(148 days)
Not Found
No
The description focuses on basic image processing (zoom, contrast, brightness, orientation) and hardware components. There is no mention of AI, ML, or related concepts like deep learning, algorithms for image analysis beyond basic adjustments, or training/test data sets.
Yes
The "Intended Use / Indications for Use" section explicitly states that 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 both hardware components (endoscope, sheath, camera, LEDs, obturator, Image Control Box) and software/image processing capabilities. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 describes a device used within the body for direct observation and intervention, not for testing samples outside the body.
- Device Description: The description details components like a sheath, camera, LEDs, and an obturator, all designed for insertion into the body for visualization and surgical procedures. There are no components related to collecting or analyzing biological samples.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is an endoscopic system used for surgical procedures and visualization within the neurological system.
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 (comma separated list FDA assigned to the subject device)
GWG, GZT
Device Description
The Aurora Surgiscope System consists of two components: (1) a sterile, single use, neurological endoscope and (2) a non-sterile, reusable control unit, Image Control Box (ICB).
The Aurora Surgiscope includes the following components:
- Sheath
- Camera
- LED (Light Emitting Diodes) ●
- Sheath Cable ●
- Obturator ●
The Sheath is fabricated from ABS plastic and is cylindrically shaped. It acts as both the insertion portion and instrument channel of the endoscope. Depth markers are located on both sides of the Sheath in 1 cm increments to aid with device insertion. LEDs are embedded into the interior wall of the Sheath that provide illumination of the surgical field. A larger diameter plastic ring, Camera mount (or Fixation ring), is located at the proximal end of the Sheath and may be used with fixation arm(s) to hold/fix the device.
The Camera assembly is rigidly attached to the Camera Mount and positioned to produce a forward view (0° direction) of the surgical site. An optical lens and prism are also incorporated for imaging.
The Surgiscope electronics are connected to the ICB by a flexible shielded Sheath Cable. The cable exits from the rear of the Camera housing and is connected 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 to minimize injury to tissue during insertion. At the proximal end, a plastic handle is used for removal of the Obturator from the Sheath and has an attachment on the handle to secure stereotactic instruments for neuronavigation. A stainless steel tube connects the Obturator tip and handle.
The Image Control Box (ICB) controls the real-time video image that it receives from the camera on the Surgiscope. It also delivers the real-time video to an external Display Monitor and provides isolated power to the Surgiscope LEDs and camera. The ICB is supplied with two cables: an isolated 110V power cable to be connected to an AC electrical outlet and a cable which is to be connected to the Display Monitor in the operating room.
The user interface is a membrane keypad with buttons that can be depressed for image adjustment, such as zoom, contrast, brightness, and orientation. The connections to the Surgiscope, Display Monitor and Power are the side of the ICB as well as the ON/OFF switch.
Mentions image processing
Yes, "Image is digitally processed by control unit".
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was conducted or adopted to demonstrate the safe and effective use and substantial equivalence to the predicates.
- Biocompatibility Testing per ISO 10993-1, including Cytotoxicity (MEM Elution), Sensitization ● (Kligman Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection), Hemolysis (In direct), Materials Mediated Pyrogenicity were adopted
- Electrical Safety and Enclosure Protection per IEC 60601-1 and IEC 60529-1 ●
- Emissions and Immunity per IEC 60601-1-2
- Particulate Testing per USP ●
- Sterilization per ISO 11135-1 to validate a SAL of 10-6 was adopted ●
- Packaging and Shelf-life per ISTA 2A and ASTM F1980
- Design Verification testing
- Software and System Verification and Validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2019
Rebound Therapeutics Naomi Gong VP of Regulatory Affairs 13900 Alton Parkway Suite 120 Irvine, California 92618
Re: K191861
Trade/Device Name: Aurora Surgiscope System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: November 12, 2019 Received: November 13, 2019
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Matthew Krueger, M.S.E. 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
2
Indications for Use
510(k) Number (if known)
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
Rebound Therapeutics
510(k) Summary
SUBMITTER
Rebound Therapeutics Corporation 13900 Alton Parkway, STE 120 Irvine, CA 92618
| Contact Person: | Naomi Gong, RAC |
|---|---|
| Vice President of Regulatory Affairs | |
| Telephone: | (949) 305-8111 |
| Email: | ngong@reboundtx.com |
| Date Prepared: | July 10, 2019 |
DEVICE
| Name of Device: | AURORA Surgiscope System |
|---|---|
| Regulation Number: | 882.1480, 882.4800 |
| Regulation Name: | Neurological endoscope, Self-retaining retractor for neurosurgery |
| Regulatory Class: | II |
| Product Code: | GWG, GZT |
PREDICATE DEVICE
AURORA Surgiscope System, K182211
DEVICE DESCRIPTION
The Aurora Surgiscope System consists of two components: (1) a sterile, single use, neurological endoscope and (2) a non-sterile, reusable control unit, Image Control Box (ICB).
