(290 days)
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is used to collect, separate, transport, and store capillary blood samples from individuals 18 years and older. The system is comprised of a capillary blood collection tube and the BD MiniDraw™ Finger Sleeve that is intended for use by a trained healthcare worker.
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is intended for sample collection used in the measurement of Alkaline Phosphatase (ALKP), Alanine Aminotransferase (ALT), Sodium (Na), Chloride (Cl), Albumin (ALB), Blood Urea Nitrogen (BUN), Calcium (Ca), Creatinine (CREAT), Total Bilirubin (TBIL), Total Protein (TP), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Total Cholesterol (CHOL), and Triglycerides (TRIG).
BD MiniDraw™ SST™ Capillary Blood Collection Tube is not intended for use with other parameters/analytes.
The BD MiniDraw™ Capillary Blood Collection System family of devices is a capillary blood collection solution designed to collect, separate, transport, and store capillary blood samples from a finger stick that are clinically equivalent to both capillary and venous comparator tubes. The system is designed to standardize the capillary blood collection procedure, thereby allowing users who are trained to use the subject device, but who may not otherwise have been trained in phlebotomy, to collect fingerstick capillary blood samples. The BD MiniDraw™ Capillary Blood Collection System is intended to be used by trained healthcare workers in ancillary healthcare facilities and clinical use environments (e.g., retail pharmacies, clinics).
The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube (MiniDraw™ SST™ System) is a subset of components in the BD MiniDraw™ Capillary Blood Collection System. It is intended to collect a whole blood specimen from a finger and deliver a serum sample for measurement of specific analytes listed in the Indication for Use. The BD MiniDraw™ SST™ Capillary Blood Collection Tube (MiniDraw™ SST™ Tube) contains a silica-based clot activator solution and a gel that creates a barrier between serum and cells during centrifugation. The tube has a unique barcode that links the tube with the patient.
The MiniDraw™ SST™ Tube is designed to be used in combination with the BD MiniDraw™ 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 SST™ and BD MiniDraw™ Cap Removal Tool.
The provided text is a 510(k) Premarket Notification from the FDA for a blood specimen collection device. It details the device, its intended use, comparison to a predicate device, and performance testing. However, it does not describe an AI/ML-based medical device. Therefore, the requested information about acceptance criteria, study design for AI models (sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is not present in the provided document.
The document discusses the clinical performance testing for a physical blood collection device. The "acceptance criteria" referred to are for the physical and chemical performance of the collection tubes, not for an AI model's diagnostic or predictive accuracy.
Therefore, I cannot provide the requested table and details as they pertain to an AI device, which is not the subject of this document.
If you are interested in the acceptance criteria and performance data for this specific device (the BD MiniDraw™ Capillary Blood Collection System), here's what can be extracted from the document:
Study Proving Device Meets Acceptance Criteria (Physical/Chemical Performance)
The study was a series of non-clinical (bench) and clinical performance tests designed to demonstrate that the BD MiniDraw™ SST™ Capillary Blood Collection System performs as intended and is substantially equivalent to predicate devices.
1. Table of acceptance criteria and reported device performance (for the physical device):
The document lists "Acceptance Criteria" being "met" or "Pass" for each test but does not provide the specific quantitative thresholds for these criteria. It states that results were evaluated against "predetermined acceptance criteria" and "Clinical Acceptance Limits (CALs)".
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Non-Clinical (Bench) Testing | All tests "Pass" |
| Cap Lid Closure Force | Pass |
| Accidental Drop Seal | Pass |
| Reverse Centrifuge Seal | Pass |
| Transit Vibration Seal | Pass |
| Cap / Container Pull-Off | Pass |
| De-Capping | 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 |
| Barcode Scan, single automation platform | Pass |
| Barcode Label Sutherland Rub Test | Pass |
| Human Factors/Usability Evaluations | Pass |
| Clinical Performance Testing | |
| Method Comparison (Clinical Equivalence) | Met CALs; "demonstrated clinical equivalence" for all analytes and medical decision levels compared to capillary and venous comparators. |
| Lot to Lot Variability | "Acceptable" |
| Within-Tube Type Stability | "Demonstrated within-tube type stability" up to 4 hours at room temp and 48 hours refrigerated. |
| Operator Variability | "Acceptable" |
| Shelf-Life (9 months) | "Demonstrated clinically equivalent performance" for aged vs. new tubes. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of samples or subjects included in the clinical performance testing. It mentions "studies were performed at internal and/or external sites."
