The BD Vacutainer™ PLUS PST II™ Tube is a lithium heparin coated plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS PST II™ Tube is used for clinical laboratory assays involving the use of patient plasma.

Device Description

The Vacutainer™ PLUS PST II™ Tubes are sterile, plastic, evacuated blood collection tubes. The Vacutainer™ PLUS PST II™ Tube consists of: (1) a closure assembly. (2) an inert acrylic gel mechanical barrier, and (3) a lithium heparin coated plastic tube. The specimen is centrifuged and the barrier material forms at the plasma interface, mechanically separating the plasma from cells. The plasma portion is used for clinical laboratory assays involving the use of patient plasma. 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

The provided text describes the BD Vacutainer™ PLUS PST II™ Tube and its 510(k) summary, primarily focusing on its substantial equivalence to a predicate device. It includes information about the device's description, intended use, and claims. However, it does not provide a detailed study report with specific acceptance criteria, sample sizes for test and training sets, information on expert ground truth establishment, or details about comparative effectiveness studies (like MRMC studies) as requested in the prompt.

Therefore, much of the requested information cannot be extracted directly from the given text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Claim	Reported Device Performance
Improved plasma quality vs. BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube	Provides improved plasma quality vs. the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube (Claim)
Selected analyte stability up to twenty-four hours after centrifugation	Provides selected analyte stability up to twenty-four hours after centrifugation (Claim)
Stability for up to two hours after centrifugation for cardiac analytes (troponin I, CKMB, myoglobin)	Provides stability for up to two hours after centrifugation for the following cardiac analytes: troponin I, creatine kinase MB fraction (CKMB), and myoglobin (Claim)
Clinically equivalent chemistry analyte results when compared to the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube	Clinical evaluations demonstrated the BD Vacutainer™ PLUS PST II™ Tube provides clinically equivalent chemistry analyte results when compared to the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube (Finding)

Missing information for this table due to lack of detail in the source text:

Specific quantitative acceptance thresholds for "improved plasma quality," "analyte stability," or "clinically equivalent chemistry analyte results." The document only states these claims were met or demonstrated without providing the actual metrics or statistical targets.

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

Sample Size (Test Set): Not specified. The document states "Clinical evaluations were performed," but does not provide the number of samples or patients involved.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

Not specified.

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

MRMC Study: No, this device is a blood collection tube, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI is not applicable and not mentioned.

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

Standalone Performance: No, this device is a blood collection tube, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable and not mentioned. The clinical evaluations compared the tube's performance to another tube.

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

The "ground truth" for the performance claims (plasma quality, analyte stability, equivalent chemistry results) would have been established through laboratory analytical testing that compares the results obtained from blood processed in the new tube versus the predicate tube, likely against established analytical standards or reference methods. The document states "Clinical evaluations were performed to determine the safety and efficacy" and "demonstrated that the BD Vacutainer™ PLUS PST II™ Tube provides clinically equivalent chemistry analyte results." This implies a direct comparison of analytical outputs, rather than expert consensus on images or pathology.

8. The sample size for the training set:

Not applicable/Not specified. As this is a physical medical device (blood collection tube) and not an AI/ML algorithm, there is no "training set" in the context of machine learning.

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

Not applicable. As above, there is no "training set" for this type of device.

Summary

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JUL 2 9 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, Preanalytical Solutions1 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:	July 24, 2002

Device

Trade Name: BD Vacutainer™ PLUS PST II™ Tube
- Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Classification: Class II .
None Established under 514 of the Food, Performance Standards: . Drug and Cosmetic Act

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Safety and Effectiveness Information Supporting the Substantial Equivalence II. Determination

> Device Description:

> Intended Use:

Claims:
The PLUS PST II™ Tube: (1) provides improved plasma quality vs. the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube: (2) provides selected analyte stability up to twenty-four hours after centrifugation; and (3) provides stability for up to two hours after centrifugation for the following cardiac analytes: troponin I, creatine kinase MB fraction (CKMB), and myoglobin.

> Synopsis of Test Methods and Results

Clinical evaluations were performed to determine the safety and efficacy of the BD Vacutainer™ PLUS PST II™ Tube. The BD Vacutainer™ PLUS PST II™ Tube was compared to the currently marketed BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube. The results of the clinical evaluation demonstrated that the BD Vacutainer™ PLUS PST II™ Tube provides clinically equivalent chemistry analyte results when compared to the BD Vacutainer™ Brand PLUS PST™ Plasma Separation Tube.

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> Substantial Equivalence

Based on a comparison of the device features, materials, and intended use, the BD Vacutainer™ PLUS PST II™ Tube are substantially equivalent to the commercially available predicate device. The only difference between the predicate Vacutainer™ PLUS PST™ Tubes and the Vacutainer™ PLUS PST IITM Tubes is the acrylic gel material. The predicate device, K number, and clearance date are identified below:

Manufacturer	Predicate Device	K-Number	Clearance Date
BD VACUTAINER™ Systems	VACUTAINER™ Brand PST™ PLUS Tube	K945952	1/18/95

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 9 2002

Mr. Jing Zhang Manager, Regulatory Affairs Becton, Dickinson and Company 1 Becton Drive, MC 300 Franklin Lakes, NJ 07417-1885

Re: K022130

Trade/Device Name: BD Vacutainer136 Plus PST IITM Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: June 28, 2002 Received: July 1, 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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" (21CFR 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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): ____________________________________________________________________________________________________________________________________________________

Koz2130

Device Name: BD Vacutainer™ PLUS PST II™ 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) ﻟﺪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ Prescription Use Or Over-the-Counter Use (Optional format 1-2-96) (Per 21 CFR § 801.109)

Hean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KO 22130

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.