(70 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, shoulder, ankle, hip, or knee and DVT prophylactic treatment applied to the foot or calf. Multipatient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the shoulder, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with pneumatic compression. The Foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.
Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings.
Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.
Here's an analysis of the provided text to extract information related to acceptance criteria and the study proving the device meets them, presented in the requested format.
It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against specific, quantitative clinical acceptance criteria. Therefore, some of the requested information (like specific target performance metrics for a novel technology or a detailed MRMC study with effect sizes) is not present because this type of submission is not designed to provide that. The "acceptance criteria" here are primarily about meeting safety and performance standards equivalent to existing devices and fulfilling regulatory requirements.
Device Name: Therm-X
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily defined by the performance characteristics of the predicate devices and general safety/performance standards for medical devices. The performance data presented isn't against pre-defined numerical thresholds for novel claims, but rather to show the new device operates similarly to cleared predicates.
| Acceptance Criterion (Implicit/Explicit) | Reported Device Performance (Therm-X) |
|---|---|
| Safety and Effectiveness Equivalence to Predicates | Demonstrated through comparison tables (pages 6-18) and various testing (EMC/Electrical, Biocompatibility, Software, Bench, Clinical, Human Factors). Concluded to be "as safe and effective as the legally marketed predicate devices." |
| Warmest Skin Temperature (Heat Therapy) | Custom range: 105°F – 110°F. Continuous custom range: 105°F – 107°F. |
| Coolest Skin Temperature (Cold Therapy) | Minimum measured skin temperature: 40°F. Custom range: 34°F - 55°F. Continuous custom range: 40°F - 50°F. |
| Compression Pressure Levels (Edema) | Lite (5 mm Hg), Low (20 mm Hg), Medium (45 mm Hg), High (70 mm Hg). Continuous: Low (20 mm Hg), Medium (45 mm Hg), High (70 mm Hg). |
| DVT Compression Pressure Levels (Calf) | 50 - 70 mmHg |
| DVT Compression Pressure Levels (Foot) | 90 - 130 mmHg (subject device) vs. 100-130mmHg (predicate). This is presented as equivalent in the comparison table despite the slight difference at the lower end, implying acceptance of this range. |
| Compliance with Electrical Safety Standards | Verified per IEC 60601-1 and IEC 60601-1-2. |
| Biocompatibility of Patient-Contacting Materials | Verified per ISO 10993-1, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation and skin sensitization). |
| Software Validation | Confirmed to meet performance requirements and specifications, classified as Moderate Level of Concern per FDA guidance. |
| Cleaning & Disinfection Efficacy (Multi-patient wraps) | Instructions validated for multi-patient use garments. |
| Usability for Intended Users and Environments | Human Factors/Usability assessments performed in simulated use environment; found "adequately safe and effective" and users can operate "as safely and as effectively as the predicate devices." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size:
- Clinical Testing (Skin Temperature): Not explicitly stated how many healthy volunteer human subjects were included, only "healthy volunteer human subjects who provided informed consent."
- Biocompatibility, EMC/Electrical, Software, Bench, Cleaning/Disinfection, Human Factors: These involve device-specific testing or material testing, not human subject sample sizes in the clinical sense.
- Data Provenance:
- Clinical Testing: Stated as "healthy volunteer human subjects who provided informed consent." No country of origin is specified.
- Retrospective/Prospective: The clinical testing for skin temperature measurement appears to be prospective ("IRB approved studies have been performed to measure the lowest skin temperature... Therm-X was tested for worst case conditions on healthy volunteer human subjects"). Other testing (bench, software, etc.) are standard verification and validation activities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Clinical Testing (Skin Temperature): The "ground truth" here is the measured skin temperature. This is a direct physical measurement from the device's application. Experts would be involved in designing and overseeing the study, but the "ground truth" itself is objective physical data rather than expert consensus on, say, an image interpretation. No specific number or qualifications of experts establishing ground truth are mentioned beyond the implication of an "IRB approved study."
