The Bone Anchor is intended to be used with commercially available stereotactic systems for intracranial and neurosurgical procedures which require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain, or nervous systems. It is designed to provide short-term fixation and positioning of compatible neurosurgical instruments or accessories under image-guidance.

Device Description

The Bone Anchor is a single-use device for temporary short-term fixation of surgical tools or accessories during a single surgical procedure. The Bone Anchor may be used during image-guided or MR interventional procedures. This device is not intended to create a seal or barrier from potential infection and has not been tested for long-term (>24 hours) use. The Bone Anchor components are listed below along with their function:

Bone Anchor (Skull Device) A device that is inserted into the Skull that is used . to hold an instrument or accessory in place after is it inserted to the desired position. Part of the Skull Fixation Device protrudes from the Skull.
Bone Anchor Driver (Driver) An optional device used to position the Skull . Fixation Device into the skull.
Bone Anchor Silicone Seal A device within the Bone Anchor which is . compressed against the inserted instrument or accessory when the Cap is tightened, thereby holding the instrument or accessory in place.
Bone Anchor Cap A device which connects to the Bone Anchor and, when . tightened, compresses the Silicone Seal against the inserted instrument or accessory.
. Bone Anchor Cover - An optional device which is placed over the Cap when inserting a flexible instrument or other accessory and can be locked into place on the Cap to secure the accessory.

AI/ML Overview

The provided text is a 510(k) summary for the ClearPoint Neuro Bone Anchor, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth for training set) are not available in this document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing for the Bone Anchor and mentions testing for the predicate and reference devices. However, it does not explicitly
state specific acceptance criteria or provide quantitative performance results (e.g., exact load values, push force values, or targeting error measurements) for the Bone Anchor, only noting that "meets all test specifications" for demonstrating substantial equivalence.

Acceptance Criteria Category	Reported Device Performance
Load Testing	Not explicitly stated (Met test specifications)
Push Force Testing	Not explicitly stated (Met test specifications)
Insertion Force Testing	Not explicitly stated (Met test specifications)
Retention Force Testing	Not explicitly stated (Met test specifications)
Removal Force Testing	Not explicitly stated (Met test specifications)
Driver Pull Force Testing	Not explicitly stated (Met test specifications)

Note: The document states that the subject device "meets all test specifications" and performs "as well as the predicate device" but does not provide the numerical values for these specifications or the device's performance against them. Similarly, for the predicate Microtable, it lists "Dimensional Stability" and "Load Testing" but no specifics. For the reference device, it lists the same tests as the subject device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the described performance testing. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The document describes engineering and mechanical performance testing, not a study involving human experts establishing ground truth for clinical data.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human assessment of data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on bench testing and comparison to predicate devices, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a mechanical medical instrument, not an AI algorithm.

7. The Type of Ground Truth Used

For the performance testing mentioned (Load, Push Force, Insertion Force, Retention Force, Removal Force, Driver Pull Force Testing), the "ground truth" would be established by the engineering and mechanical testing standards and methodologies used to evaluate the device's physical properties and functionality. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical instrument and does not involve AI/ML requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no training set for this type of device.

Summary

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April 26, 2024

Image /page/0/Picture/1 description: The image contains 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 design with overlapping human profiles. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

ClearPoint Neuro Inc. Brennan Sullivan Regulatory Affairs Manager 120 S. Sierra Avenue, Suite 100 Solana Beach, California 92075

Re: K233703

Trade/Device Name: Bone Anchor (NGS-BA-01) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: March 27, 2024 Received: March 27, 2024

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).

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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 2024.04.26, and the time is 08:11:29 -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

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K233703

Device Name

Bone Anchor (NGS-BA-01)

Indications for Use (Describe)

The Bone Anchor is intended to be used with commercially available stereotactic systems for intracranial and neurosurqical procedures which require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain, or nervous systems. It is designed to provide short-term fixation and positioning of compatible neurosurgical instruments or accessories under image-guidance.

