(28 days)
The Medtronic® Z3 Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Z3 catheter is intended to be used in the coronary or peripheral vascular system.
The Medtronic® Z3 Guide Catheter is constructed with an inner liner, stainless steel braid, segmented outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Z3 Guide Catheter has a thin lubricious coating. The Z3 Guiding Catheter (6F) has an inner lumen diameter comparable to the predicate devices.
The provided text describes a 510(k) submission for a medical device (Medtronic 6F Z3 Guiding Catheter) and focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, most of the requested information regarding AI device evaluation is not directly available in this document.
However, I can extract the available information and indicate where the document does not provide the requested details.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Specification | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|---|
| Biocompatibility | Acute Intracutaneous Reactivity | Passed (implicit) | "All materials used for the Medtronic® Z3 Guiding Catheter passed the following tests" |
| Acute Systemic Toxicity | Passed (implicit) | "All materials used for the Medtronic® Z3 Guiding Catheter passed the following tests" | |
| Cytotoxicity | Passed (implicit) | "All materials used for the Medtronic® Z3 Guiding Catheter passed the following tests" | |
| Hemolysis | Passed (implicit) | "All materials used for the Medtronic® Z3 Guiding Catheter passed the following tests" | |
| Sensitization | Test in process at time of submission (not yet passed) | "Sensitization (Test in process at the time of this submission.)" | |
| Functional Testing | Hub to Shaft Tensile | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" |
| Shaft Tensile | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Segment to Shaft Tensile | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Distal Tip to Shaft Tensile | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Torque Response | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Lumen Lubricity | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Radiopacity | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Pressure Shaft Burst | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Hub Leak | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Tip Compression (Softness) | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document details in vitro (bench) testing, not a clinical study involving a "test set" of patient data. Therefore, this information is not applicable. The tests were performed on the device itself, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI device evaluated with a clinical test set. The ground truth for in vitro tests is established by physical measurement against engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (guiding catheter).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biocompatibility tests, the ground truth is established by the results of standard ISO 10993 biological tests, which have defined pass/fail criteria. For functional testing, the ground truth is established by engineering specifications and physical measurement.
8. The sample size for the training set
Not applicable. There is no AI model or training set described in this document.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set described in this document.
Summary of the Study and Device Performance:
The study described for the Medtronic® Z3 Guiding Catheter is focused on demonstrating substantial equivalence to previously approved predicate devices (Medtronic® 6F Zuma™ Guiding Catheter and Medtronic® 6F Genius™ Guide Catheters) for regulatory clearance. This is typical for a 510(k) submission for conventional medical devices.
The "study" consists of two main types of testing:
- Biocompatibility Tests: These tests, chosen based on ISO 10993 standards for external-communicating devices with circulating blood and limited exposure (≤24 hours), evaluated the material's interaction with biological systems. The reported performance is that all materials passed the acute intracutaneous reactivity, acute systemic toxicity, cytotoxicity, and hemolysis tests. The sensitization test was "in process" at the time of submission.
- Functional Testing: This involved a series of in-vitro physical tests to ensure the catheter's mechanical integrity and performance characteristics. The reported performance is that the device "meets all of the applicable specifications" for tests such as hub to shaft tensile, torque response, lumen lubricity, radiopacity, pressure shaft burst, hub leak, and tip compression.
The document concludes that based on the intended use, design, and in-vitro test results, the Z3 guide catheter is substantially equivalent to the predicate devices. This type of submission does not involve clinical trials or AI performance evaluations, which is why much of your requested information is not present.
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Special 510(k) Notification Medtronic, Inc. 6F Z3 Guiding Catheter
Section 9
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)
1. Identifying Information
| (a) Submitters Name: | Medtronic AVE, Inc.37A Cherry Hill DriveDanvers, MA 01923 |
|---|---|
| (b) Contact Person: | Fred L. Boucher R.A.C.(978) 777-0042 |
| (c) Classification Name: | Percutaneous Catheter(21 CFR Part 870.1250) |
| (d) Proprietary Name: | Medtronic 6F Z3 Guide Catheter |
| (e) Name of Predicate Devices | Medtronic® 6F Zuma™ and 6F Genius™Guide Catheters |
-
- Description
The Medtronic® Z3 Guide Catheter is constructed with an inner liner, stainless steel braid, segmented outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of - the Z3 Guide Catheter has a thin lubricious coating. The Z3 Guiding Catheter (6F) has an inner lumen diameter comparable to the predicate devices.
- Description
-
- Intended Use
The Medtronic® Z3 Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended for used in the coronary or peripheral vascular system.
- Intended Use
-
Technological Characteristics 4.
The 6F Z3 Guide Catheters are manufactured similar to the legally marketed predicate 6F ZumaTM and 6F Genius™ Guide Catheters.
The manufacturing processes and design are substantially equivalent to the 6F Genius (K010579) with the exception of some component materials that are the same as materials used in the 6F Zuma Guide Catheter (K981198). The packaging materials are identical to the predicate devices.
- Biocompatibility tests performed per ISO10993 were chosen based on Guide Catheters న. categorized as external-communicating devices, circulating blood, limited exposure (≤24 hours). The following test results reports have been received and the results demonstrate
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that the tests were successfully performed. All materials used for the Medtronic® Z3 Guiding Catheter passed the following tests:
Acute Intracutaneous Reactivity Acute Systemic Toxicity Cytotoxicity Hemolysis Sensitization (Test in process at the time of this submission.)
Functional testing consisted of hub to shaft, shaft, segment to shaft, and distal tip to shaft 6. tensile, torque response, lumen lubricity, radiopacity, pressure shaft burst and hub leak, tip compression (softness). Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications and considered an appropriate device for the intended use. Based on a comparison of the intended use, design, in-vitro test results and the fact that the fundamental scientific technology has not changed, the Z3 guide catheter is considered to be substantially equivalent to the following device:
- Medtronic® 6F Zuma™ Guiding Catheter (K98198) .
- Medtronic® 6F Genius™ Guiding Catheter (K010579) .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2002
Mr. Fred L. Boucher Medtronic, Inc. 37A Cherry Hill Drive Danvers, MA 01923
Re: K021256
Medtronic® Z3 Guide Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY Dated: April 18, 2002 Received: April 19, 2002
Dear Mr. Boucher:
We have reviewed your Section 510(k) premarket notification of intent to market the device w for now 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 for ass based of 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 I ou rate) y ato s royisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Fred L. Boucher
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 corply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter will and hy your e FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nola Tull
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number:
Device Name:
Medtronic® Z3 Guiding Catheter
Indications for Use:
The Medtronic® Z3 Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Z3 catheter is intended to be used in the coronary or peripheral vascular system.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use
OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021756
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).