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 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.

AI/ML Overview

The provided text describes a 510(k) submission for the Terumo Venoject Luer Adapter, demonstrating its substantial equivalence to a predicate device. However, it does not contain the level of detail typically found in a clinical study report or a performance study outlining acceptance criteria and detailed device performance results.

The document focuses on:

Intended Use and Description: What the device is and what it does.
Substantial Equivalence: Comparing the proposed device to an already cleared predicate device (K983490) based on intended use, description/specifications, technology/principles of operation, materials, and performance.
Safety Information: Sterility, biocompatibility screening, and expiration dating.
Regulatory Conclusion: FDA's substantial equivalence determination.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment are not available in the provided text, as this type of information is usually presented in specific performance testing reports, not a summary of a 510(k) submission for a non-invasive, substantially equivalent device.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present:

A table of acceptance criteria and the reported device performance

The document states: "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."

It specifies material composition and operational principles as being identical to the predicate. The performance evaluation is generic and does not provide specific quantitative acceptance criteria or detailed performance metrics.

Acceptance Criteria (Implied)	Reported Device Performance
Sterility Assurance Level	10⁻⁶ SAL (Validated per EN 550, ISO 11135)
Biocompatibility	No indication for additional testing from screening tests
Expiration Dating	Established at 30 months
Functionality (General)	Performs according to specification
Equivalence to Predicate	No significant differences in specifications and performance to K983490 (Implies it meets predicate's performance)

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The document refers to "evaluation" of performance but does not provide details on specific test sample sizes.
- Data provenance: Not specified. The manufacturer is Terumo Europe N.V. (Belgium), but the source of specific performance data is not detailed. Given the nature of a 510(k) for a basic medical device, much of this "evaluation" would likely involve internal engineering tests, material testing, and potentially some simulated use or bench testing rather than clinical trials.
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 or not specified. This device is a blood collection accessory. Performance evaluation for such a device typically involves engineering and laboratory testing for physical properties, sterility, and functionality (e.g., flow rates, leak testing, ease of use with other components), rather than expert assessment of patient outcomes or image interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable or not specified. As mentioned above, the performance evaluation is not described in terms of a clinical study requiring expert adjudication.
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. This device is a mechanical blood collection adapter, not an AI-powered diagnostic or imaging device, and therefore, MRMC studies are irrelevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a mechanical blood collection adapter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not specified explicitly. For device performance, the "ground truth" would likely be engineering specifications, material standards, and functional requirements (e.g., no leaks, proper sealing, specified sterility level) rather than clinical "ground truth" like pathology or outcomes data. The document states its performance was "evaluated" against "the specification."
The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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K041358

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

II. 2. Description

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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Page 2

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

Page i of l

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.