- Other Testing (Bench, Software, etc.): Ground truth for these studies is typically defined by engineering specifications, regulatory standards, and established test protocols. The "experts" would be the engineers and quality assurance personnel conducting and reviewing the tests, but not in the sense of independent clinical experts adjudicating medical findings.
4. Adjudication Method for the Test Set
- Clinical Testing (Skin Temperature): Not applicable. The "ground truth" is a direct measurement of skin temperature. This is not an interpretive task requiring an adjudication process.
- Other Testing: Not applicable. These are engineering and performance compliance tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done.
- This type of study is typically used for diagnostic devices (e.g., AI for image interpretation) to compare the performance of human readers with and without AI assistance.
- The Therm-X is a therapeutic device (powered inflatable tube massager). The clinical testing focused on physical performance metrics (skin temperature) and safety, not on human interpretive tasks.
- Effect size of how human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, not directly applicable in the typical sense for AI/diagnostic algorithms.
- The Therm-X does contain software, and "Software Validation" was performed, which is akin to testing the "algorithm" or software functionality in isolation from human interaction, to ensure it meets its specifications. This is a component of the device's overall performance.
- However, the term "standalone" performance usually refers to an AI's diagnostic accuracy without human input for tasks like image classification. As this is not an AI diagnostic device, this concept doesn't directly apply in that context. The device's primary function is physical therapy, controlled by software.
7. The Type of Ground Truth Used
- Clinical Testing (Skin Temperature): Objective physical measurements (measured skin temperature).
- Biocompatibility: Laboratory test results against recognized standards (ISO 10993).
- Electrical Safety & EMC: Laboratory test results against recognized standards (IEC 60601 series).
- Software Validation: Conformance to pre-defined software requirements and specifications, and compliance with FDA guidance documents.
- Bench Performance: Conformance to engineering specifications for proper system operation and safety limits.
- Human Factors/Usability: Data from simulated use environments to assess safe and effective operation by intended users, typically observed directly or through surveys/interviews.
- Cleaning, Disinfection & Shelf Life: Laboratory validation of cleaning protocols and durability testing.
8. The Sample Size for the Training Set
- Not applicable. The Therm-X is presented as a physical therapy device with software control, not a machine learning/AI device that undergoes a "training" phase on a dataset of patient information (e.g., images for diagnostic AI). The software validation process ensures its functionality, but it's not "trained" on a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of an AI/machine learning model for this device.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 28, 2020
Zenith Technical Innovations % Rita King CEO MethodSense, Inc. 1 Copley Parkway Suite 410 Morrisville, NC 27560
Re: K193550
Trade/Device Name: Therm-X Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILO, JOW Dated: December 19, 2019 Received: December 20, 2019
Dear Rita King:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K193550
Device Name
Therm-X
Indications for Use (Describe)
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
✔ | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Zenith Technical Innovations K193550
| Submitter: | Zenith Technical Innovations, LLC. (Zenith)1396 St. Paul Ave.Gurnee, IL 60031Phone: (847) 672-7481Fax: (847) 672-8721 |
|---|---|
| Primary Contact: | Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: 919-313-3961Fax: 919-313-3979 |
| Company Contact: | Greg BinversieChief Technical Officer |
| Date Prepared: | December 19, 2019 |
Device Name and Classification
| Trade Name: | Therm-X |
|---|---|
| Common Name: | Massager, Powered Inflatable Tube |
| Classification: | Class II |
| Regulation Number: | 21 CFR 890.5650, Powered inflatable tube massager |
| Classification Panel: | Physical Medicine |
| Product Code: | IRP, ILO, JOW |
Predicate Devices
| Predicate: | Primary | Secondary | Reference |
|---|---|---|---|
| Trade Name: | Therm-X | Therm-X | Game Ready GRPro2.1 System |
| CommonName: | Heat and/or Cold andCompression Therapy | Heat and/or Cold andCompression Therapy | Powered InflatableTube Massager |
| 510(k)Submitter /Holder: | Zenith TechnicalInnovations, LLC.(Zenith) | Zenith TechnicalInnovations, LLC.(Zenith) | Cool Systems, Inc.(dba Game Ready) |
| 510(k) Number: | K190854 | K181149 | K192114 |
| Classification: | Class II | Class II | Class II |
| RegulationNumber: | 890.5650, PoweredInflatable tubemassager | 890.5650, PoweredInflatable tubemassager | 890.5650, PoweredInflatable tubemassager |
| ClassificationPanel: | Physical Medicine | Physical Medicine | Physical Medicine |
| Product Code: | IRP, ILO, JOW | IRP, ILO, JOW | IRP, ILO |
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Device Description
Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.
Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.
Therm-X consists of various reusable inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, hip, or knee and DVT prophylactic treatment applied to the foot or calf. Multipatient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the shoulder, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with pneumatic compression. The Foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.
Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings.
Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.
Indications for Use
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
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Risk Analysis Method
The Therm-X was assessed to determine the risks to health associated with the device modifications and evaluate risks related to safety, effectiveness, and usability. A risk analysis was conducted in accordance with ISO 14971:2007 and ISO14971:2012, Medical devices --Application of risk management to medical devices. All risks have been found acceptable.
Substantial Equivalence
Therm-X is substantially equivalent to Therm-X (K181149, K190854) by Zenith Technical Innovations, LLC. (Zenith) and Game Ready GRPro 2.1 System (K192114) by Cool Systems, Inc. (dba Game Ready) currently on the market.
Therm-X has the same intended use and indications for use as the predicate devices and uses equivalent overall design and operating principals as the predicate devices.
The table below provides a detailed comparison of Therm-X to the predicate devices.
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| Characteristic | Therm-XSubject Device | Therm-X (K190854)Primary Predicate | Therm-X (K181149)Secondary Predicate | GameReady®GRPro 2.1 System(K192114)Reference Device | Comparison |
|---|---|---|---|---|---|
| Indications for Use | Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are | Therm-X (Therm-X Pro, Therm-X Pro Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therapy. Therm- | Therm-X (Therm-X Pro, Therm-X Pro Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therapy. Therm- | Game Ready® GRPro 2.1 System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings. | The indications for use of the Therm-X (subject device) are identical to the Therm-X (K190854) with the only difference being that 1 model name has changed, and 1 model has been discontinued. |
| Characteristic | Therm-XSubject Device | Therm-X (K190854)Primary Predicate | Therm-X (K181149)SecondaryPredicate | GameReady®GRPro 2.1 System(K192114)Reference Device | Comparison |
| intended to reducethe risk of theformation of deepvenous thrombosis(DVT) by aidingblood flow back tothe heart via lowerextremity limbcompression. | X Pro and Therm-XPro Athlete areintended to reducethe risk of theformation of deepvenous thrombosis(DVT) by aidingblood flow back tothe heart via lowerextremity limbcompression. | X Pro and Therm-XPro Athlete areintended to reducethe risk of theformation of deepvenous thrombosis(DVT) by aidingblood flow back tothe heart via lowerextremity limbcompression. | |||
| Therm-X (Therm-XHome and Therm-XAT) is intended to beused by, or on theorder of, licensedhealth careprofessionals inrehabilitationfacilities, outpatientclinics, athletictraining settings, andhome settings. | Therm-X (Therm-XPro, Therm-X ProAthlete and Therm-XAT) is intended to beused by, or on theorder of, licensedhealth careprofessionals inrehabilitationfacilities, outpatientclinics, athletictraining settings, andhome settings. | Therm-X (Therm-XPro, Therm-X ProAthlete and Therm-XAT) is intended to beused by, or on theorder of, licensedhealth careprofessionals inrehabilitationfacilities, outpatientclinics, athletictraining settings, andhome settings. | |||
| Characteristic | Therm-XSubject Device | Therm-X (K190854)Primary Predicate | Therm-X (K181149)SecondaryPredicate | GameReady®GRPro 2.1 System(K192114)Reference Device | Comparison |
