(156 days)
Not Found
No
The description mentions digital image processing but does not include any terms or descriptions indicative of AI/ML, such as algorithms for analysis, interpretation, or decision support based on learned patterns.
Yes
The device is intended for "therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions."
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended for "visualization, diagnostic and/or therapeutic procedures".
No
The device description clearly outlines hardware components including a sterile, single-use endoscope (Aurora Surgiscope) with a sheath, camera, LEDs, and cable, as well as a non-sterile, reusable control unit (Image Control Box) with power and monitor cables. The performance studies also include testing related to hardware, such as biocompatibility, electrical safety, emissions, particulate testing, sterilization, packaging, and shelf-life. While there is software involved (mentioned in "Software and System Verification and Validation"), the device is not solely software.
Based on the provided information, the Aurora Surgiscope System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the system is for "endoscopic neurosurgery and pure neuroendoscopy... for visualization, diagnostic and/or therapeutic procedures". This involves direct visualization and intervention within the body, not the examination of samples taken from the body.
- Device Description: The description details a surgical endoscope system with a camera, light, and control unit. This is consistent with a device used for direct internal examination and procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis. IVD devices are specifically designed for testing samples in vitro (outside the body).
The device is clearly intended for in vivo (within the body) use for visualization and surgical procedures.
N/A
Intended Use / 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.
Product codes
GWG, GZT
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 :
- 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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 (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
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) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 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 : ●
- 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 | |
| One (1) channel | ||
| The channel provides visual access for the | ||
| camera, and working access for instruments, | ||
| including suction and irrigation. An | ||
| overflow channel is not required in the | ||
| Surgiscope. | ||
| One (1) Obturator | Trocar Model FF399R, OD 6mm | |
| 4 channels: | ||
| • Scope - 2.8mm | ||
| • Working - 2.2mm | ||
| • Irrigation - 1.4mm | ||
| • Overflow - 1.4mm | ||
| 4 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 of | |
| device | Model OP940 – LED Source | |
| Model OP - 923 Fiber Optic Cable | ||
| Control Unit | ||
| Camera | Integrated Camera | |
| Control Unit | Camera Model # PV 462 | |
| 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 | |
| components used to access the surgical site | ||
| The Obturator extends 10mm (-1mm, | ||
| +2mm) beyond distal end of Sheath | Trocar and Obturator used to access the | |
| surgical site. MINOP telescope inserted | ||
| into the Trocar. The Obturator is flush with | ||
| Trocar's distal end. | ||
| Image Acquisition | Image acquisition is achieved through an | |
| integrated camera external to the surgical | ||
| opening | Image acquisition is achieved through a | |
| connected camera external to the surgical | ||
| 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 | |
| transmission using an LED light source | ||
| incorporated into the device. | Illumination is achieved via fiber optic | |
| transmission using an external light source. | ||
| Visualization | CMOS, color, video, camera with | |
| proprietary software that is incorporated | ||
| into proximal end of the device and | ||
| controlled via control unit. | Separately supplied HD 1080 p60 camera | |
| system consisting of CCU, camera head | ||
| cable and zoom coupler. Camera head | ||
| mounted onto scope and controlled by | ||
| control unit. Alternatively, direct view | ||
| through eye-piece on the Endoscope | ||
| Trocar. | ||
| Working Channel | One | One |
| Accessories | Power Supply, Display Cable | Cables and dedicated instruments; e.g. |
| reusable scissors, biopsy forceps, fixation | ||
| and dissection forceps. | ||
| Other | ||
| Biocompatibility | Demonstrated based on externally | |
| communicating device in direct contact with | ||
| tissue/bone/dentin for a limited duration | Demonstrated based on externally | |
| communicating device in direct contact | ||
| with tissue/bone/dentin for a limited | ||
| duration | ||
| Materials | Plastic | Stainless Steel |
| Depth Markings | Yes | Yes |
| Inner Diameter | 8 mm |