BD Microtainer® Contact-Activated Lancets: The BD Microtainer® Contact-Activated Lancet is a sterile, single-use, permanently retracting, lancing device used to perform fingerstick punctures in in adults, adolescents, children, and infants (greater than 6 months of age and 10 kg [22 lbs}). The device is intended to be used by a healthcare professional in a clinical setting to obtain capillary blood specimens for testing utilizing small amounts of blood.

BD Microtainer® Quikheel™ Lancets: The BD Microtainer® Quikheel™ Lancet is a sterile, single-use medical device with a push-button activated, permanently retracting blade. The device is intended to be used by healthcare professionals to perform heel sticks in neomates, pre-term (preemie) and full-term infants (non-walking) to obtain capillary blood specimens for testing utilizing small amounts of blood.

Device Description

BD Microtainer® Contact-Activated Lancets: The BD Microtainer® Contact-Activated Lancets are sterile, single-use lancets with a permanently retracting stainless steel needle or blade used for the purpose of obtaining capillary blood specimens for testing utilizing small amounts of blood. The BD Microtainer® Contact-Activated Lancet needle/blade is never visible and remains sterile until the protective tab cap is removed. The BD Microtainer® Contact-Activated Lancet is activated by applying pressure against the puncture site upon contact; after skin puncture, the needle/blade returns into the device. Once activated, the device is auto-disabled and cannot be re-used (when used as intended) to minimize the chance of an accidental fingerstick and contamination.

BD Microtainer® Quikheel™ Lancets: The BD Microtainer® Quikheel™ Lancets are sterile, single-use lancets with a push-button activated, permanently retracting stainless steel blade used for the purpose of obtaining capillary blood specimens for testing utilizing small amounts of blood. The BD Microtainer® Quikheel™ Lancets consist of a front and back housing, a trigger, and a spring onto which a stainless-steel blade is mounted. The stainless-steel blade is non-redeployable to minimize the chance of accidental blade stick injury and contamination. The device is designed to produce a very rapid triggering of the blade along a predictable path, for low-trauma sampling.

AI/ML Overview

The provided document describes the substantial equivalence of BD Microtainer® Contact-Activated Lancets and BD Microtainer® Quikheel™ Lancets to their predicate devices, rather than establishing acceptance criteria and proving performance through a new study with explicit criteria and performance metrics.

The products are blood lancets, which are Class II devices. They were previously Class I exempt but reclassified to Class II, necessitating this 510(k) submission. Therefore, the goal of this submission is to demonstrate that the redesigned devices are substantially equivalent to the predicate devices which were legally marketed before the reclassification. This means that the new devices do not raise new questions of safety and effectiveness.

Here's an analysis of the provided information concerning acceptance criteria and study aspects, keeping in mind that this is a substantial equivalence submission, not a de novo clearance requiring a new comprehensive performance study against specific acceptance criteria.

1. A table of acceptance criteria and the reported device performance

The document does not present a table of explicit acceptance criteria with quantitative performance metrics for the device's function (e.g., blood volume collected, pain level, depth of penetration accuracy). Instead, it relies on demonstrating that the new devices are identical or equivalent to the predicate devices across various characteristics.

The "Comparison" column in Table 1 and Table 2 (Substantial Equivalence Comparison) implicitly indicates that the "acceptance criteria" are "same as predicate" or "no new questions of safety and effectiveness."

Implicit Acceptance Criteria and Reported Performance (based on "Substantial Equivalence" comparison):

