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.

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.

AI/ML Overview

The provided document is a 510(k) Summary for the BD Vacutainer® One Use Holder, a blood specimen collection device. It describes the device, its intended use, and compares it to a predicate device (Greiner Vacuette® Blood Culture Holder).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

This document does not contain information about acceptance criteria and studies that prove a device meets those criteria in the context of an AI/ML medical device. This is a 510(k) Premarket Notification for a non-AI/ML medical device, specifically a blood specimen collection holder.

Here's why the requested information cannot be extracted from the provided text:

Type of Device: The BD Vacutainer® One Use Holder is a physical, non-sterile, single-use plastic device. It is not an AI/ML-powered software device.
Study Focus: The "Non-clinical Performance Summary" states that tests were conducted to "verify that the proposed devices met all design specifications and performance standards." This typically refers to mechanical, material, and functional testing for a physical device, not the evaluation of an AI algorithm's performance on a dataset.
"Clinical Data - Not Applicable": This explicitly indicates that no clinical studies (which would be the source of test sets, ground truth establishment, expert adjudication, etc., for AI/ML devices) were required or performed for this device.
Absence of AI/ML Specific Terminology: There is no mention of algorithms, machine learning, deep learning, models, training sets, test sets, inference, sensitivity, specificity, AUC, or any other terminology associated with AI/ML device evaluation.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on indications for use, design, materials, and non-clinical performance characteristics relevant to a conventional medical device.

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)

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

Indications for Use

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 Holderis a single-use, non-sterile device usedby healthcare professionals to attachand hold a BD Vacutainer® brandvenous access device such as a bloodcollection needle, a blood collectionset, or a luer adapter duringvenipuncture connected to a BDVacutainer® blood collection tube(s).This device may also be used with aBD Vacutainer® blood collection setwith a luer adapter to obtain bloodsamples into a BD BACTEC™ bloodculture bottle.	The Blood Culture Holder is used tofill blood into blood culture bottlesand tubes in routine venipunctureprocedures. This device is to beused by properly trained healthcareprofessionals only in accordancewith these instructions.The SAFETY Blood Collection Setand/or Blood Collection Set +Blood Culture Holder are used inroutine venipuncture procedures.The winged needle of the SAFETYBlood Collection Set is designedwith a safety shield, which can beactivated to cover theneedleimmediatelyfollowingbloodcollection to aid in the protectionaccidentalneedlestickagainst	Similar; both devicesare intended to beused with a venousaccess device to fillblood collectiontubes and bloodculture bottles.The subject devicerequires thehealthcare worker toobtain and attach ablood collectionneedle, bloodcollection set, or lueradapter prior tovenipuncture.
Characteristic	Subject Device	Predicate Device	Comparison
		injury. The Blood Culture Holder isused to fill blood into blood culturebottles and tubes.	The predicate devicebeing supplied pre-attached to a needledoes not raise anynew or differentquestions of safetyor effectiveness.
Population	All patient population	All patient population	Same
Design	The cylindrical-shaped holder istranslucent to check the filling statusof the blood collection tube.It consists of a plastic barrel with afemale threaded connector at one endinto which the hub of the BDVacutainer® blood collection deviceis screwed.The other end has flanges to assist ingripping the device during use and isopen to allow the passage of a BDVacutainer® evacuated bloodcollection tube or BD BACTECTMblood culture bottle.	Cylindrical translucent holder forvacuum bottle and tube placement:cylinder with threads which arecompatible with male lueradapters.The design of the holders allowscollection of blood into bloodculture bottles and blood collectiontubes.	Different; Bothdevices arecylindrical-shaped,used in bloodcollection tube orblood culture bottleplacement duringvenipuncture forblood collection, andare compatible withmale luer adapters.While, there aredifferences in devicedesign anddimensions,performance testingof the subject deviceover the shelf lifedemonstrates thedifference does notraise new ordifferent questionsof safety andeffectiveness.
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/ BottleCompatibility	13mm & 16mm blood collection tubes& blood culture bottles	13mm & 16mm blood collectiontubes & blood culture bottles	Same
NeedleCompatibility	Blood collection needle, bloodcollection set or Multi Sample LuerAdapter	Blood collection needle, bloodcollection 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.

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.