Therm-X (Therm-X Home and Therm-X AT) combines cold, heat contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) 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. The Therm-X (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI).

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 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 (Therm-X Home and Therm-X AT) 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 (Therm-X Home and Therm-X AT) 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 chanqe 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).

Therm-X (Therm-X Home and Therm-X AT) 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 provided text describes the 510(k) premarket notification for the Therm-X device, which is a therapeutic device combining cold, heat, contrast, and compression therapies. The document focuses on demonstrating that the Therm-X device is substantially equivalent to legally marketed predicate devices, particularly the previous Therm-X (K231912) and the VascuTherm™ (K061866).

The context of the document is a regulatory submission for a medical device seeking FDA clearance, not a study proving a device meets specific acceptance criteria in the context of an AI/ML product where the acceptance criteria would be metrics like accuracy, sensitivity, specificity, etc., with corresponding ground truth and expert adjudication. The "acceptance criteria" discussed in this document refer to the regulatory requirements for demonstrating substantial equivalence to a predicate device, which largely involves comparing design, intended use, technological characteristics, and safety/performance data.

Therefore, many of the specific questions about "acceptance criteria" and "study that proves the device meets acceptance criteria" as they relate to AI/ML performance metrics (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are not directly applicable to this type of device and submission.

However, I can extract the relevant information regarding the device's performance claims and the testing undertaken to support its substantial equivalence, particularly concerning the newly added indications for use.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance (in the context of a 510(k) submission)

The primary "acceptance criteria" for this 510(k) submission is to demonstrate substantial equivalence to predicate devices for the specified indications for use, and to show the device is safe and effective. This is not about meeting specific numerical performance targets for an AI algorithm's diagnostic accuracy, but rather demonstrating that the device functions as intended and does not raise new questions of safety or effectiveness compared to existing devices.

The "device performance" reported is largely in the form of conformance to established standards and the outcome of testing, rather than specific quantitative metrics of clinical efficacy.

Table of "Acceptance Criteria" (Regulatory Requirements for Substantial Equivalence) and Reported Device Performance:

Acceptance Criteria (Regulatory/Performance Aspect)	Reported Device Performance (as demonstrated by testing)
Intended Use Equivalence	Therm-X (Subject Device) indications for use are identical to Therm-X (K231912) with the only difference being the addition of treatment for disorders associated with vascular or lymphatic insufficiency (lymphedema and CVI). The added indications are equivalent to VascuTherm™ (K061866). Conclusion: Substantially Equivalent.
Technological Characteristics Equivalence	Various direct comparisons are made (e.g., number of patients treated, programmable cycles, continuous treatment, heat/cold therapy ranges, pressure levels, DVT characteristics, cycle length, contrast therapy, DVT inflation/deflation, power down, password protection, stored cycle usage data, dimensions, weight, chilling/heating mechanisms, reservoir fluid capacity, user interface, coolant, line voltage/frequency, electrical safety standards, operating/storage temperature/humidity, atmospheric pressure/altitude, garment types). In most cases, the subject device is identical to Therm-X (K231912). Where there are differences (e.g., specific DVT pressures compared to K061866), they are deemed equivalent. A minor difference in patient-contacting material (elastic strap) is deemed not to raise new questions of safety. Conclusion: Substantially Equivalent.
Performance - Bench Testing (Proper Operation)	"Test and verification results indicate that Therm-X Home and Therm-X AT) conforms to its predetermined specifications and operates within safety limits."
Electromagnetic Compatibility / Electrical Safety	Testing performed per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. "Verification results indicated that the device is safe."
Biocompatibility	Testing performed per ISO 10993-1, ISO 10993-5, ISO 10993-10 for patient-contacting materials. "Verification results indicated that the materials comply with the standard."
Cleaning, Disinfection & Shelf Life Testing	Cleaning and disinfection validated for multi-patient use garments. Durability accelerated aging test confirmed safe use and disinfection for garment life without deterioration.
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." Validation followed FDA Guidance documents for Enhanced Documentation Level and Industry Standards (General Principles of Software Validation; Guidance for the Content of Premarket Submissions for Device Software Functions).
Clinical Testing (Lowest Skin Temperature)	IRB approved studies measured skin temperature under worst-case conditions on healthy volunteers. A minimum skin temperature of 40°F was measured and included in labeling. "Concluded that the temperature limits... do not cause any thermal damage to the skin."
Overall Safety and Effectiveness	"The studies demonstrated that there are no safety issues created by the device and that Therm-X (Therm-X Home and Therm-X AT) 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, its intended uses and use environments." "Results demonstrated that users can operate Therm-X... as safely and as effectively as the predicate devices."