The Aurora Surgiscope includes the following components:
- Sheath
- Camera
- LED (Light Emitting Diodes) ●
- Sheath Cable ●
- Obturator ●
The Sheath is fabricated from ABS plastic and is cylindrically shaped. It acts as both the insertion portion and instrument channel of the endoscope. Depth markers are located on both sides of the Sheath in 1 cm increments to aid with device insertion. LEDs are embedded into the interior wall of the Sheath that provide illumination of the surgical field. A larger diameter plastic ring, Camera mount (or Fixation ring), is located at the proximal end of the Sheath and may be used with fixation arm(s) to hold/fix the device.
The Camera assembly is rigidly attached to the Camera Mount and positioned to produce a forward view (0° direction) of the surgical site. An optical lens and prism are also incorporated for imaging.
The Surgiscope electronics are connected to the ICB by a flexible shielded Sheath Cable. The cable exits from the rear of the Camera housing and is connected 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 to minimize injury to tissue during insertion. At the proximal end, a plastic handle is used for
4
removal of the Obturator from the Sheath and has an attachment on the handle to secure stereotactic instruments for neuronavigation. A stainless steel tube connects the Obturator tip and handle.
The Image Control Box (ICB) controls the real-time video image that it receives from the camera on the Surgiscope. It also delivers the real-time video to an external Display Monitor and provides isolated power to the Surgiscope LEDs and camera. The ICB is supplied with two cables: an isolated 110V power cable to be connected to an AC electrical outlet and a cable which is to be connected to the Display Monitor in the operating room.
The user interface is a membrane keypad with buttons that can be depressed for image adjustment, such as zoom, contrast, brightness, and orientation. The connections to the Surgiscope, Display Monitor and Power are the side of the ICB as well as the ON/OFF switch.
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.
SUMMARY OF NON-CLINICAL TESTING
The following testing was conducted or adopted to demonstrate the safe and effective use and substantial equivalence to the predicates.
- Biocompatibility Testing per ISO 10993-1, including Cytotoxicity (MEM Elution), Sensitization ● (Kligman Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection), Hemolysis (In direct), Materials Mediated Pyrogenicity were adopted
- Electrical Safety and Enclosure Protection per IEC 60601-1 and IEC 60529-1 ●
- Emissions and Immunity per IEC 60601-1-2
- Particulate Testing per USP ●
- Sterilization per ISO 11135-1 to validate a SAL of 10-6 was adopted ●
- Packaging and Shelf-life per ISTA 2A and ASTM F1980
- Design Verification testing
- Software and System Verification and Validation
COMPARISON TO PREDICATE
| PREDICATE Device | SUBJECT Device | |
|---|---|---|
| Aurora Surgiscope System (K182211) | Aurora Surgiscope System | |
| 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. | Same | |
| Sheath (Trocar) | The device is a trocar: | |
| • OD ≤ 11.5mm, ID = 8 mm | ||
| • Lengths = 70, 100, 130 mm | ||
| • Incremental depth markings | ||
| • Single working channel | ||
| • Mounting ring for camera | ||
| • With obturator (conical shape, rounded tip) | Same | |
| Materials | Sheath: | |
| ABS | ||
| PET | ||
| Adhesives | Same |
5
3 Rebound Therapeutics
| PREDICATE Device | SUBJECT Device | |
|---|---|---|
| Aurora Surgiscope System (K182211) | Aurora Surgiscope System | |
| Marker: White Ink | ||
| Camera mount ring: ABS | ||
| Obturator: Polycarbonate, 304 SS, ABS, adhesives | ||
| Endoscope | The device incorporates an endoscope with optics (lens, | |
| prism): | ||
| Direction of View = 0° | ||
| Depth of field = 0 to 3 cm | Same | |
| Light Source | 6 LED lights incorporated into inner dia. of sheath near | |
| distal end | Same | |
| Camera | Integrated CMOS camera and electronics on endoscope | Equivalent |
| Image Control Box | ||
| (control unit) | · Electronics (Circuit boards, CPU with software control) | |
| · Rotational potentiometers for image adjustment by user | · Equivalent | |
| · Keypad buttons for image adjustment | ||
| by user | ||
| Other (accessories) | Power supply and cable | |
| Display cable | Equivalent | |
| Display Monitor | Not supplied | Same |
| Access to the | ||
| surgical site | Sheath and Obturator used to access the surgical site. | |
| The Obturator extends 10mm beyond distal end of sheath | Same | |
| Single working | ||
| channel | Removal of obturator reveals working channel which | |
| provides visual access for camera and working access for | ||
| instruments, including suction and irrigation. | Same | |
| Image acquisition | Image acquisition is achieved through an integrated camera | 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 sources | |
| incorporated into the device. | Same | |
| Visualization | CMOS, color, video, camera (with software) incorporated at | |
| proximal end of the device and controlled via control unit. | Equivalent | |
| Biocompatibility of | ||
| Surgiscope | Demonstrated based on externally communicating device in | |
| direct contact with tissue/bone/dentin for a limited duration | Same | |
| Use and how | ||
| supplied | Surgiscope: single use, sterile | |
| ICB (control unit): reusable, non-sterile | Same | |
| Sterilization Method | ||
| of Surgiscope | Ethylene oxide gas | Same |
CONCLUSION
The conclusion based upon the review of performance data provided in this submission and the comparison of 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 predicate device.