The MicroCatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.

Device Description

The Micrus Microcatheter consists of 4 major components:

A flexible shaft with a lubricious liner extruded from Teflon. The liner is reinforced with a metal wire made from stainless steel. The outer shaft jacket is made from Pebax,
An atraumatic distal flexible tip containing two radiopaque marker bands. The marker bands are useful in tracking catheter tip position and during placement of detachable embolic coils.
A standard luer hub insert, which is molded onto the flexible shaft.
A hydrophilic coating, which covers the distal 100 centimeters of the Microcatheter.

AI/ML Overview

This 510(k) submission (K032624) is for a medical device called the "Micrus Microcatheter," which is a diagnostic and therapeutic intravascular catheter. The submission primarily relies on demonstrating substantial equivalence to a predicate device (K960806, Tracker Excel 14 Microcatheter) rather than presenting a study with specific acceptance criteria and performance metrics for the new device.

Therefore, many of the requested sections related to acceptance criteria, device performance, ground truth, and specific study designs (MRMC, standalone algorithm) do not apply directly to this type of regulatory submission as described in the provided text. This submission focuses on non-clinical testing and comparison to an already cleared device to establish safety and effectiveness.

Here's a breakdown of the information that can be extracted or deduced from the provided text, and where the requested details are not applicable:

A table of acceptance criteria and the reported device performance

This information is not provided in the document. This 510(k) submission doesn't detail specific performance criteria or a study with numerical performance results for the Micrus Microcatheter itself. Instead, it states that based on non-clinical testing and comparison to a predicate device, it is considered substantially equivalent in safety and effectiveness. The "non-clinical testing" is not further elaborated upon for specific acceptance criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. As no clinical study results are presented, there is no mention of a test set, sample size, or data provenance. The submission refers to "non-clinical testing," which typically includes bench testing (e.g., mechanical, material properties) rather than human subject data.
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)

This information is not provided in the document. There is no mention of ground truth establishment or expert involvement for evaluating device performance in a clinical setting.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No adjudication method is described, as there is no clinical test set or human evaluation of diagnostic results.
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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices. The Micrus Microcatheter is a physical medical device (catheter) and is not an AI algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This type of study is relevant for AI-powered diagnostic devices. The Micrus Microcatheter is a physical medical device (catheter) and is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. As there is no clinical study assessing diagnostic or intervention outcomes, no ground truth type is defined.
The sample size for the training set

This information is not provided in the document. There is no training set mentioned, as this is not an AI or machine learning device.
How the ground truth for the training set was established

This information is not provided in the document. There is no training set or ground truth establishment relevant to the type of device.

Summary based on the provided text:

The submission for the Micrus Microcatheter primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Tracker Excel 14 Microcatheter, K960806). The basis for this equivalence is stated as:

Design, materials, function, and intended use of the new device being comparable to the predicate.
Non-clinical testing performed by Micrus Corporation. While the specifics of this testing are not detailed in the provided excerpts, it would typically involve bench testing for material biocompatibility, mechanical properties (e.g., tensile strength, kink resistance, pushability, trackability), and fluid dynamics, ensuring these properties are equivalent or superior to the predicate device.

Crucially, this 510(k) does not contain information about clinical studies with human subjects, diagnostic performance metrics, or AI algorithm evaluation. The FDA's letter (K032624) confirms the finding of substantial equivalence based on the information provided in the premarket notification.

Summary

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SEP 1 0 2003

K032624
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510(k) Safety and Effectiveness Summary l.

Contact Information A.

Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, CA 94085

B. Device Name

Micrus Microcatheter Device: Catheter, Intravascular, Diagnostic Regulation Number: 870.1200 Product Code: DQO Device Class: 2

C. Predicate Device(s)

Number	Description	Clearance Date
K960806	Tracker Excel 14 Microcatheter	05/02/96

D. Device Description

The Micrus Microcatheter consists of 4 major components:

A flexible shaft with a lubricious liner extruded from Teflon. The ■ liner is reinforced with a metal wire made from stainless steel. The outer shaft jacket is made from Pebax,
트 An atraumatic distal flexible tip containing two radiopaque marker bands. The marker bands are useful in tracking catheter tip position and during placement of detachable embolic coils.
A standard luer hub insert, which is molded onto the flexible shaft. ■
보 A hydrophilic coating, which covers the distal 100 centimeters of the Microcatheter.

E. Intended Use

The Micrus Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.

Intended Use Predicate Device (per products' Instructions for Use) F.

"The Target Therapeutics' Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature."

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G. 510(k) Summary of Safety and Efficacy

Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Corporation, it is concluded that the Micrus Microcatheter is substantially equivalent to the Boston Scientific/Target Therapeutics Microcatheter in safety and effectiveness.

M. Webb

Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation June 27, 2003

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 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 of three overlapping human profiles, which are meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

SEP 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Micrus Corporation c/o Mr. Morten Christensen Underwriters Laboratories, Inc. Office Coordinator 1655 Scott Boulevard Santa Clara, CA 95050-4169

K032624 Micrus Microcatheter Regulation Number: 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: DQO Dated: August 25, 2003 Received: August 26, 2003

Dear Mr. Christensen:

Re:

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.

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Page 2 - Mr. Morten Christensen

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. 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), 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,

Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Device Name:

510(k) Number (if known):

Micrus Microcatheter

Indications for Use:

The MicroCatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Over the Counter Use: or Prescription Use: (Per 21 CFR 801.109)

Veleton

andigation)
of Cardiovascular Devices 510(k) Number_

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).