The BD Vacutainer® Push Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended for use in the general population by healthcare professionals experienced with venipuncture to obtain blood specimens from patients, including those patients with difficult vein access who may have small, fragile, and or non-palpable veins, into evacuated blood collection tubes and/or bottles. When used without the male Luer adapter, the device allows the clinician to obtain a blood specimen from the female Luer connector with a syringe, if necessary. The device can be used by healthcare professionals with infusion experience for short-term, single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and is to remain under the direct supervision of a clinician.

The recommended use of the device is to activate the needle safety feature 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 a sterile, multiple-sample, single-use device used for venipuncture to obtain blood specimens from patients and may be used for the short-term intravenous administration of fluids. The BD Vacutainer® Push Button Blood Collection Set is a winged blood collection set with flexible tubing, a female luer connector and an optional male luer adapter. The BD Vacutainer® Push Button Blood Collection Set also contains a needle protector. The wingset is designed with a safety mechanism to protect against needlesticks. When the button is depressed by the user, the needle fully retracts and is enclosed and locked within the barrel of the device. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

The BD Vacutainer® Push Button Blood Collection Set consists of:

Stainless steel cannula (Intravenous end and non-patient end of cannula)
Stainless steel spring
Hub, front and rear barrel
Wings (color coded according to needle gauge)
Tubing
Female luer connector and an optional male luer adapter
Intravenous (IV) needle protector (covers the needle before use)
Pre-attached holder (connected by male luer adapter in some models)

The intravenous needle of the blood collection set is bonded to one end of the hub. The other end of the hub is bonded to the blood collection set tubing, the end of which is then bonded to a female luer connector with an optional attached male luer adapter. Some models come with a pre-attached holder connected to the male luer adapter for user convenience. A spring is loaded onto the front barrel of the hub. Once the sample is collected, and without removing the needle from the patient vein, the user depresses the raised push button on top of the hub which activates the spring mechanism to automatically retract the needle from the device. In this retracted (locked) position, the IV point of the needle is fully contained within the body of the device. This will prevent the needle from coming out of the front barrel once it has retracted as well as preventing accidental overriding of the safety feature.

The blood collection set with a male luer adapter contains threads for attachment to a Vacutainer® Brand Needle Holder, and a non-patient cannula for blood collection into evacuated blood collection tubes and/or blood culture bottles. For models without the pre-attached holder, the user is instructed to attach a holder before using the device. The pre-attached holder models come with the BD Vacutainer® Brand Holder pre-attached for user convenience. The non-patient end cannula of the luer adapter has a sleeve that recovers over the cannula to stop blood flow in between collection of multiple tubes.

When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe, if necessary. The device can be used for short-term, single infusions (up to 2 hours) with consideration given to patient size and appropriateness for the solution being infused.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the BD Vacutainer® Push Button Blood Collection Set. A 510(k) notification aims to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets a new set of defined acceptance criteria in the way a novel AI/ML device would.

Therefore, the structure of the provided document doesn't align with the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" framework seen with AI/ML systems where performance metrics (e.g., sensitivity, specificity, AUC) are rigorously tested against pre-defined thresholds.

Instead, this document focuses on demonstrating that the subject device (BD Vacutainer® Push Button Blood Collection Set, K220212) is substantially equivalent to a predicate device (BD Vacutainer® Push Button Blood Collection Set, K030573) and performs as intended through a series of non-clinical bench tests, biocompatibility, and sterilization testing. Clinical literature is cited to support the expanded indications for use, rather than a de novo clinical study with a control group and specified primary endpoints designed to meet quantitative performance acceptance criteria.

However, I can extract the relevant information and present it in a similar structure, focusing on what was demonstrated for substantial equivalence rather than a detailed "acceptance criteria" table for novel device performance.

Device: BD Vacutainer® Push Button Blood Collection Set (K220212)
Predicate Device: BD Vacutainer® Push Button Blood Collection Set (K030573)

1. Table of Acceptance Criteria and Reported Device Performance (or Demonstration of Substantial Equivalence)

Since this is a 510(k) focusing on substantial equivalence, the "acceptance criteria" are generally that the subject device performs as intended and is as safe and effective as the predicate device, despite minor differences. The performance is demonstrated through various bench and materials testing, and by referencing clinical literature.

