GyroStim

K220231 · Ultrathera Technologies, Inc. · LXV · Apr 27, 2022 · EN

Device Facts

• Record ID: K220231
• Device Name: GyroStim
• Applicant: Ultrathera Technologies, Inc.
• Product Code: LXV · EN
• Decision Date: Apr 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The GyroStim is intended to assist in the treatment of balance disorders and vestibular dysfunction in adult patients, age 18 and older, up to 400lb. It is intended to be used by a trained medical professional as prescribed by physician in a clinical environment.

Device Story

GyroStim is an AC-powered, computer-controlled, multi-axial positional and rotational chair; consists of patient chair mounted within rotational frame assembly capable of pitch and yaw rotation. Used in clinical environments by trained medical professionals. Device executes preprogrammed positional and rotational motion profiles to induce vestibular stimulation. Operational software runs on PC-based desktop; captures/monitors patient subjective responses; provides clinical decision support (CDS) for progress evaluation, profile selection, and therapy advancement. Includes libraries of prewritten positional and motion profiles (30 intensity levels, 1-30 RPM). Patient data stored for graphing/analysis. Integrated patient transfer system available for mobility-challenged patients. Output allows clinicians to individualize therapy, monitor for overstimulation, and track patient progress, potentially benefiting patients by providing effective vestibular rehabilitation.

Clinical Evidence

Retrospective clinical study compared GyroStim to standard of care (SOC) in patients with balance/vestibular disorders. Sample size not specified. Endpoints included pre/post-intervention balance scores (SOT, DHI, ABC, DVA, mDGI) and treatment duration. Results showed GyroStim was as effective as SOC, with statistically significant (p<0.0001) average balance score improvement per week of treatment compared to SOC.

Technological Characteristics

Electro-mechanical rotational chair; pitch/yaw axes (360°). PC-based control software. Electrical safety: ANSI/AAMI/ES 60601-1 Ed 3.1. EMC: ANSI/AAMI/IEC 60601-1-2 Ed 4. Five-point harness and interlocked lap/ankle restraints. Software Class B (moderate level of concern).

Indications for Use

Indicated for adult patients, age 18 and older, up to 400lb, with balance disorders and vestibular dysfunction.

Predicate Devices

• Vesticon Epley Omniax™ (K071973)

Submission Summary (Full Text)

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April 27, 2022

UltraThera Technologies, Inc. Kevin Maher President 2 North Cascade Avenue, Suite 640 Colorado Springs, Colorado 80903

Re: K220231

Trade/Device Name: GyroStim Regulatory Class: Unclassified Product Code: LXV Dated: January 26, 2022 Received: January 27, 2022

Dear Kevin Maher:

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 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K220231

Device Name GyroStim

Indications for Use (Describe)

The GyroStim is intended to assist in the treatment of balance disorders and vestibular dysfunction in adult patients, age 18 and older, up to 4001b. It is intended to be used by a trained medical professional as prescribed by physician in a clinical environment.

Restricted Device (per 21 CFR 801.420 and CFR 801.421).

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 Ultrathera Technologies, Inc. The logo features a red diamond shape with a star in the center and a curved line extending from the top left to the bottom right. To the right of the diamond is the word "ULTRATHERA" in gold letters, and below that is the phrase "TECHNOLOGIES, INC." in red letters.

# 510(k) Summary

#### 1. Sponsor/ Applicant

UltraThera Technologies, Inc. 2 North Cascade Ave., Suite 640 Colorado Springs, Colorado 80903

Kevin Maher President Phone: [phone] Fax: [phone] Email: [e-mail]

Summary Preparation Date: January 26, 2022

#### 2. Device

| Trade Name | GyroStim |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model Numbers | V4-GYROSTIM III-04 - GyroStim G 1 - Stationary canopy, no laser option<br>V4-GYROSTIM III-04 - GyroStim G 3 - Stationary canopy with laser target<br>option |
| Model Numbers | V4-GYROSTIM III-04A - GyroStim G 3X - Sliding canopy with laser target<br>option |
| Classification | Unclassified (pre-amendment) |
| Product Code | LXV |
| 510(k) Number | K220231 |
| Review Panel | Ear, Nose, and Throat (ENT) Devices |

#### 3. Predicate Device

Vesticon Epley Omniax™, 510(k) # K071973

#### Device Description 4.

GyroStim is an AC powered computer-controlled multi-axial positional and rotational chair. The device consists of a patient chair mounted within a rotational frame assembly that is capable of rotating in the pitch and yaw axes. The rotational frames are automated with computer-controlled drive systems capable of executing preprogrammed positional and rotational motion profiles. The system provides clinicians with a safe and efficient means for administering a wide range of specific positional and rotational motions for inducing stimulation of the vestibular system.

