(94 days)
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-X Pro and Therm-X Pro Athlete are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription of a licensed healthcare professional. The device is available in three configurations: Therm-X Pro, Therm-X Pro Athlete and Therm-X AT.
Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. Therm-X Pro and Therm-X Pro Athlete systems also provide DVT prophylaxis therapy.
Therm-X consists of various single-patient use inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, or knee and DVT prophylactic treatment applied to the foot or calf. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with pneumatic compression. The Foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by Therm-X Pro and Therm-X Pro Athlete systems only.
Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings. Therm-X AT and Therm-X Pro models provide an optional password protection feature that allows for a home user to use a stored cvcle without being able to change it, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first.
The Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.
The provided document describes the Therm-X device, which combines cold, heat, contrast, and compression therapy. It includes a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or detailing a clinical study to prove device performance against specific, quantifiable metrics.
Therefore, the information required to fully answer the request, particularly regarding specific acceptance criteria values and a dedicated study proving these criteria are met, is not present in the provided text. The document refers to "established performance criteria" and "predetermined specifications" but does not explicitly list them.
Based on the available text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific, quantifiable acceptance criteria and directly reported device performance values against those criteria. Instead, it makes general statements about compliance with standards and equivalence to predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for any performance testing.
- Data Provenance: Not specified. Retrospective or prospective nature is not mentioned for any testing.
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)
This information is not provided. The document details various tests (EMC/Electrical Safety, Biocompatibility, Software Validation, Bench Performance, Skin Temperature Testing, Human Factors/Usability) but does not mention the use of experts to establish a "ground truth" in the context of diagnostic accuracy, which is what "ground truth" typically refers to in medical device validation studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. This concept typically applies to studies where multiple readers assess cases and their disagreements need to be resolved, which isn't described for the Therm-X validation.
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
There is no mention of an MRMC comparative effectiveness study, human readers, AI assistance, or effect size related to AI improvement. The Therm-X is a physical therapy device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the Therm-X device. It is a physical therapy device, not an algorithm, and its performance inherently involves human interaction during application and use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically understood in diagnostic studies (e.g., expert consensus, pathology) is not applicable here. The device's validation relies on demonstrating compliance with safety standards, proper operation, and equivalence to predicate devices, rather than a diagnostic accuracy evaluation against a reference standard. For the "Clinical Testing" (skin temperature testing), the "ground truth" would implicitly be the actual skin temperature measurements and the absence of thermal damage, but the methodology for establishing this is not detailed as a "ground truth" process.
8. The sample size for the training set
This information is not provided. The term "training set" typically refers to data used to train machine learning algorithms, which is not relevant for this device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable to this device as it does not involve machine learning.
Summary of available information regarding acceptance and studies:
The document focuses on demonstrating substantial equivalence to predicate devices through various verification and validation activities.
-
Acceptance Criteria (Implicit/General):
- Conformance with established performance criteria/predetermined specifications.
- Compliance with Electromagnetic Compatibility / Electrical Safety standards (IEC 60601-1, IEC 60601-1-2).
- Biocompatibility of patient contact materials per ISO 10993 series (ISO 10993-1, ISO 10993-5, ISO 10993-10).
- Software meeting performance requirements and specifications, and complying with FDA Guidance documents and Industry Standards for Moderate Level of Concern software.
- Proper operation of the system (bench performance).
- Temperature limits not causing thermal damage to the skin (clinical testing).
- Safe and effective operation by users (human factors/usability).
- Overall safety and effectiveness equivalent to predicate devices.
-
Study/Testing Information:
- Electromagnetic Compatibility / Electrical Safety: Performed in accordance with IEC 60601-1 and IEC 60601-1-2.
- Biocompatibility: Testing of patient contact materials per ISO 10993-1, ISO 10993-5, ISO 10993-10.
- Software Validation: Completed according to an established Validation procedure and FDA Guidance documents ("General Principles of Software Validation," "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Software is classified as a Moderate Level of Concern.
- Performance (Bench): Tested for proper operation against predetermined specifications.
- Clinical Testing (Skin Temperature): Performed for maximum time limits at highest/lowest temperature settings and for contrast therapy at default settings. Concluded no thermal damage and device is safe and effective as predicate devices. The type of study and sample size are not specified.
- Human Factors / Usability: Assessments performed in a simulated use environment.
