SENSOSEEG Depth Electrodes

K213170 · Sensomedical Labs, Ltd. · GZL · Apr 18, 2023 · Neurology

Device Facts

• Record ID: K213170
• Device Name: SENSOSEEG Depth Electrodes
• Applicant: Sensomedical Labs, Ltd.
• Product Code: GZL · Neurology
• Decision Date: Apr 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

Senso Medical Depth Electrodes are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

Device Story

SENSO SEEG Depth Electrodes are sterile, single-use, disposable devices implanted into the brain by a trained clinician in a professional healthcare facility. The device consists of a smooth electrode (0.8–2.0 mm diameter) with stainless-steel ring contacts formed via weaving and braiding techniques. It is used with external recording, monitoring, and stimulation equipment to capture subsurface electrical signals or deliver stimulation. The device supports clinical decision-making by providing electrophysiological data for mapping and monitoring. It is MR unsafe. Benefits include temporary access to subsurface brain signals for diagnostic or monitoring purposes.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included mechanical, electrical, and functional verification, biocompatibility, packaging, shelf life, transit testing, and EO sterilization validation.

Technological Characteristics

Materials: Stainless-steel contacts, TPU jacket. Sensing/Actuation: Subsurface electrical signal recording and stimulation. Dimensions: 0.8–2.0 mm diameter, 360–410 mm length. Connectivity: Wired connection to external monitoring/stimulation equipment. Sterilization: Ethylene Oxide (EO). Construction: Weaving and braiding technique for ring contacts.

Indications for Use

Indicated for temporary (< 30 days) use in patients requiring recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. Contraindicated for patients at risk for infection or where surgical recording/stimulation cannot be performed safely.

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Predicate Devices

• DIXI Medical Microdeep Depth Electrode (K170959)
• Ad-tech depth electrodes (K964644)
• PMT Depthalon Electrodes (K802152)

Reference Devices

• SPENCER® PROBE DEPTH ELECTRODES (K041604)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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 (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

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Type of Use (Select one or both, as applicable)

∑ Prescription Use (Part 21 CFR 801 Subpart D)

_ | Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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<br>Nazareth 1612102, Israel<br>[phone] |
| Contact Person Name: | Sama Tarazi |
| Title: | Regulatory Affairs |
| Phone Number: | [phone] |
| 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:

K213170

# 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<br># | Electrode<br>diameter<br>(mm) | Electrode contact<br>lengths (mm) | Electrode<br>contact spacing<br>(mm) | Electrode<br>total length<br>(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 (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation ofelectrical signals at the subsurface level of the brain.

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Image /page/8/Picture/0 description: The image shows the logo for Senso Medical. The logo consists of a stylized letter S in blue, with a red dot at the top and a blue dot at the bottom. To the right of the S is the word "SENSO" in large, bold, dark blue letters. Below "SENSO" is the word "MEDICAL" in smaller, light blue letters.

