(107 days)
The SmartFrame OR is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction.
The SmartFrame OR is a hardware-only precision trajectory aiming device for procedures conducted entirely in the traditional operating room and in conjunction with commercially available optical navigation systems such as Medtronic Stealth Station S8, or functionally equivalent optical navigation systems.
The SmartFrame OR Stereotactic System tower consists of three assemblies. The reference bracket arm attaches to the skull mount and the trajectory aiming tower is attached to the mount once it is affixed to the patient skull. The ring assembly of the base is attached to the patient's skull. The socket assembly fits over the two retaining blocks on the ring assembly and is secured with the tower thumbscrews.
The SmartFrame OR Kit consists of the following Components:
- 1x SmartFrame OR Tower ●
- 1x Device Guide, 2.1mm
- 1x Centering Ring ●
- 1x Dock ●
- 1x Lock
- 1x Lock (2.1mm) ●
- 1x SNS Thumb Wheel Extension ●
- . 1x Thumb Screw Pack
The plastic tower assembly is designed to provide multi-directional orientation adjustments to the Device Guide, which is a guide tube encased in the center of the tower assembly. The Device Guide has a 14-gauge central lumen through which a peel away sheath can be placed and oriented.
The tower, when attached to the base assembly, provides adjustments in the roll, pitch, x, and y directions by turning the appropriate thumb wheels. The thumb wheels on the SMARTFrame are used to maneuver the Device Guide by either direct or indirect physician contact.
Acceptance Criteria & Device Performance:
The primary acceptance criterion for the SmartFrame OR device appears to be its targeting accuracy, both in terms of positional error and trajectory angle error, as compared to the predicate device, Medtronic NexFrame.
Here's a table summarizing the reported device performance against implicitly accepted criteria derived from the predicate device's performance:
| Metric | Acceptance Criteria (based on Predicate - Medtronic NexFrame) | Reported Device Performance (SmartFrame OR) |
|---|---|---|
| Positional Error (Mean) | ≤ 1.48 mm | 1.36 mm |
| Positional Error (99% CI Upper Bound) | Not explicitly stated for predicate, but SmartFrame OR's value (1.57 mm) needs to be acceptable | 1.57 mm |
| Trajectory Angle Error (Mean) | Not explicitly stated for predicate | 0.67 degrees |
| Trajectory Angle Error (99% CI Upper Bound) | Not explicitly stated for predicate | 0.92 degrees |
Study Details:
-
Table of Acceptance Criteria and Reported Device Performance: This has been provided above. The implied acceptance criteria for positional error is that the SmartFrame OR's performance should be at least as good as, if not better than, the predicate device (Medtronic NexFrame). The document states that the NexFrame's targeting accuracy is ±1.48 mm. The SmartFrame OR's mean positional error of 1.36 mm and 99% CI upper bound of 1.57 mm (after adding a 0.25mm measurement tool differential) suggests it performs comparably or better, meeting the implicit acceptance. For trajectory angle error, no direct predicate comparison is given in the table, but the reported values suggest the device performs within acceptable limits for its intended use.
-
Sample Size Used for the Test Set and Data Provenance: The document does not explicitly state the sample size used for the benchtop accuracy testing. The provenance of the data is from bench testing conducted by ClearPoint Neuro, Inc., the device manufacturer. It is a controlled, prospective study in a laboratory setting, not real-world patient data.
-
Number of Experts Used to Establish Ground Truth and Qualifications: The document does not mention the involvement of experts in establishing ground truth for the bench testing. Ground truth for the accuracy testing would have been established by the precise design specifications of the device and the accuracy of the measurement tools used in the benchtop environment, not through expert consensus on medical images.
-
Adjudication Method for the Test Set: Not applicable. This was a benchtop accuracy test, not a subjective assessment of medical images requiring adjudication.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. This device is a stereotaxic instrument, a hardware-only guidance system, not an AI or imaging diagnostic tool that would typically involve human readers. Therefore, there's no mention of how much human readers improve with AI assistance.
-
Standalone Performance: Yes, the accuracy testing described is a standalone (algorithm/device only) performance evaluation. It measures the physical accuracy of the SmartFrame OR system itself in a controlled environment, without human intervention in the accuracy measurement process.
