(277 days)
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.
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 (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.
The provided text is a 510(k) summary for the BD MiniDraw Capillary Blood Collection System, a medical device for collecting blood samples. It discusses the device's intended use, comparison to a predicate device, and performance testing. However, it does not include information about AI/ML models, image analysis, or expert consensus/adjudication for establishing ground truth, which are typically found in the context of AI/ML-driven medical device submissions.
Therefore, many of the requested elements for describing the acceptance criteria and study proving device performance (especially those related to AI/ML, ground truth establishment by experts, and MRMC studies) cannot be extracted from this document.
The document focuses on the physical and chemical performance of a blood collection device, primarily comparing its ability to collect, transport, and preserve blood samples for Hemoglobin (HgB) and Hematocrit (HCT) analysis, and ensuring its stability, compatibility with existing lab equipment (Sysmex XN-Series™ analyzers), and user-friendliness.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document primarily lists non-clinical (bench) tests with a "Pass" outcome, indicating that the device met the established acceptance criteria for these physical and mechanical properties. For clinical performance, it states that "clinical equivalence" and "non-inferiority" criteria were met, but does not provide quantitative acceptance limits or exact reported values for these.
| Test Method Description | Acceptance Criteria (Not explicitly quantified, but generally "Pass") | Reported Device Performance |
|---|---|---|
| Cap Lid Closure Force | Pass | Pass |
| Accidental Drop Seal | Pass | Pass |
| Transit Vibration Seal | Pass | Pass |
| Cap / Container Pull-Off | Pass | Pass |
| Tube to Collector Pull-Off Force | Pass | Pass |
| Latch Press Force | Pass | Pass |
| Tube to Collector Axial Removal Force | Pass | Pass |
| Pivot Attachment Force | Pass | Pass |
| Collector to Finger Cuff Snap De-Latch | Pass | Pass |
| Friction Retention | Pass | Pass |
| EDTA Adapter Retention Force | Pass | Pass |
| Sysmex Barcode Scan | Pass | Pass |
| Barcode Label Sutherland Rub Test | Pass | Pass |
| Clinical Performance: | (Not explicitly quantified, implied to be within Medical Decision Levels / CALs) | Clinically Equivalent / Non-Inferior |
| Method Comparison (Capillary) | Clinically Equivalent to BD MAP EDTA for HgB & HCT | Performance considered clinically equivalent |
| Method Comparison (Venous) | Clinically Equivalent to Greiner Vacuette EDTA for HgB & HCT | Performance considered clinically equivalent |
| Lot to Lot Variability (Capillary) | Non-inferiority to BD MAP EDTA for HgB & HCT | Passed non-inferiority criterion |
| Lot to Lot Variability (Venous) | Non-inferiority to Greiner Vacuette EDTA for HgB & HCT | Passed non-inferiority criterion |
| Within-Tube Type Stability | Stability up to 4 hours RT and 48 hours refrigerated for all analytes | Demonstrated stability |
| Operator Variability (Capillary) | Non-inferiority to BD MAP EDTA for HgB & HCT | Passed non-inferiority criterion |
| Operator Variability (Venous) | Non-inferiority to Greiner Vacuette EDTA for HgB & HCT | Passed non-inferiority criterion |
| Shelf-Life (9 months) | Clinically equivalent performance newly manufactured vs. aged tubes for HgB & HCT | Demonstrated clinically equivalent performance |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated with a specific number of subjects/samples for each clinical study (Method Comparison, Lot-to-Lot, etc.). It only mentions that studies were performed internally at BD's Franklin Lakes laboratory, or externally at Babson Diagnostics' laboratory, externally at Research Management, Inc. (RMI), or some combination.
- Data Provenance: The locations mentioned (Franklin Lakes, Babson Diagnostics, RMI) suggest US-based data. The studies are described as prospective clinical performance evaluations ("performed to demonstrate that blood specimens collected... produced test results that are clinically equivalent...").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. This is not an AI/ML device relying on image interpretation or diagnostic accuracy where expert consensus would establish ground truth. The "ground truth" here is the result obtained from a reference blood collection tube and analysis on a Sysmex XN-Series™ system, which is a quantitative laboratory measurement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. No human review or adjudication process is described for establishing ground truth for this type of device. The comparison is against established laboratory methods.
