(188 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the physical characteristics and intended use of the electrodes for recording and stimulation.
No.
The device is used for temporary recording and stimulation during neurosurgery, primarily for diagnostic or monitoring purposes, rather than directly treating a disease or condition. While stimulation can be therapeutic, the primary function described here is for investigation and mapping, which falls under diagnostic or intraoperative monitoring.
Yes
The device is described as being used for "recording electrical signals from target brain cells" and "recording cell potentials of single cells or of cell clusters" and "recording of local field potentials," which are all activities associated with gathering information about the physiological state of the brain. The intended use of "recording and stimulation of defined small area in the brain" implies that the recorded signals are used to understand the brain's activity, which is a diagnostic purpose.
No
The device description clearly states that the device is equipped with physical "Micro tip and a Macro tip" which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "recording and stimulation of defined small area in the brain, and for recording electrical signals from target brain cells" during neurosurgery. This is a direct interaction with the patient's body for physiological measurement and intervention.
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. This device does not analyze specimens taken from the body.
- Anatomical Site: The device is used directly on the "human brain," which is an in-vivo application, not in-vitro.
The device described is a surgical electrode used for neurophysiological monitoring and stimulation in vivo during surgery.
N/A
Intended Use / Indications for Use
The Navigation probes are intended to be used in the human brain for the recording of Neuro potentials of single brain cells and for electrical stimulation of small areas in the brain.
We Sense Navigation Probes electrodes are intended to be used in operation room during neurosurgery for temporary (less than two hours) recording and stimulation of defined small area in the brain, and for recording electrical signals from target brain cells. These electrodes can be used only by professional staff and not sell over the counter
Product codes (comma separated list FDA assigned to the subject device)
84 GZL
Device Description
NavigationProbes are equipped with a Micro tip and a Macro tip. The micro tip is used to for recording cell potentials of single cells or of cell clusters and for MicroStimulation.
The Macro tip is used for stimulation and recording of local field potentials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional staff / operation room during neurosurgery
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
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo for "rwe sense", a company that specializes in brain sensing technology. The logo features a stylized graphic of a brain with a leaf-like shape surrounding it. The text "rwe sense" is written in a bold, sans-serif font, with the tagline "Pioneers in Brain Sensing Technology" underneath.
BETT BE RECT TELET ense com Web www we COLLERS CON
Image /page/0/Picture/2 description: The image shows a handwritten word that appears to be "Coryou." The letters are connected in a cursive style, and the writing is somewhat stylized. The word is written in black ink on a white background.
510(k) Summary
FEB 2 5 2009
As Required by 21 CFR 807.87(k)510 (k) Summary
1. Subscribers Name & Address
WE SENSE LTD 2,Eksal Street , Nazareth 16000, Israel Tel: (972) 4 656-4222 Fax: (972) 4 656-4282 Official Correspondent: Mr. Nabil Jadaon
2. Trade Name
Navigation Probes
3. Predicate Device Identification
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Depth electrode | 84 GZL | II | 21 CFR 882.1330 |
4. Predicate Device Identification
Legally marketed devices to which equivalence is being 510(k) # claimed K033173 FHC microTargeting Electrodes
6. Device Description
NavigationProbes are equipped with a Micro tip and a Macro tip. The micro tip is used to for recording cell potentials of single cells or of cell clusters and for MicroStimulation.
The Macro tip is used for stimulation and recording of local field potentials.
1
Image /page/1/Picture/0 description: The image shows the logo for "we sense", a company that specializes in brain sensing technology. The logo features a stylized leaf design to the left of the company name. Below the company name is the tagline "Pioneers in Brain Sensing Technology".
7405 P.O.B. 50736 Israel Tell 9722 282 Email:Info@we sense com Web ww
7. Intended Use:
The Navigation probes are intended to be used in the human brain for the recording of Neuro potentials of single brain cells and for electrical stimulation of small areas in the brain.
8. Summary of technological characteristics of Device and Predicate Device:
The functionality for the Navigation Probes are equivalent to its predicate device the FHC Inc, microTargeting Electrode (K033173) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device and are listed on the comparison charts provided in this 510 k submission.
Nabil Jadaon General Manager
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the top of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
We Sense Ltd. % Nabil Jadaon 2 Eksal St. P.O. Box 50736 Nazareth Israel 16000
FEB 2 5 2009
Re: K082404
Trade/Device Name: Navigation Probes Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: II Product Code: GZL Dated: January 21, 2009 Received: February 2, 2009
Dear Mr. Jadaon:
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 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.
3
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Sincerely yours,
F-n Mark Dec. 1, 2005
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number K 082404
Device Name: Navigation Probes
Indication For Use:
We Sense Navigation Probes electrodes are intended to be used in operation room during neurosurgery for temporary (less than two hours) recording and stimulation of defined small area in the brain, and for recording electrical signals from target brain cells. These electrodes can be used only by professional staff and not sell over the counter
Prescription Use _0111V (21 CFR Part 801 Subpart D)
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Dra
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 1682404
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