Sterile LeadConfirm

K191739 · Alpha Omega Engineering , Ltd. · GZL · Jan 2, 2020 · Neurology

Device Facts

• Record ID: K191739
• Device Name: Sterile LeadConfirm
• Applicant: Alpha Omega Engineering , Ltd.
• Product Code: GZL · Neurology
• Decision Date: Jan 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Indications for Use

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 Story

Sterile LeadConfirm cables and adaptors serve as hardware interfaces connecting deep brain stimulation (DBS) leads to Alpha Omega's Neuro Omega or NeuroSmart physiological navigation systems. Used in the operating room by neurosurgeons during functional neurosurgery, these devices facilitate intraoperative neurophysiological recording and stimulation. The system enables the transmission of electrical signals between the implanted DBS lead and the recording/stimulation console, aiding the surgeon in precise lead placement. The device supports stimulation parameters including square wave/Lili pulses, amplitudes up to 12mA, and durations up to 500uSec. By providing a reliable connection, the device assists in the clinical decision-making process regarding optimal lead positioning, potentially improving patient outcomes in functional neurosurgical procedures.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing confirmed design outputs meet design inputs. Sterilization validation performed using Gamma radiation (VDmax method) at 20kGy achieved a Sterility Assurance Level (SAL) of 10^-6.

Technological Characteristics

Sterile, disposable hardware cables and adaptors. Materials verified for stability post-irradiation. Sterilization via Gamma radiation (20kGy). Connectivity: physical interface between DBS leads (Medtronic, Boston Scientific, Abbott) and Alpha Omega navigation systems. No software or active electronic components; passive hardware.

Indications for Use

Indicated for assisting neurosurgeons in the operating room during functional neurosurgery to aid in the placement of a compatible DBS lead in patients requiring functional neurosurgery.

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

• Sterile Disposable Recording Cables (K120098)

Submission Summary (Full Text)

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

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)

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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:[phone] Fax:[phone]

#### Submission contact person:

Mrs. Maysana Mousa Tel:[phone] Fax:[phone] Mobile: [phone]

#### 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

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)
- 2) Sterile LeadConfirm B Cable that connects to Boston Scientific Lead P150031 (BSC-DB-2201, BSC-DB-2202)
- 3) 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
- 2) 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.

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.

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Alpha Omega Engineering Ltd. Hamerkava St. 6 Tsiporit Industrial Zone Nof Hagalil 1789062, Israel Tel:[phone] Fax:[phone] [e-mail] 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

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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 .

| # | Comparison<br>parameter | Subject device:<br>Sterile LeadConfirm | Predicate device:<br>Sterile Disposable Recording<br>Cables | Substantial Equivalent discussion |
|---|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| 1 | Legally<br>distribution<br>clearance No. | Subject device | K120098 | |
| 2 | Owner | Alpha Omega Engineering<br>Ltd. | Alpha Omega Engineering<br>Ltd. | |
| 3 | Intended use and<br>indications for<br>use. | The Alpha Omega Disposable<br>Sterile LeadConfirm for MER<br>is intended to be used in<br>neurosurgery for connecting a<br>compatible DBS Lead to a<br>compatible recording and<br>stimulation device.<br><br>The Alpha Omega Disposable<br>Sterile LeadConfirm for MER<br>is indicated for assisting | Alpha Omega's Sterile<br>Disposable Recording Cables<br>for MER are intended to be<br>used in neurosurgery for<br>connecting NeuroProbes to<br>recording and stimulation<br>device. | Similarities:<br>Similar<br>Differences:<br>None |
| # | Comparison<br>parameter | Subject device:<br>Sterile LeadConfirm | Predicate device:<br>Sterile Disposable Recording | Substantial Equivalent discussion |
| | | | Cables | |
| | | Neurosurgeons, in the<br>operating room during<br>functional neurosurgery, to aid<br>in the placement of a<br>compatible DBS Lead.<br>The Alpha Omega Disposable<br>Sterile LeadConfirm should<br>only be used to connect a<br>compatible DBS Lead to a<br>compatible recording and<br>stimulation device | | |
| 4 | indications for<br>use and<br>environment | Alpha Omega's Disposable<br>Sterile LeadConfirm for MER<br>is indicated for assisting<br>Neurosurgeons, in the<br>operation room during<br>functional neurosurgery, to aid<br>in placement of Lead. | Alpha Omega's Sterile<br>Disposable Recording Cables<br>for MER are indicated for<br>assisting Neurosurgeons, in the<br>operation room during<br>functional neurosurgery, to aid<br>in placement of depth<br>electrodes. | Similarities:<br>Similar<br>Differences:<br>None |
| 5 | Device code and<br>regulation | Product Code:<br>GZL<br>Regulation #: 21CFR882.1330 | Product Code:<br>GZL<br>Regulation #: 21CFR882.1330 | Similarities:<br>Identical<br>Differences:<br>None |
| # | Comparison<br>parameter | Subject device:<br>Sterile LeadConfirm | Predicate device:<br>Sterile Disposable Recording<br>Cables | Substantial Equivalent discussion |
| 1 | Legally<br>distribution<br>clearance No. | Subject device | K120098 | |
| 2 | Owner | Alpha Omega Engineering<br>Ltd. | Alpha Omega Engineering<br>Ltd. | |
| 3 | Target treatment<br>Population | All patients that need<br>functional neurosurgery | All patients that need<br>functional neurosurgery | Similarities:<br>Identical<br>Differences:<br>None |
| 4 | Human Factors | Used by professional<br>Neurosurgeons | Used by professional<br>Neurosurgeons | Similarities:<br>Identical<br>Differences:<br>None |
| 5 | Use environment | Operating Room | Operating Room | Similarities:<br>Identical<br>Differences:<br>None |