| Intended Users | Health CareProfessionals and layusers (underprescription) | Health CareProfessionals and layusers (underprescription) | Health CareProfessionals and layusers (underprescription) | Healthcareprofessionals,athletic trainers, layusers under thedirection of ahealthcareprofessional | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| Number ofPatients that canbe treated at onetime | One | One | One | One | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| TwoProgrammableCycles | Configuration of twoprogrammable cyclesare available for allTherm-X Models | Configuration of twoprogrammable cyclesare available for allTherm-X Models | Configuration of twoprogrammable cyclesare available for allTherm-X Models | Not publiclyavailable. | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| Functions | |||||
| ContinuousTreatment Cycle | Available on Therm-X Home | Not Available | Not Available | Not publicly available | Therm-X (subjectdevice) is equivalentto GameReady®GRPro 2.1 System(K192114). |
Detailed Comparison of the Subject and Predicate Device
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| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®GRPro 2.1 System(K192114) | Comparison |
|---|---|---|---|---|---|
| Subject Device | Primary Predicate | SecondaryPredicate | Reference Device | ||
| Heat Therapy | Default: 105°F,107°F, 110°FCustom: 105°F –110°FDefault, continuous:105°F, 107°FCustom, continuous:105°F – 107°F | Default: 105°F,107°F, 110°FCustom: 105°F –110°F | Default: 105°F,107°F, 110°FCustom: 105°F –110°F | N/A | Therm-X (subjectdevice) is equivalentto Therm-X(K190854).The only differenceis that the heattherapytemperatures aremore limited forcontinuoustreatment, but fallwithin the range ofwhat has beenpreviously cleared. |
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| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®GRPro 2.1 System(K192114) | Comparison |
|---|---|---|---|---|---|
| Subject Device | Primary Predicate | SecondaryPredicate | Reference Device | ||
| Cold Therapy | Default: 34°F, 45°F,55°FCustom: 34°F - 55°FDefault, continuous:40°F, 45°F, 50°FCustom, continuous:40°F - 50°F | Default: 34°F, 45°F,55°FCustom: 34°F - 55°F | Default: 34°F, 45°F,55°FCustom: 34°F - 55°F | 34 - 50°F | Therm-X (subjectdevice) is equivalentto Therm-X(K190854).The only differenceis that the coldtherapytemperatures aremore limited forcontinuoustreatment, but fallwithin the range ofwhat has beenpreviously cleared. |
| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®GRPro 2.1 System(K192114) | Comparison |
| Subject Device | Primary Predicate | SecondaryPredicate | Reference Device | ||
| Edema PressureLevels | Available in fourlevels:Lite (5 mm Hg)Low (20 mm Hg)Medium (45 mm Hg)High (70 mm Hg)For continuoustreatment, availablein three levels:Low (20 mm Hg)Medium (45 mm Hg)High (70 mm Hg) | Available in threelevels:Low (20 mm Hg)Medium (45 mm Hg)High (70 mm Hg) | Available in threelevels:Low (20 mm Hg)Medium (45 mm Hg)High (70 mm Hg) | Available in threelevels:Low (5-15 mm Hg)Medium (5-50 mmHg)High (5-75 mm Hg) | Therm-X (subjectdevice) is equivalentto Therm-X(K190854).The only differenceis that the pressurelevels are morelimited forcontinuoustreatment and anadditionalcompression level(lite) has beenincluded. |
| Static orIntermittentPressure | Both | Static Pressure Only | Static Pressure Only | Intermittent Pressureavailable | Therm-X (subjectdevice) is equivalentto Therm-X(K190854) andGameReady®GRPro 2.1 System(K192114). |
| DVT Only | Available for Therm-X Home Model | Available for Therm-X Pro Athlete andTherm-X Pro Models | Available for Therm-X Pro Athlete andTherm-X Pro Models | N/A | Therm-X (subjectdevice) is equivalentto Therm-X(K190854). |
| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®GRPro 2.1 System(K192114) | Comparison |
| Subject Device | Primary Predicate | Secondary Predicate | Reference Device | ||
