The VACUTAINER® Brand PLUS (plastic) Tube with EDTA is an evacuated blood collection tube which provide a means of collecting, transporting, separating and processing blood in a plastic tube. When the tube is used together with VACUTAINER® Brand Needles and Holders, it is a closed system for the collection of venous blood with the same indications as described herein.

Blood collected in a tube containing EDTA Anticoagulant is primarily used for clinical laboratory testing-hematology study using whole blood but may be used for other studies including such studies as testing for lead and FEP analyses, requiring whole blood as determined by the laboratory.

Device Description

The VACUTAINER® Brand PLUS Tube with EDTA is an evacuated plastic tube for collecting, transmitting and processing blood in a closed plastic tube. The blood collection tube consists of closure assembly, a plastic tube and EDTA coating (dipotassium, K2). The plastic tube is manufactured from PET (Polyethylene terepthalate Plastic and enhances user safety and disposal because of the reduced risk of tube breakage and incineration as a method of disposal. The standard closure assembly is a basic rubber stopper. The tube is also available with VACUTAINER Systems Hemogard™ Closure assembly which is designed to reduce user exposure to blood. The EDTA anticoagulant tube coating is spray coated in a dipotassium (K2) form. The EDTA prevents specimen coagulation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the VACUTAINER® Brand PLUS Tube with EDTA Anticoagulant. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Metric	Reported Device Performance
Equivalence for FEP (Free Erythrocyte Protoporphyrin) Analysis (compared to VACUTAINER® Brand Glass Tube with EDTA)	Demonstrated analytically and statistically equivalent results and sample stability at initial time and extended tube storage.
Equivalence for Blood Lead Analysis (compared to VACUTAINER® Brand Glass Tube with EDTA)	Demonstrated analytically and statistically equivalent results and sample stability at initial time and extended tube storage.
Lead Level in Tubes (Maximum limit is 2.5 ug/L (ppb) as per draft product labeling for the Becton Dickinson VACUTAINER Systems Plus Plastic Tube with EDTA)	All tubes from three different lots tested had lead levels below 2 ug/L.
Reduced Risk of Tube Breakage	Achieved, as described in prior 510(k) K901449/A.
Enhanced Disposal (Incineration as method)	Achieved, as described in prior 510(k) K901449/A.

2. Sample Size Used for the Test Set and Data Provenance:

For FEP and Blood Lead Analysis: The specific sample size for the clinical evaluation comparing the Plus Tube to the Glass Tube is not explicitly stated.
For Tube Lead Levels: "Twenty tubes from each of the three lots" were tested, totaling 60 tubes (20 tubes/lot * 3 lots).
Data Provenance: The document does not specify the country of origin for the clinical evaluation data. It is a prospective comparison study for FEP and Blood Lead, and an analytical/bench study for tube lead levels.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document describes analytical and statistical equivalence based on laboratory measurements (FEP, Blood Lead, Atomic Absorption for lead). It does not mention the use of human experts to establish "ground truth" in the typical sense of expert consensus for diagnostic interpretation.
The "ground truth" for FEP and Blood Lead would be the quantitative measurements themselves, and for lead levels, it would be the results from Atomic Absorption.

4. Adjudication Method for the Test Set:

Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies involving human interpretation of diagnostic images or clinical assessments where there might be inter-reader variability.
Given the nature of the tests (quantitative analyte measurements and material analysis), no adjudication method was mentioned or appears to be applicable in this context. The determination of equivalence and lead levels relies on direct analytical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The study design involved comparing a new medical device (plastic tube) to an existing device (glass tube) for its ability to preserve sample integrity for specific laboratory tests (FEP and Blood Lead) and for its material properties (lead levels in the tube). This is not equivalent to an MRMC study which typically assesses the impact of AI on human reader performance in diagnostic tasks.

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

This device is a blood collection tube, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's performance is driven by its material properties and manufacturing, assessed through analytical and clinical laboratory testing.

7. The Type of Ground Truth Used:

Quantitative Analytical Measurements:
- For FEP and Blood Lead analyses: The "ground truth" was established by quantitative measurements of FEP and blood lead levels from blood samples collected in both the test (plastic) and predicate (glass) tubes. The comparison was based on the numerical results and their statistical equivalence.
- For tube lead levels: The "ground truth" was established by Atomic Absorption (AA) measurements of lead levels within the tubes.

8. The Sample Size for the Training Set:

This device is a physical medical device (blood collection tube), not an AI model that requires a "training set." Therefore, the concept of a training set does not apply to this submission.

9. How the Ground Truth for the Training Set was Established:

As concluded in point 8, there is no training set for this device.

