(28 days)
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings.
Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.
Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.
Therm-X consists of various reusable inflatable wraps for thermal treatment of the back, elbow, 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 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 change 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).
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.
The Therm-X device, a powered inflatable tube massager combining cold, heat, contrast, and compression therapy, has demonstrated substantial equivalence to its predicate device (Therm-X, K193550) through a series of verification and validation tests. The modifications in the current submission include the addition of four new anatomical garment types and one XL version of an existing garment, and an expanded range of operating temperatures for the device, and a slight difference in continuous edema pressure levels.
Here is a summary of the acceptance criteria and performance, along with details of the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes modifications to the Therm-X device as compared to its predicate (Therm-X, K193550). The acceptance criteria are implicit in the "Comparison" column, where the new device is either "identical" or the differences are deemed to "not affect the intended use or raise different questions of safety and effectiveness". For the purpose of this table, the predicate device's characteristics serve as the acceptance criteria.
| Characteristic | Acceptance Criteria (Predicate Therm-X, K193550) | Reported Device Performance (Subject Therm-X) | Device Meets Criteria? |
|---|---|---|---|
| Indications for Use | Treats post-surgical/acute injuries to reduce edema, swelling, pain; localized thermal therapy. | ||
| Therm-X Home systems also provide DVT therapy. | |||
| Used by/on order of licensed healthcare professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings. | Identical. Treats post-surgical/acute injuries to reduce edema, swelling, pain; localized thermal therapy. | ||
| Therm-X Home systems also provide DVT therapy. | |||
| Used by/on order of licensed healthcare professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings. | Yes | ||
| Intended Users | Health Care Professionals and lay users (under prescription) | Identical. Health Care Professionals and lay users (under prescription). | Yes |
| Number of Patients | One | Two (via a split umbilical hose accessory). | Yes (Difference validated not to affect safety/effectiveness) |
| Two Programmable Cycles | Available for all Therm-X Models | Identical. Available for all Therm-X Models. | Yes |
| Continuous Treatment Cycle | Available on Therm-X Home | Identical. Available on Therm-X Home. | Yes |
| Heat Therapy Settings | Default: 105°F, 107°F, 110°F; Custom: 105°F - 110°F | ||
| Default, continuous: 105°F, 107°F; Custom, continuous: 105°F - 107°F | Identical. Default: 105°F, 107°F, 110°F; Custom: 105°F - 110°F | ||
| Default, continuous: 105°F, 107°F; Custom, continuous: 105°F - 107°F | Yes | ||
| Cold Therapy Settings | 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 | Identical. 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 | Yes | ||
| Edema Pressure Levels (Continuous) | Four levels (Lite, Low, Medium, High). For continuous treatment, three levels (Lite, Low, Medium, High) | Three levels (Lite, Low, Medium). No "High" pressure during Continuous treatment, and "Lite" treatment is allowed during continuous treatment. | Yes (Difference validated not to affect safety/effectiveness) |
| Static or Intermittent Pressure | Both | Identical. Both. | Yes |
| DVT Only | Available for Therm-X Home Model | Identical. Available for Therm-X Home Model. | Yes |
| DVT Pressure | Calf: 50 - 70 mmHg; Foot: 90 - 130 mmHg | Identical. Calf: 50 - 70 mmHg; Foot: 90 - 130 mmHg. | Yes |
| Cycle Length (H/C/Comp) | Default: 10 or 20 min; Custom: 3 - 40 min | ||
| Continuous: 10 - 40 min active, 30-60 min rest | Identical. Default: 10 or 20 min; Custom: 3 - 40 min | ||
| Continuous: 10 - 40 min active, 30-60 min rest. | Yes | ||
| Contrast Therapy | Available for Therm-X AT Model only (Heat: 105°F, Cold: 38°F) | Identical. Available for Therm-X AT Model only (Heat: 105°F, Cold: 38°F). | Yes |
| Cycle Length (Contrast) | Heat: 3-10 min; Cold: 3-10 min; Total: 6-60 min | Identical. Heat: 3-10 min; Cold: 3-10 min; Total: 6-60 min. | Yes |
| DVT Cycle Length | No specified time interval, can be stopped at any time | Identical. No specified time interval, can be stopped at any time. | Yes |
| Edema Compression combined with thermal therapy | Yes (Lite, Low, Medium, High must be combined with cold, heat, or contrast therapy) | Identical. Yes (Lite, Low, Medium, High must be combined with cold, heat, or contrast therapy). | Yes |
| DVT Inflation/Deflation | Inflation: Up to 120 secs; Deflation: Up to 30 secs | Identical. Inflation: Up to 120 secs; Deflation: Up to 30 secs. | Yes |
| Power Down | Available | Identical. Available. | Yes |
| Password Protection | Available | Identical. Available. | Yes |
| Store Cycle Usage Data | Available | Identical. Available. | Yes |
| Dimensions | 15" L x 10.5" W x 9" H | Identical. 15" L x 10.5" W x 9" H. | Yes |
| Weight | 15 lbs. when full of coolant | Identical. 15 lbs. when full of coolant. | Yes |
| Chilling Mechanism | Thermoelectric | Identical. Thermoelectric. | Yes |
| Heating Mechanism | Thermoelectric | Identical. Thermoelectric. | Yes |
| Reservoir Fluid Capacity | 650 mL | Identical. 650 mL. | Yes |
| User Interface | Touch Screen | Identical. Touch Screen. | Yes |
| Recommended Coolant | 90% Distilled Water, 10% Isopropyl Alcohol | Identical. 90% Distilled Water, 10% Isopropyl Alcohol. | Yes |
| Line Voltage | 100-240 VAC | Identical. 100-240 VAC. | Yes |
| Line Frequency | 50/60 Hz | Identical. 50/60 Hz. | Yes |
| Electrical Safety Standards | ANSI/AAMI ES60601-1:2005/(R)2012, CAN/CSA C22.2 No. 60601-1:2014, Type B, IEC 60601-1-2 | Identical. ANSI/AAMI ES60601-1:2005/(R)2012, CAN/CSA C22.2 No. 60601-1:2014, Type B, IEC 60601-1-2. | Yes |
