(29 days)
Not Found
No
The device description focuses on mechanical components for fluid drainage and monitoring, with no mention of AI or ML capabilities.
Yes
The device is indicated for draining and monitoring cerebrospinal fluid to reduce intracranial pressure and provide temporary CSF drainage, which directly treats a patient's condition.
No
The device is primarily a drainage and monitoring system for CSF, and while it monitors ICP and CSF, it does not diagnose a condition.
No
The device description clearly outlines physical components like catheters, drainage bags, burettes, stopcocks, vents, and a safety locking knob, 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 draining and monitoring cerebrospinal fluid (CSF) to manage intracranial pressure and provide temporary drainage. This is a therapeutic and monitoring function performed directly on the patient's body.
- Device Description: The device is a system for physically draining fluid from the brain or spinal cord and collecting it in a bag. It involves physical connections to the patient's body.
- Lack of Diagnostic Function: The description does not mention any analysis of the CSF for diagnostic purposes (e.g., testing for specific substances, cells, or pathogens). While CSF is collected, the primary function is drainage and monitoring of pressure and volume, not in vitro analysis to diagnose a condition.
IVD devices are used to examine specimens (like blood, urine, or CSF) outside the body to provide information for diagnosis, monitoring, or treatment decisions. This device operates within the body (via the catheter connection) and its primary function is physical drainage and monitoring.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JXG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles of the brain or lumbar subarachnoid space
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)
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.
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).
0
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:
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
1
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.
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 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
3
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) |
|---|
| -------------------------------------------------------- |
| Prescription Use
| (Per 21 CFR 801.109 |
|---|
| ----------------------------------------- |
Or
| Over-the-Counter Use |
|---|
| ---------------------- |
Optional Format 1-2-96)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030289