Study Details (as applicable to this type of device submission):

Sample size used for the test set and the data provenance:
- Test Set (for clinical testing): The document mentions "healthy volunteer human subjects" for the skin temperature measurement. The exact sample size is not specified in the provided text.
- Data Provenance: Not explicitly stated, but clinical testing typically occurs in supervised settings. The nature of the device (physical therapy equipment) suggests this is likely prospective data collection for specific safety parameters. There is no indication of retrospective data from any specific country.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this device and submission. "Ground truth" in AI/ML typically refers to expert labels for diagnostic tasks. For Therm-X, "ground truth" for physical characteristics would be instrument measurements (e.g., temperature gauges, pressure sensors) or established clinical endpoints (e.g., absence of skin damage). The experts involved would be medical and engineering professionals conducting the tests, not labeling data for an algorithm.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a method used for resolving discrepancies in expert labeling of data for AI/ML validation. The testing described for Therm-X is direct physical performance validation and human factors assessment.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a framework for evaluating the diagnostic performance of AI-assisted human readers. Therm-X is a physical therapy device, not an AI for diagnosis or interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, as Therm-X is not an AI/ML algorithm. However, the device itself has "software validation" which assesses its performance independently of direct human control over its internal functions, ensuring it meets its "performance requirements and specifications."
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the skin temperature testing: The ground truth was direct physiological measurement (skin temperature) obtained from human subjects under controlled, worst-case conditions. The "ground truth" for other tests (e.g., electrical safety, biocompatibility, cleaning validation) would be adherence to scientific standards and specifications, confirmed through various laboratory and bench tests.
The sample size for the training set:
- Not applicable. Therm-X is not an AI/ML device that requires a "training set" in the machine learning sense. The device's operation is based on pre-programmed parameters and physical principles, not learned from data.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set."

Important Note: The document explicitly states: "No additional testing has been performed for the additional indications for use." This means the demonstration of substantial equivalence for the new indications (lymphedema and CVI) relies primarily on the comparison to the predicate device (VascuTherm™ K061866) which already has these indications, and on the existing testing data for the Therm-X device from its previous 510(k) clearance (K231912) and general safety and performance testing.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 21, 2024

Zenith Technical Innovations % Rita King Chief Executive Officer MethodSense, Inc. 1 Copley Parkway Suite 130 Morrisville, North Carolina 27560

Re: K240125

Trade/Device Name: Therm-X (Home); Therm-X (AT) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW, IRP, ILO Dated: May 23, 2024 Received: May 24, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

{1}------------------------------------------------

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.

Nicole M. Gillette -S

Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality

{2}------------------------------------------------

Enclosure

{3}------------------------------------------------

Reprocessed Single-Use Device Models Included in Clearance:

DeviceModel	Device Name	OriginalManufacturer
TX0107	Calf DVT Garment	ZTI
TX0106	Foot DVT Garment	ZTI
TX0102	Knee Thermal Garment	ZTI
TX0105	Back Thermal Garment	ZTI
TX0101	Shoulder Thermal Garment	ZTI
TX0110	XL Shoulder Garment	ZTI
TX0104	Ankle Thermal Garment	ZTI
TX0103	Elbow Thermal Garment	ZTI
TX0108	Hip Thermal Garment	ZTI
TX0111	Half-leg Thermal Garment	ZTI
TX0112	Hand Thermal Garment	ZTI

DVT – Deep Vein Thrombosis

ZTI – Zenith Technical Innovations

{4}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240125

Device Name

Therm-X (Therm-X Home and Therm-X AT)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

510(k) Summary

Zenith Technical Innovations K240125

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 21, 2024

Device Name and Classification

Trade Name:	Therm-X
Common Name:	Sleeve, Limb, Compressible
Classification:	Class II
Regulation Number:	21 CFR 870.5800 - Compressible limb sleeve
Classification Panel:	Cardiovascular
Product Code:	JOW, IRP, ILO