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. This device is a blood collection system, not an AI/ML diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The performance evaluated is that of the physical blood collection device in comparison to other blood collection devices, when analyzed by a lab instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" or reference for comparison were clinical laboratory results obtained from established, legally marketed predicate (BD Microtainer® MAP EDTA) and venous comparator (Greiner Vacuette® Blood Collection Tube with K2EDTA) devices, analyzed on Sysmex XN-Series™ systems. The criteria for equivalence/non-inferiority are based on "Clinical Acceptance Limits (CALs)" and the "associated Statistical Analysis Plan."
8. The sample size for the training set:
- Not applicable/Not mentioned. This is not an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned. This is not an AI/ML model.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (201) 847-6800
Contact:
Katherine Kenner Lemus Staff Regulatory Affairs Specialist Email: katherine.lemus(@bd.com
Phone: (801)541-9274
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 DeviceMiniDrawTM EDTA System | PredicateBD Microtainer® MAPK093972 | Comparison |
|---|---|---|---|
| Indications for Use | The BD MiniDrawTM Capillary BloodCollection System with BD MiniDrawTMHemoglobin & Hematocrit (H&H)Capillary Blood Collection Tube withK2EDTA is used to collect, anticoagulate,transport, and store capillary whole bloodsamples from individuals 18 years andolder. The System is comprised of acapillary blood collection tube and a BDMiniDrawTM Finger Sleeve that areintended for use by a trained healthcareworker.BD MiniDrawTM Capillary BloodCollection System with BD MiniDrawTMH&H Capillary Blood Collection Tube isintended for sample collection used in themeasurement of Hemoglobin (HgB) &Hematocrit (HCT), when analyzed onSysmex XN - SeriesTM systems.The BD MiniDrawTM Capillary BloodCollection System with BD MiniDrawTMH&H Capillary Blood Collection Tube isnot intended for use with other parameters. | BD Microtainer® MAP Microtube forAutomated Process with K2EDTA isused to collect, anticoagulate, transportand store skin puncture bloodspecimens for measurement of thefollowing hematology parameters:White Blood Cells (WBC), Red BloodCells (RBC), Hemoglobin (HgB),Hematocrit (HCT), Mean corpuscularvolume (MCV), Mean corpuscularhemoglobin (MCH), Mean corpuscularhemoglobin concentration (MCHC),Platelets, 5-part White Blood Cell(WBC) differentials (Neutrophils,Lymphocytes, Monocytes, Eosinophils,Basophils), Reticulocytes and WholeBlood Lead testing. | Both devices are intended tocollect, transport and storecapillary blood for testingwhole blood for hematocritand hemoglobin.MiniDrawTM H&H System isintended for use exclusivelywith the Sysmex XN -SeriesTM Analyzers.MiniDrawTM H&H System isnot intended for otherparameters. |
| Intended Population | Adults - individuals aged 18 and older,limited by correct fit of the Finger Sleeve | General Use - all populations | Use of the MiniDrawTM islimited to individuals aged 18and older whose fingermeasurements match theavailable sizes of FingerSleeves |
| Characteristic | Subject Device | Predicate | Comparison |
| MiniDraw™ EDTA System | BD Microtainer® MAP | ||
| K093972 | |||
| Intended Use Environment | Ancillary healthcare facilities, clinical andlaboratory environments | Clinical and laboratory environments | MiniDraw™ H&H Systemadds ancillary healthcarefacility use environments |
| Intended User | Trained Healthcare Workers:phlebotomists, clinicians, pharmacists,pharmacy technicians, and other healthcareworkers trained in the use of the device | Trained Healthcare Workers:Phlebotomists, clinicians | MiniDraw™ H&H Systemadds pharmacists, pharmacytechnicians, and otherhealthcare workers trained inthe use of the device |
| Analytes | Hemoglobin and Hematocrit | Hematology Analytes and Lead | MiniDraw™ H&H System isnot intended for otherparameters except forhemoglobin 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: PolypropyleneCollector:methylAcrylonitrileButediene Styrene(mABS)Cap: Polypropylene + Thermoplasticelastomer (TPE)Finger Sleeve: Polypropylene + colorant | Container: PolypropyleneCollector: PolypropyleneCap: High Density Polyethylene andTPEFinger Sleeve: N/A | MiniDraw™ SST™ Systemuses various differentmaterials. |
| Container Design | Flat bottomed with rounded recessed plug | Flat bottomed with rounded recessedplug | Identical |
| Container Dimensions | 13x40mm | 9x40mm | Varies by product |
| Finger Sleeve | Yes | N/A | MiniDraw™ EDTA Systemintroduces use of the FingerSleeve |
| Characteristic | Subject Device | Predicate | Comparison |
| MiniDraw™ EDTA System | BD Microtainer® MAP | ||
