Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software-controlled device for thermal and compression therapy with a touch screen interface for user control. There is no mention of AI, ML, or any features that suggest autonomous learning, pattern recognition, or data-driven decision making beyond pre-programmed therapy protocols.

Therapeutic

Yes
The device is described as combining cold, heat, contrast, and compression therapy intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain, and to treat post-surgical medical and/or surgical conditions for which localized thermal therapy is indicated. It also provides DVT therapy to reduce the risk of deep venous thrombosis. These are all therapeutic applications.

Diagnostic

No

Explanation: The device is described as a multimodality therapy device providing cold, heat, contrast, and compression therapy to reduce edema, swelling, and pain, and to aid in DVT prophylaxis. It does not mention any function for diagnosing medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "AC powered, software-controlled multimodality device" and details various hardware components like a coolant reservoir, pumps, fans, circuit board, and reusable/single-use garments. While software controls the device, it is not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Therm-X device is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that Therm-X is for treating post-surgical and acute injuries, reducing edema, swelling, and pain, and providing DVT therapy. These are all therapeutic applications performed on the patient's body.
Device Description: The device description details a system that applies thermal therapy and compression externally to the body using wraps and garments.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information.

IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or other conditions. The Therm-X device's function is entirely focused on applying physical therapies directly to the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

Product codes (comma separated list FDA assigned to the subject device)

IRP, ILO, JOW

Device Description

Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.

Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.

Therm-X consists of various reusable inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, hip, or knee and DVT prophylactic treatment applied to the foot or calf. Multipatient 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 shoulder, 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 pneumatic compression. The Foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.

Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings.

Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

back, elbow, shoulder, ankle, hip, or knee (for thermal treatment); foot or calf (for DVT prophylactic treatment)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Electromagnetic Compatibility / Electrical Safety: Testing performed in accordance with IEC 60601-1 and IEC 60601-1-2. Verification results indicated that the device is safe.
Biocompatibility: The Therm-X garment patient contact materials were verified in accordance with ISO 10993-1: 2009, ISO 10993-5: 2009, and ISO 10993-10: 2010. Verification results indicated that the materials comply with the standard.
Cleaning, Disinfection & Shelf Life Testing: Cleaning and disinfection instructions for multi-patient use garments have been validated. Durability accelerated aging test confirmed safe use and disinfection for the garment's life without deterioration.
Software Validation: Software validation testing confirmed that Therm-X software meets its performance requirements and specifications. Validation completed according to FDA Guidance documents and Industry Standards. Software is a Moderate Level of Concern.
Performance – Bench: Performance testing verified proper operation of the system. Test and verification results indicate that Therm-X conforms to its predetermined specifications and operates within safety limits.
Clinical Testing: IRB approved studies performed to measure the lowest skin temperature. Tested for worst case conditions on healthy volunteer human subjects. A minimum skin temperature of 40°F was measured and included in product labeling. Results concluded temperature limits do not cause thermal damage and the device is safe and effective.
Human Factors / Usability: Assessments performed in a simulated use environment. Therm-X found to be adequately safe and effective for intended users, uses and environments, operating as safely and effectively as predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K190854, K181149

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K192114, K171685

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.

February 28, 2020

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

Re: K193550

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: December 19, 2019 Received: December 20, 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Vivek Pinto, Ph.D. Director 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

2

Indications for Use

510(k) Number (if known)

K193550

Device Name

Therm-X

Indications for Use (Describe)

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

Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings.

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

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

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

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3

510(k) Summary

Zenith Technical Innovations K193550

| Submitter: | Zenith Technical Innovations, LLC. (Zenith)
1396 St. Paul Ave.
Gurnee, IL 60031
Phone: (847) 672-7481
Fax: (847) 672-8721 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961
Fax: 919-313-3979 |
| Company Contact: | Greg Binversie
Chief Technical Officer |
| Date Prepared: | December 19, 2019 |

Device Name and Classification

Trade Name:	Therm-X
Common Name:	Massager, Powered Inflatable Tube
Classification:	Class II
Regulation Number:	21 CFR 890.5650, Powered inflatable tube massager
Classification Panel:	Physical Medicine
Product Code:	IRP, ILO, JOW

Predicate Devices

Predicate:	Primary	Secondary	Reference
Trade Name:	Therm-X	Therm-X	Game Ready GRPro
2.1 System
Common
Name:	Heat and/or Cold and
Compression Therapy	Heat and/or Cold and
Compression Therapy	Powered Inflatable
Tube Massager
510(k)
Submitter /
Holder:	Zenith Technical
Innovations, LLC.
(Zenith)	Zenith Technical
Innovations, LLC.
(Zenith)	Cool Systems, Inc.
(dba Game Ready)
510(k) Number:	K190854	K181149	K192114
Classification:	Class II	Class II	Class II
Regulation
Number:	890.5650, Powered
Inflatable tube
massager	890.5650, Powered
Inflatable tube
massager	890.5650, Powered
Inflatable tube
massager
Classification
Panel:	Physical Medicine	Physical Medicine	Physical Medicine
Product Code:	IRP, ILO, JOW	IRP, ILO, JOW	IRP, ILO

4

Device Description

Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.

Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.

Therm-X consists of various reusable inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, hip, or knee and DVT prophylactic treatment applied to the foot or calf. Multipatient 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 shoulder, 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 pneumatic compression. The Foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.

Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings.

Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.

Indications for Use

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

Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

5

Risk Analysis Method

The Therm-X was assessed to determine the risks to health associated with the device modifications and evaluate risks related to safety, effectiveness, and usability. A risk analysis was conducted in accordance with ISO 14971:2007 and ISO14971:2012, Medical devices --Application of risk management to medical devices. All risks have been found acceptable.

Substantial Equivalence

Therm-X is substantially equivalent to Therm-X (K181149, K190854) by Zenith Technical Innovations, LLC. (Zenith) and Game Ready GRPro 2.1 System (K192114) by Cool Systems, Inc. (dba Game Ready) currently on the market.

Therm-X has the same intended use and indications for use as the predicate devices and uses equivalent overall design and operating principals as the predicate devices.

The table below provides a detailed comparison of Therm-X to the predicate devices.

6

| Characteristic | Therm-X

Subject Device | Therm-X (K190854)

Primary Predicate | Therm-X (K181149)

Secondary Predicate | GameReady®
GRPro 2.1 System
(K192114)

Reference Device | Comparison |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are | 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- | 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- | Game Ready® GRPro 2.1 System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings. | The indications for use of the Therm-X (subject device) are identical to the Therm-X (K190854) with the only difference being that 1 model name has changed, and 1 model has been discontinued. |
| Characteristic | Therm-X
Subject Device | Therm-X (K190854)
Primary Predicate | Therm-X (K181149)
Secondary
Predicate | GameReady®
GRPro 2.1 System
(K192114)
Reference Device | Comparison |
| | 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. | 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. | 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
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
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. | 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. | | |
| Characteristic | Therm-X
Subject Device | Therm-X (K190854)
Primary Predicate | Therm-X (K181149)
Secondary
Predicate | GameReady®
GRPro 2.1 System
(K192114)
Reference Device | Comparison |
| 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) | Healthcare
professionals,
athletic trainers, lay
users under the
direction of a
healthcare
professional | Therm-X (subject
device) is identical
to Therm-X
(K190854). |
| Number of
Patients that can
be treated at one
time | One | One | One | One | Therm-X (subject
device) is identical
to Therm-X
(K190854). |
| Two
Programmable
Cycles | Configuration of two
programmable cycles
are available for all
Therm-X Models | Configuration of two
programmable cycles
are available for all
Therm-X Models | Configuration of two
programmable cycles
are available for all
Therm-X Models | Not publicly
available. | Therm-X (subject
device) is identical
to Therm-X
(K190854). |
| Functions | | | | | |
| Continuous
Treatment Cycle | Available on Therm-
X Home | Not Available | Not Available | Not publicly available | Therm-X (subject
device) is equivalent
to GameReady®
GRPro 2.1 System
(K192114). |

Detailed Comparison of the Subject and Predicate Device

7

8

9

| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®
GRPro 2.1 System
(K192114) | Comparison |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate | Secondary
Predicate | Reference Device | |
| Heat Therapy | Default: 105°F,
107°F, 110°F
Custom: 105°F –
110°F
Default, continuous:
105°F, 107°F
Custom, continuous:
105°F – 107°F | Default: 105°F,
107°F, 110°F
Custom: 105°F –
110°F | Default: 105°F,
107°F, 110°F
Custom: 105°F –
110°F | N/A | Therm-X (subject
device) is equivalent
to Therm-X
(K190854).
The only difference
is that the heat
therapy
temperatures are
more limited for
continuous
treatment, but fall
within the range of
what has been
previously cleared. |

