Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define a simple mechanical holder for blood collection devices and tubes, with no mention of any computational or analytical capabilities.

Therapeutic

No
The device is used to hold other components during blood collection, which is a diagnostic procedure, not a therapeutic one. It does not provide any treatment or therapy.

Diagnostic

No
The document states that this device is a holder used during blood collection and specifically mentions it is used by healthcare professionals to attach and hold devices like needles and tubes for blood collection. It does not perform any form of analysis or diagnosis on the collected sample.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "single-use plastic device" with physical components like a barrel, threaded connector, and flanges, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the BD Vacutainer® One Use Holder is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the device is used to attach and hold other devices (needles, sets, adapters) during venipuncture and to connect them to blood collection tubes or blood culture bottles. It is a tool for the collection of a sample, not for the testing or analysis of the sample itself.
Device Description: The description reinforces its function as a holder and connector. It describes its physical components and how it facilitates the blood collection process.
Lack of Diagnostic Function: There is no mention of the device performing any diagnostic test, analyzing a sample, or providing any information about a patient's health status.

IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The BD Vacutainer® One Use Holder's role is purely in the pre-analytical phase of sample collection.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BD Vacutainer® One Use Holder is a single-use, non-sterile device used by healthcare professionals to attach and hold a BD Vacutainer® brand venous access device such as a blood collection needle, a blood collection set, or a luer adapter during venipuncture connected to a BD Vacutainer® blood collection tube(s). This device may also be used with a BD Vacutainer® blood collection set with a luer adapter to obtain blood samples into a BD BACTEC™ blood culture bottle.

Product codes

JKA

Device Description

The BD Vacutainer® One Use Holder is a non-sterile, single-use plastic device used during the blood collection process. It consists of a one piece plastic barrel with a female threaded connector at one end into which the non-patient end of the hub of a BD Vacutainer® blood collection device is screwed. The other end is open for the insertion of a BD Vacutainer® evacuated blood collection tube or BD BACTECTM Blood Culture Bottle This end also has flanges, which are intended to assist tube insertion. BD Vacutainer® One Use Holder is used to attach and hold a BD Vacutainer® Brand venous access device such as a blood collection needle, blood collection set or Multiple Sample Luer Adapter during venipuncture and to connect the subject device to a BD Vacutainer® blood collection tube or BD BACTEC™ blood culture bottle.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

All patient population

Intended User / Care Setting

healthcare professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance tests 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Greiner Vacuette® Blood Culture Holder (K122687)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 1, 2024

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

Re: K242320

Trade/Device Name: BD Vacutainer® One Use Holder Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: August 5, 2024 Received: August 5, 2024

Dear Sravan Rajamani:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

David Walloschek

David Wolloscheck, Ph.D. 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242320

Device Name BD Vacutainer® One Use Holder

Indications for Use (Describe)

The BD Vacutainer® One Use Holder is a single-use, non-sterile device used by healthcare professionals to attach and hold a BD Vacutainer® brand venous access device such as a blood collection needle, a blood collection set, or a luer adapter during venipuncture connected to a BD Vacutainer® blood collection tube(s). This device may also be used with a BD Vacutainer® blood collection set with a luer adapter to obtain blood samples into a BD BACTEC™ blood culture bottle.

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

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K242320- 510(K) SUMMARY

Summary Preparation Date:

November 1, 2024

Submitted by:

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

Phone: (201) 847-6800

Contact:

Sravan Rajamani Staff Specialist, Regulatory Affairs Integrated Diagnostic Solutions, Specimen Management email: Sravan.rajamani@bd.com Phone: (201) 452-3624 Work: (201) 847-4719

CC: Eileen Hiller Associate Director, Regulatory Affairs Integrated Diagnostic Solutions, Specimen Management Email: Eileen_hiller@bd.com

Device Name: BD Vacutainer® One Use Holder

Trade/ Common name: Blood specimen collection device

Regulatory Information

Classification Name: Blood specimen collection device Classification Regulation: 21 CFR §862.1675 Regulatory Class: Class II Product Code: JKA

Predicate Device(s)

Greiner Vacuette® Blood Culture Holder (K122687)

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Device Description

The BD Vacutainer® One Use Holder is a non-sterile, single-use plastic device used during the blood collection process. It consists of a one piece plastic barrel with a female threaded connector at one end into which the non-patient end of the hub of a BD Vacutainer® blood collection device is screwed. The other end is open for the insertion of a BD Vacutainer® evacuated blood collection tube or BD BACTECTM Blood Culture Bottle This end also has flanges, which are intended to assist tube insertion. BD Vacutainer® One Use Holder is used to attach and hold a BD Vacutainer® Brand venous access device such as a blood collection needle, blood collection set or Multiple Sample Luer Adapter during venipuncture and to connect the subject device to a BD Vacutainer® blood collection tube or BD BACTEC™ blood culture bottle.

