The VACUTAINER® Brand Sodium Citrate Pediatric Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a tube containing Sodium Citrate anticoagulant is used primarily for clinical laboratory coagulation assays.

Device Description

The VACUTAINER® Brand Sodium Citrate Pediatric Tubes are sterile, glass, evacuated blood collection tubes. The tube contains 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 the coagulation parameters to detect clotting time disorders and/or monitor patients undergoing anticoagulation therapy.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the requested information for a device like an AI-powered diagnostic tool. Instead, the document is a 510(k) summary for a VACUTAINER® Brand Sodium Citrate Pediatric Tube, which is a blood collection tube. The summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria using complex metrics like those for AI models.

Therefore, many of the requested fields are not applicable or cannot be extracted from this document, as it describes a physical medical device (a blood collection tube) and not an AI/ML-based diagnostic system.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The document describes the VACUTAINER® Brand Sodium Citrate Pediatric Tube, a sterile, glass, evacuated blood collection tube containing Sodium Citrate as an anticoagulant. The primary goal of the submission is to demonstrate substantial equivalence to a predicate device, specifically addressing a material modification to the rubber stopper. The "acceptance criteria" in this context are implicitly the analytical and statistical equivalence to the predicate device's performance for its intended use, which is for clinical laboratory coagulation assays.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Does not affect the performance or effectiveness for intended use.	"The modified VACUTAINER® Brand Sodium Citrate Pediatric Tube demonstrated analytically and statistically equivalent results."
Substantial equivalence to predicate device.	"Based on comparison of the device features, materials, and intended use, the VACUTAINER® Brand Sodium Citrate Pediatric Tube can be shown to be substantially equivalent to the commercially available predicate device."

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

Sample Size: The document states that "Clinical evaluations were performed," but it does not specify the sample size used for these evaluations.
Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device and study. The "ground truth" for a blood collection tube would relate to its ability to preserve blood components for accurate coagulation testing, which is assessed through laboratory methods comparing results to a predicate, not through expert consensus on diagnostic images or pathology.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, typically involving human readers and interpretations, which is not relevant here.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems assisting human readers in diagnostic tasks, which is not the nature of this medical device.

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

No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical blood collection tube, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by analytical and statistical equivalence of coagulation test results (e.g., clotting times, other coagulation parameters) obtained using the modified tube compared to the predicate device. It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic devices. The performance of the collected blood for "clinical laboratory coagulation assays" is the measure of effectiveness.

8. The Sample Size for the Training Set

This concept is not applicable. The device is a physical product, not an AI model requiring a training set.

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

This concept is not applicable as there is no training set for this type of device.

Summary

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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:	James W. HaynesRegulatory Affairs SpecialistTelephone no.: 201) 847-5170Fax No. (201) 847-4858
• Date of Summary:	February 2, 1999

Device =======================================================================================================================================================================

Trade Name:	VACUTAINER® Brand Sodium CitratePediatric 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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Safety and Effectiveness Information Supporting the II. 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 E quivalence 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 VACUTAINER® Brand Sodium Citrate Pediatric Tubes are sterile, glass, evacuated blood collection tubes. The tube contains 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 the coagulation parameters to detect clotting time disorders and/or monitor patients undergoing anticoagulation therapy.

Intended Use: .

The VACUTAINER® Brand Sodium Citrate Pediatric Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a tube containing Sodium Citrate anticoagulant is used primarily for clinical laboratory coagulation assays.

Synopsis of Test Methods and Results .

Becton Dickinson VACUTAINER Systems has determined that the material modification of the rubber stopper to the VACUTAINER® Brand Sodium Citrate Pediatric Tube does not affect the performance or effectiveness of the device for its intended use. Clinical evaluations were performed to determine the affects of the modifications described herein.

The VACUTAINER® Brand Sodium Citrate Pediatric Tube was compared t the currently marketed VACUTAINER® Brand Sodium Citrate Tube. The modified VACUTAINER® Brand Sodium Citrate Pediatric Tube demonstrated analytically and statistically equivalent results.

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Substantial Equivalence .

Based on comparison of the device features, materials, and intended use, the VACUTAINER® Brand Sodium Citrate Pediatric Tube can be shown to be substantially equivalent to the commercially available predicate device.

The predicate devices, 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

There are no new product claims described in this 510(k) Premarket Notification.

James W. Heyns

James W. Haynes Regulatory Affairs Specialist

February 2, 1999
Date

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 3 1999

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

Re: K991551
Trade Name: VACUTAINER® Brand Sodium Citrate Pediatric Tube Regulatory Class: II Product Code: JKA Dated: August 23, 1999 Received: August 24, 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 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 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: General regulation (21 CFR Part 820) and that, through periodic QS 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 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"(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.gov/cdrlvdsma/dsmamain.html".

Sincerely yours,

Steven Butman

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): K991551

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Gean Coogen

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991551

(Please do not Write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use_

(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.