10

| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®
GRPro 2.1 System
(K192114) | Comparison |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate | Secondary
Predicate | Reference Device | |
| Cold Therapy | Default: 34°F, 45°F,
55°F
Custom: 34°F - 55°F
Default, continuous:
40°F, 45°F, 50°F
Custom, continuous:
40°F - 50°F | Default: 34°F, 45°F,
55°F
Custom: 34°F - 55°F | Default: 34°F, 45°F,
55°F
Custom: 34°F - 55°F | 34 - 50°F | Therm-X (subject
device) is equivalent
to Therm-X
(K190854).
The only difference
is that the cold
therapy
temperatures are
more limited for
continuous
treatment, but fall
within the range of
what has been
previously cleared. |
| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®
GRPro 2.1 System
(K192114) | Comparison |
| | Subject Device | Primary Predicate | Secondary
Predicate | Reference Device | |
| Edema Pressure
Levels | Available in four
levels:
Lite (5 mm Hg)
Low (20 mm Hg)
Medium (45 mm Hg)
High (70 mm Hg)
For continuous
treatment, available
in three levels:
Low (20 mm Hg)
Medium (45 mm Hg)
High (70 mm Hg) | Available in three
levels:
Low (20 mm Hg)
Medium (45 mm Hg)
High (70 mm Hg) | Available in three
levels:
Low (20 mm Hg)
Medium (45 mm Hg)
High (70 mm Hg) | Available in three
levels:
Low (5-15 mm Hg)
Medium (5-50 mm
Hg)
High (5-75 mm Hg) | Therm-X (subject
device) is equivalent
to Therm-X
(K190854).
The only difference
is that the pressure
levels are more
limited for
continuous
treatment and an
additional
compression level
(lite) has been
included. |
| Static or
Intermittent
Pressure | Both | Static Pressure Only | Static Pressure Only | Intermittent Pressure
available | Therm-X (subject
device) is equivalent
to Therm-X
(K190854) and
GameReady®
GRPro 2.1 System
(K192114). |
| DVT Only | Available for Therm-
X Home Model | Available for Therm-
X Pro Athlete and
Therm-X Pro Models | Available for Therm-
X Pro Athlete and
Therm-X Pro Models | N/A | Therm-X (subject
device) is equivalent
to Therm-X
(K190854). |
| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®
GRPro 2.1 System
(K192114) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | Reference Device | |
| DVT Pressure | Calf: 50 - 70 mmHg
Foot: 90 - 130
mmHg | Calf: 50 - 70 mmHg
Foot: 100 - 130
mmHg | Calf: 50 - 70 mmHg
Foot: 100 – 130
mmHg | N/A | Therm-X (subject
device) is equivalent
to Therm-X
(K190854). |
| Cycle Length
(for Heat, Cold,
and
Compression) | Default: 10 or 20
minutes
Custom: 3 – 40
minutes
Continuous: 10 - 40
minutes active, 30-60
minutes rest | Heat: 20, 30, or 40
minutes
Cold: 20, 30, or 40
minutes
Compression: 20, 30,
or 40 minutes | Heat: 20, 30, or 40
minutes
Cold: 20, 30, or 40
minutes
Compression: 20, 30,
or 40 minutes | 15 minutes default,
increasing or
decreasing in 5-
minute increments to
a max of 90 min or a
min of 5 min. | Therm-X (subject
device) is equivalent
to Therm-X
(K190854).
The only difference
is that a custom and
continuous cycle
length is available
for the Therm-X
Home model.
Verification and
validation testing
has been performed
to test the
continuous
treatment cycle.
Note: K192114 does
not offer heat
therapy. |
| Characteristic | Therm-X
Subject Device | Therm-X (K190854)
Primary Predicate | Therm-X (K181149)
Secondary Predicate | GameReady®
GRPro 2.1 System
(K192114)
Reference Device | Comparison |
| Contrast
Therapy | Available for Therm-
X AT Model only

Heat: 105°F

Cold: 38°F | Available for all
Therm-X Models

Heat: 105°F

Cold: 38°F | Available for all
Therm-X Models

Heat: 105°F

Cold: 38°F | N/A | Therm-X (subject
device) is equivalent
to Therm-X
(K190854).

The only difference
is that the contrast
therapy is only
available for Therm-
X AT Model and not
for Therm-X Home
Model. |
| Cycle Length
(for Contrast
Therapy) | Heat: 3-10 minutes

Cold: 3-10 minutes

Total treatment: 6-60
minutes | Heat: 10 minutes

Cold: 10 minutes

Total treatment: 5
cycles of alternating
heat and cold
treatment for total
duration of 100
minutes | Heat: 10 minutes

Cold: 10 minutes

Edema Compression
(Lite, Low, Medium, High) must be
combined with cold,
heat, or contrast
therapy | Available

Edema Compression
(Low, Medium, High)
must be combined
with cold, heat, or
contrast therapy | Available

Edema Compression
(Low, Medium, High)
must be combined
with cold, heat, or
contrast therapy | N/A | Therm-X (subject
device) is equivalent
to Therm-X
(K190854).