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective for a 510(k) submission. No country of origin is specified for the clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of device. The "ground truth" here is the accurate measurement of analytes in the blood samples, which would be established by standard laboratory reference methods, not by expert consensus or interpretations. The comparison is between the new device's collection method and existing, cleared collection methods.
4. Adjudication method for the test set:
- Not applicable for this type of device. Adjudication is relevant for subjective interpretations (like medical images). For quantitative measurements of analytes, "adjudication" would involve laboratory quality control and statistical analysis of results against established analytical performance criteria.
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 is a blood collection device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
- Comparator Devices/Reference Methods: For clinical equivalence, the "ground truth" was established by comparing analyte measurements from samples collected using the BD MiniDraw™ SST™ Tube against measurements from samples collected using legally marketed predicate and comparator devices (BD Microtainer® SST™ (capillary) and Greiner Bio-One Vacuette® Serum Tubes (venous)), presumably analyzed using validated laboratory methods. The clinical acceptance limits (CALs) served as the benchmark for equivalence.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. Food & Drug Administration" next to it.
December 1, 2023
Becton Dickinson and Company Katherine Lemus Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K230391
Trade/Device Name: BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SSTTM Capillary Blood Collection Tube Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: October 31, 2023 Received: October 31, 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 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.
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K230391
Device Name
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube
Indications for Use (Describe)
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is used to collect, separate, transport, and store capillary blood samples from individuals 18 years and older. The system is comprised of a capillary blood collection tube and the BD MiniDraw™ Finger Sleeve that is intended for use by a trained healthcare worker.
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is intended for sample collection used in the measurement of Alkaline Phosphatase (ALKP), Alanine Aminotransferase (ALT), Sodium (Na), Chloride (Cl), Albumin (ALB), Blood Urea Nitrogen (BUN), Calcium (CREAT), Total Bilirubin (TBIL), Total Protein (TP), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Total Cholesterol (CHOL), and Triglycerides (TRIG).
BD MiniDraw™ SST™ Capillary Blood Collection Tube is not intended for use with other parameters/analytes.
| 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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BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube K230391 Becton, Dickinson and Company
510(K) SUMMARY
Device Name:
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube
Summary Preparation Date:
11/28/2023
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™ SST™ Capillary Blood Collection Tube (MiniDraw™ SST™ System) includes the following components:
- BD MiniDraw™ SST™ Capillary Blood Collection Tube (MiniDraw™ SST™ Tube) ●
- BD MiniDraw™ Finger Sleeve ●
- BD MiniDraw™ Finger Sizing Tool ●
- BD MiniDraw™ Capillary Tube Adapter SST™ ●
- 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, Vials, Systems, Serum Separators, Blood Collection
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Regulatory Information
Regulatory information for devices included in this submission is as follows:
Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection Classification Regulation: 21 CFR §862.1675 Regulatory Class: Class II Panel: Clinical Chemistry Product Code(s): JKA
Predicate Device
Predicate: K991702 BD Microtainer® SSTTM
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
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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
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
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is used to collect, separate, transport, and store capillary blood samples from individuals 18 years and older. The system is comprised of a capillary blood collection tube and the BD MiniDraw™M Finger Sleeve that are intended for use by a trained healthcare worker.
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is intended for sample collection used in the measurement of Alkaline Phosphatase (ALKP), Alanine Aminotransferase (ALT), Sodium (Na), Chloride (Cl), Albumin (ALB), Blood Urea Nitrogen (BUN), Calcium (Ca), Creatinine (CREAT), Total Bilirubin (TBIL), Total Protein (TP), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Total Cholesterol (CHOL), and Triglycerides (TRIG).
BD MiniDraw™ SST™ Capillary Blood Collection Tube is not intended for use with other parameters/analytes.
