(7 days)
Not Found
No
The device description and intended use clearly describe a simple mechanical adapter for blood collection, with no mention of any computational or analytical functions that would involve AI/ML.
No
The device is described as a non-invasive device used for blood specimen collection, acting as a conduit between a collection needle and container. It does not perform any therapeutic function (i.e. treating or curing a disease/condition).
No
The device is described as permitting blood specimen collection, acting as a conduit between a collection needle and container. It does not perform any analysis or interpretation of the collected blood, which are functions of a diagnostic device.
No
The device description clearly outlines physical components (cannula, screw connector, male luer taper, synthetic isoprene rubber tip) and its function as a conduit for blood collection, indicating it is a hardware device.
Based on the provided information, the Terumo Venoject Luer Adapter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for blood specimen collection. While the collected blood will likely be used for in vitro diagnostic testing, the device itself is a tool for the collection process, not for performing the diagnostic test on the sample.
- Device Description: The description focuses on the physical components and how it facilitates blood flow into a collection container. It does not describe any components or functions related to analyzing or testing the blood sample.
- Lack of Diagnostic Function: The device's function is to connect a needle/catheter to a collection container. It does not perform any analysis, measurement, or interpretation of the blood itself.
IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Terumo Venoject Luer Adapter is a component used before the in vitro diagnostic process begins.
N/A
Intended Use / Indications 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.
Product codes
JKA
Device Description
The Terumo Venoject Lucr 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.
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
Not Found
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)
The performance of the Venoject Luer Adapter has been evaluated and the device performs according to the specification. There are no significant differences in specifications and performance between proposed device and predicate.
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
§ 862.1675 Blood specimen collection device.
(a)
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.(b)
Classification. Class II.
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SUMMARY AND CERTIFICATION II 510(k) Summary as required by 807.92 Summary of Safety & Effectiveness Information
- Proprietary Device Name II. 1. VENOJECT® Luer Adapter
- Classification Name II.2. Blood Specimen Collection Device
- Reason for Submission II.3. New Device
II.4. 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.
II. 2. Description
The Terumo Venoject Lucr 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.
Substantial Equivalence II.6.
The "Venoject Luer Adapter", manufactured by Terumo Europe N.V., submitted in this 510(k) file is substantially equivalent in intended use, description/specifications, technology/principles of operation, materials and performance to the cleared "Venoject Luer Adapter", manufactured by Terumo Corporation which is the subject of K983490.
Both devices being Luer Adapters for blood specimen INTENDED USE: collection, are sterile and for single use, permitting blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. For blood samples obtained by single venipuncture, the lucr adapter serves as a conduit between the needle and the collection container.
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| DESCRIPTION/ SPECIFICATIONS: | Both devices are made of a stainless steel cannula joined to a screw connector which is connected to a luer taper, and the cannula covered with a synthetic isoprene rubber tip.
Materials used for proposed device and predicate are the same. |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PRINCIPLE OF TECHNOLOGY STATEMENT: | The Venoject Luer Adapter made by Terumo Europe N.V. and the Venoject Luer Adapter made by Terumo Corporation are both operated manually. |
| PERFORMANCE: | The performance of the Venoject Luer Adapter has been evaluated and the device performs according to the specification. There are no significant differences in specifications and performance between proposed device and predicate. |
II. 7. Additional Safety Information
The sterility of the Venoject Lucr Adapter is assured by using a validated sterilization method qualified in accordance with EN 550: "Sterilization of Medical Devices: Validation and routine control of ethylene oxide" and ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization" to a sterility assurance level (SAL) of 10° as required by EN 556-1: "Sterilization of Medical Devices -Requirements for medical devices to be designated "STERILE"Part - 1: Requirements for terminally sterilized medical devices".
Because this device does not come in direct contact with the patient, only biocompatibility screening tests have been performed. The results of these tests gave no indication that additional biocompatibility testing was necessary.
The expiration dating for the Venoject Luer Adapter has been established at 30 months.
II.8. Conclusion
The Venoject Luer Adapter manufactured by Terumo Europe N.V. and submitted in this 510(k) file is substantially equivalent in intended use, description, specifications, technology/principles of operation, materials and performance to the cleared Venoject Luer Adapter manufactured by Terumo Corporation which is the subject of K983490. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
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Preparation info II.9.
| Date prepared: | 05/2004 |
|---|---|
| Prepared by: | Mrs. M.J. Aerts - Manager Regulatory Affairs |
| Prepared for: | TERUMO EUROPE N.V. |
| Researchpark Zone 2, Interleuvenlaan 40, 3001 Leuven BELGIUM | |
| Tel.: | 0032 / 16 / 381 353 |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
MAY 2 8 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mrs. M.J. Aerts Manager, Regulatory Affairs Terumo Europe N.V. RESEARCHPARK ZONE 2 HAASRODE Interleuvenlaan 40 B-3001 LEUVEN-BELGIE (BEGLIUM)
K041358 Re: Trade/Device Name: Venoject® Luer Adapter Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: May 19, 2004 Reccived: May 21, 2004
Dear Mrs. Aerts
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Seain M. Cooper, US. Div.
Tean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Use Indications for
510(k) Number (if known): 504 1358
Device Name: Venoject® Luer Adapter
Indications for Use:
The Terumo Venoject Luer Adapter is a sterile, non-invasive device that permits blood The Terunio Venoject Duer Natprof is a Beach () blood vessel catheters, or blood collection specifical concentify from trypoderines (1000) samples are to be obtained with a single systems/devices with fuer adapter is a conduit between the collection needle and the collection container.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Roberts Cota
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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