Indications for Use

The BD Vacutainer® One Use Holder is a single-use, non-sterile device used by healthcare professionals to attach and hold a BD Vacutainer® brand venous access device such as a blood collection needle, a blood collection set, or a luer adapter during venipuncture connected to a BD Vacutainer® blood collection tube(s). This device may also be used with a BD Vacutainer® blood collection set with a luer adapter to obtain blood samples into a BD BACTEC™ blood culture bottle.

Substantial Equivalence

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

Characteristic	Subject Device	Predicate Device	Comparison
Indications for Use	The BD Vacutainer® One Use Holder
is a single-use, non-sterile device used
by healthcare professionals to attach
and hold a BD Vacutainer® brand
venous access device such as a blood
collection needle, a blood collection
set, or a luer adapter during
venipuncture connected to a BD
Vacutainer® blood collection tube(s).
This device may also be used with a
BD Vacutainer® blood collection set
with a luer adapter to obtain blood
samples into a BD BACTEC™ blood
culture bottle.	The Blood Culture Holder is used to
fill blood into blood culture bottles
and tubes in routine venipuncture
procedures. This device is to be
used by properly trained healthcare
professionals only in accordance
with these instructions.
The SAFETY Blood Collection Set
and/or Blood Collection Set +
Blood Culture Holder are used in
routine venipuncture procedures.
The winged needle of the SAFETY
Blood Collection Set is designed
with a safety shield, which can be
activated to cover the
needle
immediately
following
blood
collection to aid in the protection
accidental
needlestick
against	Similar; both devices
are intended to be
used with a venous
access device to fill
blood collection
tubes and blood
culture bottles.
The subject device
requires the
healthcare worker to
obtain and attach a
blood collection
needle, blood
collection set, or luer
adapter prior to
venipuncture.
Characteristic	Subject Device	Predicate Device	Comparison
		injury. The Blood Culture Holder is
used to fill blood into blood culture
bottles and tubes.	The predicate device
being supplied pre-
attached to a needle
does not raise any
new or different
questions of safety
or effectiveness.
Population	All patient population	All patient population	Same
Design	The cylindrical-shaped holder is
translucent to check the filling status
of the blood collection tube.
It consists of a plastic barrel with a
female threaded connector at one end
into which the hub of the BD
Vacutainer® blood collection device
is screwed.
The other end has flanges to assist in
gripping the device during use and is
open to allow the passage of a BD
Vacutainer® evacuated blood
collection tube or BD BACTECTM
blood culture bottle.	Cylindrical translucent holder for
vacuum bottle and tube placement:
cylinder with threads which are
compatible with male luer
adapters.
The design of the holders allows
collection of blood into blood
culture bottles and blood collection
tubes.	Different; Both
devices are
cylindrical-shaped,
used in blood
collection tube or
blood culture bottle
placement during
venipuncture for
blood collection, and
are compatible with
male luer adapters.
While, there are
differences in device
design and
dimensions,
performance testing
of the subject device
over the shelf life
demonstrates the
difference does not
raise new or
different questions
of safety and
effectiveness.
Condition of Use	Non-sterile, Single-Use	Non-sterile, Single-Use	Same
Shelf Life	5 years	5 years	Same
Sterility	Non-Sterile	Non-Sterile	Same
Material	Polypropylene / Clear	Polypropylene / Clear	Same
Tube/ Bottle
Compatibility	13mm & 16mm blood collection tubes
& blood culture bottles	13mm & 16mm blood collection
tubes & blood culture bottles	Same
Needle
Compatibility	Blood collection needle, blood
collection set or Multi Sample Luer
Adapter	Blood collection needle, blood
collection set or luer adapter	Same

Table 1: Substantial Equivalence Comparison

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BD believes the characteristics, including the indications for use and design features, of the subject and the predicate devices are substantially equivalent.

Applied Standards:

. ISO 15223-1:2021 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements.

Non-clinical Performance Summary

Non-clinical performance tests 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.

Clinical Data - Not Applicable.

Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The BD Vacutainer®One Use Holder is substantially equivalent to Greiner Vacuette ®Blood Culture Holder with respect to the indications for use, target population, and technological characteristics.