# Predicate Comparison Table

# Table 1 Shows the predicate comparison table of the SENSO SEEG Depth Electrode

| Features | New Device SEEG depth<br>electrodes | Predicate Device<br>DIXI Medical depth<br>electrode(K170959) | Predicate Device Ad-tech<br>depth electrodes<br>(K964644) | Predicate Device PMT<br>Depthalon Electrodes<br>(K802152) | Comments |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Senso Medical Depth<br>Electrodes are intended for<br>temporary (< 30 days) use<br>with recording, monitoring<br>and stimulation equipment<br>for the recording,<br>monitoring and stimulation<br>of electrical signals at the<br>subsurface level of the<br>brain. | The DIXI Medical<br>Microdeep Depth<br>Electrodes are<br>intended for temporary<br>(< 30 days) use with<br>recording, monitoring<br>and stimulation of<br>electrical signals at the<br>subsurface level of the<br>brain | The Ad-Tech Depth<br>Electrodes (Depth<br>Electrodes, Foramen Ovale<br>Depth Electrodes, Macro<br>Micro Depth Electrodes,<br>Spencer Probe Depth<br>Electrodes, Wyler<br>Sphenoidal Depth<br>Electrodes) are intended for<br>temporary (< 30 days) use<br>with recording, monitoring<br>and stimulation equipment<br>for the recording,<br>monitoring and stimulation<br>of electrical signals at the<br>subsurface level of the<br>brain. The recording of<br>electrical activity supports<br>definition of the location of<br>epileptogenic foci and brain<br>mapping. | The Stainless Steel<br>Depthalon Electrodes are<br>intended for temporary<br>(<30days) use with<br>recording, monitoring, and<br>stimulation equipment for<br>the recording, monitoring,<br>and stimulation of<br>electrical signals in the<br>subsurface of the brain | Identical |
| Clinical<br>Application | Placed in the subsurface level of the brain to support recording, monitoring and stimulation. | Placed in the subsurface level of the brain to support recording, monitoring and stimulation. | Placed in the subsurface level of the brain to support recording, monitoring and stimulation. | Not available online | Identical |
| Contraindications | These depth electrodes should not be used on any patient who the physician/surgeon considers at risk for infection or for whom the surgical recording and stimulation procedure cannot be performed safely and effectively. | Not available online | These depth electrodes should not be used on any patient who the physician/surgeon considers at risk for infection or for whom the surgical recording and stimulation procedure cannot be performed safely and effectively. | Not available online | Identical |
| Single patient use, Disposable | Yes | Yes | Yes | Yes | Identical |
| Provided Sterile | Yes | Yes | Yes | Yes | Identical |
| Environment of<br>Use | Intraoperative and Neurological<br>monitoring locations | Intraoperative and Neurological<br>monitoring locations | Intraoperative and Neurological<br>monitoring locations | Intraoperative and Neurological<br>monitoring locations | Identical |
| Duration of Use | < 30 days | < 30 days | < 30 days | < 30 days | Identical |
| Electrode<br>Contact<br>Material | Stainless steel | Platinum / Iridium | Platinum / Iridium | Stainless steel | Different with primary predicate but identical with secondary one* |
| Maximum<br>Stimulation<br>Charge Density | < 30 µC/cm2 | N/A | < 30 µC/cm2 | Not available online | Identical with secondary predicate |
| Number of<br>electrode<br>contacts | 4-16 | From 5 to 18 contacts | Up to 16 | Up to 16 contacts | Similar |
| Electrode<br>Material | Stainless Steel | Platinum Iridium | Platinum Iridium and Stainless Steel | Stainless steel | Different with primary predicate but identical with secondary ones* |
| Electrode jacket | TPU | TPU | TPU | Not available online | Identical |
| Electrode body<br>diameter (brain<br>contact) | 0.8 mm to 2 mm | 0.8 mm | 1.57 mm (Macro) | 0.8 mm to 1.8 mm | Equivalent - Design<br>Verification Testing<br>proves the<br>equivalency. A<br>comparative testing<br>with Ad depth<br>electrodes proves the<br>equivalency. |
| Stylet | Yes | Yes | Yes | Yes | Identical |
| Electrode<br>contact length<br>(along body of<br>the electrode) | 1.5 - 3[mm] Macro | 2 mm long | Not available online | Contact sizes of 2.0mm and<br>5.0mm | Similar.<br>SENSO SEEG has<br>a smaller electrode<br>contact, but does<br>not raise concern<br>over safety<br>similarly to other<br>depth electrode<br>marketed devices,<br>such as the<br>SPENCER®<br>PROBE DEPTH<br>ELECTRODES<br>K041604, with<br>similar smaller<br>contact lengths of<br>less1.5 mm |
| Overall length | 360 - 400[mm] | 500 mm and 1000 mm | < 660 mm | 27 mm | A longer electrode<br>accommodates<br>additional contacts<br>and user preference.<br>Safety and<br>performance has |
| | | | | been evaluated in the<br>design verification<br>testing. | |
| | | | | **Different: the | |
| Electrode<br>contact surface | Ring contact built from a folded<br>(coiled) exposed wire on top of<br>lead body | Ring contact | Ring contact | Ring contact | |
| | | | | electrode contact is | |
| | | | | built from folding | |
| | | | | (coiling) an exposed | |
| | | | | wire on top of the | |
| | | | | lead in the | |
| | | | | appropriate place; | |
| | | | | this coiled wire | |
| | | | | together forms a ring | |
| | | | | contact. | |

