MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015

K990333 · Medtronic PS Medical · GWG · Apr 28, 1999 · Neurology

Device Facts

• Record ID: K990333
• Device Name: MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015
• Applicant: Medtronic PS Medical
• Product Code: GWG · Neurology
• Decision Date: Apr 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Intended Use

The Introducer Sheath is a device used to make a channel through the brain into the ventricular system.

Device Story

The Medtronic PS Medical Endoscope Introducer consists of a peel-away sheath and a blunt-ended obturator. It is used to create an atraumatic channel through the brain into the ventricular system. The device is intended for use by clinicians during intracranial procedures. By providing a stable, temporary pathway, it allows for the insertion of endoscopes or other instruments, facilitating diagnostic or therapeutic interventions. The device is a sterile, single-use instrument.

Clinical Evidence

Bench testing only.

Technological Characteristics

Device consists of a peel-away sheath and blunt-ended obturator. Sterilized via Ethylene Oxide (EtO). Single-use, sterile, non-powered mechanical instrument.

Indications for Use

Indicated for creating a channel through the brain into the ventricular system to facilitate intracranial procedures.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

• Navigational F Sheath (K931973)
• Codman Peel Away Sheath (K883607)

Submission Summary (Full Text)

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4/28/99

X. **Safety and Effectiveness Summary**

K990332

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 882.4545

| Establishment Registration Number: | 2021898 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Address of Manufacturer: | Medtronic PS Medical Corporation<br>125 Cremona Drive<br>Goleta CA, 93117<br>[phone] ext. 1776<br>Fax: [phone] |
| Contact Person: | Jeffrey Henderson |
| Date: | January 29, 1998 |
| Trade or Proprietary Name: | Medtronic PS Medical Endoscope Introducer |
| Common usual or Classification Name: | Instrument, Shunt System<br>(882.4545) |

Navigational F Sheath (K931973) Codman Peel Away Sheath (K883607)

Description:

The Introducer Sheath includes two parts, a peelaway sheath and a blunt ended obturator, which fits inside the sheath. The Introducer Sheath provides an atraumatic passage into the ventricular system.

The Introducer Sheath is a device used to Intended Use: make a channel through the brain into the ventricular system

Intended Use predicate device: The Disposable Neuroview Endoscope is intended for use in direct visualization, diagnosis of disease and therapeutic applications for intracranial procedures (e.g., biopsy, tumor resection, coagulation of choroid plexus, cyst fenestration, shunt placement, etc.),

Technological comparison: Medtronic PS Medical submits that the materials of fabrication, intended uses, performance characteristics and design specifications of the Endoscope Introducer 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 Endoscope Introducer based upon the predicate and currently marketed devices.

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| Feature | Medtronic PS Medical<br>Endoscope Introducer | Neuro Navigational Peel Away<br>Introducer Sheath | Codman Peel Away Sheath |
|--------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Device<br>configuration/<br>contents | • Peel Away Sheath<br>• Obturator | • Peel Away Sheath<br>• Obturator | • Peel Away Sheath<br>• Obturator |
| Sterility Method | EtO | not specified | not specified |
| Sterile | Sterile single use device | Sterile device single use | Sterile single use device |
| Intended Use | The Introducer Sheath is a device used to make a<br>channel through the brain into the ventricular system. | The Disposable Neuroview Endoscope is intended<br>for use in direct visualization, diagnosis of disease<br>and therapeutic applications for intracranial<br>procedures (e.g., biopsy, tumor resection,<br>coagulation of choroid plexus, cyst fenestration,<br>shunt placement, etc.). | not specified |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, stylized with thick, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 1999

Mr. Jeffrey Henderson Vice President, Quality Medtronic PS Medical 125 Cremona Drive Goleta, California 93117

Re: K990333 Trade Name: Endoscope Introducer Regulatory Class: II Product Code: GWG Dated: January 29, 1999 Received: February 3, 1999

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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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. 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 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,

Colin M. Wittwer, Ph.D., MD

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: Endoscope Introducer

Indications for Use:

The Introducer Sheath is a device used to make a channel through the brain into the ventricular system.

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## CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

colla

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number L990373

Over the Counter Use: or Prescription Use: (Per 21 CFR 801.109)

(optional format 1-2-96)

Prescription Use **__**
(Per 21 CFR 801.109)