Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software-controlled device with a touch screen interface for managing therapy settings. It mentions stored cycles and password protection but does not include any language related to AI, ML, or adaptive algorithms based on data input or learning. The performance studies focus on temperature limits, safety, effectiveness compared to predicates, and usability, not on the performance of any AI/ML component.

Therapeutic

Yes
The device is intended to treat medical conditions such as post-surgical and acute injuries, reduce edema, swelling, and pain, as well as reduce the risk of deep venous thrombosis (DVT), which are all therapeutic indications.

Diagnostic

No
Explanation: The device is intended for therapeutic purposes (cold, heat, contrast, and compression therapy, DVT prophylaxis) to treat conditions and reduce symptoms, not to diagnose them.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "AC powered, software-controlled multimodality device" and details physical components like a coolant reservoir, pumps, fans, circuit board, and an enclosure made of plastic and metal. It also mentions single-patient use inflatable wraps. This indicates it is a hardware device with integrated software control, not a software-only medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Therm-X Function: Therm-X is a therapeutic device that applies physical modalities (cold, heat, compression) directly to the body's surface. It does not analyze any biological specimens.
Intended Use: The intended use clearly states it's for treating post-surgical and acute injuries, reducing edema, swelling, and pain, and providing DVT therapy. These are all therapeutic applications, not diagnostic ones.
Device Description: The description details a system that circulates coolant and applies pneumatic compression through external wraps. This aligns with a therapeutic device, not an IVD.

Therefore, Therm-X falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 intent 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 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.

Product codes

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 of a licensed healthcare professional. The device is available in three configurations: Therm-X Pro, 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 single-patient use 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 cvcle 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.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Used by, or on the order of, 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. Results indicated the device is safe.
Biocompatibility Testing: Performed on garment patient contact materials in accordance with ISO 10993-1, ISO 10993-5, and ISO 10993-10. Results indicated materials comply with the standard.
Software Validation: Conducted on Therm-X software, confirming it met performance requirements and specifications. Validation completed according to 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). Software is a Moderate Level of Concern.
Performance - Bench: Tested to verify proper operation of the system. Results indicated Therm-X conforms to predetermined specifications and is adequately safe and effective.
Clinical Testing: Skin temperature testing performed for: Maximum time limit at the highest temperature setting, Maximum time limit at the lowest temperature setting, Contrast therapy at the default time limit and temperature settings. Results concluded that temperature limits do not cause thermal damage to the skin, and the device is as safe and effective as predicate devices.
Human Factors / Usability: Assessments performed in a simulated use environment. Results demonstrated users can operate Therm-X safely and effectively.

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

Not Found

Predicate Device(s)

K171685, K061866, K072620

Reference Device(s)

K131327

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized human figure. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text.

August 3, 2018

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

Re: K181149

Trade/Device Name: Therm-X Pro, Therm-X Pro Athlete, Therm-X AT Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP. ILO. JOW Dated: June 7, 2018 Received: June 7, 2018

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/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 medical devices and radiation-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.

Michael J. Hoffmann -S

for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K181149

Device Name Therm-X Pro, Therm-X Pro Athlete, Therm-X AT

Indications for Use (Describe)

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 intent 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 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.

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 K181149

This 510(k) Summary is in conformance with 21 CFR 807.92

| 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 Technology Officer |
| Date Prepared: | June 7, 2018 |

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
Trade Name:	Med4 Elite™	VascuTherm™
(and
NanoTherm™)	GameReady®
Classic System
(GR 2)	IC-BAP-DL
BioArterial
Plus Aterial
Blood Flow
Enhancement
System
Common
Name:	Heat and/or
Cold and
Compression
Therapy	Intermittent,
External
Pneumatic
Compression
Device	Cold/compression
therapy system	BAP-DL
BioArterial
Plus Arterial
Blood Flow
Intermittent
Circulator
510(k)
Submitter /
Holder:	CoolSystems,
Inc.	ThermoTek,
Inc.	CoolSystems,
Inc.	Bio
Compression
Systems, Inc

4

| 510(k)

Number:	K171685	K061866	K072620	K131327
Classification:	Class II	Class II	Class II	Class II
Regulation
Number:	890.5650,
Powered
Inflatable
tube
massager	870.5800,
Compressible
limb sleeve	890.5650,
Powered
inflatable tube
massager	870.5800,
Compressible
limb sleeve
Classification
Panel:	Physical
Medicine	Cardiovascular	Physical Medicine	Cardiovascular
Product
Code:	IRP, ILO	JOW, ILO	IRP, ILO	JOW

5

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 of a licensed healthcare professional. The device is available in three configurations: Therm-X Pro, 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 single-patient use 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 cvcle 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.

