(246 days)
Not Found
No
The device description focuses on mechanical and manual operation, with no mention of AI/ML terms or functionalities.
Yes
The intended use statement explicitly states that the device is "intended to assist in the diagnosis and treatment of balance disorders and vertigo." The term "treatment" indicates a therapeutic function.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The TRV is intended to assist in the diagnosis and treatment of balance disorders and vertigo."
No
The device description clearly describes a physical chair with mechanical and electrical components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the diagnosis and treatment of balance disorders and vertigo." This describes a device used directly on a patient to perform physical maneuvers and examinations, not a device used to examine specimens in vitro (outside of the body).
- Device Description: The description details a mechanical chair used to position a patient. There is no mention of reagents, test strips, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Use of reagents or assays
The device is a physical therapy and diagnostic tool used for positional testing and treatment of balance disorders.
N/A
Intended Use / Indications for Use
The TRV is intended to assist in the diagnosis and treatment of balance disorders and vertigo, including benign paroxysmal positional vertigo.
Product codes
LXV
Device Description
The TRV is a multi-axial chair that can rotate 360° around both the horizontal and vertical axes. With the patient secured by a four-point harness, a head mount, a leg strap, and shoulder pads, an examiner is able to rotate the patient around the plane of each of the 6 semicircular canals and hold the patient in any position for detailed examination of the semicircular canals.
The rehabilitation of patients diagnosed with positional vertigo commonly involves traditional maneuvers such as the Epley, Semont, etc. These maneuvers can be performed efficiently and safely with the TRV chair. Kinetic energy can be added for specific maneuvers by driving the main arm of the TRV chair against a hydraulic stop in each sequence in the maneuver. This added kinetic energy accelerates the movement of the smaller otoconia.
The TRV chair is manually handled by the healthcare professional. The axes of rotation are lockable in preset positions. The primary axis has a battery-powered electromagnetic lock controlled by a footswitch and the secondary axis is manually locked with a mechanical lever. A mechanical system with an adjustable counterweight ensures that the weight of the chair and the patient are balanced during the maneuvers.
Healthcare professionals may use the TRV in combination with videonystagmography goggles to detect positional induced nystagmus while moving the patient through a series of positions.
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
Not Found
Intended User / Care Setting
Trained healthcare professional / In a medical practice
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)
Electrical safety and electromagnetic compatibility (EMC): The device complies with the IEC 60601-1 for electrical safety and the IEC 60601-1-2 standard for EMC.
Mechanical testing: To evaluate the worst-case stress loads and simulate device-use lifetime and demonstrate long-term safety of the TRV, the independent test institute Danish Technological Institute has tested the TRV based on the agreed test criteria from Interacoustics. After the testing of the TRV, the wear observed is considered not to have any effect on the safety on the patients or operator of the TRV.
Animal and clinical studies: No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate, nor its safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 27, 2020
Interacoustics A/S Erik Nielsen Director, Regulatory & Compliance Audiometer Alle 1 Middelfart, 5500 DK
Re: K192652
Trade/Device Name: TRV Regulation Number: 21 CFR N/A Regulation Name: N/A Regulatory Class: Class II Product Code: LXV Dated: Not dated Received: April 29, 2020
Dear Erik Nielsen:
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
1
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 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).
Sincerely,
for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192652
Device Name TRV
Indications for Use (Describe)
The TRV is intended to assist in the diagnosis and treatment of balance disorders and vertigo, including benign paroxysmal positional vertigo.
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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3
510(k) Summary
TRV - Multi-axial chair
Erik Nielsen, Director, Regulatory & Compliance
Interacoustics A/S
Audiometer Allé 1 5500 Middelfart
+45 6371 3555
April 17, 2020
Multi-axial chair
Unclassified
06/20/2008
Apparatus, vestibular analysis
Denmark
TRV
LXV
Submitter Information:
Company Name Address
Phone e-mail Contact Person Date Summary Prepared
Device Identification:
Trade Name Common Name Classification Name Product Code Classification Panel Device Class
Predicate Device:
Predicate Device Manufacturer 510(k) No. Date Cleared
Epley Omniax™ Vesticon inc K071973
Ear Nose & Throat
Device description
The TRV is a multi-axial chair that can rotate 360° around both the horizontal and vertical axes. With the patient secured by a four-point harness, a head mount, a leg strap, and shoulder pads, an examiner is able to rotate the patient around the plane of each of the 6 semicircular canals and hold the patient in any position for detailed examination of the semicircular canals.
