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.

AI/ML Overview

This 510(k) summary (K024052) for the Merit Medical 1-mL Syringe does not contain a study that proves the device meets acceptance criteria as typically found in AI/ML device submissions. Instead, it relies on a conformity statement to an established international standard and comparison to a predicate device.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of quantitative acceptance criteria or reported device performance metrics in the way one would expect for an AI/ML device.

Instead, the acceptance criteria are implicitly tied to conformance with the ISO 7886-1:1993 Standard for sterile hypodermic syringes for manual use. The document states:

Acceptance Criteria (Implicit via ISO Standard): Conformance to the requirements of ISO 7886-1:1993, which governs various aspects of syringe performance (e.g., dimensions, force to operate plunger, leakage, sterility, breaking force, etc.).
Reported Device Performance: The document states, "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."
- This indicates that test data will be collected to support conformance, but the results are not presented in this K024052 summary. The summary is a declaration of intent to conform.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided text.
Data Provenance: Not specified, as the data collection was stated to be "before marketing the device" and not yet submitted with this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a medical device (syringe), not an AI/ML diagnostic or prognostic tool that requires expert ground truth for image or data interpretation. Performance is assessed against physical and functional standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

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

Not applicable. This is a physical medical device (syringe), not an AI/ML system.

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

Not applicable. This is a physical medical device (syringe), not an AI/ML system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the context of expert ground truth. The "ground truth" for a syringe's performance would be objective measurements against the specified physical and functional requirements of the ISO 7886-1:1993 standard (e.g., volume accuracy, plunger force, leak tightness, material integrity, sterility, etc.).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML system that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary of the Study (or lack thereof, for AI/ML context):

The K024052 submission for the Merit Medical 1-mL Syringe is a premarket notification for a Class II medical device. It relies heavily on predicate device comparison for intended use, materials, design, operational principles, and technology, and on a commitment to conform to an FDA-recognized consensus standard (ISO 7886-1:1993) for demonstrating safety and performance.

The document explicitly states: "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."

This means that at the time of this 510(k) summary, the detailed test data collected to prove conformance to ISO 7886-1:1993 was not yet submitted. The 510(k) approval is based on the promise to conform and the substantial equivalence to a predicate device for other aspects. This is a typical approach for many conventional medical devices that align with established performance standards. This document does not describe an AI/ML study, but rather a traditional device clearance pathway.

Summary

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K024052

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)

1. Predicate Device(s) K980580, Becton Dickinson (BD) single-use Hypodermic and Insulin Syringes

5. Device Description

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.

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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.

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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.

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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

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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

K624052

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

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).