| K093972 | |||
| Compatibility withAutomated Processing | Compatible through use of BDMiniDraw™ Capillary Tube Adapter H&H | Compatible | The MiniDraw™ H&H Tubeis compatible with a tubeadapter while the BDMicrotainer® MAP tube has abuilt-in extension. |
| Finger Sizing Tool | Yes | N/A | MiniDraw™ H&H Systemintroduces use of the fingersizing tool |
| Cap Removal Tool | Yes | N/A | MiniDraw™ H&H Systemintroduces use of the capremoval 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/IncludedAnalytes | Both the subject and predicate devices are intended to collect, anticoagulate, transport and store capillary blood. The intended usestatement 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 includinghemoglobin and hematocrit, and so the subset of analytes covered by the subject vs predicate device is not considered a newintended use. Further, the selection of analytes included in this submission are supported by clinical testing which demonstratethe results are clinically equivalent. Because the proposed list of analytes of the subject device are considered to be a subset ofthose 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 onthe demographic of the patient population. This device is not intended for pediatric populations and if the patient's fingers do notfit in one of the four Finger Sleeve sizes, the MiniDraw™ H&H System should not be used. Because this proposed intendedpopulation of the subject device is considered to be a subset of those cleared for use with the predicate device this is notconsidered to be a new intended use. |
| Difference | Substantial Equivalence to the Predicate |
| Addition of AncillaryHealthcare Facility UseEnvironments | MiniDraw™ H&H System is intended for use in laboratory and clinical use environments. Blood collection may also occur atancillary healthcare facilities (e.g., retail pharmacies, retail clinics). This does not change the primary use of the device or theintended patient population and so this use environment does not result in a new intended use. Whether the intended trained useris 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 useof the MiniDraw™ H&H System (e.g., pharmacists, pharmacy technicians and other healthcare workers trained in the use of thedevice). Ultimately, the users of both the subject and predicate devices post-training are considered to be "trained healthcareworkers," so this difference is not considered a new intended use. The workflow steps of the subject device have been designedand carefully evaluated to ensure no new serious adverse events or use-related hazards that may negatively impact the overallbenefit-risk profile of capillary blood collection devices were introduced when used by the intended operators described in thissubmission. Human factors testing and clinical evaluations performed with the targeted user groups demonstrated no increase inrisk of errors in the handling and processing of capillary blood samples (i.e., storage and transport) and there was no observedincrease 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.The other materials used in the components of the subject device differ. The collector of the predicate is also made ofpolypropylene as it is molded in a single piece, and the collector of the MiniDraw™ H&H Tube is made from mABS which is aclearer plastic material intended to enhance blood visualization during collection. The cap on the MiniDraw™ H&H Tube ismade from Polypropylene instead of HDPE to allow for the hinge feature of the cap design. The BD MiniDraw™ Finger Sleeve,which does not have a matching analog from the predicate device, is made from polypropylene mixed with colorants that werefound to be both appropriate for the intended use of the device and compatible with biocompatibility considerations. Theassessment of whether these materials negatively impact device performance or have any negative effects on clinical results arenot new questions of safety or effectiveness. Non-Clinical Performance testing, Clinical testing, and Biocompatibility testingdemonstrated 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 bloodcollection and laboratory analysis. The container dimensions of the MiniDraw™ H&H Tube are designed for optimal functioningof the device and an optional tube adapter is available to enable automated processing. The combination of the MiniDraw™H&H Tube with the BD MiniDraw™ Capillary Tube Adapter H&H results in a device that matches the container dimensions ofthe BD MAP EDTA which has a built-in extender by design. Thus, tube dimensional differences do not raise new questions ofsafety or effectiveness. |
| Difference | Substantial Equivalence to the Predicate |
