MTI 1 ML SYRINGE

K991225 · Micro Therapeutics, Inc. · FMF · Jul 8, 1999 · General Hospital

Device Facts

• Record ID: K991225
• Device Name: MTI 1 ML SYRINGE
• Applicant: Micro Therapeutics, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jul 8, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

MTI 1 ml Syringe is a long-stroke, manual piston syringe used for injection or aspiration of fluids during diagnostic or therapeutic procedures. It features a male conical lock fitting for attachment to catheters and accessories. The device is provided sterile for single-use. Construction includes a transparent polyolefin barrel, a polymer resin plunger, and a silicone non-latex rubber piston with liquid silicone lubricant. It is used in clinical settings by healthcare professionals. The device facilitates fluid delivery or removal, aiding in various medical interventions.

Clinical Evidence

Bench testing only. Biocompatibility verified per ISO 10993-1. In-vitro performance testing included leakage, operating forces, volume accuracy, and dimensional inspection, confirming conformance to ISO 7886-1 and ISO 594 standards.

Technological Characteristics

Materials: polyolefin barrel, polymer resin plunger, silicone non-latex rubber piston, liquid silicone lubricant. Design: long-stroke piston syringe with male conical lock fitting. Standards: ISO 7886-1 (sterile hypodermic syringes), ISO 594 (conical fittings). Sterilization: provided sterile in Tyvek peel pouch.

Indications for Use

Indicated for the injection and aspiration of fluids in patients requiring such procedures; designed for manual use by clinicians.

Regulatory Classification

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.

Predicate Devices

• Merit Medical Systems, Inc.: Medallion Syringe

Submission Summary (Full Text)

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# 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.<br>2 Goodyear<br>Irvine, CA 92618 | Contact: | Maria D. Ochoa<br>Regulatory Affairs<br>[phone] |
| Predicate Devices | | | |

Merit Medical Systems, Inc.: Medallion Syringe

#### Device Description

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.

#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 |
|---------------------------|---------|
|---------------------------|---------|

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 | <div> <span style="text-decoration: overline;">✓</span> OR </div> (Per 21 CFR 801.109) |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| Over the Counter Use | <span style="text-decoration: overline;"></span> |