VENOJECT LUER ADAPTER

K041358 · Terumo Europe N.V. · JKA · May 28, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041358
• Device Name: VENOJECT LUER ADAPTER
• Applicant: Terumo Europe N.V.
• Product Code: JKA · Clinical Chemistry
• Decision Date: May 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Terumo® Venoject Luer Adapter is a sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. When blood samples are to be obtained with a single venipuncture, the luer adapter is a conduit between the collection needle and the collection container.

Device Story

The Venoject Luer Adapter is a sterile, single-use manual device serving as a conduit for blood specimen collection. It consists of a stainless steel cannula joined to a screw connector with a male luer taper. The cannula is covered by a synthetic isoprene rubber tip that acts as a valve; when a collection container is pressed over the cannula, the tip retracts to allow blood flow; when removed, the tip extends to stop flow. The device is used in clinical settings by healthcare professionals to facilitate blood collection from needles or catheters into evacuated collection systems. It does not have direct patient contact. The device benefits patients by enabling secure, controlled blood sample collection during venipuncture.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluated against established specifications. Biocompatibility screening tests performed with no adverse findings.

Technological Characteristics

Materials: stainless steel cannula, synthetic isoprene rubber tip. Principle: manual flow control via retractable rubber valve. Form factor: screw connector with male luer taper. Sterilization: ethylene oxide (EN 550, ISO 11135) to SAL 10^-6. Non-patient contacting.

Indications for Use

Indicated for blood specimen collection from hypodermic needles, blood vessel catheters, or luer-fitted blood collection systems. Intended for use as a conduit between a collection needle and collection container during single venipuncture procedures.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• Venoject Luer Adapter (K983490)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE

A. 510(k) Number:
K041358

B. Purpose for Submission:
New Device

C. Analyte:
N/A

D. Type of Test:
Blood Specimen Collection Device

E. Applicant:
Terumo Europe N.V.

F. Proprietary and Established Names:
Venoject® Luer Adapter

G. Regulatory Information:
1. Regulation section:
21 CFR. 862.1675
2. Classification:
Class II
3. Product Code:
JKA
4. Panel:
75

H. Intended Use:
1. Intended use(s):
The Terumo® Venoject Luer Adapter is a sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings that acts as the conduit between the collection needle and the collection container.
2. Indication(s) for use:
The Terumo® Venoject Luer Adapter is a sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. When blood samples are to be obtained with a single venipuncture, the luer adapter is a conduit between the collection needle and the collection container.

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3. Special condition for use statement(s): N/A
4. Special instrument Requirements: N/A

I. Device Description:
The Terumo® Venoject Luer Adapter is a conduit between the collection needle and the collection container. The Terumo® Venoject Luer Adapter is a sterile, single use device consisting of a cannula joined to a screw connector which is connected to a male luer taper. The cannula is covered with a synthetic isoprene rubber tip for stopping blood flow. When blood is collected using an evacuated blood collecting system, the collection container is placed over the cannula, pushing the rubber tip back, allowing blood flow. When the collection container is removed, the rubber tip extends back over the cannula, stopping blood flow. The luer adapter has no direct patient contact.

J. Substantial Equivalence Information:
1. Predicate device name(s): The Terumo® Venoject Luer Adapter manufactured by the Terumo Corporation.
2. Predicate K number(s): K983490
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. | Sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. |
| Materials | Stainless Steel Cannula
Silicone Oil Lubricant
Epoxy glue adhesive
Synthetic Isoprene Rubber Tip
Polypropylene Needle
Polypropylene and polyethylene Connector Cap | Stainless Steel Cannula
Silicone Oil Lubricant
Epoxy glue adhesive
Synthetic Isoprene Rubber Tip
Polypropylene Needle
Polypropylene and polyethylene Connector Cap |
| Principle of Operation | Manual | Manual |
| Expiration | 30 months | 30 months |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Sterilization | Ethylene Oxide Gas to SAL 10^{-6} | Gamma Radiation to SAL 10^{-6} |

K. Standard/Guidance Document Referenced (if applicable):
European Pharmacopoeia (2002) 2.6.8 (4^th edition)
EN 180 30993-4:1992-DAM 1"Biological testing of medical devices- Part 4:Tests for interaction with blood.

L. Test Principle:
N/A

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:
N/A
c. Traceability (controls, calibrators, or method):
N/A
d. Detection limit:
N/A
e. Analytical specificity:
N/A
f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
The Terumo® Venoject Luer Adapter manufactured by Europe N.V that was sterilized by Ethylene Oxide gas was compared against the Terumo® Venoject Luer Adapter manufactured by Terumo Corporation that was sterilized by gamma radiation. The current device at ages 0, 1 and 2.5 years was compared against the predicate in the following tests:
1) bonding strength between hub and cannula, 2) penetration force at setting side, 3) bonding strength between the hub and rubber tip, 4) resistance torque to screw and unscrew the luer adapter on and off the holder, 5) resealability of rubber tip, 6) conical fitting, 7) air and liquid leakage and 8) push back force.
The results of the tests performed showed that sterilization methods did not affect the safety and effectiveness of the Terumo® Venoject Luer Adapter manufactured by Europe N.V.
b. Matrix comparison:
N/A

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3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when a and b are not applicable): N/A

4. Clinical cut-off: N/A

5. Expected values/Reference range: N/A

N. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.