(179 days)
The AD-TECH Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Subdural electrodes described in this application are single patient use, disposable, sterile and non-sterile devices. The electrodes are invasive as they are placed in contact with the brain. The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician.
The provided text is a 510(k) summary for AD-TECH Subdural Electrodes. It describes the device, its intended use, and states that its technological characteristics are substantially equivalent to predicate devices.
However, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices, which is a different regulatory pathway than providing performance data against defined acceptance criteria. This type of submission typically relies on comparing the new device's design, materials, and intended use to a legally marketed predicate device, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot populate the requested table and information based on the provided text.
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MAY 30 2006
510(k) Summary
| Company Name: | AD-TECH Medical Instrument Corporation1901 William StreetRacine, WI 53404 1876 | |
|---|---|---|
| Contact: | John Ziobro, Chief Operating Officer | |
| Phone: | 262 367-9200, ext. 101 | |
| Fax: | 262 367-9149 | |
| Summary Date: | November 22, 2005 | |
| Trade Name: | Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) | |
| Common Name: | Cortical Electrodes | |
| Classification Name: | 21 CFR 882.1310, Cortical Electrode | |
| Predicate Device(s): | 510(k) Number: | K970587, K923803 |
| Manufacture: | AD-TECH Medical Instrument Corporation | |
| Trade Name: | Subdural Electrode | |
| 510(k) Number: | K021144 | |
| Manufacture: | Nicolet Biomedical Corporation | |
| Trade Name: | Subdural Strip Electrode |
1.0 Description of Electrodes
Subdural electrodes described in this application are single patient use, disposable, sterile and non-sterile devices. The electrodes are invasive as they are placed in contact with the brain.
The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician. Physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of subdural electrodes.
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2.0 Intended Use of Electrodes
The AD-TECH Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
3.0 Technological Characteristics
The technical characteristics of the Subdural Electrodes are not affected this submission.
4.0 Conclusions
The characteristics of the Subdural Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 30 2006
AD-TECH Medical Instrument Corporation C/O Mr. Gary Syring Official Correspondent for AD-TECH Medical Instrument Corporation Quality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K053363
Trade/Device Name: AD-TECH Subdural Cortical Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) Regulation Number: 882.1310 Regulation Name: Cortical Electrode Regulatory Class: II Product Code: GYC Dated: March 27, 2006 Received: March 28, 2006
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
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Page 2- Mr. Gary Syring
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. 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
eemee
Mark N. Melkerson, M.S
Director
Division of General, Restorative
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Subdural Electrodes
Indications for Use:
The AD-TECH Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) |
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| Division of General, Restorative, |
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| and Neurological Devices |
510(k) Number_KOS3363
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§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).