The Vacutainer™ PLUS SST™ Tube is a plastic evacuated blood collection tube with silica clot activator and gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS SST™ Tube is primarily used for clinical laboratory testing in chemistry using patient serum, but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the Vacutainer™ PLUS SST™ Tube is compatible with many commonly used therapeutic drugs therefore suitable for therapeutic drug monitoring (TDM). Blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery.

Device Description

The Vacutainer™ PLUS SST™ Tubes are sterile, plastic, evacuated blood collection tubes. The Vacutainer™ PLUS SST™ Tube consists of: (1) a closure assembly, (2) an inert polyester gel barrier, (3) silica clot activator, and (4) a silicone surfactant coated plastic tube. The specimen is centrifuged and the barrier material forms at the serum/blood clot interface, mechanically separating the serum from cells. The serum portion is used for clinical laboratory assays involving the use of patient serum.

AI/ML Overview

The provided text describes a 510(k) summary for the BD Vacutainer™ PLUS SST™ Tube. This device is a blood collection tube, and the acceptance criteria and study detailed are related to its performance in therapeutic drug monitoring (TDM).

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The core claim and thus the primary acceptance criterion is related to the stability of therapeutic drugs in blood samples stored in the device.

Acceptance Criteria	Reported Device Performance
Blood can be collected, processed, and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery.	Clinical evaluations demonstrated that blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery.
Storage conditions and time until analysis should be considered when collecting blood for TDM to ensure specimen integrity is maintained.	Clinical evaluations demonstrated that the storage conditions and time until analysis should be considered when collecting blood in Vacutainer™ PLUS SST™ tubes for TDM to ensure specimen integrity is maintained.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not explicitly state the sample size (number of patients or blood samples) used for the clinical evaluations.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It simply states "Clinical evaluations were performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The device is a blood collection tube, and its performance is assessed through laboratory assays, not typically by expert interpretation of images or clinical findings that require "ground truth" established by experts in the sense of, for example, radiologists. The "ground truth" here would be the actual concentration of therapeutic drugs in the blood samples, determined by standard laboratory methods.

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

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical imaging) where there might be disagreement among reviewers. For a device like a blood collection tube, performance is measured by objective laboratory assays, which do not typically involve this type of adjudication.

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

This information is not applicable and therefore not provided. MRMC studies and the concept of "human readers improving with AI assistance" relate to diagnostic or interpretative AI devices. The BD Vacutainer™ PLUS SST™ Tube is a blood collection device, not an AI-powered diagnostic tool.

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

This information is not applicable and therefore not provided. This question is relevant for AI algorithms. The described device is a physical medical device (blood collection tube).

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

The ground truth for this type of device would be the measured concentration of therapeutic drugs in the collected blood samples using established and validated analytical methods (e.g., mass spectrometry, immunoassay). The document does not explicitly state the specific analytical methods used, but "clinical laboratory testing in chemistry" is mentioned.

8. The sample size for the training set

This information is not provided and is likely not relevant in the context of this type of device submission. Training sets are typically associated with machine learning or AI models. This device's performance is demonstrated through clinical evaluations, which are essentially validation studies, not training studies.

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

This information is not applicable as there is no mention of a training set for an AI model. For the clinical evaluations (which serve as the validation study for the device's claims), the "ground truth" would be established by the analytical results of the therapeutic drug monitoring assays performed on the blood samples.

Summary

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16023075

NOV 2 5 2002

J. 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 21 § 807.92

Establishment:

•	Address:	BD Vacutainer Systems, PreanalyticalSolutions1 Becton Drive, MC 300Franklin Lakes, NJ 07417-1885
•	Registration Number:	2243072
•	Contact Person:	Jing ZhangManager Regulatory AffairsTelephone No.:(201) 847-4717Fax No. (201) 847-4858
•	Date of Summary:	Nov. 21, 2002
	Device
•	Trade Name:	BD Vacutainer™ PLUS SST™ Tube
•	Classification Name:	Tubes, Vials, Systems, Serum SeparatorsBlood Collection
•	Classification:	Class II
•	Performance Standards:	None Established under 514 of the Food,Drug and Cosmetic Act

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II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

> Device Description:

> Intended Use:

> Claims:

Blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery. The storage conditions and time until analysis should be considered when collecting blood in Vacutainer™ PLUS SST™ tubes for TDM. This will ensure specimen integrity is maintained.

Synopsis of Test Methods and Results: A

Clinical evaluations were performed to determine the safety and efficacy of the Vacutainer™ PLUS SST™ Tube. The results of the clinical evaluation demonstrated that blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery. The storage conditions and time until analysis should be considered when collecting blood in Vacutainer™ PLUS SST™ tubes for TDM. This will ensure specimen integrity is maintained.

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Substantial Equivalence:
Based on a comparison of the device features, materials, and intended use, the Vacutainer™ PLUS SST™ Tubes are substantially equivalent to the commercially available predicate device. The only difference between the predicate and the Vacutainer™ PLUS SSTTM Tubes is the performance claim for therapeutic drug monitoring (TDM). The predicate device, K number, and clearance date are identified below:

Manufacturer	Predicate Device	K-Number	Clearance Date
BD Vacutainer Systems,Preanalytical Solutions	VacutainerTMPLUS SSTTMSerum SeparatorTube	K960250	March 29, 1996

Jing Zhang Manager Regulatory Affairs

11/21/02

Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it.

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Mr. Jing Zhang Manager, Regulatory Affairs · · BD Vacutainer Systems, Preanalytical Solutions 1 Becton Drive, MCC 300 Franklin Lakes, NJ 07417

Re: K023075

Trade/Device Name: BD Vacutainer™ PLUS SSTTM Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: August 29, 2002 Received: September 16, 2002

Dear Mr. Zhang:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour 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 complies 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 deviceto 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). Other general information on your responsibilities under the Act may be obtained 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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B. INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: BD Vacutainer™ PLUS SST™ Tube

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR § 801.109)

(Optional format 1-2-96)

Or Over-the-Counter Use_

Sean Cooper
(Division Sign-Off)

Division of Clinical Labora. Jvices
510(k) Number K023075

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.