Aurora Surgiscope System

K182211 · Rebound Therapeutics Corporation · GWG · Jan 18, 2019 · Neurology

Device Facts

• Record ID: K182211
• Device Name: Aurora Surgiscope System
• Applicant: Rebound Therapeutics Corporation
• Product Code: GWG · Neurology
• Decision Date: Jan 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Aurora Surgiscope System is a single-use neurological endoscope and reusable Image Control Box (ICB). Device inputs include optical images of the surgical site captured via an integrated camera at the distal end of a plastic sheath. LEDs embedded in the sheath provide illumination. The ICB processes the video signal, allowing user-controlled digital adjustments to image quality and orientation, and outputs the feed to a third-party HD monitor. Used in neurosurgical procedures by physicians to visualize the surgical field, perform biopsies, or remove obstructions. The system facilitates minimally invasive access via a conical obturator. Clinical benefit includes improved visualization and access during neuroendoscopic procedures. The device is intended for clinical use in surgical settings.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity), electrical safety (IEC 60601-2-18, IEC 60601-1-2), particulate testing (USP 36 <788>), sterilization validation (ISO 11135-1), packaging/shelf-life testing (ISTA 2A, ASTM F1980), simulated use, and design verification/validation.

Technological Characteristics

Plastic sheath with integrated CMOS camera and distal LED illumination. System includes a reusable Image Control Box for digital image processing and display output. Dimensions: OD ≤ 11.5mm, working lengths 7cm, 10cm, 13cm. Connectivity: cable-based to ICB, output to external HD monitor. Sterilization: Ethylene Oxide (ISO 11135-1). Electrical safety: IEC 60601-2-18, IEC 60529-1. Emissions/Immunity: IEC 60601-1-2.

Indications for Use

Indicated for patients undergoing endoscopic neurosurgery or pure neuroendoscopy (e.g., ventriculoscopy) for visualization, diagnostic, or therapeutic procedures including ventriculostomies, biopsies, and removal of cysts, tumors, or other obstructions.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

• Aesculap MINOP System (K983365)
• NICO Brain Port (K120691)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K182211

Device Name Aurora Surgiscope System

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#### 1) SUBMITTER

Rebound Therapeutics Corporation 13900 Alton Parkway, STE 120 Irvine, CA 92618 Phone: [phone] 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 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

{4}------------------------------------------------

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.

#### 5) INDICATIONS FOR USE

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.

#### 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 $≤$ 11.5mm<br>One (1) channel<br>The channel provides visual access for the<br>camera, and working access for instruments,<br>including suction and irrigation. An<br>overflow channel is not required in the<br>Surgiscope.<br>One (1) Obturator | Trocar Model FF399R, OD 6mm<br>4 channels:<br>• Scope - 2.8mm<br>• Working - 2.2mm<br>• Irrigation - 1.4mm<br>• Overflow - 1.4mm<br>4 Obturators |
| Endoscope<br>(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 of<br>device | Model OP940 – LED Source<br>Model OP - 923 Fiber Optic Cable<br>Control Unit |
| Camera | Integrated Camera<br>Control Unit | Camera Model # PV 462<br>Control 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 Obturator<br>components used to access the surgical site<br>The Obturator extends 10mm (-1mm,<br>+2mm) beyond distal end of Sheath | Trocar and Obturator used to access the<br>surgical site. MINOP telescope inserted<br>into the Trocar. The Obturator is flush with<br>Trocar's distal end. |
| Image Acquisition | Image acquisition is achieved through an<br>integrated camera external to the surgical<br>opening | Image acquisition is achieved through a<br>connected camera external to the surgical<br>opening |
| Image Processing | Image is digitally processed | Image is digitally processed |
| Image Display | External monitor connection | External monitor connection |
| Illumination | Illumination is achieved via direct<br>transmission using an LED light source<br>incorporated into the device. | Illumination is achieved via fiber optic<br>transmission using an external light source. |
| Visualization | CMOS, color, video, camera with<br>proprietary software that is incorporated<br>into proximal end of the device and<br>controlled via control unit. | Separately supplied HD 1080 p60 camera<br>system consisting of CCU, camera head<br>cable and zoom coupler. Camera head<br>mounted onto scope and controlled by<br>control unit. Alternatively, direct view<br>through eye-piece on the Endoscope<br>Trocar. |
| Working Channel | One | One |
| Accessories | Power Supply, Display Cable | Cables and dedicated instruments; e.g.<br>reusable scissors, biopsy forceps, fixation<br>and dissection forceps. |
| Other | | |
| Biocompatibility | Demonstrated based on externally<br>communicating device in direct contact with<br>tissue/bone/dentin for a limited duration | Demonstrated based on externally<br>communicating device in direct contact<br>with tissue/bone/dentin for a limited<br>duration |
| 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 |

{5}------------------------------------------------

## 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.