GyroStim operational software runs on a pc-based desktop computer. The software can capture, monitor, and display the patient's subjective response to each run. The response data may be used by the clinician for clinical decision support (CDS) to assist with progress evaluation, for profile selection and rate of therapy advancement, for individualizing therapy sessions, and for monitoring and preventing overstimulation.

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Image /page/4/Picture/0 description: The image shows the logo for Ultrathera Technologies, Inc. The logo features a red diamond shape with a gold line running through it on the left side. To the right of the diamond is the word "ULTRATHERA" in gold, and below that is the phrase "TECHNOLOGIES, INC." in red.

Patient data is collected and stored and may be accessed for graphing, analysis, and reports.

The software includes libraries of prewritten profiles. A library of pre-written positional profiles located on the RUN BPPV page contains a collection of profiles for executing commonly used canalith repositioning maneuvers. A library of pre-written motion profiles located on the RUN GyroStim page contains a collection of profiles for executing motion induced vestibular stimulation.

Specifically, the library of motion profiles contains 30 levels of motion induced vestibular stimulation intensity, ranging from Level 1 to Level 30. The lowest level of motion induced vestibular stimulation intensity is Level 1, which rotates at a rate of 1 revolution per minute (RPM) or 0.016667 Hz. The highest level of motion induced vestibular stimulation intensity is Level 30. which rotates at 30 RPM or 0.5Hz. The intensity of the 30 levels differs and increments linearly at a rate of 1 RPM or 0.01667Hz per level; i.e.. Level 1 rotates at 1 RPM or 0.01667 Hz, Level 2 rotates at 2 RPM or 0.03334 Hz, Level 3 rotates at 3 RPM or 0.05 Hz, and so on up to Level 30 which rotates at 30 RPM or 0.5 Hz. Additionally, each of the 30 Levels offer a selection of run durations at 15 seconds (s), 30s, 60s, and 180s.

When configured with the integrated patient transfer system, GyroStim provides accessibility to the large population of patients with moderate to severe mobility challenges, many of whom are limited or unable to engage in the existing standard of care for balance disorders and vestibular dysfunction.

The GyroStim assembly, operational software, and libraries of profiles provide clinicians with a safe, effective, and efficient medical device for assisting in the treatment of balance disorders and vestibular dvsfunction.

#### 5. Indications for Use

The GvroStim is intended to assist in the treatment of balance disorders and vestibular dysfunction in adult patients, age 18 and older, up to 400lb. It is intended to be used by a trained medical professional as prescribed by physician in a clinical environment.

#### 6. Technological Characteristics and Substantial Equivalence

The GyroStim is substantially equivalent to the Epley Omniax regarding the intended use and technological characteristics, as explained in following table and discussion:

