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.

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.

AI/ML Overview

The Therm-X device, a powered inflatable tube massager combining cold, heat, contrast, and compression therapy, has demonstrated substantial equivalence to its predicate device (Therm-X, K193550) through a series of verification and validation tests. The modifications in the current submission include the addition of four new anatomical garment types and one XL version of an existing garment, and an expanded range of operating temperatures for the device, and a slight difference in continuous edema pressure levels.

Here is a summary of the acceptance criteria and performance, along with details of the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes modifications to the Therm-X device as compared to its predicate (Therm-X, K193550). The acceptance criteria are implicit in the "Comparison" column, where the new device is either "identical" or the differences are deemed to "not affect the intended use or raise different questions of safety and effectiveness". For the purpose of this table, the predicate device's characteristics serve as the acceptance criteria.

Characteristic	Acceptance Criteria (Predicate Therm-X, K193550)	Reported Device Performance (Subject Therm-X)	Device Meets Criteria?
Indications for Use	Treats post-surgical/acute injuries to reduce edema, swelling, pain; localized thermal therapy.Therm-X Home systems also provide DVT therapy.Used by/on order of licensed healthcare professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.	Identical. Treats post-surgical/acute injuries to reduce edema, swelling, pain; localized thermal therapy.Therm-X Home systems also provide DVT therapy.Used by/on order of licensed healthcare professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.	Yes
Intended Users	Health Care Professionals and lay users (under prescription)	Identical. Health Care Professionals and lay users (under prescription).	Yes
Number of Patients	One	Two (via a split umbilical hose accessory).	Yes (Difference validated not to affect safety/effectiveness)
Two Programmable Cycles	Available for all Therm-X Models	Identical. Available for all Therm-X Models.	Yes
Continuous Treatment Cycle	Available on Therm-X Home	Identical. Available on Therm-X Home.	Yes
Heat Therapy Settings	Default: 105°F, 107°F, 110°F; Custom: 105°F - 110°FDefault, continuous: 105°F, 107°F; Custom, continuous: 105°F - 107°F	Identical. Default: 105°F, 107°F, 110°F; Custom: 105°F - 110°FDefault, continuous: 105°F, 107°F; Custom, continuous: 105°F - 107°F	Yes
Cold Therapy Settings	Default: 34°F, 45°F, 55°F; Custom: 34°F - 55°FDefault, continuous: 40°F, 45°F, 50°F; Custom, continuous: 40°F – 50°F	Identical. Default: 34°F, 45°F, 55°F; Custom: 34°F - 55°FDefault, continuous: 40°F, 45°F, 50°F; Custom, continuous: 40°F – 50°F	Yes
Edema Pressure Levels (Continuous)	Four levels (Lite, Low, Medium, High). For continuous treatment, three levels (Lite, Low, Medium, High)	Three levels (Lite, Low, Medium). No "High" pressure during Continuous treatment, and "Lite" treatment is allowed during continuous treatment.	Yes (Difference validated not to affect safety/effectiveness)
Static or Intermittent Pressure	Both	Identical. Both.	Yes
DVT Only	Available for Therm-X Home Model	Identical. Available for Therm-X Home Model.	Yes
DVT Pressure	Calf: 50 - 70 mmHg; Foot: 90 - 130 mmHg	Identical. Calf: 50 - 70 mmHg; Foot: 90 - 130 mmHg.	Yes
Cycle Length (H/C/Comp)	Default: 10 or 20 min; Custom: 3 - 40 minContinuous: 10 - 40 min active, 30-60 min rest	Identical. Default: 10 or 20 min; Custom: 3 - 40 minContinuous: 10 - 40 min active, 30-60 min rest.	Yes
Contrast Therapy	Available for Therm-X AT Model only (Heat: 105°F, Cold: 38°F)	Identical. Available for Therm-X AT Model only (Heat: 105°F, Cold: 38°F).	Yes
Cycle Length (Contrast)	Heat: 3-10 min; Cold: 3-10 min; Total: 6-60 min	Identical. Heat: 3-10 min; Cold: 3-10 min; Total: 6-60 min.	Yes
