(110 days)
Not Found
No
The description focuses on hardware components, software for planning and monitoring, and traditional stereotactic guidance methods using real-time MR images and physical frames. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device provides guidance for surgical procedures and is not directly used for treating a disease or condition.
No
Explanation: The ClearPoint Array System is intended for stereotactic guidance during neurological procedures to precisely place instruments or devices. It does not diagnose diseases or conditions; rather, it assists in surgical interventions.
No
The device description explicitly lists multiple hardware components, including a workstation laptop, trajectory frame, guide tubes, and other accessories, in addition to the software.
Based on the provided information, the ClearPoint® Array System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "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." This describes a surgical guidance system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The components described are hardware and software for surgical planning and guidance (frames, guides, software for trajectory planning, etc.). There are no components related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens (blood, tissue, etc.), which is a defining characteristic of IVD devices.
Therefore, the ClearPoint® Array System falls under the category of a surgical guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ClearPoint® Array 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 ® Array 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 intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.
Product codes
HAW
Device Description
The ClearPoint Array System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ Array MRI-Guided Trajectory Frame, SmartFrame Array Reducer Tube Kit, the ClearPoint™ Accessory Kit, the SMARTFrame™ Array Thumb Wheel Extension Set, and the MRI Neuro Procedure Drape.
A pre-alignment may be used when it is desired to obtain an approximate alignment using a Surgical Navigation System prior to performing final alignment and device placement in the MR Scanner using real-time MR Images. Pre-alignment using an SNS is not intended to provide accurate stereotactic placement. The final alignment and insertion must be performed using real-time MR images with ClearPoint Array software prior to inserting a device in the brain. The SMARTGrid™ MRI-Guided Planning Grid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the trajectory planning software.
The SMARTFrame™ Array MRI-Guided Trajectory Frame is an adjustable trajectory frame that provides the quidance and fixation for neurosurgical tools. MRI visible fluids in the Targeting Stem along with the fiducial markers in the frame allows for trajectory feedback when the physician views the MR images, makes changes and confirms the subsequent MR images. The ClearPoint Array System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) (supplied by scanner manufacturers) that meet the physician's desired imaging quality. ClearPoint Neuro also supplies an optional head fixation frame that can be used with the ClearPoint Array System.
The ClearPoint System Array Workstation includes the following:
- ClearPoint Workstation Software (for trajectory planning and monitoring)
- Laptop Computer
The hardware components of the ClearPoint Array System are the SMARTFrame Array and accessories. They are all single use devices that are provided sterile. They include the following:
1 SMARTFrame Array Pack
a. SMARTFrame Array (adjustable trajectory frame to guide and hold the neurosurgical tools, includes Probe Adapter and Tracker Rod)
b. SMARTFrame Array Scalp Mount Base (includes fiducials, titanium screws, and support pins)
c. Entry Point Locator
d. Targeting Stem
e. Centering Device
f. Dock
g. Device Lock (2 different diameters)
h. Screwdriver
i. 2.1-mm Guide Tube
j. 4.5 Center Drill Guide
k. 4.5 Offset Drill Guide
l. 3.4-mm Drill Reducer Tube
m. Center Insertion Guide
n. Offset Insertion Guide
2 SmartFrame Array Thumb Wheel Extension Set for the trajectory frame
3 SmartFrame Array Guide Tube Kit
a. 1.7-mm Guide Tube
b. 2.5-mm Guide Tube and Device Lock
c. 3.2-mm Guide Tube and Device Lock
4 SmartFrame Array Guide Tubes (sold seperately)
a. 7.9mm Center and Offset Device Guides
b. 5.4mm Center and Offset Device Guides
Common components to ClearPoint System include:
- SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole):
a. Marking Grid
b. Marking Tool - Accessory pack:
a. Peel away sheath
b. Stylet
c. Depth Stop
d. Ruler - MRI Neuro Procedure Drape
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging
Anatomical Site
Brain (Neurological procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / MRI Suite or OR
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)
The company completed new software validation for the ClearPoint Array version 1.1 software update, which includes the addition of the preoperative planning module.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ClearPoint Array System (K202575)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2022
ClearPoint Neuro, Inc. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth St. NW Washington, District of Columbia 20004
Re: K214040
Trade/Device Name: ClearPoint Array System (version 1.1) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: February 11, 2022 Received: February 11, 2022
Dear John Smith:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K214040
Device Name
ClearPoint Array System (version 1.1)
Indications for Use (Describe)
The ClearPoint Array 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 Array 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 intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.
| 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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3
510(k) SUMMARY
ClearPoint Neuro Inc.'s ClearPoint Array System (version 1.1)
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared:
ClearPoint Neuro Inc. 5 Musick Irvine, CA 92618 Phone: (949) 900-6833 Facsimile: (888) 979-8369 Contact Person: Megan Faulkenberry, VP Quality & Regulatory
Date Prepared: April 12, 2022
Name of Device: ClearPoint Array System (version 1.1)
Common or Usual Name: ClearPoint Array System
Classification Name: Neurological Stereotaxic Instrument, 21 CFR 882.4560
Regulatory Class: Class II
Product Code: HAW
Predicate Device:
ClearPoint Array System (K202575)
Intended Use / Indications for Use
The ClearPoint® Array 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 ® Array 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 intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.
Device Description
The ClearPoint Array System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ Array MRI-Guided Trajectory Frame, SmartFrame Array Reducer Tube Kit, the ClearPoint™ Accessory Kit, the SMARTFrame™ Array Thumb Wheel Extension Set, and the MRI Neuro Procedure Drape.
A pre-alignment may be used when it is desired to obtain an approximate alignment using a Surgical Navigation System prior to performing final alignment and device placement in the MR Scanner using real-time MR Images. Pre-alignment using an SNS is not intended to provide accurate stereotactic placement. The final alignment and insertion must be performed
4
using real-time MR images with ClearPoint Array software prior to inserting a device in the brain. The SMARTGrid™ MRI-Guided Planning Grid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the trajectory planning software.
The SMARTFrame™ Array MRI-Guided Trajectory Frame is an adjustable trajectory frame that provides the quidance and fixation for neurosurgical tools. MRI visible fluids in the Targeting Stem along with the fiducial markers in the frame allows for trajectory feedback when the physician views the MR images, makes changes and confirms the subsequent MR images. The ClearPoint Array System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) (supplied by scanner manufacturers) that meet the physician's desired imaging quality. ClearPoint Neuro also supplies an optional head fixation frame that can be used with the ClearPoint Array System.
The ClearPoint System Array Workstation includes the following:
-
- ClearPoint Workstation Software (for trajectory planning and monitoring)
-
- Laptop Computer
The hardware components of the ClearPoint Array System are the SMARTFrame Array and accessories. They are all single use devices that are provided sterile. They include the following:
- 1 SMARTFrame Array Pack
- a. SMARTFrame Array (adjustable trajectory frame to guide and hold the neurosurgical tools, includes Probe Adapter and Tracker Rod)
- b. SMARTFrame Array Scalp Mount Base (includes fiducials, titanium screws, and support pins)
- c. Entry Point Locator
- d. Targeting Stem
- Centering Device e.
- f. Dock
- g. Device Lock (2 different diameters)
- Screwdriver h.
- i. 2.1-mm Guide Tube
- j. 4.5 Center Drill Guide
- 4.5 Offset Drill Guide k.
- l. 3.4-mm Drill Reducer Tube
- m. Center Insertion Guide
- n. Offset Insertion Guide
- 2 SmartFrame Array Thumb Wheel Extension Set for the trajectory frame
- 3 SmartFrame Array Guide Tube Kit
- a. 1.7-mm Guide Tube
- b. 2.5-mm Guide Tube and Device Lock
5
- c. 3.2-mm Guide Tube and Device Lock
- 4 SmartFrame Array Guide Tubes (sold seperately)
- a. 7.9mm Center and Offset Device Guides
- b. 5.4mm Center and Offset Device Guides
Common components to ClearPoint System include:
-
- SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole):
- a. Marking Grid
- b. Marking Tool
-
- Accessory pack:
- a. Peel away sheath
- b. Stylet
- c. Depth Stop
- d. Ruler
-
- MRI Neuro Procedure Drape
Summary of Technological Characteristics
The purpose of this 510(k) notice is to incorporate an update to the ClearPoint Array software. The updated version of the software includes a preoperative planning module. This optional step in the clinical workflow involves planning one or more trajectory paths into the brain prior to the day of surgery, using previously acquired images of the patient.
