(30 days)
No
The description focuses on mechanical components and software for trajectory planning and monitoring, with no mention of AI or ML algorithms.
No
The device provides stereotactic guidance for neurological procedures and does not directly treat or alleviate a medical condition.
No
Explanation: The ClearPoint System is intended for stereotactic guidance and operation of instruments during neurological procedures within the MRI environment. It provides guidance and fixation for neurosurgical tools and is an integral part of procedures like biopsies and catheter/electrode insertion, which are interventional rather than diagnostic. The device assists in performing procedures, not in diagnosing conditions.
No
The device description explicitly lists multiple hardware components, including a workstation laptop, SMARTGrid, SMARTFrame, SMARTFrame Accessory Kit, and SMARTFrame Hand Controller, in addition to the software.
Based on the provided information, the ClearPoint System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "stereotactic guidance and operation of instruments or devices during the planning and operation of neurological procedures within the MRI environment." This describes a surgical guidance system used in vivo (within the living body) during a procedure, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The components described are all related to surgical guidance and instrument manipulation within the MRI environment (workstation, frames, guides, drills, etc.). There are no components mentioned that would be used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any features or functions typical of IVD devices, such as reagents, assays, sample handling, or analysis of biological markers.
Therefore, the ClearPoint System falls under the category of a surgical guidance or navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ClearPoint System is intended to provide stereotactic guidance and operation of instruments or devices during the 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. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.
Product codes
HAW, ORR
Device Description
The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame™ Accessory Kit and the SMARTFrame™ Hand Controller.
The SMARTGrid 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 is an Adjustable Trajectory Frame (ATF) that provides the quidance and fixation for neurosurgical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allows for trajectory feedback when the physician views the MRI images, makes changes and confirms with subsequent MR images.
The ClearPoint 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) that meet the physician's desired imaging quality. MRI Interventions also supplies an optional head fixation frame and imaging coil(s) that can be used with the ClearPoint System.
The ClearPoint Workstation includes the following:
-
- ClearPoint Workstation Software (for trajectory planning and monitoring)
-
- Laptop Computer
The hardware components of the ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following:
- 3. SMARTGrid Pack (interacts with the software to determine the desired location of the burr hole)
- a. Marking Grid
- b. Marking Tool
-
- SMARTFrame Pack (SMARTFrame or SMARTFrame XG)
- a. SMARTFrame ("ATF") with Base
- b. Centering Tool
- c. Wharen Centering Guide
- d. Dock
- e. Device Lock (2 different diameters)
- f. Screwdriver
- Roll Lock Screw and Washer g.
- Rescue Screws (Extra Titanium Screws) 5.
-
- Hand Controller (for use with the ATF) and Thumbwheel Extension
-
- Accessory Pack
- a. Peel-away Sheath
- b. Stylet
- c. Lancet
- d. Depth Stop
- e. Ruler
-
- Scalp Mount Base
- Guide Tube and Device Guide Packs (Guide Cannulas) 9.
-
- SmartTip MRI Hand Drill and Drill Bit Kit
-
- SmartTwist MRII Hand Drill and 4.5mm/6.0mm Drill Guide
-
- MRI Neuro Procedure Drape, with Marker Pen and Cover
-
- MR Camera Fiberscope Accessory Kit
-
- SmartFrame MR Fiducial
Each of the above packs is sold separately. Each is intended to be used with the ClearPoint Workstation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
neurological procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / MRI 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 and phantom testing confirmed that the Wharen Centering Guide can be used to help hold the Centering Tool in place and maintain the selected entry point. Design verification was performed on the 4.5mm and 6.0mm Drill Guides with acceptable results. The tests demonstrated that the modified ClearPoint System functions as intended and is substantially equivalent to the legally marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Targeting Accuracy: $\pm$ 1.5mm @ $\le$125mm
Predicate Device(s)
Reference Device(s)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, each head facing forward. The eagle's body is formed by flowing lines, giving it a dynamic and modern appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002
March 24, 2016
MRI Interventions. Inc. % John J. Smith, MD, JD Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K160434 Trade/Device Name: ClearPoint System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW, ORR Dated: February 16, 2016 Received: February 16, 2016
Dear Dr. John Smith:
This letter corrects our substantially equivalent letter of March 17, 2016.
