(351 days)
No
The summary mentions "Image is digitally processed by control unit with software" but does not provide any details suggesting the use of AI/ML algorithms for this processing. The performance studies focus on traditional device verification and validation, not AI/ML model performance metrics.
No.
The device is used for visualization during surgical and diagnostic procedures, but it does not directly perform a therapeutic action itself; it facilitates the use of other tools that may be therapeutic.
Yes
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 the endoscope (light source, camera, HDMI output, irrigation, working channel), and a control module. Performance studies also include hardware-specific testing like dimensional verification, mechanical strength, fluid patency, and electrical safety. While software is mentioned for image processing, it is part of a larger hardware system.
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 device is for "visualization of ventricles and structures within the brain during neurological surgical procedures, diagnostic and/or therapeutic procedures". This describes a device used in vivo (within the body) for direct visualization during a medical procedure.
- Device Description: The description details a neurological endoscope system that provides light, a camera, and video output for visualization. It also mentions irrigation and a working channel for tools. These are all characteristics of a surgical or diagnostic instrument used directly on the patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens.
The device is a surgical endoscope system used for direct visualization during neurological procedures, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Digital ClarusScope System and Digital NeuroPEN System are intended for use in neurosurgery, endoscopic neurosurgery, and ventriculoscopy for visualization of ventricles and structures within the brain during neurological surgical procedures, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
Product codes
GWG
Device Description
The Digital ClarusScope System and Digital NeuroPEN System are neurological endoscopes which provide a light source, camera, and HDMI output for visualization. Irrigation is provided for flushing during the procedure. The working channel facilitates the use of tools necessary for neurological procedures (Digital ClarusScope versions only). The Digital ClarusScope and Digital NeuroPEN are intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital ClarusScope and Digital NeuroPEN terminate in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a standard off-the-shelf HDMI video monitor which is not provided by Clarus and is not part of this 510(k) application: the other fitting is an irrigation extension tube with a female Luerlock connector.
The Digital ClarusScope is a sterile, single use, neurological endoscope with a distal tip camera, light source, irrigation channel and working channel. The Digital ClarusScope is intended to be used with the non-sterile, reusable video Digital Control Module with standard HDMI output. The proximal end of the Digital ClarusScope terminates in two fittings: the endoscope connector attaches to the Digital Control Module, which interfaces to an HDMI monitor; the other fitting is an irrigation extension tube with a female Luerlock connector.
The Digital NeuroPEN is a sterile, single use, neurological endoscope with a distal tip camera, light source, and irrigation channel. The NeuroPEN is intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital NeuroPEN terminates in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a standard HDMI video monitor; the other fitting is an irrigation extension tube with a female Luer lock connector.
The Digital Control Module is powered by a medical grade DC power adapter provided with the system. The video image captured from the endoscope is transferred through the Digital Control Module and is output using a standard HDMI video cable which connects to a standard video monitor providing a digital image. The Digital Control Module provides controls for variable illumination level with level indicator along with control for white balance and system.
Mentions image processing
Image is digitally processed by control unit with software
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Distal tip CMOS, color, video, camera
Anatomical Site
ventricles and structures within the brain
Indicated Patient Age Range
adult patients.
