Therm-X (Therm-X Pro, Therm-X Pro Athlete, 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 Pro and Therm-X Pro Athlete systems also provide DVT therapy. Therm-X Pro Athlete are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow beart via lower extremity limb compression.

Therm-X (Therm-X Pro Athlete and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilities, 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 three configurations: Therm-X Pro Athlete and Therm-X AT.

Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. Therm-X Pro and Therm-X Pro Athlete systems also provide DVT prophylaxis therapy.

Therm-X consists of various reusable inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, or knee and DVT prophylactic treatment applied to the foot or calf. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with pneumatic compression. The Foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by Therm-X Pro and Therm-X Pro Athlete systems 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 Pro models provide an optional password protection feature that allows for a home user to use a stored cycle without being able to change it, 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.

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 system are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.

Therm-X is a class II medical device per FDA classification and has been previously cleared by the FDA under K181149. The Therm-X single-patient use garments under K181149 have been changed to multi-patient use garments through the use of a low-level disinfection process. Based on the guidance "Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015), the Therm-X garments are considered reusable medical devices initially supplied as non-sterile to the user and requiring the user to process (i.e., disinfect) the device for initial use, as well as to reprocess the device after each use. The qarments are considered non-critical devices in that they contact only intact skin and do no penetrate it. Therm-X garments may become contaminated with microorganisms and organic soil during patient care and such contamination may not be visible. To account for this contamination and to prevent patient harm when used with multiple patients, Zenith uses a low-level disinfection process for the Therm-X garments.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called Therm-X. This document aims to demonstrate that the Therm-X device (K190854) is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a formal table of explicit acceptance criteria with specific quantitative thresholds and corresponding reported device performance values. Instead, it relies on demonstrating substantial equivalence to predicate devices across various characteristics. The "Comparisons" column in the detailed comparison table (pages 6-7) serves as the primary mechanism for showing how Therm-X aligns with or justifies differences from the predicate devices. The acceptance criteria are implicitly that the device is "as safe and effective" as the predicate devices, and this is shown through direct comparisons and safety/performance testing.

However, we can infer some criteria and the device's performance based on the comparative table:

