(88 days)
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.
The Medtronic PS Medical EDM Ventricular 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 provided document is a 510(k) summary for the Medtronic PS Medical External Drainage and Monitoring (EDM) Ventricular Catheter with BioGlide. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself.
Therefore, the requested information elements related to acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not contained within this document. This document is a regulatory submission for premarket notification, designed to show equivalence based on material, intended use, and design specifications, not to detail a performance study against specific acceptance metrics.
However, I can extract information related to the device's characteristics and its comparison to predicate devices, which indirectly speaks to its "performance" in the context of substantial equivalence.
Here's a summary of the information that can be extracted from the provided text, along with an explanation of why other requested information is not available:
1. A table of acceptance criteria and the reported device performance
This document describes a comparison to predicate devices to establish substantial equivalence. It does not present specific quantitative acceptance criteria or a formal study with reported device performance against those criteria. The "performance" assessment here is qualitative, based on similarity to already approved devices.
| Feature | Acceptance/Comparison Criteria (Implied) | Reported Device Performance (as listed for the new device) |
|---|---|---|
| Materials | Substantially equivalent to predicate devices (Silicone elastomer). | Silicone elastomer, w/barium impregnated stripe, BioGlide surface modification. |
| Dimensions | Within range or substantially equivalent to predicate devices (1-4mm Dia., 20-40cm Length). | Diameter 1-3mm, Length 20-40cm. |
| Sterility Method | EtO as used by predicate devices (or a recognized method). | EtO. |
| Sterile Status | Sterile single-use device. | Sterile single-use device. |
| Intended Use | Substantially equivalent to predicate devices (CSF drainage/monitoring). | As the proximal component for draining and monitoring of CSF flow from the lateral ventricles of the brain. |
| General | Substantial equivalence in materials, intended uses, performance characteristics, and design specifications. | Claimed substantial equivalence, safety, and efficacy based on predicate and currently marketed devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is a 510(k) premarket notification, which relies on comparison to predicate devices rather than a de novo clinical trial or extensive test set performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Ground truth establishment and expert review in the context of a performance study are not detailed because such a study is not presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for studies comparing device output to expert consensus, which is not the focus of this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A MRMC comparative effectiveness study is not mentioned and is not applicable to this type of device (a ventricular catheter). This is a purely physical medical device, not an AI or imaging-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical ventricular catheter and does not involve an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Ground truth is not discussed in this document as it's not a study on diagnostic accuracy or clinical outcomes in the typical sense. The "ground truth" for this 510(k) is the established performance and safety of the predicate devices.
8. The sample size for the training set
This information is not applicable as the device is not an AI/machine learning model and therefore does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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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 anMonitoring (EDM) Ventricular Catheterw/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
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EDM Ventricular Catheter with BioGlide based upon the predicate and currently marketed devices.
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| Feature | Medtronic PSMedical EDMCatheter withBioGlide | Medtronic PSMedical VentricularCatheter withBioGlide | Codman ExternalDrainage CatheterSet |
|---|---|---|---|
| Materials | Silicone elastomer, | Silicone elastomer, | Silicone elastomer, |
| Dimensions | Diameter 1-3mmLength 20-40cm | Diameter 1-3mmLength 20-40cm | 1-4mm |
| Sterility Method | EtO | EtO | not specified |
| Sterile | Sterile single usedevice | Sterile single usedevice | Sterile single usedevice |
| Intended Use | The device is indicated foruse as the proximalcomponent for draining andmonitoring of CSF flow fromthe lateral ventricles of thebrain. | The ventricular Catheter isdesigned for use as theproximal component of aCSF Flow Control Shunt foruse in shuntingcerebrospinal fluid from theventricles of the brain intothe right atrium of the heartor to the peritoneal cavity. | The Codman ExternalDrainage Catheter Set isindicated for drainingcerebrospinal fluid (CSF)and other fluids of similarphysical characteristics asa means of reducing andcontrolling increasedintracranial volume andpressure when the insertionof a permanent internalshunt is not indicated. |
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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.
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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
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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)
§ 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).