The Alpha Omega Disposable Sterile LeadConfirm for MER is intended to be used in neurosurgery for connecting a compatible DBS Lead to a compatible recording and stimulation device.

The Alpha Omega Disposable Sterile LeadConfirm for MER is indicated for assisting Neurosurgeons, in the operating room during functional neurosurgery, to aid in the placement of a compatible DBS Lead.

The Alpha Omega Disposable Sterile LeadConfirm should only be used to connect a compatible DBS Lead to a compatible recording and stimulation device.

Device Description

Alpha Omega's Sterile LeadConfirm cable and adaptor connects the DBS lead to Alpha Omega's approved physiological navigation systems for recording and stimulation system: Neuro Omega (K171581) and NeuroSmart (K172042).

The purpose of the submission is to introduce the Sterile LeadConfirm Cable and Adaptor, the subject devices are sterile Hardware only.

There are three types of the subject device, Alpha Omega's Sterile LeadConfirm Cables:

1. Sterile LeadConfirm M Cable that connects to Medtronic Lead P960009 (3389, 3387)
1. Sterile LeadConfirm B Cable that connects to Boston Scientific Lead P150031 (BSC-DB-2201, BSC-DB-2202)
1. Sterile LeadConfirm A Cable that connects to Abbott Lead P140009 (6170/ 6171/ 6172/ 6173/ 6178/ 6170/ 6180/ 6181)

In addition, there are two types of Sterile LeadConfirm Adaptors:

1. Sterile LeadConfirm M Adaptor
1. Sterile LeadConfirm A Adaptor

AOE (Alpha Omega Engineering) stimulation with LeadConfirm cable and adaptor is identical to IPG/ test stimulator, with the following parameters:

a) Pulse shape: Square wave, Lili pulse
b) Amplitude up to 12mA
c) Duration up to 500uSec

AI/ML Overview

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

Disclaimer: This device is a sterile cable and adaptor, not an AI/ML powered device. Therefore, many of the requested criteria for AI/ML device studies (such as MRMC, human-in-the-loop, training set details, and expert qualifications for ground truth) are not applicable to this submission. The information provided focuses on the non-clinical performance validation.

Acceptance Criteria and Device Performance (Non-Clinical)

The "Sterile LeadConfirm" device is a hardware component (cable and adaptor) intended for connecting a Deep Brain Stimulation (DBS) lead to a recording and stimulation device during neurosurgery. The acceptance criteria and performance are focused on the safety and effectiveness of the hardware itself, primarily through verification and sterilization validation.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied from tests)	Reported Device Performance
Verification and Validation:
Meets design input specifications for complete Sterile LeadConfirm devices.	"Sterile LeadConfirm devices have been verified under a complete verification plan traceable to Sterile LeadConfirm design input. All samples passed the acceptance criteria which determines the effectiveness of Sterile LeadConfirm devices." (Implied: Design inputs were met, and effectiveness was confirmed.)
Sterilization Validation (LeadConfirm Adaptors):
Effectiveness of Gamma Radiation Sterilization for adaptors at specified dose and SAL.	"The purpose of the study was to validate the effectiveness of the Gamma Radiation Sterilization for Alpha Omega Engineering Ltd. LeadConfirm adaptors, according to VDmax Method. According to the test results (section 13), the gamma radiation sterilization process of LeadConfirm Adaptors Cat. No. STR-000071-00, STR-000072-00 and STR-000073-00, at a sterilization dose of 20kGy, was sustained. This dose gave a SAL of 6 magnitudes as requested by the standards." (Result: Sterilization effective, SAL of 10^-6 achieved at 20kGy.)
Sterilization Validation (LeadConfirm B Cable):
Effectiveness of Gamma Radiation Sterilization for B Cable at specified dose and SAL.	"The purpose of the study was to validate the effectiveness of the Gamma Radiation Sterilization for LeadConfirm B Cable, according to Vdmax Method. According to the test results (Section 13), the gamma radiation sterilization process of Electrodes lead cable, at a sterilization dose of 20kGy, was sustained. This dose gave a SAL of 6 magnitudes as requested by the standards." (Result: Sterilization effective, SAL of 10^-6 achieved at 20kGy.)
Sterilization Validation (LeadConfirm M & A Cables):
Effectiveness of Gamma Radiation Sterilization for M & A Cables at specified dose and SAL.	"The purpose of the study was to validate the effectiveness of the Gamma Radiation Sterilization for LeadConfirm M & A Cables, according to Vdmax Method. According to the test results (Section 13), the gamma radiation sterilization process of Electrodes lead cable, at a sterilization dose of 20kGy, was sustained. This dose gave a SAL of 6 magnitudes as requested by the standards." (Result: Sterilization effective, SAL of 10^-6 achieved at 20kGy.)
Integrity of materials and functionality after sterilization: (Implied from comparison)	"Functionality and materials stability, including packaging verified, after irradiation sterilization." (Comparison with predicate states "Identical", implying the subject device also maintained integrity.)
Sterility achievement method: (Implied from comparison)	"Sterilized by Alpha omega using irradiation sterilization and delivered sterile, validated process." (Comparison with predicate states "Identical", implying the subject device also uses this method and validated process.)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated as a number of devices or units. The sterilization validation studies mention testing "complete Sterile LeadConfirm Adaptors" or "complete Sterile LeadConfirm B Cable," implying that a representative sample of each type of device was used. Standard sterilization validation protocols (like VDmax method mentioned) involve specific sample sizes based on lot size and desired Sterility Assurance Level (SAL), but the exact number is not provided in this summary.
Data Provenance: The studies were non-clinical bench tests performed internally by Alpha Omega Engineering Ltd. (Israel). The data is generated from laboratory testing of the physical devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. This submission is for a hardware medical device (cable and adaptor), not an AI/ML-powered diagnostic or decision support tool. Therefore, there is no "ground truth" in the clinical sense established by human experts for a test set. The validation is based on engineering and microbiology standards for functionality and sterilization.

