(163 days)
The Orion rotary chair is an optional accessory for VisualEyes 515 eye movement recording systems.
The VisualEyes™ system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. VNG testing evaluates nystagmus using goggles mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information can then be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for videonystagmography is five years of age and above.
The Orion is a rotary chair designed to assess the Vestibular Ocula Reflex (VOR).
Orion rotary chair includes these three variants
- Orion Reclining
- Orion Auto Traverse
- Orion Comprehensive .
The Orion is considered an accessory to vestibular examination system software designated VisualEyes 525 and VisualEyes 515 manufactured by Interacoustics (FDA 510(k) K200534).
The Orion is an update of the System 2000 by Micromedical ((FDA 510(k) ID K922037).
The provided text is a 510(k) summary for a medical device (Orion Rotary Chair). It does not contain details about acceptance criteria or a study proving the device meets those criteria in a quantitative sense.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (System 2000 by Micromedical). The "performance tests" mentioned are primarily comparative, asserting that the new device performs "as specified" and is "safe and effective" based on these comparisons, rather than against predefined, quantitative acceptance criteria. There are no clinical tests performed.
Therefore, many of the requested items cannot be extracted from the provided text.
Here is a summary of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a formal table comparing them against reported performance. Instead, it offers a "Comparison table" between the Orion device and its predicate (System 2000) for various descriptive and technical characteristics, aiming to show equivalence rather than adherence to specific numeric performance thresholds.
| Description | Orion Model (Reclining) Performance (Reported as 'Same' or 'Equivalent') | System 2000 Model (Reclining) Performance (Predicate) | Equivalence Justification |
|---|---|---|---|
| Intended use | The Orion rotary chair is an optional accessory for VisualEyes 525/VisualEyes 515 eye movement recording systems | The System 2000 rotary chair is an optional accessory for eye movement recording systems | Same |
| Software to support | VisualEyes 515/525 | VisualEyes 515/525 and Spectrum | Same (Spectrum is the replaced software). Evaluated in K163149. |
| Chair and Controller | yes | yes | Same |
| Video Goggle connector | yes USB | yes Firewire | Equivalent - USB and Firewire are communication protocols |
| Patient Weight Maximum | 350 lbs (158kilo) | 350 lbs (158kilo) | Same |
| VOR, VVOR, VFX | yes .01-.64 Hz | yes .01-.64 Hz | Same |
| Step tests | max 200 | max 200 | Same |
| VOR Analysis | yes | yes | Same |
| Equipment cart | yes | yes | Same |
| Ocularmotor Tests | yes | yes | Same |
| VORTEQ/VHIT/DVA | Option | Option | Same |
| EOG | Option | Option | Same |
| Mechanical Foot Brake | Electric Lock | yes (manual foot brake) | Equivalent - both provide an immobile state for patient safety; electronic lock allows chair to be immobile before test and prevents rotation during test. |
| Sinusoidal Frequency | 0.01 to 0.64 Hz | 0.01 to 0.64 Hz | Same |
| Step Velocity (max) | 200 deg/sec | 200 deg/sec | Same |
| Acceleration (max) | 100 deg/sec² | 100 deg/sec² | Same |
| Auto Traverse / Comprehensive Models Differences | |||
| Chair and Controller | Orion: Controller is inside the Chair base | System 2000: Controller is a separate unit | Equivalent - merely a design difference. |
| Patient Weight Maximum | 400 lbs | 400 lbs | Same |
| Step Velocity (max) | 350 deg/sec | 300 deg/sec | Equivalent - typical Step Velocity test parameters do not exceed 180 d/s; SVV test uses 300 d/s. Higher max velocity is not critical. |
| Lateral movement speed | 0.8 cm/sec | 1 cm/sec | Equivalent - speed to go offset is not a critical parameter; lateral offset controls stimulation of Otolith organs, not the speed to attain it. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No formal test set or clinical study is described. The "performance tests" involved comparisons of the physical device features and operational parameters against the predicate device.
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. No ground truth was established by experts for a test set, as no clinical study or diagnostic performance assessment involving human interpretation is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication 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
Not applicable. This is a rotary chair for vestibular testing, not an AI-assisted diagnostic imaging device that would typically undergo an MRMC study. No AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device (rotary chair) that requires operation by a trained medical professional; it is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The basis for safety and effectiveness is substantial equivalence to a predicate device, demonstrated through comparative technical specifications and internal performance testing, not against a clinical ground truth.
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".
August 12, 2020
Interacoustics A/S Erik Nielsen Director, Regulatory & Compliance Audiometer Alle 1 5500 Middelfart Denmark
Re: K200529
Trade/Device Name: Orion Reclining, Orion Auto Traverse, Orion Comprehensive Regulatory Class: Unclassified Product Code: LXV Dated: July 10, 2020 Received: July 13, 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 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-reporting
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combination-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,
for Malvina Eydelman. M.D. Office 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200529
Device Name
Orion Reclining, Orion Auto Traverse, Orion Comprehensive
Indications for Use (Describe)
The Orion rotary chair is an optional accessory for VisualEyes 515 eye movement recording systems.