-
Type of Ground Truth Used: The ground truth for the benchtop accuracy testing was derived from the physical specifications and measurements of the device's components and its ability to guide instruments to a precisely defined target. This is not
expert consensus, pathology, or outcomes data. It is a calculated and measured ground truth based on engineering principles. -
Sample Size for the Training Set: The document does not mention a training set. This device is a hardware instrument, not a software algorithm or AI model that requires a training set for development.
-
How Ground Truth for the Training Set Was Established: Not applicable, as there was no training set.
{0}------------------------------------------------
January 12, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes 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: K233141
Trade/Device Name: SmartFrame OR 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 name Adam D. Pierce -S. Next to the name is the phrase "Digitally signed by Adam D. Pierce -S". Below that is the date 2024.01.12 and the time 16:32:50 -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) K233141
Device Name SmartFrame OR
Indications for Use (Describe)
The SmartFrame OR is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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
A. Device Information
| Category | Comments |
|---|---|
| Sponsor: | ClearPoint Neuro, Inc.6349 Paseo Del LagoCarlsbad, CA 92011 |
| Correspondent ContactInformation: | Brennan Sullivan120 S. Sierra Ave.Solana Beach, CA 92075617-678-1028bsullivan@clearpointneuro.com |
| Device Common Name: | Neurological Stereotactic Instrument |
| Device Regulation & Name: | Neurological Stereotaxic Instrument, 21CFR882.4560 |
| Classification & Product Code: | Class IIHAW |
| 510(k) Number: | K233155 |
| Device Proprietary Name: | SmartFrame OR Stereotaxic System |
Primary Predicate Device Information:
| Predicate Device: | Medtronic NexFrame(Navigus II Trajectory Guide) |
|---|---|
| Predicate Device Manufacturer: | Medtronic, Inc. |
| Predicate Device Common Name: | Neurological Stereotactic Instrument |
| Predicate Device Premarket Notification # | K012366 |
| Predicate Device Classification & Name | Neurological Stereotaxic Instrument,21CFR 882.4560 |
| Predicate Device Classification &Product Code: | Class IIHAW |
Reference Predicate Device Information:
| Reference Device 1 | |
|---|---|
| Predicate Device: | ClearPoint System (SmartFrame XG) |
| Predicate Device Manufacturer: | ClearPoint Neuro, Inc. |
| Predicate Device Common Name: | Neurological Stereotactic Instrument |
| Predicate Device Premarket Notification # | K222519 |
| Predicate Device Classification & Name | Neurological Stereotaxic Instrument,21CFR 882.4560 |
| Predicate Device Classification &Product Code: | Class IIHAW |
| Reference Device 2 |
{5}------------------------------------------------
| Predicate Device: | SmartFrame Array |
|---|---|
| Predicate Device Manufacturer: | ClearPoint Neuro, Inc. |
| Predicate Device Common Name: | Neurological Stereotactic Instrument |
| Predicate Device PremarketNotification # | K214040 |
| Predicate Device Classification &Name | Neurological Stereotaxic Instrument,21CFR 882.4560 |
| Predicate Device Classification &Product Code: | Class IIHAW |
B. Date Summary Prepared
December 8, 2023
C. Description of Device
The SmartFrame OR is a hardware-only precision trajectory aiming device for procedures conducted entirely in the traditional operating room and in conjunction with commercially available optical navigation systems such as Medtronic Stealth Station S8, or functionally equivalent optical navigation systems.
The SmartFrame OR Stereotactic System tower consists of three assemblies. The reference bracket arm attaches to the skull mount and the trajectory aiming tower is attached to the mount once it is affixed to the patient skull. The ring assembly of the base is attached to the patient's skull. The socket assembly fits over the two retaining blocks on the ring assembly and is secured with the tower thumbscrews.
The SmartFrame OR Kit consists of the following Components:
- 1x SmartFrame OR Tower ●
- 1x Device Guide, 2.1mm
- 1x Centering Ring ●
- 1x Dock ●
- 1x Lock
- 1x Lock (2.1mm) ●
- 1x SNS Thumb Wheel Extension ●
- . 1x Thumb Screw Pack
The plastic tower assembly is designed to provide multi-directional orientation adjustments to the Device Guide, which is a guide tube encased in the center of the tower assembly. The Device Guide has a 14-gauge central lumen through which a peel away sheath can be placed and oriented.
