MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING

K132030 · Medtronic, Inc. · DYB · Sep 27, 2013 · Cardiovascular

Device Facts

• Record ID: K132030
• Device Name: MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
• Applicant: Medtronic, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Micra introducer is intended to provide a conduit for the insertion of devices into the venous system and to minimize blood loss associated with such insertions.

Device Story

Micra Introducer is a catheter-based conduit designed for venous system access. It facilitates the insertion of medical devices while minimizing blood loss. Used by clinicians in a clinical setting. The device features a 23F sheath diameter and a 55.7 cm working length. It is a mechanical device; no electronic or software components are involved. Performance is verified through bench testing, including tensile, hemostatic leak, kink, and torque testing. Biocompatibility is established per ISO 10993-1 for limited exposure (≤ 24 hours).

Clinical Evidence

No clinical investigation has been performed for this device. Evidence is based on in-vitro bench testing, including dimensional measurement, tensile testing, hemostatic leak testing, kink testing, liquid leakage under pressure, coating integrity, and side port torque testing.

Technological Characteristics

Catheter introducer with hydrophilic coating. Sheath diameter: 23F. Working length: 55.7 cm. Biocompatibility: ISO 10993-1 compliant for external communicating device with limited exposure (≤ 24 hours). Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring venous access for the insertion of medical devices; intended for prescription use.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Medtronic Sentrant Introducer Sheath (K132030)

Submission Summary (Full Text)

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## 510(k) Summary

June 27th, 2013 Date Prepared: Applicant: Medtronic Ireland Parkmore Business Park West Galway Ireland Official Grainne Cullinan SEP 2 7 2013 Correspondent: Associate Regulatory Affairs Specialist Medtronic Ireland Parkmore Business Park West Galway Ireland Phone: [phone] Fax: [phone] Email: [e-mail] Micra™ Introducer Proprietary Name: : . Model: MI2355A Device Classification Class II Regulation Number: 21 CFR 870.1340 Classification Name: Catheter Introducer Product Code: DYB

K13203D

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## Summary of Technological Differences between the Micra™ Introducer and the Predicate Device:

| Characteristics. | Medtronic Micra™<br>Introducer | Medtronic Sentrant<br>Introducer Sheath |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended to provide a conduit for the insertion of devices into the venous system and to minimize blood loss associated with such insertions. | Intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and to minimize blood loss associated with such insertions. |
| Sheath Diameters<br>(size of device that<br>fits into sheath) | 23F | 12F-26F<br>(2F increments) |
| Sheath Working<br>Length | 55.7 cm | 28cm and 64cm |

Summary of The following in-vitro bench tests were completed on the Studies: Micra™ Introducer and verify that it meets the required performance specifications:

- Dimensional measurement .
- . Tensile testing
- o Hemostatic Leak Test
- Kink Test .
- Liquid leakage under pressure .
- Coating Presence and Coating Integrity ●
- Side Port Torque .

The MicraTM Introducer met all specified design and performance requirements.

Summary of No clinical investigation has been performed for this device. Clinical Data:

Biocompatibility Biocompatibility testing for the Micra™ Introducer has been completed in accordance with the International Information: Standard ISO10993-1:2009 "Biological Evaluation of Medical devices-Part 1: Evaluation and Testing" for an external communicating device with limited exposure i.e. whose contact with circulating blood is ≤ 24 hours.

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

September 27, 2013

Medtronic Inc. Ms. Chechamma Varughese Principal Regulatory Affairs Specialist Cardiac Rhythm Disease Management (CRDM) 8200 Coral Sea Street, MVS11 Mounds View, MN 55112

Re: K132030

> Trade/Device Name: Micra introducer sheath with hydrophilic coating Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 3, 2013 Received: July 8, 2013

Dear Ms. Varughese:

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.

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## Page 2 - Ms. Chechamma Varughese

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); 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Image /page/3/Picture/7 description: The image shows the name "Bram D. Zuckerman-S" in a bold, sans-serif font. The letters are black against a white background, creating a high contrast. The name appears to be a signature or title, with the "D." and "Zuckerman" portions having a unique, stylized design. The overall impression is clean and professional.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

K132030 510(k) Number (if known):

Micra™ Introducer Device Name:

Indications for Use: The Micra introducer is intended to provide a conduit for the insertion of devices into the venous system and to minimize blood loss associated with such insertions.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/9 description: The image shows the name "Bram D. Zuckerman -S" at the top. Below the name is the date and time "2013.09.27 16:46:33 -04'00'". In the center of the image is a stylized logo that appears to be a modified version of the FDA logo.