Category	Acceptance Criteria (Demonstrated Equivalence/Performance Goal)	Reported Device Performance / Evidence of Meeting Criteria
Intended Use	Predicate: For venipuncture to obtain blood specimens; intravenous administration of fluids. Subject Device Expansion: Intended for general population by healthcare professionals experienced with venipuncture to obtain blood specimens, including those patients with difficult vein access (DVA) who may have small, fragile, and/or non-palpable veins, into evacuated blood collection tubes and/or bottles. Can also obtain blood specimens with a syringe (when without male Luer adapter). Short-term, single infusions (up to 2 hours), not to be left in place, under direct clinician supervision. Both: activate needle safety feature prior to removal, aiding in accidental needlestick injury prevention. The expansion to DVA patients and syringe use should not raise new questions of safety/effectiveness.	Similarity/Difference and Justification:- Intended Population: Subject device explicitly adds "including patients with difficult vein access (DVA)". Justified by CLSI guideline GP41 and WHO Guidelines stating winged blood collection sets are recommended for difficult veins. This is considered a subset of 'General Use' and does not affect safety/effectiveness.- Syringe Use: Re-inclusion of syringe use (unintentionally omitted from predicate IFU) is not a new intended use and does not raise new questions of safety/effectiveness.- Overall intended use similar, with minor clarifications supported by existing clinical literature.
Technological Characteristics	Materials, dimensions, and design features should be substantially equivalent to the predicate, or any differences should not raise new questions of safety or effectiveness.	Comparison (See Table 1 in document, abridged):- Same: Needle Diameter OD/ID, Needle Point Geometry, Needle Length, Wing material, Hub material, Button Ink, Barrels (Front/Rear) material, Rear Barrel Lubricant, Spring material, IV Protector/Cannula/NP Cannula material, Tubing material, Cannula Lubricant/Adhesive, Hub-Tubing Adhesive, Female Luer Adapter/Luer Adapter Hub material, NP Sleeve, Luer Adhesive/Cannula Lubricant/Cap, Top Web, Blister material.- Different (and Justified): Presence/absence of viscous fluid (not part of subject device – no impact on safety/effectiveness). Pre-attached holder (user convenience, legally marketed holder used – no impact on safety/effectiveness).
Performance (Non-Clinical Bench Testing)	The device must pass a comprehensive suite of bench tests to verify its design specifications and performance standards, demonstrating it is as safe and effective as the predicate. This includes mechanical properties, safety features, fluid dynamics, and packaging integrity. Compliance to applicable standards (e.g., ISO, ASTM).	Passed Tests (Partial List provided):- IV Protector Pull Test- IV Cannula Removal Test- Flow Rate- Torque to Rotate Wing- Wing Removal Test- Front Barrel/Rear Barrel Separation Test- Tubing to Female Luer Adapter Pull Test- Tubing to Hub Pull Test- Product (safety feature) Pre-Activation- Retraction and Lock-out- Force to Override Lock Mechanism- Luer Cap Removal Torque- Luer Separation Test- NP Cannula Pull Test- Male Luer Adapter Spin Out from Holder Test- Torque to Unseat- NP Sleeve Function- Tube Push Off- IV Cannula Penetration Test- Submerged Leak Test (Device)- Air Leakage Test- Package Integrity Test- Luer Compatibility (ISO 594-1/2)- Sharps Injury Protection (ISO 23908)- Stainless Steel Needle Tubing (ISO 9626)Conclusion: Results demonstrate acceptable performance for the subject device and complies to applicable parts of the listed standards.
Biocompatibility	Device materials must be biocompatible for intended use and contact (externally communicating device, direct contact with circulating blood for ≤ 24 hours). Compliance to ISO 10993 series.	Passed Tests: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility (Coagulation, Platelet Activation, Complement Activation, Hemolysis), Particulates. All compliant with ISO 10993 series and USP standards.
Sterilization, Package Integrity, Shipping & Shelf Life	The device must be sterile (SAL 10-6), maintain sterility through its shelf life, and withstand shipping. Compliance to relevant ISO and ASTM standards.	Demonstrated Compliance: Sterilized via gamma irradiation, with validations for sterilization, package integrity, shipping, and shelf life (2 years) according to ISO 11137 series, ISO 11737 series, ISO 11607 series, ASTM F1980, ASTM D4169, ASTM F2096, ASTM F88.

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

As this is a 510(k) for a physical device, not an AI/ML diagnostic, there isn't a "test set" in the sense of a distinct dataset of medical images or patient records used to evaluate an algorithm's performance against a gold standard. Instead, performance is demonstrated through:

Non-Clinical Bench Testing: Tests were performed on a sufficient number of device samples to ensure reproducibility and statistical validity, though specific sample numbers for each test are not detailed in this summary. These are laboratory-based tests on manufactured devices.
Clinical Literature Review: Two literature articles are cited to support the expanded indications for use.
- Ibarra AF and Villanueva, 2019: Clinical study showing phlebotomist preference and increased patient/phlebotomist satisfaction in a Mexican general hospital. The sample size for this specific study is not detailed, but it relates to the preference of the device rather than a ground truth for a diagnostic output.
- Merrill, V.D. et al., 2021: Study on venipuncture blood draws for oncology outpatients. Sample size: 89 oncology outpatients (≥18 years of age).
  - Data Provenance: The Merrill study was conducted in an oncology outpatient clinic, implying a prospective collection of data for the purpose of the study. The location (country) is not specified but generally these studies would be in the US or similar developed healthcare systems given the context of FDA submission.

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

There is no "ground truth" derived from expert consensus in the context of an AI/ML device output for this 510(k). The clinical literature cited supports the usability and effectiveness for patient populations (e.g., DVA patients) and specimen quality, rather than establishing a diagnostic "ground truth."

For the Merrill study (2021), clinical outcomes (successful blood collection, specimen quality based on LDH, K, and plasma free hemoglobin levels) served as the "ground truth" or evaluative criteria, not expert interpretations. The healthcare professionals performing the venipuncture are the "experts" in the practical application.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring adjudication by multiple experts in the context described (e.g., for diagnostic AI device output). The clinical literature referenced presents outcomes data or user preference data.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this is a physical blood collection device, not an AI/ML diagnostic system that assists human readers. The clinical summaries provided support the use and safety of the device for a broader patient population (DVA) and user preference, rather than an aid to diagnostic interpretation.

6. Standalone Performance (Algorithm Only)

Not applicable. This is a physical medical device. There is no standalone algorithm.

7. Type of Ground Truth Used

For the clinical literature cited:

Merrill et al., 2021: The "ground truth" for the device's performance in DVA patients was based on physiological outcomes data:
- Successful blood collection from each patient.
- Specimen quality assessed by laboratory measurements of LDH, K, and plasma free hemoglobin levels, compared against normal and acceptable analyte reference ranges.
Ibarra AF and Villanueva, 2019: The "ground truth" was user (phlebotomist) preference and patient/phlebotomist satisfaction data.

For the non-clinical bench testing, the "ground truth" is adherence to engineering specifications and performance standards (e.g., force required for retraction, flow rate, leak integrity).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device; there is no AI/ML model requiring a training set.

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

Not applicable. There is no training set.

Summary

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March 24, 2023

Becton, Dickinson and Company Kelly Hilliger Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K220212

Trade/Device Name: BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FPA Dated: February 24, 2023 Received: February 24, 2023

Dear Kelly Hilliger:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Walloschek

David Wolloscheck, Ph.D. Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220212

Device Name

BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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K220212 510(K) SUMMARY

BD Vacutainer® Push Button Blood Collection Set

Summary Preparation Date:

March 24, 2023

Submitted by:

Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885

Phone: (201) 847-6800

Contact:

Kelly Hilliger Staff Regulatory Affairs Specialist email: Kelly.hilliger@bd.com

Phone: (551) 554-1675

Proprietary Names:

BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder

Common or Usual Names:

Blood Collection Tubes, Vials, Systems, Serum Separators

Regulatory Information

Classification Name: Blood Collection Set Classification Regulation: 21 CFR §862.6175 Regulatory Class: Class II Primary Product Code: JKA Secondary Product Code: FPA Classification Panel: Clinical Chemistry

Predicate Device:

BD Vacutainer® Push Button Blood Collection Set (K030573)

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Device Description

The BD Vacutainer® Push Button Blood Collection Set consists of:

Stainless steel cannula (Intravenous end and non-patient end of cannula) .
Stainless steel spring ●
Hub, front and rear barrel .
Wings (color coded according to needle gauge)
Tubing
Female luer connector and an optional male luer adapter
Intravenous (IV) needle protector (covers the needle before use)
. Pre-attached holder (connected by male luer adapter in some models)

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Indications for Use

Subject Device	Predicate Device
BD Vacutainer® Push Button Blood CollectionSetK220212	BD Vacutainer® Push Button Blood CollectionSetK030573
The BD Vacutainer® Push Button Blood CollectionSet is a sterile, multi-sample, single-use fixedwinged blood collection set intended for use in thegeneral population by healthcare professionalsexperienced with venipuncture to obtain bloodspecimens from patients, including those patientswith difficult vein access who may have small,fragile, and/or non-palpable veins, intoevacuated blood collection tubes and/or bloodculture bottles. When used without the maleLuer adapter, the device allows the clinician toobtain a blood specimen from the female Luerconnector with a syringe, if necessary. Thedevice can be used by healthcare professionalswith infusion experience for short-term, singleinfusions with consideration given to patient sizeand appropriateness for the solution being infused.The device is not to be left in place and is toremain under the direct supervision of aclinician.	The BD Vacutainer® Push Button Blood CollectionSet is a sterile, multiple-sample, single-use wingedblood collection set intended for venipuncture toobtain blood specimens from patients.The BD Vacutainer® Push Button BloodCollection Set is also indicated for theintravenous administration of fluids as indicatedin 21 CFR 880.5440. It may be used for anypatient population with consideration given topatient size and appropriateness for the solutionbeing infused and duration of therapy.
The recommended use of the device is to activatethe needle safety feature prior to removal from thevenipuncture site. The retraction of the intravenous(IV) end of the needle aids in the prevention ofaccidental needlestick injury.	The recommended use of the device is to activatethe needle safety feature prior to removal from thevenipuncture site. The retraction of the intravenous(IV) end of the needle aids in the prevention ofaccidental needlestick injury.

The proposed indications for use are similar to the predicate indications for use, except for the addition of healthy patients and patients with vascular anatomy and/or co-morbidities which may cause difficulty in locating a vein. Healthy patients with these conditions often exhibit small, fragile, and/or non-palpable veins, commonly referred to as DVA. The addition of DVA in the revised indications for use statement does not significantly change the intended use as butterfly needles have historically been used on patients with small veins and similar statements were included for previous device iterations and were inadvertently removed in subsequent submissions. This is supported by the Clinical Laboratory Standards Institute (CLSI) guideline GP41', which

Clinical Laboratory Standards Institute (CLSI) Guidelines. Collection of Diagnostic Venous Blood Specimens. 7th ed. CLSI stardard GP4. Wayne, PA: Clinical and Laboratory Standards Institute; 2017.

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states that winged blood collection sets are recommended for accessing smaller, fragile, or difficult-to-locate veins. Additionally, per the World Health Organization (WHO) Guidelines', winged blood collection sets can provide easier access and movement and better precision when drawing blood from patients with small or difficult veins. BD believes that the addition of specific reference to patients with DVA does not raise new questions of safety/effectiveness.

Furthermore, the use of a syringe was part of the instructions for use cleared under K030573, but was unintentionally omitted from the indications for use. The inclusion of the use of a syringe has been added back to the indications for use. Based on this, BD has concluded the use of a syringe with this device is not a new intended use. BD believes this does not raise new questions of safety/effectiveness.

Substantial Equivalence3

The subject and predicate device are substantially equivalent as described in Table 1.

Characteristic	Subject DeviceBD Vacutainer® Push ButtonBlood Collection Set	Predicate DeviceBD Vacutainer® Push ButtonBlood Collection SetK030573	Comparison
IntendedPopulation	General use including patientswith difficult vein access(DVA), who may have small,fragile, and/or non-palpableveins	General use	DifferentComment # 1Added specificreference to patientswith DVA which is asubset of 'GeneralUse' – no effect ondevice safety oreffectiveness
Needle DiameterOD	21G, 23G and 25G	21G, 23G and 25G	Same
Needle DiameterID	Thin wall	Thin wall	Same
Needle PointGeometry	3 Bevel	3 Bevel	Same
Needle Length	$\frac{3}{4}$ inch	$\frac{3}{4}$ inch	Same
Wing	Polyolefin	Polyolefin	Same material
Hub	Polycarbonate	Polycarbonate	Same material
Button Ink	UV Curable Ink	UV Curable Ink	Same material

Table 1:	Substantial Equivalence Comparison
----------	------------------------------------

WHO guidelines on drawing blood: best practices in phlebotomy. World Health Organization; Geneva, Switzerland, 2010.

3 The term "substantial equivalence" as used in this 510(k) notification of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amplied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification 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 the courts.

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Characteristic	Subject Device	Predicate Device	Comparison
	BD Vacutainer® Push ButtonBlood Collection Set	BD Vacutainer® Push ButtonBlood Collection SetK030573
Front Barrel	Polypropylene	Polypropylene	Same material
Rear Barrel	Acrylic	Acrylic	Same material
Rear Barrel Lubricant	Silicone	Silicone	Same material
Spring	Stainless Steel 302	Stainless Steel 302	Same material
IV Protector(CannulaProtector)	Polyethylene	Polyethylene	Same material
IV Cannula/NPCannula	Stainless Steel 304	Stainless Steel 304	Same material
Tubing	Polyvinyl Chloride	Polyvinyl Chloride	Same material
CannulaLubricant	Silicone	Silicone	Same material
Cannula Adhesive	UV cured adhesive	UV cured adhesive	Same material
Viscous Fluid	Not included in manufacture ofdevice	Included in manufacture ofdevice	Material is not partof subject device.The difference doesnot raise newquestions on thesafety andeffectiveness of thesubject device.
Hub-TubingAdhesive	UV cured adhesive	UV cured adhesive	Same material
Female LuerAdapter(Connectors)	Acrylonitrile Butadiene Styrene	Acrylonitrile Butadiene Styrene	Same material
Luer Adapter Hub	Polypropylene	Polypropylene	Same material
NP Sleeve	Synthetic Isoprene Rubber	Synthetic Isoprene Rubber	Same material
Luer Adhesive	Heat Curing Epoxy	Heat Curing Epoxy	Same material
Luer CannulaLubricant	Medical Grade Silicone	Medical Grade Silicone	Same material
Luer Cap	Polypropylene	Polypropylene	Same material
Top Web	Paper	Paper	Same material
Blister	Polyethylene terephthalate -glycol modified	Polyethylene terephthalate -glycol modified	Same material
Characteristic	Subject Device	Predicate Device	Comparison
	BD Vacutainer® Push ButtonBlood Collection Set	BD Vacutainer® Push ButtonBlood Collection SetK030573
Pre-attachedholder	Polypropylene	N/A	DifferentComment #2Model numbers wereadded to includedevices assembledwith the legallymarketed holder pre-attached for userconvenience. Thisnon-significantchange does notaffect safety oreffectiveness.
Materials	Compliant with ISO 10993series	Compliant with ISO 10993series	Same
Non-pyrogenic	Yes	Yes	Same
Non-toxic	Yes	Yes	Same
Sterile	Yes	Yes	Same
SterilityAssurance Level(SAL) 10-6	Yes	Yes	Same
SterilizationMethod	Gamma	Gamma	Same
Shelf Life	2 years	2 years	Same
Models	367323	367323	Model numbers wereadded to includedevices assembledwith the legallymarketed holder pre-attached for userconvenience. Thischange does notraised new questionsof safety oreffectiveness.
	367324	367324
	367326	367326
	367335	367335
	367336	367336
	367338	367338
	367341	367341
	367342	367342
	367344	367344
	367352
	367354
	367355
	368656
	368657
	368658
	368659

