(7 days)
The Medtronic® Launcher Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Launcher catheter is intended to be used in the coronary or peripheral vascular system.
The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a thin lubricious coating.
The provided document, K022764, describes the Medtronic 7F Launcher Guide Catheter, its intended use, and its substantial equivalence to a predicate device (Medtronic® 6F Z3 Guide Catheter - K021256). The primary method for demonstrating safety and effectiveness relies on a comparison to the predicate device and the results of in-vitro functional and biocompatibility testing. The document does not describe a study involving human subjects or AI performance analysis.
Here's an analysis of the provided information based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Acute Intracutaneous Reactivity | Passed (tests successfully performed) |
| Acute Systemic Toxicity | Passed (tests successfully performed) |
| Cytotoxicity | Passed (tests successfully performed) |
| Hemolysis | Passed (tests successfully performed) |
| Sensitization | Test in process at the time of submission (implies expectation of passing) |
| Functional Testing: | |
| Hub to shaft tensile | Meets applicable specifications |
| Shaft tensile | Meets applicable specifications |
| Distal tip to shaft tensile | Meets applicable specifications |
| Torque response | Meets applicable specifications |
| Lumen lubricity | Meets applicable specifications |
| Radiopacity | Meets applicable specifications |
| Pressure shaft burst | Meets applicable specifications |
| Hub leak | Meets applicable specifications |
| Tip compression (softness) | Meets applicable specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for each functional or biocompatibility test beyond stating "tests successfully performed." The data provenance is derived from in-vitro laboratory testing of the Medtronic 7F Launcher Guide Catheter's materials and functional components. There is no indication of country of origin for the data or whether it was retrospective or prospective in the context of human data. The testing described is prospective in nature as it evaluates the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on in-vitro testing against predetermined specifications, not on expert-established ground truth from human data. The "experts" would be the scientists and engineers conducting the tests and interpreting results against established ISO 10993 standards for biocompatibility and internal engineering specifications for functional testing. Their qualifications are not specified but are implied to be appropriate for conducting such tests.
4. Adjudication Method for the Test Set
Not applicable. There was no Adjudication method as the study was not based on human readings or interpretations that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was conducted. This submission is for a medical device (catheter), not an AI diagnostic or assistive tool. Therefore, there is no mention of human readers, AI assistance, or effect size improvements related to AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No standalone algorithm performance study was done. This document concerns a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Standards Compliance: Biocompatibility testing against ISO 10993 standards.
- Engineering Specifications: Functional testing against internal design and performance specifications for parameters like tensile strength, lubricity, radiopacity, and burst pressure.
- Predicate Device Equivalence: The overall safety and effectiveness are established through substantial equivalence to the legally marketed Medtronic® 6F Z3 Guide Catheter (K021256), implying that if the new device meets the same functional and material requirements, it will perform similarly to a device already deemed safe and effective.
8. The Sample Size for the Training Set
No training set was used. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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Section 9
KO22764
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 7F Launcher Guide Catheter |
| (e) Name of Predicate Devices | Medtronic® 6F Z3 Guide Catheter - K021256 |
2. Description
The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a thin lubricious coating.
3. Intended Use
The Medtronic Launcher 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.
4. Technological Characteristics
The 7F Launcher Guide Catheters are manufactured similar to the legally marketed predicate 6F Z3 Guide Catheters.
The manufacturing processes, materials and design are substantially equivalent to the 6F Z3 Guide Catheter.
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- Biocompatibility tests performed per ISO10993 were chosen based on Guide Catheters categorized as external-communicating devices, circulating blood, limited exposure (≤24 hours). The following test results reports have been received and the results demonstrate that the tests were successfully performed. All materials used for the Medtronic® Launcher Guiding Catheter passed the following tests:
Acute Intracutaneous Reactivity Acute Systemic Toxicity Cytotoxicity Hemolvsis Sensitization (Test in process at the time of this submission.)
- Biocompatibility tests performed per ISO10993 were chosen based on Guide Catheters categorized as external-communicating devices, circulating blood, limited exposure (≤24 hours). The following test results reports have been received and the results demonstrate that the tests were successfully performed. All materials used for the Medtronic® Launcher Guiding Catheter passed the following tests:
-
Functional testing consisted of hub to shaft, shaft, distal tip to shaft tensile, torque response, 6. lumen lubricity, radiopacity, pressure shaft burst and hub leak, tip compression (softness). Results verified that the Medtronic® Launcher 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 Launcher guide catheter is considered to be substantially equivalent to the following device:
- Medtronic® 6F Z3 Guiding Catheter
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Image /page/2/Picture/12 description: The image is a black and white seal for the Department of Human Services - USA. The seal is circular with the text "HUMAN SERVICES - USA" around the top half of the circle and "DEPARTMENT" around the bottom half of the circle. In the center of the seal is a stylized image of three birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2002
Medtronic, Inc. c/o Mr. Fred L. Boucher, R.A.C. Sr. Regulatory Affairs Manager 37A Cherry Hill Drive Danvers, MA 01923
Re: K022764
Medtronic® Launcher Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: Class II (two) Product Code: 74 DQY Dated: August 20, 2002 Received: August 21, 2002
Dear Mr. Boucher:
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.
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.
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); 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.
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Page 2 - Mr. Fred L. Boucher
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The 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) 594-4646. 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,
$\mathcal{L}$
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
510(k) Number:
Device Name:
Medtronic® Launcher Guiding Catheter
Indications for Use:
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The Medtronic® Launcher Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Launcher 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)
| (Division/Sign-Off | |
|---|---|
| Division of Cardiovascular and Respiratory Devices | |
| 510(k) Number | K022764 |
| Prescription Use | OR Over-The-Counter Use |
(Per 21 CFR 801.109).
. .
§ 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).