(246 days)
The TRV is intended to assist in the diagnosis and treatment of balance disorders and vertigo, including benign paroxysmal positional vertigo.
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 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.
The provided text describes the TRV device and its substantial equivalence to a predicate device, the Epley Omniax™. However, it does not contain information related to a study that establishes acceptance criteria and then proves the device meets those criteria, especially in the context of an AI-powered device or for clinical accuracy.
Instead, the document details a 510(k) submission for a physical medical device (a multi-axial chair) used in the diagnosis and treatment of balance disorders. The performance data presented focuses on electrical safety, electromagnetic compatibility, and mechanical testing, not on predictive performance, accuracy, or diagnostic effectiveness in the way an AI/software device would be evaluated.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in an AI/software context are not present in the provided document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (General Safety and Performance) | Reported Device Performance |
|---|---|
| Electrical Safety: Comply with IEC 60601-1 | Passed: Device complies with IEC 60601-1 for electrical safety. |
| Electromagnetic Compatibility (EMC): Comply with IEC 60601-1-2 | Passed: Device complies with IEC 60601-1-2 standard for EMC. |
| Mechanical Testing: Demonstrate long-term safety and withstand worst-case stress loads. | Passed: Wear observed after testing is considered not to have any effect on the safety of patients or operators. |
| Technological Equivalence (to predicate device): Similar indications for use, use environment, user, patient population, test options, maneuvers, movement range, and power supply (with supported differences). | Achieved: Found to be as safe, as effective, and performs comparably to the predicate device, with technological differences supported by non-clinical data. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The document does not describe a "test set" in the context of data for an algorithm. The "testing" refers to physical device safety and mechanical performance. There is no data provenance for a diagnostic or predictive model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: No "ground truth" establishment for a diagnostic output is described, as this is a physical chair, not an AI diagnostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No adjudication method for a data test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No: A multi-reader multi-case (MRMC) study was not done. The device is a physical chair, not an AI assistant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is not an algorithm. The device is a physical chair, and human healthcare professionals manually operate it. Its function is to assist professionals in performing maneuvers, not to make a standalone diagnosis or treatment decision without human input.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: See point 3. The "ground truth" in this context pertains to compliance with safety regulations and functional equivalence to a predicate device, not diagnostic accuracy.
8. The sample size for the training set
- Not Applicable / Not Provided: No training set is described, as this is a physical device and not an AI model.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: No training set or ground truth establishment for it is described.
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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
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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
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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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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.
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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 toassist in the diagnosisand treatment of balancedisorders and vertigo,including benignparoxysmal positionalvertigo. | The Epley Omniax™ isintended to assist inthe diagnosis andtreatment of balancedisorders and vertigo,including benignparoxysmal positionalvertigo. | Same |
| Use environment | In a medical practice | In a medical practice | Same |
| User | Trained healthcareprofessional | Trained healthcareprofessional | Same |
| Patient population | Patients presenting withimbalance, unsteadinessor dizziness symptomssuspected of originatingfrom dislocated otoconiain one or more of thesemicircular canals in theinner ear. | Patients presentingwith imbalance,unsteadiness ordizziness symptomssuspected oforiginating fromdislocated otoconia inone or more of thesemicircular canals inthe inner ear. | Same |
| Test options | |||
| Video recording | Yes | Yes | Same |
| Nystagmusanalysis | Yes | Yes | Same |
| Oculomotor tests | Yes | Yes | Same |
| Session logging | Yes | Yes | Same |
| Positional tests | Yes | Yes | Substantial equivalentDiscussed 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 forPSC BPPV | Customized protocolusing the Freestyle tab | Substantial equivalentBoth devices can performsame maneuver |
| Lorin | Canalith repositioning forAnterior semi-circularcanal (ASC) BPPV | Customized protocolusing the Freestyle tab | Substantial equivalentBoth devices can performsame maneuver |
| BBQ Roll Left HSC | Canalith repositioning forHorizontal semi-circularcanal (HSC) BPPVcanalithiasis, Left side | Pre-set protocol "3/4Barrel roll" -canalithiasis Left | Substantial equivalentBoth devices can performsame maneuver |
| BBQ Roll RightHSC | Canalith repositioning forHorizontal semi-circularcanal (HSC) BPPVcanalithiasis, Right side | Pre-set protocol "3/4Barrel roll" -canalithiasis Right | Substantial equivalentBoth devices can performsame maneuver |
| BBQ Roll Left HSC | Canalith repositioning forHorizontal semi-circularcanal (HSC) BPPVcupulolithiasis, Left side | Pre-set protocol "3/4Barrel roll" -cupulolithiasis Left | Substantial equivalentBoth devices can performsame maneuver |
| BBQ Roll RightHSC | Canalith repositioning forHorizontal semi-circularcanal (HSC) BPPVcupulolithiasis, Right side | Pre-set protocol "3/4Barrel roll" -cupulolithiasis Right | Substantial equivalentBoth devices can performsame maneuver |
| 360° Back Flip"incremental" | 360° Back Flip"incremental" | Pre-set protocol 360°Back Flip "incremental" | Substantial equivalentBoth devices can performsame maneuver |
| 360° Back Flip"continuous" | 360° Back Flip carriedout in slow, continuoussweep | Pre-set protocol 360°Back Flip "continuous" | Substantial equivalentBoth devices can performsame maneuver |
| 360° Forward Flip | 360° Forward Flip | Pre-set protocol 360°Forward Flip | Substantial equivalentBoth devices can performsame maneuver |
| TechnicalDimensions | Weight: 640 kgHeight: 1.9 mDepth: 1.6 mWidth: 1.2 m | Weight: 372 kgHeight: 2.1 mDepth: 2.0 mWidth: 2.3 m | The TRV is slightlysmaller in size andheavier than the predicatedevice. This differencedoes not raise newquestions of safety andeffectiveness. |
| Movement range | 2 axes, 360° each:- Primary axis is a rollmovement with thepatient in the loadposition.- Secondary axis is ayaw movement with thepatient in the loadposition. | 2 axes, 360° each:- Alpha axis is a rollmovement with thepatient in the loadposition.- Beta axis is a yawmovement with thepatient in the loadposition. | The range of motion isthe same for bothdevices. |
| Power supply | The TRV chair isequipped with a 24Vrechargeable battery thatpowers the magneticlock for the primaryframe (Linak BAJ1 (24 VDC, 2,9 Ah)).A wall-mounted batterycharger is also provided(Linak, CHJ2). | Mains power supply:Voltage input120V/240V(switchable) at 50-60HzCurrent rating: 6A@120V, 3A @ 240VFusing: 8A @120V, 4A@ 240VIsolation from mainpower designed tomeet UL/cUL 2601 | Both devices havepassed electrical securitytesting according to IEC60601-1 and EMC testingaccording to IEC 60601-1-2.The differences in theenergy source do notraise different questionsof safety andeffectiveness and aresupported by testing |
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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.
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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.
N/A