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

Indications for Use

Therm-X (Therm-X 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 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.

6

Risk Analysis Method

The Therm-X was assessed to determine the risks to health associated with the use of the device and evaluated 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, infection and improper use.

Substantial Equivalence

Therm-X is substantially equivalent to Med4 Elite by Coolsystems, Inc. (K171685), VascuTherm by ThermoTek, Inc. (K061866), GameReady® Classic System (GR 2) by Coolsystems, Inc. (K072620), and IC-BAP-DL BioArterial Plus Aterial Blood Flow Enhancement System by Bio Compression Systems, Inc, (K131327) 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.

7

| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™) (K061866)
Secondary Predicate | Game Ready® Classic System
(GR 2) (K072620)
Secondary Predicate | Comparisons and Reference Device |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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 | 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 rehabilitation facilities, outpatient clinics, and athletic training settings. | 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 | 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 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 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) are also identical to VascuTherm™ |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| | 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. | | Localized thermal
therapy (hot or
cold) for post
traumatic and
post surgical
medical and/or
surgical
conditions. | | for DVT
therapy and for
use in 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
healthcare
professionals in
rehabilitation
facilities, outpatient
clinics, athletic
training settings, and
home settings. | | Decrease the risk
of deep venous
thrombosis
(DVT).

Aids the blood
flow back to the
heart.

Treat and assist
healing of
cutaneous
ulceration
(wounds), reduce
would healing
time, enhance
arterial circulation | | The indications
for use of the
Therm-X are
equivalent to
Game Ready®
for use in home
settings with
the only
difference
being that
Game Ready
does not
provide DVT
Therapy. |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| Intended Users | Healthcare
Professionals and
patients (i.e. General
Patient Users and
"Professional" Athlete
Users at home under
prescription) | Healthcare Professionals only
(Prescription use) | (blood flow),
reduce
compartmental
pressures,
reduce edema
(swelling), reduce
the need for
anticoagulant
(blood thinning)
medications.

