The BD Vacutainer® Luer-Lok™ Access Device is a sterile, single-use, noninvasive device intended to be used by healthcare professionals for safe, closed-system venous blood collection from a female Luer of a catheter port or blood collection set, directly into an evacuated blood collection tube(s) for in vitro diagnostic testing. This device may also be used with a blood collection set with a female Luer to collect blood cultures.

BD Vacutainer® Blood Transfer Device:

The BD Vacutainer® Blood Transfer Device is a sterile, single use, noninvasive medical device intended to be used by healthcare professionals for the safe, closed-system, needleless transfer of venous blood from a BD Luer-Lok™ tip syringe into evacuated blood collection tube(s) or blood culture bottle(s) for in vitro diagnostic testing.

Device Description

The BD Vacutainer® Luer-Lok™ Access Device and the BD Vacutainer® Blood Transfer Device are sterile, single use, non-invasive devices for the safe transfer of blood into an evacuated BD Vacutainer® blood collection tube or BD BACTEC™ blood culture bottle for in vitro diagnostic testing. The only difference between the devices is the BD Vacutainer® Luer-Lok™ Access device features a male Luer lock connection with compatible female Luer catheter port (blood collection set) and the BD Vacutainer® Blood Transfer Device features a female Luer lock for connection with BD Luer-Lok™ syringes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for two medical devices: the BD Vacutainer® Luer-Lok™ Access Device and the BD Vacutainer® Blood Transfer Device. This submission primarily focuses on demonstrating substantial equivalence to a predicate device (K200027, Luer Access Device-holder with Preattached Multiple Sample Adapter) through non-clinical performance testing.

Response to your specific questions:

A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria and reported device performance in the format you requested, where specific quantitative values for acceptance criteria are listed alongside the measured performance. Instead, it states that the conducted tests verified that "the proposed devices met all design specifications and performance standards." For certain tests, it simply lists compliance with ISO standards.

However, based on the non-clinical performance summary, we can infer some of the tests performed and general outcomes:

Acceptance Criteria (Inferred from tests)	Reported Device Performance (Inferred from text)
Compliance with ISO 594-1-1986	Compliant (Stated explicitly in comparison table)
Compliance with ISO 594-2-1998	Compliant (Stated explicitly in comparison table)
Compliance with EN ISO 9626:2016	Devices met design specifications and performance standards
Compliance with EN ISO 15223-1:2016	Devices met design specifications and performance standards
Compliance with EN ISO 14971:2012	Devices met design specifications and performance standards
Compliance with EN ISO 11135:2014	Devices met design specifications and performance standards
Compliance with EN ISO 11737-1:2019	Devices met design specifications and performance standards
Compliance with ISO 11607-1:2019	Devices met design specifications and performance standards
Compliance with ISO 11607-2:2019	Devices met design specifications and performance standards
Compliance with ASTM F2096-11	Devices met design specifications and performance standards (Package Integrity test)
Compliance with ASTM F88	Devices met design specifications and performance standards (Peel Strength Test)
Compliance with ASTM F1980-16	Devices met design specifications and performance standards
Compliance with ASTM D4169-16	Devices met design specifications and performance standards
Compliance with ISO 10993 (Biocompatibility Suite)	Compliant (Stated explicitly in comparison table, and that differences in hub material do not raise new questions of safety or effectiveness due to this compliance)
Torque to Break	Met all design specifications and performance standards
Torque to Unseat	Met all design specifications and performance standards
NP Cannula Pull Test	Met all design specifications and performance standards
Air Leakage Test	Met all design specifications and performance standards
NP Sleeve Function	Met all design specifications and performance standards
Luer Compatibility as per ISO 594/80369-7	Met all design specifications and performance standards

