BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube

K230493 · Becton, Dickinson and Company · GIM · Nov 27, 2023 · Clinical Chemistry

Device Facts

• Record ID: K230493
• Device Name: BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
• Applicant: Becton, Dickinson and Company
• Product Code: GIM · Clinical Chemistry
• Decision Date: Nov 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ Hemoglobin & Hematocrit (H&H) Capillary Blood Collection Tube with K2EDTA is used to collect, anticoagulate, transport, and store capillary whole blood samples from individuals 18 years and older. The System is comprised of a capillary blood collection tube and a BD MiniDraw™ Finger Sleeve that are intended for use by a trained healthcare worker. BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H Capillary Blood Collection Tube is intended for sample collection used in the measurement of Hemoglobin (HgB) & Hematocrit (HCT), when analyzed on Sysmex XN - Series™ systems. The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H Capillary Blood Collection Tube is not intended for use with other parameters.

Device Story

System collects capillary whole blood via finger stick for hemoglobin and hematocrit measurement; comprises capillary collection tube, finger sleeve, and accessories (sizing tool, adapter, cap remover). Input: capillary blood sample; Output: anticoagulated whole blood in tube for automated analysis. Used in clinical/ancillary settings by trained healthcare workers (phlebotomists, pharmacists, technicians). Tube contains K2EDTA; features unique barcode for patient linking. Tube adapter enables compatibility with Sysmex XN-Series analyzers. Benefits: enables capillary blood collection for specific hematology parameters in non-traditional settings; provides clinically equivalent results to venous/capillary comparator tubes.

Clinical Evidence

Clinical performance evaluated via method comparison, lot-to-lot variability, operator variability, and stability studies. Compared MiniDraw H&H System against BD MAP EDTA (capillary) and Greiner Vacuette EDTA (venous) comparators. Results demonstrated clinical equivalence for Hemoglobin and Hematocrit. Stability confirmed for 4 hours at room temperature and 48 hours refrigerated. Shelf-life testing (9 months) showed performance equivalent to new tubes. No animal studies performed.

Technological Characteristics

Materials: Polypropylene container, mABS collector, TPE/Polypropylene cap, Polypropylene finger sleeve. Sensing/Actuation: Mechanical collection system. Energy: None. Dimensions: 13x40mm tube. Connectivity: Barcode-labeled for patient identification. Sterilization: Non-sterile. Software: None (mechanical device). Standards: ISO 10993 (biocompatibility), ASTM D4169, D999, D4728, D6653, D5276, D5264, F1886, F1980, ISO 11607, ISO/IEC 15415.

Indications for Use

Indicated for collection, anticoagulation, transport, and storage of capillary whole blood samples from individuals 18 years and older for the measurement of Hemoglobin and Hematocrit. Intended for use by trained healthcare workers in ancillary healthcare facilities and clinical laboratories. Not intended for use with other parameters.

Regulatory Classification

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.

Predicate Devices

• BD Microtainer® Microtube for Automated Process (MAP) (K093972)

Reference Devices

• BD Microtainer® Contact-Activated Lancet (K223243)
• Greiner Vacuette® Blood Collection Tube with K2EDTA

Submission Summary (Full Text)

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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 Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 27, 2023

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

Re: K230493

Trade/Device Name: BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: GIM Dated: February 22, 2023 Received: February 23, 2023

Dear Katherine Lemus:

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.

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 and Part 809); 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-safetyreporting-combination-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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Min W

Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics 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) K230493

Device Name

BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H Capillary Blood Collection Tube

#### Indications for Use (Describe)

The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ Hemoglobin & Hematocrit (H&H) Capillary Blood Collection Tube with K2EDTA is used to collect, anticoagulate, transport, and store capillary whole blood samples from individuals 18 years and older. The System is comprised of a capillary blood collection tube and a BD MiniDraw™ Finger Sleeve that are intended for use by a trained healthcare worker.

BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H Capillary Blood Collection Tube is intended for sample collection used in the measurement of Hemoglobin (HgB) & Hematocrit (HCT), when analyzed on Sysmex XN - Series™ systems.

