(164 days)
No
The description focuses on mechanical aspects of drug transfer and reconstitution, with no mention of AI/ML terms or functionalities.
No
The device is described as facilitating the preparation and transfer of drugs, not for directly treating a disease or condition in a patient.
No
The device is described as a sterile, single-use device for preparing drugs by transferring liquid between a syringe and a vial for mixing or reconstitution and then back into the syringe for delivery. Its function is to facilitate the preparation and transfer of medication, not to diagnose a medical condition or disease.
No
The device description explicitly states it is a sterile, single-use device with a stainless steel cannula (needle) and other physical components, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the preparation and transfer of drugs using a syringe and vial. This is a process related to drug administration, not the diagnosis of a disease or condition using in vitro examination of specimens.
- Device Description: The description focuses on the mechanical function of transferring liquid between a syringe and a vial for mixing or reconstitution of a drug. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes (biomarkers, pathogens, etc.)
- Providing diagnostic information
- Reagents or test kits
The device is a sterile, single-use device for facilitating the preparation and transfer of drugs, which falls under the category of medical devices used in drug administration.
N/A
Intended Use / Indications for 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.
Single use, sterile device for preparation of drugs in a standard luer syringe to transfer the prepared drug back into the syringe for delivery.
Product codes
LHI
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).
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
health care professionals (HCPs) such as nurses and pharmacists in a clinical setting.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
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)
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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