The rehabilitation of patients diagnosed with positional vertigo commonly involves traditional maneuvers such as the Epley, Semont, etc. These maneuvers can be performed efficiently and safely with the TRV chair. Kinetic energy can be added for specific maneuvers by driving the main arm of the TRV chair against a hydraulic stop in each sequence in the maneuver. This added kinetic energy accelerates the movement of the smaller otoconia.
4
The TRV chair is manually handled by the healthcare professional. The axes of rotation are lockable in preset positions. The primary axis has a battery-powered electromagnetic lock controlled by a footswitch and the secondary axis is manually locked with a mechanical lever. A mechanical system with an adjustable counterweight ensures that the weight of the chair and the patient are balanced during the maneuvers.
Healthcare professionals may use the TRV in combination with videonystagmography goggles to detect positional induced nystagmus while moving the patient through a series of positions
Indications for Use
The TRV is intended to assist in the diagnosis and treatment of balance disorders and vertigo, including benign paroxysmal positional vertigo.
Technological characteristics
The Technological Characteristics are the same as the predicate device. See Substantial Equivalence table below for characteristics.
Substantial Equivalence
Precise, multiaxial patient positioning for the analysis of nystagmus and the application of maneuvers used to treat vestibular disorders is the technological principal for both the subject and predicate devices.
At a high level, the subject and predicate devices are based on the same technological elements as presented in the table below.
The information regarding the videonystagmography system of the Epley Omniax™ has not been included as this function is not an integral part of the TRV.
| TRV | Epley Omniax™ | SE Comparison | |
|---|---|---|---|
| Indications for Use | The TRV is intended to | ||
| assist in the diagnosis | |||
| and treatment of balance | |||
| disorders and vertigo, | |||
| including benign | |||
| paroxysmal positional | |||
| vertigo. | The Epley Omniax™ is | ||
| intended to assist in | |||
| the diagnosis and | |||
| treatment of balance | |||
| disorders and vertigo, | |||
| including benign | |||
| paroxysmal positional | |||
| vertigo. | Same | ||
| Use environment | In a medical practice | In a medical practice | Same |
| User | Trained healthcare | ||
| professional | Trained healthcare | ||
| professional | Same | ||
| Patient population | Patients presenting with | ||
| imbalance, unsteadiness | |||
| or dizziness symptoms | |||
| suspected of originating | |||
| from dislocated otoconia | |||
| in one or more of the | |||
| semicircular canals in the | |||
| inner ear. | Patients presenting | ||
| with imbalance, | |||
| unsteadiness or | |||
| dizziness symptoms | |||
| suspected of | |||
| originating from | |||
| dislocated otoconia in | |||
| one or more of the | |||
| semicircular canals in | |||
| the inner ear. | Same | ||
| Test options | |||
| Video recording | Yes | Yes | Same |
| Nystagmus | |||
| analysis | Yes | Yes | Same |
| Oculomotor tests | Yes | Yes | Same |
| Session logging | Yes | Yes | Same |
| Positional tests | Yes | Yes | Substantial equivalent |
| Discussed below | |||
| Maneuvers | |||
| Canalith | Canalith repositioning | Pre-set protocol | Substantial equivalent |
| repositioning | (Epley) for Posterior | "Canalith | Both devices can perform |
| (Epley) | semi-circular canal | ||
| (PSC) BPPV | repositioning" | same maneuver | |
| Semont | Canalith repositioning for | ||
| PSC BPPV | Customized protocol | ||
| using the Freestyle tab | Substantial equivalent | ||
| Both devices can perform | |||
| same maneuver | |||
| Lorin | Canalith repositioning for | ||
| Anterior semi-circular | |||
| canal (ASC) BPPV | Customized protocol | ||
| using the Freestyle tab | Substantial equivalent | ||
| Both devices can perform | |||
| same maneuver | |||
| BBQ Roll Left HSC | Canalith repositioning for | ||
| Horizontal semi-circular | |||
| canal (HSC) BPPV | |||
| canalithiasis, Left side | Pre-set protocol "3/4 | ||
| Barrel roll" - | |||
| canalithiasis Left | Substantial equivalent | ||
| Both devices can perform | |||
| same maneuver | |||
| BBQ Roll Right | |||
| HSC | Canalith repositioning for | ||
| Horizontal semi-circular | |||
| canal (HSC) BPPV | |||
