ClearPoint Bone Screw Fiducials

{0}------------------------------------------------ January 12, 2024 Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and 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: K233144 Trade/Device Name: ClearPoint Bone Screw Fiducials 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 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, Image /page/1/Picture/6 description: The image shows the text "Adam D. Pierce -S" in a large, clear font. The text is arranged vertically, with "Adam D." on the top line and "Pierce -S" on the bottom line. The text appears to be part of a larger document or image, as there is additional text to the right that is partially visible. Digitally signed by Adam D. Pierce -S Date: 2024.01.12 16:44:57 -05'00' Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological {2}------------------------------------------------ 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) K233144 Device Name ClearPoint Bone Screw Fiducials Indications for Use (Describe) The ClearPoint Bone Screw Fiducials are intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 510(k) SUMMARY ## 510(k) Summary for the ClearPoint Neuro ClearPoint Bone Screw Fiducials (per 21CFR 807.87) #### 1. SUBMITTER/510(K) HOLDER ClearPoint Neuro, Inc. 120 S. Sierra Ave. Suite 100 Solana Beach, CA 29075 Contact Person: Brennan Sullivan Telephone: 617-678-1028 Date Prepared: January 11, 2024 #### 2. DEVICE INFORMATION | Name of Device: | ClearPoint Bone Screw Fiducials | |-----------------------|-----------------------------------------------------| | Common or Usual Name: | Bone Screw Fiducials | | Classification: | Neurological Stereotaxic Instrument, 21CFR 882.4560 | | Regulatory Class: | Class II | | Product Code | HAW | #### 3. PREDICATE DEVICE - Medtronic Unibody Bone Fiducials K033619 #### 4. DEVICE DESCRIPTION The ClearPoint Bone Screw Fiducials are titanium bone screw fiducials that provide fixed reference points during neurosurgical procedures. The ClearPoint Bone Screw Fiducial Kit is provided sterile and is composed of the following: - 5x - ClearPoint Bone Screw Fiducials - 1x Bone Screw Fiducial holder ● - 1x Screwdriver ● The Bone Screw Fiducial is made of titanium and comprised of a threaded portion that is screwed into a patient's skull and a non-threaded, exposed length that protrudes from the patient's head. The head contains a feature for compatibility with a T8 Torx screwdriver {5}------------------------------------------------ and small divot positioned at the center of the spherical head which is used to center the pointer tip of a navigation tool. The Bone Screw Holder is intended to assist in holding the Bone Screw Fiducials securely to the screwdriver during anchoring. This is accomplished by allowing the screwdriver to mate with the Bone Screw Fiducial without the Bone Screw Fiducial separating from the assembly therefore allowing it to be anchored to the skull. #### న. INDICATIONS FOR USE The ClearPoint Bone Screw Fiducials are intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging. #### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6. The ClearPoint Bone Screw Fiducials are substantially equivalent to the predicate device MedTronic UniBody Bone Fiducials, subject of K033619. They are identical in indications for use and both the proposed ClearPoint Bone Screw Fiducials and the predicate are bone screw fiducials made out of titanium. The devices are both comprised of a threaded portion that is screwed into a patient's skull and non-threaded, exposed length that protrudes from the patient's head and is topped by a rounded, spherical head. The top of the head of both devices is equipped with a feature for compatibility with a screwdriver. Both the subject device and the predicate are placed orthogonally into the patient's skull prior to CT-imaging to serve as fixed reference points for registration. They are both visible under CT and a minimum of 4 of each are required for proper registration. The difference between the ClearPoint Bone Screw Fiducials and the Unibody Bone Fiducials are minor design differences to the dimensions and the screwdriver compatibility. These differences do no introduce any risks of safety or efficacy. Table 12-1 provides a side-by-side comparison of the ClearPoint Bone Screw Fiducials to the Unibody Bone Fiducials. | | ClearPoint Bone Screw Fiducials | Medtronic Unibody Bone Fiducials<br>(Navigus Unibody Fiducial Marker<br>System)<br>K033619 | Comparison | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Classification | 21 