Characteristic/Implicit Acceptance Criteria	Reported Device Performance (Therm-X K190854)	Comparison/Justification
Indications for Use	Identical to Therm-X (K181149). Also provides DVT therapy and home use for certain models, similar to Med4 Elite™ and VascuTherm™.	"The indications for use of Therm-X (K190854) are identical to the primary predicate, Therm-X (K181149). The indications for use of Therm-X (K190854) are identical to the Med4 Elite™ with the only difference being that the Therm-X also provides DVT therapy and is being used in both professional and home settings. The indications for use of Therm-X (Therm-X Pro and Therm-X Pro Athlete) (K190854) are also identical to VascuTherm™ for DVT therapy with the only difference being that VascuTherm™ is not used in home settings." This demonstrates that the intended uses are equivalent or have justified extensions.
Intended Users	Health Care Professionals and lay users (under prescription).	"The intended users of Therm-X (K190854) are identical to the primary predicate, Therm-X (K181149). Therm-X (K190854) intended users are equivalent to the Med4 Elite™ and VascuTherm™ with the only difference being that the intended users for the Med4 Elite™ and VascuTherm do not include lay users in the home setting." This indicates a broadened user base, which normally requires further validation.
Number of Patients	One	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). Therm-X (K190854) is designed to treat one patient at a time and it is identical to the VascuTherm™."
Two Programmable Cycles	Available for all Therm-X Models	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149)." (Competitor products do not have this feature, but it's not deemed a dissimilarity that impacts substantial equivalence negatively).
Heat Therapy Temperature	Default: 105, 107, 110°F. Custom: 105°F – 110°F.	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). The Therm-X (K190854) Heat Therapy Temperature Range is equivalent to the Med4 Elite™."
Cold Therapy Temperature	Default: 34, 45, 55°F. Custom: 34 – 55°F.	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). The Therm-X (K190854) temperature range for Cold Therapy is equivalent to the Med4 Elite™. The Therm-X (K190854) maximum temperature range for Cold Therapy is equivalent to Med4Elite™."
Edema Pressure Levels	Low (20 mm Hg), Medium (45 mm Hg), High (70 mm Hg).	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). The edema pressure levels for Therm-X (K190854) are equivalent to the pressure levels for the Med4Elite™. Therm-X (K190854) like VascuTherm™ provides constant values for Low, Medium and High compression."
DVT Availability	Available for Therm-X Pro Athlete and Therm-X Pro Models.	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). Therm-X Pro Athlete and Therm-X Pro Models (K190854) are identical to VascuTherm™."
DVT Pressure	Calf: 50 - 70 mm Hg, Foot: 100 - 130 mm Hg.	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). Therm-X (K190854) has a higher range for Foot and Calf DVT pressures than the VascuTherm™ and has equivalent DVT pressure to reference predicate, IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System (K131327)." This is a key difference that needs to be justified.
Cycle Length (Heat, Cold, Compression)	Heat: 20, 30, or 40 minutes; Cold: 20, 30, or 40 minutes; Compression: 20, 30, or 40 minutes.	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). The Therm-X (K190854) Cycle length for Heat, Cold and Compression is equivalent to Med4 Elite™."
Contrast Therapy	Heat: 10 minutes, Cold: 10 minutes, Total treatment: 5 cycles for 100 minutes.	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). Therm-X (K190854) Contrast therapy function is equivalent to the Med4 Elite™."
DVT Cycle Length	No specified interval, can be stopped anytime.	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). Both Therm-X (K190854) and VascuTherm™ provide DVT. DVT Cycle Length for Therm-X (K190854) does not have a specified interval and provides clinicians the ability to prescribe DVT treatments for any length of minutes. At all times during treatment, the user has complete control and ability to stop the cycle and continue the cycle at any time." This difference is justified by user control.
Edema & DVT Compression Simultaneously	Available; Edema Compression must be combined with thermal therapy.	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). The ability of Therm-X (K190854) to provide Edema and DVT compression treatment at the same time is identical to Vascutherm™. The only difference is that for Therm-X (K190854), the Edema compression must be combined with cold, heat or contrast therapy. This difference does not affect the intended use or the safety and effectiveness of the device."
DVT Inflation/Deflation	Inflation: Up to 60 seconds; Deflation: Up to 30 seconds.	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). The DVT inflation and Deflation for Therm-X (K190854) is equivalent to VascuTherm™ with the difference that DVT inflation time is longer for Therm-X and DVT deflation is faster, which creates greater comfort and convenience for the user. This difference does not affect the intended use or the safety and effectiveness of the device." This difference is justified by comfort/convenience.
Power Down	Available	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149)."
Password Protection	Available for Therm-X AT and Pro Models	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149)."
Store Cycle Usage Data	Available	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149)."
Dimensions	15" L x 10.5" W x 9" H	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149)."
Weight	15 lbs when full of coolant	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). Therm-X (K190854) is equivalent to VascuTherm™."
Chilling Mechanism	Thermoelectric	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). The chilling mechanism for Therm-X (K190854) is identical to the VascuTherm™."
Heating Mechanism	Thermoelectric	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). The heating mechanism for Therm-X (K190854) is identical to the VascuTherm™."
Reservoir Fluid Capacity	650 mL	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). The Therm-X (K190854) fluid capacity is smaller than the Med4 Elite since it is designed for only one patient at a time. The Therm-X (K190854) fluid capacity is larger than VascuTherm. The Therm-X fluid capacity is designed to address the longest cycle of treatment without having to refill the coolant." Differences are justified by design and function.
User Interface	Touch Screen	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149), Med4 Elite™, and VascuTherm™."
Recommended Coolant	90% Distilled Water, 10% Isopropyl Alcohol	"The recommended coolant for Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149) and VascuTherm™. Each device is able to attain its desired performance requirements. There is no impact on the intended use or the safety and effectiveness of the device."
Electrical Safety Standards	ANSI/AAMI ES60601-1:2005/(R)2012, IEC 60601-1-2, Type BF, Class II	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). Therm-X (K190854) is equivalent to Med4 Elite™. Therm-X (K190854) complies with the same electrical safety standards for the US markets."
Operating Temperature	60°F - 80°F (16°C - 27°C)	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149) and VascuTherm™. Therm-X (K190854) is equivalent to Med4 Elite™."
Storage Temperature	33°F - 122°F (1°C to 50°C)	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). Therm-X (K190854) is equivalent to Med4 Elite™ and VascuTherm™."
Operating Humidity	Below 60% Non-condensing	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149) and VascuTherm™."
Storage Humidity	Below 60% Non-condensing	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149). Therm-X (K190854) is equivalent to the Med4 Elite™ and VascuTherm™. Therm-X (K190854) has a lower minimum and maximum limit for storage humidity. This difference does not affect the intended use or the safety and effectiveness of the device." This difference is justified.
Operating Atmospheric Pressure/Altitude	700 hPa – 1060 hPa (max. elevation 9,842 ft 6 in (3000 m))	"The Therm-X (K190854) Operating atmospheric pressure and altitude is identical to the primary predicate, Therm-X (K181149) and Med4Elite™."
Types of Garments	Various anatomical thermal garments for Back, Elbow, Shoulder, Knee, Ankle, DVT Garments: Calf and Foot	"The Therm-X (K190854) garments are identical to the primary predicate, Therm-X (K181149), garments. Therm-X (K190854) thermal garments are identical to the thermal wraps for Med4 Elite™, however, Med4 Elite™ have more garments available. Therm-X (K190854) DVT garments are identical to VascuTherm™."
Patient-Contacting Material	Thermal garment - 30 denier nylon; DVT garment - 200 denier nylon.	"The patient contacting materials for the Therm-X (K190854) garments are identical to the primary predicate, Therm-X (K181149). The patient contacting material for the Therm-X (K190854) DVT garment is identical to the VascuTherm™ thermal wrap. The patient contacting material for the Therm-X (K190854) thermal garment is equivalent to Med4 Elite™ and VascuTherm™ thermal wrap."
Biocompatibility	Cytotoxicity, Sensitization, Irritation testing per ISO 10993.	"The biocompatibility testing performed for Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149) and Med4 Elite™."
Sterile/Non-Sterile	Non-sterile only	"Therm-X (K190854) is identical to the primary predicate, Therm-X (K181149), Med4 Elite™, and VascuTherm™. The only difference is that VascuTherm provides sterile wraps in addition to non-sterile wraps. This difference does not affect the intended use or the safety and effectiveness of the device." This difference is justified.
Reusable Wraps	Yes	"Therm-X (K190854) is identical to the VascuTherm™ and Med4 Elite™." (This is a significant change from the earlier Therm-X K181149 predicate, which only had single-use wraps).
Cleaning/Disinfection Validation	Yes	"Therm-X (K190854) cleaning and disinfection validation of repeated cleaning and disinfection for reusable garments is equivalent to Med4 Elite™." This addresses the change to reusable wraps.
Human Factors Testing (Cleaning/Disinfection)	Yes	"Therm-X (K190854) Human Factors validation of repeated cleaning and disinfection for reusable garments is equivalent to Med4 Elite™." This addresses the change to reusable wraps and user instructions.
Expected Life of Reusable Garments	Based on frequency of use and continued functional performance.	"Therm-X (K190854) garments are equivalent to Med4 Elite™ garments."
Validation of repeated cleaning/disinfection	Yes	"Therm-X (K190854) validation of repeated cleaning and disinfection for reusable garments is equivalent to Med4 Elite™." This is a redundant entry in the table, but reinforces the point.