{6}------------------------------------------------
The tower, when attached to the base assembly, provides adjustments in the roll, pitch, x, and y directions by turning the appropriate thumb wheels. The thumb wheels on the SMARTFrame are used to maneuver the Device Guide by either direct or indirect physician contact.
D. Indications for Use
The SmartFrame OR is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction.
E. Comparison of Technological Characteristics
Medtronic's NexFrame was chosen as the predicate because its indications for use are identical to the SmartFrame OR Stereotactic System and it is similar in design and technological characteristics. There were no other potential predicate devices identified with the same indications for use or with similar design. NexFrame has been on the market for over 20 years with a history of safe and effective use. In 2019, NexFrame was subjected to a design-related recall. The recall was related to inaccuracy issues during the use of NexFrame in DBS lead implantation surgeries utilizing the auto-registration (fiducial-less) workflow. SmartFrame OR is not intended to be used in DBS procedures that utilize auto-registration. Bone screw fiducials are required to be used for registration in these procedures. For this reason, the issues leading to the recall are not applicable to the SmartFrame OR and the NexFrame remains the most appropriate predicate device.
The SmartFrame OR Stereotactic System is identical in indications for use as the Medtronic NexFrame, subject of K012719. The devices are similar in design in that they are adjustable, stereotactic frames composed of a base and a tower assembly. They allow for fine trajectory adjustments of the stereotactic frame and for the passage of neurosurgical tools through frame and into the patients brain. The devices utilize similar workflows and are both compatible with MedTronic StealthStation. Additionally, the SmartFrame OR Stereotactic System uses identical materials to the reference device SmartFrame Array and SmartFrame XG.
The differences between SmartFrame OR and the predicate consists of design modifications that allow for more precise trajectory adjustments and do not introduce any risks of safety or effectiveness. Both the proposed SmartFrame and the predicate devices allow for adjustments to the pitch and roll of the frame, however the proposed SmartFrame OR and the ClearPoint SmartFrame Array allow for changes in the X- and Y- translation of the device. Accuracy testing has been performed to demonstrate that SmartFrame OR performs as effectively as NexFrame.
{7}------------------------------------------------
The proposed SmartFrame OR and the primary predicate NexFrame and reference predicates ClearPoint SmartFrame XG and SmartFrame Array Systems all allow for passage of neurosurgical tools through the frame and into the patient's brain. They are all compatible with tools of different diameters via the use of adapters or guide tubes. Additionally, both the proposed SmartFrame OR and the predicate are compatible with StealthStation S8 whereas the reference predicates ClearPoint SmartFrame XG and SmartFrame Array Systems are not since those systems includes their own software. Based on these similar characteristics and verification testing performed, there are no new issues of safety or efficacy raised between the devices when used with S8. Table 1 below provides a side-by-side comparison of the proposed SmartFrame OR and the predicate device.