In conclusion, the document aims to assert substantial equivalence through demonstrating compliance with relevant standards and successful completion of various tests, rather than detailing a specific clinical study with quantifiable acceptance criteria against which the device's performance is precisely measured and reported.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized human figure. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text.
August 3, 2018
Zenith Technical Innovations % Rita King CEO MethodSense, Inc. 1 Copley Parkway, Suite 410 Morrisville, North Carolina 27560
Re: K181149
Trade/Device Name: Therm-X Pro, Therm-X Pro Athlete, Therm-X AT Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP. ILO. JOW Dated: June 7, 2018 Received: June 7, 2018
Dear Rita King:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael J. Hoffmann -S
for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181149
Device Name Therm-X Pro, Therm-X Pro Athlete, Therm-X AT
Indications for Use (Describe)
Therm-X (Therm-X Pro, Therm-X Pro Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intent post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therapy. Therm-X Pro Athlete are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow beart via lower extremity limb compression.
Therm-X (Therm-X Pro Athlete and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilities, outpatient clinics, athletic training settings, and home settings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Zenith Technical Innovations K181149
This 510(k) Summary is in conformance with 21 CFR 807.92
| Submitter: | Zenith Technical Innovations, LLC. (Zenith)1396 St. Paul Ave.Gurnee, IL 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 Technology Officer |
| Date Prepared: | June 7, 2018 |
Device Name and Classification
| Trade Name: | Therm-X |
|---|---|
| Common Name: | Heat and/or Cold and Compression Therapy |
| Classification: | Class II |
| Regulation Number: | 21 CFR 890.5650, Powered inflatable tube massage |
| Classification Panel: | Physical Medicine |
| Product Code: | IRP, ILO, JOW |
Predicate Devices
| Predicate: | Primary | Secondary | Secondary | Reference |
|---|---|---|---|---|
| Trade Name: | Med4 Elite™ | VascuTherm™(andNanoTherm™) | GameReady®Classic System(GR 2) | IC-BAP-DLBioArterialPlus AterialBlood FlowEnhancementSystem |
| CommonName: | Heat and/orCold andCompressionTherapy | Intermittent,ExternalPneumaticCompressionDevice | Cold/compressiontherapy system | BAP-DLBioArterialPlus ArterialBlood FlowIntermittentCirculator |
| 510(k)Submitter /Holder: | CoolSystems,Inc. | ThermoTek,Inc. | CoolSystems,Inc. | BioCompressionSystems, Inc |
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| 510(k)Number: | K171685 | K061866 | K072620 | K131327 |
|---|---|---|---|---|
| Classification: | Class II | Class II | Class II | Class II |
| RegulationNumber: | 890.5650,PoweredInflatabletubemassager | 870.5800,Compressiblelimb sleeve | 890.5650,Poweredinflatable tubemassager | 870.5800,Compressiblelimb sleeve |
| ClassificationPanel: | PhysicalMedicine | Cardiovascular | Physical Medicine | Cardiovascular |
| ProductCode: | IRP, ILO | JOW, ILO | IRP, ILO | JOW |
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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 of a licensed healthcare professional. The device is available in three configurations: Therm-X Pro, Therm-X Pro Athlete and Therm-X AT.
Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. Therm-X Pro and Therm-X Pro Athlete systems also provide DVT prophylaxis therapy.
Therm-X consists of various single-patient use inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, or knee and DVT prophylactic treatment applied to the foot or calf. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with pneumatic compression. The Foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by Therm-X Pro and Therm-X Pro Athlete systems only.
Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings. Therm-X AT and Therm-X Pro models provide an optional password protection feature that allows for a home user to use a stored cvcle without being able to change it, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first.
The Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.
Indications for Use
Therm-X (Therm-X Pro, Therm-X Pro Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therm-X Pro and Therm-X Pro Athlete are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
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Risk Analysis Method
The Therm-X was assessed to determine the risks to health associated with the use of the device and evaluated risks related to safety, effectiveness and usability. A risk analysis was conducted in accordance with ISO 14971:2007 and ISO14971:2012, Medical devices --Application of risk management to medical devices. Several risks were assessed, including, but not limited to, device malfunction, allergic reaction, infection and improper use.
Substantial Equivalence
Therm-X is substantially equivalent to Med4 Elite by Coolsystems, Inc. (K171685), VascuTherm by ThermoTek, Inc. (K061866), GameReady® Classic System (GR 2) by Coolsystems, Inc. (K072620), and IC-BAP-DL BioArterial Plus Aterial Blood Flow Enhancement System by Bio Compression Systems, Inc, (K131327) currently on the market.
