MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019

K061135 · Aesculap · GWG · Jul 11, 2006 · Neurology

Device Facts

• Record ID: K061135
• Device Name: MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019
• Applicant: Aesculap
• Product Code: GWG · Neurology
• Decision Date: Jul 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Intended Use

The MINOP® Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system of the brain.

Device Story

MINOP® Disposable Introducer is a single-use device designed to obtain and maintain a temporary pathway into the brain's ventricular system to facilitate endoscope insertion. The device consists of an introducer sheath and a ventricular obturator with a rounded tip. The sheath features ink depth markings. It is used by clinicians in a surgical setting. The device functions as a mechanical conduit for endoscopic procedures. It is substantially equivalent to existing introducer sets, with design modifications limited to the obturator tip geometry and the addition of depth markings on the sheath. These modifications do not impact the mechanical performance (peel force) of the sheath compared to the predicate device.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated through in-vitro bench testing, specifically peel force testing of the sheath, which met internal standards for force at break.

Technological Characteristics

Single-use introducer sheath and ventricular obturator. Features rounded obturator tip and ink depth markings on the sheath. Mechanical device; no energy source or software. Sterilization method not specified.

Indications for Use

Indicated for patients requiring temporary access to the ventricular system of the brain for endoscope insertion.

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

• Medcomp Vascu-Sheath® Introducer Set (K022513)
• Medtronic PS Medical Endoscope Introducer (K990333)

Submission Summary (Full Text)

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### A. Submitter Information:

| Submitter: | Aesculap, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Tel: [phone]<br>Fax: [phone] | JUL 1 1 2006 |
|--------------------|-------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Matthew M. Hull<br>Regulatory Affairs Manager | |
| Date Prepared: | 11 April 2006 | |
| Trade Name: | MINOP® Disposable Introducer | |
| Common Name: | Endoscope Introducer | |
| Classification: | GYK | |
| C.F.R. Section: | 882.4545 | |
| Class: | II | |
| Predicate Devices: | K022513 Medcomp Vascu-Sheath®<br>Introducer Set<br>K990333 Medtronic PS Medical Endoscope<br>Introducer | |

#### D. Device Description:

The MINOP® Disposable Introducer is a single used to obtain ventricular access and facilitate endoscope insertion. The MINOP® Disposable Introducer consists of an introducer sheath and a ventricular obturator.

#### E. Intended Use:

B.

C.

The MINOP® Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system of the brain.

### F. Comparison to Predicate Device:

The technological characteristics of the MINOP® Disposable Introducer are substantially equivalent to the predicate devices. The proposed device is equivalent to the Medcomp Vascu-Sheath® Introducer Set in terms of design, materials, performance and sterilization; while the only differences are the indications for use, the obturator of the proposed device has a rounded tip, and its sheath has ink depth markings. The proposed device is equivalent to the Medtronic PS Medical Endoscope Introducer in regard to the indications for use.

## G. Performance Data:

Performance testing was performed on the peel force of the sheath for the Medcomp Vascu-Sheath® predicate device; the only sheath design change between this device and the proposed device is the addition of ink depth markings, which do not affect the peel force of the sheath. The rounding of the obturator tip on the proposed device also has no bearing on the peel force of the sheath. All other aspects of the obturator and

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sheath are identical to the legally marketed Medcomp device. Results of the peel force testing meet the requirements defined in Medcomp's internal standards for force at break.

Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized caduceus, a symbol often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the image. The caduceus is depicted with a staff entwined by two snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1 2006

Aesculap, Inc. % Medcomp Ms. Lisa Weikert Regulatory Specialist 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K061135

Trade/Device Name: MINOP® Disposable Introducer Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: June 13, 2006 Received: June 14, 2006

Dear Ms. Weikert:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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# Page 2 - Ms. Lisa Weikert

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

J. Herbert Vennmo

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): _ 长いんしけろう

Device Name: MINOP® Disposable Introducer

Indications for Use:

THE MINOP® DISPOSABLE INTRODUCER IS INDICATED TO OBTAIN AND MAINTAIN A TEMPORARY PATHWAY INTO THE VENTRICULAR SYSTEM OF THE BRAIN.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Eyaluation (ODE)

Hulut Leun

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K061135