The Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.

Device Description

The Rebar Micro Catheter is a single-lumen catheter designed to be introduced over a steerable guidewire into the distal vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which tapers into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter has a lubricious hydrophilic coating. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. Select catheter models (.0165" lumen) have a secondary marker 3 cm proximal of the distal tip marker.

AI/ML Overview

The provided text describes the 510(k) summary for the Rebar™ Micro Catheter, which is an infusion catheter, and the FDA's clearance letter for the device. The information focuses on the device's substantial equivalence to a predicate device and its biocompatibility and performance testing against industry standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Biocompatibility	ISO 10993-1, Biological Evaluation of Medical Devices (for external communicating, blood contact, short duration device (<24 hr))	Test results confirmed biocompatibility of the Rebar catheter.
Performance Testing	ISO 10555 Sterile, single use intravascular catheters - Part 1	Device meets or exceeds the requirements of these standards.
- Dimensional Verification	ISO 10555	Meets/Exceeds requirements.
- Catheter Tensile Strength	ISO 10555	Meets/Exceeds requirements.
- Catheter Burst Strength	ISO 10555	Meets/Exceeds requirements.
- Catheter Torque Strength	ISO 10555	Meets/Exceeds requirements.
- Flexibility	ISO 10555	Meets/Exceeds requirements.
- Trackability	ISO 10555	Meets/Exceeds requirements.
- Coating Integrity	ISO 10555	Meets/Exceeds requirements.
Substantial Equivalence	Equivalence to predicate device (Micro Therapeutics, Inc. Easy Rider Micro Catheter, K974473) in intended use and principle of operation.	Rebar Micro Catheter is substantially equivalent to the predicate device in intended use and principle of operation.

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 for any of the performance or biocompatibility tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable to the type of device and studies described. The studies are engineering tests (biocompatibility, mechanical performance) against international standards, not diagnostic performance studies requiring expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are engineering tests, not clinical studies requiring adjudication of outcomes or interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is a key component, which is not the case for an infusion catheter.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study in the context of an algorithm or AI was not done. The studies mentioned are for the physical properties and biocompatibility of the catheter itself, not for an algorithm.

7. Type of Ground Truth Used

For biocompatibility, the ground truth would be the results relative to ISO 10993-1 standards (e.g., absence of cytotoxicity, irritation, etc.). For performance testing, the ground truth would be the established requirements and specifications outlined in ISO 10555 (e.g., minimum tensile strength, maximum burst pressure, acceptable flexibility range). These are objective, measurable criteria from recognized standards.

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as the device is a physical medical instrument, not an AI or machine learning model.

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

This information is not applicable as there is no training set for an AI or machine learning model. The "ground truth" for the device's physical and biological properties is established by adherence to recognized international standards (ISO 10993-1 and ISO 10555) for medical device evaluation.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Rebar™ Micro Catheter

Prepared December 2, 1999

TRADE NAME:	Rebar™ Micro Catheter
GENERIC NAME:	Infusion Catheter	CLASSIFICATION:	Class II
SUBMITTED BY:	Micro Therapeutics, Inc.2 GoodyearIrvine, CA 92618	CONTACT:	Tom DaughtersRegulatory Affairs(949) 837-3700
PREDICATEDEVICE	Micro Therapeutics, Inc. Easy Rider Micro Catheter, K974473
DEVICEDESCRIPTION	The Rebar Micro Catheter is a single-lumen catheter designed to be introduced over asteerable guidewire into the distal vasculature. The proximal end of the catheterincorporates a standard luer adapter to facilitate the attachment of accessories. Thecatheter has a semi-rigid proximal shaft which tapers into the flexible distal shaft tofacilitate the advancement of the catheter in the anatomy. The outer surface of thecatheter has a lubricious hydrophilic coating. The catheter has a radiopaque marker atthe distal end to facilitate fluoroscopic visualization. Select catheter models (.0165"lumen) have a secondary marker 3 cm proximal of the distal tip marker.
INDICATIONSFOR USE	The Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral andneuro anatomy.
SAFETY ANDPERFORMANCETESTS	Biocompatibility of the Rebar catheter was verified in accordance with ISO 10993-1,Biological Evaluation of Medical Devices. Test results confirmed biocompatibility ofthe Rebar catheter when tested as an external communicating, blood contact, shortduration device (<24 hr).Performance testing of the Rebar catheter was conducted in accordance with ISO 10555Sterile, single use intravascular catheters - Part 1. Verification tests included:dimensional verification; catheter tensile, burst and torque strength; flexibility,trackability, and coating integrity. Test results demonstrate that the device meets orexceeds the requirements of these standards and performs substantially equivalent tothe predicate device.
SUMMARY OFSUBSTANTIALEQUIVALENCE	The Rebar Micro Catheter is substantially equivalent to the predicate device in intendeduse and principle of operation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 4 2000

Mr. Tom Daughters Regulatory Affairs Micro Therapeutics, Inc. 2 Goodyear Irvine, CA 92618

Re: K993672 Rebar™ Micro Catheter Trade Name: Regulatory Class: II Product Code: KRA December 2, 1999 Dated: Received: December 6, 1999

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, 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 Regulations, 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 requlatory 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 regulations.

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Page 2 - Mr. Tom Daughters

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) 594-4586. 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,

Clintoplu.th.

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k)Number(if known)	K993672
Device Name	Rebar™ Micro Catheter
Indicationsfor Use	The Rebar Micro Catheter is intended for the controlled selectiveinfusion of physician-specified therapeutic agents or contrast mediainto the vasculature of the peripheral and neuro anatomy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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× Prescription Use_ (Per 21 CFR 801. 109)

Over-The-Counter Use_

Christopher for Witter

11:2

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).