Predicate Devices

Trade Name:	Therm-X	VascuTherm™
Common Name:	Heat and/or Cold andCompression Therapy	Intermittent, ExternalPneumatic CompressionDevice
510(k) Submitter /Holder:	Zenith Technical Innovations,LLC. (Zenith)	ThermoTek, Inc.
510(k) Number:	K231912	K061866
Classification:	Class II	Class II
Regulation Number:	890.5650, Powered Inflatable tubemassager	870.5800 - Compressiblelimb sleeve
Classification Panel:	Physical Medicine	Cardiovascular
Product Code:	IRP, ILO, JOW	JOW

The predicate devices have not been subject to a design-related recall.

{6}------------------------------------------------

Device Description

Indications for Use

Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is

{7}------------------------------------------------

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 (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI).

Risk Analysis Method

Therm-X (Therm-X Home and Therm-X AT) was assessed to determine the risks to health associated with the updated indications for use 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 management to medical devices. No additional risks were associated with the addition of treating disorders associated with vascular or lymphatic insufficiency such as lymphedema and chronic venous insufficiency (CVI) to the indications for use.

Substantial Equivalence

Therm-X (Therm-X Home and Therm-X AT) is substantially equivalent to Therm-X (K231912) by Zenith Technical Innovations, LLC. (Zenith) and VascuTherm™ (K061866) by ThermoTek, Inc. currently on the market.

Therm-X (Therm-X Home and Therm-X AT) has the same intended use as the Therm-X (K231912) and VascuTherm™ (K061866) and uses equivalent overall design and operating principals as the Therm-X predicate device (K231912).

The table below provides a detailed comparison of Therm-X Home and Therm-X AT) to the predicate devices:

