The AccuDrain™ External CSF Drainage System is indicated for draining and monitoring of cerebrospinal fluid (CSF) from the lateral ventricles of the brain or lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), monitor intracranial pressure, to monitor cerebrospinal fluid, and provide temporary CSF drainage for patients with infected hydrocephalic shunts.

Device Description

The AccuDrain™ External Drainage 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. 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 subsequently emptied into the drainage bag by opening the stopcock placed in line between the burette and the drainage bag. 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 AccuDrain™ systems will allow better drainage of the CSF to the drainage bag and will resist occlusion after contact with CSF.

AI/ML Overview

The Integra LifeSciences Corporation's AccuDrain™ External CSF Drainage System 510(k) summary provides information on the device's substantial equivalence to predicate devices, but does not describe specific acceptance criteria with numerical targets or a detailed study proving the device meets those criteria in the way typically expected for a performance study with detailed metrics.

Instead, the submission focuses on demonstrating safety and equivalence through:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance
MR Safety	Deduced to be MR safe* (no additional risk to patient, but may affect diagnostic information quality)
Antimicrobial Vent Occlusion Resistance	Resistant to occlusion after 30 minutes of exposure to fluids with high protein levels.
Strength of Bonded Components	Tested (passed, implied as no issues reported).
Leakage	Tested (passed, implied as no issues reported).
Drainage	Tested (passed, implied as no issues reported).
Package Integrity	Tested (passed, implied as no issues reported).
Needlestick Injury Reduction	Designed to reduce needlestick injuries (due to needleless sampling sites).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify sample sizes for the testing mentioned (MR safety, vent occlusion, strength, leakage, drainage, package integrity).
The data provenance (country of origin, retrospective/prospective) is not mentioned. These appear to be in-house engineering and bench tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This type of information is not applicable as the "testing" described is primarily mechanical/material performance and safety, not diagnostic accuracy requiring expert interpretation.

4. Adjudication Method:

Not applicable for the type of testing performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not performed or mentioned. The device is a medical device for draining CSF, not an imaging or diagnostic AI tool that would typically involve human reader performance comparison.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone algorithm performance study was not performed or mentioned. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the tests mentioned are based on engineering specifications and established testing methodologies for material properties, fluid dynamics (drainage), and sterility/safety (vent occlusion, package integrity, MR safety definitions). For example, MR safety is defined by the CDRH Magnetic Resonance Working Group.

8. Sample Size for the Training Set:

Not applicable. This medical device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of Device Performance and Equivalence:

The 510(k) submission for the AccuDrain™ External CSF Drainage System focuses on demonstrating substantial equivalence to legally marketed predicate devices (Hermetic Plus™, Integra NeuroSciences EDS, Codman® EDS3TM). The "studies" mentioned are primarily bench testing to ensure the device performs as intended and is safe, without raising new issues compared to its predicates. The claim of "MR safe" and resistance of the antimicrobial vent to occlusion are key safety aspects highlighted. The submission concludes that the device's design does not raise new safety and effectiveness issues, thereby supporting substantial equivalence.

Summary

{0}------------------------------------------------

K042825 1/2

AccuDrain™ External CSF Drainage System

510(k) SUMMARY

Submitter's Name and Address:

Integra LifeSciences Corporation (d/b/a Integra NeuroSciences) 311 Enterprise Drive Plainsboro, NJ 08536

Contact Person and Telephone Number:

Darlene M. Welsh, RAC Sr. Regulatory Project Manager Telephone: (609) 275-0500 Facsimile: (609) 275-9445

Date of Summary:

October 7, 2004

Name of the Device:

Proprietary Name:	AccuDrain™ External CSF Drainage System
Common Name:	External CSF Drainage System
Classification Name:	Central Nervous System Shunt and Components JXG

Substantial Equivalence:

The AccuDrain™ External CSF Drainage System is substantially equivalent in function and intended use to the Hermetic Plus™ External CSF Drainage System, Integra NeuroSciences External Drainage Set (EDS) and the Codman® External Drainage System (EDS3TM).

Intended Use:

Device Description:

{1}------------------------------------------------

K042825 2/2

systems will allow better drainage of the CSF to the drainage bag and will resist occlusion after contact with CSF.

Safety

The AccuDrain™ External CSF Drainage Systems have been demonstrated to be MR safe* when used in the Magnetic Resonance (MR) environment.

*MRI safe is defined by the CDRH Magnetic Resonance Working Group (Feb. 7, 1997) draft document A Primer on Medical Device Interactions with MRI Systems as "The device, when used in the MRI environment, has been demonstrated to present no additional risk to the patient or other individuals, but may affect the quality of the diagnostic information."

Testing has shown that the antimicrobial vent is resistant to occlusion after 30 minutes of exposure to fluids with high protein levels. The systems have been tested for strength of bonded components, leakage, drainage, and package integrity. Additionally, the needleless sampling sites were designed to reduce needlestick injuries and subsequent exposure to infected fluids.

Conclusion

The AccuDrain™ External CSF Drainage System is substantially equivalent to Hermetic Plus™ External CSF Drainage Systems, Integra NeuroSciences External Drainage Set (EDS) and the Codman® External Drainage System (EDS3TM).

The design of the AccuDrain™ External CSF Drainage System does not raise any new issues of safety and effectiveness.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2004

Ms. Darlene M. Welsh Senior Regulatory Project Manager Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K042825

Trade/Device Name: AccuDrain™ External CSF Drainage System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: November 18, 2004 Received: November 23, 2004

Dear Ms. Welsh:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becalent b r (a) pe 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 encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 2011 - 12:00 accordance with the provisions of the Federal Food, Drug, de nees mat have been route approval of a premarket approval approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aterers, inisers of the Act include requirements for annual registration, listing of general obtitle provision 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 If your device is elassinon controls. Existing major regulations affecting your device can he 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 r read or note 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.

{3}------------------------------------------------

Page 2 - Ms. Darlene M. Welsh

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 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,

Miriam C. Provost

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

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K042825

Device Name: AccuDrain™ External CSF Drainage System

Indications for Use:

Draining and monitoring of Cerebrospinal Fluid (CSF) flow from the ventricles of the brain or lumbar subarachnoid space is indicated in selected patients to:

. Reduce Intracranial Pressure (ICP)
. Monitor Intracranial Pressure (ICP)
. Monitor Cerebrospinal Fluid (CSF)
. Provide temporary CSF drainage

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K042825

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

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

の 2006年 10月 2007 10:00 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 1

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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).