Acceptance Criteria (Implicit)	Reported Device Performance
BD Microtainer® Contact-Activated Lancets
Device Classification (Class II requiring 510(k))	The subject devices were reclassified from Class I exempt to Class II. This submission addresses that requirement.
Intended Use / Indications for Use (consistent with predicate, with added specificity for age/weight)	Same as predicate, with added specificity for minimum age/weight based on CLSI GP42-A7 and WHO Guidelines. "The proposed indications for use only add specificity and clarity... the changes do not result in a new intended use."
Target Population (consistent with predicate, with added specificity for age/weight)	Same as predicate, with added specificity for minimum age/weight. "The proposed indications for use only add specificity and clarity... the changes do not result in a new target population."
Device Design (Models, Colors, Types of Lancing Device, Needle/Blade Depths, Needle/Blade Gauges/Widths, Blood Flows) Same	Same as predicate for all these characteristics.
Device Materials (Needle Carrier, Main Housing, Shield, Lever Element, Drive Spring, Return Spring, Needle/Blade, Lubricant) Same	Same as predicate for all these materials. Materials are compliant with ISO 10993 series.
Packaging and Sterility (Sterile Needle Carrier/Blade, SAL 10-6, Sterilization Method, Shelf Life) Same	Same as predicate. Shelf carton height and material density increased, support insert removed (for Contact-Activated Lancets) to accommodate new IFU; "Ship testing was conducted to support this packaging change."
BD Microtainer® Quikheel™ Lancets
Device Classification (Class II requiring 510(k))	The subject devices were reclassified from Class I exempt to Class II. This submission addresses that requirement.
Intended Use / Indications for Use (consistent with predicate)	"The current intended use statement has been converted to an indications for use statement for this initial 510(k) submission." Implied to be same in essence as predicate.
Target Population (consistent with predicate) Same	Same as predicate.
Device Design (Models, Colors, Incision Depths, Incision Lengths, Blood Flows) Same	Same as predicate for all these characteristics.
Device Materials (Blade, Spring, Trigger, Internal Trigger/Spring Lubricant, Housing) Same	Same as predicate for all these materials. Materials are compliant with ISO 10993.
Packaging and Sterility (Sterile, SAL 10-6, Sterilization Method, Shelf Life) Same	Same as predicate.
Overall Performance (Implicit Criteria)	"Results of testing demonstrate acceptable performance for the subject devices." "Performance testing confirms that the subject devices perform as intended and are as safe and effective as their respective predicate devices."
Compliance with recognized performance standards	Compliance with numerous ISO, EN ISO, ASTM, and CLSI standards for medical device quality management, risk management, sharps injury protection, packaging, symbols, information, sterilization, biological evaluation, and capillary blood specimen collection. This demonstrates that relevant safety and performance aspects are addressed according to established industry practices.

2. 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 a "test set" in the context of clinical performance or diagnostic accuracy. This is because the submission focuses on substantial equivalence for a reclassified device, not a novel device requiring a de novo clinical validation study.

Instead, the document refers to "Performance Testing - Bench Summary," stating that "Device, biocompatibility, and sterilization testing were conducted on the subject devices to validate that the devices perform as intended over the course of the product shelf life." This implies various engineering and laboratory tests, but the specific sample sizes for these tests are not provided in this summary.

Test Set Sample Size: Not specified for clinical performance. For bench testing (e.g., sterilization, biocompatibility, packaging integrity), sample sizes appropriate for those types of validation would have been used but are not detailed here.
Data Provenance: Not specified, as it's primarily bench/laboratory testing against recognized standards rather than human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The submission does not involve a diagnostic or interpretive device that requires expert adjudication to establish ground truth from a test set of cases. The device is a blood lancet, and its performance validation relies on engineering, sterility, and biocompatibility testing against recognized standards, as well as demonstrating equivalence to a predicate.

The indications for use for the BD Microtainer® Contact-Activated Lancets regarding minimum age/weight reference "recommendations outlined for fingerpricks in CLSI GP42-A7: Collection of Capillary Blood Specimens, 7th Edition (FDA Recognition Number 7-301) and WHO Guidelines On Drawing Blood: Best Practices In Phlebotomy." These guidelines represent expert consensus; however, they are being cited as context for intended use update, not experts providing ground truth for a study on the lancet's performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring expert adjudication for ground truth is described.

5. 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

Not applicable. Blood lancets are not devices that involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. Blood lancets are not algorithmic devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the purpose of this (510k) submission, the "ground truth" or standard for acceptable performance is primarily established by:

Substantial Equivalence to legally marketed predicate devices: The primary criterion.
Compliance with recognized international and national consensus standards: (e.g., ISO 13485, ISO 14971, ISO 23908, ISO 11607, ISO 15223, EN 556-1, ISO 11137, ISO 11737, ISO 13004, ISO 10993 series, ASTM standards, CLSI GP42-A7, WHO Guidelines on Drawing Blood), which represent established safe and effective practices and performance parameters for medical devices.
Absence of new safety and effectiveness concerns: The modifications (e.g., specific age/weight for Contact-Activated Lancets, packaging changes) were evaluated to ensure they do not introduce new risks.

There is no clinical ground truth (e.g., pathology, outcomes data) specifically generated for this submission in the context of human subject testing.

8. The sample size for the training set

Not applicable. There is no AI or machine learning component, and thus no training set.

