(54 days)
K922941, 510(k) unk
Not Found
No
The device description and the lack of any mention of AI, ML, image processing, or performance studies related to algorithmic analysis strongly suggest this is a traditional medical device without AI/ML components.
Yes.
The device is used for CSF drainage, which is a therapeutic intervention aimed at relieving pressure or removing excess fluid, making it a therapeutic device.
No
The device is described as a catheter for CSF drainage or monitoring, which implies a therapeutic or monitoring function, not a diagnostic one. It facilitates access to CSF but doesn't analyze or process information to make a diagnosis.
No
The device description clearly states it is a physical catheter made of silicone tubing with flow holes and a luer lock connector, indicating it is a hardware 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 "CSF drainage or monitoring from the lateral ventricles of the brain." This is a procedure performed in vivo (within the living body) to manage or assess a physiological fluid.
- Device Description: The description details a physical catheter designed for insertion into the body.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health. This device does not perform such an analysis.
The device described is a medical device used for a surgical or clinical procedure, not for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
As the proximal component for CSF drainage or monitoring from the lateral ventricles of the brain.
Product codes
JXG
Device Description
The External Drainage Ventricular Catheter consists of a barium impregnated silicone tubing with flow holes at the distal end and a luer lock connector for attachment to an external drainage system. It is provided sterile for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles of the brain
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.
K922941, 510(k) unk
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
9923779
SEP 8 1999
Attachment.VI: Summary of Safety and Effectiveness Information [510(k) Summary]
| SUBMITTER: | Radionics Inc,
76 Cambridge Street
Burlington, MA 01803
Tel.: (781) 272-1233
Fax: (781) 272-2428
Contact: Kevin J. O'Connell
Regulatory Engineer |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PROPRIETARY NAME: | Radionics XDC Ventricular Catheter |
| COMMON OR USUAL
NAME: | External Drainage Ventricular Catheter |
| CLASSIFICATION CODE: | Shunt, Central Nervous System and Components
21 CFR, Section: 882.5550 |
| PREDICATE DEVICE: | Clinical Neuro System's MoniTorr ICP™ Ventricular Catheter,
K922941
Medtronic Becker EDM Ventricular Catheters, 510(k) unk |
| DESCRIPTION: | The External Drainage Ventricular Catheter consists of a barium
impregnated silicone tubing with flow holes at the distal end and
a luer lock connector for attachment to an external drainage
system. It is provided sterile for single use only. |
| INTENDED USE: | As the proximal component for CSF drainage or monitoring
from the lateral ventricles of the brain |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 8 1999
Mr. Kevin J. O'Connell Regulatory Engineer Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803
K992379 Re:
Trade Name: Radionics XDC Ventricular Catheter Regulatory Class: II Product Code: JXG Dated: July 15, 1999 Received: July 16, 1999
Dear Mr. O'Connell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Kevin J. O'Connell
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
fi
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
3
2.0 ODE Indications Statement:
Page 1 of 1
510(k) Number (if known): __ K992379
Device Name: Radionics XDC Ventricular Catheter
Indications for use: As the proximal component for CSF drainage or monitoring from the lateral ventricles of the brain.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
bocello
19
PRESCRIPTION USE X
OR
Over-The-Counter Use
(Per 21 CFR 801.109
(Optional Format 1-2-96)