| DVT Pressure | Calf: 50 - 70 mmHgFoot: 90 - 130mmHg | Calf: 50 - 70 mmHgFoot: 100 - 130mmHg | Calf: 50 - 70 mmHgFoot: 100 – 130mmHg | N/A | Therm-X (subjectdevice) is equivalentto Therm-X(K190854). |
| Cycle Length(for Heat, Cold,andCompression) | Default: 10 or 20minutesCustom: 3 – 40minutesContinuous: 10 - 40minutes active, 30-60minutes rest | Heat: 20, 30, or 40minutesCold: 20, 30, or 40minutesCompression: 20, 30,or 40 minutes | Heat: 20, 30, or 40minutesCold: 20, 30, or 40minutesCompression: 20, 30,or 40 minutes | 15 minutes default,increasing ordecreasing in 5-minute increments toa max of 90 min or amin of 5 min. | Therm-X (subjectdevice) is equivalentto Therm-X(K190854).The only differenceis that a custom andcontinuous cyclelength is availablefor the Therm-XHome model.Verification andvalidation testinghas been performedto test thecontinuoustreatment cycle.Note: K192114 doesnot offer heattherapy. |
| Characteristic | Therm-XSubject Device | Therm-X (K190854)Primary Predicate | Therm-X (K181149)Secondary Predicate | GameReady®GRPro 2.1 System(K192114)Reference Device | Comparison |
| ContrastTherapy | Available for Therm-X AT Model onlyHeat: 105°FCold: 38°F | Available for allTherm-X ModelsHeat: 105°FCold: 38°F | Available for allTherm-X ModelsHeat: 105°FCold: 38°F | N/A | Therm-X (subjectdevice) is equivalentto Therm-X(K190854).The only differenceis that the contrasttherapy is onlyavailable for Therm-X AT Model and notfor Therm-X HomeModel. |
| Cycle Length(for ContrastTherapy) | Heat: 3-10 minutesCold: 3-10 minutesTotal treatment: 6-60minutes | Heat: 10 minutesCold: 10 minutesTotal treatment: 5cycles of alternatingheat and coldtreatment for totalduration of 100minutes | Heat: 10 minutesCold: 10 minutesTotal treatment: 5cycles of alternatingheat and coldtreatment for totalduration of 100minutes | N/A | Therm-X (subjectdevice) is equivalentto Therm-X(K190854). |
| DVT CycleLength | No specified timeinterval. DVT can bestopped at any timeby the user. | No specified timeinterval. DVT can bestopped at any timeby the user. | No specified timeinterval. DVT can bestopped at any timeby the user. | N/A | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| Characteristic | Therm-XSubject Device | Therm-X (K190854)Primary Predicate | Therm-X (K181149)Secondary Predicate | GameReady® GRPro 2.1 System(K192114)Reference Device | Comparison |
| Edema Compressionand DVT Compression atthe same time | AvailableEdema Compression(Lite, Low, Medium, High) must becombined with cold,heat, or contrasttherapy | AvailableEdema Compression(Low, Medium, High)must be combinedwith cold, heat, orcontrast therapy | AvailableEdema Compression(Low, Medium, High)must be combinedwith cold, heat, orcontrast therapy | N/A | Therm-X (subjectdevice) is equivalentto Therm-X(K190854).Note: K192114 doesnot provide DVT. |
| DVT Inflationand Deflation | DVT Inflation: Up to120 secondsDVT Deflation: Up to30 seconds | DVT Inflation: Up to60 secondsDVT Deflation: Up to30 seconds | DVT Inflation: Up to60 secondsDVT Deflation: Up to30 seconds | N/A | Therm-X (subjectdevice) is equivalentto Therm-X(K190854). |
| Power Down | Available | Available | Available | Sleep option | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| PasswordProtection | Available | Available for Therm-X AT and Therm-XPro Models. | Available for Therm-X AT and Therm-XPro Models. | Not publicly available | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| Store CycleUsage Data | Available | Available | Available | Not publicly available | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| Physical Unit | |||||
| Dimensions | 15" L x 10.5" W x 9"H | 15" L x 10.5" W x 9"H | 15" L x 10.5" W x 9"H | 16.25" L x 7.75" W x9.25 H (413 x 197 x235) mm (notincluding carryingcase) | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®GRPro 2.1 System(K192114) | Comparison |
| Subject Device | Primary Predicate | SecondaryPredicate | Reference Device | ||
