The AURORA Surgiscope System is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

Device Description

The Aurora Surgiscope System consists of two components: (1) a sterile, single use, sheath with integrated illumination LEDs and camera, with an obturator, and (2) a non-sterile, reusable control unit, Image Control Box (ICB).

The sheath is intended to provide access to the surgical site by acting as the insertable portion of the device, as well as the instrument channel to accommodate other surgical tools. Depth markers are present along the length of the sheath for user reference.

At the proximal end of the sheath is the imager, which comprises the following components: LEDs (light emitting diodes), camera (and optical components), and focus knob.

. The LEDs provide illumination to the surgical field by directing light down the sheath, along the instrument channel.
The camera captures video image of the surgical field.

The proximal end of the sheath also contains a tab, which serves as the location for the fixation arm to hold/fix the device. To facilitate insertion of the surgical site, an obturator is provided with the device. During insertion, the obturator is fully inserted into the entire unit is advanced to the desired location. The distal end of the obturator is conical in shape to minimize tissue damage. In addition, the proximal handle of the obturator is designed to accommodate various stereotactic instruments for neuronavigation. Once inserted, the obturator is removed.

The ICB is a non-sterile device that provides three main functions in the AURORA Surgiscope System:

. To power the Surgiscope LEDs and camera
. To relay the video feed captured by the Surgiscope camera to a display monitor for real-time image visualization
. To allow the user to make adjustments to the displayed video feed (e.g., contrast, brightness), as well as vary the LED light output.

The user interface is a membrane keypad with buttons located on the ICB that can be depressed for image adjustment, such as zoom, contrast, brightness, and orientation. The ICB is supplied with two cables: A power cable for connection to an AC wall outlet, and a display cable for connection to a high definition surgical monitor.

AI/ML Overview

The provided text describes the AURORA Surgiscope System, a neurological endoscope. However, it does not contain specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or details of a study designed to demonstrate them.

The document discusses various non-clinical tests performed to demonstrate the device's safety and substantial equivalence to a predicate device. These tests fall under general medical device regulatory requirements rather than specific performance outcomes for an AI/algorithm-driven device.

Therefore, for almost all of the requested information, the answer is that the data is not available in the provided text.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Not specified in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) for an algorithm. The document focuses on performance related to safety, electrical compatibility, software validation, mechanical properties, and biocompatibility.	N/A

2. Sample size used for the test set and data provenance

The document describes non-clinical testing for the device (biocompatibility, electrical safety, software V&V, mechanical testing), but does not mention a "test set" in the context of diagnostic performance or AI model evaluation.

3. Number of experts used to establish the ground truth for the test set and their qualifications

N/A. The document does not describe a study involving expert review for establishing ground truth related to diagnostic performance.

4. Adjudication method for the test set

N/A. No test set for diagnostic performance is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No. The document does not describe an MRMC study or any study evaluating human reader improvement with AI assistance. The device is a surgical endoscope, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. The document does not describe a standalone algorithm performance study.

7. The type of ground truth used

N/A. The concept of "ground truth" in the context of diagnostic or AI performance is not relevant to the non-clinical testing described. The "truth" in these tests relates to engineering specifications, material properties, safety standards, and software functionality.

8. The sample size for the training set

N/A. No training set for an AI/algorithm is described. The software validation mentioned (point 4 in "SUMMARY OF NON-CLINICAL TESTING") refers to the software controlling the endoscope's functions, not an AI algorithm for diagnostic purposes.

9. How the ground truth for the training set was established

N/A. No training set is described.

