The MTI 1 ml Syringe is a long stroke syringe designed for injection or aspiration of fluids during diagnostic and/or therapeutic procedures. The syringe will have a male conical lock fitting to facilitate attachment to various catheters and accessories. The syringe will be provided sterile and is for single-use only.

The transparent barrel is made of a heat and chemical resistant polyolefin. The plunger is composed of a polymer resin and the piston is a silicone, non-latex rubber with a liquid silicone lubricant.

The syringe is provided as a set of three, in a sterile Tyvek peel pouch and chipboard carton. The syringes are for general use.

AI/ML Overview

The provided text describes the MTI 1 ml Syringe and its regulatory review, focusing on biocompatibility and in-vitro performance testing.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from recognized international standards, and the reported performance indicates conformance to these standards.

Acceptance Criteria (Standard)	Reported Device Performance
Biocompatibility: ISO 10993-1, Biological Evaluation of Medical Devices (for externally communicating, blood path indirect, limited exposure device)	Confirmed biocompatibility of the syringe (tested as an externally communicating, blood path indirect, limited exposure device)
In-vitro Performance: ISO 7886-1: Sterile Hypodermic Syringes for Single Use - Part I: Syringes for Manual Use (May 1997)	Yielded results in conformance for leakage, forces required to operate, and volume accuracy
In-vitro Performance: ISO 594: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1 and 2 (6/86 and 5/91 resp.)	Yielded results in conformance for dimensional inspection tests

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

The document does not explicitly state the sample sizes used for the in-vitro performance testing. It mentions "Testing of the product yielded results," implying a set of samples were tested, but no specific numbers are provided.

The data provenance is not specified. It is an internal company report (Micro Therapeutics, Inc.) from April 1999, so the testing would have been conducted by or for the manufacturer. The data is retrospective in the sense that it describes tests already performed to support the 510(k) submission. No country of origin for the data is mentioned, but the manufacturer is based in Irvine, CA, USA.

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

This information is not applicable to this type of device and testing. The "ground truth" for the performance tests (leakage, operating forces, volume accuracy, dimensions) is established by the objective measurements performed according to the specified ISO standards, not by expert consensus or interpretation.

4. Adjudication Method for the Test Set

This is not applicable to the type of testing performed. The in-vitro performance tests are objective measurements against defined standards, not subjective assessments 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

This is not applicable. The MTI 1 ml Syringe is a manual medical device, not an AI software/system that would involve human readers or AI assistance.

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

This is not applicable. The MTI 1 ml Syringe is a manual medical device, not an algorithm, and does not involve AI or human-in-the-loop performance in the context of an algorithm.

7. The Type of Ground Truth Used

The ground truth for the device's performance is based on objective measurements compared against the specifications and limits defined within recognized international standards (ISO 10993-1, ISO 7886-1, ISO 594).

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" for this device. The MTI 1 ml Syringe is a physical medical device, not an AI model or software that requires training data.

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

This is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/3 description: The image shows the logo for Micro Therapeutics, Inc. The logo consists of the letters "MTI" in a bold, sans-serif font. To the left of the letters, there is a graphic of small squares that appear to be dispersing. Below the letters, the words "MICRO THERAPEUTICS, INC." are written in a smaller, sans-serif font.

510(k) Summary of Safety and Effectiveness

MT! 1 ml Syringe Prepared 8 April, 1999

Trade Name:	MTI 1 ml Syringe
Generic Name:	Piston Syringe	Classification:	Class II
Submitted By:	Micro Therapeutics, Inc.2 GoodyearIrvine, CA 92618	Contact:	Maria D. OchoaRegulatory Affairs(949) 837-3700
Predicate Devices

Merit Medical Systems, Inc.: Medallion Syringe

Device Description

The transparent barrel is made of a heat and chemical resistant polyolefin. The plunger is composed of a polymer resin and the piston is a silicone, non-latex rubber with a liquid silicone lubricant.

The syringe is provided as a set of three, in a sterile Tyvek peel pouch and chipboard carton. The syringes are for general use.

Indications For Use

The MTI 1 ml Syringe is intended for injection of fluids. The syringe is designed for manual use.

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Testing

Biocompatibility of the MTI Syringe has been verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the syringe when tested as an externally communicating, blood path indirect, limited exposure device.

In-vitro performance testing of the syringe included measurement of leakage, forces required to operate, verification of volume accuracy, and dimensional inspection tests. Testing of the product yielded results in conformance with the following recognized standards:

트 ISO 7886-1: Sterile Hypodermic Syringes for Single Use - Part I: Syringes for Manual Use (May 1997) and,
트 ISO 594 : Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1 and 2 (6/86 and 5/91 resp.)

Summary of Substantial Equivalence

The MTI Syringe is substantially equivalent to the predicate devices in intended use and principles of operation and conforms to the aforementioned consensus standards.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 1999

Ms. Maria D. Ochoa Requlatory Affairs Micro Therapeutics, Incorporated 1062-F Calle Negocio San Clemente, California 92673

K991225 Re : MTI 1 ml Syringe Trade Name: Requlatory Class: II Product Code: FMF Dated: April 8, 1999 Received: April 12, 1999

Dear Ms. Ochoa:

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 The general controls provisions of the Act 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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.

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Page 2 - Ms. Ochoa

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K991225
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Device Name: MTI 1 ml Syringe

Indications for Use:

The MTI 1 ml Syringe is intended for injection and aspiration of fluids. The syringe is designed for manual use.

Patoux Cucenite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 991225 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	✓ OR (Per 21 CFR 801.109)
Over the Counter Use

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).