(567 days)
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.
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.
This FDA 510(k) summary provides information on the SENSOSEEG Depth Electrodes. However, it does not include detailed acceptance criteria or a study that specifically proves the device meets those criteria in the typical format of a diagnostic algorithm's performance study.
This document is a premarket notification for a medical device (depth electrodes), not a diagnostic algorithm. Therefore, the "acceptance criteria" and "study" described are focused on the device's physical and functional properties, and its substantial equivalence to predicate devices, rather than on diagnostic performance metrics like accuracy, sensitivity, or specificity common to AI/ML software.
The acceptance criteria are implied by the comparison to predicate devices and the non-clinical testing performed.
Here's an attempt to categorize the information based on your request, keeping in mind the nature of this submission:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device (depth electrodes), the "acceptance criteria" are related to its design specifications, material properties, and functional performance, rather than diagnostic accuracy. The "reported device performance" is largely demonstrated by showing equivalence to legally marketed predicate devices through bench testing and material comparison.
| Acceptance Criterion (Implied) | Reported Device Performance (as demonstrated by comparison and testing) |
|---|---|
| Intended Use (Temporary recording, monitoring, stimulation of electrical brain signals) | Identical to all predicate devices (DIXI Medical Microdeep Depth Electrode (K170959), Ad-tech depth electrodes (K964644), PMT Depthalon Electrodes (K802152)). |
| Clinical Application (Placement in subsurface brain for recording, monitoring, stimulation) | Identical to DIXI Medical and Ad-tech depth electrodes. |
| Contraindications (Patients at risk for infection or unsafe surgical procedures) | Identical to Ad-tech depth electrodes. |
| Single-patient use, Disposable | Identical to all predicate devices. |
| Provided Sterile | Identical to all predicate devices; EO Sterilization validated. |
| Environment of Use (Intraoperative and Neurological monitoring locations) | Identical to all predicate devices. |
| Duration of Use (< 30 days) | Identical to all predicate devices. |
| Electrode Contact Material (Stainless steel) | Different from primary predicate (Platinum / Iridium) but identical to secondary predicate (PMT Depthalon Electrodes) and also explicitly stated as being in common with other brain implant devices. This difference is deemed not to raise new safety concerns. |
| Maximum Stimulation Charge Density (< 30 µC/cm2) | Identical to secondary predicate (Ad-tech depth electrodes). (Primary predicate N/A, PMT Not available online). |
| Number of electrode contacts (4-16) | Similar to predicate ranges (DIXI: 5-18; Ad-tech: up to 16; PMT: up to 16). |
| Electrode Material (Stainless Steel) | Different from primary predicate (Platinum Iridium) but identical to secondary predicate (PMT Depthalon, partially identical to Ad-tech which uses both Platinum Iridium and Stainless Steel). This difference is mitigated by demonstrating safety. |
| Electrode jacket (TPU) | Identical to DIXI Medical and Ad-tech depth electrodes. (PMT Not available online). |
| Electrode body diameter (brain contact) (0.8 mm to 2 mm) | Equivalent to predicate devices. While DIXI Medical is 0.8 mm and Ad-tech is 1.57 mm (Macro), and PMT is 0.8 mm to 1.8 mm, the document states "Design Verification Testing proves the equivalency. A comparative testing with Ad depth electrodes proves the equivalency." This implies the range is acceptable and supported by testing. |
| Stylet | Identical to all predicate devices. |
| Electrode contact length (1.5 - 3 mm Macro) | Similar. While DIXI is 2 mm and PMT is 2.0mm and 5.0mm, the SENSO SEEG's smaller contact length is deemed not to raise safety concerns, similar to other marketed devices (e.g., SPENCER® PROBE DEPTH ELECTRODES K041604 with <1.5 mm). |
| Overall length (360 - 400 mm) | Different from predicates (DIXI: 500 mm, 1000 mm; Ad-tech: < 660 mm; PMT: 27 mm). Longer length is accommodated by additional contacts and user preference. Safety and performance evaluated in design verification testing. |
| Electrode contact surface (Ring contact built from a folded (coiled) exposed wire) | Different in manufacturing technology (weaving/braiding vs. crimping/welding) but results in a "ring contact" similar to predicates. The difference in technology is stated not to raise concern over safety. |
| Non-clinical Performance Tests (Mechanical, electrical, functional, biocompatibility, packaging, shelf life, transit, EO sterilization) | Performed to assure safety and effectiveness and conformance to design specifications. These tests collectively demonstrate the device meets its functional and safety requirements, aligning with predicate devices. |
Since this is a medical device approval and not a diagnostic AI/ML algorithm submission, the following points are not applicable or not explicitly detailed in this 510(k) summary:
- 2. Sample sized used for the test set and the data provenance: Not applicable in the context of device design and bench testing. The "test set" would be the prototypes or production samples undergoing engineering verification and validation testing.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for a physical device refers to engineering specifications and material standards, not expert medical opinion on an image.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical medical device.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrode, not an AI assistance tool for human interpretation.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this type of device is established by engineering specifications, material standards (e.g., ISO standards for biocompatibility), and established performance benchmarks derived from predicate devices.