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 primarily focuses on demonstrating substantial equivalence to existing predicate devices through a comparison of technical characteristics and existing test data from a previous clearance (K181149) and new testing for features not present in the primary predicate (like reusable garments).

Sample Size for Test Set: Specific sample sizes for quantitative "test sets" for performance are not explicitly detailed for most aspects.
- For Performance Bench Testing (cleaning and disinfection validation): A "cleaning validation study was performed" and a "low-level disinfection validation study was performed." The exact number of units or cycles tested is not provided.
- For Durability accelerated aging test: "A durability accelerated aging test was performed." The number of garments or test conditions is not specified.
- For Human Factors / Usability testing: "The Human Factors Validation study demonstrated..." The number of participants in this study is not provided.
Data Provenance: Not explicitly stated in terms of country of origin or whether it's retrospective or prospective for the new studies (cleaning, disinfection, human factors). However, the predicate devices are legally marketed in interstate commerce, implying US market relevance for the comparison. The human factors study explicitly mentions "intended clinical users in the US market."

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)

This information is not provided in the document. The studies mentioned are focused on technical performance and user interaction with cleaning instructions rather than diagnostic accuracy or clinical outcomes requiring expert interpretation.

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

Adjudication methods are not applicable nor mentioned, as the studies are focused on technical validation (bench testing, human factors for cleaning) rather than expert consensus on diagnostic ground truth.

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

Such a study was not done. The device is a physical therapy device (cold, heat, contrast, compression, DVT therapy), not an AI-based diagnostic tool. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.

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

A standalone algorithm performance study was not done, as this device does not involve an AI algorithm for diagnosis or interpretation in the way "standalone" usually refers to in regulatory contexts for AI/ML devices. The "software-controlled" aspect refers to control logic for the physical therapies, not a diagnostic algorithm.

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

The concept of "ground truth" (in the medical diagnostic sense) is not directly applicable here. The "ground truth" for the various new tests performed would be:

Cleaning Validation: The measured reduction in soil/contaminants to an acceptable level.
Disinfection Validation: The measured reduction/destruction of microorganisms to an acceptable level, as per relevant standards for low-level disinfection.
Durability Testing: The continued functional performance of the garment after accelerated aging/reprocessing cycles.
Human Factors Validation: The successful demonstration by users of understanding and correctly performing the cleaning/disinfection procedures as outlined in the IFU.

These are established against pre-defined engineering and microbiological standards, rather than expert clinical consensus on a disease state.

8. The sample size for the training set

This information is not applicable/not provided. The device is not an AI/ML device that requires a training set in the typical sense. Any internal calibration or control system development would use functional testing data, not a "training set" of patient data.