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BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube K230391 Becton, Dickinson and Company
Becton, Dickinson and Company
Device Description
The BD MiniDraw™ Capillary Blood Collection System family of devices is a capillary blood collection solution designed to collect, separate, transport, and store capillary blood samples from a finger stick that are clinically equivalent to both capillary and venous comparator tubes. The system is designed to standardize the capillary blood collection procedure, thereby allowing users who are trained to use the subject device, but who may not otherwise have been trained in phlebotomy, to collect fingerstick capillary blood samples. The BD MiniDraw™™ Capillary Blood Collection System is intended to be used by trained healthcare workers in ancillary healthcare facilities and clinical use environments (e.g., retail pharmacies, clinics).
The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube (MiniDraw™ SST™ System) is a subset of components in the BD MiniDraw™ Capillary Blood Collection System. It is intended to collect a whole blood specimen from a finger and deliver a serum sample for measurement of specific analytes listed in the Indication for Use. The BD MiniDraw™ SST™ Capillary Blood Collection Tube (MiniDraw™ SST™ Tube) contains a silica-based clot activator solution and a gel that creates a barrier between serum and cells during centrifugation. The tube has a unique barcode that links the tube with the patient.
The MiniDraw™ SST™ Tube is designed to be used in combination with the BD MiniDraw™ 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 SST™ and BD MiniDraw™ Cap Removal Tool.
Substantial Equivalence
A comparison of the proposed and predicate device is provided in Table 1.
A discussion of equivalence between the subject device and the predicate device is provided in Table 2.
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| Characteristic | Subject Device | Predicate | Comparison |
|---|---|---|---|
| MiniDraw™ SST™ System | BD Microtainer®SST™K991702 | ||
| Indications forUse | BD MiniDraw™ Capillary BloodCollection System with BDMiniDraw™ SST™ Capillary BloodCollection Tube is used to collect,separate, transport, and storecapillary blood samples fromindividuals 18 years and older. Thesystem is comprised of a capillaryblood collection tube and the BDMiniDraw™ Finger Sleeve that isintended for use by a trainedhealthcare worker.BD MiniDraw™ Capillary BloodCollection System with BDMiniDraw™ SST™ Capillary BloodCollection Tube is intended forsample collection used in themeasurement of AlkalinePhosphatase (ALKP), AlanineAminotransferase (ALT), Sodium(Na), Chloride (Cl), Albumin (ALB),Blood Urea Nitrogen (BUN),Calcium (Ca), Creatinine (CREAT),Total Bilirubin (TBIL), Total Protein(TP), High Density Lipoprotein(HDL), Low Density Lipoprotein(LDL), Total Cholesterol (CHOL),and Triglycerides (TRIG).BD MiniDraw™ SST™ CapillaryBlood Collection Tube is notintended for use with otherparameters/analytes. | TheMICROTAINER®Brand ChemistryTubes withMICROGARD™Closures areintended tocollect, transportand store skinpuncture bloodspecimens forchemistrydeterminationrequiring serum orheparinizedplasma. | Both devicesare intended tocollect,transport andstore blood fortesting serumfor chemistryanalytes.MiniDraw™SST™ Systemis intended forcapillary bloodcollection forchemistrydeterminationsrequiringserum. It is notintended forthosedeterminationsrequiringheparinizedplasma. |
| Characteristic | Subject Device | Predicate | Comparison |
| MiniDraw™ SST™ System | BD Microtainer®SST™ | ||
| K991702 | |||
| IntendedPopulation | Adults – individuals aged 18 andolder, limited by correct fit of theFinger Sleeve | General Use – allpopulations | Use of theMiniDraw™ islimited toindividualsaged 18 andolder whosefingermeasurementsmatch theavailable sizesof FingerSleeves |
| Intended UseEnvironment | Ancillary healthcare facilities,clinical and laboratory environments | Clinical andlaboratoryenvironments | MiniDraw™SST™ Systemadds ancillaryhealthcarefacility useenvironment |
| Intended User | Trained Healthcare Workers:phlebotomists, clinicians,pharmacists, pharmacy technicians,and other healthcare workers trainedin the use of the device | TrainedHealthcareWorkers:phlebotomists andclinicians | MiniDraw™ SST™ Systemaddspharmacists,pharmacytechnicians,and otherhealthcareworkers trainedin the use ofthe device |