9. How the ground truth for the training set was established

Not applicable. There is no AI or machine learning component.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

December 16, 2022

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

Re: K223243

Trade/Device Name: BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: October 19, 2022 Received: October 20, 2022

Dear Alexandra Kirby:

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,

Jessica Carr -S

for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K223243

Device Name

BD Microtainer® Contact-Activated Lancets and BD Microtainer® Quikheel™ Lancets

Indications for Use (Describe)

BD Microtainer® Contact-Activated Lancets

The BD Microtaine® Contact-Activated Lancet is a sterile, single-use, permanently retracting, lancing device used to perform fingerstick punctures in in adults, adolescents, children, and infants (greater than 6 months of age and 10 kg [22 lbs}). The device is intended to be used by a healthcare professional in a clinical setting to obtain capillary blood specimens for testing utilizing small amounts of blood.

BD Microtainer® Quikheel™ Lancets

The BD Microtainer® Quikheel™ Lancet is a sterile, single-use medical device with a push-button activated, permanently retracting blade. The device is intended to be used by healthcare professionals to perform heel sticks in neomates, pre-term (preemie) and full-term infants (non-walking) to obtain capillary blood specimens for testing utilizing small amounts of blood.

Type of Use (Select one or both, as applicable)
Research Use Only (RUO) / For Further Manufacturing
For In-Vitro Diagnostic Use (IVD) / Intended Use

|X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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K223243

510(K) SUMMARY 5

BD Microtainer® Contact-Activated Lancets and BD Microtainer® Ouikheel™ Lancets

Summary Preparation Date: December 16, 2022

Submitted by:

Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885 Phone: (201) 847-6800

Contact:

Alexandra Kirby Staff Regulatory Affairs Specialist Email: Alexandra.Kirby@bd.com Phone: (862) 774-2318

Proprietary Names: BD Microtainer® Contact-Activated Lancets, BD Microtainer® Quikheel™ Lancets

Common or Usual Names: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Regulatory Information

Classification Name: Blood Lancets Classification Regulation: 21 CFR 878.4850(a) Regulatory Class: Class II Product Code: FMK Classification Panel: General & Plastic Surgery

Predicate Device: BD Microtainer® Contact-Activated Lancets, BD Microtainer® Quikheel™ Lancets (previously Class I exempt, reclassified to Class II devices requiring a 510(k) under Docket No. FDA-2016-N-0040 on November 22, 2021)

Device Establishment: Becton, Dickinson and Company

Registration Number: 2243072

Performance Standards:

1. EN ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
1. EN ISO 14971:2019 Medical Devices Application of risk management to medical devices

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1. 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
1. ISO 11607-1:2019 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems*
1. ISO 11607-2:2019 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes*
1. EN ISO 15223-1:2021 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
1. EN ISO 20417:2021 Medical devices Information to be supplied by the manufacturer
1. EN 556-1:2001/AC:2006 Sterilization Of Medical Devices Requirements For Medical Devices To Be Designated "Sterile" - Part 1: Requirements For Terminally Sterilized Medical Devices
1. 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
1. EN ISO 11137-2:2015 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
1. EN ISO 11137-3:2017 Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control
1. EN ISO 11737-1:2018/A1:2021 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on products
1. EN ISO 11737-2:2020 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
1. ISO/TS 13004:2013 Sterilization of health care products Radiation Substantiation of selected sterilization dose: Method VDmax D
1. ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
1. EN ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal welfare requirements
1. ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood

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BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management

Becton, Dickinson and Company

1. ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
1. ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
1. ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
1. ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
1. ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
1. ISO 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical characterization of materials
1. ISO 10993-23:2021, Biological Evaluation of Medical Devices Part 23: Tests for irritation.
1. ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
1. ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Svstems
1. ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
1. ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials
1. EN ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
1. EN ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
1. EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
1. CLSI GP42-A7: Collection of Capillary Blood Specimens. 7th Edition

For the BD Microtainer® Contact-Activated Lancets, only partial compliance is claimed for standards marked with an asterisk (*).

Indications for Use

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BD Microtainer® Contact-Activated Lancets

The BD Microtainer® Contact-Activated Lancet is a sterile, single-use, permanently retracting. lancing device used to perform fingerstick punctures in adults, adolescents, children, and infants (greater than 6 months of age and 10 kg [22 lbs]). The device is intended to be used by a healthcare professional in a clinical setting to obtain capillary blood specimens for testing utilizing small amounts of blood.