Summary

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K911449

JUN 17 1997

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CELEBRATING THE FIRST ONE HUNDRED: 1897-1997

Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417 (201) 847-4500

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

I. General Information

This Summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92

Establishment:

Becton Dickinson VACUTAINER Systems · Address: 1 Becton Drive Franklin Lakes, NJ 07417-1885
· Registration Number: 2243072
Contact Person: John A. Schalago . Regulatory Affairs Specialist Telephone no .: 201 - 847 - 6280 Facsimile no .: 201 - 847 - 4858
- April 16, 1997 · Date of Summary:

Device Name:

VACUTAINER® Brand Plus Tube · Trade Name: with EDTA Anticoagulant
Blood Specimen Collection Device . Classification Name :
· Classification: Class II
· Performance Standards: None Established under 514 of the Food, Drug and Cosmetic Act

II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination · Device Description

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The plastic tube is manufactured from PET (Polyethylene terepthalate Plastic and enhances user safety and disposal because of the reduced risk of tube breakage and incineration as a method of disposal. The standard closure assembly is a basic rubber stopper. The tube is also available with VACUTAINER Systems Hemogard™ Closure assembly which is designed to reduce user exposure to blood. The EDTA anticoagulant tube coating is spray coated in a dipotassium (K2) form. The EDTA prevents specimen coagulation.

● Intended Use

The VACUTAINER® Brand PLUS Tube with EDTA is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a plastic tube. Blood collected in a tube containing EDTA anticoagulant is used primarily for clinical laboratory hematology studies but may be used for other whole blood specimens, including but not limited to lead level testing and FEP level testing, as determined by the laboratory.

· Synopsis of Test Methods and Results

The VACUTAINER® Brand Plus Tube with EDTA anticoagulant, as described above, is a plastic tube with closure assembly (rubber stopper or HEMOGARD™ Closure). The plastic tube provides enhanced user safety and disposal because of the reduced risk of tube breakage and the use of incineration as a method of disposal. Breakage reduction and enhanced disposal studies and test results were described 510(k) Premarket Notification K901449/A which received FDA clearance on August 9, 1990.

Clinical evaluation of the VACUTAINER® Brand Plus tube with EDTA Anticoagulant was performed to demonstrate device equivalence for FEP and Blood Lead analyses. The VACUTAINER® Brand Plus Plastic Tube with EDTA was compared to VACUTAINER® Brand Glass Tube with EDTA, at initial time and extended tube storage. The VACUTAINER® Brand PLUS Tube with EDTA demonstrated analytically and statistically equivalent results and sample stability. Therefore, Clinical evaluation supports the Use of the VACUTAINER® Brand PLUS Tube with EDTA for FEP and Blood Lead analyses.

Additionally, bench testing of three different lots of VACUTAINER® Brand Plus Tube with EDTA was performed to determine the tube lead levels. As identified in the draft product labeling, the maximum limit is 2.5 ug/L (ppb). This maximum lead limit for the Plus plastic tube is significantly lower than the current Center for Disease Control and Prevention decision level of 10 ug/dL or 100 ug/L for toxicity in children. Twenty tubes from each of the three lots were tested according to internal test procedures. The Lead levels were evaluated using Atomic Absorption (AA). The calibration standards used to calibrate the AA had lead concentration levels of 2 and 4 ug/L. The results demonstrated that lead level of all tubes from the three different lots were below 2 ug/L and therefore, support the labeling claim of 2.5 ue/L. The test data and results are maintained on file at Becton Dickinson VACUTAINER Systems, Franklin Lakes, NJ.

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· Substantial Equivalence

Becton Dickinson VACUTAINER Systems believes that the VACUTAINER® Brand PLUS Tube with EDTA with the expanded Indications for Use is substantially equivalent to a commercially available blood collection tube. Clinical testing, as described in this premarket notification, demonstrates equivalent performance and effectiveness and supports the determination of substantial equivalence. The predicate devices, manufacturer, K number and clearance date are identified below:

Manufacturer	Predicate Device	K-Number	Clearance Date
VACUTAINERSystems	VACUTAINER®Brand Tube withEDTA Anticoagulant	NotApplicable	Pre-Amendment Device and,therefore, exempt from premarketnotification requirements according tothe MDA of 1976.

Also included in this premarket notification, is a description of an incremental packaging modification which occurred prior to the submission of this premarket notification. VACUTAINER Systems determined that the incremental modification did not significantly affect the safety or efficacy of the VACUTAINER® Brand Tube and Brand PLUS Tube, and therefore, did not require a 510(k) premarket notification.

Oshkoshlago

ohn A. Schalago Regulatory Affairs Specialist Regulatory Affairs Department April 16, 1997 Date

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 17

John A. Schalago Requlatory Affairs Specialist Becton Dickinson VACUTIANER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K971449 VACUTAINER® Brand PLUS (Plastic) Blood Collection Tube with EDTA Anticoagulant Requlatory Class: II Product Code: GIM Dated: April 16, 1997 Received: April 21, 1997

Dear Mr. Schalaqo:

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 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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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 requlation (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.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: VACUTAINER® Brand PLUS Tube with EDTA Anticoagulant

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 ✓ OR	Over-the-Counter Use _____
(Per 21 CFR 801.109)	(Optional Format 1-2-96)
	(Division Sign-Off)
	Division of Clinical Laboratory Devices
510(k) Number	K971449

510(K) Premarket Notification April 16, 1997 Page 45Page 45

(K) Premarket Notification VACUTAINER® Brand PLUS Tube with EDTA

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.