(131 days)
Not Found
No
The device description and performance studies focus on standard electromagnetic energy generation and application, with no mention of AI/ML algorithms for treatment planning, parameter adjustment, or outcome prediction.
Yes
The device is described as applying "therapeutic deep heat" for the "treatment of selected medical conditions," indicating a direct therapeutic purpose.
No
The device is described as a therapeutic shortwave diathermy device that applies deep heat to treat various medical conditions, rather than diagnosing them. Its intended use focuses on pain relief, reducing muscle spasms, decreasing joint stiffness, and treating inflammatory conditions.
No
The device description explicitly states it is a physical device with a metal enclosure, display touchscreen, and an applicator (monode electrode) connected to the housing. It generates and applies electromagnetic energy, which is a hardware function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a therapeutic device that applies heat to body tissues for treating various musculoskeletal and inflammatory conditions. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a shortwave diathermy device that generates and applies electromagnetic energy to the body. This mechanism is consistent with a therapeutic device, not a device that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly treat conditions through the application of heat.
N/A
Intended Use / Indications for Use
Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffness, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases.
Generally accepted indications for use:
o Pain Relief
- o Contractures
- o Reduce Muscle Spasm
- o Localized increase Blood Flow
- o Chronic Inflammatory Conditions
- o Bursitis
- o Decrease Joint Stiffness
- o Tenosynovitis
- o Synovitis
- o Chronic Inflammatory Pelvic Disease
Product codes (comma separated list FDA assigned to the subject device)
IMJ
Device Description
ThermoPro is a shortwave diathermy device for use in applying therapeutic deep heat for selected medical conditions by applying electromagnetic energy in the radio frequency band of 27.12 MHz. The ThermoPro is a device with a metal enclosure that includes a display touchscreen. The device also features an applicator that is a standard monode electrode. The applicator is connected to the device housing, where an electronic power module drives electromagnetic energy into applicator. This electromagnetic energy is generated using a sine wave synthesizer in combination with a RF power amplifier. The energy can be applied either in constant wave mode or in pulsed mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 ThermoPro device has been tested against and complies with the following voluntary standards:
ANSI/AAMI/ISO 10993-1 - Biological evaluation of medical devices – Part 1:Evaluation and testing
IEC 60601-1 - Medical Electrical Equipment, Part 1
IEC 60601-1-2 - Medical Electrical Equipment, Part 1-2, Electromagnetic Compatibility
IEC 60601-1-6 - Medical Electrical Equipment, Part 1-6, Usability
IEC 60601-2-3 - Medical Electrical Equipment, Part 2-3, Shortwave Therapy Equipment
IEC 62366-1 - Medical Devices – Part 1, Application of Usability Engineering to Medical Devices
ISO 62304 - Software Development Life Cycle
ISO 14971 - Medical devices -- Application of risk management to medical 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
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2016
Zimmer MedizinSysteme GmbH % Scott Blood Principal Consultant Quality & Regulatory Consulting 22 Nichols Street #2 Salem, Massachusetts 01970
Re: K161862
Trade/Device Name: ThermoPro Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class II Product Code: IMJ Dated: October 5, 2016 Received: October 11, 2016
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. 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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Hoffmann -A
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
2
Indications for Use
510(k) Number (if known) K161862
Device Name ThermoPro
Indications for Use (Describe)
Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffness, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases.
Generally accepted indications for use:
o Pain Relief
- o Contractures
- o Reduce Muscle Spasm
- o Localized increase Blood Flow
- o Chronic Inflammatory Conditions
- o Bursitis
- o Decrease Joint Stiffness
- o Tenosynovitis
- o Synovitis
- o Chronic Inflammatory Pelvic Disease
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 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, sans-serif font. The logo is in grayscale.
510(k) Summary
-
- Basic Information-Submitter:
| 510(k) Owner: | Zimmer MedizinSysteme GmbH
Junkersstrasse 9
D-89231 Neu-Ulm
Germany |
|-------------------------------------|------------------------------------------------------------------------------|
| Establishment Registration: 8010720 | |
Official Contact: Mr. Armin Petraschka Project Manager Phone: +49-731-9761-140 Fax: +49-731-9761-4475 E-mail: a.petraschka@zimmer.de
Date Summary Prepared: 30 June 2016
-
- Device Name:
Trade Name: ThermoPro Common Name: Shortwave Diathermy Classification Name: Diathermy, Shortwave, for use in applying therapeutic deep heat Regulation Number: 21 CFR 890.5290 Product Code: IMJ Classification: Class II
- Device Name:
-
- Predicate Devices:
INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 - K083433
- Predicate Devices:
-
- Device Description:
ThermoPro is a shortwave diathermy device for use in applying therapeutic deep heat for selected medical conditions by applying electromagnetic energy in the radio frequency band of 27.12 MHz. The ThermoPro is a device with a metal enclosure that includes a display touchscreen. The device also features an applicator that is a standard monode electrode. The applicator is connected to the device housing, where an electronic power module drives electromagnetic energy into applicator. This
- Device Description:
4
Image /page/4/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 in grayscale.
electromagnetic energy is generated using a sine wave synthesizer in combination with a RF power amplifier. The energy can be applied either in constant wave mode or in pulsed mode.
