(157 days)
Not Found
No
The description focuses on software control for managing therapy parameters and user interface, with no mention of AI or ML for decision-making, pattern recognition, or adaptive therapy.
Yes
The device is intended to treat multiple medical/surgical conditions, reduce symptoms like edema, swelling, and pain, and aid in preventing conditions like DVT. These are all therapeutic applications.
No
The device is intended for treatment (therapy) to reduce symptoms like edema, swelling, and pain, not for diagnosing conditions.
No
The device description clearly outlines physical components such as an AC power source, coolant reservoir, pumps, fans, circuit board, and reusable inflatable wraps, indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, the Therm-X device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Therm-X is a therapeutic device that applies cold, heat, contrast, and compression directly to the patient's body for treatment purposes. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device description focuses on physical therapy modalities. The core function of the Therm-X is to deliver thermal and pneumatic therapy to treat injuries and conditions. This is a physical intervention, not a diagnostic test performed on a sample.
Therefore, the Therm-X device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated. The Therm-X (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI).
Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
Product codes
JOW, IRP, ILO
Device Description
Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.
Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.
Therm-X (Therm-X Home and Therm-X AT) consists of various reusable inflatable wraps for thermal treatment of the back, elbow, hand/wrist, shoulder, ankle, hip, lower leg, or knee and DVT prophylactic treatment applied to the foot or calf. Multi-patient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the back, hand/wrist, shoulder, neck, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with or without pneumatic compression. The foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.
Therm-X (Therm-X Home and Therm-X AT) is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings. Therm-X AT and Therm-X Home models provide an optional password protection feature that allows for a user to use only stored cycles, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first. The Therm-X device also allows users to chanqe treatment pressure and temperatures to less extreme therapies (e.g. changing a warm cycle to a lower warm temperature or changing a cold cycle to a higher cold temperature).
Therm-X (Therm-X Home and Therm-X AT) is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back, elbow, hand/wrist, shoulder, ankle, hip, lower leg, knee, foot, calf, neck.
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
Bench Performance: Therm-X (Therm-X Home and Therm-X AT) has been tested for performance to verify the proper operation of the system. Test and verification results indicate that Therm-X Home and Therm-X AT) conforms to its predetermined specifications and operates within safety limits.
Electromagnetic Compatibility / Electrical Safety: Test and verification results indicated that the device is safe and comply with IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11.
Biocompatibility: The Therm-X (Therm-X Home and Therm-X AT) garment patient contacting materials were verified for cytotoxicity, irritation and skin sensitization in accordance with ISO 10993-1, ISO 10993-5, and ISO 10993-10, demonstrating compliance.
Cleaning, Disinfection & Shelf Life Testing: Cleaning and disinfection instructions for multi-patient use garments have been validated. Durability accelerated aging test has been performed and has confirmed the safe use and disinfection of a Therm-X (Therm-X Home and Therm-X AT) garment for the duration of the garment's life without evidence of deterioration.
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, following FDA Guidance documents and Industry Standards.
Clinical Testing: IRB approved studies were performed on healthy volunteer human subjects to measure the lowest skin temperature the device can generate. A minimum skin temperature of 40°F was measured and included in product labeling. The studies demonstrated no thermal damage to the skin and concluded that the device is as safe and effective as predicate devices.
Human Factors / Usability: Human Factors / Usability assessments were performed in a simulated use environment. Results demonstrated that users can operate Therm-X (Therm-X Home and Therm-X AT) as safely and effectively as the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 21, 2024
Zenith Technical Innovations % Rita King Chief Executive Officer MethodSense, Inc. 1 Copley Parkway Suite 130 Morrisville, North Carolina 27560
Re: K240125
Trade/Device Name: Therm-X (Home); Therm-X (AT) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW, IRP, ILO Dated: May 23, 2024 Received: May 24, 2024
Dear Rita King:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Nicole M. Gillette -S
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality
2
Enclosure
3
Reprocessed Single-Use Device Models Included in Clearance:
| Device
Model | Device Name | Original
Manufacturer |
|-----------------|--------------------------|--------------------------|
| TX0107 | Calf DVT Garment | ZTI |
| TX0106 | Foot DVT Garment | ZTI |
| TX0102 | Knee Thermal Garment | ZTI |
| TX0105 | Back Thermal Garment | ZTI |
| TX0101 | Shoulder Thermal Garment | ZTI |
| TX0110 | XL Shoulder Garment | ZTI |
| TX0104 | Ankle Thermal Garment | ZTI |
| TX0103 | Elbow Thermal Garment | ZTI |
| TX0108 | Hip Thermal Garment | ZTI |
| TX0111 | Half-leg Thermal Garment | ZTI |
| TX0112 | Hand Thermal Garment | ZTI |
DVT – Deep Vein Thrombosis
ZTI – Zenith Technical Innovations
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Therm-X (Therm-X Home and Therm-X AT)
Indications for Use (Describe)
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surqical conditions for which localized thermal therapy (hot or cold) are indicated. The Therm-X (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI).
Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary
Zenith Technical Innovations K240125
This 510(k) Summary is in conformance with 21 CFR 807.92
| Submitter: | Zenith Technical Innovations, LLC. (Zenith)
1396 St. Paul Ave.
Gurnee, IL 60031
Phone: (847) 672-7481
Fax: (847) 672-8721 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961 |
| Company Contact: | Greg Binversie
Chief Technical Officer |
| Date Prepared: | June 21, 2024 |
Device Name and Classification
| Trade Name: | Therm-X |
|---|---|
| Common Name: | Sleeve, Limb, Compressible |
| Classification: | Class II |
| Regulation Number: | 21 CFR 870.5800 - Compressible limb sleeve |
| Classification Panel: | Cardiovascular |
| Product Code: | JOW, IRP, ILO |
Predicate Devices
| Trade Name: | Therm-X | VascuTherm™ |
|---|---|---|
| Common Name: | Heat and/or Cold and | |
| Compression Therapy | Intermittent, External | |
| Pneumatic Compression | ||
| Device | ||
| 510(k) Submitter / | ||
| Holder: | Zenith Technical Innovations, | |
| LLC. (Zenith) | ThermoTek, Inc. | |
| 510(k) Number: | K231912 | K061866 |
| Classification: | Class II | Class II |
| Regulation Number: | 890.5650, Powered Inflatable tube | |
| massager | 870.5800 - Compressible | |
| limb sleeve | ||
| Classification Panel: | Physical Medicine | Cardiovascular |
| Product Code: | IRP, ILO, JOW | JOW |
The predicate devices have not been subject to a design-related recall.
6
Device Description
Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.
Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.
Therm-X (Therm-X Home and Therm-X AT) consists of various reusable inflatable wraps for thermal treatment of the back, elbow, hand/wrist, shoulder, ankle, hip, lower leg, or knee and DVT prophylactic treatment applied to the foot or calf. Multi-patient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the back, hand/wrist, shoulder, neck, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with or without pneumatic compression. The foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.
Therm-X (Therm-X Home and Therm-X AT) is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings. Therm-X AT and Therm-X Home models provide an optional password protection feature that allows for a user to use only stored cycles, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first. The Therm-X device also allows users to chanqe treatment pressure and temperatures to less extreme therapies (e.g. changing a warm cycle to a lower warm temperature or changing a cold cycle to a higher cold temperature).
Therm-X (Therm-X Home and Therm-X AT) is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.
Indications for Use
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is
7
intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
Therm-X (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI).
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.
Risk Analysis Method
Therm-X (Therm-X Home and Therm-X AT) was assessed to determine the risks to health associated with the updated indications for use and evaluate risks related to safety, effectiveness, and usability. A risk analysis was conducted in accordance with ISO 14971:2019, Medical devices -- Application of risk management to medical devices. No additional risks were associated with the addition of treating disorders associated with vascular or lymphatic insufficiency such as lymphedema and chronic venous insufficiency (CVI) to the indications for use.
Substantial Equivalence
Therm-X (Therm-X Home and Therm-X AT) is substantially equivalent to Therm-X (K231912) by Zenith Technical Innovations, LLC. (Zenith) and VascuTherm™ (K061866) by ThermoTek, Inc. currently on the market.
Therm-X (Therm-X Home and Therm-X AT) has the same intended use as the Therm-X (K231912) and VascuTherm™ (K061866) and uses equivalent overall design and operating principals as the Therm-X predicate device (K231912).
