(602 days)
The ThermoTK device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
The ThermoTK massage device is intended to provide a temporary reduction in the appearance of cellulite.
ThermoTK is a medical diathermy device for external tissue heating on the human skin with the purpose of increasing tissue temperature by applying electromagnetic fields of 460 or 540 KHz.
The device includes a plastic housing with a capacitive touch display which guarantees an easy handling to select and start a treatment. In this housing, an electronic power module is implemented which drives the electromagnetic energy into the connected handpiece. By using the two adjusters, it is possible to set the treatment intensity and treatment time. Two handpieces for two different treatment modes are attached and can be connected to the control unit depending on which treatment mode the therapy has to be performed. An electrode (resistive or capacitive) has to be plugged on the handpiece for treatment. The device also includes two different electrode cables which can be connected with attached common electrodes (self-adhesive or reusable). For a better stability while using the handpiece during application, a silicone spacer can be put between handpiece and electrode.
The provided text is a 510(k) summary for the Zimmer MedizinSysteme GmbH ThermoTK device. It outlines the regulatory clearance process, device description, indications for use, and a comparison to a predicate device (Winback Back 3SE).
However, the document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance data for the device itself.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly available in the provided text. The focus is on showing equivalence through technological characteristics and compliance with general safety and performance standards.
Here's a breakdown of what can and cannot be extracted from the provided document based on your request:
Information NOT available in the document (and why):
- A table of acceptance criteria and the reported device performance specific to a clinical study: The document states "No direct comparison was made since there are no significant differences in operation and test results indicate identical safety." and "According to this comparison table all required performance tests were conducted and show substantial equivalence with the predicate devices." This indicates that performance was assessed against standards for substantial equivalence, not against specific pre-defined clinical acceptance criteria in a study.
- Sample size used for the test set and data provenance: No clinical testing specific to the ThermoTK device's indications of use (pain relief, muscle spasms, cellulite reduction) is described with a test set, sample size, or data provenance. The document only lists compliance with general electrical safety, EMC, usability, software, risk management, and biocompatibility standards.
- Number of experts used to establish ground truth and qualifications: Not applicable as no
clinical study with ground truth establishment is detailed. - Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned or implied.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as there is no mention of machine learning or AI models with training sets.
- How the ground truth for the training set was established: Not applicable.
Information that CAN be inferred or extracted from the document:
The document primarily highlights the acceptance criteria for regulatory clearance through substantial equivalence, which includes:
- Compliance with recognized voluntary standards: This is the primary "performance data" presented.
- Technological equivalence to a predicate device.
- Identical Indications for Use.
Here's how to structure the available information:
Acceptance Criteria and Study for ThermoTK Device (Based on 510(k) Summary K213256)
The provided 510(k) summary for the ThermoTK device emphasizes demonstrating substantial equivalence to a predicate device (Winback Back 3SE - K162828) rather than presenting a standalone clinical performance study with specific acceptance criteria related to its stated indications for use (relief of pain, muscle spasms, increased local circulation, and reduction in cellulite appearance). The "study" in this context refers to the comprehensive testing and comparison performed to secure regulatory clearance.
