(290 days)
No
The device description and performance studies focus on the physical components and clinical equivalence of a blood collection system, with no mention of AI or ML for data analysis, image processing, or any other function.
No
The device is a blood collection system used for diagnostic purposes, not for treating or rehabilitating a medical condition.
No
This device is a blood collection system intended to collect, separate, transport, and store capillary blood samples for measurement of various analytes. It facilitates the diagnostic process by collecting samples, but it does not perform the diagnosis itself.
No
The device description clearly outlines physical components like a capillary blood collection tube, finger sleeve, lancet, and accessories, indicating it is a hardware-based medical device for blood collection.
Based on the provided information, the BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is specifically intended to collect, separate, transport, and store capillary blood samples for use in the measurement of specific analytes (ALKP, ALT, Sodium, etc.). This directly relates to diagnostic testing performed in vitro (outside the body).
- Device Description: It describes a system designed to provide a serum sample for the measurement of these analytes. The tube contains components (clot activator, gel) that facilitate the preparation of the sample for analysis.
- Performance Studies: The performance studies focus on demonstrating the clinical equivalence of the collected samples to those collected with comparator tubes used for diagnostic testing. This further supports its role in the diagnostic process.
While the device itself is a collection system and not the analytical instrument, it is an essential component in the in vitro diagnostic workflow, providing the sample that will be analyzed to generate diagnostic information. Therefore, it falls under the definition of an IVD device.
N/A
Intended Use / Indications for 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™ 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.
Product codes (comma separated list FDA assigned to the subject device)
JKA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger (for capillary blood samples)
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
Trained healthcare workers in ancillary healthcare facilities and clinical use environments (e.g., retail pharmacies, clinics).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench (Non-Clinical Testing):
Non-clinical tests were conducted to evaluate attributes such as Cap Lid Closure Force, Accidental Drop Seal, Reverse Centrifuge Seal, Transit Vibration Seal, Cap / Container Pull-Off, De-Capping, Tube to Collector Pull-Off Force, Latch Press Force, Tube to Collector Axial Removal Force, Pivot Attachment Force, Collector to Finger Cuff Snap De-Latch, Friction Retention, Barcode Scan (single automation platform), Barcode Label Sutherland Rub Test, and Human Factors/Usability Evaluations. All tests passed, demonstrating that the device functions as designed and that modifications do not impact safety or effectiveness.
Clinical Performance Testing:
The clinical performance evaluation was based on applicable standards, guidance documents, and statistical analyses at predetermined medical decision levels. Studies were performed at internal and/or external sites. Performance tests were conducted to demonstrate that blood specimens collected in MiniDraw™ SST™ Tube produced test results substantially equivalent to both capillary and venous comparator tubes.
- Method Comparison (Clinical Equivalence):
- MiniDraw™ SST™ Tube vs BD Microtainer® SST™ (Capillary Comparator): Demonstrated clinical equivalence at all medical decision levels for all tested analytes.
- MiniDraw™ SST™ Tube vs Greiner Vacuette Serum (Venous Comparator): Concluded that the mean and 95% CI of biases were within Clinical Acceptance Limits (CALs).
- Lot to Lot Variability: Acceptance criteria were met for each selected analyte, confirming the lot variability was acceptable.
- Within-Tube Type Stability: 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.
- Operator Variability: The acceptance criteria were met for each selected analyte, indicating acceptable operator variability.
- Shelf-Life: Evaluated real time aged 9 (+1) months MiniDraw™ SST™ Tubes compared to newly manufactured tubes. Aged tubes demonstrated clinically equivalent performance for selected serum chemistry analytes.
Key results:
- The MiniDraw™ SST™ System met all non-clinical testing requirements, demonstrating functionality and no negative impact on safety or effectiveness.
- Clinical performance testing showed that the MiniDraw™ SST™ System produced test results clinically equivalent to both capillary and venous comparator tubes for the specified analytes.
- Demonstrated acceptable lot-to-lot variability, within-tube stability, and operator variability.
- The 9-month shelf-life was supported by clinical equivalence studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K991702 BD Microtainer® SSTTM
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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"
1
2
(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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3
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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Becton, Dickinson and Company
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.
