The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.

Device Description

The Caerus Active System is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) and thermal exchange therapy. The Active System includes general use wraps and therapy is delivered with single-use OrthoPods, sold separately.

The Caerus Avenue8 device is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) therapy and electronic heat.

AI/ML Overview

The provided text is a 510(k) summary for the Caerus Active System and Avenue8, seeking substantial equivalence to predicate devices. It describes performance data and a clinical study conducted.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that non-clinical performance testing and a clinical study were conducted to verify device performance and satisfy special controls. However, it does not explicitly state specific acceptance criteria values (e.g., "The device must achieve X% pain reduction to be considered effective") and then report the results against those criteria in a tabular format. Instead, it reports outcomes from the clinical study and compliance with standards.

We can infer "performance" from the clinical study's outcome in terms of pain reduction effect.

Acceptance Criteria (Implied from Clinical Study Goal)	Reported Device Performance (Active System + SOC group)
Significant pain reduction compared to Standard of Care (SOC) alone	36% reduction in pain (compared to 10% reduction in SOC group) using the Mankowski scale over 2 weeks.
Low incidence of adverse events and no serious adverse events	3.3% minor complications (4 out of 120 participants), distributed equally between groups, with no serious or unanticipated adverse events.

2. Sample Size Used for the Test Set and Data Provenance

The text describes a clinical study which serves as the "test set" for demonstrating clinical performance.

Sample Size: 120 patients enrolled.
- 48 in the Active System (Shortwave Diathermy + Heating Therapy) group.
- 43 in the SOC group. (Note: The sum of these two groups is 91, not 120. There's a discrepancy in the provided numbers, as 120 is the total. This could imply other groups or just a rounding/reporting discrepancy. Assuming the reported group sizes are correct for the Active System and SOC groups, the remaining 29 participants are unaccounted for in this specific breakdown).
Data Provenance: Not specified, neither country of origin nor retrospective/prospective. However, a clinical study implies prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a clinical study measuring pain, the "ground truth" is typically the patient's self-reported pain score (Mankowski scale in this case), not an expert consensus on interpreting data like images. Therefore, expert consensus in the traditional sense (e.g., radiologists interpreting images) is not applicable here.

4. Adjudication Method for the Test Set

This information is not applicable as the "ground truth" is patient-reported pain scores, not adjudicated data. There's no mention of an adjudication process for these scores.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This device involves direct patient treatment and pain measurement, not interpretation of data by multiple human readers (e.g., radiologists) with or without AI assistance. The study described is a clinical trial comparing the device's efficacy against standard of care.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device (Active System) is a physical medical device that delivers therapy, not a standalone AI algorithm for diagnosis or interpretation. The clinical study evaluates the device's performance as a treatment.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was patient-reported pain assessment scores, specifically using the Mankowski scale, measuring the change from baseline at the end of 2 weeks.

8. The Sample Size for the Training Set

This information is not applicable or not provided. This document describes a medical device for treatment, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The clinical study serves to validate the device's effectiveness, not to train an algorithm. There is no mention of an algorithm or AI component that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or not provided as there is no "training set" in the context of an AI/ML algorithm for this device.

Summary

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December 18, 2024

Caerus Corporation % Jean-Marie Toher Regulatory Consultant MEDIcept Inc 200 Homer Avenue Ashland, Massachusetts 01721

Re: K241395

Trade/Device Name: Active System; Avenue8 Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class II Product Code: ILX, IRT, IMD Dated: December 2, 2024 Received: December 2, 2024

Dear Jean-Marie Toher:

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 (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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).

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Sincerely,

Vivek J. Pinto -S

Vivek Pinto, PhD, MBA Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241395

Device Name Active System: Avenue8

Indications for Use (Describe)

The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.