BD Microtainer® Quikheel™ Lancets

The BD Microtainer® Quikheel™ Lancet is a sterile, single-use medical device with a push-button activated, permanently retracting blade. The device is intended to be used by healthcare professionals to perform heel sticks in neonates, pre-term (preemie) and full-term infants (nonwalking) to obtain capillary blood specimens for testing utilizing small amounts of blood.

Device Description

BD Microtainer® Contact-Activated Lancets

The BD Microtainer® Contact-Activated Lancets are sterile, single-use lancets with a permanently retracting stainless steel needle or blade used for the purpose of obtaining capillary blood specimens for testing utilizing small amounts of blood. The BD Microtainer® Contact-Activated Lancet needle/blade is never visible and remains sterile until the protective tab cap is removed. The BD Microtainer® Contact-Activated Lancet is activated by applying pressure against the puncture site upon contact; after skin puncture, the needle/blade returns into the device. Once activated, the device is auto-disabled and cannot be re-used (when used as intended) to minimize the chance of an accidental fingerstick and contamination.

The BD Microtainer® Contact-Activated Lancets are made up of the following key functional components:

1. Rear Cap
1. Drive Spring
1. Lever Element
1. Needle Carrier with Protective Tab
1. Return Spring
1. Shield
1. Main Housing
1. Tab Cap
1. Silicone Lubricant

BD Microtainer® Quikheel™ Lancets

The BD Microtainer® Quikheel™ Lancets are sterile, single-use lancets with a permanently retracting stainless steel blade used for the purpose of obtaining capillary blood specimens for testing utilizing small amounts of blood. The BD Microtainer® Quikheel™ Lancets consist of a front and back housing, a trigger, and a spring onto which a stainless-steel blade is mounted. The stainless-steel blade is non-redeployable to minimize the chance of accidental blade stick injury

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BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management

Becton, Dickinson and Company

and contamination. The device is designed to produce a very rapid triggering of the blade along a predictable path, for low-trauma sampling.

The BD Microtainer® Quikheel™ Lancets are made up of the following key functional components:

1. Front Housing
1. Back Housing
1. Trigger
1. Spring
1. Blade
1. Silicone Lubricant

Substantial Equivalence1

The subject and predicate device are substantially equivalent as described in Table 1 and Table 2.