| Combination Devices andAccessories | The MiniDraw™ H&H Tube is designed to be used in combination with the BD MiniDraw™ Finger Sleeve (available in foursizes) and three accessories; BD MiniDraw™ Finger Sizing Tool, BD MiniDraw™ Capillary Tube Adapter H&H and BDMiniDraw™ Cap Removal Tool. The sample volume and quality requirements exist for a capillary sample regardless of whethera patient's finger is squeezed by the Finger Sleeve or manually. The Finger Sizing Tool is optional as correct sizing of the FingerSleeve may be assessed with the sleeve itself. The MiniDraw™ H&H Tube is compatible with a tube adapter while the BDMicrotainer® MAP tube has a built-in extension and so the adapter is not a separate component. The form factor of theMiniDraw™ H&H Tube with the Tube Adapter is consistent with the form factor of the BD Microtainer® MAP tube with thebuilt-in extender to make automated sampling possible and the requirement to remove the tube cap to access the sample alsoexists regardless of whether it is removed by hand or with a Cap Removal Tool. Use of the device and accessories do not raisenew questions of safety or effectiveness.The combination of the tube and tube adapter result in a sample configuration that is optimized for the Sysmex XN – Series™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 oreffectiveness. |
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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 devices - Part 1: Evaluation and testing within a risk management process" and in compliance with the ISO 10993 series of standards. Materials that may come into direct or indirect contact with human body for even transient or limited durations were evaluated to the identified biological endpoints. Results of testing demonstrated that the subject devices are considered safe for use for the proposed intended clinical applications.
Performance Testing - Bench (Non-Clinical Testing)
Non-clinical performance testing n Table 4 was conducted following defined protocols and with established acceptance criteria to evaluate the following attributes of the proposed devices at time-zero and over the proposed shelf life:
| Test Method Description | Outcome |
|---|---|
| Cap Lid Closure Force | Pass |
| Accidental Drop Seal | Pass |
| Transit Vibration Seal | Pass |
| Cap / Container Pull-Off | Pass |
| Tube to Collector Pull-Off Force | Pass |
| Latch Press Force | Pass |
| Tube to Collector Axial Removal Force | Pass |
| Pivot Attachment Force | Pass |
| Collector to Finger Cuff Snap De-Latch | Pass |
| Friction Retention | Pass |
| EDTA Adapter Retention Force | Pass |
| Sysmex Barcode Scan | Pass |
| Barcode Label Sutherland Rub Test | Pass |
Table 3. Non-clinical Testing
The MiniDraw™ H&H System met all non-clinical testing requirements at time-zero and over the product shelf life, demonstrating that the device functions as designed. These performance tests demonstrate that the modifications to the device do not impact its safety or effectiveness and that the subject MiniDraw™ H&H System continue to perform as intended.
Performance Testing - Animal Summary
No animal studies were performed in support of this submission.
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Performance Testing - Clinical
The clinical performance evaluation of the MiniDraw™™ EDTA System was based on applicable standards, guidance documents, statistical evaluation and accepted medical decision levels. Studies were performed internally at BD's Franklin Lakes laboratory, or externally at Babson Diagnostics' laboratory, externally at Research Management, Inc. (RMI) or at some combination of these sites. Clinical performance testing was performed to demonstrate that blood specimens collected in MiniDraw™ EDTA Tube produced test results that are clinically equivalent to both the capillary and venous comparator tubes by performing the following studies: Method Comparison (Clinical Equivalence), Lot to Lot Variability, Within-Tube Type Stability, Operator Variability and Shelf Life. Results were evaluated in accordance with the associated Statistical Analysis Plan for BD MiniDraw™ Capillary Blood Collection System. Data generated from the studies were compared to the pre-defined acceptance criteria.
Testing was performed on identified analytes (i.e., Hemoglobin (HgB) and Hematocrit (HCT)).
Method Comparison
This study was performed to evaluate Clinical Equivalence between the MiniDraw™ H&H Tube and respective capillary and venous comparator devices, BD Microtainer® Microtube for Automated Processes (BD MAP EDTA) and Greiner Vacuette® Blood Collection Tube with K2EDTA (Greiner Vacuette EDTA), for the analytes identified above. This assessment considered whether the mean and the two one-sided 95% Confidence Limits of the paired sample biases were within the Clinical Acceptance Limits (CALs).
