(23 days)
No
The description focuses on detecting electrocautery interference and muting an audio output, which is a rule-based or signal processing function, not indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device's function is to mute external audible outputs from a nerve monitor when electrocautery interference is detected. This is a supportive function to a monitoring device and does not directly treat or diagnose a disease or condition.
No
The device is an accessory that mutes external audible outputs when electrocautery interference is detected. It does not diagnose any medical condition, disease, or provide information to aid in the diagnosis of a condition. Its function is to manage audio output in the presence of interference, not to analyze physiological data for diagnostic purposes.
No
The device description explicitly states it "interfaces between the auditory signal output from a nerve monitor and the nerve monitor's external speaker," indicating a physical hardware component is involved in the signal path.
Based on the provided information, the Nicolet Electrocautery Detector is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- Device Function: The Nicolet Electrocautery Detector's function is to detect and mute audio interference from electrocautery during nerve monitoring. It interfaces with a nerve monitor and its speaker.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from a patient. Its operation is based on detecting electrical interference.
- Intended Use: The intended use is to support nerve monitoring by managing audio output, not to diagnose any condition based on biological samples.
Therefore, the Nicolet Electrocautery Detector falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nicolet Electrocautery Detector is an accessory device supporting muting of external audible outputs when electrocautery interference is detected.
Product codes
ETN
Device Description
The Nicolet Electrocautery Detector interfaces between the auditory signal output from a nerve monitor and the nerve monitor's external speaker. The Electrocautery Detector automatically mutes the nerve monitor speaker when electrocautery interference is detected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Wherever nerve monitors and stimulators are used. Typically hospitals and clinics.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for Nicolet Biomedical. The word "Nicolet" is in large, bold, sans-serif font. A thick black line is underneath the word "Nicolet". Below the line, the word "BIOMEDICAL" is in a smaller, sans-serif font, with a space between each letter.
APR 1 7 2002
Summary of Safety and Effectiveness
| Company Name: | Nicolet Biomedical
5225 Verona Road
Madison, WI 53711 |
|----------------------------|-------------------------------------------------------------------------------------|
| Contact:
Phone:
Fax: | Glen Hermanson, Manager of Standards and Compliance
608 441-2065
608 441-2007 |
| Summary Date: | March 20, 2002 |
| Trade Name: | Electrocautery Detector |
| Common Name: | Nerve Stimulator |
| Classification Name: | 21 CFR 874.1820; Product Code: ETN |
| Predicate Device: | 510(k) Number: K934426
Manufacture: XOMED-TREACE, Inc. |
Nerve Integrity Monitor-2 (NIM-2 XL) Trade Name:
Description of Device 1.0
The Nicolet Electrocautery Detector interfaces between the auditory signal output from a nerve monitor and the nerve monitor's external speaker. The Electrocautery Detector automatically mutes the nerve monitor speaker when electrocautery interference is detected.
2.0 Intended Use
The intended use of the Nicolet Electrocautery Detector is as an accessory device supporting muting of external audible outputs when electrocautery interference is detected.
45
1
Image /page/1/Picture/0 description: The image shows the logo for Nicolet Biomedical. The word "Nicolet" is in a large, bold, sans-serif font. A thick black line is underneath the word "Nicolet". Below the line, the word "BIOMEDICAL" is in a smaller, sans-serif font, with a space between each letter.
Technological 3.0
The technology of the Electrocautery Detector is equivalent to the electrocautery mute feature in the predicate device. Both devices detect the presence of electrocautery RF energy as an interference signal and mute the speaker.
Conclusions 4.0
The intended use and technology of the Nicolet Electrocautery Detector device is substantially equivalent to the predicate device, electrocautery mute feature. No new questions of safety or effectiveness are raised.
2
Specifications/Comparison to Predicates 5.0
Table 5.0-1 compares features and specifications of the Nicolet Electrocautery Detector to the predicate device
:
| Feature | Nicolet Electrocautery Detector Device
(Under Review) | XOMED NIM-2 XL
(Predicate K934426) | Substantial Equivalence Comments |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Indication for Use | The Nicolet Electrocautery Detector is an
accessory device supporting muting of external
audible outputs when electrocautery interference
is detected. | As a feature of nerve monitoring, an
electrocautery detection and muting feature is
provided. | Same features with regard to electrocautery
detection and muting of audible output. |
| Environment of
Use | Wherever nerve monitors and stimulators are
used. Typically hospitals and clinics. | Hospitals and clinics | Used in the same clinical environments. |
| Number of
electrocautery
detector inputs | 2 | 4 | Up to 2 electrocautery antenna probe inputs are
supported on the Electrocautery Detector. |
| Technology | Detection of electrocautery Radio Frequency
energy and muting of audible output. | Detection of electrocautery Radio Frequency
energy and muting of audible output. | Same |
| Recovery Time
After Mute | ≤ 1 second | ≤ 5 seconds | The Nicolet Electrocautery Detector has a faster
recovery time from a muted condition. |
| Electrocautery
Detector
Sensitivity
Adjustment | Yes - User selectable | Yes - User Selectable | Same |
| Adjustable
Sensitivity to
Electrocautery
Interference
Detection | Yes | Yes | Same |
CONFIDENTIAL
Electrocautery Mute 510(k)
12
3
Electrocautery Mute 510(k)
13
CONFIDENTIAL
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2002
Nicolet Biomedical, Inc c/o Gary Syring, Principal Consultant Ouality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589
Re: K020955
Trade/Device Name: Nicolet Electrocautery Detector Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: March 20, 2002 Received: March 25, 2002
Dear Mr. Syring:
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.
5
Page 2 - Gary Syring, Principal Consultant
This letter will allow you to begin marketing your device as described in your Section 510(k) r market notification. The FDA finding of substantial equivalence of your device to a legally promated 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 vours,
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
6
10209 510(k) Number (if known):
Device Name: Nicolet Electrocautery Detector
Indications For Use:
The Nicolet Electrocautery Detector is an accessory device supporting muting of external audible outputs when electrocautery interference is detected.
(PLEASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use yes ✓
(Per 21 CFR 801.109)
Vann Biller
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
02 510(k) Number.