{8}------------------------------------------------
| ClearPoint Neuro SmartFrame OR | Primary PredicateMedtronic NexFrame(Navigus II TrajectoryGuideK012366) | Reference PredicateClearPoint System(SmartFrame XG)K200079 and K222519 | Reference PredicateSmartFrame ArrayK202575 | ||
|---|---|---|---|---|---|
| Classification | 21 CFR 882.4560 | 21CFR 882.4560 | 21CFR 882.4560 | 21CFR 882.4560 | |
| Product Code | HAW | HAW | HAW, ORR | HAW | |
| DeviceDescription | The SmartFrame OR StereotacticSystem is a disposable, frameless,stereotactic guidance system used inconjunction with MedtronicStealthStation Navigation Systems-image-guided surgery (IGS)systems-for intracranial surgicalprocedures. | The NexFrame StereotacticSystem is a disposable,frameless, stereotacticguidance system used inconjunction with MedtronicStealthStation NavigationSystems-image-guidedsurgery (IGS) systems—forintracranial surgicalprocedures. | The ClearPoint System is usedto provide stereotacticguidance for the insertion ofone or more devices into thebrain within a magneticresonance imaging (MRI)environment. | The ClearPoint System is usedto provide stereotacticguidance for the insertion ofone or more devices into thebrain within a magneticresonance imaging (MRI)environment | |
| Indications forUse | The SmartFrame OR is intended toprovide stereotactic guidance for theplacement and operation ofinstruments or devices duringplanning and operation ofneurological procedures performedin conjunction with the use of acompatible optical stereotaxicnavigation system using preoperativeMR and/or CT imaging. Theseprocedures include biopsies, catheterplacement and electrodeintroduction. | The NexFrame StereotacticSystem is intended to providestereotactic guidance for theplacement and operation ofinstruments or devices duringplanning and operation ofneurological proceduresperformed in conjunction withthe use of an Image GuidedWorkstation System usingpreoperative MR and/or CTimaging. These proceduresinclude biopsies, catheterplacement and electrodeintroduction. The device isET0 sterilized and for one timeuse. | The ClearPoint Systemis intended to providestereotactic guidance for theplacement and operation ofinstruments or devices duringplanning and operation ofneurological procedures withinthe MRI environment and inconjunction with MR imaging.The ClearPoint System isintended as an integral part ofprocedures that havetraditionally used stereotacticmethodology.These procedures include biopsies,catheter and electrodeinsertion, including deep brainstimulation (DBS) leadplacement. The System is | The ClearPoint System isintended to providestereotactic guidance for theplacement and operation ofinstruments or devices duringplanning and operation ofneurological procedureswithin the MRI environmentand in conjunction with MRimaging. The ClearPointSystem is intended as anintegral part of procedures thathave traditionally usedstereotactic methodology.These procedures includebiopsies, catheter andelectrode insertion, includingdeep brain stimulation (DBS)lead placement. The System is | |
| ClearPoint Neuro SmartFrame OR | Primary PredicateMedtronic NexFrame(Navigus II TrajectoryGuideK012366) | Reference PredicateClearPoint System(SmartFrame XG)K200079 and K222519 | Reference PredicateSmartFrame ArrayK202575 | ||
| intended for use only with 1.5and 3.0 Tesla MRI scanners. | intended for use only with 1.5and 3.0 Tesla MRI scanners. | ||||
| Intended Use | The SmartFrame OR StereotacticSystem is intended for use by aNeurosurgeon in a standard operatingroom environment to guidecompatible neurosurgical devicesalong a planned trajectory to thespecified target in the brain duringstereotactic functional neurosurgicalprocedures. | The NexFrame StereotacticSystem is intended for use bya Neurosurgeon in a standardoperating room environment toguide compatibleneurosurgical devices along aplanned trajectory to thespecified target in the brainduring stereotactic functional neurosurgical procedures. | The ClearPoint System isintended to providestereotactic guidance for theplacement and operation ofinstruments or devices duringplanning and operation ofneurological procedureswithin the MRI environmentand in conjunction with MRimaging. | The ClearPoint System isintended to providestereotactic guidance for theplacement and operation ofinstruments or devices duringplanning and operation ofneurological procedureswithin the MRI environmentand in conjunction with MRimaging. | |
| TargetingAccuracy | ±0.78 mm | ±1.48 mm | ±1.5mm @≤125mm | <2.0 mm | |
| Environment | Operating Room | MRI Suite or OR | MRI Suite | MRI Suite | |