{8}------------------------------------------------

Detailed Comparison of the Subject and Predicate Devices

Characteristic	Therm-X	Therm-X (K231912)	VascuTherm ™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™) (K061866)	Comparison
	Subject Device	Primary Predicate	Secondary Predicate
Indications forUse	Therm-X (Therm-X Home andTherm-X AT) combines cold,heat, contrast, andcompression therapy. Therm-X is intended to treat post-surgical and acute injuries toreduce edema, swelling, andpain for which cold andcompression are indicated. Itis intended to treat posttraumatic and post-surgicalmedical and/or surgicalconditions for which localizedthermal therapy (hot or cold)are indicated.Therm-X (Therm-X Home andTherm-X AT) is also intendedfor treatment of disordersassociated with vascular orlymphatic insufficiency, suchas lymphedema and chronicvenous insufficiency (CVI).Therm-X Home systems alsoprovide DVT therapy. Therm-	Therm-X (Therm-X Home andTherm-X AT) combines cold,heat, contrast, andcompression therapy. Therm-X is intended to treat post-surgical and acute injuries toreduce edema, swelling, andpain for which cold andcompression are indicated. Itis intended to treat posttraumatic and post-surgicalmedical and/or surgicalconditions for which localizedthermal therapy (hot or cold)are indicated.Therm-X Home systems alsoprovide DVT therapy. Therm-X Home systems with DVTtherapy are intended toreduce the risk of theformation of deep venousthrombosis (DVT) by aidingblood flow back to the heartvia lower extremity limbcompression.	Treatment of disordersassociated with vascular orlymphatic insufficiency suchas Chronic VenousInsufficiency (CVI), venousstasis ulcers,post-mastectomy edema andchronic lymphedema.Reduction of Edemaassociated with soft tissueinjuries such as bums,postoperative edema, andligament sprains.Localized thermal therapy(hot or cold) for post traumaticand post surgical medicaland/or surgical conditions.Decrease the risk of deepvenous thrombosis (DVT).Aids the blood flow back tothe heart.	Therm-X (subject device)indications for use areidentical to Therm-X(K231912) with the onlydifference being that theTherm-X (subject device)also indicates that thedevice may be used fortreatment of disordersassociated with vascularor lymphatic insufficiencysuch as lymphedema andCVI.The indications for use forthe treatment of disordersassociated with vascularor lymphatic insufficiencysuch as lymphedema andCVI of Therm-X (subjectdevice) are equivalent tothe VascuThermTM(K061866) indications fortreatment of these samedisorders.
Characteristic	Therm-X	Therm-X (K231912)	VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™) (K061866)	Comparison
	Subject Device	Primary Predicate	Secondary Predicate
	X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) and 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.	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.	Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.
Intended Users	Health Care Professionals and lay users (under prescription)	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 (K231912) and VascuTherm™ (K061866).
Number ofPatients that canbe treated at onetime	Two	Two	One	Therm-X (subject device) is identical to Therm-X (K231912).
Characteristic	Therm-X	Therm-X (K231912)	VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™) (K061866)	Comparison
	Subject Device	Primary Predicate	Secondary Predicate
TwoProgrammableCycles	Configuration of twoprogrammable cycles areavailable for all Therm-XModels	Configuration of twoprogrammable cycles areavailable for all Therm-XModels	Not Available.	Therm-X (subject device)is identical to Therm-X(K231912).
ContinuousTreatment Cycle	Available on Therm-X Home	Available on Therm-X Home	Available.	Therm-X (subject device)is identical to Therm-X(K231912) andVascuTherm™(K061866).
Heat Therapy	Default: 105°F, 107°F, 110°FCustom: 105°F – 110°FDefault, continuous: 105°F,107°FCustom, continuous: 105°F –107°F	Default: 105°F, 107°F, 110°FCustom: 105°F – 110°FDefault, continuous: 105°F,107°FCustom, continuous: 105°F –107°F	105°F	Therm-X (subject device)is identical to Therm-X(K231912) and equivalentto VascuTherm™(K061866). .
Cold Therapy	Default: 34°F, 45°F, 55°FCustom: 34°F - 55°FDefault, continuous: 40°F,45°F, 50°FCustom, continuous: 40°F –50°F	Default: 34°F, 45°F, 55°FCustom: 34°F - 55°FDefault, continuous: 40°F,45°F, 50°FCustom, continuous: 40°F –50°F	43 - 49°F	Therm-X (subject device)is identical to Therm-X(K231912).
Characteristic	Therm-X	Therm-X (K231912)	VascuTherm ™(VascuTherm ™ 4 andVascuTherm ™ 5) andNanoTherm ™) (K061866)	Comparison
	Subject Device	Primary Predicate	Secondary Predicate
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 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)	Available in three levels:Low (15 mmHg)Medium (30 mmHg)High (50 mmHg)	Therm-X (subject device)is identical to Therm-X(K231912).
Static orIntermittentPressure	Both	Both	Both	Therm-X (subject device)is identical to Therm-X(K231912) andVascuTherm™(K061866)
DVT Only	Available for Therm-X HomeModel	Available for Therm-X HomeModel	Available	Therm-X (subject device)is identical to Therm-X(K231912) andVascuTherm™(K061866).
DVT Pressure	Calf: 50 - 70 mmHgFoot: 90 - 130 mmHg	Calf: 50 - 70 mmHgFoot: 90 - 130 mmHg	Calf: 45 mmHgFoot: 100 mmHg	Therm-X (subject device)is identical to Therm-X(K231912).
Characteristic	Therm-X	Therm-X (K231912)	VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™) (K061866)	Comparison

