E-Z LINK

K133097 · Duoject Medical Systems, Inc. · LHI · Mar 13, 2014 · General Hospital

Device Facts

• Record ID: K133097
• Device Name: E-Z LINK
• Applicant: Duoject Medical Systems, Inc.
• Product Code: LHI · General Hospital
• Decision Date: Mar 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

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.

Device Story

E-Z-Link is a sterile, single-use vial adapter/reconstitution device. It facilitates a sterile fluid path between a standard luer lock syringe and a 13mm pharmaceutical vial. Operation is entirely manual: the user connects the device to the vial, transfers liquid via the syringe plunger, agitates the vial to mix/reconstitute the drug, and aspirates the prepared drug back into the syringe. Used in clinical settings by healthcare professionals (nurses, pharmacists). The device simplifies drug preparation and transfer, ensuring a closed, sterile fluid path, which reduces the risk of contamination and improves efficiency in drug delivery preparation.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included needle patency, leak testing (ISO 594-1), needle attachment force (ISO 7864:1993(E)), transfer holdup volume, various mechanical forces (vial attachment/detachment, syringe attachment/detachment, packaging removal, needle shield override), coring/fragmentation, and biocompatibility (ISO 10993-1).

Technological Characteristics

Manually operated, single-use, terminally sterilized device. Components are plastic injection-molded and/or stainless steel. Features a cannula (stainless steel or plastic) for vial stopper penetration. Provides a sterile, biocompatible fluid path. Complies with ISO 594-1 (leak testing), ISO 7864:1993(E) (needle attachment), and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for healthcare professionals (nurses, pharmacists) to prepare drugs in a standard 13mm vial using liquid from a standard luer lock syringe and transfer the reconstituted drug back into the syringe for delivery.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Smart-Rod (K070584)
• Clip'n'ject (K041691)

Submission Summary (Full Text)

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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:

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).

### 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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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