| Weight | 15 lbs. when full ofcoolant | 15 lbs. when full ofcoolant | 15 lbs. when full ofcoolant | 7.3 lbs. (3.31 kg.)empty,Approximately 18 Ibsfull of ice and waterbut less when filledper instructions foruse | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| ChillingMechanism | Thermoelectric | Thermoelectric | Thermoelectric | lce | Therm-X (subjectdevice) is identical toTherm-X (K190854). |
| HeatingMechanism | Thermoelectric | Thermoelectric | Thermoelectric | Not applicable. | Therm-X (subjectdevice) is identical toTherm-X (K190854). |
| Reservoir FluidCapacity | 650 mL | 650 mL | 650 mL | Approximately 5100mL | Therm-X (subjectdevice) is identical toTherm-X (K190854). |
| User Interface | Touch Screen | Touch Screen | Touch Screen | LCD Display and 9buttons | Therm-X (subjectdevice) is identical toTherm-X (K190854). |
| RecommendedCoolant | 90% Distilled Water,10% IsopropylAlcohol | 90% Distilled Water,10% IsopropylAlcohol | 90% Distilled Water,10% IsopropylAlcohol | Tap Water and Ice | Therm-X (subjectdevice) is identical toTherm-X (K190854). |
| Characteristic | Therm-XSubject Device | Therm-X (K190854)Primary Predicate | Therm-X (K181149)Secondary Predicate | GameReady®GRPro 2.1 System (K192114)Reference Device | Comparison |
| Electrical | |||||
| Line Voltage | 100-240 VAC | 100-240 VAC | 100-240 VAC | 100-240 VAC | Therm-X (subject device) is identical to Therm-X (K190854). |
| Line Frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz | 50/60 Hz | Therm-X (subject device) is identical to Therm-X (K190854). |
| Electrical SafetyStandards | ANSI/AAMIES60601-1:2005/(R)2012CAN/CSA C22.2 No.60601-1:2014Type BIEC 60601-1-2 | ANSI/AAMIES60601-1:2005/(R)2012CAN/CSA C22.2 No.60601-1:2014Type BIEC 60601-1-2 | ANSI/AAMIES60601-1:2005/(R)2012CAN/CSA C22.2 No.60601-1:2014Type BIEC 60601-1-2 | ANSI/AAMI ES60601-1:2005/(R) 2012 &A1:2012, C1:2009 (R)2012, A2:2010/(R)2012- Part 1CAN/CSA - C22.2 No.60601- 1:14 Part 1IEC 60601-1-6:2010 +A1:2013IEC 60601-1-11:2015IEC 60601 - 1-2, Ed.4.0: 2014 BS EN60601-1-2:2015 IEC62366:2007 +A1:2014IEC 62133:2012 +C1:2013 | Therm-X (subject device) is identical to Therm-X (K190854). |
| Characteristic | Therm-XSubject Device | Therm-X (K190854)Primary Predicate | Therm-X (K181149)Secondary Predicate | GameReady®GRPro 2.1 System(K192114)Reference Device | Comparison |
| Environment | |||||
| OperatingTemperature | 60°F - 80°F (16°C -27°C) | 60°F - 80°F (16°C -27°C) | 60°F - 80°F (16°C -27°C) | 33.8°F – 104°F (1°C --40°C) | Therm-X (subjectdevice) is identical toTherm-X (K190854). |
| StorageTemperature | 33°F - 122°F (1°C -50°C) | 33°F - 122°F (1°C -50°C) | 33°F - 122°F (1°C -50°C) | 33°F -122°F (1°C -50°C) | Therm-X (subjectdevice) is identical toTherm-X (K190854). |
| OperatingHumidity | Below 60% Non-condensing | Below 60% Non-condensing | Below 60% Non-condensing | Not publicly available | Therm-X (subjectdevice) is identical toTherm-X (K190854). |
| StorageHumidity | Below 60% Non-condensing | Below 60% Non-condensing | Below 60% Non-condensing | 15% - 90% non-condensing | Therm-X (subjectdevice) is identical toTherm-X (K190854). |
| OperatingAtmosphericPressure andAltitude | 700 hPa – 1060 hPa(corresponds to amax. elevation of9,842 ft. 6 in (3000m)) | 700 hPa – 1060 hPa(corresponds to amax. elevation of9,842 ft. 6 in (3000m)) | 700 hPa - 1060 hPa(corresponds to amax. elevation of9,842 ft. 6 in (3000m)) | 0 - 9,843 ft. (0 - 3000m) | Therm-X (subjectdevice) is identical toTherm-X (K190854). |
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| Characteristic | Therm-XSubject Device | Therm-X (K190854)Primary Predicate | Therm-X (K181149)SecondaryPredicate | GameReady®GRPro 2.1 System(K192114)Reference Device | Comparison |
|---|---|---|---|---|---|
| Accessories (Garments) | |||||