4. Adjudication Method for the Test Set:

Not applicable. As this is a non-clinical hardware validation, there is no need for adjudication involving human readers or experts to determine a "truth" for the test results. The results are objective measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is not an AI/ML device that interacts with human readers. The effectiveness is determined through physical verification and sterilization validation of the hardware.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is hardware and does not contain an algorithm. Performance is assessed through physical and sterility testing.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to established engineering standards, design specifications, and internationally recognized sterilization validation methods (e.g., VDmax Method for Gamma Radiation Sterilization) and a Sterility Assurance Level (SAL) of 10^-6. These are objective, scientifically defined criteria, not medically determined "ground truth" from patient data.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware device; therefore, there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this hardware device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Alpha Omega Engineering Ltd. Maysana Mousa QA RA Manager Nazareth Industrial Park, Mount Precipice, St. 2015 Nazareth 1612102. Israel

Re: K191739

Trade/Device Name: Sterile LeadConfirm Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: November 25, 2019 Received: December 2, 2019

Dear Mrs. Maysana Mousa:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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.

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191739

Device Name Sterile LeadConfirm

Indications for Use (Describe)

The Alpha Omega Disposable Sterile LeadConfirm for MER is intended to be used in neurosurgery for connecting a compatible DBS Lead to a compatible recording and stimulation device.

The Alpha Omega Disposable Sterile LeadConfirm should only be used to connect a compatible DBS Lead to a compatible recording and stimulation device.

Type of Use (Select one or both, as applicable)X 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/3/Picture/0 description: The image shows the logo for Alpha Omega. The logo consists of a stylized letter "A" in maroon color, with a gray bridge-like structure at the bottom. To the right of the "A" is the word "omega" in gray. Below the logo is the text "Defining Neuroscience Technology" in maroon color.

510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92

Submitter Information

Alpha Omega Engineering Ltd. Hamerkava St. 6 Tsiporit Industrial Zone Nof Hagalil (Nazareth Elite) 1789062, Israel Tel:+972-4-6563-327 Fax:+972-4-6574-075

Submission contact person:

Mrs. Maysana Mousa Tel:+972-4-6563-327 Fax:+972-4-6574-075 Mobile: +972-54-9043303

Device Classification

Proprietary Device Name:	Sterile LeadConfirm
Common name:	Intraoperative neurophysiological recording and stimulating device
Product Code:	GZL
Classification Name:	Depth Electrode
Classification Regulation:	21 CFR 882.1330
Regulatory Class:	II
Predicate Devices

Sterile Disposable Recording Cables K120098

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Image /page/4/Picture/0 description: The image is a logo for Alpha Omega. The logo features the Greek letters alpha and omega, with the word "ALPHA" in red and the word "omega" in gray. The words "Defining Neuroscience Technology" are written in smaller font below the logo. The alpha and omega symbols are stylized, with the alpha symbol resembling a triangle and the omega symbol resembling a semicircle.