6
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 for | |||
| 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™ 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 | ||
| MICROTAINER® | |||
| Brand Chemistry | |||
| Tubes with | |||
| MICROGARD™ | |||
| Closures are | |||
| intended to | |||
| collect, transport | |||
| and store skin | |||
| puncture blood | |||
| specimens for | |||
| chemistry | |||
| determination | |||
| requiring serum or | |||
| heparinized | |||
| plasma. | Both devices | ||
| are intended to | |||
| collect, | |||
| transport and | |||
| store blood for | |||
| testing serum | |||
| for chemistry | |||
| analytes. | |||
| MiniDraw™ | |||
| SST™ System | |||
| is intended for | |||
| capillary blood | |||
| collection for | |||
| chemistry | |||
| determinations | |||
| requiring | |||
| serum. It is not | |||
| intended for | |||
| those | |||
| determinations | |||
| requiring | |||
| heparinized | |||
| plasma. | |||
| Characteristic | Subject Device | Predicate | Comparison |
| MiniDraw™ SST™ System | BD Microtainer® | ||
| SST™ | |||
| K991702 | |||
| Intended | |||
| Population | Adults – individuals aged 18 and | ||
| older, limited by correct fit of the | |||
| Finger Sleeve | General Use – all | ||
| populations | Use of the | ||
| MiniDraw™ is | |||
| limited to | |||
| individuals | |||
| aged 18 and | |||
| older whose | |||
| finger | |||
| measurements | |||
| match the | |||
| available sizes | |||
| of Finger | |||
| Sleeves | |||
| Intended Use | |||
| Environment | Ancillary healthcare facilities, | ||
| clinical and laboratory environments | Clinical and | ||
| laboratory | |||
| environments | MiniDraw™ | ||
| SST™ System | |||
| adds ancillary | |||
| healthcare | |||
| facility use | |||
| environment | |||
| Intended User | Trained Healthcare Workers: | ||
| phlebotomists, clinicians, | |||
| pharmacists, pharmacy technicians, | |||
| and other healthcare workers trained | |||
| in the use of the device | Trained | ||
| Healthcare | |||
| Workers: | |||
| phlebotomists and | |||
| clinicians | MiniDraw™ SST™ System | ||
| adds | |||
| pharmacists, | |||
| pharmacy | |||
| technicians, | |||
| and other | |||
| healthcare | |||
| workers trained | |||
| in the use of | |||
| the 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) | Chemistry | ||
| analytes | MiniDraw™ SST™ System | ||
| tests for | |||
| labeled subset | |||
| of analytes in | |||
| the predicate | |||
| devices. | |||
| Characteristic | Subject Device | Predicate | Comparison |
| MiniDraw™ SST™ System | BD Microtainer® | ||
| SSTTM | |||
| K991702 | |||
| Single Use | Yes | Yes | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Centrifugation | Cap Down | Cap Up | MiniDraw™ |
| SST™ System | |||
| is intended for | |||
| centrifugation | |||
| when oriented | |||
| with the cap | |||
| down (reverse | |||
| centrifugation). | |||
| Sample Type | Capillary | Capillary | Identical |
| Additive | Clot activator and gel separator | Clot activator and | |
| gel separator | Identical | ||
| Materials | Container: Polypropylene | ||
| Collector: | |||
| methylAcrylonitrileButedieneStyrene | |||
| (mABS) | |||
| Cap: Polypropylene + Thermoplastic | |||
| elastomer (TPE) | |||
| Finger Sleeve: Polypropylene + | |||
| colorant | Container: | ||
| Polypropylene | |||
| Collector: | |||
| Polypropylene | |||
| Cap: High Density | |||
| Polyethylene | |||
| Finger Sleeve: | |||
| N/A | MiniDraw™ | ||
| SST™ System | |||
| uses various | |||
| different | |||
| materials. | |||
| Container | |||
| Design | Flat bottomed with rounded recessed | ||
| plug | Flat Bottomed | ||
| with rounded | |||
| recessed plug | Identical | ||
| Container | |||
| Dimensions | 13x40mm | 9x40mm | Varies by |
| product | |||
| Finger Sleeve | Yes | N/A | MiniDraw™ |
| SST™ System | |||
| introduces use | |||
| of the Finger | |||
| Sleeve | |||
| Finger Sizing | |||
| Tool | Yes | N/A | MiniDraw™ SST™ System |
| introduces use | |||
| of the finger | |||
| sizing tool | |||
| Characteristic | Subject Device | ||
| MiniDrawTM SSTTM System | Predicate | ||
| BD Microtainer® | |||
| SSTTM | |||
| K991702 | Comparison | ||
| Cap Removal | |||
| Tool | Yes | N/A | MiniDrawTM |
| SSTTM System | |||
| introduces use | |||
| of the cap | |||
| removal tool | |||
| Shelf-Life | 9 months | 15 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 | |
| Analytes/Panels | Both the subject and predicate device are intended to collect, transport |
| and store capillary blood for analysis. The intended use statement for the | |
| predicate refers to "skin prick" collection instead of "capillary" but these | |
| are understood to be equivalent. | |
| MiniDraw™ SST™ System is intended for a narrower subset of targeted | |
| analytes than the BD Microtainer® SST™ (i.e., chemistry). The | |
| selection of analytes included in this submission are supported by | |
| clinical testing which demonstrates that the results are clinically | |
| equivalent. | |
| Because the proposed list of analytes is considered to be a subset of | |
| those cleared for use with the predicate device, this is not considered to | |
| be a new intended use. | |
| Intended | |
| Population | Intended for adult individuals aged 18 and older and whose fingers fit in |
