(270 days)
Not Found
No
The device description focuses on mechanical components for fluid drainage and measurement, with no mention of computational analysis, algorithms, or learning capabilities.
Yes
The device is used to relieve elevated intracranial pressure or fluid volume, which is a therapeutic intervention.
No
The device is described as a system for drainage of cerebrospinal fluid to relieve elevated intracranial pressure or fluid volume, indicating a therapeutic rather than diagnostic function. While it allows for "approximate volume measurement" and "visualization of the CSF flow," these are supportive features for managing the drainage rather than for diagnosing a condition. The "CSF sampling" capability could be considered diagnostic, but it is not the primary stated function of the device, which is draining fluid.
No
The device description clearly outlines a physical, disposable system with components like catheters, collection bags, valves, and syringes, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the drainage of cerebrospinal fluid to relieve elevated intracranial pressure or fluid volume. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details a system for physically collecting fluid and measuring its volume. It does not describe any components or processes for analyzing the fluid's properties or composition to diagnose a condition.
- Lack of Diagnostic Function: The device facilitates fluid drainage, injection, sampling, and pressure monitoring. While CSF sampling can be used for diagnostic purposes, the device itself is the tool for obtaining the sample and managing pressure, not for performing the diagnostic analysis on the sample.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, or CSF) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's primary function is mechanical drainage and fluid management.
N/A
Intended Use / Indications for 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).
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).
Product codes (comma separated list FDA assigned to the subject device)
JXG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain ventricles
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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 |
| Alpharetta, 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:
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),
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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.
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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 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.
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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
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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)
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