The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H Capillary Blood Collection Tube is not intended for use with other parameters.

Type of Use (Select one or both, as applicable)

| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------|
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(K) SUMMARY

## Summary Preparation Date:

11/27/2023

## Submitted by:

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

Phone: [phone]

### Contact:

Katherine Kenner Lemus Staff Regulatory Affairs Specialist Email: katherine.lemus(@bd.com

Phone: [phone]

### Proprietary Names:

The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H Capillary Blood Collection Tube (MiniDraw™ H&H System) is including the following devices:

- BD MiniDraw™ H&H Capillary Blood Collection Tube (MiniDraw™ H&H Tube) ●
- BD MiniDraw™ Finger Sleeve ●
- BD MiniDraw™ Finger Sizing Tool ●
- BD MiniDraw™ Capillary Tube Adapter H&H ●
- BD MiniDraw™ Cap Removal Tool ●

These devices are components of the BD MiniDraw™ Capillary Blood Collection System.

### Common Names:

FDA Product Code Name(s): Tubes, Vacuum Sample, With Anticoagulant

### Regulatory Information

Regulatory information for devices included in this submission is summarized as follows:

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Classification Name: Tubes, Vacuum Sample, With Anticoagulant Classification Regulation: 21 CFR §862.1675 Regulatory Class: Class II Panel: Clinical Chemistry Product Code: GIM

## Predicate Device

Predicate: K093972 BD Microtainer® Microtube for Automated Process (MAP)

## Device Establishment

Becton, Dickinson and Company

Registration Number: 2243072

## Performance Standards

ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems

EN ISO 14971:2019 Medical Devices - Application of risk management to medical devices

ASTM D999-08(2015) Standard Test Methods for Vibration Testing of Shipping Containers

ASTM D4728-17 Standard Test Method for Random Vibration Testing of Shipping Containers

ASTM D6653/D6653M-13(2021) Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method

ASTM D5276-19 Standard Test Method for Drop Test of Loaded Containers by Free Fall

ASTM D5264-98(2019) Standard Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub Tester

ISO/IEC 15415:2011 Information technology -----------------------------------------------------------------------------------------------------------------------------------techniques - Bar code symbol print quality test specification - Two-dimensional symbols

ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

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

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

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

ISO 10993-17:2002 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances

ISO 10993-18:2020 Biological evaluation of medical devices – Part 18: Chemical characterization of materials

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

## Intended Use

The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ Hemoglobin & Hematocrit (H&H) Capillary Blood Collection Tube with K2EDTA is used to collect, anticoagulate, transport, and store capillary whole blood samples from individuals 18 years and older. The System is comprised of a capillary blood collection tube and a BD MiniDraw™ Finger Sleeve that are intended for use by a trained healthcare worker.

BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™™ H&H Capillary Blood Collection Tube is intended for sample collection used in the measurement of Hemoglobin (HgB) & Hematocrit (HCT), when analyzed on Sysmex XN - Series™ systems.

The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H Capillary Blood Collection Tube is not intended for use with other parameters.

## Device Description

The MiniDraw™ H&H System is designed to collect, anticoagulate, transport, and store capillary blood samples from adults 18 years and older for measurement of hemoglobin and hematocrit requiring whole blood and is clinically equivalent to capillary and venous comparator tubes for both analytes. The system is comprised of a capillary blood collection tube and a Finger Sleeve that is intended for use by trained healthcare workers in ancillary healthcare facilities

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(e.g., retail pharmacies, clinical and laboratory use environments. It is intended to be used with Sysmex XN - Series™ Analyzers.

The MiniDraw™ H&H System is intended to collect a whole blood specimen from a finger and deliver an anticoagulated sample for measurement of hemoglobin and hematocrit. The BD MiniDraw™ H&H Capillary Blood Collection Tube (MiniDraw™ H&H Tube) contains K2EDTA for anticoagulation of whole blood samples. The tube has a unique barcode that links the tube with the patient.