| one of the four finger sleeve sizes. | |
| Addition of | |
| Ancillary | |
| Healthcare Facility | |
| Use Environments | MiniDraw™ SST™ System is intended for use in laboratory and clinical |
| use environments. Blood collection may also occur at ancillary | |
| healthcare facilities (e.g., retail pharmacies, retail clinics). This does not | |
| change the primary use of the device or the intended patient population | |
| and so this use environment does not result in a new intended use. | |
| Whether the intended trained user is capable of using the device | |
| appropriately has been validated (via Human Factors and Clinical | |
| testing). | |
| Difference | Substantial Equivalence to the Predicate |
| Intended User | The device is designed for users who may not have been previously |
| trained in phlebotomy but who are trained in the correct use of the | |
| MiniDrawTM 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 this | |
| difference is not considered a new intended use. The workflow steps of | |
| the subject device have been designed and carefully evaluated to ensure | |
| no new serious adverse events or use-related hazards that may negatively | |
| impact the overall benefit-risk profile of capillary blood collection | |
| devices were introduced when used by the intended users described in | |
| this submission. Human factors testing and clinical evaluations | |
| performed with the targeted user groups demonstrated no increase in risk | |
| of errors in the handling and processing of capillary blood samples (i.e., | |
| centrifuging, storage and transport) and there was no observed increase | |
| in erroneous downstream test results. | |
| Reverse | |
| Centrifugation | MiniDraw™ SSTTM Tube is designed to be centrifuged in the cap down |
| position so that the gel separator and clot are centrifuged into the cap, | |
| which is removed and discarded prior to testing, maximizing the serum | |
| quantity available for sampling and reducing the possibility of probe | |
| contamination during testing. Regardless of the orientation during | |
| centrifugation, the assessment of appropriate gel formation, clot | |
| separation, and absence of leakage during centrifugation/handling are | |
| not new questions of safety or effectiveness. | |
| Materials | The BD MiniDraw™ SST™ 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 of polypropylene as it is molded | |
| in a single piece, and the collector of the MiniDraw™ SST™ Tube is | |
| made from mABS which is a clearer plastic material intended to enhance | |
| blood visualization during collection. The cap on the MiniDraw™ | |
| SSTTM Tube is made from Polypropylene and TPE to ensure seal | |
| integrity during reverse centrifugation. The BD MiniDrawTM Finger | |
| Sleeve, which does not have a matching analog from the predicate | |
| device, is made from polypropylene mixed with colorants that were | |
| found to be both appropriate for the intended use of the device and | |
| compatible with biocompatibility considerations. The assessment of | |
| whether these materials do not negatively impact device performance | |
| nor have any negative effects on clinical results are not new questions of | |
| safety or effectiveness. Non-Clinical Performance testing, Clinical | |
| testing, and Biocompatibility testing demonstrated the devices perform | |
| as intended. | |
| Difference | Substantial Equivalence to the Predicate |
| Container | |
| Dimensions | The container dimensions of the MiniDrawTM SSTTM Tube are designed |
| for optimal functioning of the device. For both the subject and predicate | |
| capillary devices, use of a tube adapter is common to ensure | |
| compatibility with test instruments, and thus tube dimensional | |
| differences do not raise new questions of safety or effectiveness. | |
| Combination | |
| Devices and | |
| Accessories | The MiniDrawTM SSTTM System is a subset of component devices that |
| are intended to be used together during capillary blood collection and | |
| laboratory analysis. The MiniDrawTM SSTTM Tube is designed to be | |
| used in combination with the BD MiniDrawTM Finger Sleeve (available | |
| in four sizes) and three accessories; BD MiniDrawTM Finger Sizing Tool, | |
| BD MiniDrawTM Capillary Tube Adapter SSTTM and BD MiniDrawTM | |
| Cap Removal Tool. The sample volume and quality requirements exist | |
| for a capillary sample regardless of whether a patient's finger is | |
| squeezed by the Finger Sleeve or manually. The Finger Sizing Tool is | |
| optional as correct sizing of the Finger Sleeve may be assessed with the | |
| sleeve itself. Usage of a tube adapter is consistent with the predicate to | |
| make automated processing possible. And the requirement to remove the | |
| tube cap to access the sample also exists regardless of whether it is | |
| removed by hand or with a Cap Removal Tool. Use of the device and | |
| accessories do not raise new questions of safety or effectiveness. | |
| Shelf-Life | Shelf-life durations are based on test data currently available. This |
| difference 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
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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.