CSF400 AND CSF600

K030081 · Inmed Ltda. · JXG · Oct 6, 2003 · Neurology

Device Facts

• Record ID: K030081
• Device Name: CSF400 AND CSF600
• Applicant: Inmed Ltda.
• Product Code: JXG · Neurology
• Decision Date: Oct 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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).

Device Story

CSF400™ and CSF600™ are disposable external ventricular drainage (EVD) systems. Input: cerebrospinal fluid (CSF) drained from brain ventricles via a radiopaque silicone catheter. System components: 400/600 ml collection bag, 50 ml reservoir, drip chamber for flow visualization/measurement, one-way valve to prevent reflux, 3-way stopcock, and 20 cc priming syringe. Operation: catheter inserted into ventricular cavity using a 30 cm stainless steel stylet; system facilitates drainage, fluid injection, CSF sampling, and intracranial pressure monitoring. Used in clinical settings by healthcare professionals. Output: collected CSF volume and visual flow rate monitoring. Benefits: provides controlled drainage and pressure relief for patients with hydrocephalus or elevated intracranial pressure.

Clinical Evidence

No clinical data. Substantial equivalence is based on descriptive comparisons of technological characteristics, design, and intended use.

Technological Characteristics

Disposable EVD system. Materials: radiopaque silicone catheter, stainless steel stylet. Components: collection bag (400/600 ml), reservoir, drip chamber, one-way valve, 3-way stopcock. Non-powered, mechanical device. Sterile, single-use.

Indications for Use

Indicated for patients requiring cerebrospinal fluid drainage to relieve elevated intracranial pressure or fluid volume, such as those with hydrocephalus.

Regulatory Classification

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.

Predicate Devices

• External Ventricular Drainage System from Heyer Schulte (K820247)

Submission Summary (Full Text)

{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 Dr<br>Alpharetta, GA 30022 USA |
| 3-Phone: | [phone] |
| 4-Fax: | [phone] |
| 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:

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.

## 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),

13

{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 [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

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

510(k) Number (if known): K030081

Device Name: CSF400™ and CSF600™

Indications for Use:

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).

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