Healthcare
Professionals
only and patients
(at home under
prescription) | Healthcare
Professionals and
patients (at home
under prescription) | Therm-X
intended users
are identical to
the intended
users of the
VascuTherm™
and Game
Ready® |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™ 4 and VascuTherm™ 5) and NanoTherm™)
(K061866)
Secondary Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary Predicate | Comparisons
and Reference
Device |
| | | | | | Therm-X intended users are equivalent to the Med4 Elite™ with the only difference being that the intended users for the Med4 Elite™ do not include patients in the home setting. |
| Number of
Patients that can
be treated at one
time | One | Two | One | One | Therm-X is designed to treat one patient at a time and it is identical to the VascuTherm™ and the Game Ready®. |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| Two
Programmable
Cycles | Configuration of two
programmable cycles
are available for all
Therm-X Models | Configuration of two
programmable cycles (one
cycle per patient) | Configuration of
three
programmable
cycles (therapy
profiles) | Not Available | The Therm-
X is equivalent
to the Med4
Elite™ and
VascuTherm™. |
| | | Functions | | | |
| Heat Therapy
Temperatures | Default: 105, 107,
110°F
Custom: 105°F –
110°F | 95 – 113°F (35 – 45°C) | 105°F | Not available | The Therm-X
Heat Therapy
Temperature
Range is
equivalent to
the Med4
Elite™. |
| Cold Therapy
Temperatures | Default: 34, 45, 55°F
Custom: 34 – 55°F | 38 – 60°F (3.33 – 15.56°C) | 43 – 49°F | 34 – 50°F | The Therm-X
temperature
range for Cold
Therapy is
equivalent to
the Med4
Elite™ and
Game Ready®.
The Therm-X
minimum
temperature
range for Cold
Therapy is |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| | | | | | identical to
Game Ready®.
The Therm-X
maximum
temperature
range for Cold
Therapy is
equivalent to
Med4 Elite™ |
| Edema
Compression
combined with
heat, cold or
contrast therapy | Available | Available with or without heat
therapy, cold therapy or
contrast therapy. | Available with or
without heat
therapy, cold
therapy or
contrast therapy
(contrast therapy
is available only
in VascuTherm™
5). | Available with cold
therapy. | Therm-X is
identical to
Game Ready®
for combining
edema
compression
with cold
therapy. The
Therm-X is
equivalent to
the Med4
Elite™ and
VascuTherm™
with the
difference that
Med4 Elite™
and
VascuTherm™ |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| | | | | | also provide
compression
without heat,
cold or contrast
therapy. |
| Edema
Compression
Levels | Available in three
levels
Low (20 mm Hg)
Medium (45 mm Hg)
High (70 mm Hg) | Available in four levels
Low (5 – 15 mm Hg)
Medium - Low (5 - 30 mm Hg)
Medium (5 - 50 mm Hg)
High (5 - 75 mm Hg) | Available in three
levels (general)
Low (15 mm Hg)
Medium (30 mm
Hg)
High (50 mm Hg) | Available in three
levels
Low (5 - 15 mm Hg)
Medium (5 - 50 mm
Hg)
High (5 – 75 mm
Hg) | The edema
compression
levels for
Therm-X are
equivalent to
the
compression
levels for the
Med4 Elite™
and Game
Ready.
Therm-X like
VascuTherm™
provides
constant values
for Low,
Medium and
High
compression. |
| DVT Only | Available for Therm-
X Pro Athlete and
Therm-X Pro Models | Not Available | Available | Not Available | Therm-X Pro
Athlete and
Therm-X Pro |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| | | | | | Models are
identical to
VascuTherm™. |
| DVT
Compression | Calf: 50 - 70 mm Hg
Foot: 100 – 130 mm
Hg | Not available | Calf: 45 mm Hg
Foot: 100 mm Hg | Not available | Therm-X
(Therm-X Pro
and Therm-X
Pro Athlete
Models) has a
higher range
for Foot and
Calf DVT
compression
than the
VascuTherm™
and has
