This device is a disposable system designed for the drainage of cerebrospinal fluid from the brain ventricles to a calibrated collection bag, graduated to provide an approximate volume measurement of the fluid collected, and is indicated for use to relieve elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus).

Device Description

CSF (TM) is a disposable system designed for the drainage of cebrospinal fluid from the brain ventricles to a calibrated collection bag, graduated to provide an approximate volume measurement of the fluid collected. The radiopaque silicone ventricular catheter has been specially designed to drain the cerebropinal fluid from the ventricles through a series of perforations, and it can be inserted into the ventricular cavity with a 30 cm stainless steel stylet included in the system. The CSF (TM) includes a 400 or 600 ml collection bag (respectively CSF400™ and CSF600™) with a bottom drainage port, a small reservoir of 50 ml for liquid just drained, a 270 mm height scale for system 600 and 200 mm for model 400 which is used for positioning the collection unit, a drip chamber which enables visualization of the CSF flow as the fluid enters the bag and permits an approximate measurement of the drainage flow rate, a one-way valve to prevent reflux of the fluid, a 3 way stopcock and a 20 cc syringe to prime the system before its connection to the catheter. The system is designed to facilitate ventricular drainage, fluid injection, CSF sampling and intracranial pressure monitoring. The CSF (TM) system is presented individually packed and sterile.

AI/ML Overview

This submission describes the CSF400™ and CSF600™ Central Nervous System Fluid Drainage Sets, which are disposable systems designed for the drainage of cerebrospinal fluid from the brain ventricles to a calibrated collection bag. The purpose of this document is to determine whether the device meets acceptance criteria based on the provided information.

1. Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device rather than defining and meeting specific analytical or clinical performance acceptance criteria with numerical targets. Therefore, the "acceptance criteria" are implied to be that the device exhibits "Similar" or "Identical" technological characteristics across various categories when compared to the predicate device.

Technological Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (vs. K820247)
Indications for use	Identical (or substantially similar)	Identical
Target population	Identical (or substantially similar)	Identical
Design	Similar	Similar
Materials	Similar	Similar
Performance	Similar	Similar
Sterility	Similar	Similar
Biocompatibility	Similar	Similar
Mechanical safety	Similar	Similar
Chemical safety	Not Applicable	Not Applicable
Anatomical sites	Identical (or substantially similar)	Identical
Human factors	Similar	Similar
Energy used and/or delivered	Identical (or substantially similar)	Identical
Compatibility with environment and other devices	Identical (or substantially similar)	Identical
Where used	Identical (or substantially similar)	Identical
Standards met	Similar	Similar
Electrical safety	Not Applicable	Not Applicable
Thermal safety	Not Applicable	Not Applicable
Radiation safety	Not Applicable	Not Applicable

Summary of Device Performance: The device's performance is reported as "Similar" or "Identical" across all relevant technological characteristics when compared to the predicate device, K820247. This fulfills the implicit acceptance criteria for substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

The provided document does not describe a specific "test set" in the context of an algorithm's performance evaluation. This submission is a 510(k) premarket notification for a medical device (a CSF drainage set), not an AI/ML software device. Therefore, there is no discussion of a test set, sample size for a test set, or data provenance in the way one would analyze an AI/ML algorithm.

The demonstration of safety and effectiveness relies on comparison to a predicate device, assuming similar engineering, materials, and clinical indications imply similar safety and efficacy.

3. Number of Experts and Qualifications for Ground Truth of Test Set

As this is a 510(k) for a physical medical device and not an AI/ML algorithm, there is no mention or requirement for ground truth established by experts for a test set. The substantial equivalence is determined by reviewing the technological characteristics and intended use in comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Since there is no "test set" for an algorithm's performance, no adjudication method is described or relevant in this 510(k) submission.

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

An MRMC comparative effectiveness study is typically relevant for evaluating the impact of AI systems on human reader performance (e.g., radiologists interpreting images). This submission does not discuss an MRMC study, as it is for a physical medical device (CSF drainage set) and not an AI/ML diagnostic or assistive tool. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. Standalone Algorithm Performance Study

A standalone performance study (algorithm only, without human-in-the-loop) is a concept applicable to AI/ML software devices. This submission does not include or refer to a standalone algorithm performance study as the device is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

For a physical medical device like the CSF drainage set, the "ground truth" for demonstrating safety and effectiveness is generally derived from:

Established engineering principles and testing: Verifying material properties, mechanical integrity, sterility, biocompatibility, etc., against recognized standards.
Clinical experience with predicate devices: Relying on the known safety and efficacy profile of a substantially equivalent device already on the market.
Performance testing: While not explicitly detailed as "ground truth," performance characteristics like flow rates, volume measurements, and prevention of reflux would be validated through engineering tests.

