(56 days)
Not Found
No
The device description and performance studies focus on mechanical properties and functionality related to blood collection, with no mention of AI or ML.
No
The device is described as a non-invasive device for blood specimen collection, acting as a conduit between a collection needle and a container. Its function is to facilitate the collection of blood samples, not to treat or diagnose medical conditions or restore physiological functions.
No.
The device description and intended use clearly state that the Terumo Venoject Luer Adapter is a non-invasive device used for collecting blood specimens and acts as a conduit between the collection needle and the collection container. It does not perform any analysis or interpretation of the collected specimens to diagnose a condition.
No
The device description clearly outlines a physical, sterile, single-use device made of a cannula, connector, and rubber tip. It describes mechanical actions (pushing the rubber tip back) and physical properties (cannula elasticity, bending strength), indicating it is a hardware device. There is no mention of software components or functions.
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 luer adapter 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 function of the device in facilitating blood flow from the patient to the collection container. It does not describe any components or processes related to analyzing or testing the blood sample.
- Lack of IVD Characteristics: IVD devices are typically reagents, instruments, or systems intended for use in the examination of specimens derived from the human body in vitro to provide information for diagnostic, monitoring, or compatibility purposes. The luer adapter does not perform any of these functions.
The luer adapter is a medical device used in the process of obtaining a sample for IVD testing, but it is not an IVD device itself.
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
75 JKA
Device Description
The Terumo Venoject Luer Adapter is a sterile, single use device consisting of a cannula joined to a female connector (hub) which is connected to a luer taper. The cannula is covered with a synthetic isoprene rubber tip for stopping blood flow. When blood is collected, 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
The performance of the TERUMO® VENOJECT® Luer Adapter has been evaluated and the device performs according to specification.
The following tests were performed to evaluate the performance of the Terumo Venoject Luer Adapter submitted in this 510k:
- Cannula elasticity
- Cannula/barrel adherence ●
- Bending strength .
- Visual .
- Dimensional .
- Extraction .
Key Metrics
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.
0
NOV 30 1998
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
TERUMO® VENOJECT® Luer Adapter or similar Proprietary Device Name: proprietary name Classification Name: Blood Specimen Collection Device
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.
DESCRIPTION/SPECIFICATIONS
The Terumo Venoject Luer Adapter is a sterile, single use device consisting of a cannula joined to a female connector (hub) which is connected to a luer taper. The cannula is covered with a synthetic isoprene rubber tip for stopping blood flow. When blood is collected, 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
The Terumo Venoject Luer Adapter submitted in this 510k is substantially equivalent in intended use, design, principle of operation, and materials to the cleared B-D® Vacutainer® Luer Adapter which is the subject of K931367.
PRINCIPLE OF OPERATION/TECHNOLOGY
The Terumo Venoject Luer Adapter and the B-D Vacutainer Luer Adapter are both operated manually.
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MATERIALS
| MATERIALS | PROPOSED | PREDICATE |
|---|---|---|
| Needle | Stainless Steel | Stainless Steel |
| Hub | Polypropylene | Polystyrene |
| Rubber Tip | Synthetic Isoprene Rubber | Dipped Latex Rubber |
| Cap | Polypropylene | Polypropylene |
| Case | Polypropylene and | |
| polyethylene | Polyethylene |
PERFORMANCE
The performance of the TERUMO® VENOJECT® Luer Adapter has been evaluated and the device performs according to specification.
The following tests were performed to evaluate the performance of the Terumo Venoject Luer Adapter submitted in this 510k:
- . Cannula elasticity
- Cannula/barrel adherence ●
- Bending strength .
- Visual .
- Dimensional .
- Extraction .
ADDITIONAL SAFETY INFORMATION
The sterility of the product is assured using a sterilization method validated and qualified in accordance with the ISO 11137- "Sterilization of Healthcare Products Requirements for Validation and Routine Control - Radiation Sterilization" to a sterility assurance level (SAL) of 10-6.
Additionally each lot is monitored with calibrated Radics plastic dosimeters to determine the Gamma radiation dose delivered. Critical parameters, such as exposure time and dose delivery interruption are confirmed to comply with procedure.
Because this device does not come in direct contact with the patient, biocompatibility screening tests were performed. The results of these screening tests gave no indication that additional biocompatibility testing was necessary.
The expiration dating for the TERUMO® VENOJECT® Luer Adapter has been established to be 30 months.
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SECTION II: Summary of Safety and Effectiveness
CONCLUSION
」、
The Terumo Venoject Luer Adapter submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation, and materials to the cleared B-D® Vacutainer® Luer Adapter which is the subject of K931367. Differences between the devices cited in this section are not significant and do not raise any new issues of safety or effectiveness.
| Date Prepared | September 30, 1998 |
|---|---|
| Prepared by | Kristine Wagner |
| Regulatory Affairs Specialist | |
| Prepared for | Terumo Medical Corporation |
| 125 Blue Ball Road | |
| Elkton, MD 21921 | |
| Phone (410) 392-7241 or (410) 392-7241 | |
| Fax (410) 398-6079 |
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Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge at the bottom, creating a sense of movement and upward direction.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 30 1998
Kristine Wagner Regulatory Affairs Specialist TERUMO MEDICAL CORPORATION 125 Blue Ball Road Elkton, MD 21921
Re: K983490 Trade Name: TERUMO® VENOJECT® Luer Adapter Requlatory Class: II Product Code: 75 JKA September 30, 1998 Dated: Received: October 05, 1998
Dear Ms. Wagner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further requlatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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R 983490 510(k) Number (if known):
TERUMO® VENOJECT® Luer Adapter Device Name:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
6983490
510(k) Number
Prescription Use J (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)