(59 days)
No
The document describes a standard endoscopic visualization system with image processing capabilities for display adjustments (contrast, brightness, zoom). There is no mention of AI or ML algorithms for image analysis, diagnosis, or other functions.
Yes.
The device is intended for therapeutic procedures such as ventriculostomies, biopsies, and removal of cysts, tumors, and other obstructions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic and/or therapeutic procedures."
No
The device description clearly outlines hardware components including a sterile sheath with integrated LEDs and camera, an obturator, and a non-sterile control unit (ICB) with a membrane keypad and cables. While software is mentioned for image adjustment and control, it is integral to the function of the hardware components and not a standalone software-only device.
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 device is for visualization, diagnostic, and therapeutic procedures in vivo (within the body) during neurosurgery and neuroendoscopy. IVD devices are used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis.
- Device Description: The device is a surgical instrument designed for direct visualization and access to the surgical site within the patient's body. It includes a camera and illumination for viewing internal structures. This is characteristic of surgical endoscopes or visualization systems, not IVD devices.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, reagents, or any other components typically associated with IVD testing.
The device is a surgical visualization and access system used directly on the patient during a surgical procedure.
N/A
Intended Use / 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.
Product codes
GWG, GZT
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 may be used to manually hold 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 sheath, and 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. Two sterile, single use accessories optional for use are provided with the Aurora Surgiscope System: an Irrigation Device and 12 French Suction Device.
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.
Mentions image processing
Image processing is achieved through an integrated camera.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurosurgery, endoscopic neurosurgery, ventriculoscopy
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 to demonstrate substantial equivalence to the predicate device in terms of safety and effectiveness.
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 recommendations of the FDA Guidance FDA Guidance Use of International Standard 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
- Sensitization ●
- Irritation/Intracutaneous Reactivity .
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity ●
- Hemolysis (Indirect) .
Electrical safety and electromagnetic compatibility (EMC) testing:
Electrical safety and EMC testing were conducted on the fully assembled Aurora Surgiscope System. The system complies with the applicable clauses of IEC 60601-1-2. and IEC 60601-2-18.
Software verification and validation testing:
Software testing was conducted and documentation provided as recommended by the FDA Guidance Content of Premarket Submissions for Device Software Functions. The software documentation included in the submission was per the Enhanced Documentation Level recommendations.
Mechanical and other testing:
- . Bench testing: dimensional, imaging (visualization, image resolution, on-axis and off-axis resolution), field of view, system latency, camera resolution, temperature of contact points, illumination, tensile strength between components
- . Compatibility: instrument use in instrument channel
- Particulate testing per USP .
- . Sterilization validation to validate a Sterility Assurance Level of 106
- Package integrity and shelf life testing ●
Conclusion:
Based upon the performance data provided in this submission and comparing indications for use, design, materials, principle of operation and overall technical characteristics, the Aurora Surgiscope System has been determined to be substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
October 27, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Rebound Therapeutics Corporation Timothy Connors Senior Manager, Regulatory Affairs 13900 Alton Parkway, Suite 120 Irvine, California 92618
Re: K232618
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 28, 2023 Received: August 29, 2023
Dear Timothy Connors:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for "Adam D. Pierce -S". The date of the signature is October 27, 2023. The time of the signature is 15:14:14 -04'00'.
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
2
Enclosure
3
Indications for Use
510(k) Number (if known) K232618
Device Name Aurora Surgiscope System
Indications for Use (Describe)
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.
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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4
| Submitter Information | |
|---|---|
| Applicant | Rebound Therapeutics Corporation |
| 13900 Alton Parkway, Suite 120 | |
| Irvine, CA 92618 | |
| Owner/Operator | Integra LifeSciences |
| 1100 Campus Road | |
| Princeton, NJ 08540 | |
| Applicant Contact | Timothy Connors, RAC |
| Senior Regulatory Affairs Manager | |
| Phone: 609-325-7161 (cell) | |
| E-mail: timothy.connors@integralife.com | |
| Date Prepared | August 28, 2023 |
| Subject Device Information | |
| Name of Device | Aurora® Surgiscope® System |
| Regulation Number | 21 CFR 882.1480, 21 CFR 882.4800 |
| Regulation Name | Neurological endoscope; Self-retaining retractor |
| for neurosurgery | |
| Regulatory Class | II |
| Product Code | GWG; GZT |
| Predicate Device | Aurora Surgiscope System |
| K201840 | |
| Reference Device | Aurora Surgiscope System |
| K191861 |
510(k) Summary (per 21 CFR 807.92)
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.
5
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 may be used to manually hold 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 sheath, and 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. Two sterile, single use accessories optional for use are provided with the Aurora Surgiscope System: an Irrigation Device and 12 French Suction Device.
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.
Intended Use of the Device
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.