	Subject Device	Primary Predicate	Secondary Predicate
Cycle Length(for Heat, Cold,andCompression)	Default: 10 or 20 minutes	Default: 10 or 20 minutes	Default: 30 minutes(presumed - not clearlystated in User Manual)	Therm-X (subject device)is identical to Therm-X(K231912).
	Custom: 3 - 40 minutes	Custom: 3 - 40 minutes
	Continuous: 10 – 40 minutesactive, 30-60 minutes rest	Continuous: 10-40 minutesactive, 30-60 minutes rest	Continuous: 30 minutes(presumed not clearly statedin User Manual)Compression: Unknown
ContrastTherapy	Available for Therm-X ATModel only	Available for Therm-X ATModel only	AvailableHeat: 10 minutesCold: 20 minutesNote: Contrast therapy isavailable only inVascuTherm™ 5	Therm-X (subject device)is identical to Therm-X(K231912).
	Heat: 105°F	Heat: 105°F
	Cold: 38°F	Cold: 38°F
Cycle Length(for ContrastTherapy)	Heat: 3-10 minutes	Heat: 3-10 minutes	30 minutes (presumed notclearly stated in User Manual)	Therm-X (subject device)is identical to Therm-X(K231912).
	Cold: 3-10 minutes	Cold: 3-10 minutes
	Total treatment: 6-60 minutes	Total treatment: 6-60 minutes
DVT CycleLength	Total treatment: 6-60 minutesNo specified time interval.DVT can be stopped at anytime by the user.	Total treatment: 6-60 minutesNo specified time interval.DVT can be stopped at anytime by the user.	30 minutes (presumed notclearly stated in User Manual)	Therm-X (subject device)is identical to Therm-X(K231912).
EdemaCompressionand DVTCompression atthe same time	AvailableEdema Compression (Lite,Low, Medium, High) must becombined with cold, heat, orcontrast therapy	AvailableEdema Compression (Lite,Low, Medium, High) must becombined with cold, heat, orcontrast therapy	Available	Therm-X (subject device)is identical to Therm-X(K231912) andVascuTherm™(K061866).
Characteristic	Therm-X	Therm-X (K231912)	VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™) (K061866)	Comparison
	Subject Device	Primary Predicate	Secondary Predicate
DVT Inflationand Deflation	DVT Inflation: Up to 120 secondsDVT Deflation: Up to 30 seconds	DVT Inflation: Up to 120 secondsDVT Deflation: Up to 30 seconds	Cycle time Inflation: 20 seconds,Deflation: 40 sec	Therm-X (subject device)is identical to Therm-X(K231912).
Power Down	Available	Available	Available	Therm-X (subject device)is identical to Therm-X(K231912) andVascuTherm™(K061866).
PasswordProtection	Available	Available	VascuTherm™ 5: Thetherapy profiles can belocked. Only healthcareprofessionals can unlocktherapy profiles and justsettings.	Therm-X (subject device)is identical to Therm-X(K231912).
Store CycleUsage Data	Available	Available	VascuTherm™ 4: Settemperature can bepreprogrammed and locked.Was not able to determinefrom publicly availableinformation.	Therm-X (subject device)is identical to Therm-X(K231912).
Dimensions	15" L x 10.5" W x 9" H	15" L x 10.5" W x 9" H	VascuTherm™ 5 13.2" H x12.00" D x 6.6" W (335 mm Hx 305 mm D x 167 mm W)VascuTherm™ 4: 9.88" H x8.75" D x 9.81" W (251 mm Hx 222 mm D x 249 mm W)	Therm-X (subject device)is identical to Therm-X(K231912).
Characteristic	Therm-X	Therm-X (K231912)	VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™) (K061866)	Comparison
	Subject Device	Primary Predicate	Secondary Predicate
Weight	15 lbs. when full of coolant	15 lbs. when full of coolant	VascuTherm™ 5: 18.75 lbs.(8.5 kg)VascuTherm™ 4: 9.5 lbs	Therm-X (subject device)is identical to Therm-X(K231912).
ChillingMechanism	Thermoelectric	Thermoelectric	Thermoelectric	Therm-X (subject device) isidentical to Therm-X(K231912) andVascuTherm™ (K061866).
HeatingMechanism	Thermoelectric	Thermoelectric	Thermoelectric	Therm-X (subject device) isidentical to Therm-X(K231912) andVascuTherm™ (K061866).
Reservoir FluidCapacity	650 mL	650 mL	Vascutherm™ 5: 320 mLVascuTherm™ 4: 250 mL	Therm-X (subject device) isidentical to Therm-X(K231912).
User Interface	Touch Screen	Touch Screen	Touch Screen	Therm-X (subject device) isidentical to Therm-X(K231912).
RecommendedCoolant	90% Distilled Water, 10%Isopropyl Alcohol	90% Distilled Water, 10%Isopropyl Alcohol	90% Distilled Water, 10%Isopropyl Alcohol	Therm-X (subject device) isidentical to Therm-X(K231912) andVascuTherm™ (K061866).
Characteristic	Therm-XSubject Device	Therm-X (K231912)Primary Predicate	VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™) (K061866)Secondary Predicate	Comparison
Line Voltage	100-240 VAC	100-240 VAC	100-240 VAC	Therm-X (subject device) isidentical to Therm-X(K231912) andVascuTherm™ (K061866).
Line Frequency	50/60 Hz	50/60 Hz	50/60 Hz	Therm-X (subject device) isidentical to Therm-X(K231912) andVascuTherm™ (K061866).
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	IEC 60601-1IEC 60601-1-2UL 60601 Safety StandardsType B	Therm-X (subject device) isidentical to Therm-X(K231912).
