(43 days)
Not Found
No
The summary describes a simple electrical stimulating probe with no mention of AI or ML capabilities.
No.
The device is used for stimulating nerves during surgery for location and identification, which is a diagnostic or guidance function, not a therapeutic one.
Yes
Explanation: The device is intended to stimulate nerves for "location and identification during surgery." This function, which helps identify anatomical structures or nerve pathways for surgical precision, can be considered a form of diagnosis in the context of guiding surgical procedures.
No
The device description explicitly states it includes hardware components: a metal ball tip, an insulated flexible metal shaft, and a protected pin electrical connector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stimulate cranial and peripheral motor nerves for location and identification during surgery." This is a direct interaction with the patient's body during a surgical procedure.
- Device Description: The description details a probe with a metal tip, shaft, and electrical connector, designed for physical stimulation.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs typically involve reagents, assays, or other methods for analyzing biological specimens.
This device is a surgical instrument used for nerve stimulation in vivo (within the body) during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Ball-Tip Monopolar Stimulating Probe is intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
Product codes
ETN
Device Description
The probe includes a metal ball tip, an insulated, flexible metal shaft, and a protected pin electrical connector to attach the probe to a stimulator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial and peripheral motor nerves, spinal nerve roots
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)
Not Found
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.
Not Found
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
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Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string is "K992869". The characters are written in black ink on a white background. There is a line drawn underneath the string of characters.
510(k) Summary
1.0 Date Prepared
August 24, 1999
Submitter (Contact) 2.0
Martin D. Sargent Xomed Surgical Products Jacksonville, FL (904) 279-7586
Device Name 3.0
| Proprietary Name: | Xomed Ball-Tip Monopolar Stimulator Probe |
|---|---|
| Common Name(s): | Monopolar Stimulator Probe |
| Classification Name(s): | Surgical Nerve Stimulator/Locator |
5.0 Device Classification
Surgical Nerve Stimulator/Locator: Procode ETN Class II 21 CFR 874.1820
6.0 Device Description
The probe includes a metal ball tip, an insulated, flexible metal shaft, and a protected pin electrical connector to attach the probe to a stimulator.
7.0 Intended Use
The Ball-Tip Monopolar Stimulating Probe is intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
8.0 Substantial Equivalence
The Xomed Ball-Tip Monopolar Stimulator Probe is substantially equivalent to the Magstim/Neurosign Pedicle Hole Probe as described in K980148 in its intended use, materials, and overall design.
1
Image /page/1/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
7 1999 OCT
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Martin D. Sargent Sr. Regulatory Affairs Specialist XOMED 6743 Southpoint Dr. N. Jacksonville, Florida
Re: K992869 Trade Name: Xomed Monopolar Stimulator Probe Regulatory Class: II Product Code: 77 ETN Dated: August 25, 1999 Received: August 26, 1999
Dear Mr. Sargent:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
2
Page 2 - Mr. Martin D. Sargent
· This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): Ball-Tip Monopolar Stimulator Probe Device Name: _ Indications for Use:
The Ball-Tip Monopolar Stimulating Probe is intended to stimulate cranial and peripheral The Dail-Tip Honopolar Summandig cation during surgery, including spinal nerve roots.
(Division Sign-Off)
Division of Ophthalmic Devices
10(k) Number K992869
(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)
Prescription Use
(Per 21 CFR 801.109) ✓
Or
Over-the-Counter Use__
(Optional Format 1-2-96)