The 2.9F Cragg-McNamara™ Valved Infusion Catheter is intended to be used for the controlled selective infusion of physician specified pharmacological agents and radiopaque contrast media into the general vasculature. It is not intended for coronary, neurological, pediatric or neonatal use.

Device Description

The 2.9F Cragg-McNamara™ Valved Infusion Catheter is a single lumen plastic catheter suitable for infusion of physician-specified pharmacological agents or contrast media through its proximal luer adapter to infusion holes circumferentially placed in the distal portion of the catheter. The device is designed to be placed over a guide wire into the general vasculature. The device will be available in various catheter and infusion lengths. The 2.9F Cragg-McNamara™ Valved Infusion Catheter utilizes a plastic valve at the tip which will allow effective transmission of infusate through the side holes by effectively occluding infusion out the catheter. As a guide wire is introduced, the valve opens to permit smooth passage of the guide wire and closes again as the guide wire is removed. The recommended maximum guide wire OD is 0.018 inch. The 2.9F Cragg-McNamara™ Valved Infusion Catheter has two radiopaque markers that define fluoroscopically the location of the exit holes. The method of construction and materials used for these infusion catheters are substantially equivalent to previous infusion catheter products.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the 2.9F Cragg-McNamara™ Valved Infusion Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility: Meet qualifications for short-term use in the vascular system per ISO 10993-1:1992(E).	Device passed biocompatibility testing and is suitable for its application. (Specific test results or quantitative metrics are not provided in the summary.)
Physical Performance:
- Dimensional inspection	Yielded acceptable results. (Specific dimensions or tolerance ranges are not provided.)
- Catheter tensile strength tests	Yielded acceptable results. (Specific strength values or thresholds are not provided.)
- Static burst pressure tests	Yielded acceptable results. (Specific pressure values or thresholds are not provided.)
- Dynamic burst pressure tests	Yielded acceptable results. (Specific pressure values or thresholds are not provided.)
- Flow rate test	Yielded acceptable results. (Specific flow rates or benchmarks are not provided.)
- Performance under simulated conditions	Yielded acceptable results. (Specific simulated conditions or performance metrics are not provided.)
Substantial Equivalence:
- Constructed of same or substantially equivalent materials as predicate devices.	Constructed of the same or substantially equivalent materials as the Micro Therapeutics Infusion Catheters (K940634) and other legally marketed infusion catheters.
- Sizes and configurations equivalent to predicate devices.	Sizes and configurations available along with the packaging and sterilization methods are equivalent to predicate devices.
- Clinical indications for use identical to predicate devices.	Clinical indications for use are identical to the predicate devices.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is for biocompatibility and physical performance, which are typically lab-based tests, not clinical studies with patient data.

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

This information is not applicable and not provided in the context of this device. The "tests" described are for product specifications (biocompatibility, physical properties), not diagnostic accuracy requiring expert interpretation of images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing relates to physical and biological properties, not human interpretation or adjudication processes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is an infusion catheter, and the provided documentation focuses on its physical and biological equivalence to predicate devices, not on diagnostic or interpretative effectiveness that would involve human readers.

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

This concept is not applicable to this device. This is a physical medical device (an infusion catheter), not a software algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed was likely established by:

Biocompatibility: Established by adhering to the standards outlined in ISO 10993-1:1992(E) and performing tests such as cytotoxicity, sensitization, irritation, etc., with negative results serving as the "ground truth" for biocompatibility.
Physical Testing: Established by engineering specifications, material properties, and performance benchmarks for infusion catheters. For example, a tensile strength test would have a pre-defined passing threshold based on material science and expected stresses, and results exceeding this threshold would be the "ground truth" for acceptable strength. These are objective measures against predefined criteria.

8. The Sample Size for the Training Set

This concept is not applicable to this device. This is a physical medical device, not an AI or machine learning system that requires a "training set."

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

This concept is not applicable to this device, as it does not involve a training set.

Summary

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o Therapeutics Inc.

2964868

MAY 2 0 1997

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510(k) Summary of Safety and Effectiveness

2.9F Cragg-McNamara™ Valved Infusion Catheter

General Information

Classification	Class II
Trade Name	2.9F Cragg-McNamara™ Valved Infusion Catheter
Generic Name	Infusion Catheter
Submitter	Micro Therapeutics, Inc.1062-F Calle NegocioSan Clemente, CA 92673
Contact	Linda D'AbateClinical and Regulatory Affairs

Predicate Devices

Micro Therapeutics Infusion Catheters (K940634, October 14, 1994)

Device Description

The 2.9F Cragg-McNamara™ Valved Infusion Catheter utilizes a plastic valve at the tip which will allow effective transmission of infusate through the side holes by effectively occluding infusion out the catheter. As a guide wire is introduced, the valve opens to permit smooth passage of the guide wire and closes again as the guide wire is removed. The recommended maximum guide wire OD is 0.018 inch.

The 2.9F Cragg-McNamara™ Valved Infusion Catheter has two radiopaque markers that define fluoroscopically the location of the exit holes.

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The method of construction and materials used for these infusion catheters are substantially equivalent to previous infusion catheter products.

Intended Use

The 2.9F Cragg-McNamara™ Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacological agents or contrast media into the general vasculature.

Testing

Biocompatibility testing was performed on the 2.9F Cragg-McNamara™ Valved Infusion Catheter in Tests 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)) to establish that the materials and processes used in the manufacture of the device met the qualifications for short term use in the vascular system. 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, catheter tensile strength tests, static and dynamic burst pressure tests, flow rate test, and performance under simulated conditions. All testing of the product yielded acceptable results.

Summary of Substantial Equivalence

The 2.9F Cragg-McNamara™ Valved Infusion Catheter is constructed of the same or substantially equivalent materials as the Micro Therapeutics Infusion Catheters and other legally marketed infusion catheters. The sizes and configurations available along with the packaging and sterilization methods are also equivalent.

The clinical indications for use are identical to the predicate devices.

Therefore, due to the similarity of materials to other infusion catheters, the test results and the identical indications for use to other infusion catheters, Micro Therapeutics believes these products do not raise any new safety or effectiveness issues.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1997

Ms. Joy Tan Regulatory Affairs Micro Therapeutics, Inc. 1062-F Calle Negocio San Clemente, California 92673

K964868 Re: 2.9F Cragg-McNamara™ Valved Infusion Catheter Regulatory Class: II (two) Product Code: KRA Dated: February 19, 1997 Received: February 20, 1997

Dear Ms. Tan:

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 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requiations, Title 21, Parts 800 " A substantially equivalent determination assumes compliance to 895. with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in

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

This letter will allow you to begin marketing your device as described in you 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) 594-4648. 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" (21 CFR 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 at (301) 443-6597.

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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510(k) Number (if known): K964868

Device Name:

2.9F Cragg-McNamara™ Valved Infusion Catheter

Indications for Use:

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(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 16964868 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109)

Over the Counter Use

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).