The VisualEyes™ system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. VNG testing evaluates nystagmus using goggles mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information can then be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for videonystagmography is five years of age and above.
| 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
Orion Rotary Chair
Interacoustics A/S
Audiometer Allé 1 5500 Middelfart
+45 6371 3555
Erik Nielsen,
August 11, 2020
Orion Reclining Orion Auto Traverse Orion Comprehensive
Ear Nose & Throat
Rotary chair
Unclassified
LXV
Director, Requlatory & Compliance
Denmark
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
System 2000 by Micromedical Micromedical Technologies inc K922037 10/26/1992
Apparatus, vestibular analysis
| Device | The Orion is a rotary chair designed to assess the Vestibular Ocula |
|---|---|
| Description | Reflex (VOR). |
Orion rotary chair includes these three variants
- Orion Reclining
- Orion Auto Traverse
- Orion Comprehensive .
The Orion is considered an accessory to vestibular examination system software designated VisualEyes 525 and VisualEyes 515 manufactured by Interacoustics (FDA 510(k) K200534).
The Orion is an update of the System 2000 by Micromedical ((FDA 510(k) ID K922037).
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| Variantdescription | OrionReclining | The chair allows you to carry out all tests in aminimum of space. In addition to rotation tests, itreclines precisely to 30 degrees for caloric testingwith easy access to both ears. It also reclinescompletely to act as an exam table for positionaland Dix-Hallpike tests. | |
|---|---|---|---|
| Orion AutoTraverse | This chair features include a dark room enclosurefor eyes uncovered recording, an XY laserprojector for ocularmotor testing in both horizontaland vertical directions, and a full-field optokineticdrum that projects moving stripes on the boothwall. Also for ocularmotor testing. | ||
| Advanced features include the ability to shift thecenter of rotation off-axis and to perform adynamic subjective visual vertical test. | |||
| OrionComprehensive | This chair features a dark room enclosure for eyesuncovered recording, an XY laser projector fortesting in both horizontal and vertical directions, astatic subjective visual vertical test, and a full-fieldoptokinetic drum that projects stripes from the floorto the ceiling. Also for ocularmotor testing. | ||
| Indications foruse | The Orion rotary chair is an optional accessory for VisualEyes 525/VisualEyes 515 eye movement recording systems. | ||
| The VisualEyes™ system provides information to assist in thenystagmographic evaluation, diagnosis and documentation ofvestibular disorders. Nystagmus of the eye is recorded by use of agoggle mounted with cameras. These images are measured,recorded, displayed and stored in the software. This information then |
can be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for VisualEyes system is 5 years of age and above.
The Technological Characteristics are the same as the predicate Technological characteristics device. See Substantial Equivalence table below for characteristics.
Substantial Equivalence
Interacoustics A/S have chosen to compare the Orion Rotational Vestibular Chair with the Micromedical Technologies System 2000 -Rotational Vestibular Chair for the following reasons.
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- . Orion is an updated version of the System 2000
- The predicate systems have the same medical purpose .
- . System 2000 has obtained FDA 510(k) clearance
- Both new device and predicate device comes in the same 3 model variants
- o Reclining
- o Auto Traverse
- o Comprehensive
- Both new device and predicate device comes in the same 3 model variants
Both Orion and System 2000 are supported by the software called VisualEyes 515/525.
Comparison table
.
Orion - Rotational Vestibular Chair
Versus
System 2000 - Rotational Vestibular Chair
| Description | OrionModel:Reclining | System2000Model:Reclining | Equivalence |
|---|---|---|---|
| Intended use | The Orionrotary chair isan optionalaccessory forVisualEyes 525/VisualEyes 515eye movementrecordingsystems | The System2000 rotarychair is anoptionalaccessoryfor eyemovementrecordingsystems | Same |
| Software to support | VisualEyes515/525 | VisualEyes515/525andSpectrum | Same (Spectrum is the replacedsoftware)See also "Equivalentdiscussions (Software)" belowthis table |
| Chair andController | yes | yes | Same |
| Video Goggleconnector | yes USB | yesFirewire | Equivalent -USB and firewire arecommunication protocols |
| Patient WeightMaximum | 350 lbs(158kilo) | 350 lbs(158kilo) | Same |
| VOR, VVOR, VFX | yes .01-.64 Hz | yes .01-.64Hz | Same |
| Step tests | max 200 | max 200 | Same |
| VOR Analysis | yes | yes | Same |
| Equipment cart | yes | yes | Same |
| Ocularmotor Tests | yes | yes | Same |
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| VORTEQ/VHIT/DVA | Option | Option | Same |
|---|---|---|---|
| EOG | Option | Option | Same |
| Mechanical FootBrake | Electric Lock | yes | Equivalent -please refer to " Equivalentdiscussions (Mechanical FootBrake)" below this table |
| SinusoidalFrequency | 0.01 to 0.64Hz | 0.01 to0.64 Hz | Same |
| Step Velocity (max) | 200 deg/sec | 200deg/sec | Same |
| Acceleration (max) | 100 deg/sec2 | 100deg/sec2 | Same |
Equivalent discussions (Software)
The evaluation of the VisualEves 515/525 compared to Spectrum was included in the 510(k) submission cleared under K163149. The evaluation was done for the System 2000 rotational chair. The Orion chair hardware equivalency was established by setting tests in VisualEyes 515/525 to certain parameters and then physically measuring the chair performance.
