The BD Vacutainer™ Safety Coagulation tube is a plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays. The benefits of a safety plastic coagulation tube with Hemogard Safety Closure Assembly are:

reduced risk of specimen tube breakage .
reduced exposure to blood by laboratory personnel and to minimize blood . splatter during stopper removal

These benefits lead to increased safety of laboratory personnel and reduced necessity of repeat specimen collection.

Device Description

The BD Vacutainer™ Safety Coagulation tubes are sterile, plastic, evacuated blood collection tubes. The tubes contain 0.109M or 0.129M Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. The specimen is centrifuged and the plasma portion is analyzed for coagulation parameters to detect clotting time disorders and to monitor patients undergoing anticoagulation therapy. 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 510(k) summary for the BD Vacutainer™ Safety Coagulation tube, which is a blood collection device, not an AI/ML powered medical device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, standalone performance, number of experts, training set details) are not applicable.

However, I can extract the relevant information regarding acceptance criteria and the study that demonstrates the device meets these criteria based on the provided text.

Here's the breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly stated through the claim of "substantially equivalent results" in comparison to the predicate device. The performance is reported as meeting this equivalence.

Aspect of Performance	Acceptance Criteria Implied	Reported Device Performance
Coagulation Assay Results	Provides "substantially equivalent results" to the predicate glass tube for various patient types.	"The clinical evaluation demonstrated that the BD Vacutainer™ Safety Coagulation tube provides clinically equivalent results when compared to the VACUTAINER™ Brand Sodium Citrate Tube for Normal, Warfarin, Heparin and other patient donors."
Reduced Breakage Risk	Implied: Reduce the occurrence of accidental breakage compared to glass tubes.	Stated as a benefit: "reduced risk of specimen tube breakage."
Reduced Blood Exposure	Implied: Reduce exposure of lab personnel to blood.	Stated as a benefit: "reduced exposure to blood by laboratory personnel and to minimize blood splatter during stopper removal."
Reduced Repeat Specimens	Implied: Reduce the necessity of repeat specimens.	Stated as a benefit: "reduced necessity of repeat specimen collection."

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

Sample Size: Not explicitly stated in the provided text. The text mentions "Clinical evaluations were performed" for "Normal, Warfarin, Heparin and other patient donors" but does not give specific numbers of patients or samples.
Data Provenance: The study was a "Clinical evaluation," suggesting it involved real human blood samples. No specific country of origin is mentioned, but the submission is to the U.S. FDA. The text implies a prospective collection for the purpose of the evaluation, as the device was compared to a "currently marketed" product.

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

Not applicable. This is a blood collection device, and the "ground truth" would be the coagulation assay results themselves, typically performed by laboratory instruments and interpreted by clinical laboratory personnel, rather than subjective expert consensus on image interpretation, for example.

4. Adjudication method for the test set

Not applicable. This concept is typically relevant for subjective assessments (e.g., image interpretation where multiple readers' opinions might differ). For laboratory assay results, the measurements are objective.

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

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

7. The type of ground truth used

The ground truth used was coagulation assay results obtained from the blood samples collected in both the test device (plastic tube) and the predicate device (glass tube). The comparison was based on these objective measurements.

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that requires a training set. The "training" in this context would be the manufacturing and quality control processes for the physical device.

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

Not applicable. As above, this is not an AI/ML powered device.

Summary

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

I. 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:	Becton Dickinson VACUTAINER Systems1 Becton DriveFranklin Lakes, NJ 07417-1885
• Registration Number:	2243072
• Contact Person:	Keith M. SmithDirector, Regulatory AffairsTelephone No.:(201) 847-5837Fax No. (201) 847-7040
• Date of Summary:	September 28, 2001

Device

Trade Name: BD Vacutainer™ Safety Coagulation 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

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

II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

Substantial Equivalence Declaration:

The term "Substantial Equivalence" as used in this 510(k) Premarket Notification is limited to the definition of Substantial Equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR & 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of, substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

. Device Description:
The BD Vacutainer™ Safety Coagulation tubes are sterile, plastic, evacuated blood collection tubes. The tubes contain 0.109M or 0.129M Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. The specimen is centrifuged and the plasma portion is analyzed for coagulation parameters to detect clotting time disorders and to monitor patients undergoing anticoagulation therapy. 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:

The BD Vacutainer™ Safety Coagulation tube is an evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays. The benefits of a safety plastic coagulation tube with Hemogard Safety Closure Assembly are:

reduced risk of specimen tube breakage .
. reduced exposure to blood by laboratory personnel and to minimize blood splatter during stopper removal

These benefits lead to increased safety of laboratory personnel and reduced necessity of repeat specimen collection.

Synopsis of Test Methods and Results .
Clinical evaluations were performed to determine the safety and efficacy of the BD Vacutainer™ Safety Coagulation tube. The BD Vacutainer™ Safety Coagulation tube (plastic) was compared to the currently marketed VACUTAINER™ Brand Sodium Citrate Tube (glass). The results of the

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

clinical evaluation demonstrated that the BD Vacutainer™ Safety clinical evaluation demonstition illy equivalent results when compared to Coagulation tube provides crimidale) equalizare Tube for Normal, Warfarin, Heparin and other patient donors.

Substantial Equivalence .
Based on comparison of the device features, materials, and intended use, the BDP Based on comparison on the device havenes, macemes, which substantially equivalent to the commercially available predicate device.

The predicate device, K number, and clearance date are identified below:

Manufacturer	Predicate Device	K-Number	Clearance Date
Becton DickinsonVACUTAINER™Systems	VACUTAINER™Brand SodiumCitrate Tube	N/A	Pre-Amendment Deviceand, therefore, exemptfrom premarketnotification requirementsaccording to the MDA of1976

لغد S.D

Keith M. Smith Director, Regulatory Affairs

11/30/01
Date

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved, overlapping shapes.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 01 2002

Mr. Keith M. Smith Associate Director, Regulatory Affairs BD Pharmaceutical Systems Becton Dickinson and Company 1 Becton Drive Mail Code 440 Franklin Lakes, New Jersey 07417-1880

Re: K013971

Trade/Device Name: BD Vacutainer™ Safety Coagulation Tube Regulation Number: 21 CFR § 862.1675 Regulation Name: Tubes, Vials, Systems, Serum Separators, Blood Collection Regulatory Class: II Product Code: GIM Dated: November 28, 2001 Received: December 3, 2001

Dear Mr. Smith:

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

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

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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

{5}------------------------------------------------

B. INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

BD Vacutainer™ Safety Coagulation tube Device Name:

Indications for Use:

reduced risk of specimen tube breakage .
reduced exposure to blood by laboratory personnel and to minimize blood . splatter during stopper removal

These benefits lead to increased safety of laboratory personnel and reduced necessity of repeat specimen collection.

Aurhini Boutta

rsion Sign Sign of Clinical Laboratory Devices

(Please do not Write below this line-continue on another 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use Or

(Per 21 CFR § 801.109)

(Optional format 1-2-96)

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.