DVT Cycle Length	No specified time interval, can be stopped at any time	Identical. No specified time interval, can be stopped at any time.	Yes
Edema Compression combined with thermal therapy	Yes (Lite, Low, Medium, High must be combined with cold, heat, or contrast therapy)	Identical. Yes (Lite, Low, Medium, High must be combined with cold, heat, or contrast therapy).	Yes
DVT Inflation/Deflation	Inflation: Up to 120 secs; Deflation: Up to 30 secs	Identical. Inflation: Up to 120 secs; Deflation: Up to 30 secs.	Yes
Power Down	Available	Identical. Available.	Yes
Password Protection	Available	Identical. Available.	Yes
Store Cycle Usage Data	Available	Identical. Available.	Yes
Dimensions	15" L x 10.5" W x 9" H	Identical. 15" L x 10.5" W x 9" H.	Yes
Weight	15 lbs. when full of coolant	Identical. 15 lbs. when full of coolant.	Yes
Chilling Mechanism	Thermoelectric	Identical. Thermoelectric.	Yes
Heating Mechanism	Thermoelectric	Identical. Thermoelectric.	Yes
Reservoir Fluid Capacity	650 mL	Identical. 650 mL.	Yes
User Interface	Touch Screen	Identical. Touch Screen.	Yes
Recommended Coolant	90% Distilled Water, 10% Isopropyl Alcohol	Identical. 90% Distilled Water, 10% Isopropyl Alcohol.	Yes
Line Voltage	100-240 VAC	Identical. 100-240 VAC.	Yes
Line Frequency	50/60 Hz	Identical. 50/60 Hz.	Yes
Electrical Safety Standards	ANSI/AAMI ES60601-1:2005/(R)2012, CAN/CSA C22.2 No. 60601-1:2014, Type B, IEC 60601-1-2	Identical. ANSI/AAMI ES60601-1:2005/(R)2012, CAN/CSA C22.2 No. 60601-1:2014, Type B, IEC 60601-1-2.	Yes
Operating Temperature	60°F - 80°F (16°C – 27°C)	40°F - 130°F (4.4°C – 54.4°C).	Yes (Difference validated not to affect safety/effectiveness)
Storage Temperature	33°F - 122°F (1°C - 50°C)	Identical. 33°F - 122°F (1°C - 50°C).	Yes
Operating Humidity	Below 60% Non-condensing	Identical. Below 60% Non-condensing.	Yes
Storage Humidity	Below 60% Non-condensing	Identical. Below 60% Non-condensing.	Yes
Operating Atmospheric Pressure/Altitude	700 hPa – 1060 hPa (max. elevation of 9,842 ft. 6 in (3000 m))	Identical. 700 hPa – 1060 hPa (max. elevation of 9,842 ft. 6 in (3000 m)).	Yes
Types of Garments	Various anatomical thermal garments for: Back, Elbow, Shoulder, Knee, Ankle, Hip. DVT Garments: Calf and Foot.	Various anatomical thermal garments for: Back, Elbow, Hand, Shoulder, XL Shoulder, Knee, Half-Leg, Ankle, Hip, Neck. DVT Garments: Calf and Foot.	Yes (Difference validated not to affect safety/effectiveness)
Patient Contacting Material	Thermal garment (reusable): 30 denier nylon coated in urethane.Thermal garment (disposable): 200 denier nylon coated in urethane.DVT: 200 denier nylon coated in urethane.	Identical. Thermal garment (reusable): 30 denier nylon coated in urethane.Thermal garment (disposable): 200 denier nylon coated in urethane.DVT: 200 denier nylon coated in urethane.	Yes
Multi-Patient/Single-Patient Use Wraps	Multi-Patient Use and Single-Patient Use Available	Identical. Multi-Patient Use and Single-Patient Use Available.	Yes
Biocompatibility	Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10)	Identical. Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10). Verification results indicated materials comply with the standard.	Yes
Sterile/Non-Sterile	Non-sterile only	Identical. Non-sterile only.	Yes
Cleaning/Disinfection Validation	Yes - for Multi-patient use reusable wraps	Identical. Yes - for Multi-patient use reusable wraps.	Yes
Human Factors Training Validation	Yes - for Multi-patient use reusable wraps	Identical. Yes - for Multi-patient use reusable wraps.	Yes
Expected Life of garments	Based on frequency of use and continued functional performance	Identical. Based on frequency of use and continued functional performance. Accelerated aging test performed to confirm safe use.	Yes
Validation of repeated cleaning/disinfection	Yes - for Multi-patient use reusable wraps	Identical. Yes - for Multi-patient use reusable wraps.	Yes

