(107 days)
Not Found
No
The description focuses on optical tracking and geometric recognition for navigation and registration, with no mention of AI or ML algorithms for image processing, analysis, or decision-making.
No.
The device is used for patient registration and navigation, not for treating a disease or condition.
No
The device description indicates it is an "optical tracker" and "optical navigation wand" used for patient registration and navigation, and to align surgical systems. It does not mention any diagnostic functions such as detecting, identifying, or characterizing a disease or condition.
No
The device description explicitly lists multiple hardware components included with the device, such as the optical tracker, pointer attachment, reference array bracket arm, torx screwdriver, and reflective spheres.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for patient registration and navigation in conjunction with a stereotactic system and optical navigation system. This is a surgical guidance and navigation tool, not a test performed on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details an optical tracker and pointer used for aligning surgical equipment and image registration. It does not mention any components or processes related to analyzing biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of blood, urine, tissue, or other biological samples
- Diagnosis, monitoring, or screening of diseases based on biological markers
The device is clearly intended for use during a surgical procedure to aid the surgeon in navigating and targeting within the brain, based on pre-operative imaging. This falls under the category of surgical navigation or guidance systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ClearPointer is intended to be used in conjunction with the SmartFrame OR System and a compatible stereotactic optical navigation system for patient registration and navigation.
Product codes
HAW
Device Description
The ClearPointer Optical Navigation Wand is an optical tracker intended to be used with the SmartFrame OR Stereotactic System and ClearPoint Bone Screw Fiducials, both of which are subject of pending 510(k) submission. The ClearPointer is used in conjunction with a Medtronic StealthStation Navigation System to align the SmartFrame OR tower to the desired target. It is composed of 4 optical spheres and utilizes a sphere positional geometry that is recognizable by the Medtronic StealthStation S8 Optical navigation System. It is equipped with a Pointer attachment to allow for image registration and entry point location. The Pointer Attachment can also be removed from the Optical Tracker component, so that the Tracker can be mounted to a SmartFrame OR. The SmartFrame OR Hardware Kit is provided with the following components:
- 1x ClearPointer™ ●
- 1x Pointer Attachment ●
- 1x Reference Array Bracket Arm ●
- 1x Torx Screwdriver ●
- 10x Reflective Spheres
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The ClearPointer is intended for use by a Neurosurgeon in a standard operating room environment to place and orient the SmartFrame OR Tower towards a target in the brain along a planned trajectory during stereotactic functional neurosurgical procedures.
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)
Bench testing was performed to demonstrate that the ClearPointer is safe and effective for its intended use. Design Verification testing was performed to confirm that the ClearPointer meets all design specifications. These tests included verification of physical, performance, and safety requirements, as well as benchtop accuracy testing. Accuracy testing was performed by measuring instrument error and registration error of a simulated workflow with Stealthstation S8 software.
Key results:
- Instrument Error: 0.11 – 0.30 mm
- Registration Error: 0.2 – 0.6 mm
Risk analysis was also performed with mitigation of all identified risks to acceptable levels.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
January 12, 2024
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 & 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 ADMINISTRATION" in blue text.
ClearPoint Neuro, Inc. Brennan Sullivan Regulatory Affairs Manager 120 S. Sierra Avenue, Suite 100 Solana Beach, California 92075
Re: K233155
Trade/Device Name: ClearPointer Optical Navigation Wand Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 8, 2023 Received: December 11, 2023
Dear Brennan Sullivan:
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).
Sincerelv.
Image /page/1/Picture/6 description: The image shows a digital signature. The name "Adam D. Pierce -S" is written on the left side of the image and also appears as the signer on the right side. The date of the signature is 2024.01.12, and the time is 08:21:19 -05'00'.
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233155
Device Name ClearPointer Optical Navigation Wand
Indications for Use (Describe)
The ClearPointer is intended to be used in conjunction with the SmartFrame OR System and a compatible stereotactic optical navigation system for patient registration and navigation.
| 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
510(k) Summary
A. Device Information
| Category | Comments |
|---|---|
| Sponsor: | ClearPoint Neuro, Inc. |
| 6349 Paseo Del Lago | |
| Carlsbad, CA 92011 | |
| Correspondent Contact | |
| Information: | Brennan Sullivan |
| 120 S. Sierra Ave. | |
| Solana Beach, CA 92075 | |
| 617-678-1028 | |
| bsullivan@clearpointneuro.com | |
| Device Common Name: | Neurological Stereotactic Instrument |
| Device Regulation & Name: | Neurological Stereotaxic Instrument, 21CFR |
| 882.4560 | |
| Classification & Product Code: | Class II |
| HAW | |
| 510(k) Number: | K233155 |
| Device Proprietary Name: | ClearPointer Optical Navigation Wand |
Primary Predicate Device Information:
| Predicate Device: | NexProbe Image-Guided Probe
(Navigus Passive Probe, Model NP-1000) |
|----------------------------------------------------|-----------------------------------------------------------------------|
| Predicate Device Manufacturer: | Medtronic, Inc. |
| Predicate Device Common Name: | Neurological Stereotactic Instrument |
| Predicate Device Premarket Notification # | K040334 |
| Predicate Device Classification & Name | Neurological Stereotaxic Instrument,
21CFR 882.4560 |
| Predicate Device Classification &
Product Code: | Class II
HAW |
B. Date Summary Prepared
December 8, 2023
C. Description of Device
The ClearPointer Optical Navigation Wand is an optical tracker intended to be used with the SmartFrame OR Stereotactic System and ClearPoint Bone Screw Fiducials, both of which are subject of pending 510(k) submission. The ClearPointer is used in conjunction with a Medtronic StealthStation Navigation System to align the SmartFrame OR tower to the desired
5
ClearPoint Neuro, Inc. ClearPointer
target. It is composed of 4 optical spheres and utilizes a sphere positional geometry that is recognizable by the Medtronic StealthStation S8 Optical navigation System. It is equipped with a Pointer attachment to allow for image registration and entry point location. The Pointer Attachment can also be removed from the Optical Tracker component, so that the Tracker can be mounted to a SmartFrame OR. The SmartFrame OR Hardware Kit is provided with the following components:
- 1x ClearPointer™ ●
- 1x Pointer Attachment ●
- 1x Reference Array Bracket Arm ●
- 1x Torx Screwdriver ●
- 10x Reflective Spheres
D. Indications for Use
The ClearPointer is intended to be used in conjunction with the SmartFrame OR System and a compatible stereotactic optical navigation system for patient registration and navigation.