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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K241395

CAERUS CORP

CAERUSCORP.COM 8611 W 35W SERVICE DRIVE NE, SUITE 180 BLAINE, MN 55449

510(k) SUMMARY

I. SUBMITTER

510(k) Holder:	Caerus Corporation8611 W 35W Service Dr NE Ste 180Blaine MN 55449
----------------	---------------------------------------------------------------------------

Contact Person: Jean-Marie Toher Regulatory Consultant MEDIcept, Inc. jtoher(@medicept.com
Date Prepared: December 18, 2024

II. DEVICES

Trade Name:	Active System
Classification Name:	Shortwave Diathermy, For Use Other Than Applying Therapeutic Deep Heat
Regulatory Class:	Class II
Product Codes:	ILX - Shortwave Diathermy, For Use Other Than Applying Therapeutic Deep HeatIMD - Hot Or Cold Disposable Pack
Trade Name:	Avenue8
Classification Name:	Shortwave Diathermy, For Use Other Than Applying Therapeutic Deep Heat
Regulatory Class:	Class II
Product Codes:	ILX - Shortwave Diathermy, For Use Other Than Applying Therapeutic Deep HeatIRT – Powered Heating Pad

PREDICATE DEVICES III.

Primary Predicate: K121702 - OrthoCor Active Device Secondary Predicate (Active System): K092044 - OrthoCor Knee Active System Secondary Predicate (Avenue8): K202337 - HiDow Pulsed electromagnetic field wrap

IV. DEVICE DESCRIPTION

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therapy. The Active System includes general use wraps and therapy is delivered with single-use OrthoPods, sold separately.

INDICATIONS FOR USE V.

The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.

VI. INTENDED USE

The Active System is intended to be worn for one two-hour treatment of 2 30-minute non-thermal shortwave diathermy treatments per day by adult users. For prescription use (Rx) only.

The Avenue8 is intended to be worn for two 30-minute treatments per day by adult users. For prescription use (Rx) only.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VII. DEVICE

In accordance with the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] issued July 28, 2014, the comparison between the predicate devices and the subject devices is shown to be substantially equivalent by comparing the indications for use, principles of operation, technological characteristics, and performance testing similarities and differences (Table 2). The technological characteristic differences do not raise different questions of safety and effectiveness than the predicate device.

Table 1. Substantial Equivalence Subject Device Active System (K241395) Compared to the Predicate Devices OrthoCor Active Device (K121702) and OrthoCor Knee Active System (K092044)

Characteristic	OrthoCor ActiveSystem (K241395)	OrthoCor GeneralUse Device(Primary Predicate)K121702	OrthoCor Active KneeSystem (SecondaryPredicate)K092044	EquivalenceComparison
RegulatoryClass	Class II	Class II	Class II	Same
RegulatoryNumber	21 CFR 890.5290(b)21 CFR 890.5710	21 CFR 890.5290(b)21 CFR 890.5710	21 CFR 890.5290(b)21 CFR 890.5710	Same
Characteristic	OrthoCor ActiveSystem (K241395)	OrthoCor GeneralUse Device(Primary Predicate)K121702	OrthoCor Active KneeSystem (SecondaryPredicate)K092044	EquivalenceComparison
RegulationName	ShortwaveDiathermy, For UseOther Than ApplyingTherapeutic DeepHeat	ShortwaveDiathermy, For UseOther Than ApplyingTherapeutic DeepHeat	Shortwave Diathermy, For UseOther Than ApplyingTherapeutic Deep Heat	Same
Product Code	ILX, IMD	ILX	ILX, IMD	Similar
Indication foruse	Adjunctive use in thetemporary relief ofpain, such as painassociated with over-exertion, strains,sprains, and arthritis.	Adjunctive use in thepalliative treatmentof postoperativeedema and pain insuperficial soft tissue	Adjunctive use in the palliativetreatment of postoperativeedema and pain in superficialsoft tissue. Temporary relief ofminor aches and painsassociated with overexertion,strains, sprains, and arthritis.	Performancetesting justifiedsubstantialequivalence
Anatomical site	General Use	General Use	Knee	Similar
Frequency -short wave	27.12 MHz	27.12 MHz	27.12 MHz	Same
OutputImpedance	50 Ohm	50 Ohm	50 Ohm	Same
Burst Frequency	2 Hz	2 Hz	2 Hz	Same
Therapy ControlBurst Width	2 ms	2 ms/PPR 2Hz	2 ms/PPR 2Hz	Same
Exposure	1 hour	30 minutes	30 minutes	Performancetesting justifiedsubstantialequivalence
EnergyDeposited Via	Induction Coil	Induction Coil	Induction Coil	Same
Peak GeneratorPower	1.35 W	.5 W	.5 W	Performancetesting justifiedsubstantialequivalence
Heating Method	Chemical	NA	Chemical	Same