OperatingTemperature	40°F - 130°F (4.4°C –54.4°C)	40°F - 130°F (4.4°C –54.4°C)	VascuTherm™ 4: 60-80°F(16°C - 27°C)VascuTherm™ 5: 50-80°F(10°C - 27°C)	Therm-X (subject device) isidentical to Therm-X(K231912).
Characteristic	Therm-X	Therm-X (K231912)	VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™) (K061866)	Comparison
	Subject Device	Primary Predicate	Secondary Predicate
StorageTemperature	33°F - 122°F (1°C - 50°C)	33°F - 122°F (1°C - 50°C)	40-105°F	Therm-X (subject device) isidentical to Therm-X(K231912).
OperatingHumidity	Below 60% Non-condensing	Below 60% Non-condensing	Below 60% Non-condensing	Therm-X (subject device) isidentical to Therm-X(K231912) andVascuTherm™ (K061866).
StorageHumidity	Below 60% Non-condensing	Below 60% Non-condensing	10%-95% Non-condensing	Therm-X (subject device) isidentical to Therm-X(K231912).
OperatingAtmosphericPressure andAltitude	700 hPa - 1060 hPa(corresponds to a max.elevation of 9,842 ft. 6 in(3000m))	700 hPa – 1060 hPa(corresponds to a max.elevation of 9,842 ft. 6 in(3000m))	No information available.	Therm-X (subject device) isidentical to Therm-X(K231912).
Types ofGarments	Various anatomical thermalgarments for: Back, Elbow,Hand, Shoulder, XL Shoulder,Knee, Half-Leg, Ankle, Hip,Neck.	Various anatomical thermalgarments for: Back, Elbow,Hand, Shoulder, XL Shoulder,Knee, Half-Leg, Ankle, Hip,Neck.	Various anatomical wraps for:Arm, Wrist, Back, Face, Foot,Ankle, Hip, Knee, Shoulder,Torso, Half Arm, Head, Half-Leg, Full Leg	Therm-X (subject device)is identical to Therm-X(K231912).
	DVT Garments: Calf and Foot	DVT Garments: Calf and Foot	DVT Wraps: Calf and Foot
Characteristic	Therm-X	Therm-X (K231912)	VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™) (K061866)	Comparison
	Subject Device	Primary Predicate	Secondary Predicate
PatientContactingMaterial	Thermal garment, reusable(multi-patient) – 30 deniernylon coated in urethaneThermal garment, disposable(single-patient) – 200 deniernylon coated in urethaneDVT – 200 denier nyloncoated in urethaneButterfly Garment ElasticStrap - Lycra/Spandex,Polyester, Nylon	Thermal garment, reusable(multi-patient) – 30 deniernylon coated in urethaneThermal garment, disposable(single-patient) – 200 deniernylon coated in urethaneDVT – 200 denier nyloncoated in urethane	Thermal wrap - 200 DenierNylon OxfordDVT wrap - DuPontSoftesse® Medical Fabric(non-latex, non-woven)	Therm-X (subject device)is identical to Therm-X(K231912) with theexception that Therm-X(subject device) includesnew elastic straps for agarment that arecomprised ofLycra/Spandex, Polyester,and Nylon. Theseadditional patientcontacting materials donot raise questions ofsafety and effectivenessas they are recognized ascommonly used medicalgrade materials with along history of safe use inlegally marketed medicaldevices.
Multi-PatientUse or Single-Patient UseWraps	Multi-Patient Use and Single-Patient Use Available	Multi-Patient Use and Single-Patient Use Available	Single-Patient Use	Therm-X (subject device)is identical to Therm-X(K231912).
Characteristic	Therm-X	Therm-X (K231912)	VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™) (K061866)	Comparison
	Subject Device	Primary Predicate	Secondary Predicate
Biocompatibility	Cytotoxicity testing per ISO10993-5	Cytotoxicity testing per ISO10993-5	No information available.	Therm-X (subject device)is identical to Therm-X(K231912).
	Sensitization testing per ISO10993-10	Sensitization testing per ISO10993-10
	Irritation testing per ISO10993-10	Irritation testing per ISO10993-10
Sterile/Non-Sterile	Non-sterile only	Non-sterile only	Sterile and non-sterile	Therm-X (subject device)is identical to Therm-X(K231912).
CleaningDisinfectionValidation ofLabeling	Yes - for Multi-patient usereusable wraps	Yes - for Multi-patient usereusable wraps	No information available.	Therm-X (subject device)is identical to Therm-X(K231912).
Human FactorsTesting toconfirmintended usershave foundinstructions forcleaning anddisinfectioneasy to use	Yes - for Multi-patient usereusable wraps	Yes - for Multi-patient usereusable wraps	No information available.	Therm-X (subject device)is identical to Therm-X(K231912).
Expected Life ofgarments	Based on frequency of useand continued functionalperformance	Based on frequency of useand continued functionalperformance	No information available.	Therm-X (subject device)is identical to Therm-X(K231912).
Characteristic	Therm-XSubject Device	Therm-X (K231912)Primary Predicate	VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™) (K061866)Secondary Predicate	Comparison
Validation ofrepeatedcleaning anddisinfection forreusablegarments	Yes - for Multi-patient usereusable wraps	Yes - for Multi-patient usereusable wraps	No information available.	Therm-X (subject device)is identical to Therm-X(K231912).