Intended User / Care Setting
used by a physician in a healthcare facility
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 Digital ClarusScope, Digital NeuroPEN, and Digital Control Module have been thoroughly tested through verification of product specifications and user requirements. The following quality assurance and performance measures were applied during the development of the systems:
- Requirements/Specification Reviews
- Design Reviews
- Performance Testing (Verification):
- Endoscope dimensional verification
- Mechanical strength requirements
- Functional Tests
- Endoscope fluid patency
- System image output
- Simulated Use Test
- Interconnection testing between endoscope and control module and accessories
- Compatibility with introducer
- Compatibility of endoscope working channel with accessory devices
Non-clinical testing included:
- Sterility: ETO Sterilization Validated per ISO 11135-1, Shelf-Life per ASTM F1980, Environmental Conditioning per ASTM D4332, Distribution per ASTM D4169
- Biocompatibility per ISO 10993-1: Cytotoxicity (MEM Elution), Sensitization (Kligman Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection), Hemolysis (In direct), Materials Mediated Pyrogenicity
- Electrical Safety and Electromagnetic Compatibility: Particular Safety of Endoscopic Equipment per IEC 60601-2-18, Basic safety and Essential Performance per IEC 60601-1, Electromagnetic Immunity and Emissions per IEC 60601-1-2
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
November 21, 2023
Image /page/0/Picture/1 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Clarus Medical, LLC Mark Brown Director of Operations 13355 10th Avenue N Suite 110 Plymouth, Minnesota 55441
Re: K223615
Trade/Device Name: Digital ClarusScope System Digital NeuroPEN System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: October 20, 2023 Received: October 23, 2023
Dear Mark Brown:
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"
1
(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).
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 OS 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.
Adam D. Digitally signed by Pierce -> 08:46:56-05'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional
2
and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K223615
Device Name Digital ClarusScope System Digital NeuroPEN System
Indications for Use (Describe)
The Digital ClarusScope System and Digital NeuroPEN System are intended for use in neurosurgery, endoscopic neurosurgery, and ventriculoscopy for visualization of ventricles and structures within the brain during neurological surgical procedures, 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) |
|---|
| [x] Prescription Use (Part 21 CFR 801 Subpart D) |
| [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
A. General Information:
Submitter:
Clarus Medical, LLC 13355 10th Ave North Minneapolis, MN 55441 763-525-8403
Establishment Number:
Contact:
2183911
Mark F. Brown Director of Operations mbrown@clarus-medical.com
November 16, 2023
Date Prepared:
B. Trade Name:
Common Name: Product Code: Requlation Number: Regulation Name: Class:
C. Predicate Device:
Endoscope, Neurological GWG 21 CFR 882.1480 Neurological endoscope ll
Digital ClarusScope System Digital NeuroPEN System
| (k) Number | Description |
|---|---|
| K945633 | Clarus Model 2232 Neuro Channel Scope |
D. Reference Devices:
510 P
| 510(k) Number | Description |
|---|---|
| K942249 | Clarus NeuroPEN Endoscopes |
| K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System |
E. Device Description:
System level description;
The Digital ClarusScope System and Digital NeuroPEN System are neurological endoscopes which provide a light source, camera, and HDMI output for visualization. Irrigation is provided for flushing during the procedure. The working channel facilitates the use of tools necessary for neurological procedures (Digital ClarusScope versions only). The Digital ClarusScope and Digital NeuroPEN are intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital ClarusScope and Digital NeuroPEN terminate in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces
5
to a standard off-the-shelf HDMI video monitor which is not provided by Clarus and is not part of this 510(k) application: the other fitting is an irrigation extension tube with a female Luerlock connector.
The Digital ClarusScope Model number: 2100-500
Description: The Digital ClarusScope is a sterile, single use, neurological endoscope with a distal tip camera, light source, irrigation channel and working channel. The Digital ClarusScope is intended to be used with the non-sterile, reusable video Digital Control Module with standard HDMI output. The proximal end of the Digital ClarusScope terminates in two fittings: the endoscope connector attaches to the Digital Control Module, which interfaces to an HDMI monitor; the other fitting is an irrigation extension tube with a female Luerlock connector.
The Digital NeuroPEN Model number: 2120-515
Description: The Digital NeuroPEN is a sterile, single use, neurological endoscope with a distal tip camera, light source, and irrigation channel. The NeuroPEN is intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital NeuroPEN terminates in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a standard HDMI video monitor; the other fitting is an irrigation extension tube with a female Luer lock connector.
The Digital Control Module Model number: 5190-500
Description: The Digital control Module is powered by a medical grade DC power adapter provided with the system. The video image captured from the endoscope is transferred through the Digital Control Module and is output using a standard HDMI video cable which connects to a standard video monitor providing a digital image. The Digital Control Module provides controls for variable illumination level with level indicator along with control for white balance and system.
