(87 days)
Not Found
Not Found
No
The description focuses on the mechanical components and materials of a standard syringe and does not mention any computational or algorithmic features.
No
The device is a syringe used for injection and aspiration of fluids, which are procedures, not therapeutic actions in themselves.
No
Explanation: The device is described as a syringe for "injection and aspiration of fluids" and for use during "diagnostic and/or therapeutic procedures." While it can be used during diagnostic procedures, the syringe itself does not perform any diagnostic function (e.g., analyzing fluids or providing diagnostic information). Its purpose is solely for fluid handling.
No
The device description clearly outlines physical components like a barrel, plunger, and piston, and the performance studies focus on material biocompatibility and mechanical performance, indicating a hardware-based device.
Based on the provided information, the MTI 1 ml Syringe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for injection and aspiration of fluids." This describes a device used directly on or in a patient for therapeutic or diagnostic procedures, not for examining specimens in vitro (outside the body).
- Device Description: The description focuses on the physical characteristics and materials of a syringe designed for manual use in medical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition. IVDs are typically reagents, instruments, or systems used for such analysis.
- Performance Studies: The performance studies focus on biocompatibility and physical performance characteristics relevant to a syringe used for injection/aspiration, not on the analytical performance of an IVD.
- Predicate Device: The predicate device is a "Medallion Syringe," which is also a device used for injection and aspiration, not an IVD.
In summary, the MTI 1 ml Syringe is a medical device intended for direct use in patient procedures, not for the in vitro examination of specimens.
N/A
Intended Use / Indications for Use
The MTI 1 ml Syringe is intended for injection of fluids. The syringe is designed for manual use.
Product codes
FMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.)
Key Metrics
Not Found
Predicate Device(s)
Merit Medical Systems, Inc.: Medallion Syringe
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Goodyear | |||
| Irvine, CA 92618 | Contact: | Maria D. Ochoa | |
| Regulatory Affairs | |||
| (949) 837-3700 | |||
| 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.
1
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.
2
Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized, curved lines that resemble a person. The lines are stacked on top of each other, creating a sense of depth and movement.
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.
3
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
4
| 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 | ✓ OR (Per 21 CFR 801.109) |
|---|---|
| Over the Counter Use |