(567 days)
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No
The document describes a physical medical device (electrodes) and its intended use for recording and stimulating electrical signals. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on bench testing of the physical device.
No
The device is described as being for "recording, monitoring and stimulation of electrical signals at the subsurface level of the brain." While stimulation may have therapeutic effects, the primary intended uses listed are recording and monitoring, and the description does not explicitly state a therapeutic purpose for the stimulation.
No
The device is described as an electrode for recording, monitoring, and stimulation of electrical signals, which implies it's used for acquiring data, but not for interpreting or diagnosing a condition based on that data. The device description and performance studies focus on physical and electrical characteristics rather than diagnostic accuracy.
No
The device description clearly details physical components (electrodes made of stainless steel with specific dimensions) and mentions bench testing including mechanical, electrical, and functional testing, which are characteristic of hardware devices.
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 at the subsurface level of the brain." This involves interacting directly with the patient's body to measure electrical activity.
- Device Description: The device is a physical electrode designed to be inserted into the brain.
- 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. This device does not perform such tests on samples.
The device is a medical device used for physiological measurement and stimulation within the body, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
Senso Medical 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
April 18, 2023
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Sensomedical Labs LTD Sama Tarazi Regulatory Affairs Nazareth Industrial Park Nazareth, 1612102 Israel
Re: K213170
Trade/Device Name: SENSOSEEG Depth Electrodes Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: March 20, 2023 Received: March 20, 2023
Dear Sama Tarazi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Patrick Antkowiak -S
Patrick Antkowiak Assistant Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name SENSO SEEG Depth Electrodes
Indications for Use (Describe) Device Name: SENSO SEEG Depth Electrodes
INDICATION FOR USE:
Senso Medical Depth Electrodes are intended for temporary ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/5/Picture/0 description: The image shows the logo for Senso Medical. The logo consists of a stylized letter "S" made of a blue line with a blue dot on the bottom left and a red dot on the top right. To the right of the "S" is the word "SENSO" in a bold, sans-serif font, and below that is the word "MEDICAL" in a smaller, lighter font.
510K Summary
Premarket Notification 510(k) Summary as required by Section 807.92
General Company Information as required by 807.92 (a)
| Submitter's Name | Sensomedical Labs LTD |
|---|---|
| Address: | Nazareth Industrial Park, Mount Precipice |
| Nazareth 1612102, Israel | |
| +972 (0) 4 6800668 | |
| Contact Person Name: | Sama Tarazi |
| Title: | Regulatory Affairs |
| Phone Number: | +972 (0) 4 6800668 |
| Dated: | Apr 14 2023 |
Throughout the submission " SENSO SEEG Depth Electrodes" is covered under 510 (k) Submission.
Proprietary Name:
SENSO SEEG Depth Electrodes
Assigned K number:
Common or Usual Name:
- Electrode, depth
SensoMedical Ltd
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Image /page/6/Picture/0 description: The image shows the logo for Senso Medical. The logo consists of a stylized letter "S" made of a blue line with a blue dot on one end and a red dot on the other end. To the right of the "S" is the word "SENSO" in a bold, dark blue font. Below "SENSO" is the word "MEDICAL" in a smaller, light blue font.
Classification Name:
Depth electrode (21 CFR 882.1330)
Product Code: GZL
Device Class: II
Review Panel: Neurological and Physical Medicine
Regulation Number: 21 CFR 882.1330
Identification of the Predicate Device:
DIXI Medical Microdeep Depth Electrode (K170959), Primary Predicate Predicate Device Ad-tech depth electrodes (K964644), Secondary Predicate PMT Depthalon Electrodes (K802152), Secondary Predicate
Device Description:
The SENSO SEEG Electrode is a smooth electrode with a diameter of 0.8 - 2 mm with a rounded tip. Different configurations exist with diameters of 0.8, 1.1, 1.27, and 2.0 mm. The electrode contacts are made from stainless-steel that can be 1.5mm, 2.0, and 3.0 mm long, with a total exploration length varying from (22 - 82 mm) according to the electrode reference. The total length of the electrodes range from 360 mm to 410 mm long depending on the number of contacts and total exploration length of the electrodes. The electrodes come in 3 main configurations, but can be customized to the parameters mentioned above based on the application need.
Three standard configurations of the electrodes can be generated according to the following code:
P/N coding:
Image /page/6/Figure/13 description: The image shows a diagram of an electrode with labels indicating the different parameters. The parameters include the macro-contact spacing, distance of the first contact from the tip, electrode length, macro-contacts number, macro-contact length, and micro-contact number. A table shows the diameter of the electrode for different values, including 0.8 mm, 1.1 mm, 1.27 mm, and 2.0 mm.
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Image /page/7/Picture/0 description: The image contains the logo for Senso Medical. The logo consists of a stylized letter "S" formed by a blue line with a blue dot on one end and a red dot on the other end. To the right of the "S" is the word "SENSO" in a bold, dark blue font, and below that is the word "MEDICAL" in a smaller, light blue font.
The codes are as follows:
| Product code | Contact
| Electrode
diameter
(mm) | Electrode contact
lengths (mm) | Electrode
contact spacing
(mm) | Electrode
total length
(mm) |
|-------------------|--------------|-------------------------------|-----------------------------------|--------------------------------------|-----------------------------------|
| B-20042524-400m00 | 4 | 0.8 | 2.4 | 2.5 | 400 |
| B-20082524-400m00 | 8 | 0.8 | 2.4 | 2.5 | 400 |
| B-20162524-400m00 | 16 | 0.8 | 2.4 | 2.5 | 400 |
*SENSO SEEG Depth Electrodes are also available within the parameters mentioned earlier.
Senso Medical SEEG Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
SENSO SEEG Depth Electrodes are connected to the user under the guidance and instruction of a supervising physicians in the areas of biopotential recording, monitoring and stimulation/response studies, knowledgeable in the use of depth electrodes).
Environment of use: This device is intended to be implanted into a patient's brain by a trained clinician in a professional healthcare facility only. It is NOT intended for MR use and is MR unsafe
Device Indications for Use:
Senso Medical Depth Electrodes are intended for temporary (