The catheter is intended to be used for the controlled infusion of physician specified therapeutic agents and contrast media into the neurovascular and peripheral systems.

Device Description

The EASY RIDER® Micro Catheter is a single lumen infusion catheter designed to be introduced over a steerable guide wire into distal vasculature. The EASY RIDER® Micro Catheter has a hydrophilic coating to provide lubricity for navigation of vessels. A standard luer lock adapter on the proximal hub is used for the attachment of accessories. The catheter tip is indicated by a radiopaque marker to facilitate fluoroscopic visualization.

AI/ML Overview

The device under consideration is the EASY RIDER® Micro Catheter.

Based on the provided text, the acceptance criteria are generally qualitative and focus on safety and performance rather than specific numerical performance metrics typical for AI/ML devices. The "study" described is a series of tests to demonstrate compliance with these criteria for a medical device submitted for 510(k) clearance.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility	Device must be biocompatible according to the International Standard for the Biological Evaluation of Medical Devices, Part 1: Guidance on Selection of Tests (ISO 10993-1:1992(E)).	"Results of the tests showed that the device passed biocompatibility testing and is suitable for its application."
Physical Performance	Device must meet dimensional specifications.	"All testing of the product yielded acceptable results." (This is a general statement covering multiple aspects of physical performance.)
	Device must demonstrate adequate tensile strength.	"All testing of the product yielded acceptable results."
	Device must withstand specified burst pressure.	"All testing of the product yielded acceptable results."
	Device must have acceptable flow rates.	"All testing of the product yielded acceptable results."
	Device must exhibit acceptable torque performance.	"All testing of the product yielded acceptable results."
	Device must perform acceptably under simulated conditions.	"All testing of the product yielded acceptable results."
Intended Use	The catheter is intended for controlled infusion of therapeutic agents and contrast media into neurovascular and peripheral systems.	This is the objective statement of the device's function, and the successful completion of the biocompatibility and physical performance tests contributes to the device's suitability for this intended use, leading to a determination of substantial equivalence (inferring it meets this intent safely and effectively). The FDA's 510(k) clearance confirms that the device is cleared for this intended use.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The document mentions "testing of the product" but does not quantify the number of devices or units tested for each physical test or biocompatibility. Given the nature of a 510(k) submission for a device like a catheter, it would typically involve a statistically appropriate sample size for each test type, but these specific numbers are not provided in the summary.
Data Provenance: Not specified, but generally for medical device testing, especially for 510(k) submissions, the testing is performed in controlled laboratory environments or by contract research organizations (CROs) in the country of the manufacturer (USA, in this case, Micro Therapeutics, Inc. Sits in San Clemente, CA). The tests are prospective in nature, meaning they are designed and conducted specifically to evaluate the device against predefined criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. For this type of physical medical device (catheter), "experts" are not typically used to establish a "ground truth" in the same way they would be for an AI/ML diagnostic algorithm. The ground truth for biocompatibility is whether the device causes a biological reaction (determined by laboratory tests), and for physical tests, it's whether the device meets engineering specifications (determined by measurements and operational tests). The "experts" involved would be technicians, engineers, and scientists conducting the tests and interpreting the results against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

None (Not Applicable). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic imaging where human interpretation is involved. For the physical and biocompatibility testing of a medical device like a catheter, the results are objectively measured or observed based on standardized protocols, not subject to individual interpretation requiring adjudication.

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:

No. This is not an AI/ML medical device. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This is not an AI/ML medical device, so there is no algorithm to test in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Objective Measurement/Standardized Testing: The "ground truth" for this device is based on objective measurements against engineering specifications (for dimensional, tensile strength, burst pressure, flow rate, torque), and compliance with established international standards for biological evaluation (ISO 10993-1:1992(E)) for biocompatibility.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML medical device, so there is no "training set."

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to this device.

Summary

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JUN 17 1998

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Image /page/0/Picture/2 description: The image shows a black and white graphic of the word "KMAA13". The letters are stylized and bold, with a slightly rough or hand-drawn appearance. The letters are closely spaced, and the overall impression is one of a logo or a signature.

510(k) Summary of Safety and Effectiveness

EASY RIDER® Micro Catheter

Prepared November 21, 1997

General Information

Classification	Class II
Trade Name	EASY RIDER® Micro Catheter
Generic Name	Percutaneous Catheter
Submitted By	Micro Therapeutics, Inc.
	1062-F Calle Negocio
	San Clemente, CA 92673
	Phone: (714) 361-0616 FAX (714) 361-0210
Contact	Tom Daughters
	Regulatory Affairs

Predicate Devices

1. FasTracker™ -10 Infusion Catheter Target Therapeutics, In.
1. RapidTRANSIT™ Infusion Catheters Cordis Endovascular Systems, Inc.
1. JetStream™ Infusion Catheter Micro Interventional Systems, Inc.

Device Description

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Intended Use

The catheter is intended to be used for the controlled infusion of physician specified therapeutic agents and contrast media into the neurovascular and peripheral systems.

Testing

Biocompatibility testing was performed on the EASY RIDER Micro Catheter in accordance with the International Standard for the Biological Evaluation of Medical Devices, Part 1: Guidance on Selection of Tests (ISO 10993-1:1992(E)). Results of the tests showed that the device passed biocompatibility testing and is suitable for its application.

Physical testing of the product included dimensional inspection. tensile strength tests, burst pressure tests, flow rate tests, torque tests and performance under simulated conditions. All testing of the product vielded acceptable results.

Summary of Substantial Equivalence

The EASY RIDER Micro Catheter is substantially equivalent to the predicate devices in intended use and principles of operation.

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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 consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 1998

Mr. Tom Daughters Regulatory Affairs Micro Therapeutics, Inc. 1062-F Calle Negocio San Clemente, CA 92673

Re: K974473 EASY RIDER® Micro Catheter Trade Name: Requlatory Class: II Product Code: KRA Dated: June 6, 1998 Received: June 21, 1998

Dear Mr. Daughters:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the

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Page 2 - Tom Daughters

Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

EASY RIDER® Micro Catheter

Indications for Use:

The catheter is intended to be used for the controlled infusion of physician The catherer is intended to be ad contrast media into the neurovascular and peripheral systems.

(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
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(Per 21 CFR 801.109)	TWA
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K974473

Exhibit 8 Page 3and the state the state of the state of the first of the first of the

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).