(88 days)
Not Found
Not Found
No
The summary describes a physical introducer device and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No.
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device, an introducer, is used to facilitate the insertion of other devices into the venous system. Its function is to provide access, not to directly treat a disease or condition itself.
No
Explanation: The "Intended Use" states that the device is intended to "provide a conduit for the insertion of devices into the venous system," which describes an interventional or therapeutic function, not a diagnostic one.
No
The device description and performance studies clearly indicate this is a physical introducer sheath, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a conduit for the insertion of devices into the venous system and to minimize blood loss associated with such insertions." This describes a device used in vivo (within the body) for a procedural purpose, not for examining specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description is for an "Introducer," which is a tool used to facilitate the insertion of other devices into blood vessels. This aligns with the in vivo intended use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
Therefore, the Micra Introducer is a medical device used for a procedural purpose within the body, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
Medtronic Micra™ Introducer: Intended to provide a conduit for the insertion of devices into the venous system and to minimize blood loss associated with such insertions. Sheath Diameters: 23F. Sheath Working Length: 55.7 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following in-vitro bench tests were completed on the Micra™ Introducer and verify that it meets the required performance specifications:
- Dimensional measurement .
- Tensile testing
- 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.
No clinical investigation has been performed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
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: (353) 91 708655 Fax: (353) 91 708672 Email: grainne.cullinan@medtronic.com 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™
Introducer | Medtronic Sentrant
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
(size of device that
fits into sheath) | 23F | 12F-26F
(2F increments) |
| Sheath Working
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.
3
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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.