| Analytes | Alkaline Phosphatase (ALKP),Alanine Aminotransferase (ALT),Sodium (Na), Chloride (Cl), Albumin(ALB), Blood Urea Nitrogen (BUN),Calcium (Ca), Creatinine (CREAT),Total Bilirubin (TBIL), Total Protein(TP), High Density Lipoprotein(HDL), Low Density Lipoprotein(LDL), Total Cholesterol (CHOL),and Triglycerides (TRIG) | Chemistryanalytes | MiniDraw™ SST™ Systemtests forlabeled subsetof analytes inthe predicatedevices. |
| Characteristic | Subject Device | Predicate | Comparison |
| MiniDraw™ SST™ System | BD Microtainer® | ||
| SSTTMK991702 | |||
| Single Use | Yes | Yes | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Centrifugation | Cap Down | Cap Up | MiniDraw™SST™ Systemis intended forcentrifugationwhen orientedwith the capdown (reversecentrifugation). |
| Sample Type | Capillary | Capillary | Identical |
| Additive | Clot activator and gel separator | Clot activator andgel separator | Identical |
| Materials | Container: PolypropyleneCollector:methylAcrylonitrileButedieneStyrene(mABS)Cap: Polypropylene + Thermoplasticelastomer (TPE)Finger Sleeve: Polypropylene +colorant | Container:PolypropyleneCollector:PolypropyleneCap: High DensityPolyethyleneFinger Sleeve:N/A | MiniDraw™SST™ Systemuses variousdifferentmaterials. |
| ContainerDesign | Flat bottomed with rounded recessedplug | Flat Bottomedwith roundedrecessed plug | Identical |
| ContainerDimensions | 13x40mm | 9x40mm | Varies byproduct |
| Finger Sleeve | Yes | N/A | MiniDraw™SST™ Systemintroduces useof the FingerSleeve |
| Finger SizingTool | Yes | N/A | MiniDraw™ SST™ Systemintroduces useof the fingersizing tool |
| Characteristic | Subject DeviceMiniDrawTM SSTTM System | PredicateBD Microtainer®SSTTMK991702 | Comparison |
| Cap RemovalTool | Yes | N/A | MiniDrawTMSSTTM Systemintroduces useof the capremoval tool |
| Shelf-Life | 9 months | 15 months | Varies byProduct |
Table 1: Substantial Equivalence Comparison
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Table 2: Substantial Equivalence Discussion
| Difference | Substantial Equivalence to the Predicate |
|---|---|
| IntendedUse/IncludedAnalytes/Panels | Both the subject and predicate device are intended to collect, transportand store capillary blood for analysis. The intended use statement for thepredicate refers to "skin prick" collection instead of "capillary" but theseare understood to be equivalent. |
| MiniDraw™ SST™ System is intended for a narrower subset of targetedanalytes than the BD Microtainer® SST™ (i.e., chemistry). Theselection of analytes included in this submission are supported byclinical testing which demonstrates that the results are clinicallyequivalent. | |
| Because the proposed list of analytes is considered to be a subset ofthose cleared for use with the predicate device, this is not considered tobe a new intended use. | |
| IntendedPopulation | Intended for adult individuals aged 18 and older and whose fingers fit inone of the four finger sleeve sizes. |
| Addition ofAncillaryHealthcare FacilityUse Environments | MiniDraw™ SST™ System is intended for use in laboratory and clinicaluse environments. Blood collection may also occur at ancillaryhealthcare facilities (e.g., retail pharmacies, retail clinics). This does notchange the primary use of the device or the intended patient populationand so this use environment does not result in a new intended use.Whether the intended trained user is capable of using the deviceappropriately has been validated (via Human Factors and Clinicaltesting). |
| Difference | Substantial Equivalence to the Predicate |
| Intended User | The device is designed for users who may not have been previouslytrained in phlebotomy but who are trained in the correct use of theMiniDrawTM SSTTM System (i.e., pharmacists, pharmacy technicians,and other healthcare workers trained in the use of the device).Ultimately, the users of both the subject and predicate devices post-training are considered to be "trained healthcare workers," so thisdifference is not considered a new intended use. The workflow steps ofthe subject device have been designed and carefully evaluated to ensureno new serious adverse events or use-related hazards that may negativelyimpact the overall benefit-risk profile of capillary blood collectiondevices were introduced when used by the intended users described inthis submission. Human factors testing and clinical evaluationsperformed with the targeted user groups demonstrated no increase in riskof errors in the handling and processing of capillary blood samples (i.e.,centrifuging, storage and transport) and there was no observed increasein erroneous downstream test results. |