Equivalent discussions (Mechanical Foot Brake)
The ORION Reclining Chair implements an electronic lock. This function is designed to place the chair into an immobile state in order to ensure patient safety when seating and/or disembarking the patient from the reclining chair. It is also used to keep the chair immobile during the VNG test battery. The lock chair function is only made available prior to the test and cannot be activated during the testing procedure. This will automatically be switched off when performing a rotational chair test.
The System 2000 Reclining chair does not have an electronic braking system. A manual foot brake is found on the side of the chair drum. The operator should apply the brake to keep the chair in place for patient entry and VNG testing. When reclining the chair for Dix Hallpike, Positional, and Caloric tests, the foot brake should be released in order to rotate the chair if needed due to space constraints. The foot brake should then be reapplied when the chair is reclined to the appropriate position to keep the chair from rotating during the test.
Interacoustics A/S appraise that the function of the Mechanical Foot Brake and the electric lock is essential equivalent.
| Description | Orion | System 2000 | Equivalence |
|---|---|---|---|
| Model:Auto Traverse /Comprehensive | Model:Auto Traverse /Comprehensive | ||
| Intended use | The Orion rotarychair is anoptional | The System 2000rotary chair is anoptional | Same |
| accessory forVisualEyes 525/VisualEyes 515eye movementrecording systems | accessory for eyemovementrecording systems | ||
| Software tosupport | VisualEyes515/525 | Spectrum | Equivalent -please refer to SoftwareEquivalent discussion justabove |
| Chair andController | yes | yes | Equivalent - the controllerfor Orion is inside theChair base, whereas forSystem 2000 it is aseparate unit. |
| Video GoggleConnector | yes USB | yes FireWire | Equivalent -USB and firewire arecommunication protocols |
| Patient WeightMaximum | 400 lbs | 400 lbs | Same |
| VOR, VVOR, VFX | yes, .01 - .64 Hz | yes .01-.64 Hz | Same |
| Step tests | Yes | Yes | Same |
| VOR Analysis | yes | yes | Same |
| Equipment cart | yes | yes | Same |
| Ocularmotor Tests | yes | yes | Same |
| X-Y laser | yes | yes | Same |
| Optokineticprojector | yes | yes | Same |
| Chair enclosure | yes | yes | Same |
| Subjective VisualVertical | yes | yes | Same |
| Auto-TraverseCentrifuge | yes | yes | Same |
| VORTEQ/VHIT/DVA | Option | Option | Same |
| EOG | Option | Option | Same |
| Mechanical FootBrake | no | no | Same |
| SinusoidalFrequency | 0.01 to 0.64 Hz | 0.01 to 0.64 Hz | Same |
| Step Velocity(max) | 350 deg/sec | 300 deg/sec | Equivalent -because typical StepVelocity test parametersdo not exceed 180 d/sirrespective of themaximum constantvelocity capability of thechair. SVV testparameters use only 300d/s for the test. |
| Acceleration (max) | 200 deg/sec2 | 200 deg/sec2 | Same |
| Lateral movement | -7cm to +7cm | -7cm to +7cm | Same |
| Lateral movementspeed | 0.8 cm/sec | 1 cm/sec | Equivalent -because the speed to gooffset is not a criticalparameter. The lateraloffset from on-axisrotation is what controlsthe stimulation of Otolithorgans and not the speedto attain this offset. |
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Performance Tests
Interacoustics A/S appraise that there are only minor updates and changes to the devices and that the safety and efficiency are essential the same.
Interacoustics A/S have performed comparisons between the updated revision of Orion chairs and the predicate device. All these activities, testing and validation show that Orion chairs performs as specified and are safe and effective.
Clinical tests
No clinical tests were performed. Interacoustics A/S have performed comparisons between the Orion chairs and the predicate device. These activities, testing and validation show that Orion chairs perform as specified and are safe and effective.
Discussion of differences
Interacoustics A/S did not find any essential or maior differences between the predicate and subject devices. Any deviations between Orion chairs and predicate device are appraised to have no impact on the safety and effectiveness of the device.
Conclusion
Interacoustics A/S have compared key issues for the Orion chairs and the predicate device. Interacoustics A/S have performed a comparison validation between Orion chairs and the predicate device.
Based upon non-clinical and clinical performance testing, the Orion chairs were found to have a safety and effectiveness profile that is comparable to the predicate device. Therefore, Interacoustics A/S has demonstrated that the Orion chairs are substantially equivalent to the stated predicate device.
N/A