The BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube are plastic evacuated blood collection tubes that provide a means of collecting, transporting, and processing blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube is used for trace element testing (e.g., Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc).

Device Description

Plastic tube (13x100, 6ml)
Tube closure: Royal blue Hemogard™ closure
Additive: Silica Clot Activator or K2EDTA

AI/ML Overview

The provided submission K041071 is for a medical device (BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube), not an AI/ML diagnostic system. Therefore, most of the requested information regarding acceptance criteria and study design for an AI/ML device is not applicable.

However, I can extract the general information about the device and the nature of its performance evaluation as described in the document.

Here's a breakdown of the relevant information from the provided text, noting where specific AI/ML-related questions cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a table format for performance metrics like sensitivity, specificity, or AUC, as would be expected for an AI/ML diagnostic. Instead, it states that "Extensive mechanical and functional testing was performed to demonstrate the devices' safety and effectiveness."

The "performance" of this device is related to its ability to collect, transport, and process blood for trace element testing without interfering with the integrity of the sample or the accuracy of the subsequent trace element analysis. The substantial equivalence argument relies on comparison to predicate devices, implying that if the new device performs similarly in these functional aspects, it is acceptable.

Reported Device Performance (Implicit):
The submission implies that the device meets its intended use, which is to collect, transport, and process blood for trace element testing (e.g., Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc) in a closed tube. The performance is deemed acceptable because it is "substantially equivalent" to predicate devices, meaning it functions similarly and has comparable safety and effectiveness for its intended purpose.

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

The document does not detail specific sample sizes for "test sets" in the context of an AI/ML model, nor does it mention data provenance (e.g., country of origin, retrospective/prospective). The "extesive mechanical and functional testing" would have involved physical samples (e.g., blood) but the number of such samples is not specified.

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

This information is not applicable. "Ground truth" in the context of AI/ML diagnostics (e.g., expert consensus on image pathology) is not relevant for this device. The 'ground truth' here would be the accurate measurement of trace elements, which is performed by laboratory analytical methods, not human visual assessment or consensus.

4. Adjudication Method (for the test set)

Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI/ML model ground truth establishment. This is not relevant for a blood collection tube.

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

Not applicable. MRMC studies are used to assess the effectiveness of AI assistance on human reader performance. This device is a blood collection tube, not an AI system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is not an algorithm, so a standalone algorithm performance study is irrelevant.

7. Type of Ground Truth Used

The 'ground truth' for evaluating a blood collection tube's performance would be the accurate and precise measurement of trace elements from blood samples collected in the device and compared to a reference method or samples collected in predicate devices. This would typically involve laboratory analytical results from validated assays, ensuring that the tube does not contaminate the sample or interfere with the measurement of the trace elements.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML model, so there is no "training set."

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML model.

Summary of the Device's "Study" and Evidence for Substantial Equivalence:

The submission highlights that the safety and effectiveness of the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube were demonstrated through:

Extensive mechanical and functional testing: This refers to physical tests conducted on the tubes to ensure they perform their basic functions (e.g., maintaining vacuum, not leaking, material compatibility).
Comparison to predicate devices: The core of the justification for approval is showing "substantial equivalence" to existing, legally marketed Becton, Dickinson and Company products: the BD Vacutainer® Trace Element Serum Glass Tube and the BD Vacutainer® Trace Element Na2EDTA Glass Tube. This comparison covers device features, materials, intended use, and performance. The implication is that if the new plastic tubes perform as well as the older glass tubes for trace element collection, they are effective.

In essence, the "study" for this type of device is a series of engineering, chemical, and functional tests that confirm the device performs its basic role (blood collection and preservation for specific tests) without introducing contaminants or compromising sample integrity, and that it is comparable to already approved devices. It does not involve AI/ML performance metrics or study designs.

Summary

{0}------------------------------------------------

KO41071

Attachment 4

MAY 1 4 2004

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 CFR § 807.92

Establishment:

Address: .
Registration Number: .

Contact Person: .

BD Diagnostics, Preanalytical Systems 1 Becton Drive Franklin Lakes, NJ 07417-1885 2243072 Jing Zhang Regulatory Affairs Manager Telephone no .: 201-847-4717 Fax No. 201-847-4858 4/23/04
Date of Summary: .

Device:

Trade Name: .
Classification Name: .
Classification: .
Performance Standards: .

BD Vacutainer® Trace Element Serum Plus Tube BD Vacutainer® Trace Element K2EDTA Plus Tube

Evacuated Blood Collection Tube Class II

None Established under 514 of the Food, Drug and Cosmetic Act

Page 1 of 2

{1}------------------------------------------------

CONFIDENTIAL

II Effectiveness Information Supporting Substantial Equivalence

Device Description �
The device description of the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube are as follows:
Plastic tube (13x100, 6ml)
Tube closure: Royal blue Hemogard™ closure
Additive: Silica Clot Activator or K2EDTA
Intended Use .

The BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube are plastic evacuated blood collection tubes that provide a means of collecting, transporting, and processing blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube is used for trace element testing (e.g., Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc).

Synopsis of Performance Study Results .
Extensive mechanical and functional testing was performed to demonstrate the devices' safety and effectiveness.

III. Predicate Device Summary Table

Based on comparison of the device features, materials, intended use and performance, the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube are shown to be substantially equivalent to the commercially available predicate devices indicated in the table below.

Manufacturer	Predicate Device	510(k) Number
Becton, Dickinson andCompany	BD Vacutainer® Trace Element Serum GlassTube	Preamendment
	BD Vacutainer® Trace Element Na2EDTAGlass Tube

Jie 52

Date

4/22/14

Pages of 2.

Jing Zhang Requlatory Affairs Manager BD Diagnostics, Preanalytical Systems Becton, Dickinson and Company

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 4 2004

Ms. Jing Zhang Regulatory Affairs Manager Becton Dickinson & Co. BD Diagnostics, PreAnalytical System 1 Becton Drive Franklin Lakes, NJ 07417

K041071 Re:

Trade/Device Name: The BD Vacutainer®Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: April 23, 2004 Received: April 26, 2004

Dear Ms. 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 cither 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).

{3}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotter notification. The FDA finding of substantial equivalence of your device to a legally promated 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, Ir you stions 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). You may obtain other general information on your responsibilities under the Act 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,

Jean M. Cooper, US, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K040171

DEvICE NAME: The BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube

INDICATIONS FOR USE:

The BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube are plastic evacuated blood collection tubes that provide a means of collecting, transporting, and processing blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube is used for trace element testing (e.g., Arsenic Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, adduni,

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD4/0671

Page 1 of |

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.