| ReverseCentrifugation | MiniDraw™ SSTTM Tube is designed to be centrifuged in the cap downposition so that the gel separator and clot are centrifuged into the cap,which is removed and discarded prior to testing, maximizing the serumquantity available for sampling and reducing the possibility of probecontamination during testing. Regardless of the orientation duringcentrifugation, the assessment of appropriate gel formation, clotseparation, and absence of leakage during centrifugation/handling arenot new questions of safety or effectiveness. |
| Materials | The BD MiniDraw™ SST™ Capillary Blood Collection Tube containeris made from polypropylene the same as the predicate. The othermaterials used in the components of the subject device differ. Thecollector of the predicate is also made of polypropylene as it is moldedin a single piece, and the collector of the MiniDraw™ SST™ Tube ismade from mABS which is a clearer plastic material intended to enhanceblood visualization during collection. The cap on the MiniDraw™SSTTM Tube is made from Polypropylene and TPE to ensure sealintegrity during reverse centrifugation. The BD MiniDrawTM FingerSleeve, which does not have a matching analog from the predicatedevice, is made from polypropylene mixed with colorants that werefound to be both appropriate for the intended use of the device andcompatible with biocompatibility considerations. The assessment ofwhether these materials do not negatively impact device performancenor have any negative effects on clinical results are not new questions ofsafety or effectiveness. Non-Clinical Performance testing, Clinicaltesting, and Biocompatibility testing demonstrated the devices performas intended. |
| Difference | Substantial Equivalence to the Predicate |
| ContainerDimensions | The container dimensions of the MiniDrawTM SSTTM Tube are designedfor optimal functioning of the device. For both the subject and predicatecapillary devices, use of a tube adapter is common to ensurecompatibility with test instruments, and thus tube dimensionaldifferences do not raise new questions of safety or effectiveness. |
| CombinationDevices andAccessories | The MiniDrawTM SSTTM System is a subset of component devices thatare intended to be used together during capillary blood collection andlaboratory analysis. The MiniDrawTM SSTTM Tube is designed to beused in combination with the BD MiniDrawTM Finger Sleeve (availablein four sizes) and three accessories; BD MiniDrawTM Finger Sizing Tool,BD MiniDrawTM Capillary Tube Adapter SSTTM and BD MiniDrawTMCap Removal Tool. The sample volume and quality requirements existfor a capillary sample regardless of whether a patient's finger issqueezed by the Finger Sleeve or manually. The Finger Sizing Tool isoptional as correct sizing of the Finger Sleeve may be assessed with thesleeve itself. Usage of a tube adapter is consistent with the predicate tomake automated processing possible. And the requirement to remove thetube cap to access the sample also exists regardless of whether it isremoved by hand or with a Cap Removal Tool. Use of the device andaccessories do not raise new questions of safety or effectiveness. |
| Shelf-Life | Shelf-life durations are based on test data currently available. Thisdifference does not raise new questions of safety or effectiveness. |
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Substantial Equivalence Conclusion
Both the subject and predicate device have the same intended use. The differences between proposed device and predicate device are summarized in Table 2. These differences do not raise any new questions of safety or effectiveness. The differences in technological characteristics were evaluated through performance testing as summarized in the section below.
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.
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Performance Testing - Bench (Non-Clinical Testing)
Non-clinical tests identified in Table 3 were 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 Description | Result |
|---|---|
| Cap Lid Closure Force | Pass |
| Accidental Drop Seal | Pass |
| Reverse Centrifuge Seal | Pass |
| Transit Vibration Seal | Pass |
| Cap / Container Pull-Off | Pass |
| De-Capping | 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 |
| Barcode Scan, single automation platform | Pass |
| Barcode Label Sutherland Rub Test | Pass |
| Human Factors/Usability Evaluations | Pass |
Table 3. Non-clinical Testing
The MiniDraw™ SST™ 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™ SST™ System continue to perform as intended.
