The Hermetic Plus™ 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 Hermetic Plus™ 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 Hermetic Plus™ systems will allow better drainage of the CSF to the drainage bag and will resist occlusion after contact with CSF without the need for clamping the burette vent tube. The Safety Locking Knob of the Hermetic Plus™ system will now contain a titanium screw component and the cord lock of the suspension cord has been changed to an all plastic component.

AI/ML Overview

The provided 510(k) summary for the Hermetic Plus™ External CSF Drainage System (K030289) focuses on demonstrating substantial equivalence to a predicate device through modifications that do not affect the intended use or fundamental scientific technology, and do not raise new safety or effectiveness issues.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

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

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Substantial Equivalence: Maintain functional and intended use equivalence to predicate (K972994).	"The Hermetic Plus™ External CSF Drainage System is substantially equivalent in function and intended use to the unmodified External CSF Drainage and Management Systems which has been cleared to market under Premarket Notification 510(k) K972994."
MR Safety: Device should be safe for use in an MR environment.	"The Hermetic Plus™ External CSF Drainage Systems have been demonstrated to be MR safe* when used in the Magnetic Resonance (MR) environment." (Definition of MR safe provided).
Antimicrobial Vent Occlusion Resistance: The antimicrobial vent should resist occlusion after fluid exposure.	"Testing has shown that the antimicrobial vent is resistant to occlusion after 30 minutes of exposure to fluids with high protein levels."
Strength of Bonded Components: Components must maintain integrity.	"The systems have been tested for strength of bonded components..."
Leakage: The system must not leak.	"...leakage..."
Drainage: The system must effectively drain CSF.	"...drainage..."
Package Integrity: The packaging must maintain sterility and integrity.	"...and package integrity."
Reduction of Needlestick Injuries: Needleless sampling sites should reduce risk.	"Additionally, the needleless sampling sites were designed to reduce needlestick injuries and subsequent exposure to infected fluids."

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 provide information on the sample size used for any test set or the data provenance. The described tests (MR safety, vent occlusion, strength, leakage, drainage, package integrity) appear to be bench testing or in-vitro tests, rather than clinical studies with human subjects.

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)

This information is not applicable or not provided. The "tests" described appear to be engineering or laboratory-based, not clinical evaluations requiring expert interpretation for ground truth establishment.

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

This information is not applicable or not provided. Adjudication methods are typically used in clinical studies with human expert readers, which is not described here.

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

No MRMC comparative effectiveness study was done, as this device is not an AI-powered diagnostic tool. It is a CSF drainage system.

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

No standalone algorithm performance study was done, as this device is a physical medical device, not an algorithm or AI.

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

For the tests described:

MR Safety: Ground truth would be established by specific MR environment test protocols and measurements.
Antimicrobial Vent Occlusion Resistance, Strength of Bonded Components, Leakage, Drainage, and Package Integrity: Ground truth would be established by engineering specifications, validated test methods, and quantitative measurements.

8. The sample size for the training set

This information is not applicable. This is a physical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for this type of device.

Overall Study Description:

The provided document describes a technical performance and safety study (or series of studies) focused on demonstrating that specific modifications to an existing CSF drainage system do not compromise its safety, effectiveness, or functional equivalence to a previously cleared predicate device. These studies are primarily bench tests or in-vitro tests, rather than clinical trials. The modifications involved a change in an antimicrobial vent material, a titanium screw component in a safety locking knob, and an all-plastic cord lock. The studies aimed to confirm that these changes did not introduce new risks or negatively affect established performance characteristics like drainage efficiency, structural integrity, and MR safety. The primary "study" is the demonstration of substantial equivalence to an existing cleared device (K972994) based on these technical performance assessments.

Summary

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K030289

Hermetic Plus™ External CSF Drainage System

510(k) SUMMARY

FEB 2 6 2003

Submitter's name and address:

Integra LifeSciences Corporation Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536

Contact person and telephone number:

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

Date summary was prepared:

January 24, 2003

Name of the device:

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

Substantial Equivalence:

The Hermetic Plus™ External CSF Drainage System is substantially equivalent in function and intended use to the unmodified External CSF Drainage and Management Systems which has been cleared to market under Premarket Notification 510(k) K972994.

Intended use:

Device Description:

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antimicrobial vent used on the Hermetic Plus™ systems will allow better drainage of the CSF to the drainage bag and will resist occlusion after contact with CSF without the need for clamping the burette vent tube.

The Safety Locking Knob of the Hermetic Plus™ system will now contain a titanium screw component and the cord lock of the suspension cord has been changed to an all plastic component.

Safety

The Hermetic Plus™ 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 Hermetic Plus™ External CSF Drainage System is substantially equivalent to the unmodified External CSF Drainage Management Systems. 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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

FEB 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030289

Trade/Device Name: Hermetic Plus™ External CSF Drainage Systems Regulation Number: 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: Class II Product Code: JXG Dated: January 27, 2003 Received: January 28, 2003

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

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Page 2 – Ms. Donna R. Wallace

(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. 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Miriam C. Provost

for 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: Device Name: Hermetic Plus" External CSF Drainage System

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use(Per 21 CFR 801.109
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Over-the-Counter Use
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Optional Format 1-2-96)

Muriam C. Provost

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

510(k) Number K030289

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).