- . MiniDraw™ H&H Tube vs BD MAP EDTA (Capillary Comparator): The performance of the MiniDraw H&H Tube was considered clinically equivalent to the BD MAP EDTA for both analytes identified above.
- MiniDraw™ H&H Tube vs Greiner Vacuette EDTA (Venous Comparator): The performance of the MiniDraw H&H Tube was considered clinically equivalent to the Greiner Vacuette EDTA for both analytes identified above.
Lot to Lot Variability
This study was performed to evaluate non-inferiority of the MiniDraw™ H&H Tube in comparison to respective comparator devices (BD MAP EDTA and Greiner Vacuette EDTA) for total variability (lot-to-lot and within lot) for the analytes identified above.
- . MiniDraw™ H&H Tube vs BD MAP EDTA [Capillary comparator]: This evaluation led to the conclusion that the MiniDraw™ H&H Tube passed the non-inferiority criterion (which included lot to lot variation and within lot) for the analytes identified above when compared with capillary comparator, BD MAP EDTA.
- MiniDraw™ H&H Tube vs Greiner Vacuette EDTA [Venous comparator]: This ● evaluation led to the conclusion that MiniDraw™ H&H Tube passed the non-inferiority
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BD MiniDraw™ Capillary Blood Collection System with BD MimiDraw™ H&H Capillary Blood Collection Tube K230493
Becton, Dickinson and Company
criterion (which included lot to lot variation and within lot) for all the analytes identified above when compared with venous comparator, Greiner Vacuette EDTA.
Within-Tube Type Stability
This study evaluated within-tube type stability of analytes identified above in the MiniDraw™ H&H Tube for up to 4 hours at room temperature and up to 48 hours at refrigerated conditions.
The MiniDraw™ H&H Tube demonstrated within-tube type stability up to 4 hours with room temperature storage and up to 48 hours with refrigerated storage for all evaluated analytes.
Operator Variability
This study was performed to evaluate operator variability of the MiniDraw™ H&H Tube and respective capillary and venous comparator devices, BD MAP EDTA and Greiner Vacuette EDTA for analytes identified above.
- MiniDraw™ H&H Tube vs BD MAP EDTA [Capillary comparator]: This evaluation ● led to the conclusion that the MiniDraw™ H&H Tube passed the non-inferiority criterion for operator variability for the analytes identified above when compared with capillary comparator, BD MAP EDTA.
- MiniDraw™ H&H Tube vs Greiner Vacuette EDTA [Venous comparator]: This . evaluation led to the conclusion that MiniDraw™ H&H Tube passed the non-inferiority criterion for operator variability for all the analytes identified above when compared with venous comparator, Greiner Vacuette EDTA.
Shelf-Life
The purpose of this study was to evaluate product shelf-life by evaluating real time aged 9 (+1) months MiniDraw™ H&H Tubes in comparison with newly manufactured MiniDraw™ H&H Tubes. The MiniDraw™ H&H Tubes aged 9 (+1) months at both high and low temperature conditions demonstrated clinically equivalent performance when compared with the newly manufactured MiniDraw™M H&H Tubes for the analytes identified above that were evaluated in the study.
Conclusion
The comparison between the proposed device (MiniDraw™ H&H System) and the predicate device (BD MAP EDTA) shows that they have the same fundamental technology and technological characteristics and any differences in technology do not raise new questions of safety or effectiveness. The intended use of the MiniDraw™ H&H System is also considered to be the same as the predicate device.
The performance bench testing based on applicable standards and internal specifications demonstrates that acceptance criteria were met.
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During clinical performance testing, the evaluation device, MiniDraw™M H&H System was compared to the predicate device and the blood collected in each tube was analyzed for identified hemoglobin and hematocrit and produced test results that are considered clinically equivalent to the capillary and venous comparator tubes. The results generated in the clinical performance testing for Method Comparison (Clinical Equivalence), Lot to Lot Variability, Within-Tube Type Stability, Operator Variability and Shelf Life demonstrated appropriate performance.
Based on information provided in this submission the MiniDraw™M H&H System is substantially equivalent to the predicate device.
§ 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.