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

This information is not applicable/not provided for the reasons stated above (not an AI/ML device with a training set).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 10, 2019

Zenith Technical Innovations % Rita King CEO MethodSense, Inc. 1 Copley Parkway, Suite 410 Morrisville, North Carolina 27560

Re: K190854

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: April 1, 2019 Received: April 2, 2019

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek Pinto, PhD Assistant Director Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K190854

Device Name Therm-X

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)

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Zenith Therm-X Abbreviated 510(k)

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510(k) Summary

Zenith Technical Innovations K190854

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: 919-313-3961Fax: 919-313-3979
Company Contact:	Greg BinversieChief Technical Officergregb@zti1.com
Date Prepared:	May 6, 2019

Device Name and Classification

Trade Name:	Therm-X
Common Name:	Heat and/or Cold and Compression Therapy
Classification:	Class II
Regulation Number:	21 CFR 890.5650, Powered inflatable tube massage
Classification Panel:	Physical Medicine
Product Code:	IRP, ILO, JOW

Predicate Devices

Predicate:	Primary	Secondary	Secondary
Trade Name:	Therm-X	Med4 Elite™	VascuTherm™ (and NanoTherm™ )
Common Name:	Heat and/or Coldand CompressionTherapy	Heat and/or Coldand CompressionTherapy	Intermittent, ExternalPneumaticCompression Device
510(k) Submitter / Holder:	Zenith TechnicalInnovations, LLC	CoolSystems, Inc.	ThermoTek, Inc.
510(k) Number:	K181149	K171685	K061866
Classification:	Class II	Class II	Class II
Regulation Number:	890.5650, Poweredinflatable tubemassager	890.5650, PoweredInflatable tubemassager	870.5800, Compressiblelimb sleeve
Classification Panel:	Physical Medicine	Physical Medicine	Cardiovascular
Product Code:	IRP, ILO, JOW	IRP, ILO	JOW, ILO

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Device Description

Indications for Use

The indications for use for the Therm-X system (K190854) have not changed since the device was cleared (K181149) and are as follows:

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post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therapy. Therm-X Pro and Therm-X Pro Athlete 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 Pro Athlete 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

Therm-X (including reusable garments) was assessed to determine the risks to health associated with the use of the device and evaluate risks related to safety, effectiveness, and usability. A risk analysis was conducted in accordance with ISO 14971:2007 and ISO14971:2012, Medical devices -- Application of risk management to medical devices. Several risks were assessed, including, but not limited to, device malfunction, allergic reaction, and improper use.

Substantial Equivalence

Therm-X (K190854) is substantially equivalent to Therm-X by Zenith (K181149), Med4 Elite by Coolsystems, Inc. (K171685) and VascuTherm by ThermoTek, Inc. (K061866), currently on the market.

Therm-X (K190854) has the same indications for use as Therm-X (K181149).

Therm-X (K190854), Med4 Elite™ and VascuTherm™ all provide reusable garments.

Therm-X (K190854), Therm-X (K181149), Med4 Elite™ and VascuTherm™ provide non-sterile garments.

There are no differences in the technology between Therm-X (K190854) and Therm-X (K181149). The primary differences of the technology of the Therm-X device with the predicate devices are discussed below.

The following table provides side by side comparison of Therm-X with the predicate devices.

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Detailed Comparison of the Subject and Predicate Devices