1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Performance:
| Acceptance Criterion Type (For 510(k) Clearance) | Specific Criterion (as described) | Reported Device Performance/Evidence Submitted |
|---|---|---|
| Indications for Use Equivalence | The device's intended uses must be identical to the predicate device. | "The Indications for Use statement for ThermoTK is identical to the predicate device."Both devices: - Provide topical heating for elevating tissue temperature to treat selected medical conditions (relief of pain, muscle spasms, increase local circulation). - Provide temporary reduction in the appearance of cellulite. |
| Technological Characteristics Equivalence | The device's technological characteristics should be substantially similar to the predicate device, or any differences should not raise new questions of safety or effectiveness. | Similarities: Both are medical diathermy devices for external tissue heating (460/540 KHz vs 300 kHz-1 MHz RF), operate in unipolar/multipolar modes, have intensity adjustments (0-100%), and utilize resistive/capacitive modes. Differences: Max RF power (115VA vs 300W), presence of a patient safety switch (No vs Yes for predicate), specific electrode dimensions. Conclusion: "There are no significant technological differences... Those differences have been discussed and do not affect device safety or performance. The subject device has all features of the predicate device. ThermoTK does not raise any new types of safety or effectiveness questions." |
| Voluntary Standards Compliance | The device must meet recognized industry standards for safety and performance relevant to its classification. | The ThermoTK device complied with the following standards:- ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) (General requirements for basic safety and essential performance)- IEC 60601-1-2:2014 (Electromagnetic disturbances)- IEC 60601-1-6:2013 (Usability)- IEC 62366-1:2015 (Usability engineering)- IEC 62304:2015 (Medical devices software)- ISO 14971:2019-12 (Application of risk management)- ISO 15223-1:2016 (Symbols)- ISO 10993-1:2018, 10993-5:2009, 10993-10:2010 (Biological evaluation/Biocompatibility) |
| Safety Testing | Demonstrates electrical safety and biocompatibility. | "Electrical safety and biocompatibility have been established for both devices." Compliance with 60601-1 and 10993 series standards is listed as evidence. "Testing has been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests." |
2. Sample size used for the test set and the data provenance:
- The document does not describe a specific clinical "test set" or sample size for validating the efficacy of the ThermoTK device for its indications for use.
- Data provenance is related to compliance with general international standards and internal testing procedures for electrical safety, EMC, usability, and biocompatibility, rather than human clinical data from a specific country or nature (retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The clearance is based on technological equivalence and compliance with standards, not on "ground truth" established by experts for clinical performance outcomes in a study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set requiring adjudication of outcomes is described.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a physical therapeutic device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for the regulatory clearance process described. The "ground truth" for substantial equivalence is derived from established predicate devices and recognized international standards for device safety and performance.
8. The sample size for the training set:
- Not applicable, as there is no mention of machine learning or AI models with training sets.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of machine learning or AI models with training sets.
In summary, the provided FDA 510(k) summary demonstrates regulatory acceptance primarily through engineering, electrical, and biocompatibility testing against defined standards and a detailed comparison showing substantial equivalence in technological characteristics and indications for use to a legally marketed predicate device, rather than through a traditional clinical trial with efficacy endpoints and human-based ground truth.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 25, 2023
Zimmer MedizinSysteme GmbH % Scott Blood Principal Consultant Quality and Regulatory Services 151 Gleasondale Road Stow, Massachusetts 01775
Re: K213256
Trade/Device Name: ThermoTK Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: May 5, 2023 Received: May 8, 2023
Dear Scott Blood:
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,
| MarkTrumbore -S | Digitally signed byMark Trumbore -SDate: 2023.05.2510:01:22 -04'00' |
|---|---|
| --------------------- | --------------------------------------------------------------------------------- |
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K213256
Device Name ThermoTK
Indications for Use (Describe)
The ThermoTK device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
The ThermoTK massage device is intended to provide a temporary reduction in the appearance of cellulite.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☐ Remediation Use (Part 21 CFR 201 Subpart D) |
|---|
| ☐ Own-Use Compounding (21 CFR 201 Subpart G) |
× Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the text 'K213256' in the upper right corner. The text is in a sans-serif font and is black. The background is white. There is also a large, light gray text that is vertically oriented.
Image /page/3/Picture/1 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller, lighter font. The logo is simple and modern, and the use of two different fonts creates a visual hierarchy.
