(77 days)
Not Found
No
The device description and intended use are for a simple mechanical syringe, with no mention of AI/ML or related technologies.
No.
Explanation: The device, a syringe, is used for injecting or withdrawing fluids, which are procedures, not therapies. The device itself does not provide a therapeutic effect.
No
The device is described as a syringe used to inject or withdraw fluids, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly states it consists of a calibrated hollow barrel and a movable plunger, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from, the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details a syringe with a barrel and plunger for fluid transfer, and a Luer connector for attaching needles or other devices. This is consistent with a device used for administering or collecting substances from a living organism.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on sample analysis
- Reagents or other components typically associated with IVD tests
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This syringe's function is purely mechanical for fluid handling within or from the body.
N/A
Intended Use / Indications for Use
Merit Medical 1-mL Syringes are used to inject fluids into, or withdraw fluids from, the body.
Product codes
FMF
Device Description
Merit Medical Systems 1-mL Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
510(K) Summarv
FEB 2 1 2003
- Dec. 3. 2002 1. Preparation Date
- Merit Medical Systems, Inc. (MMS) 2. Submitted Bv 1600 West Merit Pkwy. South Jordan, UT 84095
Contact Person/ Prepared By
Stephanie A. Erskine Director, Regulatory Affairs, MMS Phone (801) 208 4349 Fax (801)253 1684 Email serskine@merit.com
| 3. | Device Identification | |
|---|---|---|
| Trade Name | Merit Medical 1-mL Syringe | |
| Common Name | Syringe, Hypodermic Syringe | |
| Classification Name | Piston Syringe (21 CFR 880.5860) |
-
- Predicate Device(s) K980580, Becton Dickinson (BD) single-use Hypodermic and Insulin Syringes
5. Device Description
Merit Medical Systems 1-mL Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.
6. Intended Use
Merit Medical 1-mL Syringes are used to inject fluids into, or withdraw fluids from, the body.
7. Statement of Intent to Conform to ISO 7886-1;1993
Merit Medical Systems. Inc. intends to establish that its 1-mL Syringes conform to the FDA-recognized Consensus Standard, ISO 7886-1:1993 Sterile hypodermic needles for single use- Part 1: Syringes for manual use, before marketing the devices. Data supporting conformance with the standard, with minor exceptions and deviations identified in the premarket notification submission, will be available before marketing the device.
8. Conclusion
The Merit Medical 1-mL Syringe is safe and effective for its intended use.
1
9. Substantial Equivalence/ Conformity with Standards
Similarities/ Differences of the proposed device when compared to 9.1 the predicate:
9.1.1 Intended Use
The Becton Dickinson (B-D) General Purpose syringes are intended for general purpose fluid aspiration/ injection. Merit Medical 1-mL Syringes are used to inject fluids into, or withdraw fluids from, the body. As such, the Intended Uses of the MMS and B-D syringes are equivalent.
9.1.2 Materials
Materials used in the manufacture of MMS syringes are typically used in the manufacture of general-purpose syringes, including the predicate device.
9.1.3 Design
The design of the MMS syringe is typical for syringes, including that of the predicate.
9.1.4 Operational Principles
The MMS syringe is manually operated by advancing and withdrawing the plunger in the barrel. The operating principles are identical for all manual syringes, including the predicate.
9.1.5 Technology
The same fundamental technology is used in the design of the MMS svringes as is employed in the design of all manual syringes, including the predicate.
9.1.6 Safety and Performance
MMS has provided a statement that its syringes will conform to the requirements of ISO 7886-1:1993, an FDA- recognized consensus standard, before marketing the devices. This statement and the data that will be collected to support conformance will be used to demonstrate safety and performance in lieu of demonstrating substantial equivalence with the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
FEB 2 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stephanie A. Erskine Director, Regulatory Affairs Merit Medical Systems, Incorporated 1600 West Merit Parkway South Jordan, Utah 84095
Re: K024052
Trade/Device Name: Merit Medical 1-mL Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: December 5, 2002 Received: December 6, 2002
Dear Ms. Erskine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Erskine
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Susan Suarez
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION(S) FOR USE STATEMENT*
Merit Medical 1-mL Syringes are used to inject fluids into, or withdraw fluids from, the body.
Signature of 510(k) Submitter:
Printed Name of Submitter:
Stephanie A. Erskine Director, Regulatory Affairs Merit Medical Systems, Inc.
Date:
*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.
Concurrence of Office of Device Evaluation
510(k) Number
Division Sign-Off Office of Device Evaluation
Prescription Use
✓
OR Over-The-Counter Use
Patuxo Crescenti
y, General Hospital. n of Anesthesiolor tion Control, Dent
510(k) Number. K