6
Summary of Technological Characteristics of the Device Compared to the Predicate Device
| | ClearPoint Array System (K202575) | ClearPoint Array System (v1.1)
(Subject Device) |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 C.F.R. § 882.4560 | 21 C.F.R. § 882.4560 |
| Product code | HAW | HAW |
| Intended Use | The ClearPoint® Array 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® Array 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 intended for use only
with 1.5 and 3.0 Tesla MRI scanners
and MR Conditional implants and
devices. | The ClearPoint® Array 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® Array 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 intended for use only
with 1.5 and 3.0 Tesla MRI scanners
and MR Conditional implants and
devices. |
| Environment | MRI Suite or OR | MRI Suite or OR |
| Sterilization | EO 10-6 SAL | EO 10-6 SAL |
| SMARTGrid Pack | MRI Planning Grid & Marking tool | MRI Planning Grid & Marking tool |
| SMARTFrame Pack | SMARTFrame Array Adjustable
Trajectory Frame, Scalp Mount Base,
Entry Point Locator, Targeting Stem,
Centering Device, Dock, Device Lock,
screwdriver, 2.1-mm Guide Tube,
Center Drill Guide, Offset Drill Guide,
3.4-mm Drill Reducer Tube, Center
Insertion Guide, Offset Insertion Guide | SMARTFrame Array Adjustable
Trajectory Frame, Scalp Mount Base,
Entry Point Locator, Targeting Stem,
Centering Device, Dock, Device Lock,
screwdriver, 2.1-mm Guide Tube,
Center Drill Guide, Offset Drill Guide,
3.4-mm Drill Reducer Tube, Center
Insertion Guide, Offset Insertion Guide |
| Hand Controller | Thumbwheel Extension | Thumbwheel Extension |
| Accessory pack | Peel away sheath, Stylet, Depth stop,
ruler | Peel away sheath, Stylet, Depth stop,
ruler |
| Drill Guides | Drill Guide, 4.5-mm (included in
SMARTFrame Pack) | Drill Guide, 4.5-mm (included in
SMARTFrame Pack) |
| Targeting Cannula ID | No ID, Targeting Stem is completely
fluid-filled | No ID, Targeting Stem is completely
fluid-filled |
| Targeting Cannula
Material | PEEK | PEEK |
| Guide Tube/Device
Guide/Drill Guide ID | Drill Guide ID: 4.5 mm (included in
SmartFrame Pack)
Drill Guide Tube ID: 3.4 mm (included in
SmartFrame Pack)
Guide Tube ID: 3.2 mm | Drill Guide ID: 4.5 mm (included in
SmartFrame Pack)
Drill Guide Tube ID: 3.4 mm (included in
SmartFrame Pack)
Guide Tube ID: 3.2 mm |
| | Guide Tube ID: 2.5 mm | Guide Tube ID: 2.5 mm |
| | Guide Tube ID: 2.1 mm | Guide Tube ID: 2.1 mm |
| | Guide Tube ID: 1.7 mm | Guide Tube ID: 1.7 mm |
| Packaging | SMARTFrame Array Pack: PETG Tray
with sealed Tyvek Lid inside of a Sealed
Mylar-Tyvek Pouch | SMARTFrame Array Pack: PETG Tray
with sealed Tyvek Lid inside of a Sealed
Mylar-Tyvek Pouch |
| | SMARTFrame Array Thumbwheel
Extension: PETG Tray sealed in a
Double Mylar-Tyvek Pouch | SMARTFrame Array Thumbwheel
Extension: PETG Tray sealed in a
Double Mylar-Tyvek Pouch |
| | SMARTFrame Array Guide Tube Kit:
Sealed Double Mylar-Tyvek Pouches | SMARTFrame Array Guide Tube Kit:
Sealed Double Mylar-Tyvek Pouches |
| Targeting Accuracy | ≤ 2.0 mm | ≤ 2.0 mm |
| Software | ClearPoint Array 1.0.x | ClearPoint Array 1.1.x |
7
Substantial Equivalence
The company completed new software validation for the ClearPoint Array version 1.1 software update, which includes the addition of the preoperative planning module.
The ClearPoint Array System has the same intended use and indications for use, similar technological characteristics and principles of operation as the predicate ClearPoint Array System. The addition of the preoperative planning module to the ClearPoint Array software does not raise new and different questions of safety and effectiveness.
Conclusions
The ClearPoint Array System is as safe and effective as the predicate device. The ClearPoint Array System has the same indications for use, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between the subject device and its predicate devices raise no new issues of safety or effectiveness. Thus, the ClearPoint Array System is substantially equivalent to the predicate device.