(88 days)
Not Found
No
The summary describes a physical catheter for CSF drainage and monitoring, with no mention of software, algorithms, or AI/ML terms.
Yes.
The device is used for cerebrospinal fluid (CSF) drainage and/or monitoring from the brain, which are therapeutic interventions.
No
The device is described as a component for cerebrospinal fluid (CSF) drainage and/or monitoring. While monitoring can involve collecting information, the primary stated function of the device is drainage, and the "monitoring" aspect is within the context of fluid dynamics, rather than generating diagnostic insights or diagnoses.
No
The device description clearly states it is a physical catheter made of silicone elastomer, 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 is for "cerebrospinal fluid (CSF) drainage and/or monitoring from the lateral ventricles of the brain." This is a procedure performed in vivo (within the living body) for therapeutic and monitoring purposes.
- Device Description: The device is a catheter designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, the Medtronic PS Medical EDM Ventricular Catheter with BioGlide is a medical device used for a surgical/monitoring procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"The EDM Ventricular Catheters with BioGlide are designed for use as the proximal component for cerebrospinal fluid (CSF) drainage and/or monitoring from the lateral ventricles of the brain."
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The Medtronic PS Medical EDM Ventricular Description: Catheter with BioGlide is manufactured of translucent silicone elastomer w/barium impregnated stripe. The catheter is provided in two sizes and incorporates a BioGlide surface modification on the interior and exterior of the catheter.
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.
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
Safety and Effectiveness Summary X.
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| 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: | Richard M. Ruedy |
| Date: | March 4, 1998 |
| Trade or Proprietary Name: | Medtronic PS Medical External Drainage an |
| Monitoring (EDM) Ventricular Catheter | |
| w/BioGlide | |
| Common usual or Classification Name: | Ventricular Catheter (882.4100) |
Predicate Device Identification: Codman External Drainage Catheter Set (K902257, K920938), Medtronic PS Medical Ventricular Catheter with BioGlide submitted under the Premarket Notification for the BioGlide Shunt Kit (K951258)
The Medtronic PS Medical EDM Ventricular Description: Catheter with BioGlide is manufactured of translucent silicone elastomer w/barium impregnated stripe. The catheter is provided in two sizes and incorporates a BioGlide surface modification on the interior and exterior of the catheter.
The Medtronic PS Medical EDM Ventricular Intended Use: Catheters with BioGlide are designed for use as the proximal component for cerebrospinal fluid (CSF) drainage and/or monitoring from the lateral ventricles of the brain.
Intended Use predicate device: "Use of the Codman External Drainage Catheter Set 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."
Technological comparison: Medtronic PS Medical submits that the materials of fabrication, intended uses, performance characteristics and design specifications of the EDM Ventricular Catheter with BioGlide 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
1
EDM Ventricular Catheter with BioGlide based upon the predicate and currently marketed devices.
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.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Feature | Medtronic PS
Medical EDM
Catheter with
BioGlide | Medtronic PS
Medical Ventricular
Catheter with
BioGlide | Codman External
Drainage Catheter
Set |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Silicone elastomer, | Silicone elastomer, | Silicone elastomer, |
| Dimensions | Diameter 1-3mm
Length 20-40cm | Diameter 1-3mm
Length 20-40cm | 1-4mm |
| Sterility Method | EtO | EtO | not specified |
| Sterile | Sterile single use
device | Sterile single use
device | Sterile single use
device |
| Intended Use | The device is indicated for
use as the proximal
component for draining and
monitoring of CSF flow from
the lateral ventricles of the
brain. | The ventricular Catheter is
designed for use as the
proximal component of a
CSF Flow Control Shunt for
use in shunting
cerebrospinal fluid from the
ventricles of the brain into
the right atrium of the heart
or to the peritoneal cavity. | The Codman External
Drainage Catheter Set 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. |
:
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized emblem, which is a symbol representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 1998
Mr. Richard M. Ruedy ·Medtronic PS Medical 125 Cremona Drive Goleta, California 93117-5500
Re: K981046
Trade Name: Medtronic PS Medical External Drainage and Monitoring (EDM) Ventricular Catheter with BioGlide Regulatory Class: II Product Code: JXG Dated: March 17, 1998 Received: March 20, 1998
Dear Mr. Ruedy:
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.
3
Page 2 - Mr. Richard M. Ruedy
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,
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
ച്ച്
4
Device Name: External Drainage and Monitoring (EDM) Ventricular Catheter with BioGlide
510(k) Number (if known): 长ያ 8 ) o 4 6
Indications for Use:
"The EDM Ventricular Catheters with BioGlide are designed for use as the proximal component for cerebrospinal fluid (CSF) drainage and/or monitoring from the lateral ventricles of the brain."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
(Division Sign-Off)
Division of General Restorative Devices K981046
510(k) Number_
Over the Counter Use:
or
Prescription Use:
(Per 21 CFR 801.109)
Prescription Use
(Per 21 CFR 801.109)
(optional format 1-2-96)