Table 1	BD Microtainer® Contact-Activated Lancet Substantial EquivalenceComparison
Characteristic	Subject DeviceBD Microtainer®Contact-ActivatedLancets	Predicate DeviceBD Microtainer®Contact-ActivatedLancets²	Comparison
DeviceClassification	Class II requiring a 510(k)	Class I 510(k) exempt	The subject BD Microtainer®Contact-Activated Lancetsdevices were reclassified fromClass I exempt devices notrequiring a 510(k) to Class IIdevices requiring a 510(k)under Docket No. FDA-2016-N-0040, effective November22, 2021.
Characteristic	Subject DeviceBD Microtainer®Contact-ActivatedLancets	Predicate DeviceBD Microtainer®Contact-ActivatedLancets2	Comparison
Intended Use /Indications for Use	The BD Microtainer®Contact-Activated Lancetis a sterile, single-use,permanently retracting,lancing device used toperform fingerstickpunctures in in adults,adolescents, children, andinfants (greater than 6months of age and 10 kg(22 lbs)). The device isintended to be used by ahealthcare professional ina clinical setting to obtaincapillary blood specimensfor testing utilizing smallamounts of blood.	The BD Microtainer®Contact-Activated Lancetis a sterile, single-use,permanently retracting,lancing device used toperform fingerstickpunctures in in adults,adolescents, children, andinfants. The device isintended to be used by ahealthcare professional in aclinical setting to collectcapillary blood specimensfor diagnostic testing.	The current intended usestatement has been convertedto an indications for usestatement for this initial510(k) submission. Thesubject devices' intendeduse/indications for use alsoincorporates a minimum ageand weight indicationconsistent withrecommendations outlined forfingerpricks in CLSI GP42-A7: Collection of CapillaryBlood Specimens, 7th Edition(FDA Recognition Number 7-301) and WHO Guidelines OnDrawing Blood: Best PracticesIn Phlebotomy. The proposedindications for use only addspecificity and clarity aboutwhat minimum age/weightcriteria are appropriate for thefingerstick; the changes do notresult in a new intended use.
Target Population	Adults, adolescents,children, and infants(greater than 6 months ofage and 10 kg (22 lbs))	Adults, adolescents,children, and infants	This proposed modificationincorporates a minimum ageand weight indicationconsistent withrecommendations outlined forfingerpricks in CLSI GP42-A7: Collection of CapillaryBlood Specimens, 7th Edition(FDA Recognition Number 7-301) and WHO Guidelines OnDrawing Blood: Best PracticesIn Phlebotomy. The proposedindications for use only addspecificity and clarity aboutwhat minimum age/weightcriteria are appropriate for thefingerstick; the changes do notresult in a new targetpopulation.
Device Design
Models	366592366593366594366599	366592366593366594366599	Same
Colors	Purple, Pink, Blue	Purple, Pink, Blue	Same
Types of LancingDevice	Needle, Blade	Needle, Blade	Same
Characteristic	Subject DeviceBD Microtainer®Contact-ActivatedLancets	Predicate DeviceBD Microtainer®Contact-ActivatedLancets2	Comparison
Needle/BladeDepths	1.5 mm, 1.8 mm, 2.0 mm	1.5 mm, 1.8 mm, 2.0 mm	Same
Needle/BladeGauges/Widths	30G (0.31 mm), 21G(0.81 mm), 1.5 mm	30G (0.31 mm), 21G (0.81mm), 1.5 mm	Same
Blood Flows	Low, Medium, High	Low, Medium, High	Same
Device Materials
Needle Carrier withProtective Tab	Polystyrene	Polystyrene	Same
Main Housing/TabCap/Rear Cap	Polypropylene	Polypropylene	Same
Shield	Polyethylene	Polyethylene	Same
Lever Element	Acrylonitrile butadienestyrene (ABS)	Acrylonitrile butadienestyrene (ABS)	Same
Drive Spring	Steel tinned wire	Steel tinned wire	Same
Return Spring	Steel tinned wire	Steel tinned wire	Same
Needle/Blade	Stainless steel	Stainless steel	Same
Needle/BladeLubricant	Silicone fluid	Silicone fluid	Same
Materials	Compliant with ISO10993 series	Compliant with ISO 10993series	Same
Packaging and Sterility
Sterile NeedleCarrier andNeedle/Blade	Yes	Yes	Same
Sterility AssuranceLevel (SAL) 10-6	Yes	Yes	Same
Sterilization Method	Gamma irradiation	Gamma irradiation	Same
Shelf Life	5 years	5 years	Same
Contains PackagingSupport Insert	No	Yes	To accommodate the new,standalone IFU created for thesubject BD Microtainer®Contact-Activated Lancets,the shelf carton height and theshelf box material density willbe increased. The increasedshelf carton height and densitywill also result in the removalof a support insert previouslyused to hold the box together.Ship testing was conducted tosupport this packaging change.

1 The term "substantial equivalence" as used in this 510(k) Notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this 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 substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts. 2 Per Docket No. FDA-2016-N-0040, " . . any 510(k)-exempt blood lances legally offered for sale on or before November 22, 2021, can serve as

predicates for substantial equivalence purposes.'

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BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management Becton, Dickinson and Company

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BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management Becton, Dickinson and Company

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BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management

Becton, Dickinson and Company

	Subject Device	Predicate Device
Characteristic	BD Microtainer®Quikheel™ Lancets	BD Microtainer®Quikheel™ Lancets3	Comparison
DeviceClassification	Class II requiring a 510(k)	Class I 510(k) exempt	The subject BDMicrotainer®Quikheel™ Lancetsdevices werereclassified from ClassI exempt devices notrequiring a 510(k) toClass II devicesrequiring a 510(k)under Docket No.FDA-2016-N-0040,effective November22, 2021.
Intended Use /Indications for Use	The BD Microtainer®Quikheel™ Lancet is a sterile,single-use medical device witha push-button activated,permanently retracting blade.The device is intended to beused by healthcareprofessionals to perform heelsticks in neonates, pre-term(preemie) and full-term infants(non-walking) to obtaincapillary blood specimens fortesting utilizing small amountsof blood.	The BD Microtainer®Quikheel™ Lancet is a sterile,single-use medical device witha push-button activated,permanently retracting blade.The device is intended to beused by healthcareprofessionals to perform heelsticks in neonates, pre-term(preemie) and full-term infants(non-walking) to obtaincapillary blood specimens fortesting utilizing small amountsof blood.	The current intendeduse statement has beenconverted to anindications for usestatement for thisinitial 510(k)submission.
Target Population	Neonates, Premature And FullTerm Infants	Neonates, Premature And FullTerm Infants	Same
Device Design
Models	368100368101	368100368101	Same
Colors	Pink, Teal	Pink, Teal	Same
Incision Depths	0.85 mm, 1.00 mm	0.85 mm, 1.00 mm	Same
Incision Lengths	1.75 mm, 2.50 mm	1.75 mm, 2.50 mm	Same
Blood Flows	Low, High	Low, High	Same
Device Materials
Blade (infant) andBlade (preemie)	Stainless steel	Stainless steel	Same
Spring	Polycarbonate	Polycarbonate	Same
Trigger	Polycarbonate	Polycarbonate	Same
Internal Trigger/Spring Lubricant	Silicone Fluid	Silicone Fluid	Same
Housing (front/back)	Polystyrene	Polystyrene	Same
Materials	Compliant with ISO 10993	Compliant with ISO 10993	Same

