The VACUTAINER Brand Blood Collection Syringe is intended to collect whole blood specimens for diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium and magnesium), metabolytes, co-oximetry, and other tests.

Device Description

The VACUTAINER® Brand Blood Collection Syringe is a sterile, single use device designed to collect whole blood specimens for diagnostic testing. The syringe contains dry calcium-balanced lithium heparin (approximately 50 IU per mL of whole blood) derived from porcine intestinal mucosa, as the anticoagulant. Calcium chloride has been added to the formulation to provide a calcium-balanced lithium heparin solution, specifically allowing the measurement of ionized calcium and magnesium. The calcium chloride solution binds to the heparin prior to blood collection allowing electrolytes such as ionized calcium and magnesium in the blood to be measured without interference from the heparin (calcium-balanced).

VACUTAINER Brand A-LINE Kit: Contains a specifically designed syringe only for aspiration of blood samples from arterial lines.

VACUTAINER Brand PRESET™ Kit: Contains a specifically designed syringe (may include needle) that can be preset to a desired volume, but permits aspiration when necessary. Includes a venting system that expels residual air through the self-venting membrane (as blood fills the syringe), which ensures rapid filling.

VACUTAINER Brand DRIHEP® PLUS Kit: Contains a specifically designed syringe (may include needle) with a self-venting membrane, (which seals automatically upon blood contact), and low plunger resistance which permits preset, aspiration, and natural fill sampling. Plunger auto-stop avoids overfill and leakage.

Please Note: The needle component may be one of two configurations. The needle may be a single lumen hypodermic needle or a SafetyGlide™ Needle, a single lumen hypodermic needle with a hinge safety mechanism.

AI/ML Overview

The provided text describes the 510(k) summary for the VACUTAINER® Brand Blood Collection Syringe. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device conformance. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting specific performance metrics against defined acceptance criteria.

Therefore, I cannot provide a complete answer to all your questions from the given text. I will extract what information is available and note where specific details are missing.

Here's the breakdown of the available information:

Acceptance Criteria and Device Performance

The document states that "Three separate performance studies (anticoagulant & hemolysis, analytical, and clinical) were done to show the performance and equivalence of the principal device with the new calcium-balanced lithium heparin anticoagulant to the predicate devices currently marketed in the United States." It concludes that "All results from the three studies show equivalence between the principal device and the predicate device."

Missing Information:

Specific quantitative acceptance criteria (e.g., "pH measurement should be within X units of the reference method").
Reported device performance values for these criteria.
The actual results of the "anticoagulant & hemolysis, analytical, and clinical" studies. The document only reports "equivalence" without detailing the specific findings.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document.

Study Details

Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided text.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only indicates the studies were conducted to show equivalence to predicate devices marketed in the United States.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not specified.

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:

MRMC Study: Not applicable. This device is a blood collection syringe, not an AI-assisted diagnostic tool involving human readers.

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

Standalone Performance: Not applicable. This device is a medical device (syringe), not an algorithm.

The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Ground Truth Type: Not explicitly stated. The studies focused on demonstrating "equivalence" in anticoagulant & hemolysis, analytical, and clinical performance, implying comparisons to established reference methods or predicate device performance. For example, "analytical studies" would likely compare measured values (pH, blood gases, electrolytes) to a gold standard analytical instrument.

The sample size for the training set:

Sample Size: Not applicable. This device is a physical product (syringe), not an algorithm that requires a training set.

How the ground truth for the training set was established:

Ground Truth Establishment: Not applicable.

In summary, the provided 510(k) summary (K981922) for the VACUTAINER® Brand Blood Collection Syringe mainly focuses on establishing substantial equivalence to existing predicate devices based on the description of the device, its intended use, and general statements about performance studies ("anticoagulant & hemolysis, analytical, and clinical") showing equivalence. It does not provide the detailed quantitative data, sample sizes, or specifics about ground truth establishment that would typically be found in a comprehensive study report for certain types of medical devices, especially AI/ML-based ones.