The table below provides a detailed comparison of Therm-X Home and Therm-X AT) to the predicate devices:
8
Detailed Comparison of the Subject and Predicate Devices
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm ™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™) (K061866) | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate | Secondary Predicate | |
| 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 (Therm-X Home and
Therm-X AT) is also intended
for treatment of disorders
associated with vascular or
lymphatic insufficiency, such
as lymphedema and chronic
venous insufficiency (CVI).
Therm-X Home systems also
provide DVT therapy. Therm- | 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. | Treatment of disorders
associated with vascular or
lymphatic insufficiency such
as Chronic Venous
Insufficiency (CVI), venous
stasis ulcers,
post-mastectomy edema and
chronic lymphedema.
Reduction of Edema
associated with soft tissue
injuries such as bums,
postoperative edema, and
ligament sprains.
Localized thermal therapy
(hot or cold) for post traumatic
and post surgical medical
and/or surgical conditions.
Decrease the risk of deep
venous thrombosis (DVT).
Aids the blood flow back to
the heart. | Therm-X (subject device)
indications for use are
identical to Therm-X
(K231912) with the only
difference being that the
Therm-X (subject device)
also indicates that the
device may be used for
treatment of disorders
associated with vascular
or lymphatic insufficiency
such as lymphedema and
CVI.
The indications for use for
the treatment of disorders
associated with vascular
or lymphatic insufficiency
such as lymphedema and
CVI of Therm-X (subject
device) are equivalent to
the VascuThermTM
(K061866) indications for
treatment of these same
disorders. |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™) (K061866) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| | X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) and by aiding blood flow back to the heart via lower extremity limb compression.
Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings. | Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings. | Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications. | |
| Intended Users | Health Care Professionals and lay users (under prescription) | Health Care Professionals and lay users (under prescription) | Health Care Professionals and lay users (under prescription) | Therm-X (subject device) is identical to Therm-X (K231912) and VascuTherm™ (K061866). |
| Number of
Patients that can
be treated at one
time | Two | Two | One | Therm-X (subject device) is identical to Therm-X (K231912). |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™) (K061866) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| 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 | Not Available. | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Continuous
Treatment Cycle | Available on Therm-X Home | Available on Therm-X Home | Available. | Therm-X (subject device)
is identical to Therm-X
(K231912) and
VascuTherm™
(K061866). |
| 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, continuous: 105°F,
107°F
Custom, continuous: 105°F –
107°F | 105°F | Therm-X (subject device)
is identical to Therm-X
(K231912) and equivalent
to VascuTherm™
(K061866). . |
| 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, continuous: 40°F,
45°F, 50°F
Custom, continuous: 40°F –
50°F | 43 - 49°F | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm ™
(VascuTherm ™ 4 and
VascuTherm ™ 5) and
NanoTherm ™) (K061866) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| 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:
Lite (5 mm Hg)
Low (20 mm Hg)
Medium (45 mm Hg) | Available in four levels:
Lite (5 mm Hg)
Low (20 mm Hg)
Medium (45 mm Hg)
High (70 mm Hg)
For continuous treatment,
available in three levels:
Lite (5 mm Hg)
Low (20 mm Hg)
Medium (45 mm Hg) | Available in three levels:
Low (15 mmHg)
Medium (30 mmHg)
High (50 mmHg) | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Static or
Intermittent
Pressure | Both | Both | Both | Therm-X (subject device)
is identical to Therm-X
(K231912) and
VascuTherm™
(K061866) |
| DVT Only | Available for Therm-X Home
Model | Available for Therm-X Home
Model | Available | Therm-X (subject device)
is identical to Therm-X
(K231912) and
VascuTherm™
(K061866). |
| DVT Pressure | Calf: 50 - 70 mmHg
Foot: 90 - 130 mmHg | Calf: 50 - 70 mmHg
Foot: 90 - 130 mmHg | Calf: 45 mmHg
Foot: 100 mmHg | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™) (K061866) | Comparison |
| | | | | |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| Cycle Length
(for Heat, Cold,
and
Compression) | Default: 10 or 20 minutes | Default: 10 or 20 minutes | Default: 30 minutes
(presumed - not clearly
stated in User Manual) | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| | Custom: 3 - 40 minutes | Custom: 3 - 40 minutes | | |
| | Continuous: 10 – 40 minutes
active, 30-60 minutes rest | Continuous: 10-40 minutes
active, 30-60 minutes rest | Continuous: 30 minutes
(presumed not clearly stated
in User Manual)
Compression: Unknown | |
| Contrast
Therapy | Available for Therm-X AT
Model only | Available for Therm-X AT
Model only | Available
Heat: 10 minutes
Cold: 20 minutes
Note: Contrast therapy is
available only in
VascuTherm™ 5 | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| | Heat: 105°F | Heat: 105°F | | |
| | Cold: 38°F | Cold: 38°F | | |
| Cycle Length
(for Contrast
Therapy) | Heat: 3-10 minutes | Heat: 3-10 minutes | 30 minutes (presumed not
clearly stated in User Manual) | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| | Cold: 3-10 minutes | Cold: 3-10 minutes | | |
| | Total treatment: 6-60 minutes | Total treatment: 6-60 minutes | | |
| DVT Cycle
Length | Total treatment: 6-60 minutes
No specified time interval.
