(72 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description is very basic.
No
The device is intended to assist neurosurgeons and aid in electrode placement, not to treat a medical condition directly.
No
Explanation: The device is intended to assist neurosurgeons and aid in the placement of depth electrodes. This describes an assistive or interventional tool rather than a device that provides a diagnosis based on the assessment of medical data.
Unknown
The provided 510(k) summary does not contain enough information to definitively determine if the NeuroDrive system is a software-only medical device. It describes the intended use and device name but lacks details about the device's components and how it functions. Without knowing if it includes hardware components beyond a potential interface, it's impossible to classify it as software-only.
Based on the provided information, the Alpha Omega NeuroDrive system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Assist neurosurgeons in the operating room during functional neurosurgery and to aid in the placement of depth electrode." This describes a device used in vivo (within a living organism) for surgical guidance and assistance.
- 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.
The NeuroDrive system's function is directly related to surgical procedures performed on a patient, not the analysis of biological samples outside the body.
N/A
Intended Use / Indications for Use
Alpha Omega NeuroDrive system is intended to be used to Assist neurosurgeons in the operating room during functional neurosurgery and to aid in the placement of depth electrode.
Product codes
GZL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgeons in the operating room
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2005
Shlomo Pundak, Ph.D QA Manager Alpha Omega Ltd. Ha'avoda Street, P.O.B 810 Nazareth Illit 17105, Israel
Re: K051830 Trade/Device Name: NeuroDrive system Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: II Product Code: GZL Dated: August 12, 2005 Received: August 23, 2005
Dear Dr. Pundak:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfall in the Medical Device 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). and Cobinette For (110) has the device, subject to the general controls provisions of the Act. The r ou may career a 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 11 your de rooms 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 or any I 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.
1
Page 2- Shlomo Pundak, Ph.D
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter whil anow you to begin manceang your and equivalence of your device to a legally premaired predicated on: "The Privating of cassification 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 If you desire specific advice for your as no novel 115. Also, please note the regulation entitled, Colliact the Office of Compullion and (21 (21CFR Part 807.97). You may obtain Misolalling of Icroronee to presidentibilities under the Act from the Division of Small other general information on your respensed its toll-free number (800) 638-2041 or Manufacturers, Internet and Statess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Buchud
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
KOS1830 510(k) Number (if known): NeuroDrive system Device Name: Alpha Omega NeuroDrive system is intended to be used to Indications for Use: Assist neurosurgeons in the operating room during functional neurosurgery and to aid in the placement of depth electrode. Over the Counter Use__________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
OR
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
05 1830 Barbara Bonehutsfr MKM
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Numbe