Therm-X has the same intended use and indications for use as the predicate devices and uses equivalent overall design and operating principals as the predicate devices.
The table below provides a detailed comparison of Therm-X to the predicate devices.
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| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™) (K061866)Secondary Predicate | Game Ready® Classic System(GR 2) (K072620)Secondary Predicate | Comparisons and Reference Device |
|---|---|---|---|---|---|
| Indications for Use | Therm-X (Therm-X Pro, Therm-X ProAthlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.Therm-X Pro and Therm-X Pro Athlete | The Med4 Elite™ combines cold, heat, contrast and compression therapies.It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated.It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold or contrast) are indicated.It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics, and athletic training settings. | Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.Reduction of edema associated with soft tissue injuries such as bums, postoperative edema, and ligament sprains | It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings. | The indications for use of the Therm-X are identical to the Med4 Elite™ with the only difference being that the Therm-X also provides DVT therapy and is being used in both professional and home settings.The indications for use of Therm-X (Therm-X Pro and Therm-X Pro Athlete) are also identical to VascuTherm™ |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| systems also provideDVT therapy. Therm-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. | Localized thermaltherapy (hot orcold) for posttraumatic andpost surgicalmedical and/orsurgicalconditions. | for DVTtherapy and foruse in homesettings. | |||
| Therm-X (Therm-XPro, Therm-X ProAthlete and Therm-XAT) is intended to beused by, or on theorder of, licensedhealthcareprofessionals inrehabilitationfacilities, outpatientclinics, athletictraining settings, andhome settings. | Decrease the riskof deep venousthrombosis(DVT).Aids the bloodflow back to theheart.Treat and assisthealing ofcutaneousulceration(wounds), reducewould healingtime, enhancearterial circulation | The indicationsfor use of theTherm-X areequivalent toGame Ready®for use in homesettings withthe onlydifferencebeing thatGame Readydoes notprovide DVTTherapy. | |||
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| Intended Users | HealthcareProfessionals andpatients (i.e. GeneralPatient Users and"Professional" AthleteUsers at home underprescription) | Healthcare Professionals only(Prescription use) | (blood flow),reducecompartmentalpressures,reduce edema(swelling), reducethe need foranticoagulant(blood thinning)medications.HealthcareProfessionalsonly and patients(at home underprescription) | HealthcareProfessionals andpatients (at homeunder prescription) | Therm-Xintended usersare identical tothe intendedusers of theVascuTherm™and GameReady® |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™ 4 and VascuTherm™ 5) and NanoTherm™)(K061866)Secondary Predicate | Game Ready®Classic System(GR 2) (K072620)Secondary Predicate | Comparisonsand ReferenceDevice |
| Therm-X intended users are equivalent to the Med4 Elite™ with the only difference being that the intended users for the Med4 Elite™ do not include patients in the home setting. | |||||
| Number ofPatients that canbe treated at onetime | One | Two | One | One | Therm-X is designed to treat one patient at a time and it is identical to the VascuTherm™ and the Game Ready®. |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| TwoProgrammableCycles | Configuration of twoprogrammable cyclesare available for allTherm-X Models | Configuration of twoprogrammable cycles (onecycle per patient) | Configuration ofthreeprogrammablecycles (therapyprofiles) | Not Available | The Therm-X is equivalentto the Med4Elite™ andVascuTherm™. |
| Functions | |||||
| Heat TherapyTemperatures | Default: 105, 107,110°FCustom: 105°F –110°F | 95 – 113°F (35 – 45°C) | 105°F | Not available | The Therm-XHeat TherapyTemperatureRange isequivalent tothe Med4Elite™. |
| Cold TherapyTemperatures | Default: 34, 45, 55°FCustom: 34 – 55°F | 38 – 60°F (3.33 – 15.56°C) | 43 – 49°F | 34 – 50°F | The Therm-Xtemperaturerange for ColdTherapy isequivalent tothe Med4Elite™ andGame Ready®.The Therm-Xminimumtemperaturerange for ColdTherapy is |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| identical toGame Ready®.The Therm-Xmaximumtemperaturerange for ColdTherapy isequivalent toMed4 Elite™ | |||||
| EdemaCompressioncombined withheat, cold orcontrast therapy | Available | Available with or without heattherapy, cold therapy orcontrast therapy. | Available with orwithout heattherapy, coldtherapy orcontrast therapy(contrast therapyis available onlyin VascuTherm™5). | Available with coldtherapy. | Therm-X isidentical toGame Ready®for combiningedemacompressionwith coldtherapy. TheTherm-X isequivalent tothe Med4Elite™ andVascuTherm™with thedifference thatMed4 Elite™andVascuTherm™ |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| also providecompressionwithout heat,cold or contrasttherapy. | |||||
| EdemaCompressionLevels | Available in threelevelsLow (20 mm Hg)Medium (45 mm Hg)High (70 mm Hg) | Available in four levelsLow (5 – 15 mm Hg)Medium - Low (5 - 30 mm Hg)Medium (5 - 50 mm Hg)High (5 - 75 mm Hg) | Available in threelevels (general)Low (15 mm Hg)Medium (30 mmHg)High (50 mm Hg) | Available in threelevelsLow (5 - 15 mm Hg)Medium (5 - 50 mmHg)High (5 – 75 mmHg) | The edemacompressionlevels forTherm-X areequivalent tothecompressionlevels for theMed4 Elite™and GameReady.Therm-X likeVascuTherm™providesconstant valuesfor Low,Medium andHighcompression. |
| DVT Only | Available for Therm-X Pro Athlete andTherm-X Pro Models | Not Available | Available | Not Available | Therm-X ProAthlete andTherm-X Pro |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| Models areidentical toVascuTherm™. | |||||
| DVTCompression | Calf: 50 - 70 mm HgFoot: 100 – 130 mmHg | Not available | Calf: 45 mm HgFoot: 100 mm Hg | Not available | Therm-X(Therm-X Proand Therm-XPro AthleteModels) has ahigher rangefor Foot andCalf DVTcompressionthan theVascuTherm™and hasequivalent DVTcompression toreferencepredicate, IC-BAP-DLBioArterial PlusArterial BloodFlowEnhancementSystem(K131327) |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| Cycle Length (forHeat, Cold andCompression) | Heat: 20, 30, or 40minutesCold: 20, 30, or 40minutesCompression: 20, 30,or 40 minutes | Heat: 5 to 30 minutes, 15minutes defaultCold: 5 to 60 minutes, 15minutes defaultCompression Only: 5 to 60minutes, 15 minutes default | Heat: 30 minutes(presumed - notclearly stated inUser Manual)Cold: 30 minutes(presumed notclearly stated inUser Manual)Compression:Unknown | Heat: Not availableCold: 5 to 90minutes, 15 minutesdefaultCompression: Notavailable | The Therm-XCycle length forHeat, Cold andCompression isequivalent toMed4 Elite™ |
| Contrast Therapy(for Heat, ColdandCompression) | AvailableHeat: 10 minutesCold: 10 minutesTotal treatment: 5cycles of alternatingheat and coldtreatment for totalduration of 100minutes | AvailableHeat: 1 - 10 minutes, default 3minutesCold: 1 - 10 minutes, default 3minutesTotal treatment: 15 - 90minutes, default 30 minutes | AvailableHeat: 10 minutesCold: 20 minutesContrast therapyis available onlyin VascuTherm™5 | Not available | Therm-XContrasttherapyfunction isequivalent tothe Med4Elite ™. |
| DVT CycleLength | No specified timeinterval. DVT can bestopped at any timeby the user. | Not available | 30 minutes(presumed notclearly stated inUser Manual) | Not available | Both theTherm-X(Therm-X Proand Therm-XPro AthleteModels) andVascuTherm™provide DVT. |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| DVT CycleLength forTherm-X doesnot have aspecifiedinterval andprovideshealthcareprofessionalsthe ability toprescribe DVTtreatments forany length ofminutes. At alltimes duringtreatment, theuser hascompletecontrol andability to stopthe cycle andcontinue thecycle at anytime. | |||||
| EdemaCompressionand DVT | Available | DVT not available | Available | DVT not available | The ability ofthe Therm-X (Therm-X Pro |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| Compression atthe same time | and Therm-XPro AthleteModels) toprovide Edemaand DVTcompressiontreatment at thesame time isidentical toVascutherm™. | ||||