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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510(k) SUMMARY

510(k) Summary for the ClearPoint Neuro Bone Anchor (per 21CFR 807.87)

3. SUBMITTER/510(K) HOLDER

ClearPoint Neuro, Inc. 120 S. Sierra Ave. Suite 100 Solana Beach, CA 92075 Contact Person: Brennan Sullivan Telephone: 617-678-1028

Date Prepared: March 26, 2024

2. DEVICE INFORMATION

Name of Device:	Bone Anchor
Common or Usual Name:	Stereotaxic Instrument
Classification:	Stereotaxic Instrument
Regulatory Class:	Class II
Product Code	HAW (21 CFR 882.4560)

3. PREDICATE DEVICES

Primary Predicate

FHC Microtable System K132611

Reference Device

SmartFlow Flex Ventricular Catheter (bone anchor component) K123605

4. DEVICE DESCRIPTION

The Bone Anchor components are listed below along with their function:

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Bone Anchor (Skull Device) A device that is inserted into the Skull that is used . to hold an instrument or accessory in place after is it inserted to the desired position. Part of the Skull Fixation Device protrudes from the Skull.
Bone Anchor Driver (Driver) An optional device used to position the Skull . Fixation Device into the skull.
Bone Anchor Silicone Seal A device within the Bone Anchor which is . compressed against the inserted instrument or accessory when the Cap is tightened, thereby holding the instrument or accessory in place.
Bone Anchor Cap A device which connects to the Bone Anchor and, when . tightened, compresses the Silicone Seal against the inserted instrument or accessory.
. Bone Anchor Cover - An optional device which is placed over the Cap when inserting a flexible instrument or other accessory and can be locked into place on the Cap to secure the accessory.

ട. INDICATIONS FOR USE

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Bone Anchor is equivalent in indications and intended use to FHC Microtable System, subject of K132611. The Bone Anchor is also similar in its operational characteristics to the Microtable in that they are used with commercially available Stereotactic Navigation Systems (SNS) to provide fixation and alignment for surgical instruments. Both devices are fixed to the patient's skull and allow for surgical instruments to be pass through the device and into the patient before the instrument can be fixed in place once it reaches the desired target. The devices differ in that the Microtable is a custom device that is manufactured specifically for each patient while the Bone Anchor is a standard device that is not custom-made. Additionally, the Bone Anchor is screwed directly into the patient's skull while the Microtable is affixed to the patient using 3 or more bone screws. These differences do not impact the safety or efficacy of the Bone Anchor when compared to the predicate device.

ClearPoint has manufactured the Bone Anchor as part of another device family, the SmartFlow Flex Ventricular Catheter cleared under K123605 and distributed by Brainlab as Brainlab Flexible Catheter (Model Numbers: 19770, 19771, 19772 and 19773). Therefore, the proposed Bone Anchor is identical to the Bone Anchor that was cleared by the Food and Drug Administration as part of the SmartFlow Flex Ventricular Catheter 510(k) submission, subject of K123605. This device was cleared with a different indication for use from the proposed Bone Anchor. The indications for use are different because the bone anchor is a component of a delivery device; however, the use and functionality are

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identical to that of the proposed Bone Anchor and the Visualase Bone Anchor in that they all provide fixation to the skull and provide both fixation and trajectory for small surgical instruments or accessories, during neurosurgical procedures.

The Bone Anchor is the identical device to the Bone Anchor component of the ClearPoint SmartFlow Flex Ventricular Catheter subject of K123605. The design, materials of manufacture, and dimensions are identical since ClearPoint manufactures this component on behalf of Brainlab (the distributor of the SmartFlow Flex). The proposed Bone Anchor and the predicate Bone Anchor subject of K123605 include the bone anchor, seal, cap, cover, and driver components.

7. CONCLUSION

The ClearPoint Neuro Bone Anchor is substantially equivalent to the primary predicate, MicroTable and reference Bone Anchor component of the SmartFlow Flex Ventricular Catheter devices. The Bone Anchor is the identical device to that which ClearPoint manufactures and supplies as a component to the SmartFlow Flex Ventricular Catheter cleared under K123605 (currently distributed by Brainlab). The Bone Anchor is substantially equivalent to the MicroTable because the subject device raises no new issues of safety and effectiveness, meets all test specifications, and the non-clinical testing performed demonstrates that the subject device is as safe, as effective, and performs as well as the predicate device. Additionally, The Bone Anchor is identical in design and operational and technological characteristics to the SmartFlow Flex Ventricular Catheter Bone Anchor.