Performance Testing - Clinical
The clinical performance evaluation of the MiniDraw™ SST™ System was based on applicable standards, guidance documents, and statistical analyses at predetermined medical decision levels. Studies were performed at internal and/or external sites. Clinical performance testing was performed to demonstrate that blood specimens collected in MiniDraw™ SST™ Tube produced test results that are substantially 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™
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Capillary Blood Collection System. Data generated from the studies were compared to the predefined acceptance criteria.
Testing was performed on selected analytes: Alkaline Phosphatase (ALKP), Alanine Aminotransferase (ALT), Sodium (Na), Chloride (Cl), Albumin (ALB), Blood Urea Nitrogen (BUN), Calcium (Ca), Creatinine (CREAT), Total Bilirubin (TBIL), Total Protein (TP), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Total Cholesterol (CHOL), and Triglycerides (TRIG)
Method Comparison
This study was performed to evaluate Clinical Equivalence between the MiniDraw™ SST™ Tube and respective capillary and venous comparator devices, BD Microtainer® SST™ Tubes (BD Microtainer® SST™) and Greiner Bio-One Vacuette® Serum Tubes with Clot Activator and Gel Separator (Greiner Vacuette Serum), for the serum chemistry analytes identified above. This assessment considered whether the mean and 95% Confidence Interval (CI) were within the Clinical Acceptance Limits (CALs).
- MiniDraw™ SST™ Tube vs BD Microtainer® SST™ (Capillary Comparator): ● Comparison of the MiniDraw™ SST™ Tube vs BD Microtainer® SST™ demonstrated clinical equivalence at all medical decision levels for all analytes identified above.
- MiniDraw™ SST™ Tube vs Greiner Vacuette Serum (Venous Comparator): ● Comparison of the MiniDraw™ SST™ Tube vs Greiner Vacuette Serum led to a conclusion that the mean and 95% CI of biases were within CALs identified above
Lot to Lot Variability
This study was performed to evaluate the total variability (lot-to-lot and within lot) of the MiniDraw™ SST™ Tube for the selected chemistry analytes and included testing in comparator devices (BD Microtainer® SST™ and Greiner Vacuette Serum) for . The acceptance criteria were met for each selected analyte, the lot variability in the MiniDraw™ SST™ Tube was considered acceptable.
Within-Tube Type Stability
This study evaluated within-tube type stability of selected chemistry analytes in the MiniDraw™ SST™ Tube for up to 4 hours at room temperature and up to 48 hours at refrigerated conditions.
The MiniDraw™ SST™ 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 chemistry analytes.
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BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube K230391 Becton, Dickinson and Company
Becton, Dickinson and Company
Operator Variability
This study was performed to evaluate operator variability of the MiniDraw™ SST™ Tube for selected serum chemistry analytes. The respective capillary and venous comparator devices, BD Microtainer® SST™ and Greiner Vacuette Serum were also tested in this study. The acceptance criteria were met for each selected analyte, therefore, the operator variability in the MiniDraw™ SSTTM Tube was considered acceptable.
Shelf-Life
The purpose of this study was to evaluate product shelf-life by evaluating real time aged 9 (+1) months MiniDraw™ SST™ Tubes in comparison with newly manufactured MiniDraw™ SST™ Tubes. The BD MiniDraw™ SST™ Capillary Blood Collection Tube aged 9(+1) months at both high and low temperature conditions demonstrated clinically equivalent performance when compared with the newly manufactured BD MiniDraw™ SST™ Capillary Blood Collection Tube for the selected serum chemistry analytes identified above that were evaluated in the study.
Conclusion
The comparison between the proposed device (MiniDraw™ SST™ System) and the predicate device (BD Microtainer® SST™) 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™ SST™ 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.
During clinical performance testing, the evaluation device, MiniDraw™ SSTIM System was compared to the predicate device and the blood collected in each tube was analyzed for identified chemistry analytes and produced test results that are clinically equivalent to both the capillary and venous comparator tubes. The results generated in the clinical performance testing for Method Comparison (Clinical Equivalence), Lot to Lot Variability, Stability, Operator Variability and Shelf-Life demonstrated appropriate performance.
Based on information provided in this submission the MiniDraw™ SST™ 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.