Device Description

The purpose of the submission is to introduce the Sterile LeadConfirm Cable and Adaptor, the subject devices are sterile Hardware only.

There are three types of the subject device, Alpha Omega's Sterile LeadConfirm Cables:

1. Sterile LeadConfirm M Cable that connects to Medtronic Lead P960009 (3389, 3387)
1. Sterile LeadConfirm B Cable that connects to Boston Scientific Lead P150031 (BSC-DB-2201, BSC-DB-2202)
1. Sterile LeadConfirm A Cable that connects to Abbott Lead P140009 (6170/ 6171/ 6172/ 6173/ 6178/ 6170/ 6180/ 6181)

In addition, there are two types of Sterile LeadConfirm Adaptors:

1. Sterile LeadConfirm M Adaptor
1. Sterile LeadConfirm A Adaptor

AOE (Alpha Omega Engineering) stimulation with LeadConfirm cable and adaptor is identical to IPG/ test stimulator, with the following parameters:

a) Pulse shape: Square wave, Lili pulse
b) Amplitude up to 12mA
c) Duration up to 500uSec

Indications for Use Statement

The Alpha Omega Disposable Sterile LeadConfirm for MER is intended to be used in neurosurgery for connecting a compatible DBS Lead to a compatible recording and stimulation device.

Page 2 of 10

Alpha Omega Engineering Ltd. Hamerkava St. 6 Tsiporit Industrial Zone Nof Hagalil 1789062, Israel Tel:+972-4-6563-327 Fax:+972-4-6574-075 info@alphaomega-eng.com www.alphaomega-eng.com

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Image /page/5/Picture/0 description: The image is a logo for Alpha Omega. The logo has the letters Alpha and Omega in it. The word Alpha is in a dark red color, and the word Omega is in a gray color.

-Defining Neuroscience Technology

The Alpha Omega Disposable Sterile LeadConfirm should only be used to connect a compatible DBS Lead to a compatible recording and stimulation device

Page 3 of 10

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Image /page/6/Picture/0 description: The image is a logo for Alpha Omega, a company that defines neuroscience technology. The logo features the letters "A" and "O" in a stylized font, with the "A" in maroon and the "O" in gray. Above the letters "ALPHA" is a maroon line that resembles a heartbeat. Below the logo is the tagline "Defining Neuroscience Technology" in a simple, sans-serif font.

Safety & Effectiveness

The Sterile LeadConfirm devices have been compared to the predicate device, Sterile Disposable Recording Cables (under K12008), in terms of intended use, indications for use, components, principles of operation, technological characteristics and safety features.

Intended Use Comparison .

#	Comparisonparameter	Subject device:Sterile LeadConfirm	Predicate device:Sterile Disposable RecordingCables	Substantial Equivalent discussion
1	Legallydistributionclearance No.	Subject device	K120098
2	Owner	Alpha Omega EngineeringLtd.	Alpha Omega EngineeringLtd.
3	Intended use andindications foruse.	The Alpha Omega DisposableSterile LeadConfirm for MERis intended to be used inneurosurgery for connecting acompatible DBS Lead to acompatible recording andstimulation device.The Alpha Omega DisposableSterile LeadConfirm for MERis indicated for assisting	Alpha Omega's SterileDisposable Recording Cablesfor MER are intended to beused in neurosurgery forconnecting NeuroProbes torecording and stimulationdevice.	Similarities:SimilarDifferences:None
#	Comparisonparameter	Subject device:Sterile LeadConfirm	Predicate device:Sterile Disposable Recording	Substantial Equivalent discussion
			Cables
		Neurosurgeons, in theoperating room duringfunctional neurosurgery, to aidin the placement of acompatible DBS Lead.The Alpha Omega DisposableSterile LeadConfirm shouldonly be used to connect acompatible DBS Lead to acompatible recording andstimulation device
4	indications foruse andenvironment	Alpha Omega's DisposableSterile LeadConfirm for MERis indicated for assistingNeurosurgeons, in theoperation room duringfunctional neurosurgery, to aidin placement of Lead.	Alpha Omega's SterileDisposable Recording Cablesfor MER are indicated forassisting Neurosurgeons, in theoperation room duringfunctional neurosurgery, to aidin placement of depthelectrodes.	Similarities:SimilarDifferences:None
5	Device code andregulation	Product Code:GZLRegulation #: 21CFR882.1330	Product Code:GZLRegulation #: 21CFR882.1330	Similarities:IdenticalDifferences:None
#	Comparisonparameter	Subject device:Sterile LeadConfirm	Predicate device:Sterile Disposable RecordingCables	Substantial Equivalent discussion
1	Legallydistributionclearance No.	Subject device	K120098
2	Owner	Alpha Omega EngineeringLtd.	Alpha Omega EngineeringLtd.
3	Target treatmentPopulation	All patients that needfunctional neurosurgery	All patients that needfunctional neurosurgery	Similarities:IdenticalDifferences:None
4	Human Factors	Used by professionalNeurosurgeons	Used by professionalNeurosurgeons	Similarities:IdenticalDifferences:None
5	Use environment	Operating Room	Operating Room	Similarities:IdenticalDifferences:None