equivalent DVT
compression to
reference
predicate, IC-
BAP-DL
BioArterial Plus
Arterial Blood
Flow
Enhancement
System
(K131327) |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| Cycle Length (for
Heat, Cold and
Compression) | Heat: 20, 30, or 40
minutes
Cold: 20, 30, or 40
minutes
Compression: 20, 30,
or 40 minutes | Heat: 5 to 30 minutes, 15
minutes default
Cold: 5 to 60 minutes, 15
minutes default
Compression Only: 5 to 60
minutes, 15 minutes default | Heat: 30 minutes
(presumed - not
clearly stated in
User Manual)
Cold: 30 minutes
(presumed not
clearly stated in
User Manual)
Compression:
Unknown | Heat: Not available
Cold: 5 to 90
minutes, 15 minutes
default
Compression: Not
available | The Therm-X
Cycle length for
Heat, Cold and
Compression is
equivalent to
Med4 Elite™ |
| Contrast Therapy
(for Heat, Cold
and
Compression) | Available
Heat: 10 minutes
Cold: 10 minutes
Total treatment: 5
cycles of alternating
heat and cold
treatment for total
duration of 100
minutes | Available
Heat: 1 - 10 minutes, default 3
minutes
Cold: 1 - 10 minutes, default 3
minutes
Total treatment: 15 - 90
minutes, default 30 minutes | Available
Heat: 10 minutes
Cold: 20 minutes
Contrast therapy
is available only
in VascuTherm™
5 | Not available | Therm-X
Contrast
therapy
function is
equivalent to
the Med4
Elite ™. |
| DVT Cycle
Length | No specified time
interval. DVT can be
stopped at any time
by the user. | Not available | 30 minutes
(presumed not
clearly stated in
User Manual) | Not available | Both the
Therm-X
(Therm-X Pro
and Therm-X
Pro Athlete
Models) and
VascuTherm™
provide DVT. |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| | | | | | DVT Cycle
Length for
Therm-X does
not have a
specified
interval and
provides
healthcare
professionals
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. |
| Edema
Compression
and DVT | Available | DVT not available | Available | DVT not available | The ability of
the Therm-
X (Therm-X Pro |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| Compression at
the same time | | | | | and Therm-X
Pro Athlete
Models) to
provide Edema
and DVT
compression
treatment at the
same time is
identical to
Vascutherm™. |
| DVT Inflation and
Deflation | DVT Inflation: Up to
60 seconds
DVT Deflation: Up to
30 seconds | Not available | Cycle time
Inflation 20
seconds,
Deflation 40 sec | Not available | The DVT
inflation and
Deflation for
Therm-X
(Therm-X Pro
and Therm-X
Pro Athlete
Models) is
equivalent to
VascuTherm™
with the
difference that
DVT inflation
time is longer
for Therm-X
and DVT
deflation is |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| | | | | | 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. |
| Rest Timer | Available | Snooze function Available | Available | Sleep option
available | Therm-X is
identical to the
VascuTherm™
and equivalent
to the Med4
Elite™ and
Game Ready®. |
| Pre-programmed
cycles (Quick
Picks) | Available | Available, Med4 Elite™ allows
user to setup default settings
for heat, cold, contrast and
compression therapy. | Configuration of
three
programmable
cycles (therapy
profiles) in
VascuTherm™ 5 | Available | Therm-X is
identical to
Game Ready®
and equivalent
to Med4 Elite™
and |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™)
(K061866) Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary Predicate | Comparisons and Reference Device |
| Password Protection
(Modification of settings) | Available for Therm-X AT and Therm-X Pro Models. | Available, only users with password can adjust system default settings | VascuTherm™ 5: The therapy profiles can be locked. Only healthcare professionals can unlock therapy profiles and just settings.