The proposed Bone Anchor is identical to the reference Bone Anchor that was part of K123605. In addition, the clinical utility and functionality are similar to the primary predicate Microtable System subject of K132611, and do not raise any new concerns of safety or efficacy. A side-by-side comparison of the subject device to the predicate can be found below in Table 1

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K233703 Page 4 of 6

Characteristic	Subject Device	Primary Predicate	Reference Device	Discussion
	Proposed ClearPoint NeuroBone Anchor	FHCMicrotable Stereotactic SystemK132611	ClearPoint Neuro (manufacturedfor Brainlab)Bone Anchor ComponentSmartFlow Flex VentricularCatheter K123605
Classification	Stereotaxic Instrument21 CFR 882.4560	Stereotaxic Instrument21 CFR 882.4560	Ventricular Catheter21 CFR 882.4100	Identical
Product Code	HAW	HAW	HCA	Identical
Intended use	The Bone Anchor is intendedto provide fixation to the skulland provide both fixation andtrajectory for small surgicalinstruments or accessories,duringneurosurgicalprocedures..	The Microtable System is apatient-specific surgical adapter,designed to be secured on a skull-based anchor mounting set to holdand align surgical instrumentswith patient anatomy and to allowselected targets to be reached withsub-millimeter accuracy.	The SmartFlow Flex VentricularCatheter is intended for injection ofCytarabine or removal of CSF fromthe ventricles during intracranialprocedures. The device is not intendedfor implant. This device is intended forsingle patient use only.	Similar
Indications for Use	The Bone Anchor is intendedto be used with commerciallyavailable stereotactic systemsfor intracranial andneurosurgical procedureswhich require accuratepositioning of compatiblesmall surgical instruments oraccessories in the cranium,brain, or nervous systems. It isdesigned to provide short-termfixation and positioning ofcompatible neurosurgicalinstruments or accessoriesunder image-guidance.	The Microtable StereotacticSystem is intended to be used withcommercially availablestereotactic systems for intra-cranial and neurosurgicalprocedures which require theaccurate positioning ormicroelectrodes, stimulatingelectrodes, or other instruments inthe cranium, brain, or nervoussystems.	The SmartFlow Flex VentricularCatheter is intended for injection ofCytarabine or removal of CSF fromthe ventricles during intracranialprocedures. The bone anchorcomponent provides fixation to theskull for fixation and trajectory ofinstruments or accessories duringneurosurgical procedures.	Similar to primarypredicateFunctionalityidentical toreferencepredicate
Principles of Operation	● A 3.2-3.4 mm access holeis drilled into the patient'sskull.	● Microtable is custom-madefor the patient	● A 3.2-3.4 mm access hole isdrilled into the patient's skull.	Essentiallyidentical

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	• The Bone Anchor ismounted into the accesshole manually or usingthe Driver to keep thebone anchor aligned to thetrajectory guidanceequipment.• An instrument oraccessory is insertedthrough the Bone Anchor.• The Cap is hand tightenedto secure the device.	• Microtable is affixed topatient's skull using bone-mounted anchors• Instrument or accessory isinserted through theMicrotable• Device can be secured using	• The Bone Anchor is mounted intothe access hole manually or usingthe Driver.• The Bone Anchor is screwed intothe skull until it is tight.• An instrument or accessory isinserted through the BoneAnchor.• The Cap is hand tightened tosecure the device.
Where used	MRI Suite/ Surgical Room(OR)	MRI Suite/ Surgical Room (OR)	MRI Suite/ Surgical Room (OR)	Identical
Anatomical Sites	Skull	Skull	Skull	Identical
Design	A bone anchor device that isinserted into the Skull that isused to hold an instrument oraccessory in place after it isinserted to the desiredposition. Components includea bone anchor, driver, siliconeseal, cap and cover.	Microtable System is composedof the following:• Custom-madeMicrotable• Mounting hardware andtools	This kit includes a ventricular catheterand bone anchor device that is insertedinto the Skull to hold an instrument oraccessory in place after is it inserted tothe desired position. Componentsinclude a bone anchor driver, siliconeseal, cap and cover.	Identical toprimary predicateFunctionalityidentical toreferencepredicate
Working Lumen Size	1.8-2.1 mm	N/A, Device is patient-specific	1.8-2.1 mm	Similar
Drill Size	3.2-3.4 mm	N/A, Device is patient-specific	3.2-3.4 mm	Similar
Materials	• Nylon• Silicone• PEEK	Polycarbonate or Ultem	• Nylon• Silicone• PEEK	Similar to primarypredicate.Identical toreferencepredicate.
Performance Testing	• Load Testing• Push Force Testing	• Dimensional Stability• Load Testing	• Load Testing• Push Force Testing	Identical toReference
Insertion Force Testing Retention Force Testing Removal Force Testing Driver Pull Force Testing	Targeting Error	Insertion Force Testing Retention Force Testing Removal Force Testing Driver Pull Force Testing	Predicate, similarto PrimaryPredicate

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K233703 Page 6 of 6

Regulation Number and Section

§ 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).