F. Indications For Use:
The Digital ClarusScope System and Digital NeuroPEN System are intended for use in neurosurgery, endoscopic neurosurgery, and ventriculoscopy for visualization of ventricles and structures within the brain during neurological surgical procedures, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
G. Comparison to Predicate and reference Devices:
The Digital ClarusScope System and Digital NeuroPEN System are substantially equivalent to the predicate devices in terms of design, materials, and performance. The
6
predicate and subject devices have similar indications and very similar construction.
Differences in Indications for Use:
The Indications for Use are similar to the predicate device. The endoscopes are used for visualization, diagnostic and/or therapeutic procedures of structures within the brain during neurological surgical procedures.
Comparison of technological characteristics:
| Subject Device | Predicate Device | Reference Device | Reference Device | |
|---|---|---|---|---|
| Device Name | Digital ClarusScope | |||
| System and Digital | ||||
| NeuroPEN System | Clarus Model 2232 | |||
| Neuro Channel | ||||
| Scope | Clarus NeuroPEN | |||
| Endoscopes | KARL STORZ | |||
| Flexible Video- | ||||
| Neuro-Endoscope | ||||
| System | ||||
| 510(k) | K223615 | K945633 | K942249 | K161112 |
| Product | ||||
| code | GWG | GWG | GWG | GWG |
| Indication | ||||
| for use | The Digital ClarusScope | |||
| System and Digital | ||||
| NeuroPEN System are | ||||
| intended for use in | ||||
| neurosurgery, | ||||
| endoscopic | ||||
| neurosurgery, and | ||||
| ventriculoscopy for | ||||
| visualization of ventricles | ||||
| and structures within the | ||||
| brain during neurological | ||||
| surgical procedures, | ||||
| diagnostic and/or | ||||
| therapeutic procedures | ||||
| such as | ||||
| ventriculostomies, | ||||
| biopsies and removal of | ||||
| cysts, tumors and other | ||||
| obstructions. | The Model 2232 is | |||
| intended as both a | ||||
| diagnostic instrument | ||||
| to visualize the | ||||
| intracranial space | ||||
| and the surrounding | ||||
| tissues of the brain, | ||||
| and to allow the | ||||
| passage of surgical | ||||
| instruments. | The Clarus NeuroPEN | |||
| and Channel Scope | ||||
| endoscopes is | ||||
| intended for accessing | ||||
| and visualizing nerves, | ||||
| neural tissue and | ||||
| surrounding tissue | ||||
| where cerebrospinal | ||||
| fluid (CSF) may be | ||||
| contacted during | ||||
| neurosurgical | ||||
| (including intracranial) | ||||
| procedures. The | ||||
| endoscope is passively | ||||
| deflectable and has an | ||||
| irrigation channel for | ||||
| sterile fluid flush. | The KARL STORZ | |||
| Flexible Video-Neuro- | ||||
| Endoscope System is | ||||
| indicated to provide | ||||
| visualization and access | ||||
| during cranial | ||||
| diagnostic and | ||||
| therapeutic | ||||
| procedures such as | ||||
| tumor biopsy and | ||||
| resection, | ||||
| hydrocephalus | ||||
| treatment, endoscopic | ||||
| third | ||||
| ventriculostomy | ||||
| with choroid | ||||
| plexus | ||||
| cauterization | ||||
| (ETV/CPC), | ||||
| endoscopic third | ||||
| ventriculostomy, | ||||
| cyst fenestration, | ||||
| and aqueduct | ||||
| exploration. | ||||
| Type of | ||||
| scope | Digital ClarusScope: | |||
| Rigid | ||||
| Digital NeuroPEN: | ||||
| passively deflective | rigid | passively deflective | flexible | |
| 510(K) Summary | ||||
| Insertion | ||||
| shaft | ||||
| diameter | 4.2mm Digital | |||
| ClarusScope | ||||
| 1.14mm Digital NeuroPEN | 3.5 to 4.2 mm | 1.14mm | 3.2mm x 2.4mm | |
| Insertion | ||||
| Shaft | ||||
| Length | 13cm Digital ClarusScope | |||
| 15.5cm Digital NeuroPEN | 13.0cm and 21.6cm | 15.5cm and 19.0cm | ||
| (NeuroPEN) | 35 cm | |||
| Light | ||||
| source | External LED (intensity | |||
| adjustable) | same | External Xenon bulb | ||
| (intensity adjustable) | External light source | |||