Image /page/5/Picture/13 description: The image shows the logo for CAERUS. The logo features the word "CAERUS" in a simple, sans-serif font. To the left of the word, there is a stylized graphic that resembles a crescent shape with a pointed element extending upwards, possibly representing a sail or a stylized leaf. The overall design is clean and modern.

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Image /page/6/Picture/3 description: The image shows the word "CAERUS" in a sans-serif font. To the left of the word is a stylized graphic that resembles a bird's wing or a stylized leaf. The image is in black and white, and the background is a light gray color.

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Table 2. Substantial Equivalence Subject Device Avenue8 (K241395) Compared to the Predicate Devices OrthoCor Active Device (K121702) and HiDow Pulsed electromagnetic field wrap (K202337)

Characteristic	Avenue8 (K241395)	OrthoCor GeneralUse Device(PrimaryPredicate)K121702	HiDow Pulsed ElectromagneticField Wrap(Secondary Predicate)K202337	EquivalenceComparison
RegulatoryClass	Class II	Class II	Class II	Same
RegulatoryNumber	21 CFR 890.5290(b)21 CFR 890.5740	21 CFR890.5290(b)	21 CFR 890.529021 CFR 890.5740	Similar
RegulationName	ShortwaveDiathermy, For UseOther ThanApplyingTherapeutic DeepHeat	ShortwaveDiathermy, For UseOther ThanApplyingTherapeutic DeepHeat	Shortwave Diathermy	Similar
Product Code	ILX, IRT	ILX	ILX, IRT	Similar
Indication foruse	Adjunctive use inthe temporary reliefof pain, such as painassociated withover-exertion,strains, sprains, andarthritis.	Adjunctive use inthe palliativetreatment ofpostoperativeedema and pain insuperficial softtissue	Adjunctive use in the palliativetreatment of postoperative edemaand pain in superficial soft tissue.It is also indicated for thetemporary relief of minor achesand pains associated withoverexertion, strains, sprains, andarthritis.	Performancetesting justifiedsubstantialequivalence
Anatomical site	General Use	General Use	General Use	Same
Frequency -short wave	27.12 MHz	27.12 MHz	27.12 MHz	Same
OutputImpedance	50 Ohm	50 Ohm	Not Publicly Available	Same
BurstFrequency	2 Hz	2 Hz	Not Publicly Available	Same
TherapyControl BurstWidth	2 ms	2 ms/PPR 2Hz	Not Publicly Available	Same
Exposure	1 hour	30 minutes	Not Publicly Available	Performancetesting justifiedsubstantialequivalence
Characteristic	Avenue8 (K241395)	OrthoCor GeneralUse Device(PrimaryPredicate)K121702	HiDow Pulsed ElectromagneticField Wrap(Secondary Predicate)K202337	EquivalenceComparison
EnergyDeposited Via	Induction Coil	Induction Coil	Not Publicly Available	Same
Peak GeneratorPower	1.35 W	.5 W	Not Publicly Available	Performancetesting justifiedsubstantialequivalence
Heating Method	Electrical	NA	Electrical	Same

Image /page/7/Picture/4 description: The image shows the logo for CAERUS. The logo features the company name in a simple, sans-serif font, with the letters "CAERUS" clearly visible. To the left of the name is a stylized graphic element that resembles a bird's wing or a stylized leaf, adding a touch of visual interest to the overall design.

