(399 days)
Not Found
No
The device description and intended use focus on mechanical drainage and monitoring of CSF. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies.
Yes.
The device's intended use includes reducing intracranial pressure and providing temporary drainage of CSF, which are therapeutic interventions.
Yes
The device is described as "allowing for pressure monitoring" and "monitoring CSF" and "monitoring ICP," which are diagnostic functions.
No
The device description clearly outlines physical components like a disposable drainage bag, drainage tubing set, calibrated scale, and graduated drip chamber, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for drainage and monitoring of cerebrospinal fluid (CSF) directly from the body (lateral ventricles and lumbar subarachnoid space). This is a therapeutic and monitoring function performed in vivo (within the living body).
- Device Description: The description details a system for collecting and measuring fluid drained from the body. It does not mention any components or processes for analyzing biological samples in vitro (outside the living body) to diagnose a condition.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, assays, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such analysis.
N/A
Intended Use / Indications for Use
The XDS allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The XDS provides a simple to use, closed loop system for the drainage of cerebrospinal fluid (CSF) and allows for pressure monitoring. XDS consists of a disposable drainage bag attached to a drainage tubing set that incorporates a calibrated scale and a graduated drip chamber used for estimation of drainage fluids. The systems will be provided sterile and will be labeled 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 and the 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)
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.
Medtronic Becker External Drainage and Monitoring System, K984053
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
AUG = 4 2000
992226
Attachment V: 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:
COMMON OR USUAL NAME:
CLASSIFICATION CODE:
PREDICATE DEVICE:
DESCRIPTION:
INTENDED USE:
Radionics External CSF Drainage and Monitoring System (XDS) External Drainage System
Shunt, Central Nervous System and Components 21 CFR, Section: 882.5550
Medtronic Becker External Drainage and Monitoring System, K984053
The XDS provides a simple to use, closed loop system for the drainage of cerebrospinal fluid (CSF) and allows for pressure monitoring. XDS consists of a disposable drainage bag attached to a drainage tubing set that incorporates a calibrated scale and a graduated drip chamber used for estimation of drainage fluids. The systems will be provided sterile and will be labeled for single use only.
The XDS allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above three wavy lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2000 AUG
Mr. Kevin J. O'Connell Senior Regulatory Associate Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803
K992226 Re:
Trade Name: External CSF Drainage and Monitoring System Regulatory Class: II Product Code: JXG Dated: May 9, 2000 Received: May 10, 2000
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 ass bated in 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 vours.
Danne R. Lochner.
1 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
3
2.0 ODE Indications Statement
Page 1 of 1
510(k) Number (if known): K992226
Device Name: Radionics External CSF Drainage and Monitoring System
Indications for use: Allows for drainage and monitoring of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Dana R. bochner
Division Sign-Off) Division of General Restorative Devices 510(k) Number 4992226
PRESCRIPTION USE
(Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)