(163 days)
No
The description focuses on the mechanical function of a rotary chair and image processing for measurement and recording, with no mention of AI or ML algorithms for analysis or interpretation.
No
This device, a rotary chair, is described as an accessory for systems that assist in the nystagmographic evaluation and diagnosis of vestibular disorders, but it does not directly treat or cure a disease.
Yes
The VisualEyes™ system, of which the Orion rotary chair is an accessory, states its purpose is to "provide information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders." This explicitly mentions diagnosis.
No
The device description explicitly states that the Orion is a "rotary chair designed to assess the Vestibular Ocula Reflex (VOR)" and lists three hardware variants. While it is an accessory to software, the device itself is a physical piece of equipment.
Based on the provided information, the Orion rotary chair itself is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Orion's Function: The Orion rotary chair is described as an accessory to the VisualEyes system. Its purpose is to assess the Vestibular Ocula Reflex (VOR) by physically moving the patient. It does not directly analyze biological specimens.
- VisualEyes System: The VisualEyes system, which the Orion is an accessory to, does involve the collection and analysis of data (eye movements captured by cameras) to assist in diagnosis. However, this is not considered an in vitro process as it involves observing and measuring a physiological response in a living person, not analyzing a specimen taken from the body.
In summary: The Orion rotary chair is a piece of equipment used in conjunction with a diagnostic system (VisualEyes), but it does not perform the in vitro diagnostic testing itself. The VisualEyes system, while involved in diagnosis, is also not an IVD in the traditional sense because it analyzes a physiological response rather than a biological specimen.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LXV
Device Description
The Orion is a rotary chair designed to assess the Vestibular Ocular 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).
Mentions image processing
These images are measured, recorded, displayed and stored in the software.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The target population for videonystagmography is five years of age and above.
Intended User / Care Setting
Not Found
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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
1
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
2
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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3
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).
4
| Variant
description | Orion
Reclining | The chair allows you to carry out all tests in a
minimum of space. In addition to rotation tests, it
reclines precisely to 30 degrees for caloric testing
with easy access to both ears. It also reclines
completely to act as an exam table for positional
and Dix-Hallpike tests. | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Orion Auto
Traverse | This chair features include a dark room enclosure
for eyes uncovered recording, an XY laser
projector for ocularmotor testing in both horizontal
and vertical directions, and a full-field optokinetic
drum that projects moving stripes on the booth
wall. Also for ocularmotor testing. | |
| | | Advanced features include the ability to shift the
center of rotation off-axis and to perform a
dynamic subjective visual vertical test. | |
| | Orion
Comprehensive | This chair features a dark room enclosure for eyes
uncovered recording, an XY laser projector for
testing in both horizontal and vertical directions, a
static subjective visual vertical test, and a full-field
optokinetic drum that projects stripes from the floor
to the ceiling. Also for ocularmotor testing. | |
| Indications for
use | 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 the
nystagmographic evaluation, diagnosis and documentation of
vestibular disorders. Nystagmus of the eye is recorded by use of a
goggle 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.
5
- . 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 | Orion
Model:
Reclining | System
2000
Model:
Reclining | Equivalence |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 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)
See also "Equivalent
discussions (Software)" below
this table |
| 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 |
6
| VORTEQ/VHIT/DVA | Option | Option | Same |
|---|---|---|---|
| EOG | Option | Option | Same |
| Mechanical Foot | |||
| Brake | Electric Lock | yes | Equivalent - |
| please refer to " Equivalent | |||
| discussions (Mechanical Foot | |||
| Brake)" below this table | |||
| 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 |
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 rotary | ||
| chair is an | |||
| optional | The System 2000 | ||
| rotary chair is an | |||
| optional | Same | ||
| accessory for | |||
| VisualEyes 525/ | |||
| VisualEyes 515 | |||
| eye movement | |||
| recording systems | accessory for eye | ||
| movement | |||
| recording systems | |||
| Software to | |||
| support | VisualEyes | ||
| 515/525 | Spectrum | Equivalent - | |
| please refer to Software | |||
| Equivalent discussion just | |||
| above | |||
| Chair and | |||
| Controller | yes | yes | Equivalent - the controller |
| for Orion is inside the | |||
| Chair base, whereas for | |||
| System 2000 it is a | |||
| separate unit. | |||
| Video Goggle | |||
| Connector | yes USB | yes FireWire | Equivalent - |
| USB and firewire are | |||
| communication protocols | |||
| Patient Weight | |||
| Maximum | 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 |
| Optokinetic | |||
| projector | yes | yes | Same |
| Chair enclosure | yes | yes | Same |
| Subjective Visual | |||
| Vertical | yes | yes | Same |
| Auto-Traverse | |||
| Centrifuge | yes | yes | Same |
| VORTEQ/VHIT/DVA | Option | Option | Same |
| EOG | Option | Option | Same |
| Mechanical Foot | |||
| Brake | no | no | Same |
| Sinusoidal | |||
| Frequency | 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 Step | |||
| Velocity test parameters | |||
| do not exceed 180 d/s | |||
| irrespective of the | |||
| maximum constant | |||
| velocity capability of the | |||
| chair. SVV test | |||
| parameters use only 300 | |||
| d/s for the test. | |||
| Acceleration (max) | 200 deg/sec2 | 200 deg/sec2 | Same |
| Lateral movement | -7cm to +7cm | -7cm to +7cm | Same |
| Lateral movement | |||
| speed | 0.8 cm/sec | 1 cm/sec | Equivalent - |
| because the speed to go | |||
| offset is not a critical | |||
| parameter. The lateral | |||
| offset from on-axis | |||
| rotation is what controls | |||
| the stimulation of Otolith | |||
| organs and not the speed | |||
| to attain this offset. |
7
8
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.