VascuTherm™ 4: Set temperature can be preprogrammed and locked. | Not Available | VascuTherm™ 5. The Therm-X is identical to the VascuTherm™ and equivalent to the Med4 Elite™. |
| Store Cycle Usage Data | Available | Available | Not Available | Not Available | The Therm-X is identical to the Med4 Elite™. |
| Dimensions | 15" L x 10.5" W x 9" H | 32.5" L x 24.75" W x 43" H (83 cm L x 63 cm W x 109cm H) | VascuTherm™ 5 13.2" H x 12.00" D x 6.6" W (335 mm H x 305 mm D x 167 mm W) | 16.25" L x 7.75" W x 9.25" H (413 x 197 x 235) mm (not including carrying case) | Therm-X is equivalent to Game Ready®. |
| Characteristic | Therm-X
(this submission) | Med4 EliteTM
(K171685) Primary predicate | VascuThermTM
(VascuThermTM
4 and
VascuThermTM
5) and
NanoThermTM)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| | | | VascuThermTM 4:
9.88" H x 8.75" D
x 9.81" W
(251 mm H x 222
mm D x 249 mm
W) | | |
| Weight | 15 lbs when full of
coolant | 172 lbs (78 kg) | VascuThermTM 5:
18.75 lbs (8.5 kg)
VascuThermTM 4:
9.5 lbs | 7.3 lbs (3.31 kgs)
empty
Approximately 18
lbs full of ice and
water | Therm-X is
equivalent to
VascuThermTM
5 and Game
Ready® . |
| Chilling
Mechanism | Thermoelectric | Vapor compression | Thermoelectric | Ice | The chilling
mechanism for
the Therm-X is
identical to the
VascuThermTM. |
| Heating
Mechanism | Thermoelectric | Resistance heaters | Thermoelectric | Not applicable | The heating
mechanism for
the Therm-X is
identical to the
VascuThermTM. |
| Reservoir Fluid
Capacity | 650 mL | Heat reservoir: 1 gallon (3.8 L)
Cold reservoir: 1 gallon (3.8 L) | 8.5 fl oz (250 mL) | Cold reservoir only
for ice and water:
1.25 gallons | The Therm-X
fluid capacity is
smaller than
the Med4 EliteTM
since it is
designed for |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| | | | | | only one
patient at a
time. The
Therm-X 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. The
fluid capacity
does not affect
the intended
use, or |
| User Interface | Touch Screen | Touch Screen | Touch Screen | No | Therm-X is
identical to the
Med4 Elite™
and
VascuTherm™ |
| Characteristic | Therm-X
(this submission) | Med4 EliteTM
(K171685) Primary predicate | VascuThermTM
(VascuThermTM
4 and
VascuThermTM
5) and
NanoThermTM)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| Recommended
Coolant | 90% Distilled Water,
10% Isopropyl
Alcohol | Distilled Water | 90% Distilled
Water, 10%
Isopropyl Alcohol | Tap Water and ice | The
recommended
coolant for the
Therm-X is
identical to the
VascuThermTM.
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 | | | | | |
| Line Voltage | 100-240 VAC | 100-240 VAC | 100-240 VAC | 100-240 VAC | Therm-X is
identical to
Med4 EliteTM,
VascuThermTM
and Game
Ready®. |
| Line Frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz | 50/60 Hz | Therm-X is
identical to
Med4 EliteTM |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| Electrical Safety
Standards | ANSI/AAMI
ES60601-
1:2005/(R)2012
Type BF
Class II
IEC 60601-1-2 | ANSI/AAMI ES60601-
1:2005/(R)2012
CAN/CSA C22.2 No. 60601-
1:2014
Type B | IEC 60601-1
UL 60601
Type B
Class II
IEC 60601-1-2 | ANSI/AAMI
ES60601-
1:2005/(R)2012
CAN/CSA C22.2
No. 60601-1:2014
Type BF
Class I
IEC 60601-1-2 | VascuTherm™
and Game
Ready®.
Therm-X is
equivalent to
Med4 Elite™.
Therm-X
complies with
the same
electrical safety
standards for
the US
markets. |
| | | Environment | | | |
| Operating
Temperature | 60°F - 80°F (16°C –
27°C) | 50°F - 90°F (10°C – 32°C) | 60°F - 80°F
(16°C – 27°C) | 33.8°F – 104°F(1–
40°C) | Therm-X is
identical to
VascuTherm™.
Therm-X is
equivalent to
Med4 Elite™
and Game
Ready®. |
| Storage
Temperature | 33°F – 122°F (1°C to
50°C) | 33°F - 122°F (1°C to 50°C) | 32°F - 122°F
(0°C to 50°C) | 33°F - 122°F (1°C
to 50°C) | Therm-X is
equivalent to
Med4 Elite™,
VascuTherm™ |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| Operating
Humidity | Below 60% Non-
condensing | 30 to 90% Non-condensing | Below 60% Non-
condensing | 30 to 90% Non-
condensing | and Game
Ready®.
Therm-X is
identical to the
VascuTherm™. |
| Storage Humidity | Below 60% Non-
condensing | 10 to 95% Non-condensing | 10 to 95% Non-
condensing | 10 to 95% Non-
condensing | Therm-X is
equivalent to
the Med4
Elite™,
VascuTherm™
and Game
Ready®.
Therm-X has a
lower minimum
and maximum
limit for storage
humidity than
the predicates.
This difference
does not affect
the intended
use or the
safety and
effectiveness of
the device. |
| Operating
Atmospheric | 700 hPa – 1060 hPa
(corresponds to a | 700 hPa – 1060 hPa | Unknown | Atmospheric
pressure at | The Therm-X
Operating |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| Pressure and
Altitude | max. elevation of
9,842 ft 6 in (3000
m)) | (corresponds to a max.