Summary

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K981922

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. SmithSenior Regulatory Affairs SpecialistTelephone no.: 201-847-6280Fax No. 201-847-4858
Date of Summary:	August 14, 1998

Device

Trade Name:	VACUTAINER® Brand Blood CollectionSyringe
Classification Name:	Tubes, Vials, Systems, Serum Separators,Blood Collection

Class II Classification: . None Established under 514 of the Performance Standards: . Food, Drug and Cosmetic Act

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II. Safety and Effectiveness Information Supporting Substantial Equivalence

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 berein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

· Device Description

VACUTAINER Brand A-LINE Kit

Contains a specifically designed syringe only for aspiration of blood samples from arterial lines.

VACUTAINER Brand PRESET™ Kit

Contains a specifically designed syringe (may include needle) that can be preset to a desired volume, but permits aspiration when necessary. Includes a venting system that expels residual air through the self-venting membrane (as blood fills the syringe), which ensures rapid filling.

VACUTAINER Brand DRIHEP® PLUS Kit

Contains a specifically designed syringe (may include needle) with a self-venting membrane, (which seals automatically upon blood contact), and low plunger resistance which permits preset, aspiration, and natural fill sampling. Plunger auto-stop avoids overfill and leakage.

Please Note:

The needle component may be one of two configurations. The needle may be a single lumen hypodermic needle or a SafetyGlide™ Needle, a single lumen hypodermic needle with a hinge safety mechanism. The single lumen hypodermic needle is a pre-amendment device for Becton Dickinson and the SafetyGlide™ Needle was cleared on 10/10/95 via 510(k) K951254.

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Intended Use
The VACUTAINER® Brand Blood Collection Syringe is intended to collect whole blood specimens for diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium and magnesium), metabolytes, co-oximetry, and other tests.

· Synopsis of Performance Study Results

Three separate performance studies (anticoagulant & hemolysis, analytical, and clinical) were done to show the performance and equivalence of the principal device with the new calcium-balanced lithium heparin anticoagulant to the predicate devices currently marketed in the United States.

The VACUTAINER® Blood Collection Syringes are substantially equivalent to the performance of the currently marketed predicate devices as presented in this submission. All results from the three studies show equivalence between the principal device and the predicate device. Therefore, the performance of the VACUTAINER Blood Collection Syringes are substantially equivalent to the predicate devices.

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· Substantial Equivalence

Based on comparison of the device features, materials, intended use and performance, the VACUTAINER® Blood Collection Syringe can be shown to be substantially equivalent to the commercially available predicate devices indicated in the table below. The predicate devices, K number, and clearance date are also identified in the table below.

Manufacturer	Predicate Device	K-Number	Clearance Date
Becton DickinsonDivision	Becton DickinsonDivision ArterialBlood Gas Syringe	N/A	Exempt from premarketnotification
RADIOMETERAMERICA INC.	Smooth ETMArterial BloodSampler	K896514	unknown
CHIRON/DiagnosticsRapidLyte™ ArterialBlood Sampler	VACUTAINERBrand SafetyBlood CollectionAssembly	K875117	2/29/88

Kim Reid

8/14/98

Date

Keith M. Smith Senior Regulatory Affairs Specialist Becton Dickinson VACUTAINER Systems Becton Dickinson and Company

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three wavy lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

SEP 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Keith M. Smith Senior Regulatory Affairs Specialist Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417-1885

Re : K982922 VACUTAINER® Brand Blood Collection Syringes Regulatory Class: II Product Code: JKA Dated: August 14, 1998 August 19, 1998 Received:

Dear Mr. Smith:

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 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. ਸ 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 requlatory 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 leqally 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/cdrh/dsmamain.html".

Sincerely yours,
Steven Dietman

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): K892922

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Device Name: VACUTAINER® Brand Blood Collection Syringe

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

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Per 21 CFR § 801.109)

ef 29
(Optional format 1-2-96)
(Division Sign-Off)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K982822

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.