(51 days)
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.
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).
The provided document is a 510(k) summary for the Integra NeuroSciences NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System. It describes a MODIFIED device that is substantially equivalent to a previously cleared device (K013930). This type of submission focuses on demonstrating that the modifications do not alter the fundamental scientific technology or intended use, rather than conducting new clinical studies to prove the device meets acceptance criteria from scratch.
Therefore, the document does NOT contain information about acceptance criteria, a study proving the device meets those criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily compares the modified device to the original device, stating that most parameters are "Identical to the original NeuroSensor® System." It mentions "extensive performance testing" for safety but does not provide details of the testing or specific acceptance criteria.
Based on the provided text, I cannot answer the requested questions as the information is not present in a 510(k) summary for a modified device.
Here is what CAN be extracted (and why other parts cannot):
- Acceptance Criteria & Reported Performance: Not explicitly stated for performance metrics. The document focuses on showing the modified device is identical in specifications to the predicate device.
- Sample Size (Test Set) & Data Provenance: Not applicable/not provided. This is not a new clinical study.
- Number of Experts & Qualifications / Adjudication: Not applicable/not provided. No ground truth establishment activity is described for a new clinical study.
- MRMC Comparative Effectiveness Study: No, this is not an AI/software device undergoing such a study.
- Standalone Performance: No, this is a hardware medical device, not a standalone algorithm.
- Type of Ground Truth: Not applicable/not provided.
- Sample Size (Training Set): Not applicable/not provided.
- How Ground Truth for Training Set Established: Not applicable/not provided.
The document contains the following relevant information for its purpose (demonstrating substantial equivalence):
- Device Name: NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System
- Indication for Use: Monitoring cerebral blood flow in patients at risk of cerebral ischemia, and direct monitoring of intracranial pressure in intraparenchymal applications.
- Measured Parameters: Cerebral Blood Flow and Intracranial Pressure.
- Operating Principle: Laser Doppler for blood flow, MEMS strain gauge pressure sensor for ICP.
- System Specifications (Cerebral Blood Flow):
- Range: 0 to 300 ml/100g/min
- Resolution: 1ml/100g/min
- (These are specifications of the device, not acceptance criteria for a study proving its performance.)
- 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."
In summary, this document is a regulatory submission demonstrating substantial equivalence of a modified medical device, not a clinical study report proving performance against detailed acceptance criteria.
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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 PressureMonitoring System |
| Unmodified | NeuroSensor ® Cerebral Blood Flow and Intracranial PressureMonitoring System, 510(k) K013930 |
| Common Name: | Cerebral Blood Flow and Intracranial Pressure MonitoringSystem |
| Classification Name: | Extravascular Blood ProbesProduct Code DPT, 21 CFR 870.2120Blood FlowmetersProduct Code DPW, 21 CFR 2100 |
| Classification Panel: | Cardiovascular Device Panel |
| Classification Name: | Intracranial Pressure Monitoring DeviceProduct 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.
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| Table II - Substantial Equivalence | |||
|---|---|---|---|
| -- | -- | ------------------------------------ | -- |
| Parameter | Original NeuroSensor® System | Modified NeuroSensor® System |
|---|---|---|
| Indications for Use | Intended for use by a qualified clinician inmonitoring cerebral blood flow in patients at riskof cerebral ischemia, and for the direct monitoringof intracranial pressure in intraparenchymalapplications. | Identical to the originalNeuroSensor® System |
| Measured parameters | Cerebral Blood Flow and Intracranial Pressure | Identical to the originalNeuroSensor® System |
| Operating Principle | Laser Doppler for measurement of blood flow andMEMS strain gauge pressure sensor formeasurement of ICP | Identical to the originalNeuroSensor® System |
| Probe Construction | Type 304 stainless steel or titanium probe | Identical to the originalNeuroSensor® System |
| Probe Body Size | 6F (2.0mm) diameter | Identical to the originalNeuroSensor® System |
| Probe Working Length | 25mm with 5 depth markings at zero insertionfrom bolt and at 5mm intervals | Identical to the originalNeuroSensor® System |
| System Specifications(Cerebral Blood Flow) | Range0 to 300 ml/100g/minResolution1ml/100g/min | Identical to the originalNeuroSensor® System |
| CBF Sensor Type | Fiberoptic (Laser Doppler Flowmetry) | Identical to the originalNeuroSensor® System |
| ICP Sensor Type | MEMS (Micro-Electro Mechanical System)silicon strain gauge | Identical to the originalNeuroSensor® System |
| Indwelling time | Five (5) days | Identical to the originalNeuroSensor® System |
| Method of ProbePlacement | Inserted through a cranial access bolt | Identical to the originalNeuroSensor® System |
| Packaging Method andMaterials | Tyvek lid heat sealed to a thermoformed trayinserted into a second thermoformed tray. Boxedindividually. | Identical to the originalNeuroSensor® System |
| Sterilization Process | 100% Ethylene Oxide to a sterility assurance levelof 106. | Identical to the originalNeuroSensor® 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
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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.
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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.
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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
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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_________________________________________________________________________________________________________________________________________________________________
§ 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).