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 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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the TERUMO® VENOJECT® Luer Adapter, seeking substantial equivalence to a predicate device, the B-D® Vacutainer® Luer Adapter (K931367). This type of submission focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, rather than proving absolute safety and effectiveness through extensive clinical trials as might be required for a novel device.

Therefore, the information you've requested about acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML performance metrics, multi-reader studies, and detailed ground truth establishment, is not applicable to this specific document. This document describes a medical device (a blood collection accessory), not an AI/ML diagnostic or measurement tool. The evaluation centers on material comparability and basic functional performance tests, not AI algorithm performance.

Here's an analysis of the provided text in relation to your request, highlighting why many points are not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the document. The performance evaluation focuses on confirming the device "performs according to specification" without detailing what those specifications are in quantitative terms.
Reported Device Performance:
- Tests Performed:
  - Cannula elasticity
  - Cannula/barrel adherence
  - Bending strength
  - Visual
  - Dimensional
  - Extraction
- Results: The document generally states, "The performance of the TERUMO® VENOJECT® Luer Adapter has been evaluated and the device performs according to specification." No specific numerical results or detailed qualitative outcomes for each test are provided.
- Sterility: Validated according to ISO 11137 to a sterility assurance level (SAL) of 10-6.
- Biocompatibility: Screening tests performed, "gave no indication that additional biocompatibility testing was necessary."
- Expiration Dating: Established at 30 months.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The "test set" in this context refers to the physical devices undergoing engineering and bench tests, not a clinical data set for an AI/ML algorithm. The document does not specify the number of physical units subjected to each test.
Data Provenance: Not applicable for this type of device evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This relates to human interpretation of diagnostic data, which is not relevant for a luer adapter. Ground truth here (if the term were applied) would come from engineering measurements and inspections. No expert panel is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of medical images or clinical data, which is irrelevant for this device's evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are for evaluating diagnostic image interpretation performance. This document is about a blood collection accessory.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Implicit. The "ground truth" for a physical device like this is its adherence to engineering specifications and international standards (e.g., ISO 11137 for sterility). The document states the device "performs according to specification," implying that these engineering specifications serve as the "ground truth."

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" for this device.

Summary of what is present:

The document focuses on demonstrating substantial equivalence to a predicate device (B-D® Vacutainer® Luer Adapter, K931367) based on:

Intended Use: Identical.
Design: Similar (cannula, hub, luer taper, rubber tip).
Principle of Operation: Both operated manually.
Materials: Largely similar, with some differences (e.g., Polypropylene vs. Polystyrene for the hub, Synthetic Isoprene Rubber vs. Dipped Latex Rubber for the rubber tip). The document implies these material differences are not significant enough to raise new safety/effectiveness concerns.
Performance Tests: A list of basic physical/mechanical tests were performed (cannula elasticity, adherence, bending strength, visual, dimensional, extraction), and the device was reported to perform "according to specification." No specific numerical "acceptance criteria" or quantitative results are provided in this summary.
Safety Information: Sterility validation (ISO 11137 to SAL 10-6), biocompatibility screening (no further testing needed), and established expiration dating (30 months).

In essence, this 510(k) submission relies on demonstrating that the new device is fundamentally the same as a previously cleared device, backed up by standard engineering tests and safety protocols, rather than a clinical study with detailed performance metrics.

Summary

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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

DESCRIPTION/SPECIFICATIONS

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 andpolyethylene	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

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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 WagnerRegulatory Affairs Specialist
Prepared for	Terumo Medical Corporation125 Blue Ball RoadElkton, MD 21921Phone (410) 392-7241 or (410) 392-7241Fax (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:

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.