(107 days)
No
The description focuses on a hardware-only mechanical aiming device used in conjunction with existing optical navigation systems. There is no mention of AI, ML, or any software-driven analytical or predictive capabilities.
No.
The device is a trajectory aiming device that provides stereotactic guidance and adjustments for instrument placement during neurological procedures; it does not directly treat a disease or condition.
No
The device is described as a hardware-only precision trajectory aiming device that provides stereotactic guidance for the placement and operation of instruments or devices during neurological procedures. Its function is to aid in the physical placement of tools for procedures like biopsies, catheter placement, and electrode introduction, not to diagnose a condition or disease.
No
The device description explicitly states that the SmartFrame OR is a "hardware-only precision trajectory aiming device" and lists multiple physical components.
Based on the provided information, the SmartFrame OR is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- SmartFrame OR Function: The SmartFrame OR is a hardware-only precision trajectory aiming device used during surgical procedures (biopsies, catheter placement, electrode introduction) in the operating room. It provides stereotactic guidance for instruments based on pre-operative imaging (MR/CT).
- No Sample Analysis: The device does not analyze any biological samples from the patient. Its function is purely mechanical and navigational, assisting the surgeon in guiding instruments to a specific location within the brain.
Therefore, the SmartFrame OR falls under the category of a surgical instrument or device used for guidance during a procedure, not an in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
preoperative MR and/or CT imaging
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeon in a standard operating room environment
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
The navigational accuracy validation values and how they compare to the predicate device are presented in the table below.
| Device | Positional Error (mm) Mean | Positional Error (mm) Standard Deviation | Positional Error (mm) 99% CI* Upper Bound | Trajectory Angle Error (degrees) Mean | Trajectory Angle Error (degrees) Standard Deviation | Trajectory Angle Error (degrees) 99% CI* Upper Bound |
|---|---|---|---|---|---|---|
| SmartFrame OR | 1.36 | 0.86 | 1.57 | 0.67 | 0.46 | 0.92 |
*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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Targeting Accuracy: ±0.78 mm
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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) |
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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: | 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 II
HAW |
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 II |
| HAW | |
| Reference Device 2 |
5
| Predicate Device: | SmartFrame Array |
|---|---|
| Predicate Device Manufacturer: | ClearPoint Neuro, Inc. |
| Predicate Device Common Name: | Neurological Stereotactic Instrument |
| Predicate Device Premarket | |
| Notification # | K214040 |
| 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 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.
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| | ClearPoint Neuro SmartFrame OR | Primary Predicate
Medtronic NexFrame
(Navigus II Trajectory
Guide
K012366) | Reference Predicate
ClearPoint System
(SmartFrame XG)
K200079 and K222519 | Reference Predicate
SmartFrame Array
K202575 | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Classification | 21 CFR 882.4560 | 21CFR 882.4560 | 21CFR 882.4560 | 21CFR 882.4560 | |
| Product Code | HAW | HAW | HAW, ORR | HAW | |
| Device
Description | The SmartFrame OR Stereotactic
System is a disposable, frameless,
stereotactic guidance system used in
conjunction with Medtronic
StealthStation Navigation Systems-
image-guided surgery (IGS)
systems-for intracranial surgical
procedures. | The NexFrame Stereotactic
System is a disposable,
frameless, stereotactic
guidance system used in
conjunction with Medtronic
StealthStation Navigation
Systems-image-guided
surgery (IGS) systems—for
intracranial surgical
procedures. | The ClearPoint System is used
to provide stereotactic
guidance for the insertion of
one or more devices into the
brain within a magnetic
resonance imaging (MRI)
environment. | The ClearPoint System is used
to provide stereotactic
guidance for the insertion of
one or more devices into the
brain within a magnetic
resonance imaging (MRI)
environment | |
| 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. | The NexFrame Stereotactic
System 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 an Image Guided
Workstation System using
preoperative MR and/or CT
imaging. These procedures
include biopsies, catheter
placement and electrode
introduction. The device is
ET0 sterilized and for one time
use. | The ClearPoint System
is intended to provide
stereotactic guidance for the
placement and operation of
instruments or devices during
planning and operation of
neurological procedures within
the MRI environment and in
conjunction with MR imaging.
The ClearPoint System is
intended as an integral part of
procedures that have
traditionally used stereotactic
methodology.
These procedures include biopsies,
catheter and electrode
insertion, including deep brain
stimulation (DBS) lead
placement. The System is | The ClearPoint System is
intended to provide
stereotactic guidance for the
placement and operation of
instruments or devices during
planning and operation of
neurological procedures
within the MRI environment
and in conjunction with MR
imaging. The ClearPoint
System is intended as an
integral part of procedures that
have traditionally used
stereotactic methodology.
These procedures include
biopsies, catheter and
electrode insertion, including
deep brain stimulation (DBS)
lead placement. The System is | |
| | ClearPoint Neuro SmartFrame OR | Primary Predicate
Medtronic NexFrame
(Navigus II Trajectory
Guide
K012366) | Reference Predicate
ClearPoint System
(SmartFrame XG)
K200079 and K222519 | Reference Predicate
SmartFrame Array
K202575 | |
| | | | intended for use only with 1.5
and 3.0 Tesla MRI scanners. | intended for use only with 1.5
and 3.0 Tesla MRI scanners. | |
| Intended Use | The SmartFrame OR Stereotactic
System is intended for use by a
Neurosurgeon in a standard operating
room environment to guide
compatible neurosurgical devices
along a planned trajectory to the
specified target in the brain during
stereotactic functional neurosurgical
procedures. | The NexFrame Stereotactic
System is intended for use by
a Neurosurgeon in a standard
operating room environment to
guide compatible
neurosurgical devices along a
planned trajectory to the
specified target in the brain
during stereotactic functional neurosurgical procedures. | The ClearPoint System is
intended to provide
stereotactic guidance for the
placement and operation of
instruments or devices during
planning and operation of
neurological procedures
within the MRI environment
and in conjunction with MR
imaging. | The ClearPoint System is
intended to provide
stereotactic guidance for the
placement and operation of
instruments or devices during
planning and operation of
neurological procedures
within the MRI environment
and in conjunction with MR
imaging. | |
| Targeting
Accuracy | ±0.78 mm | ±1.48 mm | ±1.5mm @≤125mm |