6
| Summary of Technological Characteristics Compared to Predicate Device | |||
|---|---|---|---|
| Subject Device | Predicate Device | Reference Device | |
| 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. | Same | Same, without | |
| "neurosurgery" | |||
| included prior to | |||
| "endoscopic | |||
| neurosurgery" | |||
| Sheath | • OD = 11mm, ID = 8.4mm | ||
| • Lengths: 70, 100 and 130mm | |||
| • Incremental depth markings | |||
| • With obturator | |||
| (conical shape, | |||
| rounded tip) | • OD = 16.2mm, ID = 11mm | ||
| • Lengths: 60 and 80mm | |||
| • Same | |||
| • Same | • OD ≤ 11.5mm, ID = 8mm | ||
| • Lengths: 70, 100 and 130mm | |||
| • Same | |||
| • Same | |||
| Materials | Methyl methacrylate ABS | ||
| (Sheath), Polycarbonate | |||
| (Tab), pad printing ink, | |||
| hardner, and thinner | 6061-T6 Aluminum | ||
| (Sheath and tab) with | |||
| bright dip and clear | |||
| anodization, 17-7 PH | |||
| stainless steel – | |||
| passivated (retaining | Lustran ABS, PET, | ||
| ColorCon No Tox Ink, | |||
| plastic ring mount for | |||
| camera assembly | |||
| ring); cyanoacrylate | |||
| adhesive | |||
| Imager | The device incorporates | ||
| and imaging system with | |||
| camera and optics (lens, | |||
| prism): | |||
| • Direction of View: 0° | |||
| • Depth of field = 0 to 3 cm | Same | Same | |
| Light Source | 2 LED lights, incorporated | ||
| onto Imager, user can vary | |||
| intensity level | 4 LED lights, | ||
| incorporated onto | |||
| Imager, user can vary | |||
| intensity level | 6 LED lights, | ||
| incorporated onto distal | |||
| end of sheath, fixed | |||
| intensity level | |||
| Camera | Integrated CMOS camera | ||
| and electronics | Same | Same | |
| Image Control Box | • Electronics (circuit | ||
| boards, CPU with | |||
| software control) | |||
| • Keypad buttons for | |||
| image adjustment by | |||
| user | • Same | • Equivalent | |
| • Same | |||
| Sterile Accessories | • Irrigation device | ||
| • 12 French Suction | |||
| device | |||
| (Optional for use) | N/A | N/A | |
| Non-sterile | |||
| Accessories | • Power supply and | ||
| cable | |||
| • Display cable | |||
| • Display cable adaptor | Same | Same, without display | |
| cable adaptor | |||
| Display Monitor | Not supplied | Same | Same |
| Access to Surgical | |||
| Site | Sheath and obturator used | ||
| to access the surgical site. | Same | Same | |
| The obturator extends | |||
| 10mm beyond distal end | |||
| of the sheath. | |||
| Single Working | |||
| Channel | Removal of obturator | ||
| reveals working channel | |||
| which provides visual | |||
| access for camera and | |||
| working access for | |||
| instruments including | |||
| suction, bipolar, irrigation | |||
| and tissue removal | |||
| devices. | Same | Same | |
| Image Acquisition | Image acquisition is | ||
| achieved through an | |||
| integrated camera. | Same | Same | |
| Image Processing | Image processing is | ||
| achieved through an | |||
| integrated camera. | Same | Same | |
| Image Display | Image is displayed via | ||
| external display monitor | |||
| connection. | Same | Same | |
| Illumination | Illumination is achieved | ||
| via direct LED light | |||
| sources incorporated into | |||
| the device. | Same | Same | |
| Visualization | CMOS, color, video, | ||
| camera (with software) | |||
| incorporated at proximal | |||
| end of the device and | |||
| controlled via ICB. | Same | Same | |
| Biocompatibility | Surgiscope: demonstrated | ||
| based on externally | Same | Same | |
| communicating device in | |||
| direct contact with | |||
| tissue/bone/dentin for a | |||
| limited duration. | |||
| Use / How Supplied | Surgiscope: single use, | ||
| sterile | |||
| Image Control Box: | |||
| reusable, non-sterile | Same | Same | |
| Sterilization | |||
| Method | Surgiscope: ethylene oxide | ||
| gas | Same | Same | |
| Summary of Non-clinical Testing |
7
8
9
The following testing was conducted to demonstrate substantial equivalence to the predicate device in terms of safety and effectiveness.
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 recommendations of the FDA Guidance FDA Guidance Use of International Standard 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
- Sensitization ●
- Irritation/Intracutaneous Reactivity .
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity ●
- Hemolysis (Indirect) .
The patient contacting components are categorized as:
- Category: External communicating device ●
- Contact: Tissue/bone/dentin
- Contact Duration: Limited (≤ 24 hours) ●
The ICB and non-sterile accessories are not intended to have direct or indirect patient contact.
Electrical safety and electromagnetic compatibility (EMC)
10
Electrical safety and EMC testing were conducted on the fully assembled Aurora Surgiscope System. The system complies with the applicable clauses of IEC 60601-1-2. and IEC 60601-2-18.
Software verification and validation testing
Software testing was conducted and documentation provided as recommended by the FDA Guidance Content of Premarket Submissions for Device Software Functions. The software documentation included in the submission was per the Enhanced Documentation Level recommendations.
Mechanical and other testing
- . Bench testing: dimensional, imaging (visualization, image resolution, on-axis and off-axis resolution), field of view, system latency, camera resolution, temperature of contact points, illumination, tensile strength between components
- . Compatibility: instrument use in instrument channel
- Particulate testing per USP .
- . Sterilization validation to validate a Sterility Assurance Level of 106
- Package integrity and shelf life testing ●
Conclusion
Based upon the performance data provided in this submission and comparing indications for use,
design, materials, principle of operation and overall technical characteristics, the Aurora Surgiscope System has been determined to be substantially equivalent to the predicate device.