(66 days)
Not Found
No
The summary describes a monitoring system that measures and displays physiological variables. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The software testing focuses on standard software validation protocols, not AI/ML model performance.
No
The device is a monitoring system intended to measure cerebral blood flow and intracranial pressure, not to treat a condition.
No
The device is a monitoring system that measures and displays cerebral blood flow and intracranial pressure, rather than diagnosing a specific condition or disease.
No
The device description explicitly states it consists of a single-use parenchymal probe (hardware) and a monitor (hardware) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes monitoring cerebral blood flow and intracranial pressure directly in patients. This involves measurements taken within the body (intraparenchymal), not on samples taken from the body.
- Device Description: The device consists of a probe inserted into the parenchyma and a monitor. This is a system for in vivo measurement, not in vitro analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs direct physiological measurements within the body.
N/A
Intended Use / Indications for Use
The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.
NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System, is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.
Product codes
GWM
Device Description
The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System consists of a single-use parenchymal probe for the real-time measurement of cerebral blood flow (CBF) and intracranial pressure (ICP) and a monitor for the display and storage of these measured variables and the computation and display of derived variables.
The NeuroSensor® System consists of a single-use probe and introducer for the continuous real-time measurement of Cerebral Blood Flow (CBF) and Intracranial Pressure (ICP), and a monitor for the display and storage of these measured parameters and the computation and display of derived parameters.
Two transducers are located at the tip of the probe. The CBF transducer consists of two optical fibers and functions by the principles of laser doppler flowmetry. The ICP sensor is a MEMS (Micro-Electro Mechanical System) silicon strain gauge. The probe is designed for use with the NeuroSensor® Model NS-100 monitor. A "cranial bolt" introducer is included with each probe. The cranial bolt is inserted in a twist drill hole in the skull. The probe is inserted into brain and is held in position by the cranial bolt.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral, intraparenchymal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified clinician
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
System testing was performed in accordance with established protocols to confirm the NeuroSensor System requirements as outlined in the product's functional specification met the product's defined requirements. These tests included verification and validation of the following System operations:
- Screen Administrative Functions
- Data Integrity, Display and Storage
- Mechanical and Electrical Functionality
- Instructional and Informational Content
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The result of software testing indicates the System Requirements Specifications and System Functional Specifications have been fully met and that the NeuroSensor System is safe for use as a cerebral blood flow and intracranial pressure monitoring system in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).
0
071525
Page 1 of 2
510(k) SUMMARY
Submitter's Name and Address:
Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 609-275-0500 (Telephone) 609-275-9445 (Fax)
Contact Person and Telephone Number:
Jon Caparotta, RAC Director Requlatory Affairs Integra LifeSciences Corporation 609-936-2495
Date Summary was Prepared: July 24, 2007
Name of the Device:
| Trade Name: | NeuroSensor® Cerebral Blood Flow and Intracranial
Pressure Monitoring System |
|-----------------------|---------------------------------------------------------------------------------|
| Common Name: | Neurological Diagnostic Device |
| Classification Name: | Intracranial Pressure Monitoring Device,
21 CFR 882.1620, Product Code GWM |
| Classification Panel: | Neurology Device Panel |
Substantial Equivalence:
The modified NeuroSensor® Cerebral Biood Flow and Intracranial Pressure Monitoring System is substantially equivalent in function and intended use to the NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System previously cleared under 510(k) K050720 on 5/11/05.
Testing was performed by Integra NeuroSciences, San Diego, CA, Integra NeuroSciences, Andover,UK and GemSoft, Inc in accordance with Integra established test protocols utilizing the following guidelines and standards:
- . FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
- FDA Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf . Software Use in Medical Devices, September 9, 1999
- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002
- AAMI TIR32:2004, Medical Device Software Risk Management .
- IEC 601.1, General Requirements for Safety Medical Electrical Equipment (in . process and to be completed prior to market release)
The result of software testing indicates the System Requirements Specifications and System Functional Specifications have been fully met and that the NeuroSensor System
AUG -6 2007
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Page 2 of 2
is safe for use as a cerebral blood flow and intracranial pressure monitoring system in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.
System testing was performed in accordance with established protocols to confirm the NeuroSensor System requirements as outlined in the product's functional specification met the product's defined requirements. These tests included verification and validation of the following System operations:
- Screen Administrative Functions
- 를 Data Integrity, Display and Storage
- . Mechanical and Electrical Functionality
- 트 Instructional and Informational Content
Device Description:
The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System consists of a single-use parenchymal probe for the real-time measurement of cerebral blood flow (CBF) and intracranial pressure (ICP) and a monitor for the display and storage of these measured variables and the computation and display of derived variables.
Indications for Use:
The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.
Technological Characteristics:
The NeuroSensor® System consists of a single-use probe and introducer for the continuous real-time measurement of Cerebral Blood Flow (CBF) and Intracranial Pressure (ICP), and a monitor for the display and storage of these measured parameters and the computation and display of derived parameters.
Two transducers are located at the tip of the probe. The CBF transducer consists of two optical fibers and functions by the principles of laser doppler flowmetry. The ICP sensor is a MEMS (Micro-Electro Mechanical System) silicon strain gauge. The probe is designed for use with the NeuroSensor® Model NS-100 monitor. A "cranial bolt" introducer is included with each probe. The cranial bolt is inserted in a twist drill hole in the skull. The probe is inserted into brain and is held in position by the cranial bolt.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2007
Integra Lifesciences Corporation % Mr. Jon Caparotta Director Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K071505
Trade/Device Name: NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: July 19, 2007 Received: July 20, 2007
Dear Mr. Caparotta:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Mr. Jon Caparotta
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon othnia 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) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours,
Mark N. Milbersen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7/505
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name: NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System
Indications for Use:
NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System, is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Melkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number