| Feature | Subject Device<br>UltraThera GyroStim | Predicate Device<br>Vesticon Epley<br>Omniax | Comparison<br>of Devices |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| 510(k) Number | K220231 | K071973 | N/A |
| Intended Use | The GyroStim is intended to<br>assist in the treatment of<br>balance disorders and<br>vestibular dysfunction. | The Omniax is intended to<br>assist in the diagnosis and<br>treatment of balance<br>disorders and vertigo,<br>including benign<br>paroxysmal positional<br>vertigo | Comparable |
| Target patient<br>population | Adults, age 18 and older,<br>maximum 400lb | Adults, age 18 and older,<br>maximum 350lb | Comparable |
| Use environment | Professional healthcare / | Professional healthcare / | Same |
| Feature | Subject Device<br>UltraThera GyroStim | Predicate Device<br>Vesticon Epley<br>Omniax | Comparison<br>of Devices |
| | clinical environment | clinical environment | |
| Delivery of Therapy | Whole body positioning and<br>rotation | Whole body positioning<br>and rotation | Comparable |
| Library of Profiles | Libraries of positional<br>maneuvers and rotational<br>profiles | Library of positional<br>maneuvers | Comparable |
| Intended User | Trained medical personnel | Trained medical personnel | Same |
| Frequency of use | As prescribed by physician | As prescribed by physician | Same |
| Prescription and/or<br>over-the-counter use | By prescription only | By prescription only | Same |
| Operator Interface | Computer with operational<br>software to control the<br>rotational and positional<br>motion of the chair | Computer with operational<br>software to control the<br>rotational and positional<br>motion of the chair | Same |
| Positional and<br>Rotational Means | Electro-mechanical motion<br>chair | Electro-mechanical motion<br>chair | Same |
| Axis of Motion &<br>Rotational Degrees | Pitch: 360°<br>Yaw: 360° | Pitch, 360°<br>Yaw, 360°<br>Roll, 360° | Comparable |
| Maximum<br>Acceleration | 180 deg/s2 | (Information is redacted) | Unknown |
| Maximum Velocity | 180 deg/s<br>(30 RPM) | (Information is redacted) | Unknown |
| Collects and reports<br>patient response to<br>vestibular stimulation | Yes | Yes | Same |
| Patient Restraint<br>System | Five-point harness and<br>interlocked lap and ankle<br>restraints | Two parallel over-shoulder<br>straps, lap belt | Comparable |
| Electrical Safety<br>Performance | Complies with<br>ANSI/AAMI/ES 60601-1,<br>Ed 3.1 and applicable<br>collateral standards | Complies with IEC 60601-<br>1 | Same |
| EMC | Complies with<br>ANSI/AAMI/IEC 60601-1-2,<br>Ed 4, Class A, professional<br>healthcare environment | Complies with IEC 60601-<br>1-2 | Same |

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Image /page/5/Picture/0 description: The image shows the logo for Ultrathera Technologies, Inc. The logo consists of a red diamond shape with a stylized star inside, followed by the company name in gold lettering. Below the company name, the words "TECHNOLOGIES, INC." are written in red.

### Non-clinical Bench (Performance) testing 7.

The performance of the GyroStim is verified based on the successful completion of following tests:

| Item Tested | Test Method | Purpose | Acceptance Criteria | Results |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| V4-GYROSTIM III-04A | ANSI/AAMI/ES<br>60601-1, Ed 3.1 | Electrical safety | Complies with<br>ANSI/AAMI/ES 60601-1,<br>Ed 3.1 | Pass |
| V4-GYROSTIM III-04A | ANSI/AAMI/IEC<br>60601-1-2, Ed 4 | EMC | Complies with Class A,<br>Professional Healthcare<br>Environment of<br>ANSI/AAMI/IEC 60601- | Pass |
| Item Tested | Test Method | Purpose | Acceptance Criteria | Results |
| V4-GYROSTIM III-04,<br>V4-GYROSTIM III-04A | Engineering<br>Analysis per Clause<br>9.8.2 and Table 21<br>of IEC 60601-1, Ed<br>3.1 | Determination of static<br>loading safety factors | 1-2, Ed 4<br>Safety factor determined<br>to be greater than the<br>2.5x requirements of<br>Table 21 of IEC 60601-1 | Pass,<br>Min.<br>safety<br>factor,<br>27.5x |
| V4-GYROSTIM III-04,<br>V4-GYROSTIM III-04A | Engineering<br>Analysis | Determination of floor<br>loading distribution for<br>installation into non-<br>residential<br>environments | Complies with uniform<br>and concentrated live<br>load requirements per<br>IBC, 2018* | Pass |
| V4-GYROSTIM III-04,<br>V4-GYROSTIM III-04A | Engineering<br>Analysis | Reliability analysis,<br>including fatigue and<br>dynamic loading, and<br>retrospective data<br>analysis | Device shall remain<br>reliable and not cause<br>patient or end user injury<br>for 10-year shelf life | Pass |
| V4-GYROSTIM III-04,<br>V4-GYROSTIM III-04A,<br>GyroStim software | IEC 62304:<br>2006/A1:2016,<br>clause 5.7 and<br>FDA's Guidance for<br>Industry and FDA<br>Staff, "Guidance for<br>the Content for the<br>Premarket<br>Submissions for<br>Software Contained<br>in Medical Devices". | Software verification | Software complies with<br>pre-defined<br>requirements of the<br>software requirement<br>specification for a Class<br>B / "moderate" level of<br>concern due to software<br>failure | Pass |
| V4-GYROSTIM III-04,<br>V4-GYROSTIM III-04A,<br>GyroStim software | Measurement of<br>rotational accuracy<br>in pitch and yaw<br>directions | Accuracy of Controls | System meets the<br>defined accuracy<br>requirements for RPM,<br>acceleration, and<br>degrees of rotation | Pass |
| V4-GYROSTIM III-04,<br>V4-GYROSTIM III-04A, | IEC 62366-1, 2015<br>+A2020 and FDA's<br>Guidance for<br>Industry and FDA<br>Staff, "Applying<br>Human Factors and<br>Usability<br>Engineering to<br>Medical Devices" | Summative Usability<br>Study | No instances of use<br>errors or close calls with<br>potential for harm | Pass,<br>none<br>observed |