Summary of what the document DOES describe regarding "studies" and "performance":

The document outlines a series of non-clinical tests that demonstrate the device's safety and functional performance in accordance with regulatory standards for a medical device (neurological endoscope). These include:

Biocompatibility testing: MEM Elution (cytotoxicity), Sensitization (Kligman Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection), Hemolysis (Indirect), Materials Mediated Pyrogenicity. The device sheath with LEDs and camera is considered tissue-contacting for less than 24 hours. The ICB (Image Control Box) has no patient contact.
Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-18.
Software verification and validation testing: Conducted as per FDA Guidance for "major level of concern" software (meaning failure could cause serious injury or death). This ensures the software controlling the device functions correctly.
Mechanical and other testing: Dimensional, imaging (visualization, resolution), illumination, tensile strength, simulated use (clinician evaluation), instrument compatibility, particulate testing (USP <788>), sterilization (ISO 11135-1 for SAL of 10-6), packaging and shelf-life (ISTA 2A and ASTM F1980).

These tests are designed to show the device is safe and performs its intended function (visualization, diagnostic/therapeutic procedures using an endoscope), and that it is substantially equivalent to a predicate device based on its technical characteristics. It does not involve AI or diagnostic performance metrics typically requested for such systems.

Summary

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November 4, 2020

Rebound Therapeutics Naomi Gong VP of Regulatory Affairs 13900 Alton Parkway Suite 120 Irvine, California 92618

Re: K201840

Trade/Device Name: Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG, GZT Dated: July 1, 2020 Received: July 2, 2020

Dear Naomi Gong:

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

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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 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 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,

Adam D. Pierce, Ph.D. Assistant Director 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) K201840

Device Name AURORA Surgiscope System

Indications for Use (Describe)

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)

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510(k) Summary (K201840)

SUBMITTER

Rebound Therapeutics 13900 Alton Parkway, Suite 120 Irvine, CA 92618

Contact Person:	Naomi Gong, RACVice President of Regulatory Affairs
Telephone:	(949) 523-6510
Email:	naomi.gong@integralife.com
Date Prepared:	November 4, 2020

DEVICE

Name of Device:	AURORA Surgiscope System
Regulation Number:	21 CFR 882.1480, 21 CFR 882.4800
Regulation Name:	Neurological endoscope, Self-retaining retractor for neurosurger
Regulatory Class:	II
Product Code:	GWG, GZT

PREDICATE DEVICE

AURORA Surgiscope System, Rebound Therapeutics, K191861 NICO BrainPath, NICO Corp, K172433 (Reference device)

DEVICE DESCRIPTION

At the proximal end of the sheath is the imager, which comprises the following components: LEDs (light emitting diodes), camera (and optical components), and focus knob.

. The LEDs provide illumination to the surgical field by directing light down the sheath, along the instrument channel.
The camera captures video image of the surgical field.

The ICB is a non-sterile device that provides three main functions in the AURORA Surgiscope System:

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. To power the Surgiscope LEDs and camera
. To relay the video feed captured by the Surgiscope camera to a display monitor for real-time image visualization
. To allow the user to make adjustments to the displayed video feed (e.g., contrast, brightness), as well as vary the LED light output.

INDICATIONS FOR USE

The Aurora Surgiscope System is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

SUMMARY OF NON-CLINICAL TESTING

The following testing was conducted to demonstrate the safe and substantial equivalence to the predicate device.

(1) Biocompatibility testing
The AURORA Surgiscope System is intended to come into direct contact with human tissue during use and was evaluated and tested per the requirements and recommendations of the FDA Guidance, "Use of ISO-10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process." The battery of testing included the following tests:

-Cytotoxicity (MEM Elution) -Sensitization (Kligman Maximization) -Irritation (Intracutaneous Injection) -Systemic Toxicity (Systemic Injection) -Hemolysis (In direct) -Materials Mediated Pyrogenicity

The sheath with LEDs and camera portion is considered a tissue contacting and externally communicating for a duration of less than 24 hours. The ICB is not intended to have direct or indirect patient contact and therefore biocompatibility for it was not evaluated.

(2) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the AURORA Surgiscope System consisting of both components, sheath with LEDs and camera, and the ICB. The system complied with the IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-18.
(3) Software verification and validation testing
Software verification and validation testing were conducted and documentation was provided as recommended by the FDA Guidance. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a major level of concern, since a failure or latent flow in the software could directly result in a serious injury or death to the patient or operator.