The MiniDraw™ H&H Tube is designed to be used in combination with the BD MiniDraw™M Finger Sleeve (available in four sizes), the BD Microtainer® Contact-Activated Lancet (clearance K223243) and three accessories; BD MiniDraw™ Finger Sizing Tool, BD MiniDraw™ Capillary Tube Adapter H&H, and BD MiniDraw™ Cap Removal Tool.

### Substantial Equivalence

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

A discussion of equivalence between the subject and predicate device is provided in Table 3

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| Characteristic | Subject Device<br>MiniDrawTM EDTA System | Predicate<br>BD Microtainer® MAP<br>K093972 | Comparison |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The BD MiniDrawTM Capillary Blood<br>Collection System with BD MiniDrawTM<br>Hemoglobin & Hematocrit (H&H)<br>Capillary Blood Collection Tube with<br>K2EDTA is used to collect, anticoagulate,<br>transport, and store capillary whole blood<br>samples from individuals 18 years and<br>older. The System is comprised of a<br>capillary blood collection tube and a BD<br>MiniDrawTM Finger Sleeve that are<br>intended for use by a trained healthcare<br>worker.<br>BD MiniDrawTM Capillary Blood<br>Collection System with BD MiniDrawTM<br>H&H Capillary Blood Collection Tube is<br>intended for sample collection used in the<br>measurement of Hemoglobin (HgB) &<br>Hematocrit (HCT), when analyzed on<br>Sysmex XN - SeriesTM systems.<br>The BD MiniDrawTM Capillary Blood<br>Collection System with BD MiniDrawTM<br>H&H Capillary Blood Collection Tube is<br>not intended for use with other parameters. | BD Microtainer® MAP Microtube for<br>Automated Process with K2EDTA is<br>used to collect, anticoagulate, transport<br>and store skin puncture blood<br>specimens for measurement of the<br>following hematology parameters:<br>White Blood Cells (WBC), Red Blood<br>Cells (RBC), Hemoglobin (HgB),<br>Hematocrit (HCT), Mean corpuscular<br>volume (MCV), Mean corpuscular<br>hemoglobin (MCH), Mean corpuscular<br>hemoglobin concentration (MCHC),<br>Platelets, 5-part White Blood Cell<br>(WBC) differentials (Neutrophils,<br>Lymphocytes, Monocytes, Eosinophils,<br>Basophils), Reticulocytes and Whole<br>Blood Lead testing. | Both devices are intended to<br>collect, transport and store<br>capillary blood for testing<br>whole blood for hematocrit<br>and hemoglobin.<br>MiniDrawTM H&H System is<br>intended for use exclusively<br>with the Sysmex XN -<br>SeriesTM Analyzers.<br>MiniDrawTM H&H System is<br>not intended for other<br>parameters. |
| Intended Population | Adults - individuals aged 18 and older,<br>limited by correct fit of the Finger Sleeve | General Use - all populations | Use of the MiniDrawTM is<br>limited to individuals aged 18<br>and older whose finger<br>measurements match the<br>available sizes of Finger<br>Sleeves |
| Characteristic | Subject Device | Predicate | Comparison |
| | MiniDraw™ EDTA System | BD Microtainer® MAP | |
| | | K093972 | |
| Intended Use Environment | Ancillary healthcare facilities, clinical and<br>laboratory environments | Clinical and laboratory environments | MiniDraw™ H&H System<br>adds ancillary healthcare<br>facility use environments |
| Intended User | Trained Healthcare Workers:<br>phlebotomists, clinicians, pharmacists,<br>pharmacy technicians, and other healthcare<br>workers trained in the use of the device | Trained Healthcare Workers:<br>Phlebotomists, clinicians | MiniDraw™ H&H System<br>adds pharmacists, pharmacy<br>technicians, and other<br>healthcare workers trained in<br>the use of the device |
| Analytes | Hemoglobin and Hematocrit | Hematology Analytes and Lead | MiniDraw™ H&H System is<br>not intended for other<br>parameters except for<br>hemoglobin and hematocrit. |
| Single Use | Yes | Yes | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Sample Type | Capillary | Capillary | Identical |
| Additive | K2EDTA, Spray dried | K2EDTA, Spray dried | Identical |
| Materials | Container: Polypropylene<br>Collector:<br>methylAcrylonitrileButediene Styrene<br>(mABS)<br>Cap: Polypropylene + Thermoplastic<br>elastomer (TPE)<br>Finger Sleeve: Polypropylene + colorant | Container: Polypropylene<br>Collector: Polypropylene<br>Cap: High Density Polyethylene and<br>TPE<br>Finger Sleeve: N/A | MiniDraw™ SST™ System<br>uses various different<br>materials. |
| Container Design | Flat bottomed with rounded recessed plug | Flat bottomed with rounded recessed<br>plug | Identical |
| Container Dimensions | 13x40mm | 9x40mm | Varies by product |
| Finger Sleeve | Yes | N/A | MiniDraw™ EDTA System<br>introduces use of the Finger<br>Sleeve |
| Characteristic | Subject Device | Predicate | Comparison |
| | MiniDraw™ EDTA System | BD Microtainer® MAP | |
| | | K093972 | |
| Compatibility with<br>Automated Processing | Compatible through use of BD<br>MiniDraw™ Capillary Tube Adapter H&H | Compatible | The MiniDraw™ H&H Tube<br>is compatible with a tube<br>adapter while the BD<br>Microtainer® MAP tube has a<br>built-in extension. |
| Finger Sizing Tool | Yes | N/A | MiniDraw™ H&H System<br>introduces use of the finger<br>sizing tool |
| Cap Removal Tool | Yes | N/A | MiniDraw™ H&H System<br>introduces use of the cap<br>removal tool |
| Shelf Life | 9 months | 18 months | Varies by Product |