Characteristic	Therm-X(this submission - K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)Secondary Predicate	VascuTherm™(and NanoTherm™)(K061866)Secondary Predicate	Comparisons
Indications forUse	Therm-X (Therm-X Pro, Therm-X Pro Athlete, 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 Pro and Therm-X Pro Athlete systems also provide DVT	Therm-X (Therm-X Pro, Therm-X Pro Athlete, 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 Pro and Therm- X Pro Athlete systems also provide DVT therapy. Therm- X Pro and Therm-X Pro Athlete are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by	The Med4 Elite combines cold, heat, contrast and compression therapies.It is intended to treat post- surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated.It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold or contrast) are indicated.It is intended to be used by, or on the order of, licensed healthcare professionals in	Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.Reduction of edema associated with soft tissue injuries such as bums, postoperative edema, and ligament sprains.Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.Decrease the risk of deep venous thrombosis (DVT).Aids the blood flow back to the heart.	The indications for use of Therm-X (K190854) are identical to the primary predicate, Therm-X (K181149).The indications for use of Therm-X (K190854) are identical to the Med4 Elite™ with the only difference being that the Therm-X also provides DVT therapy and is being used in both professional and home settings.The indications for use of Therm-X (Therm-X Pro and Therm-X Pro Athlete) (K190854) are also identical to VascuTherm™ for DVT therapy with the only difference being that VascuTherm™ is not used in home settings.
Characteristic	Therm-X(this submission - K190854)	Therm-X (K181149)Primary predicate	Med4 Elite ™(K171685)Secondary Predicate	VascuTherm ™(and NanoTherm ™)(K061866)Secondary Predicate	Comparisons
therapy. Therm- X Pro and Therm-X Pro Athlete 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 Pro, Therm-X Pro Athlete 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	aiding blood flow back to the heart via lower extremity limb compression.Therm-X (Therm-X Pro, Therm-X Pro Athlete 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.	rehabilitation facilities, outpatient clinics, and athletic training 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.
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
Intended Users	Health CareProfessionals andlay users (underprescription)	Health CareProfessionals and layusers (underprescription)	Health CareProfessionals only(Prescription use)	Health CareProfessionals only(Prescription use)	The intended users ofTherm-X (K190854)are identical to theprimary predicate,Therm-X (K181149).Therm-X (K190854)intended users areequivalent to the Med4Elite™ andVascuTherm™ withthe only differencebeing that the intendedusers for the Med4Elite™ andVascuTherm do notinclude lay users in thehome setting.
Number ofPatients thatcan be treatedat one time	One	One	Two	One	Therm-X (K190854) isidentical to the primarypredicate, Therm-X(K181149).Therm-X (K190854) isdesigned to treat onepatient at a time and itis identical to theVascuTherm™.
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
TwoProgrammableCycles	Configuration oftwoprogrammablecycles areavailable for allTherm-X Models	Configuration of twoprogrammable cyclesare available for allTherm-X Models	Not Available	Not Available	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).
Heat Therapy	Default: 105, 107,110°FCustom: 105°F –110°F	Default: 105, 107, 110°FCustom: 105°F – 110°F	95 – 113°F (35 –45°C)	105°F	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).The Therm-X(K190854) HeatTherapy TemperatureRange is equivalentto the Med4 Elite™.
Cold Therapy	Default: 34, 45,55°FCustom: 34 –55°F	Default: 34, 45, 55°FCustom: 34 – 55°F	38 – 60°F (3.33– 15.56°C)	43 – 49°F	Therm-X (K190854) isidentical to the primarypredicate, Therm-X(K181149).The Therm-X(K190854) temperaturerange for Cold Therapyis equivalent to theMed4 Elite™. TheTherm-X (K190854)maximum temperaturerange for Cold Therapyis equivalent toMed4Elite™.
Characteristic	Therm-X(this submission - K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)Secondary Predicate	VascuTherm™(and NanoTherm™)(K061866)Secondary Predicate	Comparisons
Edema PressureLevels	Available in threelevelsLow (20 mm Hg)Medium (45 mm Hg)High (70 mm Hg)	Available in three levelsLow (20 mm Hg)Medium (45 mm Hg)High (70 mm Hg)	Available in fourlevelsLow (5 – 15 mm Hg)Medium – Low (5 – 30 mm Hg)Medium (5 – 50 mm Hg)High (5 – 75 mm Hg)	Available in threelevels (general)Low (15 mm Hg)Medium (30 mm Hg)High (50 mm Hg)	Therm-X (K190854) is identical to theprimary predicate, Therm-X (K181149).The edema pressure levels for Therm-X(K190854) are equivalent to thepressure levels for the Med4Elite™.Therm-X (K190854) like VascuTherm™provides constant values for Low,Medium and High compression.
DVT Only	Available for Therm-X ProAthlete and Therm-X ProModels.	Available for Therm-X Pro Athlete and Therm-X Pro Models.	Not Available	Available	Therm-X (K190854) is identical to theprimary predicate, Therm-X (K181149).Therm-X Pro Athlete and Therm-X ProModels (K190854) are identical toVascuTherm™
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
DVT Pressure	Calf: 50 - 70 mmHgFoot: 100 - 130mm Hg	Calf: 50 - 70 mm HgFoot: 100 – 130 mm Hg	Not available	Calf: 45 mm HgFoot: 100 mm Hg	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).Therm-X (K190854)has a higher range forFoot and Calf DVTpressures than theVascuTherm™ andhas equivalent DVTpressure toreference predicate,IC-BAP-DL BioArterialPlus Arterial BloodFlow EnhancementSystem (K131327).