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the individual non-clinical performance tests (e.g., number of devices tested for Torque to Break, Air Leakage, etc.). The provenance of the data (country of origin, retrospective/prospective) is also not mentioned, as these are in vitro engineering performance tests rather than clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the non-clinical performance testing described. These tests involve objective measurements against engineering and biocompatibility standards, not expert interpretation of clinical data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or imaging studies where expert consensus is required for diagnosis or interpretation. The tests described are objective engineering and laboratory tests.
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 comparative effectiveness study was done. The submission explicitly states "Clinical Data: Not applicable," and the devices are for blood collection/transfer, not for interpretation or diagnosis requiring human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. These are physical medical devices for blood collection, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical performance tests is compliance with established international and ASTM standards (e.g., ISO 594, ISO 10993, EN ISO 9626, ASTM F88, ASTM F2096), as well as the manufacturer's own design specifications. There is no expert consensus, pathology, or outcomes data used as ground truth for these types of tests.
The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established

Not applicable, as this is not an AI/ML device that requires a training set.

Summary

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March 10, 2023

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

Re: K222478

Trade/Device Name: BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: December 9, 2022 Received: December 12, 2022

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 (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,

Daniel 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222478

Device Name

BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device

Indications for Use (Describe)

BD Vacutainer® Luer-Lok™ Access Device:

BD Vacutainer® Blood Transfer Device:

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K222478 - 510(K) SUMMARY

Summary Preparation Date

03/10/2023

Submitted by:

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

Phone: (201) 847-6800

Contact:

Sravan Rajamani Senior Regulatory Affairs Specialist email: sravan.rajamani@bd.com Work: (201) 847 4719

Proprietary Names:

BD Vacutainer® Luer-Lok™ Access Device BD Vacutainer® Blood Transfer Device

Common or Usual Names:

Blood Collection Tubes, Vials, Systems, Serum Separators

Regulatory Information

Classification Name: Blood specimen collection device Classification Regulation: 21 CFR §862.1675 Review Panel: Clinical Chemistry Class: II Product Code: JKA

Predicate Device(s)

Luer Access Device-holder with Preattached Multiple Sample Adapter (K200027)

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Device Description

Proposed DeviceBD Vacutainer® Luer-LokTMAccess Device	Proposed DeviceBD Vacutainer® Blood TransferDevice	K200027Luer Access Device-holder withpreattached multiple sampleadapter
The BD Vacutainer® Luer-LokTM Access Device is a sterile, single- use, noninvasive device intended to be used by healthcare professionals for safe, closed-system venous blood collection from a female Luer of a catheter port or blood collection set, directly into an evacuated blood collection tube(s) for in vitro diagnostic testing. This device may also be used with a blood collection set with a female Luer to collect blood cultures.	The BD Vacutainer® BloodTransfer Device is a sterile, single use, noninvasive medical device intended to be used by healthcare professionals for the safe, closed-system, needleless transfer of venous blood from a BD Luer-LokTM tip syringe into evacuated blood collection tube(s) or blood culture bottle(s) for in vitro diagnostic testing.	The Luer access device- holder with preattached multiple sample adapter is a sterile, non-invasive device used to connect devices with male or female Luer connectors to blood collection tubes for the collection of blood.
Characteristic	Subject Device	Predicate Device	Comparison
	BD Vacutainer® Luer-Lok™Access Device, BDVacutainer® Blood Transfer	Luer Access Device-holderwith preattached multiplesample adapter
	Device	K200027
Product Code	JKA	JKA	Same
RegulationNumber	21 CFR 862.1675	21 CFR 862.1675	Same
Class	II	II	Same
Number of Uses	Single Use	Single Use	Same
Material	Hub (Polycarbonate)Non-patient (NP) Cannula(Stainless Steel)Rubber Sleeve (IsopreneRubber)Holder (Polypropylene (PP))Bonding agent/adhesive*	Luer Lock Male Hub (MABS)Non-patient Needle/Tube(Stainless Steel)Rubber Sleeve (IsopreneRubber)Holder (PP)	Difference in HubMaterial. The use of adifferent polymer forthe hub componentdoes not raise newquestions of safety oreffectiveness of thedevice.
Label/Labeling	Conform with 21 Part 801	Conform with 21 Part 801	Same
Length	BTD: 61.98 mm (2.44 in),LLAD: 63.42 mm (2.50 in)	60.8±0.2mm	Difference in Length.This difference doesnot affect theintended use orperformance of thedevice or raise newquestions of safety oreffectiveness.
ISO 594	Compliant	Compliant	Same
Biocompatibility	ISO 10993 Compliant including:In vitro toxicitySkin sensitizationIntracutaneousReactivityAcute System ToxicityHemocompatibility	ISO 10993 Compliant including:In vitro toxicitySkin sensitizationIntracutaneousReactivityAcute System ToxicityHemocompatibility	Same
SterilizationMethod	EO	EO	Same
SterilizationAssurance Level(SAL)	10-6	10-6	Same
Connector Type	Luer-Lok™ Access Device -Male LuerBlood Transfer Device - FemaleLuer	Male & Female Luers	Same
Characteristic	Subject DeviceBD Vacutainer® Luer-Lok™Access Device and BDVacutainer® Blood TransferDevice	Predicate DeviceLuer Access Device-holderwith preattached multiplesample adapterK200027	Comparison
Sample Collected	Blood	Blood	Same

