The ProMedTek Model C1400 Shortwave Diathermy device delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:

Relieving pain
Reducing muscle spasm
Increasing range of motion of contracted joints using heat and stretch techniques
Increasing blood flow to tissues in the treatment area.

Device Description

The ProMedTek C1400 shortwave diathermy device operates at 27.12 MHz. It provides traditional shortwave diathermy using an inductive drum or soft-rubber electrodes. The unit offers both continuous or pulsed modes of operation with a variety of frequencies and pulse widths to choose from. An easy-to-use LCD Touch Screen guides the user through setup. A Patient Safety Pull-Cord allows the patient to stop all output. The base of the ProMedTek C1400 is a sturdy cart with large locking wheels that allows the ProMedTek C1400 to be moved easily around the clinic and supports the arm and drum applicator during treatment.

AI/ML Overview

The provided document is a 510(k) summary for the ProMedTek Model C1400 Shortwave Diathermy Device. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through technological comparison and compliance with relevant standards, rather than extensive clinical studies or AI-driven performance evaluations.

Given the nature of this submission for a shortwave diathermy device, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically understood for AI/ML-driven diagnostic devices (e.g., sensitivity, specificity, clinical endpoints) are not directly applicable in the same way. Instead, "acceptance criteria" here refer to meeting regulatory standards and demonstrating comparable performance to the predicate device through technical and safety testing.

Therefore, many of the requested numbered items for AI/ML device studies will not be present or directly relevant to this document. I will extract what information is available and indicate when a specific point is not applicable.

Acceptance Criteria and Study for ProMedTek Model C1400 Shortwave Diathermy Device

This device is a shortwave diathermy device, which primarily relies on established physical principles for deep tissue heating, rather than diagnostic algorithms or AI/ML. The "acceptance criteria" for this type of device in a 510(k) submission generally revolve around safety, electrical performance, and functional equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured by Compliance to Standards & Predicate Equivalence)	Reported Device Performance (ProMedTek Model C1400)
Safety & Electrical Performance:
IEC 60601-1 (General Requirements for Basic Safety and Essential Performance)	Complies with IEC 60601-1
IEC 60601-1-2 (Electromagnetic Compatibility)	Complies with IEC 60601-1-2
IEC 60601-2-3 (Particular Requirements for the Basic Safety and Essential Performance of Short-wave Therapy Equipment)	Complies with IEC 60601-2-3
Functional Equivalence to Predicate Device (Auto Therm 390, Model ME 390 K042554):
Intended Use / Indications for Use Statement	"Almost identical" to predicate. New device statement: "...relieving pain, reducing muscle spasm, increasing range of motion of contracted joints using heat and stretch techniques, increasing blood flow to tissues in the treatment area."
Technology (System Components, Applicator Components, Accessories)	Same as predicate (Unit with Cart and Arm for Inductive Drum Applicator, Inductive Drum Applicator, Soft-Rubber Applicators (2), Felt spacers, Cloth cover, Velcro Receptive Elastic Straps).
Input (100-240 VAC, 50-60 Hz)	Same as predicate
Frequency (27.12 MHz)	Same as predicate
Output Types (Continuous, Pulsed)	Same as predicate
HF Output Continuous (100 W Average Power)	Same as predicate
HF Output Pulsed (200 W Peak Power)	Same as predicate
Pulse Rate Settings (10Hz, 20 Hz, 50 Hz, 100 Hz, 400 Hz)	Same as predicate
Pulse Width Settings (65 μs, 100 μs, 200 μs, 300 μs, 400 μs)	Same as predicate
Modes (Inductive, Capacitive)	Same as predicate
Treatment Time (1-30 minutes)	Same as predicate
Software controlled	Yes (Same as predicate, which is also software controlled according to comparison table)
User Display and Interface	LCD Touch Screen displays interactive instructions and indicators. (Predicate: "Similar User interface has tactile selection buttons and LED indicators." This is noted as a difference, but not one that raises new questions of safety or effectiveness according to the summary.)
Software Verification & Validation	Conducted as recommended by FDA guidance. Software level of concern: "moderate."

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 applicable as this device is a physical therapy device (shortwave diathermy) and not an AI/ML diagnostic or predictive device that would typically involve a "test set" of patient data in this context. The "testing" referred to is primarily electrical, safety, and functional conformance to standards and predicate device specifications.

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 applicable. Ground truth experts are typically required for interpreting complex diagnostic images or patient data to validate AI/ML algorithms. This device's function is therapeutic deep heating, and its safety and efficacy are evaluated through engineering tests and comparison to predicate devices, not by expert interpretation of patient outcomes in a diagnostic "test set" validation.

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

This information is not applicable. Adjudication methods are specific to conflict resolution in expert ground truth establishment for diagnostic or predictive tasks, not for the type of device being reviewed here.

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 applicable. MRMC studies are used to assess the impact of AI on human reader performance for diagnostic tasks. This device is not an AI-assisted diagnostic tool.

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

This information is not applicable. This device is not an algorithm-only diagnostic or predictive tool. It is a physical therapy device operated by a human.

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

This information is not applicable in the context of typical AI/ML device validation. The "ground truth" for this device's performance is established by:

Compliance with recognized electrical safety and EMC standards (IEC 60601-1, -1-2, -2-3).
Demonstrating functional equivalence to a legally marketed predicate device (Auto Therm 390), meaning it operates in the same way and produces the same therapeutic effects, which have been previously deemed safe and effective.
Software verification and validation ensuring the control systems function as intended.

8. The sample size for the training set

This information is not applicable. This device does not use an AI/ML algorithm that requires a "training set" of data.