Note: K192114 does
not provide DVT. |
| DVT Inflation
and Deflation | DVT Inflation: Up to
120 seconds

DVT Deflation: Up to
30 seconds | DVT Inflation: Up to
60 seconds

CAN/CSA C22.2 No.
60601-1:2014
Type B

IEC 60601-1-2 | ANSI/AAMI
ES60601-
1:2005/(R)2012

CAN/CSA C22.2 No.
60601-1:2014
Type B

IEC 60601-1-2 | ANSI/AAMI
ES60601-
1:2005/(R)2012

CAN/CSA C22.2 No.
60601-1:2014
Type B

IEC 60601-1-2 | ANSI/AAMI ES60601-
1:2005/(R) 2012 &
A1:2012, C1:2009 (R)
2012, A2:2010/(R)
2012- Part 1

CAN/CSA - C22.2 No.
60601- 1:14 Part 1

IEC 60601-1-6:2010 +
A1:2013

IEC 60601-1-11:2015

IEC 60601 - 1-2, Ed.
4.0: 2014 BS EN
60601-1-2:2015 IEC
62366:2007 +
A1:2014

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| Characteristic | Therm-X
Subject Device | Therm-X (K190854)
Primary Predicate | Therm-X (K181149)
Secondary
Predicate | GameReady®
GRPro 2.1 System
(K192114)
Reference Device | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Accessories (Garments) | | | | | |
| Types of
Garments | Various anatomical
thermal garments for:
Back, Elbow,
Shoulder, Knee,
Ankle, Hip.
DVT Garments: Calf
and Foot | Various anatomical
thermal garments for:
Back, Elbow,
Shoulder, Knee,
Ankle.
DVT Garments: Calf
and Foot | Various anatomical
thermal garments for:
Back, Elbow,
Shoulder, Knee,
Ankle.
DVT Garments: Calf
and Foot | Various anatomical
wraps in different
sizes for: Straight
Knee, Straight
Elbow, Ankle,
Shoulder, Back,
Traumatic Amputee,
Neck, Lower Limb,
Full Leg Boot and
Chest | Therm-X (subject
device) is equivalent
to Therm-X
(K190854). The only
difference is that
one additional type
of garment for the
hip is available.
This new anatomical
garment type is
substantially
equivalent to
another reference
device, Med4 Elite™
(K171685), for cold,
heat, and contrast
therapy of the hip. |
| Characteristic | Therm-X
Subject Device | Therm-X (K190854)
Primary Predicate | Therm-X (K181149)
Secondary
Predicate | GameReady®
GRPro 2.1 System
(K192114)
Reference Device | Comparison |
| Patient
Contacting
Material | Thermal garment,
reusable (multi-
patient) - 30 denier
nylon coated in
urethane
Thermal garment,
disposable (single-
patient) - 200 denier
nylon coated in
urethane
DVT – 200 denier
nylon coated in
urethane | Thermal garment
(multi-patient) – 30
denier nylon coated
in urethane
DVT – 200 denier
nylon coated in
urethane | Thermal garment
(multi-patient) – 30
denier nylon coated
in urethane
DVT – 200 denier
nylon coated in
urethane | 70 denier nylon &
polyester | Therm-X (subject
device) is identical
to Therm-X
(K190854). |
| Multi-Patient
Use or Single-
Patient Use
Wraps | Multi-Patient Use and
Single-Patient Use
Available | Multi-Patient Use | Multi-Patient Use | Not publicly available | Therm-X (subject
device) is equivalent
to Therm-X
(K190854). The only
difference is that
Therm-X (subject
device) now has
both multi-patient
and single-patient
use garments
available. |
| Characteristic | Therm-X
Subject Device | Therm-X (K190854)
Primary Predicate | Therm-X (K181149)
Secondary Predicate | GameReady®
GRPro 2.1 System
(K192114)
Reference Device | Comparison |
| Biocompatibility | Cytotoxicity testing
per ISO 10993-5 | Cytotoxicity testing
per ISO 10993-5 | Cytotoxicity testing
per ISO 10993-5 | Primary patient contacting
components verified
as acceptable
according to ISO 10993-1 using
cytotoxicity, primary
irritation and skin
sensitization.
Additional
elastomeric materials
were
verified as
acceptable according
to ISO 10993-1 using
acute systematic
toxicity, primary
irritation and skin
sensitization. | Therm-X (subject
device) is identical
to Therm-X
(K190854). |
| | Sensitization testing
per ISO 10993-10 | Sensitization testing
per ISO 10993-10 | Sensitization testing
per ISO 10993-10 | | |
| | Irritation testing per
ISO 10993-10 | Irritation testing per
ISO 10993-10 | Irritation testing per
ISO 10993-10 | | |
| Sterile/Non-Sterile | Non-sterile only | Non-sterile only | Non-sterile only | Non-sterile only | Therm-X (subject
device) is identical
to Therm-X
(K190854). |
| Cleaning
Disinfection
Validation of
Labeling | Yes - for Multi-
Patient use reusable
wraps | Yes - for Multi-
Patient use reusable
wraps | N/A | Yes | Therm-X (subject
device) is identical
to Therm-X
(K190854). |
| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®
GRPro 2.1 System
(K192114) | Comparison |
| | Subject Device | Primary Predicate | Secondary
Predicate | Reference Device | |
| Human Factors
Testing to
confirm
intended users
have found
instructions for
cleaning and
disinfection
easy to use | Yes - for Multi-
Patient use reusable
wraps | Yes - for Multi-
Patient use reusable
wraps | N/A | Not publicly available | Therm-X (subject
device) is identical
to Therm-X
(K190854). |
| Expected Life of
garments | Based on frequency
of use and continued
functional
performance | Based on frequency
of use and continued
functional
performance | N/A | Based on frequency
of use | Therm-X (subject
device) is identical
to Therm-X
(K190854). |
| Validation of
repeated
cleaning and
disinfection for
reusable
garments | Yes - for Multi-
Patient use reusable
wraps | Yes - for Multi-
Patient use reusable
wraps | N/A | Yes | Therm-X (subject
device) is identical
to Therm-X
(K190854). |

