The VACUTAINER® Brand Safety Blood Collection Assembly is intended to provide a pre-assembled Direct Draw Adapter/safety needle combination for venipuncture to obtain blood samples. The VACUTAINER® Brand Safety Blood Collection Assembly contains a sliding shield that covers the needle point after use. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal.

Device Description

The VACUTAINER® Brand Safety Blood Collection Assembly is a configuration of the commercially available BDD SafetyGlide™ Needle preattached to a VACUTAINER® Direct Draw Adapter (Blood Collection Holder assembly). The VACUTAINER® Brand Safety Blood Collection Assembly is intended to be marketed as a sterile, multi-sample, single use device.

AI/ML Overview

Acceptance Criteria and Device Performance Study for the VACUTAINER® Brand Safety Blood Collection Assembly

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a "Simulated Use Study" designed to evaluate the safety features of the VACUTAINER® Brand Safety Blood Collection Assembly, specifically the successful activation of its protective shield.

Acceptance Criteria (Implicit)	Reported Device Performance
High rate of successful shield activation	100% successful shield activation for all 500 devices tested.
Acceptable confidence limits for successful shield activation	0.7% Upper 95% Confidence Limit; 1.1% Upper 99% Confidence Limit.
Acceptable "Ease of Activation"	Over 90% of investigators reported "As Expected" Ease of Use; remaining equally divided between "Easier Than Expected" or "Harder Than Expected."
Manageable blood splatter	Blood splatter was observed in some instances; package labeling includes handling recommendations to reduce risk.
No significant modification to venipuncture technique required	Evaluated by investigators; no specific metrics provided but implied to be acceptable.
Accommodates left/right-handed and single-handed use	Evaluated by investigators; no specific metrics provided but implied to be acceptable.
Inability to deactivate the safety mechanism post-activation*	The original SafetyGlide™ Needle, which is pre-attached, "could not be deactivated."

Note: While the "inability to deactivate" was a specific finding from the original SafetyGlide™ Needle 510(k) and not re-tested in the Simulated Use Study, it's a critical safety feature of the component pre-attached to this device.

2. Sample Size and Data Provenance

Test Set Sample Size: 500 VACUTAINER Safety Blood Collection Assembly devices.
Data Provenance: The document does not explicitly state the country of origin where the Simulated Use Study was conducted, nor does it specify if the data was retrospective or prospective. Given the nature of a "Simulated Use Study," it would highly likely be prospective data collection. The study was conducted by "VACUTAINER Systems" which is a division of Becton Dickinson, a US-based company, suggesting the study likely took place in the US or under their oversight.

3. Number of Experts and Qualifications

The document refers to "investigators" who participated in the Simulated Use Study. It does not specify the number of investigators or their individual qualifications (e.g., specific medical titles, years of experience). It can be inferred that these investigators are healthcare professionals who perform venipuncture, as the study was designed to evaluate the device "in a blood drawing environment."

4. Adjudication Method

The document does not describe an explicit adjudication method for establishing ground truth within the Simulated Use Study. The study relies on direct observation and reporting by the "investigators" regarding shield activation, blood splatter, ease of activation, and technique modification. This suggests a direct assessment without a separate adjudication process for discrepant opinions. The 100% success rate for shield activation implies a clear (binary) outcome easily observable.

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

No, an MRMC comparative effectiveness study was not done as described in the provided text. The study mentioned is a "Simulated Use Study" which focuses on assessing the device's functional performance and safety features directly, rather than comparing human reader performance with and without AI assistance. The device is a physical medical device (blood collection assembly), not an AI-powered diagnostic tool.

6. Standalone Performance Study

Yes, a standalone study was done, in the sense that the "Simulated Use Study" evaluates the device directly without human intervention to interpret results from an algorithm. The study directly assessed the operational success of the device's safety mechanism (shield activation). It's a study of the device's physical performance, not its algorithmic output.

7. Type of Ground Truth Used

The ground truth for the Simulated Use Study was based on direct observation and subjective reporting by trained investigators during simulated venipuncture. For successful shield activation, it was a clear, objective outcome (did it activate or not). For ease of activation, it was subjective ("As Expected," "Easier Than Expected," "Harder Than Expected"). Blood splatter was also based on observation.

