(307 days)
No
The summary describes a system for monitoring intracranial pressure using physical sensors and displaying the data. There is no mention of AI or ML for data analysis, interpretation, or decision support.
No
The device is indicated for monitoring intracranial pressure and cerebrospinal fluid drainage, which are diagnostic/monitoring functions, not therapeutic interventions.
Yes
The device is indicated for "intraventricular pressure monitoring and cerebrospinal fluid drainage applications" and "subdural or parenchymal pressure monitoring." Monitoring intracranial pressure provides information that aids in diagnosing and managing conditions affecting the brain.
No
The device description explicitly lists multiple hardware components, including a monitor, catheters, cables, and a drill, indicating it is a hardware-based system with potential software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The Pressio® ICP Monitoring System is designed to directly measure intracranial pressure within the patient's body (in vivo) via implanted catheters. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "intraventricular pressure monitoring and cerebrospinal fluid drainage applications" and "subdural or parenchymal pressure monitoring." These are all in-vivo procedures.
Therefore, the Pressio® ICP Monitoring System falls under the category of an in-vivo diagnostic or monitoring device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pressio® Ventricular Intracranial Pressure Monitoring Kit with Tunneling, Model PSO-VT, is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage applications.
The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Tunneling, Model PSO-PT, is indicated for use in subdural or parenchymal pressure monitoring.
The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Bolt, Model PSO-PB, is indicated for use in parenchymal pressure monitoring.
Product codes
GWM
Device Description
The Pressio® ICP Monitoring System (PSO-3000) is an electromedical device designed for the monitoring of a patient's intracranial pressure (ICP) via a catheter implanted in the parenchyma (PSO-PB or PSO-PT) or in the ventricles (PSO-VT). The Pressio® ICP Monitoring System is sold as a kit containing a Pressio® ICP Monitor (PSO-3000), a Power Supply Cable (PSO-AC) and the Catheter Extension Cable (PSO-EC20).
The Pressio® ICP Monitor can be connected to a patient monitor via a compatible monitor connection cable (PSO-MCxx). This permits medical staff to display intracranial pressure curves on the patient monitor. This connection is not necessary for Pressio™ Intracranial Pressure Monitor functioning. The calibration of patient monitor is performed via a host monitor calibration key on Pressio™ Intracranial Pressure Monitor.
The Pressio® ICP Monitoring System is composed of the following:
- Pressio® ICP Monitor (PSO-3000)
- Pressio® ICP Catheters: there are three available types of implantable . catheters:
- Catheter implanted in ventricles via tunnelling (PSO-VT) .
- Catheter implanted in parenchyma via tunnelling (PSO-PT) .
- Catheter implanted in parenchyma via a bolt (PSO-PB) .
- . Pressio® Serial Transmitter Model (PSO-TX00)
- . Pressio® Intracranial Pressure Interface Control Unit (PSO-IN00)
- Catheter Extension Cable (PSO-EC20) .
- Monitor Connexion Cable (PSO-MCxx): "xx" depends on the type of . patient monitor available in the hospital, it exists 9 different references
- Power Supply Cable (PSO-AC) .
- Pressio® Pole Clamp (PSO-CL) .
- . Pressio® Disposable Hand Drill (PSO-DR)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility studies were conducted per ISO 10993 standard and have demonstrated that the materials used to manufacture the Pressio® ICP monitoring system are safe for its intended use.
In addition, the three Implantable catheters were subjected to extensive performance testing. Results of the testing showed that the catheter designs are safe for their intended uses.
The Pressio® Intracranial Pressure Monitor, the Pressio® Interface Control Unit and the Pressio® Serial Transmitter underwent numerous safety tests, including testing to IEC 60601-1 and UL 2601.
Finally, the manufacturing process of the Pressio® ICP Monitoring System complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K945585, K914479, K991222, K974088
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
JUL -5 2007
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Name, Address, Phone and Fax Number of the Applicant 3.1
Sophysa SA 22 rue Jean Rostand Parc Club Orsay Université 91893 ORSAY Cedex, France Tel: 011-331-69 35 35 00 Fax: 011 331 69 35 36 90
Contact Person 3.2
Jean-Christophe Audras 22 rue Jean Rostand Parc Club Orsay Université 91893 ORSAY Cedex, France Tel: 011-331-69 35 35 06
Date Prepared 3.3
June 19, 2007
3.4 Device Name
The Pressio® ICP Monitoring system is composed of the following elements:
- Pressio® ICP Monitor (PSO-3000) .
- Pressio® ICP Catheters (PSO-VT, PSO-PT, PSO-PB): there are four . available types of implantable catheters:
- Catheter implanted in ventricles via tunnelling (PSO-VT) .
- Catheter implanted in parenchyma via tunnelling (PSO-PT) .
- Catheter implanted in parenchyma via a bolt (PSO-PB) .