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In this submission. Zenith has added a new Therm-X carment anatomical type – hip. This new anatomical garment type is substantially equivalent to another reference device, Med4 Elite™ (K171685), for cold, heat, and contrast therapy of the hip.

Testing

Therm-X and Therm-X software were verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the type of tests performed.

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.

Biocompatibility:

The Therm-X garment patient contact materials were verified in accordance with the following standards:

. ISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 10993-5: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro . cvtotoxicitv
. 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

Therm-X garments are intended for use over intact skin or sterile dressings only. They are provided non-sterile and not intended to be user sterilized. Cleaning and disinfection instructions are provided for multi-patient use garments within each garment IFU. Such cleaning and disinfection instructions have been validated.

The Therm-X System components and garments do not have a definitive shelf life based on packaging or time. Expected life is based on frequency of use and continued functional performance. Durability accelerated aging test has been performed and has confirmed the safe use and disinfection of a Therm-X garment for the duration of the garment's life without evidence of deterioration of the garment due to cleaning and/or disinfection.

23

Software Validation:

Zenith has conducted software validation testing on the Therm-X software and confirmed that Therm-X software meets its performance requirements and specifications. Software Validation has been completed according to an established Validation procedure and FDA Guidance documents and Industry Standards:

General Principles of Software Validation; Final Guidance for Industry and FDA Staff, ● January 11, 2002
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005

The Software is a Moderate Level of Concern as per FDA quidance. All required items related to software as required by FDA guidance have been included in this submission.

Performance – Bench:

Therm-X has been tested for performance to verify the proper operation of the system. Test and verification results indicate that Therm-X conforms to its predetermined specifications and operates within safety limits.

Clinical Testing:

IRB approved studies have been performed to measure the lowest skin temperature the Therm-X device can generate. As required by the FDA guidance for heating and cooling devices, Therm-X was tested for worst case conditions on healthy volunteer human subjects who provided informed consent. A minimum skin temperature of 40°F was measured and has been included in the product labeling.

Based on these results, it has been concluded that the temperature limits of Therm-X do not cause any thermal damage to the skin. The studies demonstrated that there are no safety issues created by the device and that Therm-X is as safe and effective as the predicate devices.

Human Factors / Usability:

Human Factors / Usability assessments have been performed in a simulated use environment to optimize the device design and support the safe use of Therm-X. Therm-X has been found to be adequately safe and effective for the intended users, its intended uses and use environments. The results demonstrated that users can operate Therm-X as safely and as effectively as the predicate devices.

Substantial Equivalence Conclusions

In conclusion, the intended use for Therm-X is substantially equivalent to that of the predicate devices. The technological characteristics comparison demonstrates that Therm-X is equivalent to the predicate devices, and the testing shows that Therm-X is substantially equivalent to the predicate devices and assures that Therm-X is as safe and effective as the predicate devices.

Conclusion

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