| DVT Inflation andDeflation | DVT Inflation: Up to60 secondsDVT Deflation: Up to30 seconds | Not available | Cycle timeInflation 20seconds,Deflation 40 sec | Not available | The DVTinflation andDeflation forTherm-X(Therm-X Proand Therm-XPro AthleteModels) isequivalent toVascuTherm™with thedifference thatDVT inflationtime is longerfor Therm-Xand DVTdeflation is |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| faster, whichcreates greatercomfort andconveniencefor the user.This differencedoes not affectthe intendeduse or thesafety andeffectiveness ofthe device. | |||||
| Rest Timer | Available | Snooze function Available | Available | Sleep optionavailable | Therm-X isidentical to theVascuTherm™and equivalentto the Med4Elite™ andGame Ready®. |
| Pre-programmedcycles (QuickPicks) | Available | Available, Med4 Elite™ allowsuser to setup default settingsfor heat, cold, contrast andcompression therapy. | Configuration ofthreeprogrammablecycles (therapyprofiles) inVascuTherm™ 5 | Available | Therm-X isidentical toGame Ready®and equivalentto Med4 Elite™and |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™ 4 andVascuTherm™ 5) andNanoTherm™)(K061866) SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)Secondary Predicate | Comparisons and Reference Device |
| Password Protection(Modification of settings) | Available for Therm-X AT and Therm-X Pro Models. | Available, only users with password can adjust system default settings | VascuTherm™ 5: The therapy profiles can be locked. Only healthcare professionals can unlock therapy profiles and just settings.VascuTherm™ 4: Set temperature can be preprogrammed and locked. | Not Available | VascuTherm™ 5. The Therm-X is identical to the VascuTherm™ and equivalent to the Med4 Elite™. |
| Store Cycle Usage Data | Available | Available | Not Available | Not Available | The Therm-X is identical to the Med4 Elite™. |
| Dimensions | 15" L x 10.5" W x 9" H | 32.5" L x 24.75" W x 43" H (83 cm L x 63 cm W x 109cm H) | VascuTherm™ 5 13.2" H x 12.00" D x 6.6" W (335 mm H x 305 mm D x 167 mm W) | 16.25" L x 7.75" W x 9.25" H (413 x 197 x 235) mm (not including carrying case) | Therm-X is equivalent to Game Ready®. |
| Characteristic | Therm-X(this submission) | Med4 EliteTM(K171685) Primary predicate | VascuThermTM(VascuThermTM4 andVascuThermTM5) andNanoThermTM)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| VascuThermTM 4:9.88" H x 8.75" Dx 9.81" W(251 mm H x 222mm D x 249 mmW) | |||||
| Weight | 15 lbs when full ofcoolant | 172 lbs (78 kg) | VascuThermTM 5:18.75 lbs (8.5 kg)VascuThermTM 4:9.5 lbs | 7.3 lbs (3.31 kgs)emptyApproximately 18lbs full of ice andwater | Therm-X isequivalent toVascuThermTM5 and GameReady® . |
| ChillingMechanism | Thermoelectric | Vapor compression | Thermoelectric | Ice | The chillingmechanism forthe Therm-X isidentical to theVascuThermTM. |
| HeatingMechanism | Thermoelectric | Resistance heaters | Thermoelectric | Not applicable | The heatingmechanism forthe Therm-X isidentical to theVascuThermTM. |
| Reservoir FluidCapacity | 650 mL | Heat reservoir: 1 gallon (3.8 L)Cold reservoir: 1 gallon (3.8 L) | 8.5 fl oz (250 mL) | Cold reservoir onlyfor ice and water:1.25 gallons | The Therm-Xfluid capacity issmaller thanthe Med4 EliteTMsince it isdesigned for |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| only onepatient at atime. TheTherm-X fluidcapacity islarger thanVascuTherm.The Therm-xfluid capacity isdesigned toaddress thelongest cycle oftreatmentwithout havingto refill thecoolant. Thefluid capacitydoes not affectthe intendeduse, or | |||||
| User Interface | Touch Screen | Touch Screen | Touch Screen | No | Therm-X isidentical to theMed4 Elite™andVascuTherm™ |
| Characteristic | Therm-X(this submission) | Med4 EliteTM(K171685) Primary predicate | VascuThermTM(VascuThermTM4 andVascuThermTM5) andNanoThermTM)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| RecommendedCoolant | 90% Distilled Water,10% IsopropylAlcohol | Distilled Water | 90% DistilledWater, 10%Isopropyl Alcohol | Tap Water and ice | Therecommendedcoolant for theTherm-X isidentical to theVascuThermTM.Each device isable to attain itsdesiredperformancerequirements.There is noimpact on theintended use orthe safety andeffectiveness ofthe device. |
| Electrical | |||||
