(26 days)
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI/ML terms or functionalities.
No.
The device is for drainage, sampling, and collection of CSF, which are diagnostic and monitoring functions, not therapeutic.
No
The device is described as collecting, measuring, and draining CSF. There is no mention of analysis or interpretation of the collected CSF, or any other diagnostic function.
No
The device description clearly outlines physical components such as a graduated cylinder, IV pole attachment, Velcro straps, stopcock, drainage bag, and a hydrophobic vent filter. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "cerebrospinal fluid (CSF) drainage, sampling and collection." This describes a procedure performed on the patient's body (in vivo) to remove fluid.
- Device Description: The description details a system for collecting and measuring CSF that has been drained from the patient. It involves connecting to a catheter inserted into the patient.
- Lack of In Vitro Activity: An IVD is a device intended for use in the examination of specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to collect the specimen from the body, not to perform tests or analysis on it in vitro.
The device is a tool for a medical procedure (CSF drainage) and for collecting a sample, but it does not perform any diagnostic testing or analysis on that sample itself.
N/A
Intended Use / Indications for Use
The External Drainage Sets are intended for cerebrospinal fluid (CSF) drainage, sampling and collection.
Product codes
JXG
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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.
1
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.
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.
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