- Pressio® Serial Transmitter Model (PSO-TX00) .
- Pressio® Intracranial Pressure Interface Control Unit (PSO-IN00) .
- Catheter Extension Cable (PSO-EC20) .
- Monitor connexion cable (PSO-MCxx): "xx" depends on the type of . patient monitor available in the hospital, it exists 9 different references
- Power Supply Cable (PSO-AC) .
- Pressio® Pole Clamp (PSO-CL) .
- . Pressio® Disposable Hand Drill (PSO-DR)
Page 52
1
3.5 Device Description
The Pressio® ICP Monitoring System (PSO-3000) is an electromedical device designed for the monitoring of a patient's intracranial pressure (ICP) via a catheter implanted in the parenchyma (PSO-PB or PSO-PT) or in the ventricles (PSO-VT). The Pressio® ICP Monitoring System is sold as a kit containing a Pressio® ICP Monitor (PSO-3000), a Power Supply Cable (PSO-AC) and the Catheter Extension Cable (PSO-EC20).
The Pressio® ICP Monitor can be connected to a patient monitor via a compatible monitor connection cable (PSO-MCxx). This permits medical staff to display intracranial pressure curves on the patient monitor. This connection is not necessary for Pressio™ Intracranial Pressure Monitor functioning. The calibration of patient monitor is performed via a host monitor calibration key on Pressio™ Intracranial Pressure Monitor.
The Pressio® ICP Monitoring System is composed of the following:
- Pressio® ICP Monitor (PSO-3000)
- Pressio® ICP Catheters: there are three available types of implantable . catheters:
- Catheter implanted in ventricles via tunnelling (PSO-VT) .
- Catheter implanted in parenchyma via tunnelling (PSO-PT) .
- Catheter implanted in parenchyma via a bolt (PSO-PB) .
- . Pressio® Serial Transmitter Model (PSO-TX00)
- . Pressio® Intracranial Pressure Interface Control Unit (PSO-IN00)
- Catheter Extension Cable (PSO-EC20) .
- Monitor Connexion Cable (PSO-MCxx): "xx" depends on the type of . patient monitor available in the hospital, it exists 9 different references
- Power Supply Cable (PSO-AC) .
- Pressio® Pole Clamp (PSO-CL) .
- . Pressio® Disposable Hand Drill (PSO-DR)
3.6 Device Intended Use
The Pressio® Ventricular Intracranial Pressure Monitoring Kit with Tunneling, Model PSO-VT, is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage applications.
The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Tunneling, Model PSO-PT, is indicated for use in subdural or parenchymal pressure monitoring.
The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Bolt, Model PSO-PB, is indicated for use in parenchymal pressure monitoring.
2
Substantial Equivalence Summary 3.7
The Pressio® ICP monitoring system is substantially equivalent to the Codman® ICP express monitoring system (K945585, K914479, K991222 and K974088) in terms of intended use, materials, design, function and operating characteristics. The two monitoring systems utilize the same technology (strain gauge) to monitor Intracranial pressure (ICP).
Device Testing 3.8
Biocompatibility studies were conducted per ISO 10993 standard and have demonstrated that the materials used to manufacture the Pressio® ICP monitoring system are safe for its intended use.
In addition, the three Implantable catheters were subjected to extensive performance testing. Results of the testing showed that the catheter designs are safe for their intended uses.
The Pressio® Intracranial Pressure Monitor, the Pressio® Interface Control Unit and the Pressio® Serial Transmitter underwent numerous safety tests, including testing to IEC 60601-1 and UL 2601.
Finally, the manufacturing process of the Pressio® ICP Monitoring System complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.
3
Image /page/3/Picture/12 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract caduceus symbol with three figures in profile, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 5 2007
SOPHYSA % Mr. Jean-Christophe Audras Director, Regulatory Affairs 22 rue Jean Rostand Parc Club Orsay Universite 91893 ORSAY Cedes - France
Re: K062584/S2
Trade/Device Name: Pressio® ICP Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: June 25, 2007 Received: June 26, 2007
Dear Mr. Audras:
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.
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 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.
4
Page 2 - Mr. Jean-Christophe Audras
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 a legally 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 may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Anastacia In Bile
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Appendix E. Indications for Use
510(k) Number (if known): 上の62584
Device Name: Pressio® Intracranial Pressure Monitoring System Indications for Use:
The Pressio® Ventricular Intracranial Pressure Monitoring Kit with Tunneling, Model PSO-VT, is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage applications.
The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Tunneling, Model PSO-PT, is indicated for use in subdural or parenchymal pressure monitoring.
The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Bolt, Model PSO-PB, is indicated for use in parenchymal pressure monitoring.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
Anastasia Mc Bile
(Division Sign-Off Division of General, Restorative. and Neurological Devices
510(k) Number K062584