E. Comparison of Technological Characteristics
The ClearPointer is substantially equivalent to the predicate device NexProbe, subject of K040334. The devices are similar in design in that they consist of a consist of a reference frame in a similar geometry and are assembled with 4 optical tracking spheres. They can both be attached to a stereotactic frame for registration and alignment using the Medtronic StealthStation Software and they utilize similar workflows to achieve alignment.
The differences between the devices primarily relate to the difference in stereotactic frame with which they are compatible. The ClearPointer is intended to be used with the ClearPoint SmartFrame OR System and the NexProbe is intended to be used with NexFrame. Any differences between the ClearPointer and NexProbe do not present any additional risks of safety or efficacy.
| | ClearPointer | NexProbe® Image-Guided
Probe
(Navigus Passive Probe,
Model NP-1000) | Comparison
on |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Classification | 21CFR 882.4560 | 21CFR 882.4560 | Identical |
| Product Code | HAW | HAW | Identical |
| | NexProbe® Image-Guided | | |
| | | Probe | Comparis |
| | ClearPointer | (Navigus Passive Probe,
Model NP-1000) | on |
| Indications for
Use | The ClearPointer is intended to be
used in conjunction with the
SmartFrame OR System and a
compatible stereotactic optical
navigation system for patient
registration and navigation. | The Navigus Passive Probe is
intended to be used in
conjunction with the Navigus
family of trajectory guides and
the Medtronic StealthStation®
Treatment Guidance System for
patient registration and
navigation. The device is
provided sterile and for single
use | Identical |
| Intended Use | The ClearPointer is intended for
use by a Neurosurgeon in a
standard operating room
environment to place and orient the
SmartFrame OR Tower towards a
target in the brain along a planned
trajectory during stereotactic
functional neurosurgical
procedures. | The NexProbe Image-guided
Probe is intended for use by a
Neurosurgeon in a standard
operating room environment to
place and orient the Nexframe
Tower towards a target in the
brain along a planned trajectory
during stereotactic functional
neurosurgical procedures. | Identical |
| Materials | Titanium Ti 6Al-4V
Silicone
PEEK
Nylon
370HR composite
20% Glass-filled polycarbonate | Polymer material
Stainless Steel | Similar |
| Components | ClearPointer Optical Tracker
Pointer Attachment
Optical Tracker Reflective Spheres
Reference Array Bracket Arm
T8 Torx Screwdriver | NexProbe subassembly
11.5mm passive spheres | Similar |
| Compatibility | Medtronic StealthStation S8
O-Arm® Registration
PointMerge Registration | Medtronic StealthStation S8
O-Arm® Registration
PointMerge Registration | Identical |
| Single Use or
Reusable | Single-Use | Single-use | Identical |
| Sterile? | EtO Sterilized | Sterile | Identical |
Table 1: Side-by-side comparison of ClearPointer with Predicate Device
6
ClearPoint Neuro, Inc. ClearPointer
F. Bench Testing
ClearPoint Neuro has performed extensive testing to demonstrate that the ClearPointer is safe and effective for its intended use. The development of the ClearPointer was conducted in conformance with the company's design control procedures. Design inputs provided the requirements for the respective product specifications. Design Verification testing was performed to confirm that the ClearPointer meets all design specifications. These tests included
7
ClearPoint Neuro, Inc. ClearPointer
verification of physical, performance, and safety requirements, as well as benchtop accuracy testing. Accuracy testing was performed by measuring instrument error and registration error of a simulated workflow with Stealthstation S8 software. The results are summarized in Table 2 below:
| Test | Error |
|---|---|
| Instrument Error | 0.11 – 0.30 mm |
| Registration Error | 0.2 – 0.6 mm |
Table 2: ClearPointer Accuracy Results
Risk analysis was also performed with mitigation of all identified risks to acceptable levels.
G. Conclusion
The subject ClearPointer and the predicate Medtronic NexProbe have identical indications for use and similar technological characteristics and principles of operation. ClearPoint Neuro has performed extensive bench testing to demonstrate that the differences between ClearPointer and the predicate device do not raise any risks of safety or efficacy. ClearPointer has been demonstrated to meet all test specifications and has been shown to be as safe, as effective, and to perform as well as the predicate device.