DVT can be stopped at any
time by the user. | Total treatment: 6-60 minutes
No specified time interval.
DVT can be stopped at any
time by the user. | 30 minutes (presumed not
clearly stated in User Manual) | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Edema
Compression
and DVT
Compression at
the same time | Available
Edema Compression (Lite,
Low, Medium, High) must be
combined with cold, heat, or
contrast therapy | Available
Edema Compression (Lite,
Low, Medium, High) must be
combined with cold, heat, or
contrast therapy | Available | Therm-X (subject device)
is identical to Therm-X
(K231912) and
VascuTherm™
(K061866). |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™) (K061866) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| DVT Inflation
and Deflation | DVT Inflation: Up to 120 seconds
DVT Deflation: Up to 30 seconds | DVT Inflation: Up to 120 seconds
DVT Deflation: Up to 30 seconds | Cycle time Inflation: 20 seconds,
Deflation: 40 sec | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Power Down | Available | Available | Available | Therm-X (subject device)
is identical to Therm-X
(K231912) and
VascuTherm™
(K061866). |
| Password
Protection | Available | Available | VascuTherm™ 5: The
therapy profiles can be
locked. Only healthcare
professionals can unlock
therapy profiles and just
settings. | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Store Cycle
Usage Data | Available | Available | VascuTherm™ 4: Set
temperature can be
preprogrammed and locked.
Was not able to determine
from publicly available
information. | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Dimensions | 15" L x 10.5" W x 9" H | 15" L x 10.5" W x 9" H | VascuTherm™ 5 13.2" H x
12.00" D x 6.6" W (335 mm H
x 305 mm D x 167 mm W)
VascuTherm™ 4: 9.88" H x
8.75" D x 9.81" W (251 mm H
x 222 mm D x 249 mm W) | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™) (K061866) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| Weight | 15 lbs. when full of coolant | 15 lbs. when full of coolant | VascuTherm™ 5: 18.75 lbs.
(8.5 kg)
VascuTherm™ 4: 9.5 lbs | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Chilling
Mechanism | Thermoelectric | Thermoelectric | Thermoelectric | Therm-X (subject device) is
identical to Therm-X
(K231912) and
VascuTherm™ (K061866). |
| Heating
Mechanism | Thermoelectric | Thermoelectric | Thermoelectric | Therm-X (subject device) is
identical to Therm-X
(K231912) and
VascuTherm™ (K061866). |
| Reservoir Fluid
Capacity | 650 mL | 650 mL | Vascutherm™ 5: 320 mL
VascuTherm™ 4: 250 mL | Therm-X (subject device) is
identical to Therm-X
(K231912). |
| User Interface | Touch Screen | Touch Screen | Touch Screen | Therm-X (subject device) is
identical to Therm-X
(K231912). |
| Recommended
Coolant | 90% Distilled Water, 10%
Isopropyl Alcohol | 90% Distilled Water, 10%
Isopropyl Alcohol | 90% Distilled Water, 10%
Isopropyl Alcohol | Therm-X (subject device) is
identical to Therm-X
(K231912) and
VascuTherm™ (K061866). |
| Characteristic | Therm-X
Subject Device | Therm-X (K231912)
Primary Predicate | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™) (K061866)
Secondary Predicate | Comparison |
| Line Voltage | 100-240 VAC | 100-240 VAC | 100-240 VAC | Therm-X (subject device) is
identical to Therm-X
(K231912) and
VascuTherm™ (K061866). |
| Line Frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz | Therm-X (subject device) is
identical to Therm-X
(K231912) and
VascuTherm™ (K061866). |
| Electrical Safety
Standards | 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 | IEC 60601-1
IEC 60601-1-2
UL 60601 Safety Standards
Type B | Therm-X (subject device) is
identical to Therm-X
(K231912). |
| Operating
Temperature | 40°F - 130°F (4.4°C –
54.4°C) | 40°F - 130°F (4.4°C –
54.4°C) | VascuTherm™ 4: 60-80°F
(16°C - 27°C)
VascuTherm™ 5: 50-80°F
(10°C - 27°C) | Therm-X (subject device) is
identical to Therm-X
(K231912). |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™) (K061866) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| Storage
Temperature | 33°F - 122°F (1°C - 50°C) | 33°F - 122°F (1°C - 50°C) | 40-105°F | Therm-X (subject device) is