Cycle Length(for Heat, ColdandCompression)	Heat: 20, 30, or 40minutesCold: 20, 30, or 40minutesCompression: 20,30, or 40 minutes	Heat: 20, 30, or 40minutesCold: 20, 30, or 40minutesCompression: 20, 30, or40 minutes	Heat: 5 to 30minutes, 15 minutesdefaultCold: 5 to 60minutes, 15 minutesdefaultCompression: 5 to60 minutes, 15minutes default	Heat: 30 minutes(presumed - notclearly stated in UserManual)Cold: 30 minutes(presumed not clearlystated in User Manual)Compression:Unkown	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).The Therm-X(K190854) Cyclelength for Heat, Coldand Compression isequivalent to Med4Elite™
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
ContrastTherapy (forHeat, Cold andCompression)	AvailableHeat: 10 minutesCold: 10 minutesTotal treatment: 5cycles ofalternating heatand coldtreatment for totalduration of 100minutes	AvailableHeat: 10 minutesCold: 10 minutesTotal treatment: 5cycles of alternatingheat and cold treatmentfor total duration of 100minutes	AvailableHeat: 1 - 10minutes, default 3minutesCold: 1 - 10minutes, default 3minutesTotal treatment:15 – 90 minutes,default 30minutes	AvailableHeat: 10 minutesCold: 20 minutes	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).Therm-X (K190854)Contrast therapyfunction is equivalentto the Med4 Elite™.
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
DVT CycleLength	No specified timeinterval. DVT canbe stopped at anytime by the user.	No specified timeinterval. DVT can bestopped at any time bythe user.	Not available	30 minutes(presumed not clearlystated in UserManual)	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).Both Therm-X(K190854) andVascuTherm™provide DVT. DVTCycle Length forTherm-X (K190854)does not have aspecified interval andprovides clinicians theability to prescribeDVT treatments forany length of minutes.At all times duringtreatment, the userhas complete controland ability to stop thecycle and continuethe cycle at any time.
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
EdemaCompressionand DVTCompression atthe same time	AvailableEdemaCompression(Low, Medium,High) must becombined withcold, heat orcontrast therapy.	AvailableEdema Compression(Low, Medium, High)must be combined withcold, heat or contrasttherapy.	DVT notavailable	Available with orwithout cold, heat orcontrast therapy	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).The ability of Therm-X(K190854) to provideEdema and DVTcompression treatmentat the same time isidentical toVascutherm™.The only difference isthat for Therm-X(K190854), the Edemacompression must becombined with cold,heat or contrasttherapy. Thisdifference does notaffect the intended useor the safety andeffectiveness of thedevice.
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
DVT Inflationand Deflation	DVT Inflation: Upto 60 secondsDVT Deflation:Up to 30 seconds	DVT Inflation: Up to 60secondsDVT Deflation: Up to 30seconds	Not available	Cycle timeInflation 20 seconds,Deflation 40 sec	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).The DVT inflation andDeflation for Therm-X(K190854) isequivalent toVascuTherm™ withthe difference that DVTinflation time is longerfor Therm-X and DVTdeflation is faster,which creates greatercomfort andconvenience for theuser. This differencedoes not affect theintended use or thesafety andeffectiveness of thedevice.
Power Down	Available	Available	Snooze functionAvailable	Not Available	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).
PasswordProtection	Available forTherm-X AT andTherm-X ProModels.	Available for Therm-XAT and Therm-X ProModels.	Not Available	Not Available	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
Store CycleUsage Data	Available	Available	Not Available	Not Available	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).
Dimensions	15" L x 10.5" W x9" H	15" L x 10.5" W x 9" H	32.5" L x 24.75"W x 43" H (83cm L x 63 cm Wx 109cm H)	9.88" H x 8.75" D x9.81" W (251 mm H x222 mm D x 249 mmW)	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).
Weight	15 lbs when full ofcoolant	15 lbs when full ofcoolant	172 lbs (78 kg)	10 lbs without fluidWeight Uknown whenfull of coolant	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).Therm-X (K190854)is equivalent toVascuTherm™.
ChillingMechanism	Thermoelectric	Thermoelectric	Vaporcompression	Thermoelectric	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).The chillingmechanism forTherm-X (K190854)is identical to theVascuTherm™.
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
HeatingMechanism	Thermoelectric	Thermoelectric	Resistanceheaters	Thermoelectric	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149).The heatingmechanism forTherm-X (K190854)is identical to theVascuTherm™.
Reservoir FluidCapacity	650 mL	650 mL	Heat reservoir: 1gallon (3.8 L)Cold reservoir: 1gallon (3.8 L)	8.5 fl oz (250 mL)	Therm-X (K190854) isidentical to the primarypredicate, Therm-X(K181149).The Therm-X(K190854) fluidcapacity is smallerthan the Med4 Elitesince it is designed foronly one patient at atime. The Therm-X(K190854) fluidcapacity is larger thanVascuTherm. TheTherm-X fluid capacityis designed to addressthe longest cycle oftreatment withouthaving to refill thecoolant.
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
User Interface	Touch Screen	Touch Screen	Touch Screen	Touch Screen	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149),Med4 Elite™, andVascuTherm™
RecommendedCoolant	90% DistilledWater, 10%Isopropyl Alcohol	90% Distilled Water,10% Isopropyl Alcohol	Distilled Water	90% Distilled Water,10% Isopropyl Alcohol	The recommendedcoolant for Therm-X(K190854) is identicalto the primarypredicate, Therm-X(K181149) andVascuTherm™. Eachdevice is able toattain its desiredperformancerequirements. Thereis no impact on theintended use or thesafety andeffectiveness of thedevice.
Electrical
Line Voltage	100-240 VAC	100-240 VAC	100-240 VAC	100-240 VAC	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149),Med4 Elite™, andVascuTherm™
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
Line Frequency	50/60 Hz	50/60 Hz	50/60 Hz	50/60 Hz	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149),Med4 Elite™, andVascuTherm™.