8. Sample Size for the Training Set

The document does not mention a training set as this device is a physical medical device and not an AI/machine learning model that requires a training set. The 500 devices were part of the test set for the "Simulated Use Study."

9. How Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI/machine learning model. The study focused on evaluating the physical device's performance directly.

Summary

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KA92404

JUL 22 1997

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CELEBRATING THE FIRST ONE HUNDRED: 1897-1997

BECTON
DICKINSON

Becton Dickinson VACUTAINEA Systems 1 Becton Drive Franklin Lakes, New Jersey 07417 (201) 847-4500

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

General Information I.

This Summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92 Establishment:

•	Address:	Becton Dickinson VACUTAINER Systems1 Becton DriveFranklin Lakes, NJ 07417-1885
•	Registration Number:	2243072
•	Contact Person:	• John A. SchalagoRegulatory Affairs SpecialistTelephone no.: 201 - 847 - 6280Facsimile no.: 201 - 847 - 4858
•	Date of Summary:	June 20, 1997
Device Name:
•	Trade Name:	VACUTAINER® Brand Safety BloodCollection AssemblyPre-attached SafetyGlide™ Needle and DirectDraw Adapter
•	Classification Name :	Blood Specimen Collection Device
•	Classification:	Class II
•	Performance Standards:	None Established under 514 ofthe Food, Drug and Cosmetic Act

Safety and Effectiveness Information Supporting the Substantial II. Equivalence Determination

· Device Description

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intended to be marketed as a sterile, multi-sample, single use device.

● Intended Use

· Synopsis of Test Methods and Results

The original SafetyGlide™ Needle 510(k) premarket notification K951254 described bench and simulated use testing to support the functional performance and a decision of substantial equivalence. The bench testing which compared the SafetyGlide™ Needle to two commercially available devices included force to activate; hub/arm separation force, safety barrier penetration resistance and reset force. The results demonstrated equivalent or improved performance of the SafetyGlide™ Needle force to activate, hub/arm separation force, safety barrier penetration resistance and reset force. Further, the SafetyGlide™ Needle could not be deactivated.

VACUTAINER Systems, in accordance with the Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions For Medical Devices with Sharps Injury Prevention Features, conducted a Simulated Use Study. The Simulated Use Study was designed to evaluate successful shield activation in a blood drawing environment, observe blood splatter and to evaluate Ease of Activation. The investigators were also requested to document any modification to the current venipuncture technique, observe left/right handed use and single handed use.

A total of 500 VACUTAINER Safety Blood Collection Assembly devices were tested. Results of the study demonstrated successful shield activation for all 500 devices, a 100% success rate with a 0.7% Upper 95% Confidence Limit and a 1.1% Upper 99% Confidence Limit. (The confidence limits is based on the table included in the Supplementary Guidance). Over 90% of the investigators reported "As Expected" Ease of Use with the remaining investigators approximately equally divided in regards to "Easier Than Expected Activation" or "Harder than Expected Activation". Blood Splatter was observed in some instances of use. The Package labeling instructions for use includes handling recommendations intended to reduce the risk of exposure.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jul 22 1997

John A. Schalago · Regulatory Affairs Specialist Becton Dickinson VACUTAINER Systems ' 1 Becton Drive Franklin Lakes, New Jersey 07417

Re : K972404 VACUTAINER® Brand Safety Blood Collection Assembly Regulatory Class: II Product Code: KJA Dated: June 25, 1997 Received: June 26, 1997

Dear Mr. Schalago:

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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Requlations.

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Page 2

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.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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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510(k) Number (if known): -- --------

Device Name:_VACUTAINER® Brand Safety Blood Collection Assembly

Indications for Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number -972404

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

510(K) Premarket Notification VACUTAINER® Brand Safety Blood Collection Assembly

Regulation Number and Section

§ 864.2240 Cell and tissue culture supplies and equipment.

(a)
Identification. Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.(b)
Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the devices are not labeled or otherwise represented as sterile, they are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.