The Aurora Surgiscope System is intended for use in 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: A sterile, single use, neurological endoscope called the Aurora Surgiscope and a non-sterile, reusable control unit called the Image Control Box (ICB).

The Aurora Surgiscope includes the following parts:

Sheath
Camera
LED (Light Emitting Diodes)
Sheath Cable
Obturator

The Sheath is fabricated from plastic and shaped like a hollow cylinder. It acts as both the insertion portion and instrument channel of the endoscope. LEDs are embedded into the Sheath's distal end for illumination. The Sheath's proximal end incorporates a larger diameter plastic ring with a fixation tab. The Camera is rigidly attached to the plastic ring and positioned to produce a forward view of the surgical site. The Sheath's electronics are connected to the ICB by a flexible shielded cable. The cable exits from the rear of the Camera housing and connects to the ICB during system set-up. The Obturator is pre-loaded into the Sheath. Its distal tip is fabricated from clear plastic and is conical shaped. It has a plastic handle at the proximal end to facilitate removal. A cannulated steel post connects the Obturator tip and handle.

The Image Control Box is supplied with two cables; one for power and the other for connection to a 3rd party external HD Monitor. The ICB delivers power to the LEDs and Camera, transfers the video image to the HD Monitor, and allows a user to turn knobs that digitally adjust image quality and orientation.

AI/ML Overview

I am sorry, but the provided text focuses on the FDA clearance document (K182211) for the Aurora Surgiscope System. This document details the device description, indications for use, comparison to predicate devices, and a summary of non-clinical testing conducted to establish substantial equivalence.

However, the document does not contain the specific information required to answer your questions regarding acceptance criteria, the detailed study design (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set information.

The document states that "The following testing was conducted to demonstrate the safe and effective use of the Aurora Surgiscope System and its' substantial equivalence to the primary predicate," and then lists several types of non-clinical testing such as:

Biocompatibility Testing
Electrical Safety and Enclosure Protection
Emissions and Immunity
Particulate testing
Sterilization
Packaging and Shelf-life
Simulated use testing
Design verification testing
Software and System Verification and Validation

While these tests demonstrate performance against certain standards, the document does not specify acceptance criteria in a quantifiable manner (e.g., specific metrics and thresholds for accuracy, sensitivity, specificity, resolution) that would typically be found in a clinical study report for an AI/CADe device. It also does not describe a "study that proves the device meets the acceptance criteria" in the context of an algorithm's diagnostic performance for the criteria you've outlined.

Therefore, I cannot populate the table or answer the specific questions about the study design with the information provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

January 18, 2018

Rebound Therapeutics Corporation Jane Metcalf Vice President Regulatory Affairs 13900 Alton Parkway Irvine, California 92618

Re: K182211

Trade/Device Name: Aurora Surgiscope System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG, GZT Dated: August 13, 2018 Received: August 15, 2018

Dear Jane Metcalf:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Matthew C. Krueger -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182211

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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1) SUBMITTER

Rebound Therapeutics Corporation 13900 Alton Parkway, STE 120 Irvine, CA 92618 Phone: (949) 305-8111 www.reboundtx.com Contact Person: Jane Metcalf Date Prepared: August 13, 2018

2) DEVICE

Name of Device: Aurora Surgiscope System Common or Usual Name: Neurological Endoscope Classification Names: Neurological endoscope, Self-retaining retractor for neurosurgery Classification Numbers: 882.1480, 882.4800 Regulatory Class: II Product Code: GWG, GZT

3) PREDICATE DEVICE

Primary Predicate: Aesculap MINOP System, K983365 Secondary Predicate: NICO Brain Port, K120691

4) DEVICE DESCRIPTION

The Aurora Surgiscope includes the following parts:

Sheath ●
Camera
LED (Light Emitting Diodes) ●
Sheath Cable ●
Obturator .

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shaped. It has a plastic handle at the proximal end to facilitate removal. A cannulated steel post connects the Obturator tip and handle.

5) INDICATIONS FOR USE

6) SUMMARY OF NON-CLINICAL TESTING

The following testing was conducted to demonstrate the safe and effective use of the Aurora Surgiscope System and its' substantial equivalence to the primary predicate.

