(120 days)
Not Found
No
The summary describes a planning and image-guided surgical system using passive reflective markers for spatial tracking. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a planning and intraoperative guidance system that enables computer-assisted surgery, and a pointer for anatomy palpation and spatial localization. It does not directly treat or prevent a disease or condition, but rather aids in surgical procedures.
No
The device is described as a "planning and intraoperative guidance system" and is primarily used for navigation and spatial localization during surgery, not for diagnosing a medical condition.
No
The device description explicitly mentions the "BrightMatter Pointer," which is a handheld passive instrument made of titanium alloy or stainless steel. This is a physical hardware component, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery" for "neurosurgical cranial procedures." This describes a surgical navigation system used during a procedure, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a "planning and image guided surgical system" and a "handheld passive instrument" used for "anatomy palpation" and "spatial localization and identification." This aligns with surgical tools and navigation, not diagnostic testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on such analysis.
Therefore, the BrightMatter Guide and BrightMatter Pointer are surgical navigation and guidance tools, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
BrightMatter Guide is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
The BrightMatter Pointer is intended to be used for anatomy palpation and as a pointing tool to enable spatial localization and identification by BrightMatter Guide navigational systems.
The system should be operated only by trained personnel such as surgeons and other clinic staff.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
BrightMatter Guide is a planning and image guided surgical system that enables computer assisted surgery where use of stereotactic image guidance may be considered appropriate. The BrightMatter Pointer is a handheld passive instrument which can be used for anatomy palpation using its tip. This tool can be tracked using passive reflective markers in order for BrightMatter Guide to identify and spatially track its location. There are rigid features on the subject device where the markers (passive spheres) that reflect infrared (IR) signals can be attached. The markers are arranged in a unique pattern on the device so that the BrightMatter Guide can differentiate it from other instruments. The Pointer portion of the device is provided non sterile and requires steam sterilization before use. The passive reflective markers are single-use.
The BrightMatter Pointer is made of either titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or 17-4 stainless steel conforming to ASTM A564 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel such as surgeons and other clinic staff.
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)
No FDA performance standards have been established for the BrightMatter Guide with BrightMatter Pointer. The following tests were performed to demonstrate substantial equivalence between the subject and predicate devices.
Test: Dimensional analysis
Purpose: Comparison of measured dimensions to ensure tolerances are within acceptable limits.
Results: Measurements found within acceptable tolerances. If outside tolerance, navigational accuracy testing was performed.
Test: Navigational accuracy
Purpose: Accuracy of navigational components evaluated to ensure performance of the system.
Results: Accuracy testing demonstrated the subject device was as accurate as the predicate device.
Test: Cytotoxicity
Purpose: Cytotoxicity of the device evaluated to demonstrate biocompatibility.
Results: Testing demonstrated the device is not cytotoxic.
Test: Sensitization
Purpose: Sensitization of the device evaluated to demonstrate biocompatibility.
Results: Testing demonstrated the device is not sensitizing.
Test: Irritation
Purpose: Irritation of the device evaluated to demonstrate biocompatibility.
Results: Testing demonstrated the device is not an irritant.
Test: Pyrogenicity
Purpose: Material mediated pyrogenicity evaluated to demonstrate the absence of a febrile response in an in vivo model.
Results: Testing demonstrated the device is non-pyrogenic.
Test: Endotoxin (LAL test)
Purpose: Amount of gram negative bacteria evaluated to demonstrate endotoxin units are within acceptable limits.
Results: Endotoxin units were found to be
§ 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 and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three figures intertwined to represent people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2016
Synaptive Medical Inc. % Allison Komiyama, PhD, RAC Principal Consultant AcKnowledge Regulatory Strategies 2834 Hawthorn Street San Diego. California 92104
Re: K160523
Trade/Device Name: BrightMatter Guide with BrightMatter Pointer Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 26, 2016 Received: May 27, 2016
Dear Dr. Allison Komiyama:
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. Isting 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 -$ D/A
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
Indications for Use
510(k) Number (if known) K160523
Device Name BrightMatter Guide with BrightMatter Pointer
Indications for Use (Describe)
BrightMatter Guide is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
The BrightMatter Pointer is intended to be used for anatomy palpation and as a pointing tool to enable spatial localization and identification by BrightMatter Guide navigational systems.
