MINOP Disposable Introducer 26F

K142315 · Aesculap, Inc. · GWG · Nov 14, 2014 · Neurology

Device Facts

• Record ID: K142315
• Device Name: MINOP Disposable Introducer 26F
• Applicant: Aesculap, Inc.
• Product Code: GWG · Neurology
• Decision Date: Nov 14, 2014
• Decision: SESE
• Submission Type: Special
• 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. The purpose of the Minop® Disposable introducer is to obtain and maintain a temporary pathway to the ventricular system of the patient. The Minop® Disposable Introducer is designed to be split lengthwise and peeled down to the skull level of the patient, accommodating different depth requirements.

Device Story

The MINOP Disposable Introducer is a mechanical device used to establish and maintain a temporary access pathway to the ventricular system of the brain. It is designed to be split lengthwise and peeled down to the patient's skull level, allowing for adjustment to different depth requirements. The device is intended for use by clinicians in a surgical or clinical setting. It functions as a physical conduit to facilitate neurological procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical introducer device; peelable/split-sheath design for adjustable depth; non-powered; sterile, single-use.

Indications for Use

Indicated for patients requiring a temporary pathway into the ventricular system of the brain.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 14, 2014

Aesculap, Inc. Ms. Corina Duffy Regulatory Associate Medical Components, Inc. (MedComp) 1499 Delp Drive Harleysville, PA 19438

Re: [510(k) Number] K142315

Trade/Device Name: MINOP Disposable Introducer Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: October 8, 2014 Received: October 16, 2014

Dear Ms. Duffy:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Corina Duffy

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -SD/Δ

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K142315/S001

Device Name Minop® Disposable Introducer 26F

## Indications for Use (Describe)

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

The purpose of the Minop® Disposable introducer is to obtain and maintain a temporary pathway to the ventricular system of the patient. The Minop® Disposable Introducer is designed to be split lengthwise and peeled down to the skull level of the patient, accommodating different depth requirements.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span><span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span></div> | <div style="display:flex; align-items:center;"><span><span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> |

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