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VIII. PERFORMANCE DATA

Non-clinical performance testing was conducted to verify the subject device performance. The following performance data was provided in support of the substantial equivalence determination.

Electrical safety and electromagnetic compatibility (EMC):

The systems comply with the IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing:

The software is classified as a Basic Level of Documentation. Testing and documentation for a Basic Level of Documentation are provided in the submission in compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (June 2023)

Non-Clinical Testing Summary:

The following testing was conducted to satisfy the under the Special Controls under regulation 890.5290(0):

Peak output power: .
Pulse width; ●
Pulse frequency; .
Duty cycle; ●
Characteristics of other types of modulation that may be used; .
Average measured output powered into the RF antenna/applicator;

Image /page/8/Picture/17 description: The image shows the logo for CAERUS. The logo features the company name in a simple, sans-serif font, with the letters "CAERUS" clearly visible. To the left of the name is a stylized graphic element that resembles a wing or a stylized leaf, adding a unique visual element to the logo.

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Specific absorption rates in saline gel test load or other appropriate model;
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
Characterization of the deposited energy density in saline gel test load or other appropriate model.
Temperature testing was completed on participants of varying skin types to demonstrate that the devices were capable of maintaining a skin temperature of 40 - 45 degrees Celsius for 20 minutes.

Clinical Study:

In compliance with the special controls for regulation 890.5290(b), a clinical study was performed. 120 patients were enrolled, 48 in the Active System (Shortwave Diathermy + Heating Therapy) group and 43 in the SOC group, both males, over 18 years of age, with a history of pain in superficial soft tissue, such as in the ankle, back, knee, wrist, elbow, shoulder, foot, or neck. The incidence of adverse events in this study was notably low, with only 3.3% of participants (4 out of 120) experiencing minor complications. These events were distributed equally across both the Active System + Standard of Care (SOC) and Standard of Care (SOC) groups. The nature of these events were mild, consisting of shoulder pain, sleepiness. discomfort associated with the device wrap, and a tingling or numb sensation in the cervicothoracic region. Critically, there were no reports of serious adverse events or unanticipated adverse device effects. The lack of significant complications and the minimal

occurrence of adverse events reinforces the safety profile of the Active System treatment, affirming its suitability for clinical use in pain management.

This study was conducted in compliance with the Special Controls under regulation 21 CFR 890.5290(b)(2)(iv). The study examined the change from baseline in pain assessment scores at the end of 2 weeks of study treatment using the Mankowski scale. The SOC group experienced a 10% reduction in pain while the Active System + SOC group had 36% reduction in pain.

The findings from this clinical study report establish the Active System as an adjunctive therapy is a significantly more effective intervention for pain management in soft tissue injuries, than Standard of Care (SOC) alone as outlined in the study protocol. Specifically, the study primarily enrolled participants in the foot, knee and shoulder groups. The clinical data was clinically meaningful in the foot, knee and shoulder.

CONCLUSIONS IX.

The substantial equivalence tables and performance testing results demonstrate that the Caerus Corporation Active System and Avenue8 devices are substantially equivalent to the OrthoCor Active Device.

Image /page/9/Picture/13 description: The image shows the logo for CAERUS. The logo features the word "CAERUS" in a sans-serif font. To the left of the word is a stylized graphic that resembles a leaf or a flame. The logo is presented in black against a light gray background.

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CAERUSCORP.COM 8611 W 35W SERVICE DRIVE NE, SUITE 180 BLAINE, MN 55449

Image /page/10/Picture/2 description: The image shows the word "CAERUS" in all capital letters. To the left of the word is a stylized graphic that resembles a leaf or a wing. The text and graphic are in a dark color, set against a light background. The overall impression is clean and modern.

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.