| canalithiasis, Right side | Pre-set protocol "3/4 | ||
| Barrel roll" - | |||
| canalithiasis Right | Substantial equivalent | ||
| Both devices can perform | |||
| same maneuver | |||
| BBQ Roll Left HSC | Canalith repositioning for | ||
| Horizontal semi-circular | |||
| canal (HSC) BPPV | |||
| cupulolithiasis, Left side | Pre-set protocol "3/4 | ||
| Barrel roll" - | |||
| cupulolithiasis Left | Substantial equivalent | ||
| Both devices can perform | |||
| same maneuver | |||
| BBQ Roll Right | |||
| HSC | Canalith repositioning for | ||
| Horizontal semi-circular | |||
| canal (HSC) BPPV | |||
| cupulolithiasis, Right side | Pre-set protocol "3/4 | ||
| Barrel roll" - | |||
| cupulolithiasis Right | Substantial equivalent | ||
| Both devices can perform | |||
| same maneuver | |||
| 360° Back Flip | |||
| "incremental" | 360° Back Flip | ||
| "incremental" | Pre-set protocol 360° | ||
| Back Flip "incremental" | Substantial equivalent | ||
| Both devices can perform | |||
| same maneuver | |||
| 360° Back Flip | |||
| "continuous" | 360° Back Flip carried | ||
| out in slow, continuous | |||
| sweep | Pre-set protocol 360° | ||
| Back Flip "continuous" | Substantial equivalent | ||
| Both devices can perform | |||
| same maneuver | |||
| 360° Forward Flip | 360° Forward Flip | Pre-set protocol 360° | |
| Forward Flip | Substantial equivalent | ||
| Both devices can perform | |||
| same maneuver | |||
| Technical | |||
| Dimensions | Weight: 640 kg | ||
| Height: 1.9 m | |||
| Depth: 1.6 m | |||
| Width: 1.2 m | Weight: 372 kg | ||
| Height: 2.1 m | |||
| Depth: 2.0 m | |||
| Width: 2.3 m | The TRV is slightly | ||
| smaller in size and | |||
| heavier than the predicate | |||
| device. This difference | |||
| does not raise new | |||
| questions of safety and | |||
| effectiveness. | |||
| Movement range | 2 axes, 360° each: |
- Primary axis is a roll
movement with the
patient in the load
position. - Secondary axis is a
yaw movement with the
patient in the load
position. | 2 axes, 360° each: - Alpha axis is a roll
movement with the
patient in the load
position. - Beta axis is a yaw
movement with the
patient in the load
position. | The range of motion is
the same for both
devices. |
| Power supply | The TRV chair is
equipped with a 24V
rechargeable battery that
powers the magnetic
lock for the primary
frame (Linak BAJ1 (24 V
DC, 2,9 Ah)).
A wall-mounted battery
charger is also provided
(Linak, CHJ2). | Mains power supply:
Voltage input
120V/240V
(switchable) at 50-
60Hz
Current rating: 6A
@120V, 3A @ 240V
Fusing: 8A @120V, 4A
@ 240V
Isolation from main
power designed to
meet UL/cUL 2601 | Both devices have
passed electrical security
testing according to IEC
60601-1 and EMC testing
according to IEC 60601-
1-2.
The differences in the
energy source do not
raise different questions
of safety and
effectiveness and are
supported by testing |
5
6
Positional tests discussion
The multi-axial positioning has been evaluated comparing the positions available from the TRV and the Omniax. Interacoustics has found that the positionings enables the same maneuvers and both devices offer multi-axial patient positioning with rotation around 2 axes.
Discussion of differences
Interacoustics did not find any essential or major differences between the devices.
7
Performance data
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the TRV. The device complies with the IEC 60601-1 for electrical safety and the IEC 60601-1-2 standard for EMC.
Mechanical testing
To evaluate the worst-case stress loads and simulate device-use lifetime and demonstrate long-term safety of the TRV, the independent test institute Danish Technological Institute has tested the TRV based on the agreed test criteria from Interacoustics. After the testing of the TRV, the wear observed is considered not to have any effect on the safety on the patients or operator of the TRV.
Animal and clinical studies
No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate, nor its safety and effectiveness.
Conclusion
Based on its intended use, design principles, and technological characteristics, the TRV was found to be as safe, as effective, and performs comparably to the predicate device.
The technological differences identified do not raise new questions of safety and effectiveness as the non- clinical data support the safety of the device and demonstrate that the TRV performs as intended in the specified use conditions.