(162 days)
Not Found
Neurosign Model 100
No
The summary explicitly states the device has the same technological characteristics and mode of operation as the predicate device, and there are no mentions of AI, ML, or related concepts.
No
The device aids in nerve location during surgery and does not directly treat a condition or disease.
No
Explanation: The device provides electrical stimulation to aid in nerve location during surgical procedures. It is an assistive tool for nerve identification, not for diagnosing a medical condition.
No
The device description explicitly states it is a "Nerve Stimulator," which implies a hardware component that delivers electrical stimulation. The summary does not mention any software-only functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures." This describes a device used in vivo (within a living organism) to interact with the body directly.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body.
The Gyrus ENT Nerve Stimulator is clearly used on the patient during surgery, not on a sample taken from the patient.
N/A
Intended Use / Indications for Use
The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
ETN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial and peripheral motor nerves
Indicated Patient Age Range
Not Found
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)
The Gyrus ENT Nerve Stimulator that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate device. The intended use is substantially equivalent to the described predicate Neurosign Model 100. The Gyrus ENT Nerve Stimulator is designed to meet:
- UL2601/IEC 601 safety testing for 100Vac, 50/60 Hz. .
- UL2601/IEC 601 safety testing for 120Vac, 50/60 Hz. .
- UL2601/IEC 601 safety testing for 220Vac, 50/60 Hz. .
- UL2601/IEC 601 safety testing for 240Vac, 50/60 Hz. .
- EMC Testing, IEC 601-1-2. .
Conclusion: As a nerve stimulator only the Gyrus ENT Nerve Stimulator has the same intended use and the same basic technological characteristics as the Neurosion Model 100 Neural Tissue Stimulator and does not raise any new issues of safety or effectiveness.
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.
Not Found
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.
Neurosign Model 100
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
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
0
OCT 2 4 2002
510(k) Summary of Safety and Effectiveness
| Trade Name: | Gyrus ENT Nerve Stimulator |
|---|---|
| Common Name: | Surgical nerve stimulator/locator |
| Classification Name: | Surgical nerve stimulator/locator (§ 874.1820) |
| Official Contact: | Gregory Sredin |
| Sr. Regulatory Affairs Specialist | |
| Gyrus ENT LLC | |
| 2925 Appling Road | |
| Bartlett, TN 38133 | |
| Telephone: | (901) 373-0200 |
| Telefax: | (901) 387-3914 |
| Date Prepared: | May 13, 2002 |
The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures.
The Gyrus ENT Nerve Stimulator that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate device. The intended use is substantially equivalent to the described predicate Neurosign Model 100. The Gyrus ENT Nerve Stimulator is designed to meet:
- UL2601/IEC 601 safety testing for 100Vac, 50/60 Hz. .
- UL2601/IEC 601 safety testing for 120Vac, 50/60 Hz. .
- UL2601/IEC 601 safety testing for 220Vac, 50/60 Hz. .
- UL2601/IEC 601 safety testing for 240Vac, 50/60 Hz. .
- EMC Testing, IEC 601-1-2. .
Conclusion: As a nerve stimulator only the Gyrus ENT Nerve Stimulator has the same intended use and the same basic technological characteristics as the Neurosion Model 100 Neural Tissue Stimulator and does not raise any new issues of safety or effectiveness.
1
| Gyrus ENT Nerve Monitor | Neurosign 100 Nerve Monitor | |
|---|---|---|
| Intended Use | The Gyrus ENT Nerve Stimulator is intended | |
| to provide electrical stimulation to the body to | ||
| locate and identify nerves and to test their | ||
| excitability. | The device is intended to stimulate and monitor | |
| cranial motor nerves. | ||
| Power Supply | 100-240VAC; 50-60Hz, features power | |
| on LED. | 100-240VAC; 50-60Hz | |
| Frequency | 3, 10, 30Hz, touch pad and frequency | |
| confirm indicator. | 3, 30Hz, 2-position switch, no | |
| frequency confirm indicator. | ||
| Current | 0.1 - 5.0 ma, in 0.1 ma increments | |
| with display to show setting and | ||
| current confirm indicator. | 0.15 - 5.0 ma, variable settings, but no | |
| display to show actual setting. Does | ||
| feature current confirm indicator, | ||
| Probes supported | Monopolar and Bipolar | Monopolar and Bipolar |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged vertically, with "Public Health" on the first line and "Service" on the second line. The text is black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gyrus ENT c/o Greg Sredin Sr. Regulatory Affairs Specialist 2925 Appling Road Bartlett, TN 38133
Re: K021595
Trade/Device Name: Gyrus ENT Nerve Stimulator Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: September 17, 2002 Received: September 18, 2002
Dear Mr. Sredin:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
OCT 24 2002
Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three birds in flight.
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Page 2 – Greg Sredin
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Food and Drug Administration 510(k) Notification - Gyrus ENT Nerve Stimulator May 13, 2002
510(k) Number: Device Name:
:
KO215-95
Gyrus ENT Nerve Stimulator
Indications for Use:
The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use . (Per 21 CFR 801.109)
(Optional Format 1-2-96)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | --- |
OR
| Over-the-Counter | |
|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off)Division of Onhthalmic Ear, Nose a: .. session
510(k) Number K021595
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