The BD Vacutainer™ SST™ II PLUS Tube is a plastic evacuated blood collection tube with silica clot activator and gel barrier material that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a BD Vacutainer™ SST™ II PLUS Tube is primarily used for clinical laboratory testing - chemistry assays using patient serum but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the BD Vacutainer™ SST™ II PLUS Tube is compatible with many commonly used therapeutic drugs and is therefore suitable for therapeutic drug monitoring (TDM).

Device Description

The BD Vacutainer™ SST™ II PLUS Tubes are sterile, plastic, evacuated blood collection tubes. The BD Vacutainer™ SST™ II PLUS Tube consists of: (1) a closure assembly, (2) an acrylic gel barrier, (3) silica clot activator, (4) a silicone surfactant coating, and (5) a 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 and TDM involving the use of patient serum.

AI/ML Overview

This 510(k) premarket notification describes the BD Vacutainer™ SST™ II PLUS Tube. However, the provided document does not contain the specific acceptance criteria or detailed study results, such as accuracy metrics or statistical analyses, that would typically be presented to prove the device meets said criteria.

The document primarily focuses on establishing "substantial equivalence" of the new device to existing predicate devices based on device features, materials, and intended use. While it mentions "clinical evaluations were performed to determine the efficacy," it does not elaborate on the methodology, results, or how these results demonstrate fulfillment of pre-defined acceptance criteria.

Therefore, many of the requested sections regarding acceptance criteria and study details cannot be fulfilled from the provided text.

Here's an attempt to answer the questions based on the available information, noting where information is absent:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria (e.g., specific thresholds for analytical performance, such as bias, recovery, or precision relative to predicate devices) are provided in the document. The document primarily focuses on a claim of "equivalent clinical performance" and "better compatibility" with predicate devices.

Acceptance Criterion	Reported Device Performance
Not specified in document	- Equivalent clinical performance to predicate PLUS SST tubes and Glass Serum Tubes for clinical laboratory testing - chemistry assays using patient serum.
Not specified in document	- Equivalent clinical performance to predicate Glass Serum tubes for many commonly used therapeutic drugs (suitable for TDM).
Not specified in document	- Better compatibility than predicate PLUS SST tubes with many commonly used therapeutic drugs.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. It only states that "Clinical evaluations were performed."

3. 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)

This information is not provided in the document. The study involves blood collection and chemistry assays, where "ground truth" would likely be established by validated laboratory instruments and recognized reference methods, rather than expert consensus on images or clinical assessments.

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

This information is not provided in the document. Adjudication methods are typically relevant for subjective assessments or complex clinical endpoints, which do not appear to be the primary focus of this device's evaluation (which concerns analytical performance of blood tubes).

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

A MRMC comparative effectiveness study is not applicable and not mentioned. This type of study is typically used for diagnostic imaging devices involving human interpretation (readers) and AI assistance. The BD Vacutainer™ SST™ II PLUS Tube is a blood collection device, not an imaging or AI-assisted diagnostic tool.

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

A standalone algorithm performance study is not applicable and not mentioned. This device does not involve an algorithm.

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

The document implicitly suggests that the ground truth for the "clinical evaluations" would be based on analytical results from clinical laboratory assays. For chemistry assays and Therapeutic Drug Monitoring (TDM), this would involve quantitative measurements from established laboratory instruments and methodologies, often compared against reference intervals or medically relevant thresholds. The specific "type of ground truth" (e.g., a specific reference standard method) for each analyte is not explicitly detailed.

8. The sample size for the training set

Not applicable and not provided. As this is a blood collection tube and not an AI/ML-based device, there is no "training set."

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

Not applicable and not provided. As this is a blood collection tube and not an AI/ML-based device, there is no "training set" or ground truth establishment method for a training set.

Summary

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K023331

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, 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:	Oct. 3, 2002

Device

Trade Name:	BD Vacutainer™ SST™ II PLUS Tube
Classification Name:	Tubes, Vials, Systems, Serum Separators, Blood 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:
The BD Vacutainer™ SST™ II PLUS Tube is a plastic evacuated blood collection tube with silica clot activator and gel barrier material that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a BD Vacutainer™ SST™ II PLUS Tube is primarily used for clinical laboratory testing chemistry assays using patient serum but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the BD Vacutainer™ SST™ II PLUS Tube is compatible with many commonly used therapeutic drugs and is therefore suitable for therapeutic drug monitoring (TDM).
Claims:
- SST II tubes demonstrate equivalent clinical performance to the predicate PLUS . SST tubes and Glass Serum Tubes for clinical laboratory testing - chemistry assays using patient serum.
- SST II tubes demonstrate equivalent clinical performance to the predicate Glass . Serum tubes for many commonly used therapeutic drugs and are therefore suitable for therapeutic drug monitoring (TDM).
- SST II tubes demonstrate better compatibility than the predicate PLUS SST tubes . with many commonly used therapeutic drugs.
Synopsis of Test Methods and Results

Clinical evaluations were performed to determine the efficacy of the BD Vacutainer™ SST™ II PLUS Tube. The results of the clinical evaluation demonstrated that blood can be collected, processed and stored in a BD Vacutainer™ SST™ II PLUS tube for chemistry assays and Therapeutic Drug Monitoring.

Substantial Equivalence
Based on a comparison of the device features, materials, and intended use, the BD

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Vacutainer™ SST™ II PLUS Tubes are substantially equivalent to the commercially available predicate devices identified below:

Manufacturer	Predicate Device	510(k)Number	ClearanceDate
BD Vacutainer Systems	BD Vacutainer™ Brand Serum Tube	Preamendment	NA
BD Vacutainer Systems	BD Vacutainer™ PLUS SST Tube	K960250	3/29/96

Die zu

10/3/02

Date

Jing Zhang Manager Regulatory Affairs

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal features an abstract image of an eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle.

Food and Drug Administra 2098 Gaither Road Rockville MD 2085

NOV 2 5 2002

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

K023331 Re: Trade/Device Name: BD Vacutainer™ SSTTM II PLUS Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: October 3, 2002 Received: October 4, 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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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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B. INDICATIONS FOR US

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: BD Vacutainer™ SST™ II PLUS 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)
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Prescription Use(Per 21 CFR § 801.109)
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Or	Over-the-Counter Use(Optional format 1-2-96)
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Lian Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number -

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.