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(4) Mechanical and other testing
- Bench testing dimensional, imaging (visualization, resolution, etc.), illumination, tensile . strength between components
- Simulated use testing – clinician evaluation
- . Compatibility - instrument use in instrument channel, use with other devices (i.e., bipolar electrosurgical)
- Particulate Testing per USP <788> .
- Sterilization per ISO 11135-1 to validate a SAL of 10-6 .
- . Packaging and Shelf-life per ISTA 2A and ASTM F1980 _

COMPARISON OF TECHNICAL CHARACTERISTICS TO PREDICATE DEVICE

	PREDICATE Device	SUBJECT Device
	Aurora Surgiscope System (K191861)	Aurora Surgiscope System
INDICATIONSFOR USE	The Aurora Surgiscope System is intended for use inendoscopic neurosurgery and pure neuroendoscopy(i.e. ventriculoscopy) for visualization, diagnosticand/or therapeutic procedures such asventriculostomies, biopsies and removal of cysts,tumors and other obstructions.	The Aurora Surgiscope System is intended for use inneurosurgery, and endoscopic neurosurgery andpure neuroendoscopy (i.e. ventriculoscopy) forvisualization, diagnostic and/or therapeuticprocedures such as ventriculostomies, biopsies andremoval of cysts, tumors and other obstructions.

Sheath	■ OD ≤ 11.5mm, ID = 8 mm■ Lengths = 70, 100, 130 mm■ Incremental depth markings■ Single working channel■ With obturator (conical shape, rounded tip)	■ OD = 16.2 mm, ID = 11 mm■ Lengths = 60 and 80 mm■ Same■ Same■ Same
Materials	Sheath: ABS, PET, adhesives, white ink depth markerObturator: Polycarbonate, 304 SS, ABS, adhesives	Sheath: Aluminum, adhesivesObturator: Same
Imager	The device incorporates an imaging system withcamera and optics (lens, prism):Direction of View = 0°Depth of field = 0 to 3 cm	Same
Light SourceCamera	6 LED incorporated into inner dia. of sheath neardistal end - fixed intensity levelIntegrated CMOS camera and electronics	4 LEDs incorporated into Imager (proximal end ofsheath) - user can vary intensity levelSame
Image Control Box(control unit)	■ Electronics (Circuit boards, CPU with softwarecontrol)■ Keypad buttons for image adjustment by user	■ Equivalent■ Same
Other (accessories)	Power supply and cableDisplay cable	Same
Display Monitor	Not supplied	Same

Access to thesurgical site	Sheath and Obturator used to access the surgical site.The Obturator extends 10mm beyond distal end ofsheath	Same
Single workingchannel	Removal of obturator reveals working channel whichprovides visual access for camera and working accessfor instruments including suction, bipolar, andirrigation.	Same
Image acquisition	Image acquisition is achieved through an integratedcamera	Same
Image processing	Image is digitally processed by control unit	Same
Image display	External display monitor connection	Same
Illumination	Illumination is achieved via direct LED light sourcesincorporated into the device.	Same
Visualization	CMOS, color, video, camera (with software)incorporated at proximal end of the device andcontrolled via control unit.	Equivalent

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	PREDICATE Device	SUBJECT Device
	Aurora Surgiscope System (K191861)	Aurora Surgiscope System
Biocompatibility	Surgiscope: Demonstrated based on externallycommunicating device in direct contact withtissue/bone/dentin for a limited duration	Same
Use and howsupplied	Surgiscope: single use, sterileICB (control unit): reusable, non-sterile	Same
SterilizationMethod	Surgiscope: Ethylene oxide gas	Same

The NICO BrainPath device (K172433) is included as a reference device because its sheath diameter is comparable and its sheath/obturator has the same intended use to access the surgical field during neurosurgery.

CONCLUSION

Based upon the performance data provided in this submission and comparing indications for use, design, materials, principle of operation and overall technological characteristics, the AURORA Surgiscope System has been determined to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).