(509 days)
No
The summary describes a physical medicine device with firmware controlling basic functions and user interface, with no mention of AI, ML, or related concepts. The performance testing focuses on signal output and magnetic flux, not algorithmic performance.
Yes
The device is intended for the "stimulation of healthy muscles in order to improve or facilitate muscle performance," which is a therapeutic purpose.
No
The device description clearly states its purpose is to "stimulate healthy muscles in order to improve or facilitate muscle performance," which is a treatment function, not a diagnostic one. There is no mention of it analyzing, detecting, or monitoring any medical conditions or physiological states.
No
The device description explicitly mentions hardware components such as a "main control unit" and a "large loop coil applicator (coils)," indicating it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Nova HD+ Function: The Nova HD+ is described as a device that uses electrically generated magnetic fields to stimulate muscles. It works externally on the body and does not involve the analysis of biological specimens.
- Intended Use: The intended use is for "stimulation of healthy muscles in order to improve or facilitate muscle performance." This is a physical therapy or performance enhancement application, not a diagnostic one based on analyzing bodily fluids or tissues.
- Device Description: The description focuses on the physical components and how it generates magnetic fields for external application. There is no mention of collecting or analyzing biological samples.
Therefore, based on the provided information, the Nova HD+ clearly falls outside the definition and function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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
Product codes
NGX
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.
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
adults
Intended User / Care Setting
Over the Counter (OTC), both home care and clinical professional 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)
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
-
. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bemer Classic Set and Bemer Pro-Set (K210174)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
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
1
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
2
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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Image /page/3/Picture/0 description: The image shows the logo for AURA. The logo consists of a colorful circular design above the word "AURA" in a simple, sans-serif font. The circular design is made up of several small circles in various colors, including shades of blue, green, purple, orange, and red. The circles are arranged in a pattern that radiates outward from the center, creating a visually appealing and modern design.
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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Image /page/4/Picture/0 description: The image shows a logo for a company or organization called "AURA". The logo consists of the word "AURA" in a simple, sans-serif font, positioned below a colorful, circular design. The circular design is made up of many small circles in various colors, including shades of blue, green, purple, and orange. The overall design is modern and visually appealing.
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 Device | |||
| K220938 | Predicate Device | ||
| K210174 | |||
| Classification Code | Identical | Primary: Powered Muscle | |
| Stimulator NGX 890.5850 | Same | ||
| Indication for Use | Similar | The Nova HD+ is intended for | |
| the stimulation of healthy muscles | |||
| in order to improve or facilitate | |||
| muscle performance. | The BEMER therapy is | ||
| indicated: | |||
| • To temporarily increase local | |||
| blood circulation in healthy leg | |||
| muscles. | |||
| • To stimulate healthy muscles in | |||
| order to improve and facilitate | |||
| muscle performance | |||
| Primary Mode of | |||
| Action | Identical | Non-invasive tissue stimulation | |
| via 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 (Main | |||
| Unit): | 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 Peak | |||
| Frequency | Different but | ||
| does not raise | |||
| any safety | |||
| concerns | 1.58 kHz | Public information not available. | |
| Average Flux | |||
| Density (Applicator) | Different but | ||
| does not raise | |||
| any safety | |||
| concerns | 1.8 mT (max level) | 150 µT (max level) | |
| Power Consumption | Different but | ||
| does not raise | |||
| safety or | |||
| effectiveness | |||
| concerns | 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 Device | |||
| K220938 | Predicate Device | ||
| K210174 | |||
| Number of Output | |||
| Channels | Similar | 1 | 2 |
| Microprocessor | |||
| controlled | Identical | Yes | Same |
| Therapy Amplitude | |||
| Control | Identical | Power level 1-10 controlled by | |
| operator | Power level 1-10 controlled by | ||
| operator | |||
| User-controlled | |||
| therapy start/stop | Identical | Yes | Yes |
| Compliance with | |||
| voluntary standards | Identical | IEC 60601-1 | |
| IEC 60601-1-2 | |||
| IEC 60601-1-6 | |||
| IEC 62366-1 | |||
| IEC 60601-1-11 | Same | ||
| Firmware developed | |||
| per IEC 62304 | Identical | Yes | Same |
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Image /page/5/Picture/0 description: The image shows a logo for a company called AURA. The logo consists of the word "AURA" in a simple, sans-serif font, with the letters in a light gray color. Above the word "AURA" is a circular design made up of many small, colored dots. The dots are arranged in concentric circles, with the colors ranging from green and blue on the outside to purple, orange, and yellow in the center.
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
6
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.