm-X (K193550) | Comparison |
| | | | |
| | Subject Device | Primary Predicate | |
| Intended Users | Health Care Professionals and lay
users (under prescription) | Health Care Professionals and lay
users (under prescription) | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Number of Patients
that can be treated
at one time | Two | One | Therm-X (subject device) is different
from Therm-X (K193550). |
| | | | This difference is limited to the ability
of the Therm-X (subject device) to
treat two patients instead of one via a
split umbilical hose accessory.
Verification and Validation testing
have been conducted to confirm this
difference does not affect the intended
use or raise different questions of
safety and effectiveness. |
| Two Programmable
Cycles | Configuration of two programmable
cycles are available for all Therm-X
Models | Configuration of two programmable
cycles are available for all Therm-X
Models | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Continuous
Treatment Cycle | Available on Therm-X Home | Available on Therm-X Home | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Heat Therapy | Default: 105°F, 107°F, 110°F | Default: 105°F, 107°F, 110°F | Therm-X (subject device) is identical
to Therm-X (K193550). |
| | Custom: 105°F - 110°F | Custom: 105°F — 110°F | |
| | Default, continuous: 105°F, 107°F | Default, continuous: 105°F, 107°F | |
| | Custom, continuous: 105°F - 107°F | Custom, continuous: 105°F - 107°F | |
| Characteristic | Therm-X | Therm-X (K193550) | Comparison |
| | | | |
| | Subject Device | Primary Predicate | |
| Cold Therapy | Default: 34°F, 45°F, 55°F | Default: 34°F, 45°F, 55°F | Therm-X (subject device) is identical
to Therm-X (K193550). |
| | Custom: 34°F - 55°F | Custom: 34°F - 55°F | |
| | Default, continuous: 40°F, 45°F, 50°F | Default, continuous: 40°F, 45°F, 50°F | |
| | Custom, continuous: 40°F – 50°F | Custom, continuous: 40°F – 50°F | |
| Edema Pressure
Levels | 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
three levels:
Lite (5 mm Hg)
Low (20 mm Hg)
Medium (45 mm Hg) | 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
three levels:
Lite (5 mm Hg)
Low (20 mm Hg)
Medium (45 mm Hg)
High (70 mm Hg) | Therm-X (subject device) is different
to Therm-X (K193550).
The difference is limited to the Therm-
X (subject device) not providing the
option for High pressure during
Continuous treatment and allowing for
Lite treatment during continuous
treatment.
This difference in options of
compression levels for continuous
treatments does not affect the
intended use or raise different
questions of safety and effectiveness. |
| Static or
Intermittent
Pressure | Both | Both | Therm-X (subject device) is identical
to Therm-X (K193550). |
| DVT Only | Available for Therm-X Home Model | Available for Therm-X Home Model | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Characteristic | Therm-X | Therm-X (K193550) | Comparison |
| | | | |
| | Subject Device | Primary Predicate | |
| DVT Pressure | Calf: 50 - 70 mmHg
Foot: 90 - 130 mmHg | Calf: 50 - 70 mmHg
Foot: 90 - 130 mmHg | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Cycle Length (for
Heat, Cold, and | Default: 10 or 20 minutes | Default: 10 or 20 minutes | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Compression) | Custom: 3 - 40 minutes | Custom: 3 - 40 minutes | |
| | Continuous: 10 - 40 minutes active,
30-60 minutes rest | Continuous: 10 - 40 minutes active,
30-60 minutes rest | |
| Contrast Therapy | Available for Therm-X AT Model only | Available for Therm-X AT Model only | Therm-X (subject device) is identical
to Therm-X (K193550). |
| | Heat: 105°F | Heat: 105°F | |
| | Cold: 38°F | Cold: 38°F | |
| Cycle Length (for
Contrast Therapy) | Heat: 3-10 minutes | Heat: 3-10 minutes | Therm-X (subject device) is identical
to Therm-X (K193550). |
| | Cold: 3-10 minutes | Cold: 3-10 minutes | |
| | Total treatment: 6-60 minutes | Total treatment: 6-60 minutes | |
| DVT Cycle Length | No specified time interval. DVT can | No specified time interval. DVT can be | Therm-X (subject device) is identical
