(602 days)
Not Found
No
The summary describes a standard diathermy device with manual controls for intensity and time, and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is described as "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" and "to provide a temporary reduction in the appearance of cellulite," which are therapeutic applications.
No
The device description, intended use, and indications for use all describe a therapeutic device that provides topical heating and massage for treatment purposes, not for diagnosing conditions.
No
The device description clearly outlines physical hardware components including a plastic housing, capacitive touch display, electronic power module, handpieces, electrode cables, electrodes, and a silicone spacer. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the ThermoTK device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "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" and "to provide a temporary reduction in the appearance of cellulite." These are therapeutic applications performed on the body, not diagnostic tests performed on samples taken from the body.
- Device Description: The description details a medical diathermy device that applies electromagnetic fields externally to the human skin. This aligns with a therapeutic device, not a device that analyzes biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ThermoTK device's function and intended use fall outside this definition.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PBX
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Whole body excepted those mentioned in the contraindications
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ThermoTK device has been investigated and tested against and complies with the following voluntary standards:
- ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) - ANSI AAMI - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- 60601-1-2:2014 (Edition 4.0) - IEC - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- 60601-1-6:2013 (Edition 3.1) - IEC - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- 62366-1:2015 (Edition 1.0) - IEC - Medical devices - Part 1: Application of usability engineering to medical devices
- 62304:2015 (Edition 1.1) - IEC - Medical devices software -software life cycle processes
- 14971:2019-12 (Edition 3.0) - ISO - Medical devices - Application of risk management to medical devices
- 15223-1:2016 (Edition 3) - ISO - Medical devices - Symbols to be used with medical device 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 management process
- 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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,
| Mark
Trumbore -S | Digitally signed by
Mark Trumbore -S
Date: 2023.05.25
10:01:22 -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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
4
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 DEVICE
Zimmer MedizinSysteme GmbH
ThermoTK
This Submission | PREDICATE DEVICE
WINBACK USA Corp
Winback Back 3SE
K162828 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | General & Plastic Surgery
21 CFR 878.4400
PBX - Massager, Radio Frequency
Induced Heat | General & Plastic Surgery
21 CFR 878.4400
PBX - Massager, Radio Frequency
Induced Heat |
| Indications for
Use | 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 Winback Back 3SE 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 | The Winback Back 3SE massage |
| | device is intended to provide a
temporary reduction in the
appearance of cellulite. | device is intended to provide a
temporary reduction in the
appearance 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:
5
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.
| Technological
Characteristics | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
ThermoTK
This Submission | PREDICATE DEVICE
WINBACK USA Corp
Winback Back 3SE
K162828 |
|--------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------|
| Massaging hand
piece | Yes | Yes |
| Electrode Shapes | Rectangular and circular | Square and circular |
| Infrared Light | No | No |
| Vacuum (suction) | No | No |
| Treatment Activation | Finger selection on capacitive
touch 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 with
accessories | Cart mounted console with
accessories |
| Patient Safety Switch | No | Yes |
| Temperature
Capacitive mode
Resistive mode | Skin Temperature +1°C to max.
42°C ± 5% | 40°C - 43°C |
| Treatment Area | Whole body excepted those
mentioned in the contraindications | Whole body excepted those
mentioned in the contraindications |
| Operating modalities | Continuous
Pulsed | Continuous
Pulsed |
| Modes | Resistive
Capacitive
Hands-free | Resistive
Capacitive |
6
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.
| Technological
Characteristics | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
ThermoTK
This Submission | PREDICATE DEVICE
WINBACK USA Corp
Winback Back 3SE
K162828 |
|----------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------|
| 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:
7
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 | Standards
Organization | Standards Title |
|-------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ES60601-
1:2005/(R)2012
and A1:2012,
C1:2009/(R)2012
and
A2:2010/(R)2012
(Consolidated
Text) | ANSI AAMI | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance |
| 60601-1-2:2014
(Edition 4.0) | IEC | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests |
| 60601-1-6:2013
(Edition 3.1) | IEC | Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability |
| 62366-1:2015
(Edition 1.0) | IEC | Medical devices - Part 1: Application of usability
engineering to medical devices |
| 62304:2015
(Edition 1.1) | IEC | Medical devices software -software life cycle
processes |
| 14971:2019-12
(Edition 3.0) | ISO | Medical devices - Application of risk management to
medical devices |
| 15223-1:2016
(Edition 3) | ISO | Medical devices - Symbols to be used with medical
device 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 management
process |
| 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:
8
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 DEVICE
Zimmer MedizinSysteme GmbH
ThermoTK
This Submission | PREDCIATE DEVICE
WINBACK USA Corp
Winback Back 3SE
K162828 |
|--------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------|
| 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 10993-1
ISO 10993-5
ISO 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.