(90 days)
Not Found
No
The device description and intended use focus on mechanical components for CSF drainage and pressure monitoring, with no mention of AI/ML technologies.
Yes
The "Intended Use / Indications for Use" section explicitly states that drainage is to be used as a "therapeutic maneuver" to reduce intracranial pressure and provide temporary CSF drainage for infected shunts.
Yes
The "Intended Use / Indications for Use" section explicitly states "Monitor CSF chemistry, cytology and physiology" and "The monitoring of the intracranial pressure (ICP) is indicated in selected patients", which are diagnostic activities.
No
The device description clearly outlines physical, reusable hardware components (pressure scale, mounting clamp, laser level) and disposable hardware components (patient line, drip chamber, drainage bag). This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is used for draining and monitoring cerebrospinal fluid (CSF) flow and pressure directly from the patient's body (lateral ventricles or lumbar subarachnoid space). It is a system for managing and observing a physiological process within the patient.
- Lack of Sample Analysis: The device does not perform any analysis on a sample in vitro (outside the body). While it can be used to monitor CSF chemistry, cytology, and physiology, the device itself is not performing the diagnostic test on these aspects. It's facilitating the collection or observation of the fluid.
The device is a therapeutic and monitoring system used in vivo (within the body) or externally connected to the body for drainage and pressure measurement.
N/A
Intended Use / Indications for Use
"Draining and monitoring of CSF flow from the - lateral ventricles or lumbar subarachnoid space is indicated in selected patients to - 1. Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative; - 2. Monitor CSF chemistry, cytology and physiology; - 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with 1. Severe head injury; - 2. Subarachnoid hemorrhage graded III, IV or V preoperatively; - 3. Reves syndrome or similar encephalopathies; - 4. Hydrocephalus; - 5. Intracranial hemorrhage - 6. Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupving lesions."
Product codes (comma separated list FDA assigned to the subject device)
JXG, GWM
Device Description
The reusable portion of the system is comprised of a pressure scale, mounting clamp and optional laser level. All components of the reusable device are integrated during manufacture. The scale has a blue anodized finish with contrasting pressure scale. Down the center of the scale is a track for the disposable device to be retained. The scale is integrated into a pole clamp that has been ergonomically designed to facilitate use. An optional laser device may be attached to the pole clamp. It is used to obtain a zero pressure reference with the patients Foramen of Monro. The disposable device is comprised of three basic elements: a patient line that is attached to an externalized CSF drainage catheter, graduated drip chamber, and drainage bag. The drip chamber has an integrated mounting bracket that is inserted into the track on the reusable scale.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles 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)
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
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).
0
JAN 26 1999
Safety and Effectiveness Summary X.
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 882.1620
| Establishment Registration Number: | 2021898 |
|---|---|
| Address of Manufacturer: | Medtronic PS Medical Corporation |
| 125 Cremona Drive | |
| Goleta CA, 93117 | |
| (805) 968-1546 ext. 1776 | |
| Fax: (805) 968-5038 | |
| Contact Person: | Jeffrey Henderson |
| Date: | July 20, 1998 |
| Trade or Proprietary Name: | Medtronic PS Medical Niveau Drainage |
| System | |
| Common usual or Classification Name: | Intracranial Pressure Monitoring Devices |
| (882.1620) |
Predicate Device Identification:
Codman External Drainage System (K954021), Clinical Neuro Systems MoniTorr (K920156)
Description:
The reusable portion of the system is
comprised of a pressure scale, mounting clamp and optional laser level. All components of the reusable device are integrated during manufacture. The scale has a blue anodized finish with contrasting pressure scale. Down the center of the scale is a track for the disposable device to be retained. The scale is integrated into a pole clamp that has been ergonomically designed to facilitate use. An optional laser device may be attached to the pole clamp. It is used to obtain a zero pressure reference with the patients Foramen of Monro.
The disposable device is comprised of three basic elements: a patient line that is attached to an externalized CSF drainage catheter, graduated drip chamber, and drainage bag. The drip chamber has an integrated mounting bracket that is inserted into the track on the reusable scale.
Intended Use:
"Draining and monitoring of CSF flow from the
- lateral ventricles or lumbar subarachnoid space is indicated in selected patients to
-
- Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative;
-
- Monitor CSF chemistry, cytology and physiology;
-
- Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
The monitoring of the intracranial pressure (ICP) is indicated in selected patients with 1. Severe head injury;
1
-
- Subarachnoid hemorrhage graded III, IV or V preoperatively;
-
- Reves syndrome or similar encephalopathies;
-
- Hydrocephalus;
-
- Intracranial hemorrhage
-
- Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupving lesions."
