(88 days)
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.
Micra™ Introducer : . Model: MI2355A
The provided text describes the 510(k) summary for the Medtronic Micra™ Introducer. There is no information on acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning device. The document is for a medical device (catheter introducer) and focuses on its physical and functional aspects.
Therefore, I cannot provide the requested information as it pertains to an AI/ML device study.
However, I can extract the information related to the performance testing of the Micra™ Introducer as described in the document, which serves a similar purpose to "acceptance criteria" for this type of device.
Here's the information based on the provided text, adapted to the closest relevant details for a non-AI medical device:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional measurement | Meets required specifications (not detailed) | Met all specified design and performance requirements |
| Tensile testing | Meets required specifications (not detailed) | Met all specified design and performance requirements |
| Hemostatic Leak Test | Meets required specifications (not detailed) | Met all specified design and performance requirements |
| Kink Test | Meets required specifications (not detailed) | Met all specified design and performance requirements |
| Liquid leakage under pressure | Meets required specifications (not detailed) | Met all specified design and performance requirements |
| Coating Presence and Coating Integrity | Meets required specifications (not detailed) | Met all specified design and performance requirements |
| Side Port Torque | Meets required specifications (not detailed) | Met all specified design and performance requirements |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the in-vitro bench tests. The document only states that "The following in-vitro bench tests were completed on the Micra™ Introducer".
- Data Provenance: The tests are stated as "in-vitro bench tests," implying laboratory testing. No country of origin is specified for these tests. The nature is experimental/prospective for the in-vitro bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This device is not an AI/ML device requiring expert ground truth for its performance evaluation in clinical scenarios. The performance evaluation is based on engineering and material testing standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are typically used for clinical or image-based studies involving human interpretation, not for in-vitro bench testing of a physical medical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This is not an AI/ML device. The document explicitly states: "No clinical investigation has been performed for this device."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI/ML device. Performance was evaluated via in-vitro bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications/Standards: For the in-vitro bench tests, the "ground truth" would be established engineering specifications and performance requirements for each test (e.g., a specific tensile strength or leak rate). The document doesn't detail these specific numerical criteria but states the device "met all specified design and performance requirements."
8. The sample size for the training set
- Not Applicable: This is not an AI/ML device, so there is no training set in the context of an algorithm.
9. How the ground truth for the training set was established
- Not Applicable: This is not an AI/ML device.
{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
{1}------------------------------------------------
Summary of Technological Differences between the Micra™ Introducer and the Predicate Device:
| Characteristics. | Medtronic Micra™Introducer | Medtronic SentrantIntroducer 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 thatfits into sheath) | 23F | 12F-26F(2F increments) |
| Sheath WorkingLength | 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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus symbol.
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
{4}------------------------------------------------
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.
§ 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).