510(k) Summary ThermoTK K213256
-
- Basic Information-Submitter:
510(k) Owner:
- Basic Information-Submitter:
Zimmer MedizinSysteme GmbH Junkersstrasse 9 89231 Neu-Ulm Germany Establishment Registration: 8010720
- Official Contact:
Mrs. Ute Hauss Manager Regulatory Affairs Phone: +49-731-9761-216 Fax: +49-731-9761-118 E-mail: u.hauss@zimmer.de
Date Summary Prepared:
September 29, 2021
-
- Device Name:
Trade Name: Common Name: Classification Name:
- Device Name:
Requlation Number: Product Code: Classification:
-
- Predicate Device: Company Name:
ThermoTK Massager, Radio Frequency Induced Heat Electrosurgical cutting and coagulation device and accessories 21 CFR 878.4400 РВХ Class II
- Predicate Device: Company Name:
Winback Back 3SE - K162828 WINBACK USA Corp
-
- Device Description:
ThermoTK is a medical diathermy device for external tissue heating on the human skin with the purpose of increasing tissue temperature by applying electromagnetic fields of 460 or 540 KHz.
- Device Description:
The device includes a plastic housing with a capacitive touch display which guarantees an easy handling to select and start a treatment. In this housing, an electronic power module is implemented which drives the electromagnetic energy into the connected handpiece. By using the two adjusters, it is possible to set the treatment intensity and treatment time. Two handpieces for two different treatment modes are attached and can be connected to the control unit depending on which treatment mode the therapy has to be performed. An
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Image /page/4/Picture/1 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "r". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, lighter font. The logo is in gray color.
electrode (resistive or capacitive) has to be plugged on the handpiece for treatment. The device also includes two different electrode cables which can be connected with attached common electrodes (self-adhesive or reusable). For a better stability while using the handpiece during application, a silicone spacer can be put between handpiece and electrode.
Indications for Use Statement:
ThermoTK is indicated to be used for:
Provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
The ThermoTK massage device is intended to provide a temporary reduction in the appearance of cellulite.
| ATTRIBUTE | SUBJECT DEVICEZimmer MedizinSysteme GmbHThermoTKThis Submission | PREDICATE DEVICEWINBACK USA CorpWinback Back 3SEK162828 |
|---|---|---|
| General & Plastic Surgery21 CFR 878.4400PBX - Massager, Radio FrequencyInduced Heat | General & Plastic Surgery21 CFR 878.4400PBX - Massager, Radio FrequencyInduced Heat | |
| Indications forUse | The ThermoTK device isintended to provide topical heatingfor the purpose of elevating tissuetemperature for the treatment ofselected medical conditions such asrelief of pain, muscle spasms, andincrease in local circulation. | The Winback Back 3SE device isintended to provide topical heatingfor the purpose of elevating tissuetemperature for the treatment ofselected medical conditions such asrelief of pain, muscle spasms, andincrease in local circulation. |
| The ThermoTK massage | The Winback Back 3SE massage | |
| device is intended to provide atemporary reduction in theappearance of cellulite. | device is intended to provide atemporary reduction in theappearance of cellulite. |
The Indications for Use statement for ThermoTK is identical to the predicate device.
-
- Technological Characteristics:
Both devices are consoles with electrode accessories capable of operation in unipolar and multipolar modes of 460 kHz or 540 kHz radiofrequencies.
- Technological Characteristics:
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Image /page/5/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, lighter font. The logo is simple and modern, and the use of a bold font and horizontal line makes it easily recognizable.
Both devices operate in the same treatment range and voltage and feature intensity adjustments from 0-100%. Electrical safety and biocompatibility have been established for both devices. No direct comparison was made since there are no significant differences in operation and test results indicate identical safety.
The table below summarizes the equivalence of the devices.
| TechnologicalCharacteristics | SUBJECT DEVICEZimmer MedizinSysteme GmbHThermoTKThis Submission | PREDICATE DEVICEWINBACK USA CorpWinback Back 3SEK162828 |
|---|---|---|
| Massaging handpiece | Yes | Yes |
| Electrode Shapes | Rectangular and circular | Square and circular |
| Infrared Light | No | No |
| Vacuum (suction) | No | No |
| Treatment Activation | Finger selection on capacitivetouch display and adjuster | Finger selection on console |
| RF Type | Multipolar/Unipolar | Multipolar/Unipolar |
| RF Frequency | 460 kHz or 540 kHz | 300 kHz – 1 MHz |
| Max RF Power | 115VA | 300 W |
| Intensity Adjustment | 0-100% | 0-100% |
| Configuration | Standalone console withaccessories | Cart mounted console withaccessories |
| Patient Safety Switch | No | Yes |
| TemperatureCapacitive modeResistive mode | Skin Temperature +1°C to max.42°C ± 5% | 40°C - 43°C |
| Treatment Area | Whole body excepted thosementioned in the contraindications | Whole body excepted thosementioned in the contraindications |
| Operating modalities | ContinuousPulsed | ContinuousPulsed |
| Modes | ResistiveCapacitiveHands-free | ResistiveCapacitive |
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Image /page/6/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller, lighter font. The logo is simple and modern, and the use of gray gives it a professional look.