# Table 1: Substantial Equivalence Comparison

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## Table 2: Substantial Equivalence Discussion

| Difference | Substantial Equivalence to the Predicate |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Included<br>Analytes | Both the subject and predicate devices are intended to collect, anticoagulate, transport and store capillary blood. The intended use<br>statement for the predicate refers to "skin prick" collection instead of "capillary" but this is a semantic difference. |
| | Both the MiniDraw™ H&H System and BD Microtainer® MAP are intended for analysis of whole blood analytes including<br>hemoglobin and hematocrit, and so the subset of analytes covered by the subject vs predicate device is not considered a new<br>intended use. Further, the selection of analytes included in this submission are supported by clinical testing which demonstrate<br>the results are clinically equivalent. Because the proposed list of analytes of the subject device are considered to be a subset of<br>those evaluated from a whole blood sample, this is not considered to be a new intended use. |
| Intended Population | Intended for adult individuals aged 18 and older. Use of the system is dependent upon the correct fit of the Finger Sleeve, not on<br>the demographic of the patient population. This device is not intended for pediatric populations and if the patient's fingers do not<br>fit in one of the four Finger Sleeve sizes, the MiniDraw™ H&H System should not be used. Because this proposed intended<br>population of the subject device is considered to be a subset of those cleared for use with the predicate device this is not<br>considered to be a new intended use. |
| Difference | Substantial Equivalence to the Predicate |
| Addition of Ancillary<br>Healthcare Facility Use<br>Environments | MiniDraw™ H&H System is intended for use in laboratory and clinical use environments. Blood collection may also occur at<br>ancillary healthcare facilities (e.g., retail pharmacies, retail clinics). This does not change the primary use of the device or the<br>intended patient population and so this use environment does not result in a new intended use. Whether the intended trained user<br>is capable of using the device appropriately has been validated (via Human Factors and Clinical testing). |
| Intended User | The device is designed for users who may have not been previously trained in phlebotomy but who are trained in the correct use<br>of the MiniDraw™ H&H System (e.g., pharmacists, pharmacy technicians and other healthcare workers trained in the use of the<br>device). Ultimately, the users of both the subject and predicate devices post-training are considered to be "trained healthcare<br>workers," so this difference is not considered a new intended use. The workflow steps of the subject device have been designed<br>and carefully evaluated to ensure no new serious adverse events or use-related hazards that may negatively impact the overall<br>benefit-risk profile of capillary blood collection devices were introduced when used by the intended operators described in this<br>submission. Human factors testing and clinical evaluations performed with the targeted user groups demonstrated no increase in<br>risk of errors in the handling and processing of capillary blood samples (i.e., storage and transport) and there was no observed<br>increase in erroneous downstream test results. |
