MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118

K981046 · Medtronic PS Medical · JXG · Jun 16, 1998 · Neurology

Device Facts

• Record ID: K981046
• Device Name: MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118
• Applicant: Medtronic PS Medical
• Product Code: JXG · Neurology
• Decision Date: Jun 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Translucent silicone elastomer ventricular catheter with barium-impregnated stripe; incorporates BioGlide surface modification on interior and exterior surfaces. Used as proximal component for external cerebrospinal fluid (CSF) drainage and monitoring from lateral ventricles. Operated by clinicians in clinical settings. Catheter facilitates reduction and control of intracranial volume and pressure. BioGlide modification intended to improve surface properties. Device is sterile, single-use.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: Silicone elastomer with barium-impregnated stripe. Surface modification: BioGlide. Dimensions: 1-3mm diameter, 20-40cm length. Sterilization: Ethylene Oxide (EtO). Form factor: Ventricular catheter. Connectivity: None.

Indications for Use

Indicated for drainage and/or monitoring of cerebrospinal fluid (CSF) from the lateral ventricles of the brain in patients requiring intracranial pressure management or fluid drainage when permanent internal shunting is not indicated.

Regulatory Classification

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.

Predicate Devices

• Codman External Drainage Catheter Set (K902257, K920938)
• Medtronic PS Medical Ventricular Catheter with BioGlide (K951258)

Submission Summary (Full Text)

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## Safety and Effectiveness Summary X.

k981046

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 |
| | [phone] ext. 1776 |
| | Fax: [phone] |
| Contact Person: | Richard M. Ruedy |
| Date: | March 4, 1998 |
| Trade or Proprietary Name: | Medtronic PS Medical External Drainage an<br>Monitoring (EDM) Ventricular Catheter<br>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

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EDM Ventricular Catheter with BioGlide based upon the predicate and currently marketed devices.

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| Feature | Medtronic PS<br>Medical EDM<br>Catheter with<br>BioGlide | Medtronic PS<br>Medical Ventricular<br>Catheter with<br>BioGlide | Codman External<br>Drainage Catheter<br>Set |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Silicone elastomer, | Silicone elastomer, | Silicone elastomer, |
| Dimensions | Diameter 1-3mm<br>Length 20-40cm | Diameter 1-3mm<br>Length 20-40cm | 1-4mm |
| Sterility Method | EtO | EtO | not specified |
| Sterile | Sterile single use<br>device | Sterile single use<br>device | Sterile single use<br>device |
| Intended Use | The device is indicated for<br>use as the proximal<br>component for draining and<br>monitoring of CSF flow from<br>the lateral ventricles of the<br>brain. | The ventricular Catheter is<br>designed for use as the<br>proximal component of a<br>CSF Flow Control Shunt for<br>use in shunting<br>cerebrospinal fluid from the<br>ventricles of the brain into<br>the right atrium of the heart<br>or to the peritoneal cavity. | The Codman External<br>Drainage Catheter Set is<br>indicated for draining<br>cerebrospinal fluid (CSF)<br>and other fluids of similar<br>physical characteristics as<br>a means of reducing and<br>controlling increased<br>intracranial volume and<br>pressure when the insertion<br>of a permanent internal<br>shunt 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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"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."

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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)