Table 1: Indications for Use

The proposed and predicate device have the same basic indication for use, the collection of a blood sample using a male or female Luer connector on a multiple sample adapter with a preattached holder. All devices use an ISO 594 connector of various gender (male/female) connected to a compatible 6% Luer to transfer blood into an evacuated container (blood collection tube, blood culture bottle) for in vitro diagnostic testing. The differences in the indications statement are in language and do not pose new questions of safety or effectiveness.

Substantial Equivalence

The subject and predicate device are substantially equivalent as described in Table 3.

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Substantial Equivalence Comparison Table 2:

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*The clearance for the predicate K200027 did not list the bonding agent used.

Difference in Hub Material: The materials of hub from proposed device are different with predicate device. However, the biocompatibility test for proposed device has been tested and the results comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantial equivalence or safety/effectiveness.

Difference in Length: The length of between the proposed device and predicate device is different. This difference in length is not substantial. This difference does not affect intended use or the performance of the device. Therefore, this difference does not affect substantial equivalence or safety/effectiveness.

Difference in precautions: The proposed Luer-Lok™ Access Device has an added precaution for use in urinalysis to address reported adverse events associated with reasonably foreseeable misuse. This difference does not affect substantial equivalence or safety/effectiveness. This difference does not affect the Blood Transfer Device.

Conclusion: The differences between proposed device and predicated device include materials of manufacture, product length and device labeling. These differences do not raise any question regarding its safety and effectiveness. The differences in technological characteristics may be evaluated through performance testing.

Non-clinical Performance Testing:

1. Performance Testing

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 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods

EN ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied

EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices

2. Sterilization, Package Integrity, Shipping and Shelf Life

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EN ISO 11135:2014 Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization Residuals

EN ISO 11737-1:2019 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

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 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

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 Systems

3. Biocompatibility

BD Vacutainer® Luer-Lok™ Access Device and BD Vacutainer® Blood Transfer Device are classified as a surface medical devices that comes in contact with intact skin for a limited (≤24 hours) duration.

ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements

ISO 10993-4:2017 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood

ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-7:2008/AC:2009 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals

ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

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ISO 10993-12:2012 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials

ISO 10993-23:2021, Biological Evaluation of Medical Devices - Part 23: Tests for irritation.

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.

Torque to Break
. Torque to Unseat
NP Cannula Pull Test •
Air Leakage Test
Torque to Break .
Torque to Unseat
NP Sleeve Function
Package Integrity test ●
Peel Strength Test .
Luer Compatibility as per ISO 594/80369-7.

Clinical Data

Not applicable

Conclusion

Based on the comparison and analysis above and the performance testing conducted, each of the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.

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.