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

The provided document describes a Special 510(k) Notification for the Medtronic 8F Launcher Guiding Catheter. This type of submission is for modifications to a currently cleared device, demonstrating substantial equivalence to a predicate device. As such, the study focuses on functional and material equivalence rather than clinical performance against specific disease detection criteria.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to the predicate device, the Medtronic 7F Launcher Guide Catheter (K022764), in terms of materials, manufacturing processes, design, and performance in in-vitro tests.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility	Compliance with ISO 10993 for external-communicating devices, circulating blood, limited exposure (<24 hours), including: Acute Intracutaneous Reactivity, Acute Systemic Toxicity, Cytotoxicity, Hemolysis, Sensitization.	"All materials used for the Medtronic® Launcher Guiding Catheter passed the following tests: Acute Intracutaneous Reactivity, Acute Systemic Toxicity, Cytotoxicity, Hemolysis, Sensitization."
Functional Performance	Meeting applicable specifications for: hub to shaft, shaft, distal tip to shaft tensile, torque 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."
Technological Equivalence	Manufacturing processes, materials, and design are substantially equivalent to the 7F Launcher Guide Catheter.	"The manufacturing processes, materials and design are substantially equivalent to the 7F Launcher Guide Catheter."
Intended Use	Consistent with the predicate device: providing a pathway for therapeutic devices in the coronary or peripheral vascular system.	"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." (Matches predicate's use)

Study Details

Given this is a 510(k) notification for a guiding catheter, the "study" is primarily an in-vitro testing and comparison assessment rather than a clinical trial with human subjects for diagnostic accuracy.

Sample size used for the test set and the data provenance:
- The document does not specify a numerical sample size for the in-vitro functional and biocompatibility tests. It refers to "tests" being performed.
- Data Provenance: The tests were conducted internally by Medtronic AVE, Inc. (the submitter). The provenance is therefore considered internal company testing, and by nature, it is prospective with respect to the testing itself (i.e., the tests were performed specifically for this submission). There's no indication of country of origin for the data other than the submitter's location in Danvers, MA, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this type of device and submission. "Ground truth" in this scenario would refer to the established performance specifications for medical devices of this type (e.g., ISO standards, internal Medtronic specifications). These specifications are typically set by engineering and scientific teams within the company and regulatory bodies, not by "experts" in the sense of clinical reviewers for diagnostic accuracy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used in clinical studies when there are differing opinions from human readers on a diagnostic task. For in-vitro functional and biocompatibility testing, adherence to a specification is typically a pass/fail outcome, not subject to human adjudication of interpretation.
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 device is a physical medical instrument (a catheter), not an AI-powered diagnostic or assistive tool. MRMC studies are specific to evaluating diagnostic systems, especially those involving AI or human interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. As mentioned, this is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance claims relies on established engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and manufacturing quality control parameters. For the claim of substantial equivalence, the "ground truth" is the proven performance of the predicate device.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the machine learning sense. The device's design and manufacturing processes are likely derived from years of experience and iterative development, but not a formally defined "training set" for an algorithm.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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K023402

NOV 6 2002

Special 510(k) Notification Medtronic, Inc. 8F Launcher 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 8F Launcher™ Guide Catheter
(e) Name of Predicate Devices	Medtronic® 7F Launcher™ Guide CatheterK022764

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 8F Launcher Guide Catheters are manufactured similar to the legally marketed predicate 7F Guide Catheters.

The manufacturing processes, materials and design are substantially equivalent to the 7F Launcher Guide Catheter.

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K023402

Special 510(k) Notification Medtronic, Inc. 8F Launcher Guiding Catheter

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 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® 7F Launcher Guiding Catheter .

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or strokes, possibly representing the human form or a flame.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 2002 NOV

Medtronic, Inc. c/o Mr. Fred L. Boucher, RAC Sr. Regulatory Affairs Manager 37A Cherry Hill Drive Danvers, MA 01923

Re: K023402

Trade Name: 8F Launcher™ Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: October 9, 2002 Received: October 10, 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

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Page 2 - Mr. Fred L. Boucher, RAC

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 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,

Bram D. Zuckerman, M.D. Directoř Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Notification Medtronic, Inc. 8F Launcher™ Guiding Catheter

INDICATIONS FOR USE

510(k) Number:

K023402

Device Name:

Medtronic® 8F 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)

Division of Cardiovascul
510(k) Number 1-023462

Labels	Values
Prescription Use	\checkmark
Over-The-Counter Use

(Per 21 CFR 801.109)

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).