| Operating Temperature | 60°F - 80°F (16°C – 27°C) | 40°F - 130°F (4.4°C – 54.4°C). | Yes (Difference validated not to affect safety/effectiveness) |
| Storage Temperature | 33°F - 122°F (1°C - 50°C) | Identical. 33°F - 122°F (1°C - 50°C). | Yes |
| Operating Humidity | Below 60% Non-condensing | Identical. Below 60% Non-condensing. | Yes |
| Storage Humidity | Below 60% Non-condensing | Identical. Below 60% Non-condensing. | Yes |
| Operating Atmospheric Pressure/Altitude | 700 hPa – 1060 hPa (max. elevation of 9,842 ft. 6 in (3000 m)) | Identical. 700 hPa – 1060 hPa (max. elevation of 9,842 ft. 6 in (3000 m)). | Yes |
| Types of Garments | Various anatomical thermal garments for: Back, Elbow, Shoulder, Knee, Ankle, Hip. DVT Garments: Calf and Foot. | Various anatomical thermal garments for: Back, Elbow, Hand, Shoulder, XL Shoulder, Knee, Half-Leg, Ankle, Hip, Neck. DVT Garments: Calf and Foot. | Yes (Difference validated not to affect safety/effectiveness) |
| Patient Contacting Material | Thermal garment (reusable): 30 denier nylon coated in urethane. | ||
| Thermal garment (disposable): 200 denier nylon coated in urethane. | |||
| DVT: 200 denier nylon coated in urethane. | Identical. Thermal garment (reusable): 30 denier nylon coated in urethane. | ||
| Thermal garment (disposable): 200 denier nylon coated in urethane. | |||
| DVT: 200 denier nylon coated in urethane. | Yes | ||
| Multi-Patient/Single-Patient Use Wraps | Multi-Patient Use and Single-Patient Use Available | Identical. Multi-Patient Use and Single-Patient Use Available. | Yes |
| Biocompatibility | Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10) | Identical. Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10). Verification results indicated materials comply with the standard. | Yes |
| Sterile/Non-Sterile | Non-sterile only | Identical. Non-sterile only. | Yes |
| Cleaning/Disinfection Validation | Yes - for Multi-patient use reusable wraps | Identical. Yes - for Multi-patient use reusable wraps. | Yes |
| Human Factors Training Validation | Yes - for Multi-patient use reusable wraps | Identical. Yes - for Multi-patient use reusable wraps. | Yes |
| Expected Life of garments | Based on frequency of use and continued functional performance | Identical. Based on frequency of use and continued functional performance. Accelerated aging test performed to confirm safe use. | Yes |
| Validation of repeated cleaning/disinfection | Yes - for Multi-patient use reusable wraps | Identical. Yes - for Multi-patient use reusable wraps. | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to a clinical testing study that was "IRB approved" and conducted "on healthy volunteer human subjects who provided informed consent." This indicates a prospective study design.
- Sample Size: The exact number of human subjects is not specified in the provided text. It mentions "healthy volunteer human subjects."
- Data Provenance: The country of origin of the data is not specified. The mention of "IRB approved studies" implies a research institution setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
For the clinical testing for skin temperature, the "ground truth" was established by direct measurement of the skin temperature using the device on human subjects. This is not a situation where a human expert consensus is used to establish ground truth for a diagnostic interpretation. The study was to measure the lowest skin temperature the device could generate.
- Number of experts: Not applicable in the context of diagnostic "ground truth" establishment, as it was a direct physical measurement.
- Qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The clinical study described was to measure skin temperature directly, not to adjudicate results from interpretive tasks.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Therm-X device is a physical therapy device (powered inflatable tube massager) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Therm-X device is a physical therapy device and does not inherently involve an algorithm for diagnostic interpretation in a standalone fashion. Its software controls the physical modalities (temperature, compression, cycles). Software validation ensures the software operates as intended, but this is not "standalone algorithm performance" in the context of diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the human clinical study mentioned:
- Type of Ground Truth: The ground truth for the performance related to skin temperature was direct physical measurement ("lowest skin temperature ... measured") on human subjects under "worst case conditions."
For other tests:
- Performance - Bench: Predetermined specifications/performance criteria.
- Electromagnetic Compatibility / Electrical Safety: Conformance to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11).
- Biocompatibility: Conformance to international standards (ISO 10993-1, ISO 10993-5, ISO 10993-10).
- Cleaning, Disinfection & Shelf Life Testing: Validation of instructions and accelerated aging tests against expected performance and absence of deterioration.
- Software Validation: Conformance to performance requirements and specifications, and FDA Guidance documents (e.g., General Principles of Software Validation, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices/Device Software Functions).
- Human Factors / Usability: Adequacy for safe and effective use by intended users in intended environments.
8. The sample size for the training set
Not applicable. The Therm-X device does not appear to involve machine learning or AI that would require a "training set" in the typical sense for diagnostic algorithms. The software validation ensures its functionality based on established design specifications.
9. How the ground truth for the training set was established
Not applicable, as there is no mention or indication of an AI model requiring a training set in the document.
§ 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).