elevation of 9,842 ft 6 in (3000
m)) | | 0 - 8,000 Ft
(0 - 2,500 m) | atmospheric
pressure and
altitude is
identical to the
Med4 Elite™ |
| Accessories (Garments) | | | | | |
| Types of
Garments | Various anatomical
thermal garments for:
Back, Elbow,
Shoulder, Knee,
Ankle,
DVT Garments: Calf
and Foot | Various anatomical wraps in
different sizes for:
Straight Knee, Flexed Elbow,
Ankle, Shoulder, Back, | Various
anatomical
Wraps in different
sizes for:
Back, Large
Knee, Foot/Ankle
Wrap (Open
Heel), Foot/Ankle
(Elbow Wrap),
Standard
Shoulder,
DVT Garments:
Calf and Foot | Various anatomical
Wraps in different
sizes for:
Straight Knee,
Straight Elbow,
Ankle, Shoulder,
Back, | Therm-X
thermal
garments are
equivalent to
the thermal
wraps for Med4
Elite ™,
VascuTherm™
and Game
Ready®,
Therm-X DVT
garments are
equivalent to
VascuTherm™ . |
| Patient
Contacting
Material | Thermal garment -
30 denier nylon
DVT garment – 200
denier nylon | 70 Denier nylon
Silcryn (hose covering) | Thermal wrap -
200 Denier Nylon
Oxford
DVT wrap –
DuPont | 70 Denier nylon | The patient
contacting
material for the
Therm-X DVT
garment is
identical to the |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| | | | Softesse®
Medical Fabric
(non-latex, non-
woven) | | VascuTherm™
thermal wrap.
The patient
contacting
material for the
Therm-X
thermal
garment is
equivalent to
Med4 Elite™,
Game Ready®
and
VascuTherm
thermal wrap. |
| Biocompatibility | Cytotoxicity testing
per ISO 10993-5
Sensitization testing
per ISO 10993-10
Irritation testing per
ISO 10993-10 | Cytotoxicity testing per ISO
10993-5
Sensitization testing per ISO
10993-10
Irritation testing per ISO
10993-10 | No information | Cytotoxicity testing
per ISO 10993-5
Sensitization testing
per ISO 10993-10
Irritation testing per
ISO 10993-10 | The
biocompatibility
testing
performed for
Therm-X is
identical to the
Med4 Elite™
and Game
Ready®. |
| Sterile/Non-
Sterile | Non-sterile only | Non-sterile only | Sterile and non-
sterile | Non-sterile only | Therm-X is
identical to
Med4 Elite™,
Game Ready®. |
| Characteristic | Therm-X
(this submission) | Med4 Elite™
(K171685) Primary predicate | VascuTherm™
(VascuTherm™
4 and
VascuTherm™
5) and
NanoTherm™)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| | | | | | 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. |
| Single Patient
Use | Yes | No | Yes, they provide
both single
patient and
reusable wraps | No | Therm-X is
identical to the
VascuTherm™.
The only
difference is
that
VascuTherm™
also provides
reusable wraps
in addition to |
| Characteristic | Therm-X
(this submission) | Med4 EliteTM
(K171685) Primary predicate | VascuThermTM
(VascuThermTM
4 and
VascuThermTM
5) and
NanoThermTM)
(K061866)
Secondary
Predicate | Game Ready®
Classic System
(GR 2) (K072620)
Secondary
Predicate | Comparisons
and Reference
Device |
| | | | | | the single
patient use
garments. This
difference does
not affect the
intended use or
the safety and
effectiveness of
the device |

Detailed Comparison of the Subject and Predicate Device

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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 test 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 Unit is not patient contacting. The Therm-X garment patient contact materials were verified in accordance with the following standards:

. ISO 10993-1: 2009. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 10993-5: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro ● cytotoxicity
ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for Irritation ● and Skin Sensitization

Verification results indicated that the materials comply with the standard.

Software Validation:

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

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

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:

The Therm-X was tested for performance to verify the proper operation of the system.

30

Test and verification results indicate that Therm-X conforms to its predetermined specifications. Therm-X has been found to be adequately safe and effective for the intended users, its intended uses and use environments.

Clinical Testing:

Zenith has performed skin temperature testing for:

Maximum time limit at the highest temperature setting
. Maximum time limit at the lowest temperature setting
. Contrast therapy at the default time limit and temperature settings

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 clinical study 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 were performed in a simulated use environment to optimize the device design and support the safe use of Therm-X. 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 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.