The VACUTAINER® Brand CTAD Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. The CTAD additive, a combination of a buffered sodium citrate, theophylline, adenosine and dipyridamole, provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.

Device Description

The VACUTAINER® Brand CTAD Tubes are sterile, glass, evacuated blood collection tubes. The tubes contain 0.109M Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. In addition to citrate, the CTAD tube contains theophylline, adenosine and dipyridamole (inhibitors of platelet activation). 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a comparison study rather than setting explicit numerical acceptance criteria for a new device. The "performance" is reported as demonstrating clinical equivalence or superior performance in specific contexts.

Acceptance Criteria (Inferred)	Reported Device Performance
Normal Donors: Clinical equivalence in coagulation parameters compared to the predicate device.	The VACUTAINER® Brand CTAD Tube provided clinically equivalent results.
Warfarin Donors: Clinical equivalence in coagulation parameters compared to the predicate device.	The VACUTAINER® Brand CTAD Tube provided clinically equivalent results.
Heparin Donors: Demonstrate the effects of the CTAD additive to prevent platelet activation and subsequent release of platelet factor 4, leading to more accurate monitoring of anticoagulant therapy.	The VACUTAINER® Brand CTAD Tube demonstrated clinically non-equivalent aPTT, Heparin Xa, and Platelet Factor 4 results. This indicates superior performance by minimizing heparin neutralization due to platelet activation, leading to longer aPTT clotting times, higher Heparin Xa results, and lower Platelet Factor 4 results.

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

Sample Size: Not explicitly stated. The document refers to "Normal Donors," "Warfarin Donors," and "Heparin Donors," implying multiple participants in each group, but the exact count is not provided.
Data Provenance: Not explicitly stated. There is no mention of the countries of origin for the data or whether it was prospective or retrospective.

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

This information is not provided in the document. The study compares two blood collection tubes; the "ground truth" here would likely be the actual coagulation parameters measured, rather than interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of comparing laboratory results from blood samples, an adjudication method in the traditional sense (e.g., for image interpretation) is unlikely to be applicable.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a blood collection tube, not an AI-powered diagnostic tool, so "human readers" and "AI assistance" are not applicable.

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

A standalone performance study was not done in the context of an algorithm. This device is a medical device (blood collection tube) that is used by humans to collect samples for laboratory analysis.

7. The Type of Ground Truth Used

The ground truth used was laboratory analysis of coagulation parameters. The document mentions "coagulation parameters," "aPTT," "Heparin Xa," and "Platelet Factor 4 results," which are objective measures obtained from blood samples.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a physical medical device (blood collection tube), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided. As above, this device does not involve a training set or AI model.

Summary

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K99/120

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

2243072

Establishment:

A d d re s s : .
Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, NJ 07417-1885
. Registration Number:
. Contact Person:

James W. Haynes Regulatory Affairs Specialist Telephone No .: 201) 847-5170 Fax No. (201) 847-4858

. Date of Summary: March 31, 1999

Device

. Trade Namc: VACUTAINER® Brand CTAD Tube
- Classitication Name: Tubes, Vials, Systems, Scrum 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
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 upplication by the couris.

Device Description: .
The VACUTAINER® Brand CTAD Tubes are sterile, glass, evacuated blood collection tubes. The tubes contain 0.109M Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. In addition to citrate, the CTAD tube contains theophylline, adenosine and dipyridamole (inhibitors of platelet activation). 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.
Intended Use:
The VACUTAINER® Brand CTAD Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. The CTAD additive, a combination of a buffered sodium citrate, theophylline, adenosine and dipyridamole, provides an anticoagulated specimen that may be used for clinical laboratory coagulation аззауз.
. Synopsis of Test Methods and Results
Clinical evaluations were performed to determine the safety and efficacy of the VACUTAINER® Brand CTAD Tube. The VACUTAINER® Brand CTAD Tube was compared to the currently marketed VACUTAINER® Brand Sodium Citrate Tube. The results of the clinical evaluation demonstrate that the VACUTAINER® Brand CTAD Tube provides clinically equivalent results when compared to the VACUTAINER® Brand Sodium Citrate Tube for Normal Donors and Warfarin Donors. The superior performance of the VACUTAINER® Brand CTAD Tube was distinctly demonstrated for patients undergoing heparin anticoagulant therapy. For the Heparin Donors, the tube demonstrated clinically non-equivalent aPTT, Heparin Xa and Platelet Factor 4 results when compared to the VACUTAINER® Brand Sodium Citrate Tube. These expected results clearly illustrated the effects of the CTAD additive to provent platelet activation and subsequent release of platelet factor 4. The reduced levels of platelet factor 4 minimized the neutralization of heparin in the sample,

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thus leading to longer aPT" clotting times, higher Heparin Xa results and lower Platelet Factor 4 results. This stabilization of heparin in the collected sample allows for a more accurate monitoring of anticoagulant therapy in heparinized patients.

Substantial Equivalence ◆
Based on comparison of the device features, materials, and intended use, the VACUTAINER® Brand CTAD Tube can be shown to be substantially cquivalent to the commercially available prodicate 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 premarket notificationrequirements according tothe MDA of 1976

James W. Haynes

James W. Ilayncs Regulatory Affairs Specialist

March 31, 1999

Date

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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 (HHS) of the USA. The seal features a stylized eagle with three stripes forming its body, symbolizing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

MAY 1 9 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. James W. Haynes Regulatory Affairs Specialist Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417-1885

Re: K991120

Trade Name: VACUTAINER® Brand CT AD Tube Regulatory Class: II Product Code: JKA Dated: March 31, 1999 Received: April 2, 1999

Dear Mr. Haynes:

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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment datc of the Medical Device Amendments, or to devices that have heen 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: Gencral regulation (21 CFR Part 820) and that, through periodic ()S 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 allect 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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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CIJA-88), this device may Onder the Chilical Laboratory Improvise.
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 I his icter will anow you to oogin martoung your device of your device to a legally marketed nothication. The PDA Inding of sunnantal equivalize and thus, permits your device to proceed to the market.

If you desirc specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific acvice to: your do rises), please contact the Office of Compliance at additionally 807.10 for mi vitto diagnosis on the promotion and advertising of your device, (201) 594-4360. Tructionally, roll processes (301) 594-4639. Also, please note the regulation prease contact the Office of Compilance (start notification"(21 CFR 807.97). Other general enfined, "Wissoranding by reference to president to promotion from the Division of Small Information on your responsibility the number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrls/dsma/dsmamain.html"

Sincerely yours,

Steven Autman

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): _ K991120

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The VACUTAINER® Brand CTAD Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. The CTAD additive, a combination of a buffered sodium cirate, theophyline, adenosine and dipyridamole, provides an anticoagulated specimen that may be used for clinical laboratory

Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991120

(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 1

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Pct 21 CFR § 801.109)

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(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.