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

{12}------------------------------------------------

{13}------------------------------------------------

{14}------------------------------------------------

{15}------------------------------------------------

{16}------------------------------------------------

{17}------------------------------------------------

{18}------------------------------------------------

{19}------------------------------------------------

{20}------------------------------------------------

In this submission, Zenith has added additional indications for use for the treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI). Therm-X (Therm-X Home and Therm-X AT) with these additional indications is substantially equivalent to the identified predicate devices. Therm-X (K231912) and VascuTherm™ (K061866).

Testing

No additional testing has been performed for the additional indications for use. Therm-X (Therm-X Home and Therm-X AT) and Therm-X software were previously 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 (Therm-X Home and Therm-X AT) has been tested for performance to verify the proper operation of the system. Test and verification results indicate that Therm-X Home and Therm-X AT) 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 (Therm-X Home and Therm-X AT) garment patient contacting 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.

Cleaning, Disinfection & Shelf Life Testing:

{21}------------------------------------------------

Therm-X (Therm-X Home and Therm-X AT) 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 (Therm-X Home and Therm-X AT) 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 (Therm-X Home and Therm-X AT) 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 document requirements for Enhanced Documentation Level and Industry Standards:

. General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002
. Guidance for the Content of Premarket Submissions for Device Software Functions, June 14, 2023

Clinical Testing:

IRB approved studies have been performed to measure the lowest skin temperature the Therm-X (Therm-X Home and Therm-X AT) device can generate. As required by the FDA guidance for heating and cooling devices. Therm-X (Therm-X Home and Therm-X AT) 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 Home and Therm-X AT) 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 (Therm-X Home and Therm-X AT) is as safe and effective as the predicate devices.

Human Factors / Usability:

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 Home and Therm-X AT). Therm-X (Therm-X Home and Therm-X AT) 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 (Therm-X Home and Therm-X AT) as safely and as effectively as the predicate devices.

{22}------------------------------------------------

Substantial Equivalence Conclusion

In conclusion, the intended use for Therm-X (Therm-X Home and Therm-X AT) is substantially equivalent to that of the predicate devices. Additionally, the technological characteristics comparison demonstrates that Therm-X (Therm-X Home and Therm-X AT) is substantially equivalent to the predicates, assuring that Therm-X (Therm-X Home and Therm-X AT) is as safe and effective as the predicate devices.

Conclusion

The 510(k) Pre-market Notification for Therm-X (Therm-X Home and Therm-X AT) contains adequate information and data to determine that Therm-X (Therm-X Home and Therm-X AT) is as safe and effective as the legally marketed predicate devices.

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).