The system should be operated only by trained personnel such as surgeons and other clinic staff.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Summary K160523
DATE PREPARED
June 23, 2016
MANUFACTURER AND 510(k) OWNER
Synaptive Medical, Inc. 101 College Street, Suite 200, Toronto, Ontario M5G 1L7, Canada Telephone: (416) 673-6679 Fax: (888) 650-5230 Official Contact: Cameron Piron, President
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies Telephone: akomiyama@acknowledge-rs.com Email:
PROPRIETARY NAME OF SUBJECT DEVICE
BrightMatter Guide with BrightMatter Pointer
COMMON NAME
Neurological stereotaxic instrument
DEVICE CLASSIFICATION
Stereotaxic instrument (21 CFR 882.4560, Product Code HAW, Class II)
PREMARKET REVIEW
ODE/DNPMD/NNDB Neurology Panel
PURPOSE OF SUBMISSION
The purpose of this submission is to introduce a titanium version of the Pointer tool.
INDICATIONS FOR USE
BrightMatter Guide is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the
4
"Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
The BrightMatter Pointer is intended to be used for anatomy palpation and as a pointing tool to enable spatial localization and identification by BrightMatter Guide navigational systems.
The system should be operated only by trained personnel such as surgeons and other clinic staff.
DEVICE DESCRIPTION
BrightMatter Guide is a planning and image guided surgical system that enables computer assisted surgery where use of stereotactic image guidance may be considered appropriate. The BrightMatter Pointer is a handheld passive instrument which can be used for anatomy palpation using its tip. This tool can be tracked using passive reflective markers in order for BrightMatter Guide to identify and spatially track its location. There are rigid features on the subject device where the markers (passive spheres) that reflect infrared (IR) signals can be attached. The markers are arranged in a unique pattern on the device so that the BrightMatter Guide can differentiate it from other instruments. The Pointer portion of the device is provided non sterile and requires steam sterilization before use. The passive reflective markers are single-use.
The BrightMatter Pointer is made of either titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or 17-4 stainless steel conforming to ASTM A564 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.
| The BrightMatter Pointer is substantially equivalent to the following predicates: | ||
|---|---|---|
| 510(k) | ||
| Number | Predicate Device Name / Manufacturer | Primary |
| Predicate | ||
| K142024 | BrightMatter Navigation System v1.0 / Synaptive, Inc. | ✓ |
| K153281 | BrightMatter Guide with Surface Trace Registration / | |
| Synaptive, Inc. | ||
| K142344 | Disposable Passive Accessory for Medtronic StealthStation | |
| System / IZI Medical Products LLC | ||
| K080450 | Stryker Power Tool Navigator / Stryker Instruments |
PREDICATE DEVICE IDENTIFICATION
The BrightMatter Pointer is substantially equivalent to the following predicates:
5
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the BrightMatter Guide with BrightMatter Pointer. The following tests were performed to demonstrate substantial equivalence between the subject and predicate devices.
| Test | Purpose | Results |
|---|---|---|
| Dimensional | ||
| analysis | Comparison of measured dimensions to | |
| ensure tolerances are within acceptable | ||
| limits. | Measurements found within | |
| acceptable tolerances. If outside | ||
| tolerance, navigational accuracy | ||
| testing was performed. | ||
| Navigational | ||
| accuracy | Accuracy of navigational components | |
| evaluated to ensure performance of the | ||
| system. | Accuracy testing demonstrated | |
| the subject device was as accurate | ||
| as the predicate device. | ||
| Cytotoxicity | Cytotoxicity of the device evaluated to | |
| demonstrate biocompatibility. | Testing demonstrated the device | |
| is not cytotoxic. | ||
| Sensitization | Sensitization of the device evaluated to | |
| demonstrate biocompatibility. | Testing demonstrated the device | |
| is not sensitizing. | ||
| Irritation | Irritation of the device evaluated to | |
| demonstrate biocompatibility. | Testing demonstrated the device | |
| is not an irritant. | ||
| Pyrogenicity | Material mediated pyrogenicity | |
| evaluated to demonstrate the absence | ||
| of a febrile response in an in vivo model. | Testing demonstrated the device | |
| is non-pyrogenic. | ||
| Endotoxin | ||
| (LAL test) | Amount of gram negative bacteria | |
| evaluated to demonstrate endotoxin | ||
| units are within acceptable limits. | Endotoxin units were found to be |