The VACUTAINER® Brand Luer Adapter is a sterile, non-invasive device used to connect venous access devices such as needles, blood collection sets, and infusion sets to blood collection tubes. They are also used in connection with non-needle devices for collection of blood from catheters. The VACUTAINER® Brand Luer Adapter is sold by itself and as a component of other VACUTAINER Brand devices.

Device Description

The VACUTAINER® Brand Multiple Sample Luer Adapter consists of a male luer-slip fitting which mates with the female connector of other medical devices, and a non-patient (NP) cannula which punctures the stopper of an evacuated tube. The luer hub is injection molded polystyrene to which the stainless steel NP cannula is assembled with epoxy. The hub is threaded at the NP end to allow assembly to a VACUTAINER Brand Needle Holder.

The NP cannula of the multi-sample luer adapter is covered by a sleeve that recovers over the cannula to stop blood flow during collection of multiple tubes. In the principal device, this sleeve is manufactured of latex-free synthetic isoprene rubber.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (VACUTAINER® Brand Multiple Sample Luer Adapter), which details its description, intended use, and a comparison to predicate devices for substantial equivalence. It does not contain information about acceptance criteria, detailed study designs, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI devices. The document predates common AI/ML regulations and evaluation methods.

Therefore, I cannot extract the requested information about acceptance criteria or a study that proves the device meets those criteria from the provided text in the format you've requested for AI/ML devices. The text describes a traditional medical device's regulatory submission based on substantial equivalence to existing predicate devices, not an AI-powered diagnostic or treatment device with performance metrics like sensitivity, specificity, or AUC against a defined ground truth.

Here's a breakdown of why each requested point cannot be answered:

1. Table of acceptance criteria and reported device performance: Not present. The document states "Functional and Mechanical testing was done to compare the performance..." and "Results of the testing demonstrated that the modified... performed as well or better than both the currently manufactured... and the TERUMO® Brand VENOJECT™ Lucr Adapter." However, specific numerical acceptance criteria (e.g., "tensile strength > X N") and corresponding quantitative performance metrics values are not provided.
2. Sample size for test set and data provenance: No sample size is mentioned for the functional and mechanical testing. Data provenance is not applicable as this is a physical device, not an AI model trained on data.
3. Number of experts and qualifications: Not applicable. This is not an AI/ML study involving expert ground truth labeling.
4. Adjudication method: Not applicable. This is not an AI/ML study involving expert ground truth labeling.
5. MRMC comparative effectiveness study: No. This is a physical device, not an AI system.
6. Standalone performance: "Functional and Mechanical testing" was performed on the device itself, but specific performance metrics are not detailed in this summary.
7. Type of ground truth: Not applicable in the context of AI/ML. For a physical device, performance is typically assessed against engineering specifications and functional requirements.
8. Sample size for the training set: Not applicable. This is not an AI/ML model.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML model.

Summary

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I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary Of Safety and Effectiveness

I. General Information

This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21CFR § 807.92

Establishment:

Address:	Becton Dickinson VACUTAINER Systems1 Becton DriveFranklin Lakes, NJ 07417-1885
Registration Number:	2243072
Contact Person:	Andrea HroncichRegulatory Affairs AssociateTelephone no.: 201-847-6173Fax No. 201-847-4858
Date of Summary:	March 31, 1999
Trade Name:	VACUTAINER® Brand Multiple SampleLuer Adapter
Classification Name:	Tubes, Vials, Systems, SerumSeparators, Blood Collection
Classification:	Class II
Performance Standards:	None Established under 514 of theFood Drug and Cosmetic Act

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II. Safety and Effectiveness Information Supporting Substantial Equivalence

Substantial E quiculence Declaration:

The term "Substantial Equivalence" as used in this 510(k) Premarket Notification is limited to the definition of Substantial Equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR § 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have ary bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of, substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

· Device Description
The VACUTAINER® Brand Multiple Sample Luer Adapter consists of a male luer-slip fitting which mates with the female connector of other medical devices, and a non-patient (NP) cannula which punctures the stopper of an evacuated tube. The luer hub is injection molded polystyrene to which the stainless steel NP cannula is assembled with epoxy. The hub is threaded at the NP end to allow assembly to a VACUTAINER Brand Needle Holder.

Intended Use
The VACUTAINER® Brand Luer Adapter is a sterile, non-invasive device used to connect venous access devices such as needles, blood collection sets, and infusion sets to blood collection tubes. They are also used in connection with non-needle devices for collection of blood from catheters. The VACUTAINER® Brand Luer Adapter is sold by itself and as a component of other VACUTAINER Brand devices.
· Synopsis of Performance Study Results
Functional and Mechanical testing was done to compare the performance of the modified VACUTAINER® Brand Luer Adapter with the new latex-free synthetic isoprene rubber sleeve against both the currently manufactured VACUTAINER® Brand Luer Adapter and the TERUMO® Brand VENOJECT™ Luer Adapter.

Results of the testing demonstrated that the modified VACUTAINER Brand Multiple Sample Luer Adapter with Latex-Free Sleeve performed as well or better than both the currently manufactured VACUTAINER® Brand Multiple Sample Luer Adapter and the TERUMO® Brand VENOJECT™ Lucr Adapter.

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III.Predicate Device Summary Table

Substantial Equivalence

Based on comparison of the device features, intended use, basic design, technology/principles of operation, materials, and performance, the VACUTAINER® Brand Multiple Sample Luer Adapter with Latex-Free Sleeve can be shown to be substantially equivalent to the commercially available predicate devices indicated in the table below. The predicate devices, K number, and clearance date are also identified in the table below.

Manufacturer	Predicate Device	K-Number	Clearance Date
BectonDickinsonVACUTAINERSystems	VACUTAINER®Brand MultipleSample LuerAdapter	K931367	5/18/93
Terumo MedicalCorporation	TERUMO®BrandVENOJECT™Luer Adapter	K983490	11/30/98

Sandra Thomas

Andrea Hroncich Regulatory Affairs Associate Becton Dickinson VACUTAINER Systems Becton Dickinson and Company

March 31, 1999 Date

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, creating a sense of depth and unity.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 8 1999

Andrea Hroncich Regulatory Affairs Associate Beckton Dickinson Vacutainer Systems l Becton Drive Franklin Lakes, NJ 07417

Re: K991088 Trade Name: Vacutainer Brand Multiple Sample Luer Adapter Requlatory Class: II Product Code: JKA Dated: March 31, 1999 Received: April 01, 1999

Dear Ms. Hroncich:

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 Regulation (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 regulatory action. In addition, FDA may publish further 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 regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 general 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 Sutman

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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B. INDICATIONS FOR USE

510(k) Number (if known): _ _ 99/088

Device Name: VACUTAINER® Brand Multiple Sample Luer Adapter

Indications for Use:

Stan Cooper

(Division Sign-Off)

Division of Clinical Laboratory Devices 1991060 510(k) Number_

(Please do not Write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _

Over-the-Counter Use_

(Per 21 CFR § 801.109)

(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.