(272 days)
K891920B
No
The summary describes a passive electrode for monitoring evoked potentials and explicitly states that AI, DNN, or ML are not mentioned.
No
The device is described as being "intended for measurement of muscle MEP (Motor Evoked Potential) type monitoring" during surgery, indicating a diagnostic or monitoring function rather than a therapeutic one.
Yes
The device is intended for "measurement of muscle MEP (Motor Evoked Potential) type monitoring during spinal surgery." This measurement provides information about a patient's physiological state, which can be used to inform clinical decisions during surgery.
No
The device description explicitly states it is an "electrode," which is a hardware component used for measurement. The summary does not mention any software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "measurement of muscle MEP (Motor Evoked Potential) type monitoring during spinal surgery." This involves measuring electrical signals directly from the body (in vivo), not analyzing samples taken from the body (in vitro).
- Device Description: The device is an electrode placed "epidurally for monitoring evoked potentials." This is a direct interaction with the patient's nervous system, not an analysis of a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of blood, urine, tissue, or other biological samples, which are the hallmarks of IVD devices.
Therefore, based on the provided information, the Ad-Tech Spinal Electrode is a medical device used for physiological monitoring in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ad-Tech's Spinal Electrode is intended for measurement of muscle MEP (Motor Evoked Potential) type monitoring during spinal surgery.
Product codes (comma separated list FDA assigned to the subject device)
84GYC, GZL, GWF, JXE
Device Description
The Ad-Tech Spinal Electrode addressed in this premarket notification has identical materials, technological characteristics, sterilization procedures and packaging as the commercially available Ad-Tech Depth Electrode (K891920B). The device has similar intended use, materials and technological characteristics to the commercially available Nicolet Epidural Spinal Electrode (K882053). Like this device, the Ad-Tech Spinal Electrode is to be placed epidurally for monitoring evoked potentials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / during spinal surgery
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.
Nicolet Epidural Spinal Electrode (K882053)
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.
Ad-Tech Depth Electrode (K891920B)
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
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).
0
JUN 1 0 1998
AD-TECH MEDICAL INSTRUMENT CORPORATION
510(k) Summary April 20, 1998
General Information L
Contact Name and Manufacturing Address:
Curtis Van Allen II Ad-Tech Medical Instrument Corp. 1901 William Street Racine, WI 53404 Tel. (414) 634-1555 Fax. (414) 634-5668
Device Trade Name:
Common Name:
Classification:
Intended Use:
Predicate Device:
Product Code / Classification:
Establishment Registration Number:
Ad-Tech's Spinal Electrode
Electrode, Cortical
Class II 882.1310 Cortical Electrode
Ad-Tech's Spinal Electrode is intended for measurement of muscle MEP (Motor Evoked Potential) type monitoring during spinal surgery.
Nicolet Epidural Spinal Electrode (K882053)
84GYC
2183456
Safety and Effectiveness Information Supporting the Substantial Equivalence II. Determination
A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.
1901 WILLIAM STREET RACINE, WISCONSIN 53404, U.S.A. TELEPHONE 414-634-1555 TELEFAX 414-634-5668
1
General Safety and Effectiveness Concerns
Ad-Tech Spinal Electrode labeling contains instructions for the proper use of this product. It includes a description of the product, directions for use and applicable safety information. These instructions promote safe and effective use of the device when followed by a physician.
Description of the Device and Basis for Substantial Equivalence
The Ad-Tech Spinal Electrode addressed in this premarket notification has identical materials, technological characteristics, sterilization procedures and packaging as the commercially available Ad-Tech Depth Electrode (K891920B). The device has similar intended use, materials and technological characteristics to the commercially available Nicolet Epidural Spinal Electrode (K882053). Like this device, the Ad-Tech Spinal Electrode is to be placed epidurally for monitoring evoked potentials. Ad-Tech believes that the information provided in this premarket notification clearly demonstrate that it is safe and equivalent to the mentioned commercially marketed predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes, with a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 1998
Mr. Curtis Van Allen II Vice President Director of Marketing and Planning Ad-Tech Medical Instrument Corporation 1901 William Street Racine, Wisconsin 53404
K973454 Re: Ad-Tech's Spinal Electrode Trade Name: Requlatory Class: II Product Codes: GZL, GWF, and JXE Dated: April 24, 1998 May 11, 1998 Received:
Dear Mr. Allen:
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. ਕੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlations.
3
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) 594-4659. 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510K Number:
Device Name: Ad-Tech's Spinal Electrode
Indications for Use: Ad-Tech's Spinal Electrode is intended for measurement of muscle MEP (Motor Evoked Potential) type monitoring during spinal surgery.
Prescription Use
(Per 21 CFR 801.109)
bcolleDo
Division Sign-Off) (Division of General Restorative Devices 11-973454 510(k) Number
File Name: FDA no. 5.doc
: