The BD Vacutainer™ Push Button Blood Collection Set is a sterile, multiplesample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients.

The BD Vacutainer™ Push Button Blood Collection Set is also indicated for the intravenous administration of fluids as indicated in 21 CFR §880.5440. It may be used for any patient population with consideration given to patient size and appropriateness for the solution being infused and duration of therapy.

The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

Device Description

The BD Vacutainer™ Push Button Blood Collection Set is for venous blood collection and IV administration. It contains a needle that will retract into the body of the device when a button is depressed, helping to prevent accidental needle sticks.

AI/ML Overview

The provided text is a 510(k) summary for the BD Vacutainer™ Push Button Blood Collection Set. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or an analytical study proving the device meets particular performance metrics.

Instead, it states:
"Based upon previously demonstrated performance and successful completion of biocompatibility testing, Push Button Blood Collection Set will perform as intended."

This indicates that the safety and effectiveness are supported by:

Previously demonstrated performance: This implies that the device's design is similar to existing, already cleared devices (predicate devices listed in the summary, K980414 and K022875) and is expected to perform comparably. No new performance study with specific acceptance criteria is detailed for this specific submission.
Successful completion of biocompatibility testing: This is a standard requirement for medical devices that come into contact with the body.

Therefore, many of the requested points regarding acceptance criteria and a specific study cannot be answered from the provided text. The document focuses on regulatory compliance through substantial equivalence, rather than detailing a de novo performance study with quantitative acceptance criteria.

Summary of Information NOT Found in the Provided Text:

A table of acceptance criteria and reported device performance.
Sample size used for a test set.
Data provenance for a test set.
Number of experts used to establish ground truth for a test set, and their qualifications.
Adjudication method for a test set.
Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
Details of a standalone (algorithm only) performance study.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a performance study.
Sample size for a training set.
How ground truth for a training set was established.

Information that can be extracted or inferred:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantitative metrics. The implicit acceptance criterion is that the device "will perform as intended" based on similarity to predicate devices and biocompatibility.
- Reported Device Performance: No specific quantitative performance data is reported. The document relies on the "previously demonstrated performance" of predicate devices and "successful completion of biocompatibility testing."
Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. (The document refers to "previously demonstrated performance," implying reliance on historical data or characteristics of predicate devices, but no details are given for this device's specific testing related to performance.)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified as no such test set or ground truth establishment process is described beyond biocompatibility testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/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:
- No MRMC study was mentioned. This device is a blood collection set and does not involve AI or human image interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility, the "ground truth" would be established by standardized laboratory tests according to ISO 10993 standards, not expert consensus or pathology in the context of diagnostic accuracy. For performance, it relies on the established performance of predicate devices.
The sample size for the training set:
- Not applicable. No "training set" in the machine learning sense is mentioned or relevant for this type of device submission.
How the ground truth for the training set was established:
- Not applicable.

In conclusion, the document emphasizes the device's substantial equivalence to previously cleared devices and successful biocompatibility testing as the basis for its safety and effectiveness, rather than providing a detailed performance study with specific acceptance criteria.

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:	BD Vacutainer Systems, PreanalyticalSolutions1 Becton DriveFranklin Lakes, NJ 07417-1885
•	Registration Number:	2243072
•	Contact Person:	M. Wendy BallesterosRegulatory Affairs SpecialistTelephone no.: 201-847-6280Fax No. 201-847-4858
•	Date of Summary:	February 21, 2003
	Device
•	Trade Name:	BD VacutainerTM Push Button BloodCollection Set
•	Classification Name:	Tubes, Vials, Systems, SerumSeparators, Blood Collection
•	Classification:	Class II
•	Performance Standards:	None Established under 514 of theFood Drug and Cosmetic Act

KO35573

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II. Safety and Effectiveness Information Supporting Substantial Equivalence

· Device Description
The BD Vacutainer™ Push Button Blood Collection Set is for venous blood collection and IV administration. It contains a needle that will retract into the body of the device when a button is depressed, helping to prevent accidental needle sticks.
· Intended Use
The BD Vacutainer™ Push Button Blood Collection Set is a sterile, multiplesample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients.

· Synopsis of Performance Study Results
Based upon previously demonstrated performance and successful completion of biocompatibility testing, Push Button Blood Collection Set will perform as intended.

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III. Predicate Device Summary Table

• Substantial Equivalence

Based on comparison of the device features, materials, intended use and performance, the BD Vacutainer™ Push Button Blood Collection Set is 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
BD VacutainerSystems,PreanalyticalSolutions	BD VACUTAINER™Brand Safety-Lok™Blood Collection Set	K980414	March 3, 1998
BD VacutainerSystems,PreanalyticalSolutions	BD Vacutainer™ PushButton BloodCollection Set	K022875	September 11, 2002

M. Wendy Ballesta

2/21/03
Date

Date

M. Wendy Ballesteros Regulatory Affairs Specialist BD Vacutainer Systems, Preanalytical Solutions Becton Dickinson and Company

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 8 2003

BD Vacutainer Systems, Preanalytical Solutions Ms. M. Wendy Ballesteros Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417-1885

Re: K030573

Trade/Device Name: BD Vacutainer™ Push Button Blood Collection Set Regulation Number: 21 CFR 862.1675, 21 CFR 880.5440 Regulation Name: Blood Specimen Collection Device, Intravascular Administration Set Regulatory Class: II Product Code: 75 JKA. 80 FPA Dated: February 21, 2003 Received: February 24, 2003

Dear Ms. Ballesteros:

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.

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Page 2 - Ms. Ballesteros

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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Susan Dunner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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):	K030543
---------------------------	---------

Device Name: BD Vacutainer™ Push Button Blood Collection Set

Indications for Use:

The BD Vacutainer™ Push Button Blood Collection Set is a sterile, multiplesample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients.

The BD Vacutainer™ Push Button Blood Collection Set is also indicated for intravenous administration of fluids as indicated in 21 CFR §880.5440. It may be used for any patient population with consideration given to patient size and appropriateness for the solution being infused and duration of therapy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
Or	Over-the-Counter Use

(Per 21 CFR § 801.109)

(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices	(Optional format 1-2-96)

510(k) Number:	K030575
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PAGE: 8

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.