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

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.

AI/ML Overview

This document describes the design and performance characteristics of the ThermoPro shortwave diathermy device, manufactured by Zimmer MedizinSysteme GmbH. The device is intended for applying therapeutic deep heat in body tissues for the treatment of various medical conditions.

Based on the provided information, much of the requested detail regarding acceptance criteria linked to a specific study demonstrating device performance (especially in a clinical or AI-assisted context) is not present. The document focuses on regulatory submission for a 510(k) clearance, which primarily establishes substantial equivalence to a predicate device rather than presenting novel clinical study results with acceptance criteria.

However, I can extract information related to technical characteristics and compliance with recognized standards, which serve as a form of "acceptance criteria" for regulatory clearance based on substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available:

1. A table of acceptance criteria and the reported device performance

The document does not present "acceptance criteria" in the typical sense of a clinical trial (e.g., x% sensitivity/specificity), but rather technical specifications and compliance with international standards. The "performance" is implicitly demonstrated by meeting these technical specifications and by substantial equivalence to the predicate device.

Acceptance Criteria (Technical/Regulatory Standard)	Reported Device Performance (ThermoPro)	Basis of Acceptance
Intended Use	Applying therapeutic deep heat in body tissues for the treatment of selected medical conditions.	Verified via comparison to predicate device (Intelect SWD 100).
Operating Frequency	27.12 MHz	Matches predicate device. Essential for shortwave diathermy.
Output Power (CW)	100 W	Matches predicate device.
Pulsed Output Power	200 W (limited to 64W peak mean power)	Matches predicate device.
Applied Part Type	BF	Matches predicate device.
Protection Class	I	Matches predicate device.
Touch screen Interface	Yes	Matches predicate device.
External Memory	No	Matches predicate device.
Modifiable waveform parameters / Customizable treatment parameters	Yes	Matches predicate device.
Pulse Rate	CW mode: 10 - 1000 Hz	Comparable to predicate device (10-800 Hz). Differences deemed not to raise new safety/effectiveness questions.
Duty Cycle (%)	10 - 90%	Different from predicate (0.02 - 32% preset), but not deemed to raise new safety/effectiveness issues based on the submission.
Pulse Width	250 µs – 90ms	Different from predicate (20 – 400 µs), but not deemed to raise new safety/effectiveness issues based on the submission.
Accuracy (%)	+/- 20%	Matches predicate device.
Maximum Treatment Time (mins)	30	Matches predicate device.
Favorites / named user-defined programs	Yes	Matches predicate device.
Calculated and displayed energy	Yes	Matches predicate device.
Displayed treatment time	Yes	Matches predicate device.
Biological evaluation (ISO 10993-1)	Complies	Tested against and complies with the standard.
Medical Electrical Equipment (IEC 60601-1)	Complies	Tested against and complies with the standard.
EMC (IEC 60601-1-2)	Complies	Tested against and complies with the standard.
Usability (IEC 60601-1-6 & IEC 62366-1)	Complies	Tested against and complies with the standard.
Shortwave Therapy Equipment (IEC 60601-2-3)	Complies	Tested against and complies with the standard.
Software Development Life Cycle (ISO 62304)	Complies	Tested against and complies with the standard.
Risk Management (ISO 14971)	Complies	Tested against and complies with the standard.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission is for a 510(k) premarket notification, which relies heavily on demonstrating substantial equivalence to an existing device through technical and performance characteristic comparisons and compliance with relevant standards, rather than new clinical trials with patient-based test sets. The tests mentioned are for safety and performance against standards, not typically clinical efficacy with a "test set" of patients.

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. As noted above, the submission primarily focuses on technical equivalence and compliance with standards, not on deriving ground truth from human experts for a performance evaluation in a clinical setting.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Not applicable in the context of the presented regulatory submission which lacks a clinical test set requiring expert adjudication.

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

This information is not provided. The device is a physical therapy device (shortwave diathermy), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The ThermoPro is a physical therapy device, not an algorithm. Its performance is evaluated through its physical and electrical characteristics and its ability to safely deliver energy according to its specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not explicitly stated in terms of clinical ground truth. For the technical aspects, the "ground truth" would be established by the specifications of the predicate device (Intelect SWD 100) and the requirements of the international standards (e.g., IEC 60601 series, ISO 14971). The device's "performance" is its ability to meet these engineering and safety specifications.

8. The sample size for the training set

This information is not applicable/not provided. The device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/not provided. The device is not an AI algorithm that requires a training set.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K161862

Device Name ThermoPro

Indications for Use (Describe)

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)

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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

1. Basic Information-Submitter:

510(k) Owner:	Zimmer MedizinSysteme GmbHJunkersstrasse 9D-89231 Neu-UlmGermany
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

1. 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
1. Predicate Devices:
  INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 - K083433
1. 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

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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.

1. 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.

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 ●
1. 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.

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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 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:

TechnologicalCharacteristics	SUBJECT DEVICEZimmer MedizinSysteme GmbHThermo Pro	PREDICATE DEVICEChattanooga GroupIntelect SWD 100K083433
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 electrodeOptional: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)	200Limited to 64W peak meanpower	200Limited to 64W peak meanpower
Applied Part Type(applicator)	BF	BF
Protection Class	I	I
Touch screen Interface	Yes	Yes
External Memory	No	No
Modifiable waveformparameters / Customizabletreatment parameters	Yes	Yes
Pulse Rate	CW mode10 - 1000 HzAdjustable from:10 Hz – 200 Hz in 10 Hzincrements200 Hz - 800 Hz in 100 Hzincrements1000 Hz	CW mode10 - 800 HzAdjustable in 10 Hz increments
Duty Cycle (%)	10 - 90%	0.02 - 32%preset - not adjustable
Pulse Width	250 $\mu$ s – 90msin 250 $\mu$ s increments	20 – 400 $\mu$ sin 20 $\mu$ s increments
TechnologicalCharacteristics	SUBJECT DEVICEZimmer MedizinSysteme GmbHThermoPro	PREDICATE DEVICEChattanooga GroupIntelect SWD 100K083433
	preset - not adjustable
Accuracy (%)	$+/- 20%$	$+/- 20%$
Maximum Treatment Time(mins)	30	30
Favorites / named userdefined programs	Yes	Yes
Calculated and displayedenergy	Yes	Yes
Displayed treatment time	Yes	Yes

Premarket Notification, ThermoPro Proprietary and Confidential Information of Zimmer MedizinSysteme GmbH

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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.

1. Performance data:
  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 ofUsability Engineering to Medical Devices
ISO 62304	Software Development Life Cycle
ISO 14971	Medical devices -- Application of riskmanagement to medical devices

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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.

1. 510(k) Summary:
  Zimmer MedizinSysteme GmbH has demonstrated that the ThermoPro device is substantially equivalent to the predicate device listed above.

Regulation Number and Section

§ 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.