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to a clinical testing study that was "IRB approved" and conducted "on healthy volunteer human subjects who provided informed consent." This indicates a prospective study design.

Sample Size: The exact number of human subjects is not specified in the provided text. It mentions "healthy volunteer human subjects."
Data Provenance: The country of origin of the data is not specified. The mention of "IRB approved studies" implies a research institution setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

For the clinical testing for skin temperature, the "ground truth" was established by direct measurement of the skin temperature using the device on human subjects. This is not a situation where a human expert consensus is used to establish ground truth for a diagnostic interpretation. The study was to measure the lowest skin temperature the device could generate.

Number of experts: Not applicable in the context of diagnostic "ground truth" establishment, as it was a direct physical measurement.
Qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The clinical study described was to measure skin temperature directly, not to adjudicate results from interpretive tasks.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Therm-X device is a physical therapy device (powered inflatable tube massager) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The Therm-X device is a physical therapy device and does not inherently involve an algorithm for diagnostic interpretation in a standalone fashion. Its software controls the physical modalities (temperature, compression, cycles). Software validation ensures the software operates as intended, but this is not "standalone algorithm performance" in the context of diagnostic AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the human clinical study mentioned:

Type of Ground Truth: The ground truth for the performance related to skin temperature was direct physical measurement ("lowest skin temperature ... measured") on human subjects under "worst case conditions."

For other tests:

Performance - Bench: Predetermined specifications/performance criteria.
Electromagnetic Compatibility / Electrical Safety: Conformance to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11).
Biocompatibility: Conformance to international standards (ISO 10993-1, ISO 10993-5, ISO 10993-10).
Cleaning, Disinfection & Shelf Life Testing: Validation of instructions and accelerated aging tests against expected performance and absence of deterioration.
Software Validation: Conformance to performance requirements and specifications, and FDA Guidance documents (e.g., General Principles of Software Validation, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices/Device Software Functions).
Human Factors / Usability: Adequacy for safe and effective use by intended users in intended environments.

8. The sample size for the training set

Not applicable. The Therm-X device does not appear to involve machine learning or AI that would require a "training set" in the typical sense for diagnostic algorithms. The software validation ensures its functionality based on established design specifications.

9. How the ground truth for the training set was established

Not applicable, as there is no mention or indication of an AI model requiring a training set in the document.

Summary

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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 (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

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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) 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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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 60031Phone: (847) 672-7481Fax: (847) 672-8721
Primary Contact:	Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: 919-313-3961
Company Contact:	Greg BinversieChief 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

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 (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 DeviceTherm-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 PredicateTherm-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 layusers (under prescription)	Health Care Professionals and layusers (under prescription)	Therm-X (subject device) is identicalto Therm-X (K193550).
Number of Patientsthat can be treatedat one time	Two	One	Therm-X (subject device) is differentfrom Therm-X (K193550).
			This difference is limited to the abilityof the Therm-X (subject device) totreat two patients instead of one via asplit umbilical hose accessory.Verification and Validation testinghave been conducted to confirm thisdifference does not affect the intended use or raise different questions ofsafety and effectiveness.
Two ProgrammableCycles	Configuration of two programmablecycles are available for all Therm-XModels	Configuration of two programmablecycles are available for all Therm-XModels	Therm-X (subject device) is identicalto Therm-X (K193550).
ContinuousTreatment Cycle	Available on Therm-X Home	Available on Therm-X Home	Therm-X (subject device) is identicalto Therm-X (K193550).
Heat Therapy	Default: 105°F, 107°F, 110°F	Default: 105°F, 107°F, 110°F	Therm-X (subject device) is identicalto 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 identicalto 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 PressureLevels	Available in four levels:Lite (5 mm Hg)Low (20 mm Hg)Medium (45 mm Hg)High (70 mm Hg)For continuous treatment, available inthree 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 inthree levels:Lite (5 mm Hg)Low (20 mm Hg)Medium (45 mm Hg)High (70 mm Hg)	Therm-X (subject device) is differentto Therm-X (K193550).The difference is limited to the Therm-X (subject device) not providing theoption for High pressure duringContinuous treatment and allowing forLite treatment during continuoustreatment.This difference in options ofcompression levels for continuoustreatments does not affect theintended use or raise differentquestions of safety and effectiveness.
Static orIntermittentPressure	Both	Both	Therm-X (subject device) is identicalto Therm-X (K193550).
DVT Only	Available for Therm-X Home Model	Available for Therm-X Home Model	Therm-X (subject device) is identicalto Therm-X (K193550).
Characteristic	Therm-X	Therm-X (K193550)	Comparison

	Subject Device	Primary Predicate
DVT Pressure	Calf: 50 - 70 mmHgFoot: 90 - 130 mmHg	Calf: 50 - 70 mmHgFoot: 90 - 130 mmHg	Therm-X (subject device) is identicalto Therm-X (K193550).
Cycle Length (forHeat, Cold, and	Default: 10 or 20 minutes	Default: 10 or 20 minutes	Therm-X (subject device) is identicalto 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 identicalto Therm-X (K193550).
	Heat: 105°F	Heat: 105°F
	Cold: 38°F	Cold: 38°F
Cycle Length (forContrast Therapy)	Heat: 3-10 minutes	Heat: 3-10 minutes	Therm-X (subject device) is identicalto 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 identicalto 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 identicalto Therm-X (K193550).
Compression andDVT 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 identicalto Therm-X (K193550).
at the same time	with cold, heat, or contrast therapy	cold, heat, or contrast therapy
DVT Inflation andDeflation	DVT Inflation: Up to 120 seconds	DVT Inflation: Up to 120 seconds	Therm-X (subject device) is identicalto 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 identicalto Therm-X (K193550).
PasswordProtection	Available	Available	Therm-X (subject device) is identicalto Therm-X (K193550).
Store Cycle UsageData	Available	Available	Therm-X (subject device) is identicalto 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 identicalto Therm-X (K193550).
Weight	15 lbs. when full of coolant	15 lbs. when full of coolant	Therm-X (subject device) is identicalto Therm-X (K193550).
ChillingMechanism	Thermoelectric	Thermoelectric	Therm-X (subject device) is identical toTherm-X (K193550).
HeatingMechanism	Thermoelectric	Thermoelectric	Therm-X (subject device) is identical toTherm-X (K193550).
Reservoir FluidCapacity	650 mL	650 mL	Therm-X (subject device) is identical toTherm-X (K193550).
User Interface	Touch Screen	Touch Screen	Therm-X (subject device) is identical toTherm-X (K193550).
Characteristic	Therm-X	Therm-X (K193550)	Comparison