- 8. The sample size for the training set: Not applicable for device testing.
- 9. How the ground truth for the training set was established: Not applicable for device testing.
The "study that proves the device meets the acceptance criteria" is the set of Non-clinical testing performed as listed on page 12 of the document:
- Verification testing (mechanical, electrical, and functional testing)
- Biocompatibility Testing
- Packaging, shelf life and transit testing
- EO Sterilization Validation
These tests ensure the device performs as intended, is safe for its indicated use, and is substantially equivalent to predicate devices, thereby meeting the necessary acceptance criteria for a 510(k) clearance. The details of these tests (e.g., number of samples, specific methodologies) are typically found in the full 510(k) submission, not in the summary document.
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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 (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
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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 PrecipiceNazareth 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# | Electrodediameter(mm) | Electrode contactlengths (mm) | Electrodecontact spacing(mm) | Electrodetotal 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 (< 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 depthelectrodes | Predicate DeviceDIXI Medical depthelectrode(K170959) | Predicate Device Ad-techdepth electrodes(K964644) | Predicate Device PMTDepthalon Electrodes(K802152) | Comments |
|---|---|---|---|---|---|
| Indicationsfor Use | Senso Medical DepthElectrodes are intended fortemporary (< 30 days) usewith recording, monitoringand stimulation equipmentfor the recording,monitoring and stimulationof electrical signals at thesubsurface level of thebrain. | The DIXI MedicalMicrodeep DepthElectrodes areintended for temporary(< 30 days) use withrecording, monitoringand stimulation ofelectrical signals at thesubsurface level of thebrain | The Ad-Tech DepthElectrodes (DepthElectrodes, Foramen OvaleDepth Electrodes, MacroMicro Depth Electrodes,Spencer Probe DepthElectrodes, WylerSphenoidal DepthElectrodes) are intended fortemporary (< 30 days) usewith recording, monitoringand stimulation equipmentfor the recording,monitoring and stimulationof electrical signals at thesubsurface level of thebrain. The recording ofelectrical activity supportsdefinition of the location ofepileptogenic foci and brainmapping. | The Stainless SteelDepthalon Electrodes areintended for temporary(<30days) use withrecording, monitoring, andstimulation equipment forthe recording, monitoring,and stimulation ofelectrical signals in thesubsurface of the brain | Identical |
| ClinicalApplication | 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 ofUse | Intraoperative and Neurologicalmonitoring locations | Intraoperative and Neurologicalmonitoring locations | Intraoperative and Neurologicalmonitoring locations | Intraoperative and Neurologicalmonitoring locations | Identical |
| Duration of Use | < 30 days | < 30 days | < 30 days | < 30 days | Identical |
| ElectrodeContactMaterial | Stainless steel | Platinum / Iridium | Platinum / Iridium | Stainless steel | Different with primary predicate but identical with secondary one* |
| MaximumStimulationCharge Density | < 30 µC/cm2 | N/A | < 30 µC/cm2 | Not available online | Identical with secondary predicate |
| Number ofelectrodecontacts | 4-16 | From 5 to 18 contacts | Up to 16 | Up to 16 contacts | Similar |
| ElectrodeMaterial | 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 bodydiameter (braincontact) | 0.8 mm to 2 mm | 0.8 mm | 1.57 mm (Macro) | 0.8 mm to 1.8 mm | Equivalent - DesignVerification Testingproves theequivalency. Acomparative testingwith Ad depthelectrodes proves theequivalency. |
| Stylet | Yes | Yes | Yes | Yes | Identical |
| Electrodecontact length(along body ofthe electrode) | 1.5 - 3[mm] Macro | 2 mm long | Not available online | Contact sizes of 2.0mm and5.0mm | Similar.SENSO SEEG hasa smaller electrodecontact, but doesnot raise concernover safetysimilarly to otherdepth electrodemarketed devices,such as theSPENCER®PROBE DEPTHELECTRODESK041604, withsimilar smallercontact lengths ofless1.5 mm |
| Overall length | 360 - 400[mm] | 500 mm and 1000 mm | < 660 mm | 27 mm | A longer electrodeaccommodatesadditional contactsand user preference.Safety andperformance has |
| been evaluated in thedesign verificationtesting. | |||||
| **Different: the | |||||
| Electrodecontact surface | Ring contact built from a folded(coiled) exposed wire on top oflead 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 ofConclusion | Proposed Device | PredicateDevices |
|---|---|---|---|
| 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 areintended for temporary (< 30 days) usewith recording, monitoring and stimulationequipment for the recording, monitoringand stimulation of electrical signals at thesubsurface 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
§ 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).