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.

Device 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medtronic 5F Launcher™ Guide Catheter:

Summary of Acceptance Criteria and Device Performance

The Medtronic 5F Launcher™ Guide Catheter was evaluated against a set of biocompatibility tests and functional engineering specifications. The documentation states that the device successfully met all these criteria.

This information indicates that the device's acceptance was based on a combination of biological safety assessments and mechanical performance tests, ensuring it is safe for its intended use and performs as expected.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests/Metrics	Reported Device Performance	Comments
Biocompatibility	Acute Intracutaneous Reactivity	Passed	Performed per ISO 10993 for external-communicating devices, circulating blood, limited exposure (≤24 hours).
	Acute Systemic Toxicity	Passed
	Cytotoxicity	Passed
	Hemolysis	Passed
	Sensitization	Passed
Functional Performance	Hub-to-Shaft Tensile	Meets applicable specifications	Ensures structural integrity at the connection point.
	Shaft Tensile	Meets applicable specifications	Assesses the strength of the catheter shaft.
	Distal Tip-to-Shaft Tensile	Meets applicable specifications	Ensures the integrity of the flexible tip attachment.
	Torque Response	Meets applicable specifications	Evaluates the catheter's ability to transmit rotational forces for steering.
	Lumen Lubricity	Meets applicable specifications	Verifies smooth passage of therapeutic devices through the catheter.
	Radiopacity	Meets applicable specifications	Confirms visibility under fluoroscopy.
	Pressure Shaft Burst	Meets applicable specifications	Tests the catheter's resistance to internal pressure.
	Hub Leak	Meets applicable specifications	Ensures no fluid leakage at the hub connector.
	Tip Compression (Softness)	Meets applicable specifications	Assesses the flexibility and atraumatic nature of the distal tip.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each of the biocompatibility and functional tests. It mentions "test results reports have been received," implying data was collected.

Sample Size: Not explicitly stated for individual tests.
Data Provenance: The study was conducted by Medtronic AVE, Inc., suggesting internal testing. The country of origin of the data is not specified, but Medtronic AVE, Inc. is located in Danvers, MA, USA, which implies the testing was likely conducted in the USA or supervised by US-based personnel. The study appears to be a prospective assessment of newly manufactured devices against established performance specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" in this context refers to engineering specifications and ISO standards, not clinical interpretations by medical experts. The "experts" would be the engineers and quality assurance personnel who designed the tests, interpreted the results, and determined compliance with the specifications and standards (e.g., ISO 10993). Their specific number and qualifications are not detailed in this regulatory summary.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable here. Adjudication processes are typically used in clinical trials or studies where subjective interpretations (e.g., by human readers of medical images) need to be reconciled. In this case, the results of the biocompatibility and functional engineering tests are objective and assessed against predefined pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done.

This type of study is relevant for evaluating the performance of AI algorithms in assisting human readers with diagnostic tasks. The Medtronic 5F Launcher™ Guide Catheter is a physical medical device, not an AI diagnostic tool, so such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study (in the context of an algorithm) was not done.

Similar to point 5, this question pertains to AI algorithms. The "standalone performance" of the catheter refers to its ability to meet its functional specifications and biocompatibility requirements, which were indeed evaluated without human intervention in the operational performance of the device itself (e.g., the catheter's material strength is an intrinsic property, not dependent on a human operator's judgment during the test). However, it is not an "algorithm only" study.

7. The Type of Ground Truth Used

The "ground truth" against which the device was evaluated consists of:

Established engineering specifications: These are internal Medtronic standards detailing acceptable ranges for mechanical properties (e.g., tensile strength, burst pressure, lubricity, torque response, radiopacity, tip softness).
International standards for biocompatibility: Specifically, ISO 10993 series for medical devices (categorized as external-communicating, circulating blood, limited exposure ≤24 hours).
Predicate device characteristics: The current device's performance was also compared to the characteristics of the legally marketed predicate devices (Medtronic 6F Launcher™ Guide Catheter and Medtronic 5F Genius™ Guide Catheter) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable.

A "training set" is used for machine learning algorithms. The Medtronic 5F Launcher™ Guide Catheter is a physical medical device, not an AI algorithm, so there is no training set in this context. The manufacturing processes and materials were established based on existing knowledge and experience with predicate devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

As there is no training set for a machine learning algorithm, the process of establishing its ground truth is irrelevant to this device. The "ground truth" for the device's design and manufacturing was established through established engineering practices, material science, and regulatory standards for medical device development based on extensive prior experience with similar devices.

Summary

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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 Drive Danvers, MA 01923

Fred L. Boucher R.A.C. (b) Contact Person: (978) 777-0042
Percutaneous Catheter (c) Classification Name: (21 CFR Part 870.1250)
Medtronic 5F Launcher™ Guide (d) Proprietary Name: Catheter
(e) Name of Predicate Devices Catheter

Medtronic 6F Launcher™ Guide K021256

Medtronic 5F Genius™ Guide Catheter K010579

2. Description

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 5F Launcher Guide Catheters are manufactured similar to the legally marketed predicate 6F Guide Catheters.

The manufacturing processes, materials and design are substantially equivalent to the 6F Launcher Guide Catheter and 5F Genius.

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1. 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 Hemolysis Sensitization
Functional testing consisted of hub to shaft, shaft, distal tip to shaft tensile, torque 6. response, 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, invitro 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:
- o Medtronic 6F Launcher Guiding Catheter
- Medtronic 5F Genius Guiding Catheter O

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or other bird with three curved lines representing its wings or feathers.

APR 2 4 2003

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic, Inc. Mr. Fred L. Boucher, R.A.C. Sr. Regulatory Affairs Manager 37A Cherry Hill Drive Danvers, MA 01923

Re: K030779

Trade/Device Name: 5F Launcher™ Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: April 7, 2003 Received: April 8, 2003

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

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Page 2 - Mr. Fred L. Boucher, R.A.C.

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) 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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) you may obtain. 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,

N. Oele VTu
Bram D. Zuckerman, M.D.

m D. Zuckerman, M 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:

1630779

Device Name:

Medtronic® 5F Launcher™ Guiding Catheter

Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter Use _ OR

N. Delette

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K030779

Regulation Number and Section

§ 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).