This device is intended for inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.

Device Description

The covers are offered sterile, single use. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.

AI/ML Overview

The provided document describes the acceptance criteria and testing summary for the International Medsurg Connections Piston Syringe and Needles, submitted for 510(k) clearance (K022159).

1. Table of Acceptance Criteria and Reported Device Performance

Testing Items	Acceptance Criteria	Reported Device Performance (Summary)
Syringe Column Sealing (Positive Pressure)	No leakage at 300 Kpa	No leakage
Syringe Column Sealing (Negative Pressure)	No leakage at 88 Kpa	No leakage
Volume	± 4%	Met criteria (implied)
Tip Sealing Property	No Leakage	No Leakage
Indicating Ruler - 0 level line	Within ¼ range	Met criteria (implied)
Tip size, Draw Strength	No separation at 25N	No separation at 25N
Residue Contents	< 0.075 mL	Met criteria (implied)
Sliding Property	Average <10N	Met criteria (implied)
Appearance	Clean, Smooth	Clean, Smooth
Non-Bacteria	Non-Bacteria	Non-Bacteria
Pyrogen	Pyrogen-Free	Pyrogen-Free
Toxicity	Non-toxic, no toxicity reaction for human body	Non-toxic, no toxicity reaction for human body

Note: The document provides the criteria and states that all materials used were "evaluated for" these criteria. For each criterion, the "Reported Device Performance" column implies that the device met these criteria, as the submission was granted 510(k) clearance, indicating substantial equivalence. Specific numerical results for each test (e.g., exact volume deviation, actual residue content) are not provided in this summary.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set for any of the individual tests. The data provenance is not explicitly stated in terms of country of origin, nor whether the data was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer as part of the submission for market clearance in the US.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This submission describes the testing of physical properties and biological compatibility of a medical device (syringes and needles). It does not involve medical image analysis or diagnostic tasks where human expert-established ground truth would be relevant. Therefore, this question is not applicable to the provided document.

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

Not applicable. This device testing does not involve human adjudication of results in the typically understood context of diagnostic or interpretive tasks. The evaluation is based on objective measurements against predefined criteria.

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 submission for a physical medical device (syringes and needles), not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI improvement effect size are irrelevant.

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

Not applicable. This involves a physical medical device, not an algorithm.

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

The "ground truth" for this device is based on established industry standards and regulatory requirements for medical devices of this type. This includes objective physical measurements (e.g., pressure, volume, strength), chemical analyses (e.g., residue content), and biological tests (e.g., bacterial, pyrogen, toxicity). These "ground truths" are derived from recognized standards and scientific principles rather than expert consensus on diagnostic interpretations, pathology, or outcomes data in the usual sense.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for this type of submission.

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

Not applicable. See response to question 8.

Summary

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K022159

Attachment 3

9.0 SUMMARY OF SAFETY AND EFFECTIVENESS

NOV 7 2002 INTERNATIONAL MEDSURG CONNECTIONS SYRINGE AND NEEDLES

Manufacturer:	International Medsurg Connections, Inc.935 N. Plum Grove Road, Suite FSchaumburg, Illinois 60173-4770
Regulatory Affairs Contact:	Michele VovolkaP.O. Box 848Grayslake, Illinois 60030
Telephone:	(847) 856-0355
Date Summary Prepared:	October 11, 2002
Product Trade Name:	International Medsurg Connections Equipment Covers
Common Name:	Piston Syringe and Needles
Classification:	Class II
Predicate Devices:

The International Medsurg Connections piston syringe and hypodermic needle. Description: The covers are offered sterile, single use.

This device is intended for inject fluids into, or withdraw fluids from, parts of the Intended Use: body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger

Substantial Equivalence:

The International Medsurg Connections piston syringe and hypodermic needles are substantially equivalent to the Becton Dickinson Piston Syringes and the Nipro needles in that they provide the following characteristics:

Intended use is the same
Size, configuration, color are similar
Materials
Physical properties are similar

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Attachment 3

Summary of Testing: All materials used in the fabrication of the International Medsurg Connections O.R. piston syringe and hypodermic needles were evaluated for:

Testing Items	Code Requirement
Syringe ColumnSealing	300 Kpa Positive Pressure - Noleakage88 Kpa Negative Pressure - Noleakage
Volume	$\pm 4%$
Tip Sealing Property	No Leakage
Indicating Ruler - 0level line	Within ¼ range
Tip size, DrawStrength	No separation at 25N
Residue Contents	< 0.075 mL
Sliding Property	Average <10N
Appearance	Clean, Smooth
Non-Bacteria	Non-Bacteria
Pyrogen	Pyrogen-Free
Toxicity	Non-toxic, no toxicity reaction forhuman body

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other. The profiles are connected by curved lines, creating a flowing, abstract design.

Public Health Service

7 2002 NOV

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

International Medsurg Connection C/O Ms. Michele H. Vovolka Vantage Consulting International, Limited P.O. Box 848 Grayslake, Illinois 60030

Re: K022159

Trade/Device Name: International Medsurg Connections Syringe and Needles Regulation Number: 880.5860 and 880.5570 Regulation Name: Piston Syringe and Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMF and FMI Dated: October 11, 2002 Received: October 15, 2002

Dear Ms. Vovolka:

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. Vovolka

. . . . . .

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.

Susan Runyon

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Attachment 4

510(k) Number (if known): K022159

International Medsurg Connections Syringe and Needles Device Name:

Indications For Use:

. .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cucchi

vision of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number: K022159

(Optional Format 3/10/98)

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).