CFR 882.4560 | 21CFR 882.4560 | Identical | | Product Code | HAW | HAW | Identical | | Device<br>Description | The ClearPoint Bone Screw<br>Fiducials are titanium bone screw<br>fiducials that are anchored directly to<br>the patient's head and are used as a<br>fixed reference point to register a<br>pre-operative image to the optical<br>navigation system | The Medtronic Unibody Bone<br>Fiducials are titanium bone screw<br>fiducials anchored directly to a<br>patient's head and are used as fixed<br>reference points for presurgery CT<br>imaging for patients requiring<br>stereotactic surgery. | Identical | | Indications for<br>Use | The ClearPoint Bone Screw<br>Fiducials are intended to provide<br>fixed reference point(s) in patients | The Navigus Unibody Fiducial Marker<br>System is intended to provide fixed<br>reference point(s) in patients requiring | Identical | | Table 5-1: Side-by-side comparison of ClearPoint Bone Screw Fiducials with Predicate | | | | |--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | | | | | | ClearPoint Bone Screw Fiducials | Medtronic Unibody Bone Fiducials<br>(Navigus Unibody Fiducial Marker<br>System)<br>K033619 | Comparison | | | requiring stereotactic surgery in<br>conjunction with CT imaging. | stereotactic surgery in conjunction<br>with CT imaging. | | | Principle of<br>Operation | A minimum of five locations for<br>placement of the bone fiducials<br>should be chosen. The locations<br>should cover the entire cranium<br>and be noncoplanar. Bone fiducials are inserted into<br>the bone screw holder. The bone<br>screw holder is positioned and<br>held to ensure the bone fiducial<br>is placed orthogonally to the<br>skull surface. Using a manual or powered<br>screwdriver the ClearPoint<br>Bone Screw Fiducial is driven<br>until it is flush with the skull. This is repeated for the<br>remaining bone fiducials. A manual screwdriver is used to<br>ensure each bone fiducial is<br>fully seated. CT imaging can then be<br>performed to acquire the<br>patient's CT scans | A minimum of four locations for<br>placement of the bone fiducials<br>should be chosen. The locations<br>should cover the entire cranium<br>and be noncoplanar. Bone fiducials are inserted through<br>a screwdriver guide sleeve. The<br>guide sleeve is positioned and held<br>to ensure the bone fiducial is placed<br>orthogonally to the skull surface. Using a powered screwdriver with<br>the bone fiducial is driven until it is<br>flush with the skull. This is repeated for the remaining<br>bone fiducials. A manual screwdriver used to<br>ensure each bone fiducial is<br>fully seated. A protective cap is inserted over<br>each bone fiducial. CT imaging can then be<br>performed to acquire the<br>patient's CT scans. | Similar | | Length | 17 mm | 7 mm<br>10 mm<br>13 mm | Different | | Screw Head | Torx | 1.6-mm cross-type blade t | Different | | Materials | Bone Fiducials - Titanium<br>Bone Screw Fiducial Holder -<br>Polycarbonate<br>Screwdriver - Titanium, ABS &<br>Nylon | Bone Fiducials – Titanium<br>Protective Caps – Thermo-plastic<br>Screwdriver Guide - Polycarbonate | Similar | | Biocompatibility | Yes | Yes | Identical | | Sterile | Yes | Yes | Identical | | Single Use | Yes | Yes | Identical | {6}------------------------------------------------ #### 7. BENCH TESTING ClearPoint Neuro has performed extensive verification testing to demonstrate that the ClearPoint Bone Screw Fiducials are as safe and effective for its intended use as the predicate device. The development of the subject device 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 relative to these specifications. These tests included verification of physical, performance, and safety requirements, as well as simulated workflow testing for usability and effectiveness. The {7}------------------------------------------------ results from all testing demonstrated that the ClearPoint Bone Screw Fiducials comply with all design and performance specifications. Risk analysis was performed with mitigation of all identified risks to acceptable levels. The tests and risk analysis demonstrated that the ClearPoint Bone Screw Fiducials function as intended and are substantially equivalent to the legally marketed Medtronic Unibody Bone Fiducials. #### 8. CONCLUSION The subject ClearPoint Bone Screw Fiducials and the predicate Unibody Bone Fiducials 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 ClearPoint Bone Screw Fiducials and the predicate device do not raise any risks of safety or efficacy. ClearPoint Bone Screw Fiducials have 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.