| Line Voltage | 100-240 VAC | 100-240 VAC | 100-240 VAC | 100-240 VAC | Therm-X isidentical toMed4 EliteTM,VascuThermTMand GameReady®. |
| Line Frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz | 50/60 Hz | Therm-X isidentical toMed4 EliteTM |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| Electrical SafetyStandards | ANSI/AAMIES60601-1:2005/(R)2012Type BFClass IIIEC 60601-1-2 | ANSI/AAMI ES60601-1:2005/(R)2012CAN/CSA C22.2 No. 60601-1:2014Type B | IEC 60601-1UL 60601Type BClass IIIEC 60601-1-2 | ANSI/AAMIES60601-1:2005/(R)2012CAN/CSA C22.2No. 60601-1:2014Type BFClass IIEC 60601-1-2 | VascuTherm™and GameReady®.Therm-X isequivalent toMed4 Elite™.Therm-Xcomplies withthe sameelectrical safetystandards forthe USmarkets. |
| Environment | |||||
| OperatingTemperature | 60°F - 80°F (16°C –27°C) | 50°F - 90°F (10°C – 32°C) | 60°F - 80°F(16°C – 27°C) | 33.8°F – 104°F(1–40°C) | Therm-X isidentical toVascuTherm™.Therm-X isequivalent toMed4 Elite™and GameReady®. |
| StorageTemperature | 33°F – 122°F (1°C to50°C) | 33°F - 122°F (1°C to 50°C) | 32°F - 122°F(0°C to 50°C) | 33°F - 122°F (1°Cto 50°C) | Therm-X isequivalent toMed4 Elite™,VascuTherm™ |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| OperatingHumidity | Below 60% Non-condensing | 30 to 90% Non-condensing | Below 60% Non-condensing | 30 to 90% Non-condensing | and GameReady®.Therm-X isidentical to theVascuTherm™. |
| Storage Humidity | Below 60% Non-condensing | 10 to 95% Non-condensing | 10 to 95% Non-condensing | 10 to 95% Non-condensing | Therm-X isequivalent tothe Med4Elite™,VascuTherm™and GameReady®.Therm-X has alower minimumand maximumlimit for storagehumidity thanthe predicates.This differencedoes not affectthe intendeduse or thesafety andeffectiveness ofthe device. |
| OperatingAtmospheric | 700 hPa – 1060 hPa(corresponds to a | 700 hPa – 1060 hPa | Unknown | Atmosphericpressure at | The Therm-XOperating |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| Pressure andAltitude | max. elevation of9,842 ft 6 in (3000m)) | (corresponds to a max.elevation of 9,842 ft 6 in (3000m)) | 0 - 8,000 Ft(0 - 2,500 m) | atmosphericpressure andaltitude isidentical to theMed4 Elite™ | |
| Accessories (Garments) | |||||
| Types ofGarments | Various anatomicalthermal garments for:Back, Elbow,Shoulder, Knee,Ankle,DVT Garments: Calfand Foot | Various anatomical wraps indifferent sizes for:Straight Knee, Flexed Elbow,Ankle, Shoulder, Back, | VariousanatomicalWraps in differentsizes for:Back, LargeKnee, Foot/AnkleWrap (OpenHeel), Foot/Ankle(Elbow Wrap),StandardShoulder,DVT Garments:Calf and Foot | Various anatomicalWraps in differentsizes for:Straight Knee,Straight Elbow,Ankle, Shoulder,Back, | Therm-Xthermalgarments areequivalent tothe thermalwraps for Med4Elite ™,VascuTherm™and GameReady®,Therm-X DVTgarments areequivalent toVascuTherm™ . |
| PatientContactingMaterial | Thermal garment -30 denier nylonDVT garment – 200denier nylon | 70 Denier nylonSilcryn (hose covering) | Thermal wrap -200 Denier NylonOxfordDVT wrap –DuPont | 70 Denier nylon | The patientcontactingmaterial for theTherm-X DVTgarment isidentical to the |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| Softesse®Medical Fabric(non-latex, non-woven) | VascuTherm™thermal wrap.The patientcontactingmaterial for theTherm-Xthermalgarment isequivalent toMed4 Elite™,Game Ready®andVascuThermthermal wrap. | ||||
| Biocompatibility | Cytotoxicity testingper ISO 10993-5Sensitization testingper ISO 10993-10Irritation testing perISO 10993-10 | Cytotoxicity testing per ISO10993-5Sensitization testing per ISO10993-10Irritation testing per ISO10993-10 | No information | Cytotoxicity testingper ISO 10993-5Sensitization testingper ISO 10993-10Irritation testing perISO 10993-10 | Thebiocompatibilitytestingperformed forTherm-X isidentical to theMed4 Elite™and GameReady®. |
| Sterile/Non-Sterile | Non-sterile only | Non-sterile only | Sterile and non-sterile | Non-sterile only | Therm-X isidentical toMed4 Elite™,Game Ready®. |
| Characteristic | Therm-X(this submission) | Med4 Elite™(K171685) Primary predicate | VascuTherm™(VascuTherm™4 andVascuTherm™5) andNanoTherm™)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| andVascuTherm™.The onlydifference isthatVascuThermprovides sterilewraps inaddition to non-sterile wraps.This differencedoes not affectthe intendeduse or thesafety andeffectiveness ofthe device. | |||||