identical to Therm-X
(K231912). |
| Operating
Humidity | Below 60% Non-condensing | Below 60% Non-condensing | Below 60% Non-condensing | Therm-X (subject device) is
identical to Therm-X
(K231912) and
VascuTherm™ (K061866). |
| Storage
Humidity | Below 60% Non-condensing | Below 60% Non-condensing | 10%-95% Non-condensing | Therm-X (subject device) is
identical to Therm-X
(K231912). |
| Operating
Atmospheric
Pressure and
Altitude | 700 hPa - 1060 hPa
(corresponds to a max.
elevation of 9,842 ft. 6 in
(3000
m)) | 700 hPa – 1060 hPa
(corresponds to a max.
elevation of 9,842 ft. 6 in
(3000
m)) | No information available. | Therm-X (subject device) is
identical to Therm-X
(K231912). |
| Types of
Garments | Various anatomical thermal
garments for: Back, Elbow,
Hand, Shoulder, XL Shoulder,
Knee, Half-Leg, Ankle, Hip,
Neck. | Various anatomical thermal
garments for: Back, Elbow,
Hand, Shoulder, XL Shoulder,
Knee, Half-Leg, Ankle, Hip,
Neck. | Various anatomical wraps for:
Arm, Wrist, Back, Face, Foot,
Ankle, Hip, Knee, Shoulder,
Torso, Half Arm, Head, Half-
Leg, Full Leg | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| | DVT Garments: Calf and Foot | DVT Garments: Calf and Foot | DVT Wraps: Calf and Foot | |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™) (K061866) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| 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
Butterfly Garment Elastic
Strap - Lycra/Spandex,
Polyester, Nylon | 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 wrap - 200 Denier
Nylon Oxford
DVT wrap - DuPont
Softesse® Medical Fabric
(non-latex, non-woven) | Therm-X (subject device)
is identical to Therm-X
(K231912) with the
exception that Therm-X
(subject device) includes
new elastic straps for a
garment that are
comprised of
Lycra/Spandex, Polyester,
and Nylon. These
additional patient
contacting materials do
not raise questions of
safety and effectiveness
as they are recognized as
commonly used medical
grade materials with a
long history of safe use in
legally marketed medical
devices. |
| Multi-Patient
Use or Single-
Patient Use
Wraps | Multi-Patient Use and Single-
Patient Use Available | Multi-Patient Use and Single-
Patient Use Available | Single-Patient Use | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™) (K061866) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| Biocompatibility | Cytotoxicity testing per ISO
10993-5 | Cytotoxicity testing per ISO
10993-5 | No information available. | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| | Sensitization testing per ISO
10993-10 | Sensitization 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 | Sterile and non-sterile | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Cleaning
Disinfection
Validation of
Labeling | Yes - for Multi-patient use
reusable wraps | Yes - for Multi-patient use
reusable wraps | No information available. | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| 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 | No information available. | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Expected Life of
garments | Based on frequency of use
and continued functional
performance | Based on frequency of use
and continued functional
performance | No information available. | Therm-X (subject device)
is identical to Therm-X
(K231912). |
| Characteristic | Therm-X
Subject Device | Therm-X (K231912)
Primary Predicate | VascuTherm™
(VascuTherm™ 4 and
VascuTherm™ 5) and
NanoTherm™) (K061866)
Secondary Predicate | Comparison |
| Validation of
repeated
cleaning and
disinfection for
reusable
garments | Yes - for Multi-patient use
reusable wraps | Yes - for Multi-patient use
reusable wraps | No information available. | Therm-X (subject device)
is identical to Therm-X
(K231912). |
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In this submission, Zenith has added additional indications for use for the treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI). Therm-X (Therm-X Home and Therm-X AT) with these additional indications is substantially equivalent to the identified predicate devices. Therm-X (K231912) and VascuTherm™ (K061866).