| TechnologicalCharacteristics | SUBJECT DEVICEZimmer MedizinSysteme GmbHThermoTKThis Submission | PREDICATE DEVICEWINBACK USA CorpWinback Back 3SEK162828 |
|---|---|---|
| Electrode dimensions | Resistive electrode:Ø 30mm, 50mm, 70mm | Resistive electrode:Ø 40mm, 60mm, 70mm |
| Electrode dimensions | Capacitive electrode:Ø 30mm, 50mm, 70mm | Capacitive electrode:Ø 40mm, 60mm, 70mm |
| Common electrode:140mm x 240mm | Common electrode:Not mentioned | |
| Common electrode Self-adhesive:105mm x 200mm | Common electrode Self-adhesive:Not mentioned | |
| Safety features | Several output protections | Not publicly available |
There are no significant technological differences between the ThermoTK device and the predicate device. There are few and not significant technological differences between the subject device and the predicate device. Those differences have been discussed and do not affect device safety or performance. The subject device has all features of the predicate device. ThermoTK does not raise any new types of safety or effectiveness questions.
6. Performance data
The ThermoTK device has been investigated and tested against and complies with the following voluntary standards:
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Image /page/7/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, sans-serif font. Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller, sans-serif font. The logo is in gray.
| Standards | StandardsOrganization | Standards Title |
|---|---|---|
| ES60601-1:2005/(R)2012and A1:2012,C1:2009/(R)2012andA2:2010/(R)2012(ConsolidatedText) | ANSI AAMI | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance |
| 60601-1-2:2014(Edition 4.0) | IEC | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard: Electromagneticdisturbances - Requirements and tests |
| 60601-1-6:2013(Edition 3.1) | IEC | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability |
| 62366-1:2015(Edition 1.0) | IEC | Medical devices - Part 1: Application of usabilityengineering to medical devices |
| 62304:2015(Edition 1.1) | IEC | Medical devices software -software life cycleprocesses |
| 14971:2019-12(Edition 3.0) | ISO | Medical devices - Application of risk management tomedical devices |
| 15223-1:2016(Edition 3) | ISO | Medical devices - Symbols to be used with medicaldevice labels, labeling, and information to be supplied- Part 1: General requirements |
| 10993-1:2018(Edition 5)10933-10 | ISO | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess |
| 10993-5:2009(Edition 3) | ISO | Biological evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity |
| 10993-10:2010(Edition 3) | ISO | Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization |
The following table shows a comparison of the performance testing in comparison to the predicate device:
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Image /page/8/Picture/0 description: The image contains the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, sans-serif font. The logo is in grayscale.
| Standards | SUBJECT DEVICEZimmer MedizinSysteme GmbHThermoTKThis Submission | PREDCIATE DEVICEWINBACK USA CorpWinback Back 3SEK162828 |
|---|---|---|
| ANSI AAMI 60601-1 | X | X |
| IEC 60601-1-2 | X | X |
| IEC 60601-1-6 | X | X |
| IEC 62366-1 | X | X |
| ISO 14971 | X | X |
| ISO 10993-1ISO 10993-5ISO 10933-10 | X | X |
According to this comparison table all required performance tests were conducted and show substantial equivalence with the predicate devices.
Testing has been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests.
7. 510(k) Summary:
Zimmer MedizinSysteme GmbH has demonstrated that the ThermoTK device is substantially equivalent to the predicate device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.