(51 days)
Not Found
No
The document describes a system for measuring and displaying physiological parameters (CBF, ICP, SAP) and computing derived parameters (CPP, CVR). There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description focuses on real-time measurement and computation based on standard physiological formulas.
No
The device is a monitoring system intended for diagnostic purposes (monitoring cerebral blood flow and intracranial pressure), not for directly treating a condition.
Yes
Explanation: The device is used to monitor cerebral blood flow and intracranial pressure, which are physiological parameters used to assess the patient's condition and diagnose potential issues like cerebral ischemia.
No
The device description explicitly states that the system consists of a single-use probe, introducer, and a monitor, indicating the presence of hardware components beyond just software.
Based on the provided information, the NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- NeuroSensor® Function: The NeuroSensor® system directly monitors physiological parameters (cerebral blood flow and intracranial pressure) within the patient's body (intraparenchymal). It does not analyze samples taken from the body.
Therefore, the NeuroSensor® is an in vivo monitoring device, not an in vitro diagnostic device.
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.
Product codes (comma separated list FDA assigned to the subject device)
DPT, DPW, GWM
Device Description
Each 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. The NeuroSensor® monitor can be connected to a hospital bedside monitor for display of ICP. The NeuroSensor® monitor can accept Systemic Arterial Pressure (SAP) data from a hospital bedside monitor, and can use this data and the measured CBF and ICP to compute Cerebral Perfusion Pressure (CPP) and Cerebrovascular Resistance (CVR).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, Intraparenchymal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified clinician / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The NeuroSensor® System was subjected to extensive performance testing. Results of the testing showed that the probe design was technically sound and the product safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
CONFIDENTIAL
MAY 1 1 2005
050720
//3
510(k) SUMMARY
Submitter's name and address:
Integra NeuroSciences 5955 Pacific Center Blvd. San Diego, CA 92121, USA
Contact person and telephone number:
Nancy A. Mathewson, Esq. Director, Regulatory Affairs (858) 455-1115 ext. 185
Date summary was prepared:
March 18, 2005
Name of the device:
| Proprietary Name: | |
|---|---|
| Modified: | NeuroSensor ® Cerebral Blood Flow and Intracranial Pressure |
| Monitoring System | |
| Unmodified | NeuroSensor ® Cerebral Blood Flow and Intracranial Pressure |
| Monitoring System, 510(k) K013930 | |
| Common Name: | Cerebral Blood Flow and Intracranial Pressure Monitoring |
| System | |
| Classification Name: | Extravascular Blood Probes |
| Product Code DPT, 21 CFR 870.2120 | |
| Blood Flowmeters | |
| Product Code DPW, 21 CFR 2100 | |
| Classification Panel: | Cardiovascular Device Panel |
| Classification Name: | Intracranial Pressure Monitoring Device |
| Product Code GWM, 21 CFR 882.1620 | |
| Classification Panel: | Neurology Device Panel |
Substantial Equivalence:
ﺔ ﺗ
The modified NeuroSensor® System has the following similarities to the unmodified NeuroSensor® System.
1
2/3
| Table II - Substantial Equivalence | |||
|---|---|---|---|
| -- | -- | ------------------------------------ | -- |
| Parameter | Original NeuroSensor® System | Modified NeuroSensor® System |
|---|---|---|
| Indications for Use | 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. | Identical to the original | |
| NeuroSensor® System | ||
| Measured parameters | Cerebral Blood Flow and Intracranial Pressure | Identical to the original |
| NeuroSensor® System | ||
| Operating Principle | Laser Doppler for measurement of blood flow and | |
| MEMS strain gauge pressure sensor for | ||
| measurement of ICP | Identical to the original | |
| NeuroSensor® System | ||
| Probe Construction | Type 304 stainless steel or titanium probe | Identical to the original |
| NeuroSensor® System | ||
| Probe Body Size | 6F (2.0mm) diameter | Identical to the original |
| NeuroSensor® System | ||
| Probe Working Length | 25mm with 5 depth markings at zero insertion | |
| from bolt and at 5mm intervals | Identical to the original | |
| NeuroSensor® System | ||
| System Specifications | ||
| (Cerebral Blood Flow) | Range | |
| 0 to 300 ml/100g/min | ||
| Resolution | ||
| 1ml/100g/min | Identical to the original | |
| NeuroSensor® System | ||
| CBF Sensor Type | Fiberoptic (Laser Doppler Flowmetry) | Identical to the original |
| NeuroSensor® System | ||
| ICP Sensor Type | MEMS (Micro-Electro Mechanical System) | |
| silicon strain gauge | Identical to the original | |
| NeuroSensor® System | ||
| Indwelling time | Five (5) days | Identical to the original |
| NeuroSensor® System | ||
| Method of Probe | ||
| Placement | Inserted through a cranial access bolt | Identical to the original |
| NeuroSensor® System | ||
| Packaging Method and | ||
| Materials | Tyvek lid heat sealed to a thermoformed tray | |
| inserted into a second thermoformed tray. Boxed | ||
| individually. | Identical to the original | |
| NeuroSensor® System | ||
| Sterilization Process | 100% Ethylene Oxide to a sterility assurance level | |
| of 106. | Identical to the original | |
| NeuroSensor® System |
Device Description:
Each 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
2
CONFIDENTIAL
K050720 1/2
and the computation and display of derived parameters. The NeuroSensor® monitor can be connected to a hospital bedside monitor for display of ICP. The NeuroSensor® monitor can accept Systemic Arterial Pressure (SAP) data from a hospital bedside monitor, and can use this data and the measured CBF and ICP to compute Cerebral Perfusion Pressure (CPP) and Cerebrovascular Resistance (CVR).
Statement of Intended 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.
Safety:
Biocompatibility studies were conducted per FDA G95-1 and ISO 10993 and have demonstrated that the materials used to manufacture the NeuroSensor® probe are safe for their intended use.
In addition, the NeuroSensor® System was subjected to extensive performance testing. Results of the testing showed that the probe design was technically sound and the product safe for its intended use.
The NeuroSensor® System manufacturing process complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.
Conclusion:
ﺑﺮﺩ ﻣﺠ
In summary, the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring System described in this submission is substantially equivalent to the unmodified predicate device and the modifications made do not affect the intended use or fundamental scientific technology of the device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three figures in profile facing right. The figures are connected by a flowing line, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 2005
Integra Neurosciences Corporation Ms. Nancy Mathewson Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K050720
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: May 4, 2005 Received: May 5, 2005
Dear Ms. Mathewson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becareer on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the entrebutes) 70 the enactment date of the Medical Device Amendments, or to conimered pror to rilly 20, 2011 accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic rear (110) market the device, subject to the general controls provisions of the Act. The r ou may, diereleve, mains of the Act include requirements for annual registration, listing of general controls provisions of use ice, 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 it may of subject to Ston additions, 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 r lease of actived a determination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must of any I cueral statutes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fart 007), adoning (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant) byocal provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 – Ms. Nancy Mathewson
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manieting your and equivalence of your device to a legally premarket notification: "The PDF 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 If you desire specific acrice ior your at (240) 276-0115 . Also, please note the regulation entitled, Comact the Office of Compulance in (21 transmitted notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response in the toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Styph Rhodes
S. Michael C. Duncan, Ph.D.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
CONFIDENTIAL
Special 510(k) Premarket Notification NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System Integra NeuroSciences
Indications for Use
K050720 510(k) Number (if known):
Device Name: NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System
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.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B-001
Styp Kurdin
(Division Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number_________________________________________________________________________________________________________________________________________________________________