The document's statement: "This device is safe and effective as the other predicate device cited above" indicates that the ground truth for safety and effectiveness is tied to the established safety and effectiveness of the predicate device (K820247).

8. Sample Size for the Training Set

The concept of a "training set" applies to machine learning algorithms. This 510(k) submission for a physical medical device does not involve or mention a training set.

9. How the Ground Truth for the Training Set was Established

As there is no training set mentioned or applicable for this type of device submission, there is no discussion of how ground truth for a training set was established.

Summary

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

510(k) Summary OCT - 6 2003 As Required by 21 section 807.92 ( c )

1-Submitter Name:	Mansour Consulting LLC
2-Address:	1308 Morningside Park DrAlpharetta, GA 30022 USA
3-Phone:	(678) 908-8180
4-Fax:	(425) 795-9341
5-Contact Person:	Jay Mansour
6-Date summary prepared:	December 28th, 2002
7-Device Trade or Proprietary Name:	CSF400™ and CSF600™
8-Device Common or usual name:	Central nervous system fluid drainage set
9-Device Classification Name:	Central nervous system fluid shunt
10-Substantial Equivalency is claimed against the following device:

External Ventricular Drainage System from Heyer Schulte ● 510k # K820247

11-Description of the Device:

The radiopaque silicone ventricular catheter has been specially designed to drain the cerebropinal fluid from the ventricles through a series of perforations, and it can be inserted into the ventricular cavity with a 30 cm stainless steel stylet included in the system.

The CSF (TM) includes a 400 or 600 ml collection bag (respectively CSF400™ and CSF600™) with a bottom drainage port, a small reservoir of 50 ml for liquid just drained, a 270 mm height scale for system 600 and 200 mm for model 400 which is used for positioning the collection unit, a drip chamber which enables visualization of the CSF flow as the fluid enters the bag and permits an approximate measurement of the drainage flow rate, a one-way valve to prevent reflux of the fluid, a 3 way stopcock and a 20 cc syringe to prime the system before its connection to the catheter.

The system is designed to facilitate ventricular drainage, fluid injection, CSF sampling and intracranial pressure monitoring.

The CSF (TM) system is presented individually packed and sterile.

12-Intended use of the device:

CSF (TM) is a disposable system designed for the drainage of cerebrospinal fluid from the brain ventricles to a calibrated collection bag, graduated to provide an approximate volume measurement of the fluid collected, and is indicated for use to relieve elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus).

13-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below),

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

K030081

14-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SIMILAR to the predicate device.

FDA file reference number	510k # K820247
Attachments inside notification submission file	510k summary print out
TECHNOLOGICAL CHARACTERISTICS	Comparison result
Indications for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Similar
Sterility	Similar
Biocompatibility	Similar
Mechanical safety	Similar
Chemical safety	Not Applicable
Anatomical sites	Identical
Human factors	Similar
Energy used and/or delivered	Identical
Compatibility with environment and other devices	Identical
Where used	Identical
Standards met	Similar
Electrical safety	Not Applicable
Thermal safety	Not Applicable
Radiation safety	Not Applicable

Image /page/1/Picture/4 description: The image shows the numbers 5, 4, and 3 written in a handwritten style. The numbers are written in black ink on a white background. The numbers are slightly smudged, but they are still legible. The numbers appear to be part of a sequence or list.

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

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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 6 2003

Inmed LTDA c/o Mr. Jay Mansour President Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, Georgia 30022

Re: K030081

Trade/Device Name: CSF400™ and CSF600TM Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: July 21, 2003 Received: July 24, 2003

Dear Mr. Mansour:

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.

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

Page 2 - Mr. Jay Mansour

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

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

510(k) Number (if known): K030081

Device Name: CSF400™ and CSF600™

Indications for Use:

Miriam C. Provost

and Neurological Devi

510(k) Number K03008/

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

----------------------Concurence of CDRH, Office of Device Evaulation (ODE)

(Optional Format 3-10-98)

3 4 13

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).