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

This information is not applicable. This device does not involve a training set or associated ground truth.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 17, 2016

ProMedTek Inc. % Diane Horwitz President Mandell Horwitz Consultants LLC 2995 Steven Martin Dr. Fairfax, Virginia 22031

Re: K162240

Trade/Device Name: ProMedTek Model C1400 Shortwave Diathermy Device Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class II Product Code: IMJ Dated: October 14, 2016 Received: October 15, 2016

Dear Ms. Horwitz:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related 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) K162440

Device Name

ProMedTek Model C1400 Shortwave Diathermy Device

Indications for Use (Describe)

1. Relieving pain
1. Reducing muscle spasm
1. Increasing range of motion of contracted joints using heat and stretch techniques
1. Increasing blood flow to tissues in the treatment area

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 PROMEDTEK. The logo features the company name in gray, with a stylized figure above the "M" and a globe in orange replacing the "O". The font is sans-serif and appears to be a modern design.

510(k) SUMMARY

GENERAL INFORMATION 1.

1.1 Submitter and 510(k) Owner

Dan Puchek, President and CEO ProMedTek Inc. 4110 N Scottsdale Road, Suite 270 Scottsdale AZ 85251

1.2 Official Correspondent

Diane Horwitz, Ph.D., RAC, Regulatory Consultant 2995 Steven Martin Dr. Fairfax, VA 22031

Telephone: 703.307.2921 Fax: 703.242.1117 Email: dmh@mandellhorwitzconsulting.com

1.3 Date of Preparation

November 15, 2016

2. NAME OF THE DEVICE

2.1.1 Trade/Proprietary Name

ProMedTek Model C1400 Shortwave Diathermy

2.1.2 Common/Usual Name

Diathermy, Shortwave, for use in Applying Therapeutic Deep Heat

2.1.3 Classification Information

Classification Name:	Shortwave diathermy
Classification Regulation:	21 CFR 890.5290
Class:	II
Product Code:	IMJ
Panel:	Physical Medicine

3. PREDICATE DEVICE

The predicate device is Auto Therm 390, Model ME 390 (Mettler Electronics Corp., K042554).

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4. DESCRIPTION OF THE DEVICE

5. INTENDED USE

The intended use / indications for use for the Model C1400 Shortwave Diathermy is as follows:

"The ProMedTek Model C1400 Shortwave Diathermy device delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:

1. Relieving pain
1. Reducing muscle spasm
1. Increasing range of motion of contracted joints using heat and stretch techniques.
1. Increasing blood flow to tissues in the treatment area."

SUBSTANTIAL EQUIVALENCE COMPARISON 6.

The Model C1400 Shortwave Diathermy and the predicate device share intended use and technological features. The intended use and indications for use statements are almost identical. There are no differences in technology between the two devices. A comparison of the characteristics to the predicate device follows.

Characteristic	ProMedTek Model C1400Shortwave DiathermyNew device	Predicate (K042554)AutoTherm 390Mettler Electronics Corp.
INTENDED USE / INDICATIONS FOR USE STATEMENT
Statement	The ProMedTek Model C1400Shortwave Diathermy device deliversenergy in the radio band of 27.12MHz to provide deep heatingtherapeutic effects to body tissues.When shortwave diathermy isdelivered to the body at intensitiescapable of generating a deep tissuetemperature increase, it can be used totreat selected medical conditions suchas:1. Relieving pain2. Reducing muscle spasm	Shortwave diathermy deliversenergy in the radio band of 27.12MHz to provide deep heatingtherapeutic effects to bodytissues. When shortwavediathermy is delivered to thebody at intensities capable ofgenerating a deep tissuetemperature increase, it can beused to treat selected medicalconditions such as:1. Relieving pain2. Reducing muscle spasm
Characteristic	ProMedTek Model C1400Shortwave Diathermy	Predicate (K042554)AutoTherm 390
	New device	Mettler Electronics Corp.
	3. Increasing range of motion ofcontracted joints using heat andstretch techniques.4. Increasing blood flow to tissues inthe treatment area.	3. Increasing range of motion ofcontracted joints using heat andstretch techniques.4. Increasing blood flow totissues in the treatment area.
TECHNOLOGY
System Components	Unit with Cart and Arm for InductiveDrum Applicator	Same
Applicator Components	Inductive Drum ApplicatorSoft-Rubber Applicators (2)	Same
Accessories	Felt spacers for Soft-RubberApplicators (6)Cloth cover for Soft-RubberApplicators (2)Velcro Receptive Elastic Straps (2)	Same
Input	100-240 VAC, 50-60 Hz	Same
Frequency	27.12 MHz	Same
Output Types	ContinuousPulsed	Same
HF Output Continuous	100 W Average Power	Same
HF Output Pulsed	200 W Peak Power	Same
Pulse Rate Settings	10Hz, 20 Hz, 50 Hz, 100 Hz, 400 Hz	Same
Pulse Width Settings	65 μs, 100 μs, 200 μs, 300 μs, 400 μs	Same
Modes	InductiveCapacitive	Same
Treatment Time	1-30 minutes	Same
Software controlled	Yes	Same
User Display andInterface	LCD Touch Screen displaysinteractive instructions and indicators	SimilarUser interface has tactileselection buttons and LEDindicators

TECHNOLOGY OF THE MODEL C1400 SHORTWAVE DIATHERMY AND THE PREDICATE DEVICE

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PERFORMANCE TESTING 7.

The 510(k) submission provided performance data to establish the substantial equivalence of the ProMedTek Model C1400 to the predicate device. A summary of these performance tests is provided below.

Software verification and validation testing: Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and

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FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Electrical safety and electromagnetic compatibility: The Model C1400 complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-3 and was found to meet all applicable requirements.

8. CONCLUSIONS

This 510(k) submission demonstrates that the ProMedTek Model C1400 is substantially equivalent to the predicate device.

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.