(65 days)
No
The document describes a stereotactic guidance system for neurological procedures within an MRI environment, focusing on hardware and software for trajectory planning and monitoring. There is no mention of AI, ML, or related concepts like image processing beyond standard MR imaging, nor are there descriptions of training or test sets typically associated with AI/ML development. The 510(k) is primarily for expanding the indication to 3.0 Tesla MRI scanners.
No
The device description states "The System itself provides no therapeutic or diagnostic functionality." Its primary purpose is stereotactic guidance for neurological procedures, not treatment.
No
The "Device Description" explicitly states, "The System itself provides no therapeutic or diagnostic functionality."
No
The device description explicitly states that the ClearPoint Stereotactic System is comprised of two separate device groups: a hardware group (SmartFrame and Accessories) and a software group (ClearPoint Workstation). This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ClearPoint 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." This describes a surgical guidance system, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces this by stating the system provides "trajectory planning, guidance and fixation of neurosurgical tools" and explicitly says "The System itself provides no therapeutic or diagnostic functionality."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
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 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. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.
Product codes
LNH, ORR
Device Description
The hardware and software components of the SurgiVision ClearPoint System 37 are identical to the predicate device. The sole purpose of this 510(k) application is to expand the indications for the ClearPoint System to 3.0 Tesla MRI scanners. The ClearPoint System 3T is intended to provide trajectory planning, guidance and fixation of neurosurgical tools during minimally invasive stereotactic surgical procedures in the brain conducted in the MR suite. The System itself provides no therapeutic or diagnostic functionality.
The ClearPoint Stereotactic System is comprised of two separate device groups, a hardware and a software group. The software group is known as the ClearPoint Workstation. It includes the following:
- ClearPoint Workstation Software (for trajectory planning and . monitoring)
- Laptop Computer .
The hardware device group under the ClearPoint Stereotactic System umbrella is known as the SmartFrame and Accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging
Anatomical Site
neurological procedures within the MRI environment, human brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Testing addressed force, torque, heating, image artifacts, Bo and accuracy testing within the 3T environment, using ClearPoint 1.1 software and accessories, ruled substantially equivalent within K100836. These tests demonstrated that the ClearPoint System 3T functions as intended and is substantially equivalent to the legally marketed predicate ClearPoint System. Non-clinical testing demonstrated the ClearPoint SmartFrame and Accessories as MRI Conditional.
Key Metrics
System Accuracy: Equivalent to ClearPoint System, with predicate having +/- 1.5mm accuracy
Predicate Device(s)
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
510(k) Summary
JUN 2 2 2 2011
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the SurgiVision ClearPoint System 3T. ウ
Company Making the Submission: 1.
| Name of Owner: | SurgiVision, Inc. |
|---|---|
| Address: | 5 Musick |
| Irvine, CA 92618 | |
| Telephone: | 949-900-6833 |
| Fax: | 949-900-6834 |
| Contact: | Edward Waddell |
| E-mail: | ewaddell@surgivision.com |
2. Device Name:
| Common Name: | Neurological Stereotaxic
Instrument |
|--------------------|----------------------------------------|
| Proprietary Name: | ClearPoint System 3T |
| Classification: | II |
| Regulation Number: | 21 CFR 882.4560 |
| Product Code: | LNH, ORR |
3. Predicate Device:
ClearPoint System, ruled substantially equivalent K100836 on June 16, 2010.
4. Intended Use Statement:
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. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.
Description of Device: 5.
The hardware and software components of the SurgiVision ClearPoint System.
1
37 are identical to the predicate device. The sole purpose of this 510(k) application is to expand the indications for the ClearPoint System to 3.0 Tesla MRI scanners. The ClearPoint System 3T is intended to provide trajectory planning, guidance and fixation of neurosurgical tools during minimally invasive stereotactic surgical procedures in the brain conducted in the MR suite. The System itself provides no therapeutic or diagnostic functionality.
The ClearPoint Stereotactic System is comprised of two separate device groups, a hardware and a software group. The software group is known as the ClearPoint Workstation. It includes the following:
- ClearPoint Workstation Software (for trajectory planning and . monitoring)
- Laptop Computer .
The hardware device group under the ClearPoint Stereotactic System umbrella is known as the SmartFrame and Accessories.
Summary of the Technological Characteristics of the Device Compared 6. to the Predicate Device
| | SurgiVision
ClearPoint System 3T | Predicate Device:
ClearPoint System
K100836 |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Product Code | LNH, ORR | LNH, ORR |
| Intended 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. 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 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. The
System is intended for use
only in 1.5 Tesla MRI
scanners. |
2
510(k) (Traditional) Submission Section 5, 510(k) Summary
| | SurgiVision
ClearPoint System 3T | Predicate Device:
ClearPoint System
K100836 |
|--------------------------------------------------------------|-------------------------------------|---------------------------------------------------|
| Software
Version | ClearPoint 1.1 | ClearPoint 1.1 |
| Compatibility
with
environment
and other
devices | 1.5/3T MRI environment | 1.5T MRI environment |
| System
Accuracy | Equivalent to ClearPoint
System | $\pm$ 1.5mm |
7. Testing:
Testing to applicable standards has been completed with acceptable outcomes. The following bench testing has been performed:
Testing addressed force, torque, heating, image artifacts, Bo and accuracy testing within the 3T environment, using ClearPoint 1.1 software and accessories, ruled substantially equivalent within K100836. These tests demonstrated that the ClearPoint System 3T functions as intended and is substantially equivalent to the legally marketed predicate ClearPoint System.
Non-clinical testing demonstrated the ClearPoint SmartFrame and Accessories as MRI Conditional.
8. Rx or OTC:
The Surgi Vision ClearPoint System 3T is an Rx prescription device per 21 CFR Part 801, Subpart D.
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9. Substantial Equivalence:
The SurgiVision ClearPoint System 3T is as safe and effective as the predicate ClearPoint System. The ClearPoint System 3T has the same intended uses and essentially identical indications, technological characteristics, and principles of operation as its predicate device. Performance data demonstrate that the ClearPoint system 3T is as safe and effective as the predicate ClearPoint System.
SurgiVision, Inc.
Edward Waddell
Edward Waddell Director of Regulatory Affairs
Date: Jun 17, 2011
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Surgivision, Inc. c/o Mr. Edward Waddell Director, Regulatory 5 Musick Irvine, CA 92618
Re: K111073
Trade/Device Name: ClearPoint System 3T Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ORR, LNH Dated: April 15, 2011 Received: April 18, 2011
JUN 2 2 2011
Dear Mr. Waddell:
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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
5
device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Rekhmn. f
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use Statement KI11073
510(k) Number (if known):
Device Name: SurgiVision, Inc. ClearPoint System™ 3T Indications for 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. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Con Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
X
Per 21 CFR 801.109)
John Doucet
(Division Sign-Off) (Division Sign-Off)
Division of Ophthalmic, Neurological and Ear. Division of Throat Devices
K111073
510(k) Number
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