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Substantial Equivalence Discussion:

Comment #1

The subject device indicates that the intended population is for general use, including a subset of patients who may have difficult veins, whereas the predicate device population is general use. Both devices are used on all patient populations regardless of their vein status. Adding a reference to patients with difficult veins has no effect on clinical safety or effectiveness. This is supported by

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the Clinical Laboratory Standards Institute (CLSI) guideline GP41', which states that winged blood collection sets are recommended for accessing smaller, fragile, or difficult-to-locate veins. Additionally, per the World Health Organization (WHO) Guidelines2, winged blood collection sets can provide easier access and movement and better precision when drawing blood from patients with small or difficult veins.

Comment #2

The subject device is available in models with and without a pre-attached holder. The predicate device is only available in models without the pre-attached holder and requires the user to add a holder in order to use the device for blood collection. Adding models with the pre-attached holder to the subject device is a user convenience and does not affect clinical safety or effectiveness.

Performance Testing - Non-Clinical Bench Summary

Non-Clinical Bench, Biocompatibility, and Sterilization testing were conducted on the subject device to validate that the device performs as intended over the course of the product shelf life and was substantially equivalent (SE) to the predicate device. Results of testing demonstrate acceptable performance for the subject device and complies to applicable parts of the following standards:

Performance Testing I.

. EN ISO 23908:2013 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -● Requirements and test methods
ISO 594-1-1986 Conical fittings with 6 % (Luer) taper for syringes, needles and certain ● other medical equipment - Part 1: General requirements
ISO 594-2-1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain ● other medical equipment -Part 2: Lock fittings
. EN ISO 14971:2019 Medical Devices - Application of risk management to medical devices

II. Sterilization, Package Integrity, Shipping and Shelf Life

The devices are sterilized via gamma irradiation. The sterilization and package integrity, shipping and shelf life validations to support the shelf life claim was conducted according to the following standards:

EN ISO 11137-1:2015/A2:2019 Sterilization of health care products Radiation Part 1: . Requirements for development, validation, and routine control of a sterilization process for medical devices

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EN ISO 11137-2:2015 Sterilization of health care products Radiation Part 2: ● Establishing the sterilization dose
EN ISO 11737-1:2018 Sterilization of health care products Microbiological methods -● Part 1: Determination of a population of microorganisms on products
EN ISO 11737-2:2019 Sterilization of medical devices Microbiological methods Part . 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11607-1:2019 Packaging for terminally sterilized medical devices Part 1: . Requirements for materials, sterile barrier systems and packaging systems
. ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
. ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Svstems
ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by ● Internal Pressurization (Bubble Test)
ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials .

III. Biocompatibility

The BD Vacutainer® Push Button Blood Collection Set is classified as an externally communicating device that comes into direct contact with circulating blood for a limited (≤ 24 hours) duration. Biocompatibility was evaluated on the final, finished device with the following endpoints:

Cytotoxicity (ISO 10993-5:2009) ●
Sensitization (ISO 10993-10:2010)
Irritation (ISO 10993-10:2010)
Acute Systemic Toxicity (ISO 10993-11:2017) ●
Pyrogenicity (ISO 10993-11:2017, USP<151>) ●
Hemocompatibility: Coagulation, Platelet Activation, Complement Activation and Hemolysis (ISO 10993-4:2017, ISO 10993-7:2017)
Particulates (USP<788>) ●

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Non-clinical Performance Summary

The non-clinical performance tests below were conducted to verify that the proposed devices met all design specifications and performance standards and are each Substantially Equivalent (SE) to the predicate device.

