The Nova HD+ system is a noninvasive physical medicine device that uses electrically generated magnetic fields to stimulate muscles in order to improve and facilitate muscle performance.

The Nova HD+ is noninvasive, fully reusable (no disposable components such as electrodes) and have configurations allowing both home care and clinical professional use.

In addition to the main control unit, the Nova HD+ includes a large loop coil applicator (coils) which allow the operator to administer optimal treatment to the desired anatomical part of the body.

The device contains firmware that controls the user interface, the operator controls the magnetic pulse generator intensity and duration of the treatment.

AI/ML Overview

This document is a 510(k) premarket notification for the Nova HD+ device, a powered muscle stimulator. The FDA has determined the device is substantially equivalent to a predicate device (Bemer Classic Set and Bemer Pro-Set K210174).

Here's an analysis of the acceptance criteria and the study that proves the device meets the criteria, based on the provided text:

No specific acceptance criteria or clinical study to prove the device meets those criteria were provided in the document. This submission primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device rather than presenting a novel clinical study with specific performance metrics and acceptance criteria.

The document explicitly states: "Clinical Testing: Not applicable." This means no dedicated clinical study was performed for this 510(k) submission to demonstrate the Nova HD+ meets specific clinical performance acceptance criteria.

Instead, the submission relies on non-clinical testing to demonstrate performance equivalence to the predicate device.

Here's a breakdown of the requested information based on what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study with specific acceptance criteria was performed, this table cannot be fully completed as requested. The "reported device performance" is essentially the results of the non-clinical tests demonstrating output and compliance with standards.

Acceptance Criteria Category	Specific Acceptance Criteria (Not provided as device-specific goals)	Reported Device Performance (from non-clinical testing)
Functional Equivalence	Implicit: Device must perform similarly to predicate	Performed equivalent to predicate applicator.
Signal Waveform Output	Not specified in terms of direct numerical AC	Multiple measurements demonstrated signal waveform output (volts) generated from Nova HD+ with its applicators.
Magnetic Flux Output	Not specified in terms of direct numerical AC	Magnetic flux output (mT) generated from the applicator at all signal intensity input levels 1-10 was measured.
Software Safety	Compliance with IEC 62304 for 'Moderate' level of concern.	All software features documented and tested in accordance with IEC 62304 for 'Moderate' level of concern.
Electrical Safety/EMC	Compliance with IEC 60601-1, -1-2, -1-6, -1-11; IEC 62366-1.	Evaluated per and complies with listed IEC standards.
Biocompatibility	Compliance with ISO 10993-1, -5, -10.	Complies with listed ISO standards.

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

Test Set Sample Size: Not applicable for a clinical test set. For non-clinical testing, the "sample size" would refer to the number of devices or components tested. This information is not provided in the document, but it typically involves a certain number of manufactured units to ensure consistency and compliance.
Data Provenance: The general context implies that the non-clinical performance testing was conducted by Aura Wellness, LLC or a contracted lab. The document does not specify country of origin or if it's retrospective/prospective, but performance testing is inherently prospective for the device being submitted.

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

Not applicable, as no clinical study with a test set requiring expert ground truth was conducted.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical study with a test set was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a powered muscle stimulator, not an AI diagnostic or assistance tool that would involve human readers or AI assistance.

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

Not applicable. This device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

Not applicable for a clinical ground truth. For the non-clinical performance testing, the "ground truth" would be established by validated measurement equipment and established engineering specifications/standards.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. This device is not an AI/ML model that requires a training set.

Summary Conclusion from the Document:

The provided 510(k) summary states that clinical testing was not applicable. The primary evidence for substantial equivalence relies on:

Comparison of technological characteristics and intended use with a predicate device.
Non-clinical performance testing demonstrating that the subject treatment applicator performed equivalently to the predicate applicator, involving measurements of signal waveform output (volts) and magnetic flux output (mT).
Compliance with various electrical, EMC, software, and biocompatibility international standards (IEC 60601-series, IEC 62304, IEC 62366-1, ISO 10993-series).

The FDA's clearance (K220938) indicates that, based on this non-clinical data and comparison to the predicate, the Nova HD+ was deemed substantially equivalent and therefore does not raise new questions of safety and effectiveness.

Summary

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August 22, 2023

Aura Wellness, LLC Scott Blomberg Director of Regulatory Affairs 11530 Electron Drive Louisville, Kentucky 40299

Re: K220938

Trade/Device Name: Nova HD+ Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: August 21, 2023 Received: August 21, 2023

Dear Scott Blomberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Heather L. Dean -S

Heather Dean, Ph.D Assistant Director, Acute Injury Devices Team 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) K220938

Device Name Nova HD+

Indications for Use (Describe)

The Nova HD+ is intended for use by adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K220938

(as required by 21CFR 807.92)

I Submitter

Aura Wellness, LLC 11530 Electron Drive Louisville, KY 40299 Phone: 502-714-1993 Fax: 502-369-5226

Submitter Contact:	Scott Blomberg
Submission Correspondent:	scott@aurawell.com
Establishment Registration:	10081462
Submission Date:	August 21, 2023

II Device

Proprietary or Trade Name:	Nova HD+
Common/Usual Name:	Powered Muscle Stimulator
Classification Name:	Stimulator, Muscle, Powered, For Muscle Conditioning
Regulation:	890.5850
Regulatory Class:	2
Product Code:	NGX
Device Panel:	Neurological and Physical Medicine Devices
III Predicate Device	Bemer Classic Set and Bemer Pro-Set (K210174)

IV Device Description

The Nova HD+ system is a noninvasive physical medicine device that uses electrically generated magnetic fields to stimulate muscles in order to improve and facilitate muscle performance.

The Nova HD+ is noninvasive, fully reusable (no disposable components such as electrodes) and have configurations allowing both home care and clinical professional use.

In addition to the main control unit, the Nova HD+ includes a large loop coil applicator (coils) which allow the operator to administer optimal treatment to the desired anatomical part of the body.

The device contains firmware that controls the user interface, the operator controls the magnetic pulse generator intensity and duration of the treatment.

V Indication for Use

The Nova HD+ is intended for use by adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

Environments of use: Over the Counter (OTC), both home care and clinical professional use

Nova HD+ Traditional 510(k)

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VI Comparison of Technological Characteristics and Performance with the Predicate

Table 1 below provides the summarized substantial equivalence comparison of general intended uses/actions, specific indications for use, equivalence of key clinical and technical features between subject and predicate device, along with a full listing of technical and conformance specifications.

Table 1: Comparison of Subject vs. Predicate

		Nova HD+	BEMER Pro Set
		Subject DeviceK220938	Predicate DeviceK210174
Classification Code	Identical	Primary: Powered MuscleStimulator NGX 890.5850	Same
Indication for Use	Similar	The Nova HD+ is intended forthe stimulation of healthy musclesin order to improve or facilitatemuscle performance.	The BEMER therapy isindicated:• To temporarily increase localblood circulation in healthy legmuscles.• To stimulate healthy muscles inorder to improve and facilitatemuscle performance
Primary Mode ofAction	Identical	Non-invasive tissue stimulationvia magnetic field induction	Same
Therapy Timer	Similar	1-20 minutes	8-20 minutes
Model (System)	Similar	Nova HD+	Pro Set
Weight	Similar	System:5.6 pounds (2.5 kg)	System:2.9 pounds (1.3 kg)[B.BOX Classic]System:3.1 pounds (1.4 kg)[B.BOX Professional]
Dimensions (MainUnit):	Similar	9.7" x 10.64" x 3.57"	Public information not available
Size of Therapy Area	Similar	147.2 in² (Large Loop)	Public information not available
Magnetic Field PeakFrequency	Different butdoes not raiseany safetyconcerns	1.58 kHz	Public information not available.
Average FluxDensity (Applicator)	Different butdoes not raiseany safetyconcerns	1.8 mT (max level)	150 µT (max level)
Power Consumption	Different butdoes not raisesafety oreffectivenessconcerns	81.6 Watts maximum	30 Watts maximum
Input Power	Similar	100-130 Vac, 60 Hz, 0.68 A	100-240 Vac, 50-60 Hz, 0.6 A;
		Nova HD+	BEMER Pro Set
		Subject DeviceK220938	Predicate DeviceK210174
Number of OutputChannels	Similar	1	2
Microprocessorcontrolled	Identical	Yes	Same
Therapy AmplitudeControl	Identical	Power level 1-10 controlled byoperator	Power level 1-10 controlled byoperator
User-controlledtherapy start/stop	Identical	Yes	Yes
Compliance withvoluntary standards	Identical	IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 62366-1IEC 60601-1-11	Same
Firmware developedper IEC 62304	Identical	Yes	Same

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VII Equivalence Rationale

Principle of Operation

The principle of operation for the Nova HD+ is identical to the predicate, Bemer Classic Set and Bemer Pro-Set (K210174). The Nova HD+ and the predicate systems deliver therapeutic massage to the patient through the use of low-level magnetic fields administered directly to the body.

Use Mode

The use of the Nova HD+ is essentially the same as the predicate device. Both units have main control units have interchangeable treatment applicators (coils) for administering the therapy to desired area of the controls on the control unit allow the user to select the time and intensity of the therapy and allow for adjustment of the intensity during the session.

Non-clinical Testing

Performance testing demonstrated that the subject treatment applicator performed equivalent to the predicate applicator. Testing included:

Performance testing involved multiple measurements of:

Signal waveform output (volts) generated from Nova HD+ with its applicators. ●
Magnetic flux output (mT) generated from the applicator at all signal intensity input levels 1-10.

Software

All software features documented and tested in accordance with IEC 62304 for 'Moderate' level of concern.
Electrical / EMC evaluated per
IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Basic ● Safety And Essential Performance
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements For ● Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests

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Image /page/6/Picture/0 description: The image shows the logo for AURA. The logo consists of a colorful circular design made up of many small circles in shades of green, blue, purple, and orange. Below the circular design, the word "AURA" is written in a simple, sans-serif font.

. IEC 60601-1-11 - Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in The Home Healthcare Environment
IEC 60601-1-6 - Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
. IEC 62366-1 - Medical devices - Part 1: Application of usability engineering to medical devices

Biocompatibility

ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management ● process
. ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation And . Skin Sensitization

Clinical Testing

Not applicable.

CONCLUSIONS

The analysis of the differences between Nova HD+ and the predicate device does not raise new questions of safety and effectiveness for the subject device performance test results, Aura Wellness determines that the Nova HD+ system performs within its design specifications and is equivalent to the predicate device.

The information in this 510(k) submission demonstrates that the Nova HD+ system is substantially equivalent to the predicate device.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).