	Subject Device	Primary Predicate
RecommendedCoolant	90% Distilled Water, 10% IsopropylAlcohol	90% Distilled Water, 10% IsopropylAlcohol	Therm-X (subject device) is identical toTherm-X (K193550).
Line Voltage	100-240 VAC	100-240 VAC	Therm-X (subject device) is identical toTherm-X (K193550).
Line Frequency	50/60 Hz	50/60 Hz	Therm-X (subject device) is identical toTherm-X (K193550).
Electrical SafetyStandards	ANSI/AAMI ES60601-1:2005/(R)2012CAN/CSA C22.2 No. 60601-1:2014Type BIEC 60601-1-2	ANSI/AAMI ES60601-1:2005/(R)2012CAN/CSA C22.2 No. 60601-1:2014Type BIEC 60601-1-2	Therm-X (subject device) is identical toTherm-X (K193550).
OperatingTemperature	40°F - 130°F (4.4°C –54.4°C)	60°F - 80°F (16°C –27°C)	Therm-X (subject device) is differentthan Therm-X (K193550).The difference is limited to the Therm-X(subject device) allowing for use of thedevice in a wider range of operatingtemperatures. This difference does notaffect the intended use or raisedifferent questions of safety andeffectiveness.
StorageTemperature	33°F - 122°F (1°C - 50°C)	33°F - 122°F (1°C - 50°C)	Therm-X (subject device) is identical toTherm-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 toTherm-X (K193550).
Storage Humidity	Below 60% Non-condensing	Below 60% Non-condensing	Therm-X (subject device) is identical toTherm-X (K193550).
OperatingAtmosphericPressure andAltitude	700 hPa – 1060 hPa(corresponds to a max. elevation of9,842 ft. 6 in (3000m))	700 hPa – 1060 hPa(corresponds to a max. elevation of9,842 ft. 6 in (3000m))	Therm-X (subject device) is identical toTherm-X (K193550).
Types of Garments	Various anatomical thermal garmentsfor: Back, Elbow, Hand, Shoulder, XL Shoulder,Knee, Half-Leg, Ankle, Hip,Neck.DVT Garments: Calf and Foot	Various anatomical thermal garmentsfor: Back, Elbow, Shoulder, Knee,Ankle, Hip.DVT Garments: Calf and Foot	Therm-X (subject device) is differentto Therm-X (K193550).The difference is limited to theaddition of four garments for newanatomical locations, and one XLversion of an existing garment. Thisdifference does not affect the intendeduse or raise different questions ofsafety or effectiveness.
Patient ContactingMaterial	Thermal garment, reusable (multi-patient) - 30 denier nylon coated inurethaneThermal garment, disposable (single-patient) – 200 denier nylon coated inurethaneDVT - 200 denier nylon coated inurethane	Thermal garment, reusable (multi-patient) - 30 denier nylon coated inurethaneThermal garment, disposable (single-patient) – 200 denier nylon coated inurethaneDVT - 200 denier nylon coated inurethane	Therm-X (subject device) is identicalto Therm-X (K193550).
Characteristic	Therm-X	Therm-X (K193550)	Comparison

	Subject Device	Primary Predicate
Multi-Patient Useor Single-PatientUse Wraps	Multi-Patient Use and Single-PatientUse Available	Multi-Patient Use and Single-PatientUse Available	Therm-X (subject device) is identicalto Therm-X (K193550).
Biocompatibility	Cytotoxicity testing per ISO 10993-5Sensitization testing per ISO 10993-10Irritation testing per ISO 10993-10	Cytotoxicity testing per ISO 10993-5Sensitization testing per ISO 10993-10Irritation testing per ISO 10993-10	Therm-X (subject device) is identicalto Therm-X (K193550).
Sterile/Non-Sterile	Non-sterile only	Non-sterile only	Therm-X (subject device) is identicalto Therm-X (K193550).
CleaningDisinfectionValidation ofLabeling	Yes - for Multi-patient use reusablewraps	Yes - for Multi-patient use reusablewraps	Therm-X (subject device) is identicalto Therm-X (K193550).
Human FactorsTesting to confirmintended usershave foundinstructions forcleaning anddisinfection easy touse	Yes - for Multi-patient use reusablewraps	Yes - for Multi-patient use reusablewraps	Therm-X (subject device) is identicalto Therm-X (K193550).
Expected Life ofgarments	Based on frequency of use andcontinued functional performance	Based on frequency of use andcontinued functional performance	Therm-X (subject device) is identicalto Therm-X (K193550).
Validation ofrepeated cleaningand disinfection forreusable garments	Yes - for Multi-patient use reusablewraps	Yes - for Multi-patient use reusablewraps	Therm-X (subject device) is identicalto 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.

Regulation Number and Section

§ 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).