IV Protector Pull Test ●
IV Cannula Removal Test ●
Flow Rate ●
Torque to Rotate Wing ●
Wing Removal Test
Front Barrel/Rear Barrel Separation Test
Tubing to Female Luer Adapter Pull Test ●
. Tubing to Hub Pull Test
Product (safety feature) Pre-Activation
Retraction and Lock-out
Force to Override Lock Mechanism
Luer Cap Removal Torque
Luer Separation Test
NP Cannula Pull Test
Male Luer Adapter Spin Out from Holder Test
Torque to Unseat
NP Sleeve Function ●
Tube Push Off
IV Cannula Penetration Test
Submerged Leak Test (Device) ●
Air Leakage Test
Package Integrity Test
Luer Compatibility as per ISO 594-1 and ISO 594-2 ●
Sharps Injury Protection Testing as per ISO 23908 ●
Stainless Steel Needle Tubing testing as per ISO 9626 ●

Performance Testing - Animal Summary

Not applicable

Performance Testing - Clinical Summary

The real-world clinical data of the study submitted as part of this 510(k) indicate that the BD Vacutainer® Push Button Blood Collection Set was preferred by phlebotomists when compared to conventional blood collection needles as demonstrated by increased patient and phlebotomist satisfaction with the subject device as compared to a conventional (straight) blood collection needle (Ibarra AF and Villanueva, 2019)4. Additionally, winged blood collection sets, such as the subject device, were shown to improve venipuncture collection for patients with DVA. The BD

4 Ibarra AF and Villanueva, S. Evaluation of phlebotomy-related anxiety, pain and safety in a Mexican general hospital using winged blood collection sets. BJSTR 2019; 13(5):10219-10221. DOI: 10.26717/BJSTR.2019.13.002455. ISSN: 2574-1241.

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Vacutainer® Push Button Blood Collection Set allows healthcare professionals to draw blood from patients with small, fragile, and/or non-palpable veins (DVA) without compromising sample quality as supported by clinical literature (Merrill, 2021)5. In this study, venipuncture blood draws were collected from a total of 89 oncology outpatients ≥18 years of age using the BD Vacutainer® Push Button Blood Collection Set or devices similar to the subject device. Chemotherapy impacts the vasculature causing veins to become much smaller, fragile, and difficult to anchor for venous access (Lynn, 2011). Specimen quality (LDH, K and plasma free hemoglobin levels) were measured from specimens collected with each winged blood collection set. The results of the study indicate that the devices provided the ability to draw blood from oncology patients, who may have small, fragile and non-palpable veins (DVA), as each device achieved successful blood collections from each patient, and the sample quality was not compromised as LDH, K and plasma free hemoglobin levels were within the normal and acceptable analyte reference ranges (Merrill, 2021) 5.

Conclusion

In summary, the BD Vacutainer® Push Button Blood Collection Set has the same intended use as its predicate device. In addition, the BD Vacutainer® Push Button Blood Collection Set has the same technological characteristics and principles of operation as its predicate. The clinical literature sufficiently supports the determination that patients with DVA (small, fragile and nonpalpable veins) is a subset of the current patient population for the BD Vacutainer® Push Button Blood Collection Set. The risk profile of patients with small, fragile, and/or non-palpable veins is not substantially different from that of the general patient population and is supported by the clinical literature evidence presented under this submission. Furthermore, the changes made to the device since K030573, do not raise different questions of safety or effectiveness because they do not alter the device's diagnostic/therapeutic purpose, blood collection functionality, mechanism of action, or method of use. Performance testing confirms that the subject device performs as intended and is as safe and effective as the predicate device. Based on information provided in this submission the proposed device is substantially equivalent to the predicate device.

3 Merrill, V.D., Ward, M.D., Diaz-McNair, J., Picket, E.A., Duh, S.H., Christenson, R.H., Assessing Phlebotomy device preference and specimen quality in an oncology outpatient clinic. J Appl Lab Med 2021; ifab109, https://doi.org/10.1093/jalm/ffab109.

6 Lynn K. (2011). Challenges of the oncology draw. MLO: medical laboratory observer, 43(1), 22.

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.