BD Microtainer® Ouikheel™ Lancet Substantial Equivalence ComparisonTable 2
--------------------------------------------------------------------------------	--	--	--	--

3 Per Docket No. FDA-2016-N-0040, " ...ary 510(k)-exempt blood lancets legally offered for sale on or before November 22, 2021, can serve as predicates for substantial equivalence purposes."

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BD Life Sciences, Integrated Diagnostic Solutions, Specimen Management Becton, Dickinson and Company

Characteristic	Subject DeviceBD Microtainer®QuikheelTM Lancets	Predicate DeviceBD Microtainer®QuikheelTM Lancets3	Comparison
Packaging and Sterility
Sterile	Yes	Yes	Same
Sterility AssuranceLevel (SAL) 10-6	Yes	Yes	Same
Sterilization Method	Gamma irradiation	Gamma irradiation	Same
Shelf Life	5 years	5 years	Same

As provided in Table 1 and Table 2, the subject devices and their respective predicates use the same operating principles, incorporate the same detailed designs, are manufactured from the same materials, are sterilized using the same method (gamma irradiation) with the same SAL of 10°, use the same technological characteristics, have identical shelf lives (5 years), are packaged using similar sterile barrier and case materials, and have the same intended use. The new indications for use established as part of this 510(k) submission align with the respective predicates' intended uses.

The subject BD Microtainer® Contact-Activated Lancets' intended use incorporates a minimum age and weight indication consistent with recommendations outlined for fingerpricks in CLSI GP42-A7: Collection of Capillary Blood Specimens, 7th Edition (FDA Recognition Number 7-301) and WHO Guidelines On Drawing Blood: Best Practices In Phlebotomy. The proposed indications for use only add specificity and clarity about what minimum age/weight criteria are appropriate for the fingerstick; the changes do not result in a new intended use.

The subject and predicate BD Microtainer® Quiltheel™ Lancets have the same intended use. The current intended use statement has been converted to an indications for use statement for this initial 510(k) submission.

Performance Testing - Bench Summary

Device, biocompatibility, and sterilization testing were conducted on the subject devices to validate that the devices perform as intended over the course of the product shelf life. Results of testing demonstrate acceptable performance for the subject devices.

Performance Testing - Animal Summary

Per the blood lancets classification regulation (21 CFR 878.4850(a)), animal testing is not required for the clearance of the subject devices. Therefore, BD is not submitting any animal performance data in support of this 510(k) submission.

Performance Testing - Clinical Summarv

Per the blood lancets classification regulation (21 CFR 878.4850(a)), clinical testing is not required for the clearance of the subject devices. Therefore, BD is not submitting any clinical performance data in support of this 510(k) submission.

Conclusion

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In summary, the BD Microtainer® Contact-Activated Lancets have the same intended use as their predicate device, and a new indication for use statement which aligns to this intended use. The BD Microtainer® Quikheel™ Lancets have the same intended use as their predicate device, and the indications for use statement is identical to the predicate's intended use statement. In addition, the BD Microtainer® Contact-Activated Lancets and BD Microtainer® Quikheel™ Lancets have the same technological characteristics and principles of operation as their respective predicates. Performance testing confirms that the subject devices perform as intended and are as safe and effective as their respective predicate devices.

The subject devices were reclassified from Class I exempt devices not requiring a 510(k) to Class II devices requiring a 510(k) under Docket No. FDA-2016-N-0040, effective November 22, 2021. This 510(k) serves as BD's initial 510(k) submission for these devices in response to the reclassification and 510(k) requirement.

Based on information provided, the proposed devices are substantially equivalent to their respective predicate devices.

Regulation Number and Section

§ 878.4850 Blood lancets.

(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.