| Image | ||||
| acquisition | Distal tip CMOS, color, | |||
| video, camera | Lens and imaging | |||
| fiberoptics at distal tip | Lens and imaging | |||
| fiberoptics at distal tip | Distal tip CMOS, color, | |||
| video, camera | ||||
| Image | ||||
| processing | Image is digitally | |||
| processed by control unit | ||||
| with software | none | none | Image is digitally | |
| processed by control | ||||
| unit | ||||
| with software | ||||
| Image | ||||
| display | External display monitor | |||
| connection | External display with | |||
| camera system or | ||||
| viewed through | ||||
| eyepiece | External display with | |||
| camera system or | ||||
| viewed through | ||||
| eyepiece | External display monitor | |||
| connection | ||||
| Sterile | EO | same | same | same |
| Use | Single Use | same | same | same |
| Image | ||||
| control Box | Electronics (Circuit | |||
| boards, CPU with | ||||
| firmware control), Keypad | ||||
| buttons for illumination | ||||
| adjustment by user | none | none | same |
7
8
H. Non-Clinical Performance Data:
The Digital ClarusScope, Digital NeuroPEN, and Digital Control Module have been theroughly tested through verification of product specifications and user requirements. The following quality assurance and performance measures were applied during the development of the systems:
- Requirements/Specification Reviews ●
- Design Reviews ●
- Performance Testing (Verification):
- Endoscope dimensional verification
- o Mechanical strength requirements
- Functional Tests
- Endoscope fluid patency o
- O System image output
- Simulated Use Test
- o Interconnection testing between endoscope and control module and accessories
- Compatibility with introducer O
- Compatibility of endoscope working channel with accessory devices O
Sterility
- . ETO Sterilization Validated per ISO 11135-1
- Shelf-Life per ASTM F1980
- Environmental Conditioning per ASTM D4332
- Distribution per ASTM D4169 ●
Biocompatibility per ISO 10993-1
- Cytotoxicity (MEM Elution) ●
- Sensitization (Kligman Maximization)
- Irritation (Intracutaneous Injection) ●
- Systemic Toxicity (Systemic Injection) ●
- Hemolysis (In direct)
- Materials Mediated Pyrogenicity
Electrical Safety and Electromagnetic Compatibility
- Particular Safety of Endoscopic Equipment per IEC 60601-2-18 ●
- Basic safety and Essential Performance per IEC 60601-1 ●
- Electromagnetic Immunity and Emissions per IEC 60601-1-2 ●
9
-Comparison to Predicate and reference devices:
The Digital ClarusScope System and Digital NeuroPEN System are substantially equivalent to the predicate based on the following technological elements:
-
. Design: The construction of the subject device, predicate, and the reference devices are similar with the addition of a distal tip imaging device in the subject device. The subject device also makes use of a control box to allow for light output and white balance adjustment.
The Karl Storz reference device uses the same CMOS distal tip imaging technology with digital control box as the subject device. -
Materials: The materials of the subject device, and references are very similar medical grade stainless steel and or plastics.
-
Environment of Use: The subject device, predicate, and reference devices must be used by a physician in a healthcare facility.
-
Patient Population: The patient populations are the same as the predicate and ● reference devices, namely, adult patients.
The following technological differences exist between the subject and predicate devices:
The construction of the subject device and the predicate are the same with the addition of a distal tip camera in the subject device. The subject device also makes use of a control box to allow for light output and white balance adjustment.
Substantial Equivalence Conclusion:
Clarus Medical has demonstrated through performance testing, design and non-clinical testing that the proposed subject device and the predicate device have been found to be substantially equivalent.