The External Drainage Set is designed for cerebrospinal fluid (CSF) drainage, sampling and collection. The system connects to a ventricular or lumbar catheter via a Luer connection to a patient line.

The graduated cylinder of the External Drainage Set is attached to an IV pole and may be moved up and down to change positioning of the graduated cylinder by using the Velcro straps. CSF can be collected and measured in the graduated cylinder and subsequently emptied to the drainage bag by opening the stopcock placed in-line between the graduated cylinder and the drainage bag.

A hydrophobic vent filter is included in the graduated cylinder cap of the External Drainage Set. This vent filter allows air to enter the graduated cylinder to facilitate drainage from the graduated cylinder to the drainage bag while protecting the system from contamination.

AI/ML Overview

The provided text describes a 510(k) summary for an "External Drainage Set" and its substantial equivalence to a previously cleared device. It does not contain information about acceptance criteria, detailed device performance studies, sample sizes, expert involvement, or any of the other specific study design elements typically associated with demonstrating performance for a medical device that might use AI or require extensive clinical validation.

Here's why and what information can be extracted:

510(k) summaries primarily focus on demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device and doesn't raise new questions of safety or effectiveness. They are not typically elaborate clinical study reports.
The device in question ("External Drainage Set") appears to be a physical medical instrument for CSF drainage. The context does not suggest it uses AI or complex algorithms.

Given this, I can only fill in the table and address certain prompts based on what is available in the provided document. Many fields will be marked as "Not Applicable/Not Provided" because the document does not contain that type of information.

Acceptance Criteria and Device Performance

Criteria	Acceptance Criteria (Not explicitly stated as numerical targets)	Reported Device Performance
Safety (Biological/Physical)	- Must be sterile. - Bonded components must have adequate tensile strength. - Must withstand pressure and prevent leakage. - Must effectively drain CSF. - Must maintain package integrity. - Needleless sampling sites must reduce needlestick injuries and exposure to infected fluids (in compliance with Needlestick Safety and Prevention Act). - Must not raise new issues of safety.	- The External Drainage Set is provided sterile. - The External Drainage Set has been tested for tensile strength of bonded components. - The External Drainage Set has been tested for pressure and leakage. - The External Drainage Set has been tested for drainage. - The External Drainage Set has been tested for package integrity. - 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. - "The modifications do not affect... do not raise new issues of safety and effectiveness." (Implies meeting safety criteria by virtue of equivalence to predicate)
Effectiveness (Intended Use)	- Must be able to perform cerebrospinal fluid (CSF) drainage. - Must be able to perform CSF sampling. - Must be able to perform CSF collection. - Must be substantially equivalent in function and intended use to the predicate device (K910853). - Must not raise new issues of effectiveness.	- "The External Drainage Set is designed for cerebrospinal fluid (CSF) drainage, sampling and collection." - "CSF can be collected and measured in the graduated cylinder..." - "A hydrophobic vent filter... allows air to enter the graduated cylinder to facilitate drainage..." - "The External Drainage Set is substantially equivalent in function and intended use to the Unmodified External Drainage Set which has been cleared to market under Premarket Notification 510(k) K910853." - "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." (Implies meeting effectiveness criteria by virtue of equivalence to predicate)
Material/Design Specifications	- Connects to ventricular or lumbar catheter via Luer connection. - Graduated cylinder attached to IV pole, movable with Velcro straps. - Stopcock between graduated cylinder and drainage bag. - Hydrophobic vent filter in graduated cylinder cap.	- "The system connects to a ventricular or lumbar catheter via a Luer connection to a patient line." - "The graduated cylinder of the External Drainage Set is attached to an IV pole and may be moved up and down to change positioning of the graduated cylinder by using the Velcro straps." - "CSF can be collected and measured in the graduated cylinder and subsequently emptied to the drainage bag by opening the stopcock placed in-line between the graduated cylinder and the drainage bag." - "A hydrophobic vent filter is included in the graduated cylinder cap..."

Study Information

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not Applicable/Not Provided. The document mentions tests for tensile strength, pressure and leakage, drainage, and package integrity, but does not specify the sample sizes for these engineering or bench tests. It does not describe a clinical test set.
- Data Provenance: Not Applicable/Not Provided. The tests described appear to be bench tests rather than clinical data from specific countries or populations. The manufacturer is based in France with an authorized agent in the US.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided. The document describes engineering/performance tests, not a study requiring expert-established ground truth from, for example, image interpretation or clinical diagnosis.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided. This is not a study design involving adjudication.
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. A MRMC comparative effectiveness study was not performed. This device is a physical drainage set and does not involve human readers or AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. A standalone algorithm performance study was not performed. This device does not incorporate an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the tests mentioned (tensile strength, pressure, leakage, drainage, package integrity) would be based on engineering specifications and established test methods for material and device performance, rather than clinical consensus or outcomes data. For needle-stick prevention, the "ground truth" would be compliance with the specified Act.
The sample size for the training set:
- Not Applicable/Not Provided. This device does not involve a "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not Applicable/Not Provided. This device does not involve a training set.

Summary

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OCT = 6 2003 External Drainage Set

510(k) SUMMARY

Submitter's Name and Address:

Integra NeuroSciences Implants S.A. 2905 Route des Dolines 06921 Sophia Antipolis Cedex, France

Contact Person and Telephone Number:

Anne Bigeard Regulatory Affairs Specialist Integra NeuroSciences Implants S.A. 2905 Route des Dolines 06921 Sophia Antipolis Cedex, France Telephone: 33 4 93 95 56 00

Authorized Agent in the United States:

Judith E. O'Grady Integra LifeSciences Corporation Sr. Vice President Regulatory, Quality and Clinical Affairs 311 Enterprise Drive Plainsboro, NJ 08536, USA Telephone: 609-936-2311

Date Summary was Prepared:

September 9, 2003

Name of Device:

Proprietary Name:	External Drainage Set
Common Name:	External CSF Drainage Systems
Classification Name:	Central Nervous System Shunts and Components JXC

Substantial Equivalence:

The External Drainage Set is substantially equivalent in function and intended use to the Unmodified External Drainage Set which has been cleared to market under Premarket Notification 510(k) K910853.

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Intended Use:

The External Drainage Sets are intended for cerebrospinal fluid (CSF) drainage, sampling and collection.

Device Description:

The External Drainage Set is designed for cerebrospinal fluid (CSF) drainage, sampling and collection. The system connects to a ventricular or lumbar catheter via a Luer connection to a patient line.

Safety:

The External Drainage Set is provided sterile. The External Drainage Set has 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 External Drainage Set is substantially equivalent to the unmodified External Drainage Set. 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 and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a single snake winding around a staff, and the overall design is simple and monochromatic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 6 2003

Integea NeuroSciences Implants S.A. c/o Ms. Judith E. O'Grady Integra LifeSciences Corporation Senior Vice President Regulatory, Quality and Clinical Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K032817

Trade/Device Name: External Drainage Set Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: September 9, 2003 Received: September 11, 2003

Dear Ms. O'Grady:

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. Judith E. O'Grady

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). 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

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INDICATIONS FOR USE STATEMENT

(032 510(k) Number:

Device Name: External Drainage Set

Indications for Use:

The drainage sets are intended for cerebrospinal fluid (CSF) drainage, sampling and collection.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Or Over-the-Counter Use (Per 21 CFR 801.109

Optional Format 1-2-96)

Muriam C. Provost

Tivision S Division of General, Restorative and Neurological Devices

510(k) Number K03287

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).