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.

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)

AI/ML Overview

The provided text does not contain acceptance criteria for a device, nor does it describe a study proving the device meets specific performance criteria.

Instead, this document is a 510(k) summary for the Pressio® ICP Monitoring system, submitted to the FDA in 2007 for premarket notification. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing general safety and performance testing.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

No Acceptance Criteria: The document mentions "extensive performance testing" and compliance with standards like ISO 10993, IEC 60601-1, and UL 2601, but it does not specify any quantitative or qualitative acceptance criteria (e.g., accuracy, precision, drift limits for ICP measurements).
No Specific Study Details: While "extensive performance testing" is mentioned, no specific study design, methodology, or results (beyond general statements of safety and suitability) are provided. There's no information about sample sizes for test sets, data provenance, ground truth establishment, or expert involvement.
No mention of AI/ML components: The device described is an "electromedical device designed for the monitoring of a patient's intracranial pressure (ICP) via a catheter." There is no indication of any Artificial Intelligence or Machine Learning (AI/ML) components in its design or function. Therefore, questions related to AI-specific studies (e.g., MRMC studies, standalone performance, training sets) are not applicable.

Summary of what can be extracted related to testing:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: The document generally states that "Results of the testing showed that the catheter designs are safe for their intended uses" and that the system components "underwent numerous safety tests, including testing to IEC 60601-1 and UL 2601." It also mentions "Biocompatibility studies were conducted per ISO 10993 standard and have demonstrated that the materials used... are safe for its intended use." No quantitative performance data (e.g., accuracy, reliability) is provided.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no specific clinical or diagnostic test set with ground truth established by experts is described. Testing appears to be primarily engineering performance and safety focused.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as the device does not employ AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as the device does not employ an algorithm in this context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic performance. The ground truth for functional tests would likely be established by a reference standard or validated measurement device for parameters like pressure, temperature, etc., which is not detailed here.
The sample size for the training set: Not applicable, as the device does not employ AI/ML that requires a training set.
How the ground truth for the training set was established: Not applicable, as the device does not employ AI/ML.

In conclusion, the provided 510(k) summary gives an overview of the device and its general testing for safety and substantial equivalence but lacks the specific details regarding acceptance criteria and performance study outcomes that would be required to answer your questions comprehensively.

Summary

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K062584

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

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3.5 Device Description

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® 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.

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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.

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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.

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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

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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® 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

Regulation Number and Section

§ 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).