Biocompatibility Testing per ISO 10993-1 Cytotoxicity (MEM Elution), Sensitization (Kligman ● Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection, Material Mediated Pyrogenicity)
Electrical Safety and Enclosure Protection per IEC 60601-2-18 and IEC 60529-1
Emissions and Immunity per IEC 60601-1-2 ●
Particulate testing per USP 36 <788>: ●
Sterilization per ISO 11135-1 to validate a SAL of 10-6
Packaging and Shelf-life per ISTA 2A and ASTM F1980
Simulated use testing
Design verification testing
Software and System Verification and Validation

7) TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE

	SUBJECT DEVICE	PRIMARY PREDICATE
	Aurora Surgiscope System	Aesculap MINOP System
System Components
Trocar	The device is a Trocar with OD $≤$ 11.5mmOne (1) channelThe channel provides visual access for thecamera, and working access for instruments,including suction and irrigation. Anoverflow channel is not required in theSurgiscope.One (1) Obturator	Trocar Model FF399R, OD 6mm4 channels:• Scope - 2.8mm• Working - 2.2mm• Irrigation - 1.4mm• Overflow - 1.4mm4 Obturators
Endoscope(Telescope)	The device is an Endoscope	Model PE184A is an Endoscope
	Direction of View - 0°	Direction of View - 0°
	Shaft Diameter $≤$ 11.5mm	Shaft Diameter - 2.7mm
	Shaft length - 130mm, 100mm, 70mm for	Shaft length 180 mm
	each of 3 models respectively
	SUBJECT DEVICE	PRIMARY PREDICATE
	Aurora Surgiscope System	Aesculap MINOP System
Light Source	LED lights incorporated into distal end ofdevice	Model OP940 – LED SourceModel OP - 923 Fiber Optic CableControl Unit
Camera	Integrated CameraControl Unit	Camera Model # PV 462Control Unit Model # PV460
Monitor	Not supplied	PV 646 24" Full HD LCD Monitor
Principles of Operation
Access to the surgical site	Aurora Surgiscope's Sheath and Obturatorcomponents used to access the surgical siteThe Obturator extends 10mm (-1mm,+2mm) beyond distal end of Sheath	Trocar and Obturator used to access thesurgical site. MINOP telescope insertedinto the Trocar. The Obturator is flush withTrocar's distal end.
Image Acquisition	Image acquisition is achieved through anintegrated camera external to the surgicalopening	Image acquisition is achieved through aconnected camera external to the surgicalopening
Image Processing	Image is digitally processed	Image is digitally processed
Image Display	External monitor connection	External monitor connection
Illumination	Illumination is achieved via directtransmission using an LED light sourceincorporated into the device.	Illumination is achieved via fiber optictransmission using an external light source.
Visualization	CMOS, color, video, camera withproprietary software that is incorporatedinto proximal end of the device andcontrolled via control unit.	Separately supplied HD 1080 p60 camerasystem consisting of CCU, camera headcable and zoom coupler. Camera headmounted onto scope and controlled bycontrol unit. Alternatively, direct viewthrough eye-piece on the EndoscopeTrocar.
Working Channel	One	One
Accessories	Power Supply, Display Cable	Cables and dedicated instruments; e.g.reusable scissors, biopsy forceps, fixationand dissection forceps.
Other
Biocompatibility	Demonstrated based on externallycommunicating device in direct contact withtissue/bone/dentin for a limited duration	Demonstrated based on externallycommunicating device in direct contactwith tissue/bone/dentin for a limitedduration
Materials	Plastic	Stainless Steel
Depth Markings	Yes	Yes
Inner Diameter	8 mm	<2.7mm
Working Lengths	7cm, 10cm and 13cm	18cm
Obturator Tip	Conical Shaped	Rounded
Use and How Supplied	Endoscope - Single Use, Sterile	Endoscope – Reusable, Non-sterile

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8) CONCLUSION

Upon reviewing the performance data provided in this submission and comparing indicated use, design, materials, principle of operation and overall technological characteristics, the Aurora Surgiscope System has been determined, by Rebound Therapeutics Corporation, to be substantially equivalent to the primary predicate.

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).