| Materials | The BD MiniDraw™ H&H Capillary Blood Collection Tube container is made from polypropylene the same as the predicate.<br>The other materials used in the components of the subject device differ. The collector of the predicate is also made of<br>polypropylene as it is molded in a single piece, and the collector of the MiniDraw™ H&H Tube is made from mABS which is a<br>clearer plastic material intended to enhance blood visualization during collection. The cap on the MiniDraw™ H&H Tube is<br>made from Polypropylene instead of HDPE to allow for the hinge feature of the cap design. The BD MiniDraw™ Finger Sleeve,<br>which does not have a matching analog from the predicate device, is made from polypropylene mixed with colorants that were<br>found to be both appropriate for the intended use of the device and compatible with biocompatibility considerations. The<br>assessment of whether these materials negatively impact device performance or have any negative effects on clinical results are<br>not new questions of safety or effectiveness. Non-Clinical Performance testing, Clinical testing, and Biocompatibility testing<br>demonstrated the devices perform as intended. |
| Container Dimensions | The MiniDraw™ H&H System is a subset of component devices that are intended to be used together during capillary blood<br>collection and laboratory analysis. The container dimensions of the MiniDraw™ H&H Tube are designed for optimal functioning<br>of the device and an optional tube adapter is available to enable automated processing. The combination of the MiniDraw™<br>H&H Tube with the BD MiniDraw™ Capillary Tube Adapter H&H results in a device that matches the container dimensions of<br>the BD MAP EDTA which has a built-in extender by design. Thus, tube dimensional differences do not raise new questions of<br>safety or effectiveness. |
| Difference | Substantial Equivalence to the Predicate |
| Combination Devices and<br>Accessories | The MiniDraw™ H&H Tube is designed to be used in combination with the BD MiniDraw™ Finger Sleeve (available in four<br>sizes) and three accessories; BD MiniDraw™ Finger Sizing Tool, BD MiniDraw™ Capillary Tube Adapter H&H and BD<br>MiniDraw™ Cap Removal Tool. The sample volume and quality requirements exist for a capillary sample regardless of whether<br>a patient's finger is squeezed by the Finger Sleeve or manually. The Finger Sizing Tool is optional as correct sizing of the Finger<br>Sleeve may be assessed with the sleeve itself. The MiniDraw™ H&H Tube is compatible with a tube adapter while the BD<br>Microtainer® MAP tube has a built-in extension and so the adapter is not a separate component. The form factor of the<br>MiniDraw™ H&H Tube with the Tube Adapter is consistent with the form factor of the BD Microtainer® MAP tube with the<br>built-in extender to make automated sampling possible and the requirement to remove the tube cap to access the sample also<br>exists regardless of whether it is removed by hand or with a Cap Removal Tool. Use of the device and accessories do not raise<br>new questions of safety or effectiveness.<br>The combination of the tube and tube adapter result in a sample configuration that is optimized for the Sysmex XN – Series™<br>analyzers which the MiniDraw™ H&H is intended to be used with. |
| Shelf Life | Shelf-life durations are based on test data currently available. This difference does not raise new questions of safety or<br>effectiveness. |

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### Substantial Equivalence Conclusion

Both the subject and predicate device have intended use. The differences between proposed device and predicate device are summarized in Table 3. These differences do not raise any new questions of safety or effectiveness in technological characteristics were evaluated through performance testing as summarized in the section below.

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## Biocompatibility Testing

An assessment of biocompatibility risks for the devices included in this submission was performed per FDA Guidance issued September 4, 2020. Use of International Standard ISO 10993-1, "Biological evaluation of medical…