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Image /page/9/Picture/0 description: The image shows the logo for Senso Medical. The logo consists of a stylized letter "S" in blue, with a blue dot on one end and a red dot on the other. To the right of the "S" is the word "SENSO" in dark blue, with the word "MEDICAL" in a lighter blue underneath.

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Image /page/10/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, and below that is the word "MEDICAL" in a smaller, light blue font.

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Image /page/11/Picture/0 description: The image contains the logo for Senso Medical. The logo consists of a stylized letter S in blue with a red dot on the upper right and a blue dot on the lower left. To the right of the S is the word "SENSO" in a dark blue, sans-serif font, and below that is the word "MEDICAL" in a lighter blue, sans-serif font.

** A difference in the manufacturing technology of predicates devices vs. SENSOMEDICAL SEEG contributes to a difference in the way the electrode contacts are formed. The SENSO SEEG depth electrode are built by weaving and braiding techniques (same materials as used in predicate devices and in almost most of brain implant levices contacts are built by crimping and welding stainless steel pieces to the body of the electrode. However, the difference in technology does not raise concern over the safety of this device.

#### Substantial equivalence including comparison with predicate devices

The Senso Medical Depth Electrodes are substantially equivalent to the DIXI Medical depth electrode (K170959) as they have the similar intended use in the same patient population, utilize similar performance specifications and have comparable technological features to achieve the same mechanism of action: therefore, the Senso Medical Depth Electrodesdo not raise any different issues of safety or effectiveness. Additional predicate for comparison to technological characteristics, the Ad-tech electrodes (K964644), and PMT Depthalon Electrodes (K802151).

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Image /page/12/Picture/0 description: The image shows the logo for Senso Medical. The logo consists of a stylized letter "S" in blue, with a red dot at the top and a blue dot at the bottom. To the right of the "S" is the word "SENSO" in dark blue, with the word "MEDICAL" in a smaller font size and light blue color underneath.

#### Non-clinical testing performed

Performance testing was performed to assure safety and effectiveness of the Senso Medical Depth Electrodes. All necessary bench testing was conducted on the Senso Medical Depth Electrodes to ensure conformance to design specifications and to support a determination of substantial equivalence to the predicate devices. [807.92(b)(1)] The nonclinical, bench testing performed included:

- Verification testing (mechanical, electrical, and functional testing)
- Biocompatibility Testing .
- . Packaging, shelf life and transit testing; and
- EO Sterilization Validation .

### CONCLUSION:

| S.No. | Parameter of<br>Conclusion | Proposed Device | Predicate<br>Devices |
|-------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 1 | Product Code | GZL | Same |
| 2 | Regulation Number | 21 CFR 882.1330 | Same |
| 3 | Regulatory Class | II | Same |
| 4 | Intended Use | Senso Medical Depth Electrodes are<br>intended for temporary (< 30 days) use<br>with recording, monitoring and stimulation<br>equipment for the recording, monitoring<br>and stimulation of electrical signals at the<br>subsurface level of the brain. | Identical |
| 5 | Sterilization | EO Sterilization | Same |
| 6 | Performance Test | Functional, mechanical and electrical | Same |
| 7 | Contact material | Stainless-steel | Same |

Table 2 Identifies the proposed device's features relative to the predicate device features

From the data available we can justify that the " Senso Medical Depth Electrodes " has the same intended use and the same technological characteristics as the already marketed predicate devices identified above. Hence our device can be considered substantially equivalent to the predicates.

SensoMedical Ltd