| Single PatientUse | Yes | No | Yes, they provideboth singlepatient andreusable wraps | No | Therm-X isidentical to theVascuTherm™.The onlydifference isthatVascuTherm™also providesreusable wrapsin addition to |
| Characteristic | Therm-X(this submission) | Med4 EliteTM(K171685) Primary predicate | VascuThermTM(VascuThermTM4 andVascuThermTM5) andNanoThermTM)(K061866)SecondaryPredicate | Game Ready®Classic System(GR 2) (K072620)SecondaryPredicate | Comparisonsand ReferenceDevice |
| the singlepatient usegarments. Thisdifference doesnot affect theintended use orthe safety andeffectiveness ofthe device |
Detailed Comparison of the Subject and Predicate Device
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Testing
Therm-X and Therm-X software were verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the type of test performed.
Electromagnetic Compatibility / Electrical Safety:
Electromagnetic Compatibility / Electrical Safety testing was performed in accordance with the following standards:
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic ● safety and essential performance
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
Verification results indicated that the device is safe.
Biocompatibility:
The Therm-X Unit is not patient contacting. The Therm-X garment patient contact materials were verified in accordance with the following standards:
- . ISO 10993-1: 2009. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- ISO 10993-5: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro ● cytotoxicity
- ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for Irritation ● and Skin Sensitization
Verification results indicated that the materials comply with the standard.
Software Validation:
Zenith has conducted software validation testing on the Therm-X software and confirmed that Therm-X software met its performance requirements and specifications. Software Validation has been completed according to an established Validation procedure and FDA Guidance documents and Industry Standards:
- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Januarv 11. 2002
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
The Software is a Moderate Level of Concern as per FDA quidance. All required items related to software as required by FDA guidance have been included in this submission.
Performance - Bench:
The Therm-X was tested for performance to verify the proper operation of the system.
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Test and verification results indicate that Therm-X conforms to its predetermined specifications. Therm-X has been found to be adequately safe and effective for the intended users, its intended uses and use environments.
Clinical Testing:
Zenith has performed skin temperature testing for:
- Maximum time limit at the highest temperature setting
- . Maximum time limit at the lowest temperature setting
- . Contrast therapy at the default time limit and temperature settings
Based on these results, it has been concluded that the temperature limits of Therm-X do not cause any thermal damage to the skin. The clinical study demonstrated that there are no safety issues created by the device and that Therm-X is as safe and effective as the predicate devices.
Human Factors / Usability:
Human Factors / Usability assessments were performed in a simulated use environment to optimize the device design and support the safe use of Therm-X. The results demonstrated that users can operate Therm-X as safely and as effectively as the predicate devices.
Substantial Equivalence Conclusions
In conclusion, the intended use for Therm-X is substantially equivalent to that of the predicate devices. The technological characteristics comparison demonstrates that Therm-X is equivalent to predicate devices, and the testing shows that Therm-X is substantially equivalent to the predicate devices and assures that Therm-X is as safe and effective as the predicate devices.
Conclusion
The 510(k) Pre-market Notification for Therm-X contains adequate information and data to determine that Therm-X is as safe and effective as the legally marketed predicate devices.
§ 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).