"The MoniTorr system allows for drainage and Intended Use predicate device: 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."
"Use of the Codman External Drainage System II is indicated for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing and controlling increased intracranial volume and pressure when the insertion of a permanent internal shunt is not indicated."
Medtronic PS Medical submits that the Technological comparison: materials of fabrication, intended uses, performance characteristics and design specifications of the Niveau Drainage System are substantially equivalent to those of the predicate devices. Based upon the summary above, Medtronic PS Medical determines substantial equivalence, safety, and efficacy of the Niveau Drainage System based upon the predicate and currently marketed devices.
2
| Feature | Medtronic PS Medical Niveau
Drainage System | Clinical Neuro Systems MoniTorr | Codman External Drainage System II |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
configuration/
contents | Locking bracket integral with
mounting panel | Pole mount bracket assembly,
braided cord and cord lock | Doubled 24 in. string w/Cord-loc®
locking mechanism |
| | Mounting panel main system
section with pressure scale in
mmHg and cmH20 | System Panel with instruction
label | 27 cm measuring backboard |
| | 50 cc Conical sliding graduated
flow chamber with
locking bracket and vent
system | 100 ml graduated chamber with
filter vent | 75 ml drip chamber with anti-reflux
valve and atmospheric vent |
| | Nondistensible blue striped
patient connection line | Nondistensible green striped
patient connection line | 157 cm patient line with two slide
clamps |
| | Two four way stopcocks | Two four way stopcocks | Two four way stopcocks
with female luer port |
| | One non-latex
injection/sampling sites | Two injection sites | Two latex injection/sampling sites |
| | 500 - 800 ml drainage bag
(removable) with volumetric
graduations, microbial filter and
drain port | 500ml drainage bag with valve
and drain port | 700 ml capacity graduated vinyl
collection bag |
| | Drainage bag connection line | | |
| | Laser leveling device | Line level | |
| Feature | Medtronic PS Medical Niveau
Drainage System | Clinical Neuro Systems MoniTorr | Codman External Drainage System
II |
| Sterility Method | EtO | EtO | not specified |
| Sterile | Sterile device with reusable
mounting panel section and
disposable fluid contact section | Sterile device with reusable
mounting panel section and
disposable fluid contact section | Sterile single use device |
| Intended Use | "Draining and monitoring of CSF flow from the
lateral ventricles or lumbar subarachnoid
space is indicated in selected patients to
Reduce intracranial pressure (ICP), e.g. pre-
intra- or postoperative; Monitor CSF
chemistry, cytology and physiology;
Provide temporary CSF drainage in patients
with infected cerebrospinal fluid shunts.
The monitoring of the intracranial pressure
(ICP) is indicated in selected patients with
Severe head injury; Subarachnoid
hemorrhage graded III, IV or V preoperatively;
Reyes syndrome or similar encephalopathies;
Hydrocephalus; Intracranial hemorrhage
Miscellaneous problems when drainage is to
be used as a therapeutic maneuver.
Monitoring can also be used to evaluate the
status pre-and postoperatively for space
occupying lesions." | "The MoniTorr system 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." | "Use of the Codman External Drainage System II
is indicated for draining cerebrospinal fluid (CSF)
and other fluids of similar physical characteristics
as a means of reducing and controlling increased
intracranial volume and pressure when the
insertion of a permanent internal shunt is not
indicated." |
.
:
3
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 26 1999
Mr. Jeffrey Henderson Vice President, Quality Medtronic PS Medical 125 Cremona Drive Goleta, California 93117
Re: K983799
Trade Name: Medtronic PS Medical Niveau Drainage System Regulatory Class: II Product Code: JXG and GWM Dated: October 23, 1998 Received: October 28, 1998
Dear Mr. Henderson:
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 (OS) 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.
5
Page 2 - Mr. Jeffrey Henderson
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 vour 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,
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
6
Device Name: Niveau Drainage System
510(k) Number (if known):
Indications for Use:
"Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to
-
- Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative;
-
- Monitor CSF chemistry, cvtology and physiology;
-
- Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
The monitoring of the intracranial pressure (ICP) is indicated in selected patients with
-
- Severe head injury:
-
- Subarachnoid hemorrhage graded III, IV or V preoperatively;
-
- Reves syndrome or similar encephalopathies;
-
- Hydrocephalus;
-
- Intracranial hemorrhage
-
- Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
ACD
Division Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use:
(Per 21 CFR 801.109) X
(optional format 1-2-96)