(125 days)
The Nydiag 200 rotary chair is an optional accessory for the Interacoustics eye movement recording systems. The rotary chair is used to elicit Vestibulo-Ocular Reflexes in patients aged 2 years or older who weigh less than 135 kg / 300 lbs who are being tested for bilateral or unilateral lesions in the peripheral vestibular organs.
The Nydiag 200 is a rotation chair, including a chair unit and a motor pedestal unit. The Nydiag 200 is controlled by software. The rotating chair is an optional accessory and is used for stimulation of the patients balance organs. The chair is supplied from the mains and controlled from a computer through an USB connection. The chair unit includes the chair itself attached to a frame assembly, seat belts and other restraints, patient discomfort signal device and goggle connections (Firewire and USB). The pedestal includes a power unit and motor and gearing units.
The Nydiag 200 Rotary Chair is a medical device, and the provided document is a 510(k) premarket notification summary. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or performance against specific, quantifiable acceptance criteria in the same way a new drug or novel high-risk device might.
Therefore, many of the typical performance study details (like sample size, ground truth establishment, expert qualifications, and MRMC studies) are not present in this type of submission for this particular device. The "acceptance criteria" here are primarily about meeting safety standards and demonstrating equivalence to the predicate device in terms of technological characteristics and intended use.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration for 510(k)) | Reported Device Performance |
|---|---|
| Safety and Efficiency | Tested according to appropriate standards; found safe and efficient for its purpose. |
| Technological Characteristics Equivalence | Functionally similar to the predicate device (System 2000 ROTATIONAL VESTIBULAR CHAIR). Both are rotary chairs controlled by software, used for vestibular stimulation. |
| Indications for Use Equivalence | Same indications for use as the predicate device: eliciting Vestibulo-Ocular Reflexes in patients (2+ years old, |
N/A