| Types ofGarments | Various anatomicalthermal garments for:Back, Elbow,Shoulder, Knee,Ankle, Hip.DVT Garments: Calfand Foot | Various anatomicalthermal garments for:Back, Elbow,Shoulder, Knee,Ankle.DVT Garments: Calfand Foot | Various anatomicalthermal garments for:Back, Elbow,Shoulder, Knee,Ankle.DVT Garments: Calfand Foot | Various anatomicalwraps in differentsizes for: StraightKnee, StraightElbow, Ankle,Shoulder, Back,Traumatic Amputee,Neck, Lower Limb,Full Leg Boot andChest | Therm-X (subjectdevice) is equivalentto Therm-X(K190854). The onlydifference is thatone additional typeof garment for thehip is available.This new anatomicalgarment type issubstantiallyequivalent toanother referencedevice, Med4 Elite™(K171685), for cold,heat, and contrasttherapy of the hip. |
| Characteristic | Therm-XSubject Device | Therm-X (K190854)Primary Predicate | Therm-X (K181149)SecondaryPredicate | GameReady®GRPro 2.1 System(K192114)Reference Device | Comparison |
| PatientContactingMaterial | Thermal garment,reusable (multi-patient) - 30 deniernylon coated inurethaneThermal garment,disposable (single-patient) - 200 deniernylon coated inurethaneDVT – 200 deniernylon coated inurethane | Thermal garment(multi-patient) – 30denier nylon coatedin urethaneDVT – 200 deniernylon coated inurethane | Thermal garment(multi-patient) – 30denier nylon coatedin urethaneDVT – 200 deniernylon coated inurethane | 70 denier nylon &polyester | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| Multi-PatientUse or Single-Patient UseWraps | Multi-Patient Use andSingle-Patient UseAvailable | Multi-Patient Use | Multi-Patient Use | Not publicly available | Therm-X (subjectdevice) is equivalentto Therm-X(K190854). The onlydifference is thatTherm-X (subjectdevice) now hasboth multi-patientand single-patientuse garmentsavailable. |
| Characteristic | Therm-XSubject Device | Therm-X (K190854)Primary Predicate | Therm-X (K181149)Secondary Predicate | GameReady®GRPro 2.1 System(K192114)Reference Device | Comparison |
| Biocompatibility | Cytotoxicity testingper ISO 10993-5 | Cytotoxicity testingper ISO 10993-5 | Cytotoxicity testingper ISO 10993-5 | Primary patient contactingcomponents verifiedas acceptableaccording to ISO 10993-1 usingcytotoxicity, primaryirritation and skinsensitization.Additionalelastomeric materialswereverified asacceptable accordingto ISO 10993-1 usingacute systematictoxicity, primaryirritation and skinsensitization. | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| Sensitization testingper ISO 10993-10 | Sensitization testingper ISO 10993-10 | Sensitization testingper ISO 10993-10 | |||
| Irritation testing perISO 10993-10 | Irritation testing perISO 10993-10 | Irritation testing perISO 10993-10 | |||
| Sterile/Non-Sterile | Non-sterile only | Non-sterile only | Non-sterile only | Non-sterile only | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| CleaningDisinfectionValidation ofLabeling | Yes - for Multi-Patient use reusablewraps | Yes - for Multi-Patient use reusablewraps | N/A | Yes | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®GRPro 2.1 System(K192114) | Comparison |
| Subject Device | Primary Predicate | SecondaryPredicate | Reference Device | ||
| Human FactorsTesting toconfirmintended usershave foundinstructions forcleaning anddisinfectioneasy to use | Yes - for Multi-Patient use reusablewraps | Yes - for Multi-Patient use reusablewraps | N/A | Not publicly available | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| Expected Life ofgarments | Based on frequencyof use and continuedfunctionalperformance | Based on frequencyof use and continuedfunctionalperformance | N/A | Based on frequencyof use | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
| Validation ofrepeatedcleaning anddisinfection forreusablegarments | Yes - for Multi-Patient use reusablewraps | Yes - for Multi-Patient use reusablewraps | N/A | Yes | Therm-X (subjectdevice) is identicalto Therm-X(K190854). |
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In this submission. Zenith has added a new Therm-X carment anatomical type – hip. This new anatomical garment type is substantially equivalent to another reference device, Med4 Elite™ (K171685), for cold, heat, and contrast therapy of the hip.