Testing
No additional testing has been performed for the additional indications for use. Therm-X (Therm-X Home and Therm-X AT) and Therm-X software were previously verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the type of tests performed.
Performance - Bench
Therm-X (Therm-X Home and Therm-X AT) has been tested for performance to verify the proper operation of the system. Test and verification results indicate that Therm-X Home and Therm-X AT) conforms to its predetermined specifications and operates within safety limits.
Electromagnetic Compatibility / Electrical Safety:
Electromagnetic Compatibility / Electrical Safety testing was performed in accordance with the following standards:
- . IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests Verification results indicated that the device is safe
- . IEC 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Biocompatibility:
The Therm-X (Therm-X Home and Therm-X AT) garment patient contacting materials were verified in accordance with the following standards:
- ISO 10993-1: 2009. Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process.
- . ISO 10993-5: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization
Verification results indicated that the materials comply with the standard.
Cleaning, Disinfection & Shelf Life Testing:
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Therm-X (Therm-X Home and Therm-X AT) garments are intended for use over intact skin or sterile dressings only. They are provided non-sterile and not intended to be user sterilized. Cleaning and disinfection instructions are provided for multi-patient use garments within each garment IFU. Such cleaning and disinfection instructions have been validated. The Therm-X (Therm-X Home and Therm-X AT) System components and garments do not have a definitive shelf life based on packaging or time. Expected life is based on frequency of use and continued functional performance. Durability accelerated aging test has been performed and has confirmed the safe use and disinfection of a Therm-X (Therm-X Home and Therm-X AT) garment for the duration of the garment's life without evidence of deterioration of the garment due to cleaning and/or disinfection.
Software Validation:
Zenith has conducted software validation testing on the Therm-X software and confirmed that Therm-X software meets its performance requirements and specifications. Software Validation has been completed according to an established Validation procedure and FDA Guidance document requirements for Enhanced Documentation Level and Industry Standards:
- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002
- . Guidance for the Content of Premarket Submissions for Device Software Functions, June 14, 2023
Clinical Testing:
IRB approved studies have been performed to measure the lowest skin temperature the Therm-X (Therm-X Home and Therm-X AT) device can generate. As required by the FDA guidance for heating and cooling devices. Therm-X (Therm-X Home and Therm-X AT) was tested for worst case conditions on healthy volunteer human subjects who provided informed consent. A minimum skin temperature of 40°F was measured and has been included in the product labeling.
Based on these results, it has been concluded that the temperature limits of Therm-X Home and Therm-X AT) do not cause any thermal damage to the skin. The studies demonstrated that there are no safety issues created by the device and that Therm-X (Therm-X Home and Therm-X AT) is as safe and effective as the predicate devices.
Human Factors / Usability:
Human Factors / Usability assessments have been performed in a simulated use environment to optimize the device design and support the safe use of Therm-X Home and Therm-X AT). Therm-X (Therm-X Home and Therm-X AT) has been found to be adequately safe and effective for the intended users, its intended uses and use environments. The results demonstrated that users can operate Therm-X (Therm-X Home and Therm-X AT) as safely and as effectively as the predicate devices.
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Substantial Equivalence Conclusion
In conclusion, the intended use for Therm-X (Therm-X Home and Therm-X AT) is substantially equivalent to that of the predicate devices. Additionally, the technological characteristics comparison demonstrates that Therm-X (Therm-X Home and Therm-X AT) is substantially equivalent to the predicates, assuring that Therm-X (Therm-X Home and Therm-X AT) is as safe and effective as the predicate devices.
Conclusion
The 510(k) Pre-market Notification for Therm-X (Therm-X Home and Therm-X AT) contains adequate information and data to determine that Therm-X (Therm-X Home and Therm-X AT) is as safe and effective as the legally marketed predicate devices.