Electrical SafetyStandards	ANSI/AAMIES60601-1:2005/(R)2012Type BFClass IIIEC 60601-1-2	ANSI/AAMI ES60601-1:2005/(R)2012Type BFClass IIIEC 60601-1-2	ANSI/AAMIES60601-1:2005/(R)2012CAN/CSA C22.2No. 60601-1:2014Type B	IEC 60601-1UL 60601Type BClass IIIEC 60601-1-2	Therm-X (K190854) isidentical to the primarypredicate, Therm-X(K181149).Therm-X (K190854)is equivalent to Med4Elite™. Therm-X(K190854) complieswith the sameelectrical safetystandards for the USmarkets.
Environment
OperatingTemperature	60°F - 80°F(16°C - 27°C)	60°F - 80°F (16°C –27°C)	50°F - 90°F(10°C - 32°C)	60°F - 80°F (16°C –27°C)	Therm-X (K190854) isidentical to the primarypredicate, Therm-X(K181149) andVascuTherm™.Therm-X (K190854)is equivalent to Med4Elite™
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 EliteTM(K171685)SecondaryPredicate	VascuThermTM(andNanoThermTM)(K061866)SecondaryPredicate	Comparisons
StorageTemperature	33°F - 122°F(1°C to 50°C)	33°F - 122°F (1°C to50°C)	33°F - 122°F(1°C to 50°C)	32°F - 122°F (0°C to50°C)	Therm-X (K190854) isidentical to the primarypredicate, Therm-X(K181149).Therm-X (K190854)is equivalent to Med4EliteTM andVascuThermTM
OperatingHumidity	Below 60% Non-condensing	Below 60% Non-condensing	30 to 90% Non-condensing	Below 60% Non-condensing	Therm-X (K190854) isidentical to theprimary predicate,Therm-X (K181149)and VascuThermTM.
StorageHumidity	Below 60% Non-condensing	Below 60% Non-condensing	10 to 95% Non-condensing	10 to 95% Non-condensing	Therm-X (K190854) isidentical to the primarypredicate, Therm-X(K181149).Therm-X (K190854)is equivalent to theMed4 EliteTM andVascuThermTM.Therm-X (K190854)has a lower minimumand maximum limit forstorage humidity. Thisdifference does notaffect the intendeduse or the safety andeffectiveness of thedevice.
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
OperatingAtmosphericPressure andAltitude	700 hPa – 1060hPa (correspondsto a max.elevation of 9,842ft 6 in (3000 m))	700 hPa – 1060 hPa(corresponds to a max.elevation of 9,842 ft 6 in(3000 m))	700 hPa – 1060 hPa(corresponds toa max. elevationof 9,842 ft 6 in(3000 m))	Unknown	The Therm-X(K190854) Operatingatmospheric pressureand altitude isidentical to theprimary predicate,Therm-X (K181149)and Med4Elite™.
Accessories (Garments)
Types ofGarments	Variousanatomical thermalgarments for:Back, Elbow,Shoulder, Knee,Ankle,DVT Garments:Calf and Foot	Various anatomicalthermal garments for:Back, Elbow, Shoulder,Knee, Ankle,DVT Garments: Calfand Foot	Various anatomicalwraps in differentsizes for:Straight Knee,ArticulatedKnee, Elbow,Ankle, Shoulder,Back, Hip-Groin,Hand-Wrist,Flexed Elbow,Half-leg boot	Various anatomicalWraps in different sizesfor:Full leg, Kneesegmental & ROM,Half Arm, Foot/Ankle,Shoulder w/ brace,Back w/ & w/o brace,lower & upper Cervical,Hip, Wrist-Hand, Arm,Half leg knee, Head,Face,DVT Garments: Calfand Foot	The Therm-X(K190854) garmentsare identical to theprimary predicate,Therm-X (K181149),garments.Therm-X (K190854)thermal garments areidentical to the thermalwraps for Med4Elite™, however, Med4Elite™ have moregarments available.Therm-X (K190854)DVT garments areidentical toVascuTherm™
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
PatientContactingMaterial	Thermal garment -30 denier nylonDVT garment -200 denier nylon	Thermal garment – 30denier nylonDVT garment – 200denier nylon	70 Denier nylonSilcryn (hosecovering)	Thermal wrap - 200Denier Nylon OxfordDVT wrap – DuPontSoftesse® MedicalFabric (non-latex,non-woven)	The patientcontacting materialsfor the Therm-X(K190854) garmentsare identical to theprimary predicate,Therm-X (K181149)The patientcontacting materialfor the Therm-X(K190854) DVTgarment is identical tothe VascuTherm™thermal wrap. Thepatient contactingmaterial for theTherm-X (K190854)thermal garment isequivalent to Med4Elite™ andVascuTherm™ thermalwrap.
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 EliteTM(K171685)SecondaryPredicate	VascuThermTM(andNanoThermTM)(K061866)SecondaryPredicate	Comparisons
Biocompatibility	Cytotoxicity testingper ISO 10993-5Sensitizationtesting per ISO10993-10Irritation testingper ISO 10993-10	Cytotoxicity testing perISO 10993-5Sensitization testing perISO 10993-10Irritation testing per ISO10993-10	Cytotoxicity testingper ISO 10993-5Sensitization testingper ISO 10993-10Irritation testing perISO 10993-10	No information	The biocompatibilitytesting performed forTherm-X (K190854)is identical to theprimary predicate,Therm-X (K181149)and Med4 EliteTM.
Sterile/Non-Sterile	Non-sterile only	Non-sterile only	Non-sterile only	Sterile and non-sterile	Therm-X (K190854)is identical to theprimary predicate,Therm-X (K181149),Med4 EliteTM, andVascuThermTM. Theonly difference is thatVascuTherm providessterile wraps inaddition to non-sterilewraps. This differencedoes not affect theintended use or thesafety andeffectiveness of thedevice.
Reusable Wraps	Yes	No, single use wrapsonly	Yes	Yes	Therm-X (K190854) isidentical to theVascuThermTM andMed4 EliteTM.
Characteristic	Therm-X(this submission- K190854)	Therm-X (K181149)Primary predicate	Med4 Elite™(K171685)SecondaryPredicate	VascuTherm™(andNanoTherm™)(K061866)SecondaryPredicate	Comparisons
CleaningDisinfectionvalidation oflabeling	Yes	N/A	Yes	Unknown	Therm-X (K190854)cleaning anddisinfection validationof repeated cleaningand disinfection forreusable garments isequivalent to Med4Elite™
Human FactorsTesting toconfirmintended usershave foundinstructions forcleaning anddisinfectioneasy to use	Yes	N/A	Yes	Unknown	Therm-X (K190854)Human Factorsvalidation of repeatedcleaning anddisinfection forreusable garments isequivalent to Med4Elite™
Expected Life ofreusablegarments	Based onfrequency of useand continuedfunctionalperformance	N/A	Based onfrequency of useand continuedfunctionalperformance	Unknown	Therm-X (K190854)garments areequivalent to Med4Elite™ garments.
Validation ofrepeatedcleaning anddisinfection forreusablegarments	Yes	N/A	Yes	Unknown	Therm-X (K190854)validation of repeatedcleaning anddisinfection forreusable garments isequivalent to Med4Elite™