Page 4 of 10

Alpha Omega Engineering Ltd. Hamerkava St. 6 Tsiporit Industrial Zone Nof Hagalil 1789062, Israel Tel:+972-4-6563-327 Fax:+972-4-6574-075 info@alphaomega-eng.com www.alphaomega-eng.com

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Image /page/7/Picture/0 description: The image shows a logo with the words "ALPHA" and "omega". The word "ALPHA" is in a dark red color and has a line going through it. The word "omega" is in gray and is located below the word "ALPHA".

Defining Neuroscience Technology

Page 5 of 10

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Image /page/8/Picture/0 description: The image is a logo for Alpha Omega, a company that defines neuroscience technology. The logo features the letters "Alpha" and "Omega" in a stylized font. The word "Alpha" is in red, and the word "Omega" is in gray. The tagline "Defining Neuroscience Technology" is below the logo.

Performance Comparison .

Page 6 of 10

Alpha Omega Engineering Ltd. Hamerkava St. 6 Tsiporit Industrial Zone Nof Hagalil 1789062, Israel Tel:+972-4-6563-327 Fax:+972-4-6574-075 info@alphaomega-eng.com www.alphaomega-eng.com

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Image /page/9/Picture/0 description: The image shows the logo for Alpha Omega. The logo consists of the Greek letters alpha and omega, with the word "ALPHA" written in a stylized font above the word "omega". The alpha symbol is red, while the omega symbol is gray. The word "ALPHA" is also red, and the word "omega" is gray.

Defining Neuroscience Technology

#	Comparisonparameter	Subject device:Sterile LeadConfirm	Predicate device:Sterile Disposable RecordingCables	Substantial Equivalent discussion
6	Integrity ofmaterials andfunctionalityafter sterilization	Functionality and materialsstability, including packagingverified, after irradiationsterilization.	Functionality and materialsstability, including packagingverified, after irradiationsterilization.	Similarities:IdenticalDifferences:None
7	Sterilityachievementmethod	Sterilized by Alpha omegausing irradiation sterilizationand delivered sterile, validatedprocess	Sterilized by Alpha omegausing irradiation sterilizationand delivered sterile.	Similarities:IdenticalDifferences:None

Page 7 of 10

Alpha Omega Engineering Ltd. Hamerkava St. 6 Tsiporit Industrial Zone Nof Hagalil 1789062, Israel Tel:+972-4-6563-327 Fax:+972-4-6574-075 info@alphaomega-eng.com www.alphaomega-eng.com

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Image /page/10/Picture/0 description: The image is a logo for Alpha Omega. The logo features the letters "Alpha" and "Omega" in a stylized font. The word "Alpha" is in a dark red color, while the word "Omega" is in gray. Below the words is the phrase "Defining Neuroscience Technology" in a smaller font and dark red color.

Based on the performance results provided in this submission (including test results) and the analysis of similarities and differences presented above, Alpha Omega Technologies Ltd. believes that the proposed device is substantially equivalent to the predicate device without raising new safety and/or effectiveness issues.

