ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM

• K Number: K042825
• Device Name: ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
• Manufacturer: INTEGRA LIFESCIENCES CORPORATION
• Date Cleared: 2004-12-21 ( 70 days)
• Product Code: JXG
• Regulation Number: 882.5550

Intended Use

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.

Predicate Devices

K/DEN number: JXG

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical components for fluid drainage and monitoring, with no mention of AI/ML algorithms or data processing for decision-making or analysis.

Therapeutic

Yes
The device is indicated for reducing intracranial pressure (ICP), monitoring ICP and CSF, and providing temporary CSF drainage, all of which are therapeutic interventions.

Diagnostic

No

The device is primarily indicated for draining and monitoring of cerebrospinal fluid (CSF) and intracranial pressure (ICP), and for temporary CSF drainage. While it monitors these parameters, its main function is therapeutic (draining) rather than diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as catheters, luer connections, patient lines, drainage bags, burettes, stopcocks, and antimicrobial vents, indicating it is a hardware-based system for draining and monitoring CSF.

IVD (In Vitro Diagnostic)

Based on the provided information, the AccuDrain™ External CSF Drainage System is not an IVD (In Vitro Diagnostic) device.

Here's why:

• IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
• The AccuDrain™ system is designed to drain and monitor cerebrospinal fluid from the body. It's a system for managing fluid within the patient, not for analyzing a sample of that fluid in a lab setting.
• The description focuses on the mechanical aspects of drainage and collection, not on any analytical or diagnostic testing of the CSF itself. While CSF is collected, the system's purpose is drainage and measurement of volume, not analysis of its composition for diagnostic purposes.

Therefore, the AccuDrain™ External CSF Drainage System is a medical device used for therapeutic and monitoring purposes in vivo, not an IVD device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

JXG

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lateral ventricles of the brain or lumbar subarachnoid space

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

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.

Key Metrics

Not Found

Predicate Device(s)

Hermetic Plus™ External CSF Drainage System, Integra NeuroSciences External Drainage Set (EDS), Codman® External Drainage System (EDS3TM)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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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: [phone] Facsimile: [phone]

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:

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™

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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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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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)

Or

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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