(276 days)
The Micropuncture Introducer Set is intended for the placement of wire guides up to .038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.
The Micropuncture Introducer Sets contains a coaxial catheter, a wire guide, and a needle. The device is utilized to gain access to the vasculature using the Seldinger technique.
Here's an analysis of the provided document regarding the acceptance criteria and supporting studies for the Micropuncture® Introducer Set:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a general statement that "The predetermined acceptance criteria were met" for each test. Specific numerical acceptance criteria were not detailed in this summary.
| Test Conducted | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Insertion force testing | Predetermined acceptance criteria (not specified numerically) | Met |
| Coaxial catheter tensile testing | Hub would not be dislodged during insertion and withdrawal (not specified numerically) | Met |
| Wire guide resistance to damage testing | No damage or defects after repeated flexing (not specified numerically) | Met |
| Wire guide resistance to fracture testing | No signs of fracture (not specified numerically) | Met |
| Wire guide tensile strength testing | Distal tip withstands 4.0N before failure | Met |
| Wire guide torque response and torque strength | Output rotation within 90 degrees of input rotation; withstands 10 rotations without failure | Met |
| Biocompatibility testing (various assays) | In conformance with ISO 10993-1:2009 (not specified numerically) | Met |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not provide information on the sample sizes used for any of the tests. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable as the document describes performance testing for a medical device (introducer set), not a diagnostic algorithm or image analysis tool requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The document describes laboratory-based performance testing, not studies involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device described is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. The tests performed are laboratory-based engineering and material science tests. The "ground truth" would be the direct measurement of physical properties (e.g., force, rotation, tensile strength) or biological responses (e.g., cytotoxicity).
8. The Sample Size for the Training Set
Not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 1 0 2015
Cook Medical, Inc. Mr. David Lehr, RAC Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K133114
Trade/Device Name: Micropuncture® Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code Dated: May 23, 2014 Received: May 27, 2014
Dear Mr. Lehr:
This letter corrects our substantially equivalent letter of July 3, 2014.
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
{1}------------------------------------------------
Page 2 - Mr. David Lehr
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 (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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133114
Device Name Micropuncture® Introducer Set
The Micropuncture Introducer Set is intended for the placement of wire guides up to .038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
M.A. Stilleman
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif font at the top of the logo. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font. The background of the logo is gray.
5. 510(k) Summary
Micropuncture® Introducer Set Traditional 510(k) 510(k) Summary 21 CFR §807.92
Cook Incorporated
750 Daniels Way Bloomington, IN 47404
David Lehr. RAC
812-332-0281
812-335-3575 ext. 102309
Submitter Information:
Applicant: Address:
Contact: Email: Contact Phone Number: Contact Fax Number:
Date Prepared:
September 27, 2013 (Revised May 23, 2014)
Device Information:
| Trade Name: | Micropuncture® Introducer Set |
|---|---|
| Common Name: | Introducer Set |
| Classification Name: | Catheter IntroducerDYB (21 CFR §870.1340) |
Predicate Devices:
The Micropuncture® Introducer Set is substantially equivalent to the VSI Micro-Introducer Set (Vascular Solutions, Inc., K101604) with the VSI Guidewire (K112631).
Comparison to Predicate:
It has been demonstrated that the Micropuncture® Introducer Set is comparable to the predicate device in terms of intended use, duration of use, principles of operation, technological characteristics, insertion method, and anatomical location.
Device Description:
The Micropuncture Introducer Sets contains a coaxial catheter, a wire guide, and a needle. The device is utilized to gain access to the vasculature using the Seldinger technique.
{4}------------------------------------------------
Attachment 2 - page 2
Cook Incorporated Micropuncture® Introducer Set Traditional 510(k) May 23, 2014
Intended Use:
The Micropuncture Introducer Set is intended for the placement of wire guides up to .038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.
Test Data:
The proposed Micropuncture® Introducer Set was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:
- Insertion force testing Testing simulated percutaneous insertion force through a silicone ● sheet. The predetermined acceptance criteria were met.
- . Coaxial catheter tensile testing - Testing verified that the hub would not be dislodged during insertion and withdrawal when utilized according to the device's intended use. The predetermined acceptance criteria were met.
- . Wire guide resistance to damage testing - Testing verified that the wire guide would not show any damage or defects when subjected to repeated flexing. The predetermined acceptance criteria were met.
- . Wire guide resistance to fracture testing - Testing verified that the wire guide would show no signs of fracture when subjected to the resistance to fracture testing. The predetermined acceptance criteria were met.
- . Wire guide tensile strength testing - Testing verified that the distal tip of the wire guide would withstand a load of 4.0N before failure. The predetermined acceptance criterion was met.
- Wire guide torque response and torque strength testing - Testing verified that the output rotation of the wire guide would be within 90 degrees of the input rotation, and that the wire guide would withstand 10 rotations without failure. The predetermined acceptance criteria were met.
- . Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance) demonstrated the device as biocompatible. In conformance with the applicable sections of ISO 10993-1:2009, the predetermined acceptance criteria were met.
In conclusion, the results of these tests provide reasonable assurance that the device is as safe and as effective as the predicate device and support a determination of substantial equivalence.
§ 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).