Rational for Substantial Equivalency

The proposed Sterile LeadConfirm devices have been compared to the predicate and reference device in terms of intended use, indications for use, components, principles of operation, technological characteristics and safety features.

Based on the performance results provided in this submission (including test results and clinical data) and the analysis of similarities and differences presented above, Alpha Omega believes that the proposed device is substantially equivalent to the predicate device without raising new safety and/or effectiveness issues.

Substantial Equivalence Statement

Based on the above, it is Alpha Omega's opinion that the proposed Sterile LeadConfirm devices are substantially equivalent in terms of design principles, performance features and of safety & effectiveness to the predicate legally cleared devices referred to in section 4 of this document.

Non Clinical and Clinical validation data

Verification and validation bench tests were performed, to demonstrate the safety and effectiveness of the proposed Sterile LeadConfirm devices.

The purposes of the design verification & validation processes were to verify the Device specifications and to verify the proper function of all device components and options.

After comparing the predicate device to the subject device, results show that with the above intended use, the device is equivalent in safety and effectiveness.

Therefore, the subject devices of this 510(k) notification, the Sterile LeadConfirm devices, did not clinical studies to to support safety and effectiveness of of the require device.

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Image /page/11/Picture/0 description: The image shows the logo for Alpha Omega. The logo consists of the Greek letters alpha and omega, with the word "ALPHA" in red and the word "omega" in gray. The alpha symbol is stylized with a red arch above a gray bridge-like structure. A red line extends from the top of the "A" in ALPHA, creating a wave-like pattern above the word.

-Defining Neuroscience Technology Performance Tests

Test	Test Method Summary	Results
Verification andValidation	This verification performed oncomplete Sterile LeadConfirmdevices, the subject devices, andchecked that the design outputmeets the design input	Sterile LeadConfirm devices havebeen verified under a completeverification plan traceable to SterileLeadConfirm design input. Allsamples passed the acceptancecriteria which determines theeffectiveness of SterileLeadConfirm devices.
SterilizationValidationLeadConfirmAdaptors finalReport	This Sterilization validationperformed on complete SterileLeadConfirm Adaptors	The purpose of the study was tovalidate the effectiveness of theGamma Radiation Sterilization forAlpha Omega Engineering Ltd.LeadConfirm adaptors, accordingto VDmax Method. According tothe test results (section 13), thegamma radiation sterilizationprocess of LeadConfirm AdaptorsCat. No. STR-000071-00, STR-000072-00 and STR-000073-00, ata sterilization dose of 20kGy, wassustained. This dose gave a SAL of6 magnitudes as requested by thestandards
SterilizationValidationLeadConfirm BCable final Report	This Sterilization validationperformed on complete SterileLeadConfirm B Cable	The purpose of the study was tovalidate the effectiveness of theGamma Radiation Sterilization forLeadConfirm B Cable, according toVdmax Method. According to thetest results (Section 13), the gammaradiation sterilization process ofElectrodes lead cable, at asterilization dose of 20kGy, wassustained. This dose gave a SAL of6 magnitudes as requested by thestandards
SterilizationValidation	This Sterilization validationperformed on complete Sterile	The purpose of the study was tovalidate the effectiveness of the
-Defining Neuroscience Technology
LeadConfirm M &A Cables finalReport	LeadConfirm M & A Cables	Gamma Radiation Sterilization forLeadConfirm M & A Cables,according to Vdmax Method.According to the test results(Section 13), the gamma radiationsterilization process of Electrodeslead cable, at a sterilization dose of20kGy, was sustained. This dosegave a SAL of 6 magnitudes asrequested by the standards

Page 9 of 10

Alpha Omega Engineering Ltd. Hamerkava St. 6 Tsiporit Industrial Zone Not Hagali 1789062, Israel
Tel:+972-4-6563-327 Fax:+972-4-6574-075 info@alphaomega-eng.com

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Image /page/12/Picture/0 description: The image shows a logo with the words "ALPHA omega" in a stylized font. The word "ALPHA" is in a dark red color, and the word "omega" is in gray. The "A" in "ALPHA" is stylized with a dark red arch over a gray bridge-like structure. A red line extends from the "A" in "ALPHA" to the "A" in "omega", creating a visual connection between the two words.

Page 10 of 10

Regulation Number and Section

§ 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).