| PrincipalOperator | Neurosurgeon | Neurosurgeon | Neurosurgeon | Neurosurgeon | |
| Components | SmartFrame OR Tower & BaseCentering RingTorx ScrewdriverEntry Point LocatorDevice Guides / Adapters | Nexframe socket and ringassembliesCenter alignment andmultilumen adaptersOffset alignment andmultilumen adapters. | SmartFrame XG,Scalp Mount Base, BoneScrews, Stand-Off Pins,Screwdriver, Centering Tool,Wharen Centering Guide(packaged and soldseparately), Dock and Lock,Roll Lock Screw with Washer,Rescue Screws (packagedseparately) | SmartFrame Array,Scalp Mount Base, BoneScrews, Stand-Off Pins,Screwdriver, Centering Tool,Wharen Centering Guide(packaged and soldseparately), Dock and Lock,Roll Lock Screw withWasher,Rescue Screws (packagedseparately) | |
| Materials | 20% Glass-Filled PolycarbonateTitanium (Ti-6Al-4V per ASTMF136)SiliconeNylonPolycarbonatePEEK | PolycarbonateSilicone RubberTitaniumStainless SteelAcetalNylonOther polymer materials | PolycarbonateSilicone RubberTitaniumStainless SteelAcetalNylonOther polymer materials | PolycarbonateSilicone RubberTitaniumStainless SteelAcetal | |
| ClearPoint Neuro SmartFrame OR | Primary PredicateMedtronic NexFrame(Navigus II TrajectoryGuideK012366) | Reference PredicateClearPoint System(SmartFrame XG)K200079 and K222519 | Reference PredicateSmartFrame ArrayK202575 | ||
| AcetalUltem-1000PTFEKapton | NylonOther polymer materials | ||||
| Principle ofOperation | Patient ScanningMRI for planningCT for registration | Patient ScanningMRI for planningCT for registration | Patient ScanningMRI for planningMRI for registration | Patient ScanningMRI for planningMRI for registration | |
| Surgical PlanningSelect target locationSelect entry point | Surgical PlanningSelect target locationSelect entry point | Surgical PlanningSelect target locationSelect entry point | Surgical PlanningSelect target locationSelect entry point | ||
| Optional Non-Sterile Registration | Optional Non-SterileRegistration | MRI Registration | MRI Registration | ||
| IGS System Setup and SterileRegistration | IGS System Setup and SterileRegistration | IGS System Setup and SterileRegistration | IGS System Setup and SterileRegistration | ||
| Range ofMotion | Pitch - ±33°Roll: ±26°X-translation: ±2.5mmY-translation: ±2.5mm | Angulation: ±25°Rotation: 360° | Pitch - ±33°Roll: ±26°X-translation: ±2.5mmY-translation: ±2.5mm | Pitch - ±33°Roll: ±26° | |
| Burr Hole | 14mm or drill bit when appropriate | 14mm | 14mm or drill bit whenappropriate | 14mm or drill bit whenappropriate | |
| Sterile | Yes | Yes | Yes | Yes | |
| Single Use | Yes | Yes | Yes | Yes | |
| Multi-lumenspacing | Continuous XY-stage | 2 mm | Continuous XY-stage | 3-mm center-to-center virtualoffset array |
Table 1: Side-by-side comparison of SmartFrame OR with Predicate and Reference Devices
{9}------------------------------------------------
K233141 Page 6 of 8
ClearPoint Neuro, Inc. SmartFrame OR
{10}------------------------------------------------
K233141 Page 7 of 8
ClearPoint Neuro, Inc. SmartFrame OR
{11}------------------------------------------------
F. Bench Testing
ClearPoint Neuro has performed extensive testing to demonstrate that the SmartFrame OR System is safe and effective for its intended use. The modifications implemented in SmartFrame OR System were 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 benchtop accuracy testing. The navigational accuracy validation values and how they compare to the predicate device are presented in the table below.
| Device | Positional Error (mm) | Trajectory Angle Error (degrees) | ||||
|---|---|---|---|---|---|---|
| Mean | Standard Deviation | 99% CI*Upper Bound | Mean | Standard Deviation | 99% CI*Upper Bound | |
| SmartFrameOR | 1.36 | 0.86 | 1.57 | 0.67 | 0.46 | 0.92 |
Table 1: Accuracy Performance Comparison*
*Measurement tools used in accuracy testing were found to add up to a 0.25 mm differential to results. To represent worst case of this measurement error, this 0.25 mm has been added to the results in Table 1.
Risk analysis was performed with mitigation of all identified risks to acceptable levels. The tests and risk analysis demonstrated that the SmartFrame OR System functions as intended and is substantially equivalent to the legally marketed Medtronic NexFrame.
G. Conclusion
The subject SmartFrame OR and the predicate NexFrame have the 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 SmartFrame OR and the predicate device do not raise any risks of safety or efficacy. SmartFrame OR 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.
§ 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).