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. The general controls provisions of the Actinclude 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 requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S 同心
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K160434
Device Name
ClearPoint System
Indications for Use (Describe)
The ClearPoint System is intended to provide stereotactic quidance and operation of instruments or devices during the 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. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
[ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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FORM FDA 3881 (1/14)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
3
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the MRII ClearPoint System.
1. Company Making the Submission:
| Name of Owner: | MRI Interventions, Inc. |
|---|---|
| Address: | 5 Musick |
| Irvine, CA 92618 | |
| Telephone: | 949-900-6833 |
| Fax: | 949-900-6834 |
| Contact: | Pete Piferi |
| E-mail: | ppiferi@mriinterventions.com |
| Date Prepared: | March 15, 2016 |
2. Device Name:
| Common Name: | Neurological Stereotaxic
Instrument |
|----------------------|----------------------------------------|
| Proprietary Name: | ClearPoint System |
| Classification Name: | Stereotaxic Instrument |
| Regulatory Class: | II |
| Regulation Number: | 21 C.F.R. § 882.4560 |
| Product Code: | HAW, ORR |
3. Predicate Device:
MRII ClearPoint System, K142505
4. Device Description:
The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame™ Accessory Kit and the SMARTFrame™ Hand Controller.
The SMARTGrid 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 is an Adjustable Trajectory Frame (ATF) that provides the quidance and fixation for neurosurgical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allows for trajectory feedback when the physician views the MRI images, makes changes and confirms with subsequent MR images.
The ClearPoint 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) that meet the physician's desired imaging quality. MRI Interventions also supplies an optional head fixation frame and imaging coil(s) that can be used with the ClearPoint System.
The ClearPoint Workstation includes the following:
-
- ClearPoint Workstation Software (for trajectory planning and monitoring)
-
- Laptop Computer
4
The hardware components of the ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following:
-
- SMARTGrid Pack (interacts with the software to determine the desired location of the burr hole)
- a. Marking Grid
- b. Marking Tool
-
- SMARTFrame Pack (SMARTFrame or SMARTFrame XG)
- a. SMARTFrame ("ATF") with Base
- b. Centering Tool
- c. Wharen Centering Guide
- d. Dock
- e. Device Lock (2 different diameters)
- f. Screwdriver
- Roll Lock Screw and Washer g.
- Rescue Screws (Extra Titanium Screws) 5.
-
- Hand Controller (for use with the ATF) and Thumbwheel Extension
-
- Accessory Pack
- a. Peel-away Sheath
- b. Stylet
- c. Lancet
- d. Depth Stop
- e. Ruler
-
- Scalp Mount Base
- Guide Tube and Device Guide Packs (Guide Cannulas) 9.
-
- SmartTip MRI Hand Drill and Drill Bit Kit
-
- SmartTwist MRII Hand Drill and 4.5mm/6.0mm Drill Guide
-
- MRI Neuro Procedure Drape, with Marker Pen and Cover
-
- MR Camera Fiberscope Accessory Kit
-
- SmartFrame MR Fiducial
Each of the above packs is sold separately. Each is intended to be used with the ClearPoint Workstation.
5. Indications for Use:
The ClearPoint System is intended to provide stereotactic guidance and operation of instruments or devices during the 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. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.
6. Comparison of the Technological Characteristics of the Device with the Predicate Device:
Modifications to the predicate ClearPoint System are as follows:
- a) Addition of 4.5mm and 6.0mm Drill Guides that are compatible with the SmartFrame XG and can be used in place of the Targeting Cannula to facilitate the use of the cleared SmartTwist MRII Hand Drill (K151536) with the SmartFrame XG.
5
- b) Addition of the Wharen Centering Guide, an optional accessory designed to make the cleared Centering Tool (K100836) easier to use with the Scalp Mount Base. The use of this accessory is not required for proper use of the ClearPoint System, does not materially alter the clinical work flow, and does not change the intended use of the device. It can hold the Centering Tool in place and eliminate potential scalp movement during a) removing the lower pad of the Marking Grid, and b) during mounting of the Scalp Mount Base. Eliminating scalp movement during these steps will help ensure an accurate alignment of the SmartFrame to the entry point.
| | ClearPoint System
K142505 | ClearPoint System
Modified |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Product Code | HAW, ORR | HAW, ORR |
| Intended Use | The ClearPoint System is intended to
provide stereotactic guidance and
operation of instruments or devices
during the 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. The
System is intended for use only with
1.5 and 3.0 Tesla MRI scanners. | The ClearPoint System is intended to
provide stereotactic guidance and
operation of instruments or devices
during the 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. The
System is intended for use only with
1.5 and 3.0 Tesla MRI scanners. |
| Environment | MRI Suite | MRI Suite |
| Sterilization | EO 10-6 SAL | EO 10-6 SAL |
| SmartGrid Pack | MRI Planning Grid & Marking Tool | MRI Planning Grid & Marking Tool |
| SmartFrame Pack | SmartFrame XG, Scalp Mount Base,
Bone Screws, Scalp Mount Base,
Screws, Stand-Off Pins, Screwdriver,
Centering Tool, Dock and Lock, Roll
Lock Screw with Washer, Rescue
Screws (packaged separately) | SmartFrame XG, Scalp Mount Base,
Bone Screws, Scalp Mount Base,
Screws, Stand-Off Pins, Screwdriver,
Centering Tool, Wharen Centering
Guide (packaged and sold
separately), Dock and Lock, Roll Lock
Screw with Washer, Rescue Screws
(packaged separately) |
| Hand Controller | Thumbwheel Extension (Light Hand
Controller) | Thumbwheel Extension (Light Hand
Controller) |
| Accessory Kit | Peel-away Sheath, Lancet, Stylet,
Depth Stop, Ruler | Peel-away Sheath, Lancet, Stylet,
Depth Stop, Ruler |
| Drill Guides | Not included | 4.5mm & 6.0mm |
| Targeting
Cannula ID | 0.0825" | 0.0825" |
| Targeting
Cannula Material | Ultem and PEEK | Ultem and PEEK |
| Guide Tube /
Device Guide /
Drill Guide ID | 0.0938 & 0.141" | 0.0938, 0.141, 0.191, 0.250" |
| Guide Tube / | Ultem | Ultem |
| | ClearPoint System
K142505 | ClearPoint System
Modified |
| Device Guide /
Drill Guide
Material
Packaging | Sterile, Sealed Tray, Inside Sterile
Tyvek Pouch | Sterile, Sealed Tray, Inside Sterile
Tyvek Pouch
(Wharen Centering Guide and Drill
and Device Guides are Sterile in a
double Tyvek Pouch Without a Tray;
Wharen Centering Guide Packaging
includes PVC) |
| Targeting
Accuracy | $\pm$ 1.5mm @ ≤125mm | $\pm$ 1.5mm @ ≤125mm |
| Software | 1.5 | |
6
7. Performance Data:
Bench and phantom testing confirmed that the Wharen Centering Guide can be used to help hold the Centering Tool in place and maintain the selected entry point. Design verification was performed on the 4.5mm and 6.0mm Drill Guides with acceptable results. The tests demonstrated that the modified ClearPoint System functions as intended and is substantially equivalent to the legally marketed device.
The ClearPoint System complies with the following recognized consensus standards:
- AAMI/ANSI/ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing.
- · ANSI/AAMI/ISO 11135-1 Sterilization of health care products Ethylene oxide -Part 1: Requirements for development, validation, and routine control of sterilization process for medical devices.
8. Conclusions:
The modifications to the ClearPoint System were made in conformance with the company's design control procedures and the performance testing performed for the predicate ClearPoint System (K142505). The modified ClearPoint System has the same intended use and indications for use and similar technologies characteristics and principles of operation as the predicate ClearPoint System. The minor technological differences between the modified ClearPoint System and its predicate ClearPoint System raise no new issues of safety and effectiveness. Thus, the modifications are substantially equivalent to the previously cleared ClearPoint System.