Therm-X

K231912 · Zenith Technical Innovations · IRP · Jul 27, 2023 · Physical Medicine

Device Facts

• Record ID: K231912
• Device Name: Therm-X
• Applicant: Zenith Technical Innovations
• Product Code: IRP · Physical Medicine
• Decision Date: Jul 27, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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.

Device Story

Therm-X is an AC-powered, software-controlled multimodality device for thermal and compression therapy. It uses a centralized coolant reservoir, pumps, fans, and thermoelectric modules to circulate fluid through flexible garments (back, elbow, hand/wrist, shoulder, neck, ankle, hip, knee, calf, foot). The device provides cold, heat, contrast, and pneumatic compression. Therm-X Home includes DVT prophylaxis. Operated via touch screen interface; allows adjustment of treatment time, temperature, and compression settings. Features password protection for cycle compliance. Used in clinical or home settings by healthcare professionals or patients under prescription. Benefits include edema/pain reduction and DVT risk mitigation. The device supports two-patient treatment via split umbilical hose.

Clinical Evidence

Bench testing verified performance, electrical safety (IEC 60601-1, 1-2, 1-11), and biocompatibility (ISO 10993). Clinical testing consisted of an IRB-approved study on healthy volunteers to measure minimum skin temperature (40°F) to ensure no thermal damage. Human factors/usability assessments in simulated environments confirmed safe and effective operation by intended users.

Technological Characteristics

Thermoelectric heating/cooling; pneumatic compression. Materials: 30/200 denier nylon coated in urethane. Dimensions: 15"x10.5"x9". Power: 100-240 VAC, 50/60 Hz. Connectivity: Standalone with touch screen interface. Software: Moderate level of concern (per 2005 guidance) / Enhanced Document Level (per 2023 guidance). Biocompatibility per ISO 10993-5/10. Non-sterile.

Indications for Use

Indicated for patients requiring cold, heat, contrast, or compression therapy for post-surgical/acute injury edema, swelling, and pain reduction. Therm-X Home indicated for DVT prophylaxis via lower extremity compression. Intended for use by or on order of licensed healthcare professionals in clinics, rehab, athletic training, or home settings.

Regulatory Classification

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.

Predicate Devices

• Therm-X (K193550)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family: Arial;"> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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### 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)<br>1396 St. Paul Ave.<br>Gurnee, IL 60031<br>Phone: [phone]<br>Fax: [phone] |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO<br>MethodSense, Inc.<br>Email: [e-mail]<br>Phone: [phone] |
| Company Contact: | Greg Binversie<br>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.

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### 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.

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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:

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# Detailed Comparison of the Subject and Predicate Device

| Characteristic | Therm-X | Therm-X (K193550) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Subject Device<br>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.<br><br>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.<br><br>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<br>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.<br><br>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.<br><br>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<br>users (under prescription) | Health Care Professionals and lay<br>users (under prescription) | Therm-X (subject device) is identical<br>to Therm-X (K193550). |
| Number of Patients<br>that can be treated<br>at one time | Two | One | Therm-X (subject device) is different<br>from Therm-X (K193550). |
| | | | This difference is limited to the ability<br>of the Therm-X (subject device) to<br>treat two patients instead of one via a<br>split umbilical hose accessory.<br>Verification and Validation testing<br>have been conducted to confirm this<br>difference does not affect the intended <br>use or raise different questions of<br>safety and effectiveness. |
| Two Programmable<br>Cycles | Configuration of two programmable<br>cycles are available for all Therm-X<br>Models | Configuration of two programmable<br>cycles are available for all Therm-X<br>Models | Therm-X (subject device) is identical<br>to Therm-X (K193550). |
| Continuous<br>Treatment Cycle | Available on Therm-X Home | Available on Therm-X Home | Therm-X (subject device) is identical<br>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<br>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<br>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<br>Levels | Available in four levels:<br>Lite (5 mm Hg)<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg)<br>For continuous treatment, available in<br>three levels:<br>Lite (5 mm Hg)<br>Low (20 mm Hg)<br>Medium (45 mm Hg) | Available in four levels:<br>Lite (5 mm Hg)<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg)<br>For continuous treatment, available in<br>three levels:<br>Lite (5 mm Hg)<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg) | Therm-X (subject device) is different<br>to Therm-X (K193550).<br>The difference is limited to the Therm-<br>X (subject device) not providing the<br>option for High pressure during<br>Continuous treatment and allowing for<br>Lite treatment during continuous<br>treatment.<br>This difference in options of<br>compression levels for continuous<br>treatments does not affect the<br>intended use or raise different<br>questions of safety and effectiveness. |
| Static or<br>Intermittent<br>Pressure | Both | Both | Therm-X (subject device) is identical<br>to Therm-X (K193550). |
| DVT Only | Available for Therm-X Home Model | Available for Therm-X Home Model | Therm-X (subject device) is identical<br>to Therm-X (K193550). |
| Characteristic | Therm-X | Therm-X (K193550) | Comparison |
| | | | |
| | Subject Device | Primary Predicate…