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Image /page/6/Picture/0 description: The image contains the logo for Ultrathera Technologies, Inc. The logo features a red diamond shape with a stylized star inside on the left. To the right of the diamond is the word "ULTRATHERA" in large, gold, sans-serif font. Below "ULTRATHERA" is the text "TECHNOLOGIES, INC." in a smaller, red, sans-serif font.

#### 8. Biocompatibility Testing

The biocompatibility evaluation for the GyroStim device was conducted in accordance with the FDA's Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

Overall, it can be concluded that the GyroStim materials in limited, direct, or transient patient contact with intact skin pose a very low biocompatibility risk based upon materials characterization, common use in healthcare and commercial applications, and history of safe use.

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Image /page/7/Picture/0 description: The image shows the logo for Ultrathera Technologies, Inc. The logo features a red diamond shape with a white star in the center and two yellow lines curving around the star. To the right of the diamond is the word "ULTRATHERA" in yellow, and below that is the phrase "TECHNOLOGIES, INC." in red.

#### Clinical Testing 9.

A preliminary clinical study was conducted to compare the outcomes of the RUN GyroStim profiles to outcomes of the current standard of care (SOC) for treatment of balance disorders and vestibular dysfunction. The study utilized retrospective data from the two treatment groups: GyroStim group, and SOC Group.

The clinical comparison included data from pre and post intervention assessments from both patient groups. The assessments and treatments were performed by a vestibular and balance medical specialist (DPT) and with guantitative equipment and methods, including SOT, DHI, ABC, DVA, and mDGI. Both groups received the same intake, balance education, and training for at-home daily exercise routines. The only variable between the two groups was the treatment: treatment with GyroStim, or treatment with SOC. Assessment data from multiple vestibular/balance disorders were collected retrospectively and presented for both groups.

Data comparison was conducted for both treatment groups to compare the following:

- difference in pre- and post- objective or subjective balance scores .
- duration of treatment time between pre- and post- therapy balance scores .

The analysis of retrospective clinical test data from patients with vestibular and balance disorder indicated that the RUN GyroStim profiles provided treatment that was as effective as the current SOC.

The retrospective data also indicated that treatment with RUN GyroStim profiles provided a statistically relevant (p<0.0001) average balance score improvement per week of treatment when compared to SOC. Overall, the preliminary clinical study indicated that treatment with GyroStim provided substantially equivalent treatment of vestibular/balance disorders as the current standard of care.

#### 10. Conclusion:

The subject device, GyroStim, has a substantially equivalent intended use and technological characteristics as the cited predicate device. The minor changes or differences presented do not raise new questions of safety or effectiveness. The nonclinical test results have demonstrated the subject device is as safe and can perform with substantial equivalence as the predicate device. The preliminary clinical study provides evidence that the subject device is as effective as the current standard of care for balance disorders and vestibular dysfunction.

Therefore, it is concluded that no new questions of safety and effectiveness were raised. We conclude that the subject device is substantially equivalent to the cited predicate device.