The E-Z-Link device is a sterile, single use device that, through the use of a stainless steel cannula (needle), facilitates creation of a sterile fluid path to transfer liquid from a standard luer lock syringe to a standard pharmaceutical 13 mm vial containing a drug, in order to mix or reconstitute the drug and aspirate and transfer the prepared drug back into the luer lock syringe for delivery. The product line will include devices with different gauge transfer needles (20 and 27 Gauge).

AI/ML Overview

The E-Z-Link device is a sterile, single-use vial adapter/reconstitution device. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and performance testing. It does not describe a study involving a test set, ground truth, or expert readers in the context of typical AI/diagnostic device evaluation.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The regulatory submission for the E-Z-Link device focuses on demonstrating that its performance characteristics meet established standards for similar devices. The "acceptance criteria" are implied by the successful completion of the listed tests, indicating the device meets the functional, safety, and quality requirements.

Acceptance Criteria (Implied)	Reported Device Performance
Meet standards for needle patency	Data generated verifying design for needle patency
Meet leak testing requirements per ISO 594-1	Data generated verifying design for leak testing
Meet needle attachment force requirements per ISO 7864:1993(E)	Data generated verifying design for needle attachment force
Meet transfer holdup volume specifications	Data generated verifying design for transfer holdup volume
Meet force to transfer liquid to vial specifications	Data generated verifying design for force to transfer liquid to vial
Meet vial attachment force specifications	Data generated verifying design for vial attachment force
Meet vial detachment force specifications	Data generated verifying design for vial detachment force
Meet packaging removal force specifications	Data generated verifying design for packaging removal force
Meet force to attach/detach luer lock syringe specifications	Data generated verifying design for force to attach/detach luer lock syringe
Meet needle shield override force specifications	Data generated verifying design for needle shield override force
Meet coring/fragmentation requirements	Data generated verifying design for coring/fragmentation
Meet biocompatibility standards per ISO 10993-1	Data generated verifying design for biocompatibility

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of evaluating an AI or diagnostic algorithm on a specific dataset of cases. The performance data refers to physical and biological testing of the device itself. Therefore, information about sample size and data provenance for a test set is not applicable here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes physical device testing, not a study evaluating human or AI performance against a ground truth from experts.

4. Adjudication Method for the Test Set

This information is not applicable.

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

An MRMC study is not applicable to this type of device (a mechanical vial adapter). The document does not describe any human reader performance evaluation or AI assistance.

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

This information is not applicable. The E-Z-Link is a manually operated mechanical device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The concept of "ground truth" as typically used in diagnostic imaging or AI studies is not applicable here. For mechanical devices like E-Z-Link, the "ground truth" is defined by adherence to engineering specifications, international standards (e.g., ISO), and accepted medical device performance parameters for safety and functionality. For example, for "Leak Testing of connections per ISO 594-1," the "ground truth" is the specified leak rate threshold outlined in the ISO standard.

8. The Sample Size for the Training Set

This information is not applicable. The E-Z-Link is a mechanical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable.

Summary

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510(k) Summary : K133097

2.1. SUMMARY OF SAFETY AND EFFECTIVENESS

Prepared By: Marie-Christine Messier Quality Manager Engineering Services Division DUOJECT Medical Systems Inc. 50 chemin de Gaspe, Complex B-5 Bromont (Quebec) Canada J2L 2N8 Date Prepared: March 13th, 2014

2.2. Trade/Proprietary Name: E-Z-Link

2.3. Common/Usual Name:	Vial Adapter/Reconstitution Device
2.4. Classification Name:	Intravascular Administration Set
Regulation Number:	21CFR 880.5440
Class :	II
Product Code:	LHI

2.5. Device description:

2.6. Statement of intended use

The device is a sterile, single use device indicated for the preparation of drugs in a standard vial using liquid from a standard luer lock syringe and transfer of the prepared drug back into the syringe for delivery.

The device is intended to be used by health care professionals (HCPs) such as nurses and pharmacists in a clinical setting.

2.7. Substantial Equivalence

The E-Z-Link device is substantially equivalent to the Smart-Rod (K070584) and the Clip'n'ject (K041691).

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2.8. Technological Characteristics

The E-Z-Link shares the same and does not introduce any new technological characteristics as the predicate devices. The device characteristics are as follows:

Manually operated .
- o Device is manually, mechanically connected to a compatible drug vial
- o Liquid is manually transferred using a syringe plunger rod
- o Mixing is manually achieved through manual agitation of the vial
- o Liquid is manually aspirated using a syringe plunger rod
Terminally sterilized and provided sterile .
For single use only .
Penetrates the vial stopper with a stainless steel or a plastic cannula .
Assembled from plastic injection molded and/or stainless steel components .
. has a sterile, biocompatible fluid path

2.9. Performance Data

Data on the following testing were generated verifying the design of the device:

Needle patency .
Leak Testing of connections per ISO 594-1. .
. Needle Attachment Force per ISO 7864:1993(E )
Transfer Holdup Volume .
Force to transfer liquid to vial .
Vial attachment force .
. Vial Detachment force
. Packaging Removal Force
Force to Attach/Detach luer lock syringe .
Needle Shield Override force .
Coring/Fragmentation .
Biocompatibility: per ISO 10993-1, "Biological Evaluation of Medical Devices Part . 1: Evaluation and Testing".

2.10. Conclusion

Based on the information presented, Duoject Medical Systems concludes that the new product is substantially equivalent to products currently legally marketed in the USA.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 13, 2014

Duoject Medical Systems Inc. Marie-Christine Messier Quality Manager 50 Chemin De Gaspe Complex B-5 Bromont, Quebec J2L 2N8

Re: K133097

Trade/Device Name: E-Z Link Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: February 6. 2014 Received: February 12, 2014

Dear Ms. Messier:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Messier

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/6 description: The image shows the text "Erin Kitchen-S" in a bold, sans-serif font. The word "Erin" is clearly legible on the left side of the image. The word "Kitchen" is stylized with a decorative border around each letter, making it appear more complex. The "-S" is written in a similar font to "Erin" and is located on the right side of the image.

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K133097

Device Name

E-Z-Link

Indications for Use (Describe)

Single use, sterile device for preparation of drugs in a standard luer syringe to transfer the prepared drug back into the syringe for delivery.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Digitally signed by Richard C. Chapman Date: 2014.03.12 17:12:12 -04'00'

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Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.