The MoniTorr ICP™ system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.

Device Description

The MoniTorr ICPTM External CSF Drainage and Monitoring Systems are designed to externally drain cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space to a drainage bag in selected patients. The systems connect to a ventricular or lumbar catheter via a luer connection to a patient line and ultimately to a drainage bag. In most of the systems, the patient line is connected to a graduated burette that is then connected to the drainage bag. CSF can be collected and measured in the burette and subsequestly emptied into the drainage bag by opening the stopcock placed in line between the burette and the drainage bag. In systems with this burette, an antimicrobial vent is included in the burette cap. This antimicrobial vent allows air to enter the burette to facilitate drainage from the burette to the drainage bag while protecting the system from microbial contamination. The antimicrobial vent used on the current MoniTorr ICPTM systems is being replaced with a vent that will allow better drainage of the CSF to the drainage bag and will better resist occlusion after contact with CSF. The antimicrobial media chosen for the vent is not compatible with the current method of sterilization, therefore, an alternate sterilization method, ethylene oxide has been chosen to sterilize the entire line of MoniTorr ICP™ systems. A vented cap will be used in place of the current closed end cap to allow flow of gas through the patient line. Additionally, the fluid path from the burette to the drainage bag has been enlarged and the current sampling sites are being replaced with needleless sampling sites.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MoniTorr ICP™ External CSF Drainage and Monitoring System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria as would be typical for new, high-risk devices or software algorithms.

Therefore, many of the requested categories for AI/software-based studies (like sample sizes for test sets, ground truth establishment for training, MRMC studies, standalone performance) are not applicable to this particular device submission. The "study" mentioned here refers to basic engineering and biological compatibility testing to ensure safety and functionality of the modified components and new sterilization method.

Here's an attempt to answer the questions based on the provided text, acknowledging the limitations due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated Goal / Intended Performance)	Reported Device Performance (Safety Testing)
Sterility (of the entire line of systems)	Systems have been shown to be sterile and non-pyrogenic.
Non-pyrogenicity	Systems have been shown to be sterile and non-pyrogenic.
Antimicrobial vent resistance to occlusion	Antimicrobial vent is resistant to occlusion after 30 minutes of exposure to fluids with high protein levels.
Microbial retention of antimicrobial vent	Antimicrobial media subjected to an aerosol challenge with B. diminuta yielded a microbial retention of 10⁷.
Tensile strength of bonded components	Tested for tensile strength of bonded components. (Explicit performance value not given, but successful testing implies meeting an internal standard.)
Pressure and leakage	Tested for pressure and leakage. (Explicit performance value not given, but successful testing implies meeting an internal standard.)
Drainage effectiveness	Tested for drainage. (Explicit performance value not given, implies effective and improved drainage due to modifications.)
Package integrity	Tested for package integrity. (Explicit performance value not given, implies maintaining sterility and protection.)
Reduction of needlestick injuries	Needleless sampling sites were designed to reduce needlestick injuries and subsequent exposure to infected fluids in compliance with the Needlestick Safety and Prevention Act, H.R.5178.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for these safety tests (e.g., how many vents were tested for occlusion, how many systems for sterility). The data provenance is not mentioned, as these are likely internal lab tests rather than clinical data from a specific country. They are prospective tests conducted on the modified device components.

3. 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. This is not an AI/diagnostic imaging device where expert ground truth is typically established. The "ground truth" here is determined by objective laboratory measurements and biological analyses (e.g., microbial retention, sterility tests).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of imaging/clinical data, which is not relevant to the described engineering and biological safety tests.

5. 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. This device is an external CSF drainage and monitoring system, not an AI-assisted diagnostic or interpretation tool. No human reader studies were conducted for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests described is based on objective laboratory measurements and established scientific standards for sterility, microbial retention, physical integrity (tensile strength, pressure/leakage), and functional performance (drainage, occlusion resistance). For example, sterility is a binary outcome determined by microbial culture. Microbial retention is a measurable percentage.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses training sets.

9. How the ground truth for the training set was established

Not applicable.

Summary

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AUG 2 3 2002

Confidential

22554/

MoniTorr ICP™ External CSF Drainage and Monitoring System

510(k) SUMMARY

Submitter's name and address:

Integra NeuroSciences 309 Commerce Drive Exton, PA 19341

Contact person and telephone number:

Donna R. Wallace Director, Regulatory Affairs (609) 275-0500

Date summary was prepared:

August 1, 2002

Name of the device:

Proprietary Name:	MoniTorr ICPTM External CSF Drainage and Monitoring System
Common Name:	External Cerebrospinal Fluid Drainage and Monitoring System
Classification Name:	Central Nervous System Shunt and Components JXG

Substantial Equivalence:

The MoniTorr ICP™ External CSF Drainage and Monitoring System is substantially equivalent in function and intended use to the unmodified MoniTorr™ External CSF Drainage and Monitoring System which has been cleared to market under Premarket Notification 510(k) K920156.

Intended use:

Device Description:

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line between the burette and the drainage bag. In systems with this burette, an antimicrobial vent is included in the burette cap. This antimicrobial vent allows air to enter the burette to facilitate drainage from the burette to the drainage bag while protecting the system from microbial contamination. The antimicrobial vent used on the current MoniTorr ICPTM systems is being replaced with a vent that will allow better drainage of the CSF to the drainage bag and will better resist occlusion after contact with CSF. The antimicrobial media chosen for the vent is not compatible with the current method of sterilization, therefore, an alternate sterilization method, ethylene oxide has been chosen to sterilize the entire line of MoniTorr ICP™ systems. A vented cap will be used in place of the current closed end cap to allow flow of gas through the patient line.

Additionally, the fluid path from the burette to the drainage bag has been enlarged and the current sampling sites are being replaced with needleless sampling sites.

Safety

The MoniTorr ICP™ External CSF Drainage and Monitoring Systems have been shown to be sterile and non-pyrogenic. Testing has shown that the antimicrobial vent is resistant to occlusion after 30 minutes of exposure to fluids with high protein levels. The antimicrobial media was subjected to an aerosol challenge with B.diminuta yielding a microbial retention of 10'. The MoniTorr ICP™ systems have been tested for tensile strength of bonded components, pressure and leakage, drainage, and package integrity. Additionally, the needleless sampling sites were designed to reduce needlestick injuries and subsequent exposure to infected fluids in compliance with the Needlestick Safety and Prevention Act, H.R.5178.

Conclusion

The MoniTorr ICP™ External CSF Drainage and Monitoring System is substantially equivalent to the unmodified MoniTorr ICP™ system. The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2007

Integra NeuroSciences Donna R. Wallace Director, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K022554

Trade/Device Name: MoniTorr ICP™ External CSF Drainage and Monitoring System Regulation Number: 882.5550 Regulation Name: Central Nervous System Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: August 1, 2002 Received: August 2, 2002

Dear Ms. Wallace:

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 – Ms. Donna R. Wallace

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark N. Mullenn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

K022554 510(k) Number:

Device Name: MoniTorr ICP™ External Drainage and Monitoring Systems

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use(Per 21 CFR 801.109
Optional Format 1-2-96)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Or Over-the-Counter Use __________

for Mark N Melkerson

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

C001	510(k) Number K022534
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Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).