(379 days)
Not Found
Not Found
No
The summary describes a physical electrode device for recording and stimulating brain signals, with no mention of software, algorithms, or AI/ML terms.
No.
The device is used for recording, monitoring, and stimulation of electrical signals, which are diagnostic and monitoring functions, not therapeutic.
Yes
Explanation: The device is intended for "recording, monitoring, and stimulation of electrical signals in the subsurface of the brain," which directly relates to diagnosing brain activity.
No
The device description is not available, but the intended use clearly describes "Depth Electrodes," which are physical hardware components intended for insertion into the brain. This indicates the device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for recording, monitoring, and stimulation of electrical signals in the subsurface of the brain. This is a direct interaction with the patient's body (in vivo), not the examination of specimens derived from the human body (in vitro).
- Anatomical Site: The anatomical site is the "subsurface of the brain," which is an internal part of the patient.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on specimens outside the body.
IVD devices are specifically designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to interact directly with the brain's electrical activity.
N/A
Intended Use / Indications for Use
The Platinum Depthalon® Depth Electrodes are intended for temporary (
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2016
PMT Corporation Kim Schmelzer Quality Manager 1500 Park Road Chanhassen, MN 55317
Re: K151790
Trade/Device Name: PMT Platinum Depthalon Depth Electrodes Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: June 9, 2016 Received: October 9, 2015
Dear Kim Schmelzer:
This letter corrects our substantially equivalent letter of July 14, 2016.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
CFR Part 807); labeling (21 CFR Part 801 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
William J.
Heetderks -A
Digitally signed by William J. Heetderks -A
DN: c=US, o=U.S. Government, ou=HHS,
ou=NIH, ou=People,
0.9.2342.19200300.100.1.1=0010149848,
cn=William J. Heetderks -A
Date: 2016.07.29 11:32:59 -04'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a logo or wordmark, possibly for a company or organization. The letters "PMI" are prominently displayed in a bold, stylized font. Above the letters, there are horizontal lines or bars that appear to be part of the overall design. The text and design elements are filled with a pattern of small dots or specks, giving it a textured appearance.
1500 Park Road • Chanhassen, MN 55317 USA • Phone (952) 470-0866 • Fax (952) 470-0865 • www.pmtcorp.com
Indications for Use Statement
510(k) Number (if known): ____K151790
Device Name
PMT® Platinum Depthalon® Depth Electrodes
Indications for Use
The Platinum Depthalon® Depth Electrodes are intended for temporary (