to Therm-X (K193550). |
| | be stopped at any time by the user. | stopped at any time by the user. | |
| Edema | Available | Available | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Compression and
DVT Compression | Edema Compression (Lite, Low,
Medium, High) must be combined | Edema Compression (Lite, Low,
Medium, High) must be combined with | Therm-X (subject device) is identical
to Therm-X (K193550). |
| at the same time | with cold, heat, or contrast therapy | cold, heat, or contrast therapy | |
| DVT Inflation and
Deflation | DVT Inflation: Up to 120 seconds | DVT Inflation: Up to 120 seconds | Therm-X (subject device) is identical
to Therm-X (K193550). |
| | DVT Deflation: Up to 30 seconds | DVT Deflation: Up to 30 seconds | |
| Characteristic | Therm-X | Therm-X (K193550) | Comparison |
| | Subject Device | Primary Predicate | |
| Power Down | Available | Available | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Password
Protection | Available | Available | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Store Cycle Usage
Data | Available | Available | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Dimensions | 15" L x 10.5" W x 9" H | 15" L x 10.5" W x 9" H | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Weight | 15 lbs. when full of coolant | 15 lbs. when full of coolant | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Chilling
Mechanism | Thermoelectric | Thermoelectric | Therm-X (subject device) is identical to
Therm-X (K193550). |
| Heating
Mechanism | Thermoelectric | Thermoelectric | Therm-X (subject device) is identical to
Therm-X (K193550). |
| Reservoir Fluid
Capacity | 650 mL | 650 mL | Therm-X (subject device) is identical to
Therm-X (K193550). |
| User Interface | Touch Screen | Touch Screen | Therm-X (subject device) is identical to
Therm-X (K193550). |
| Characteristic | Therm-X | Therm-X (K193550) | Comparison |
| | | | |
| | Subject Device | Primary Predicate | |
| Recommended
Coolant | 90% Distilled Water, 10% Isopropyl
Alcohol | 90% Distilled Water, 10% Isopropyl
Alcohol | Therm-X (subject device) is identical to
Therm-X (K193550). |
| Line Voltage | 100-240 VAC | 100-240 VAC | Therm-X (subject device) is identical to
Therm-X (K193550). |
| Line Frequency | 50/60 Hz | 50/60 Hz | Therm-X (subject device) is identical to
Therm-X (K193550). |
| Electrical Safety
Standards | 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
IEC 60601-1-2 | Therm-X (subject device) is identical to
Therm-X (K193550). |
| Operating
Temperature | 40°F - 130°F (4.4°C –
54.4°C) | 60°F - 80°F (16°C –
27°C) | Therm-X (subject device) is different
than Therm-X (K193550).
The difference is limited to the Therm-X
(subject device) allowing for use of the
device in a wider range of operating
temperatures. This difference does not
affect the intended use or raise
different questions of safety and
effectiveness. |
| Storage
Temperature | 33°F - 122°F (1°C - 50°C) | 33°F - 122°F (1°C - 50°C) | Therm-X (subject device) is identical to
Therm-X (K193550). |
| Characteristic | Therm-X | Therm-X (K193550) | Comparison |
| | Subject Device | Primary Predicate | |
| Operating Humidity | Below 60% Non-condensing | Below 60% Non-condensing | Therm-X (subject device) is identical to
Therm-X (K193550). |
| Storage Humidity | Below 60% Non-condensing | Below 60% Non-condensing | Therm-X (subject device) is identical to
Therm-X (K193550). |
| Operating
Atmospheric
Pressure and
Altitude | 700 hPa – 1060 hPa
(corresponds to a max. elevation of
9,842 ft. 6 in (3000
m)) | 700 hPa – 1060 hPa
(corresponds to a max. elevation of
9,842 ft. 6 in (3000
m)) | Therm-X (subject device) is identical to
Therm-X (K193550). |
| Types of Garments | Various anatomical thermal garments
for: Back, Elbow, Hand, Shoulder, XL Shoulder,
Knee, Half-Leg, Ankle, Hip,
Neck.
DVT Garments: Calf and Foot | Various anatomical thermal garments
for: Back, Elbow, Shoulder, Knee,
Ankle, Hip.
DVT Garments: Calf and Foot | Therm-X (subject device) is different
to Therm-X (K193550).
The difference is limited to the
addition of four garments for new
anatomical locations, and one XL
version of an existing garment. This
difference does not affect the intended
use or raise different questions of
safety or effectiveness. |
| Patient Contacting
Material | Thermal garment, reusable (multi-
patient) - 30 denier nylon coated in
urethane
Thermal garment, disposable (single-
patient) – 200 denier nylon coated in
urethane
DVT - 200 denier nylon coated in
urethane | Thermal garment, reusable (multi-
patient) - 30 denier nylon coated in
urethane
Thermal garment, disposable (single-
patient) – 200 denier nylon coated in
urethane
DVT - 200 denier nylon coated in
urethane | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Characteristic | Therm-X | Therm-X (K193550) | Comparison |
| | | | |
| | Subject Device | Primary Predicate | |
| Multi-Patient Use
or Single-Patient
Use Wraps | Multi-Patient Use and Single-Patient
Use Available | Multi-Patient Use and Single-Patient
Use Available | Therm-X (subject device) is identical
to Therm-X (K193550). |
| 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 | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Sterile/Non-Sterile | Non-sterile only | Non-sterile only | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Cleaning
Disinfection
Validation of
Labeling | Yes - for Multi-patient use reusable
wraps | Yes - for Multi-patient use reusable
wraps | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Human Factors
Testing to confirm
intended users
have found
instructions for
cleaning and
disinfection easy to
use | Yes - for Multi-patient use reusable
wraps | Yes - for Multi-patient use reusable
wraps | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Expected Life of
garments | Based on frequency of use and
continued functional performance | Based on frequency of use and
continued functional performance | Therm-X (subject device) is identical
to Therm-X (K193550). |
| Validation of
repeated cleaning
and disinfection for
reusable garments | Yes - for Multi-patient use reusable
wraps | Yes - for Multi-patient use reusable
wraps | Therm-X (subject device) is identical
to Therm-X (K193550). |
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In this submission. Zenith has added 4 new anatomical garment types: Multi-Patient Use Half Leg, Multi-Patient Use Hand, Single Patient Use (SPU) Hand, and SPU Cervical garments. Therm-X with these additional garments is substantially equivalent to the identified predicate (K193550).
Testing
Therm-X and Therm-X software were verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the type of tests performed.
Performance - Bench
Therm-X has been tested for performance to verify the proper operation of the system with the new thermal garments. Test and verification results indicate that Therm-X conforms to its predetermined specifications and operates within safety limits.
Electromagnetic Compatibility / Electrical Safety:
Electromagnetic Compatibility / Electrical Safety testing was performed in accordance with the following standards:
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic . safety and essential performance
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests Verification results indicated that the device is safe
- IEC 60601-1-11: 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
Biocompatibility:
The Therm-X garment patient contact materials were verified in accordance with the following standards:
- . ISO 10993-1: 2009, 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 Verification results indicated that the materials comply with the standard
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Cleaning. Disinfection & Shelf Life Testing
Therm-X garments are intended for use over intact skin or sterile dressings only. They are provided non-sterile and not intended to be user sterilized. Cleaning and disinfection instructions are provided for multi-patient use garments within each garment IFU. Such cleaning and disinfection instructions have been validated. The Therm-X System components and garments do not have a definitive shelf life based on packaging or time. Expected life is based on frequency of use and continued functional performance. Durability accelerated aging test has been performed and has confirmed the safe use and disinfection of a Therm-X garment for the duration of the garment's life without evidence of deterioration of the garment due to cleaning and/or disinfection.
Software Validation:
Zenith has conducted software validation testing on the Therm-X software and confirmed that Therm-X software meets its performance requirements and specifications. Software Validation has been completed according to an established Validation procedure and FDA Guidance documents and Industry Standards:
- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Januarv 11. 2002
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
- Guidance for the Content of Premarket Submissions for Device Software Functions, . June 14, 2023
The Therm-X software is a Moderate Level of Concern per FDA guidance Content of Premarket Submissions for Software Contained in Medical Devices from 2005: however, a new Guidance for the Content of Premarket Submissions for Device Software Functions from 2023 has since been released which changes the classifications of software. Per the new guidance, the Therm-X Software is classified as an Enhanced Document Level. As the Therm-X Software has a Declaration of Conformity with IEC 62304, no additional software documentation is required for the Enhanced Document Level classification.
Clinical Testing:
IRB approved studies have been performed to measure the lowest skin temperature the Therm-X device can generate. As required by the FDA guidance for heating and cooling devices, Therm-X was tested for worst case conditions on healthy volunteer human subjects who provided informed consent. A minimum skin temperature of 40°F was measured and has been included in the product labeling.
Based on these results, it has been concluded that the temperature limits of Therm-X do not cause any thermal damage to the skin. The studies demonstrated that there are no safety issues created by the device and that Therm-X is as safe and effective as the predicate devices.
Human Factors / Usability:
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Human Factors / Usability assessments have been performed in a simulated use environment to optimize the device design and support the safe use of Therm-X. Therm-X has been found to be adequately safe and effective for the intended users, its intended uses and use environments. The results demonstrated that users can operate Therm-X as safely and as effectively as the predicate devices.
Substantial Equivalence Conclusions
In conclusion, the indications for use of the Therm-X are identical to Therm-X (K193550). The technological characteristics and testing demonstrate that the Therm-X is substantially equivalent to the predicate device Therm-X (K193550), assuring that Therm-X is as safe and effective as the predicate device.
Conclusion
The 510(k) Pre-market Notification for Therm-X contains adequate information and data to determine that Therm-X is as safe and effective as the legally marketed predicate device.