Testing
Therm-X and Therm-X software were verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the type of tests performed.
Electromagnetic Compatibility / Electrical Safety:
Electromagnetic Compatibility / Electrical Safety testing was performed in accordance with the following standards:
- . IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
Verification results indicated that the device is safe.
Biocompatibility:
The Therm-X garment patient contact materials were verified in accordance with the following standards:
- . ISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- ISO 10993-5: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro . cvtotoxicitv
- . ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization
Verification results indicated that the materials comply with the standard.
Cleaning, Disinfection & Shelf Life Testing
Therm-X garments are intended for use over intact skin or sterile dressings only. They are provided non-sterile and not intended to be user sterilized. Cleaning and disinfection instructions are provided for multi-patient use garments within each garment IFU. Such cleaning and disinfection instructions have been validated.
The Therm-X System components and garments do not have a definitive shelf life based on packaging or time. Expected life is based on frequency of use and continued functional performance. Durability accelerated aging test has been performed and has confirmed the safe use and disinfection of a Therm-X garment for the duration of the garment's life without evidence of deterioration of the garment due to cleaning and/or disinfection.
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Software Validation:
Zenith has conducted software validation testing on the Therm-X software and confirmed that Therm-X software meets its performance requirements and specifications. Software Validation has been completed according to an established Validation procedure and FDA Guidance documents and Industry Standards:
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, ● January 11, 2002
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
The Software is a Moderate Level of Concern as per FDA quidance. All required items related to software as required by FDA guidance have been included in this submission.
Performance – Bench:
Therm-X has been tested for performance to verify the proper operation of the system. Test and verification results indicate that Therm-X conforms to its predetermined specifications and operates within safety limits.
Clinical Testing:
IRB approved studies have been performed to measure the lowest skin temperature the Therm-X device can generate. As required by the FDA guidance for heating and cooling devices, Therm-X was tested for worst case conditions on healthy volunteer human subjects who provided informed consent. A minimum skin temperature of 40°F was measured and has been included in the product labeling.
Based on these results, it has been concluded that the temperature limits of Therm-X do not cause any thermal damage to the skin. The studies demonstrated that there are no safety issues created by the device and that Therm-X is as safe and effective as the predicate devices.
Human Factors / Usability:
Human Factors / Usability assessments have been performed in a simulated use environment to optimize the device design and support the safe use of Therm-X. Therm-X has been found to be adequately safe and effective for the intended users, its intended uses and use environments. The results demonstrated that users can operate Therm-X as safely and as effectively as the predicate devices.
Substantial Equivalence Conclusions
In conclusion, the intended use for Therm-X is substantially equivalent to that of the predicate devices. The technological characteristics comparison demonstrates that Therm-X is equivalent to the predicate devices, and the testing shows that Therm-X is substantially equivalent to the predicate devices and assures that Therm-X is as safe and effective as the predicate devices.
Conclusion
The 510(k) Pre-market Notification for Therm-X contains adequate information and data to determine that Therm-X is as safe and effective as the legally marketed predicate devices.
§ 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).