-
- Indications for Use Statement:
Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffness, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases.
- Indications for Use Statement:
Generally accepted indications for use:
- Pain Relief ●
- . Contractures
- Reduce Muscle Spasm ●
- Localized increase Blood Flow ●
- Chronic Inflammatory Conditions ●
- . Bursitis
- . Decrease Joint Stiffness
- Tenosynovitis ●
- Synovitis ●
- Chronic Inflammatory Pelvic Disease ●
-
- Technological Characteristics:
Shortwave diathermic therapy relies on the conversion of electric power into heat energy that takes place directly inside the tissue, as opposed to a typical heat treatment method in which heat (e.g. heat packs) is supplied from the outside of the tissue. A highfrequency field generates eddy currents in the treated tissues that lead to molecular excitations and convert the electrical energy into heat.
The energy can be applied either in constant wave mode or in pulsed mode. To run a therapy, the user selects the mode, pulse frequency and duty cycle (if applicable), power level and duration of therapy .The coupling is dependent on the distance between the applicator and the patient and can easily be controlled by supervising the coupling indicator on the display.
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 ThermoPro shares the same intended use and the same basic characteristics and features as the predicate device, the Intelect SWD100. The table below summarizes the comparison of those critical features of the ThermoPro device with the predicate device:
| Technological
Characteristics | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
Thermo Pro | PREDICATE DEVICE
Chattanooga Group
Intelect SWD 100
K083433 |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Dimensions (in.) | 33.6 h x 22.9 w x 18.0 d | 45.0 h x 16.5 w x 16.1 d |
| Weight (lbs) | 81.6 | 60.0 |
| Enclosure material | Metal | Metal |
| Applicator | Standard:
Monode electrode | Standard:
Monode electrode
Optional:
Flexible electrode,
Diplode electrode,
Capacitive electrodes |
| Frequency (MHz) | 27.12 | 27.12 |
| Power Source | 100 - 240 VAC, 50 / 60Hz | 100 - 240 VAC, 50 / 60Hz |
| Output power (W) | 100 | 100 |
| Pulsed Output Power (W) | 200
Limited to 64W peak mean
power | 200
Limited to 64W peak mean
power |
| Applied Part Type
(applicator) | BF | BF |
| Protection Class | I | I |
| Touch screen Interface | Yes | Yes |
| External Memory | No | No |
| Modifiable waveform
parameters / Customizable
treatment parameters | Yes | Yes |
| Pulse Rate | CW mode
10 - 1000 Hz
Adjustable from:
10 Hz – 200 Hz in 10 Hz
increments
200 Hz - 800 Hz in 100 Hz
increments
1000 Hz | CW mode
10 - 800 Hz
Adjustable in 10 Hz increments |
| Duty Cycle (%) | 10 - 90% | 0.02 - 32%
preset - not adjustable |
| Pulse Width | 250 $\mu$ s – 90ms
in 250 $\mu$ s increments | 20 – 400 $\mu$ s
in 20 $\mu$ s increments |
| Technological
Characteristics | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
ThermoPro | PREDICATE DEVICE
Chattanooga Group
Intelect SWD 100
K083433 |
| | preset - not adjustable | |
| Accuracy (%) | $+/- 20%$ | $+/- 20%$ |
| Maximum Treatment Time
(mins) | 30 | 30 |
| Favorites / named user
defined programs | Yes | Yes |
| Calculated and displayed
energy | Yes | Yes |
| Displayed treatment time | Yes | Yes |
Premarket Notification, ThermoPro Proprietary and Confidential Information of Zimmer MedizinSysteme GmbH
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 letters "zi". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, sans-serif font.
Any differences in their technological characteristics are explained to demonstrate in this submission that these differences do not raise any new questions of safety and effectiveness.
-
- Performance data:
The ThermoPro device has been tested against and complies with the following voluntary standards:
- Performance data:
| ANSI/AAMI/ISO 10993-1 | Biological evaluation of medical devices –
Part 1:Evaluation and testing |
|-----------------------|--------------------------------------------------------------------------------------|
| IEC 60601-1 | Medical Electrical Equipment, Part 1 |
| IEC 60601-1-2 | Medical Electrical Equipment, Part 1-2,
Electromagnetic Compatibility |
| IEC 60601-1-6 | Medical Electrical Equipment, Part 1-6,
Usability |
| IEC 60601-2-3 | Medical Electrical Equipment, Part 2-3,
Shortwave Therapy Equipment |
| IEC 62366-1 | Medical Devices – Part 1, Application of
Usability Engineering to Medical Devices |
| ISO 62304 | Software Development Life Cycle |
| ISO 14971 | Medical devices -- Application of risk
management to medical devices |
7
Image /page/7/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 in grayscale.
Testing has been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests.
-
- 510(k) Summary:
Zimmer MedizinSysteme GmbH has demonstrated that the ThermoPro device is substantially equivalent to the predicate device listed above.
- 510(k) Summary: