The BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and Kits are intended for the collection and transport of urine samples for culture and sensitivity testing of bacteria.

The BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tube is filled with lyophilized urine maintenance formula and evacuated to draw approximately 4 - 10 mL (depending on the tube size) of urine. The lyophilized urine maintenance formula can maintain the bacterial population in the urine specimen for a period of 48 hours at room temperature levels comparable to those urine specimens without additive, held under refrigeration for the same period of time.

Device Description

The BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tube is a sterile, plastic, evacuated urine collection and transport tube for culture and sensitivity testing of bacteria. The benefits of a plastic tube decrease the occurrence of accidental breakage increases the safety of laboratory personnel and reduces the necessity of repeat specimens.

AI/ML Overview

Acceptance Criteria and Study for BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and Kits

This document describes the acceptance criteria and the study that demonstrates the BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and Kits meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the device is its ability to maintain bacterial population in urine samples for 48 hours at room temperature, comparable to refrigerated samples without additive. The study's results are presented relative to this criterion.

Acceptance Criteria	Reported Device Performance
Maintain bacterial population in urine specimens for 48 hours at room temperature at levels comparable to those urine specimens without additive, held under refrigeration for the same period of time.	"The lyophilized urine maintenance formula can maintain the bacterial population in the urine specimen for a period of 48 hours at room temperature levels comparable to those urine specimens without additive, held under refrigeration for the same period of time."

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not explicitly state the specific number of samples used in the "extensive functional and 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 mentions "functional and clinical evaluations," implying a prospective approach, but no direct confirmation is provided.

3. Number and Qualifications of Experts for Ground Truth

This assessment does not involve expert establishment of ground truth in the manner of diagnostic image interpretation. Instead, the ground truth relates to the bacterial population levels in the urine samples themselves, which would be determined through laboratory culture and quantification methods.
The document does not specify the number or qualifications of experts involved in the laboratory testing or data analysis.

4. Adjudication Method for the Test Set

As the study focuses on quantitative bacterial population maintenance rather than subjective interpretation, an adjudication method (like 2+1 or 3+1 for expert review) is not applicable or described. The results would be based on objective laboratory measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic collection and transport device, not a diagnostic imaging or interpretation tool where human readers assess cases. The study focuses on the device's ability to preserve specimens for laboratory analysis.

6. Standalone Performance Study

Yes, a standalone study was performed. The "extensive functional and clinical evaluations" were conducted to assess the performance of the BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and kits themselves to determine their safety and efficacy. The comparison was against predicate devices and refrigerated non-additive samples, establishing the standalone performance of the new device in maintaining bacterial viability.

7. Type of Ground Truth Used

The ground truth used was laboratory culture and quantification of bacterial populations in urine samples. This objective measurement determined whether the "bacterial population in the urine specimen" was maintained at comparable levels.

8. Sample Size for the Training Set

This document does not describe a training set as would be relevant for machine learning algorithms. The study involves laboratory evaluations of a device, not the development or training of an AI model.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of this device evaluation.

Summary

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K. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

K024240

510(k) Summary Of Safety and Effectiveness

1.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:	Dec. 20, 2002

Device

• Trade Name:	BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and Kits
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Classification Name: Aerobic Transport System . (Microbiological specimen collection and transport device)
. Classification: Class I
. Performance Standards: None Established under 514 of the Food, Drug and Cosmetic Act

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Safety and Effectiveness Information Supporting the Substantial Equivalence 2. Determination

Device Description:
The BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tube is a sterile, plastic, evacuated urine collection and transport tube for culture and sensitivity testing of bacteria. The benefits of a plastic tube decrease the occurrence of accidental breakage increases the safety of laboratory personnel and reduces the necessity of repeat specimens.
Intended Use/Indications for Use:
The BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and kits are intended for the collection and transport of urine samples for culture and sensitivity testing of bacteria.

Synopsis of Test Methods and Results
Extensive functional and clinical evaluations were performed to determine the safety and efficacy of the BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and kits. They were compared to the currently marketed BD Vacutainer™ Brand non-additive tube and Glass Urine C&S Preservative Tubes and kits. The results of the tests demonstrated that the BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes provide functionally and clinically equivalent results when compared to the BD Vacutainer™ Brand non-additive tubes and Glass Urine C&S Preservative Tubes.
A Substantial Equivalence
Based on comparison of the device features, materials, and intended use, the BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes can be shown to be substantially equivalent to the commercially available predicate device identified below:

Manufacturer	Predicate Device	K-Number	Clearance Date
BD Vacutainer Systems,Preanalytical Solutions	BD Vacutainer™ Brand Glass UrineC&S Preservative Tubes and Kits	K790336	4/4/79

Jing Zhang Manager, Regulatory Affairs

12/20/02

Date

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three wavy lines that resemble a bird or a symbol representing health and human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 6 2003

Mr. Jing Zhang Manager, Regulatory Affairs Becton, Dickson and company BD Vacutainer Systems, Preanalytical Solutions 1 Becton Drive Franklin Lakes, NJ 07417

Re: K024240
Trade/Device Name: BD Vacutainer 1M PLUS Plastic Urine C&S Tubes and Kits Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I Product Code: JSM Dated: December 20, 2002 Received: December 23, 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, 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 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 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). 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 Putman

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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C. INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: BD Vacutainer™ PLUS Plastic Urine C&S Tubes and Kits

Indications for Use:

The BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and Kits are intended for the collection and transport of urine samples for culture and sensitivity testing of bacteria.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (Per 21 CFR § 801.109)

Over-the-Counter Use (Optional format 1-2-96)

Freddie Lu Poole

(Division Sim-()ff) .. Imeal opy Number _

Regulation Number and Section

§ 866.2390 Transport culture medium.

(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).