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Alpha Omega Engineering Ltd. Hamerkava St. 6 Tsiporit Industrial Zone Nof Hagalil 1789062, Israel Tel:[phone] Fax:[phone] [e-mail] 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

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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 .

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Alpha Omega Engineering Ltd. Hamerkava St. 6 Tsiporit Industrial Zone Nof Hagalil 1789062, Israel Tel:[phone] Fax:[phone] [e-mail] 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

| # | Comparison<br>parameter | Subject device:<br>Sterile LeadConfirm | Predicate device:<br>Sterile Disposable Recording<br>Cables | Substantial Equivalent discussion |
|---|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| 6 | Integrity of<br>materials and<br>functionality<br>after sterilization | Functionality and materials<br>stability, including packaging<br>verified, after irradiation<br>sterilization. | Functionality and materials<br>stability, including packaging<br>verified, after irradiation<br>sterilization. | Similarities:<br>Identical<br>Differences:<br>None |
| 7 | Sterility<br>achievement<br>method | Sterilized by Alpha omega<br>using irradiation sterilization<br>and delivered sterile, validated<br>process | Sterilized by Alpha omega<br>using irradiation sterilization<br>and delivered sterile. | Similarities:<br>Identical<br>Differences:<br>None |

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Alpha Omega Engineering Ltd. Hamerkava St. 6 Tsiporit Industrial Zone Nof Hagalil 1789062, Israel Tel:[phone] Fax:[phone] [e-mail] 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 and<br>Validation | This verification performed on<br>complete Sterile LeadConfirm<br>devices, the subject devices, and<br>checked that the design output<br>meets the design input | Sterile LeadConfirm devices have<br>been verified under a complete<br>verification plan traceable to Sterile<br>LeadConfirm design input. All<br>samples passed the acceptance<br>criteria which determines the<br>effectiveness of Sterile<br>LeadConfirm devices. |
| Sterilization<br>Validation<br>LeadConfirm<br>Adaptors final<br>Report | This Sterilization validation<br>performed on complete Sterile<br>LeadConfirm Adaptors | The purpose of the study was to<br>validate the effectiveness of the<br>Gamma Radiation Sterilization for<br>Alpha Omega Engineering Ltd.<br>LeadConfirm adaptors, according<br>to VDmax Method. According to<br>the test results (section 13), the<br>gamma radiation sterilization<br>process of LeadConfirm Adaptors<br>Cat. No. STR-000071-00, STR-<br>000072-00 and STR-000073-00, at<br>a sterilization dose of 20kGy, was<br>sustained. This dose gave a SAL of<br>6 magnitudes as requested by the<br>standards |
| Sterilization<br>Validation<br>LeadConfirm B<br>Cable final Report | This Sterilization validation<br>performed on complete Sterile<br>LeadConfirm B Cable | The purpose of the study was to<br>validate the effectiveness of the<br>Gamma Radiation Sterilization for<br>LeadConfirm B Cable, according to<br>Vdmax Method. According to the<br>test results (Section 13), the gamma<br>radiation sterilization process of<br>Electrodes lead cable, at a<br>sterilization dose of 20kGy, was<br>sustained. This dose gave a SAL of<br>6 magnitudes as requested by the<br>standards |
| Sterilization<br>Validation | This Sterilization validation<br>performed on complete Sterile | The purpose of the study was to<br>validate the effectiveness of the |
| -Defining Neuroscience Technology | | |
| LeadConfirm M &<br>A Cables final<br>Report | LeadConfirm M & A Cables | Gamma Radiation Sterilization for<br>LeadConfirm M & A Cables,<br>according to Vdmax Method.<br>According to the test results<br>(Section 13), the gamma radiation<br>sterilization process of Electrodes<br>lead cable, at a sterilization dose of<br>20kGy, was sustained. This dose<br>gave a SAL of 6 magnitudes as<br>requested by the standards |

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Alpha Omega Engineering Ltd. Hamerkava St. 6 Tsiporit Industrial Zone Not Hagali 1789062, Israel
Tel:[phone] Fax:[phone] [e-mail]

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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.

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