Zenith Therm-X Abbreviated 510(k) - K190854

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Testing

Therm-X and Therm-X software (K190854) have been verified and validated under K181149 in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the type of tests performed:

Electromagnetic Compatibility / Electrical Safety:
. Biocompatibility
Software Validation .
Performance Bench Testing
. Clinical Testing
Human Factors / Usability .

Therm-X Garments and reprocessing instructions have been verified and validated in accordance with "Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015) and documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the types of tests performed:

Performance - Bench:

The cleaning and disinfection processes used to reprocess Therm-X (K190854) have been validated. A cleaning validation study was performed that the cleaning process is adequate to remove soil and contaminants. Similarly, a low-level disinfection validation study was performed and confirmed that the disinfection process is adequate to destroy pathogenic or other kinds of microorganisms by chemical means.

A durability accelerated aging test was performed and 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.

Human Factors / Usability:

Human Factors Validation Testing was performed following the Guidance for Industry and Food and Drug Administration Staff "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016). The Human Factors Validation study demonstrated that the cleaning and disinfection processes and instructions within each Therm-X garment Instructions for Use (IFU) have been found to be safe and effective for the intended clinical users in the US market and for the intended uses and use environments of the Therm-X system (K190854). The study showed that the IFU for each Therm-X garment are able to be understood as it relates to the cleaning and disinfection processes and that users are able to adequately clean and disinfect the garments following the processes outlined in the IFUs.

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Substantial Equivalence Conclusions

In conclusion, the indications for use of Therm-X (K190854) are identical to Therm-X (K181149). The technological characteristics and testing demonstrate that Therm-X is substantially equivalent to the predicate devices (Therm-X (K181149), Med4 Elite™ and VascuTherm™), assuring that Therm-X (K190854) is as safe and effective as the predicate devices.

Conclusion

The abbreviated 510(k) Pre-market Notification for Therm-X (K190854) contains adequate information and data to determine that Therm-X is as safe and effective as the legally marketed predicate devices.

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).