(577 days)
Not Found
No
The device is a blood collection tube and does not involve any computational analysis or algorithms.
No.
The device is described as an "in vitro diagnostic medical device" used for the "collection, transportation, and processing of blood in a closed tube" for "trace element testing," which indicates its purpose is for diagnosis or monitoring, not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are plastic, evacuated, sterile, single use, in vitro diagnostic medical devices." They are used for collecting blood specimens for trace element testing, which is a diagnostic purpose.
No
The device description clearly outlines physical components such as plastic tubes, closure assemblies, and chemical coatings (EDTA, silica clot activator). The performance studies also focus on physical attributes and clinical equivalence related to blood collection and trace element testing, not software functionality.
Yes, the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are plastic, evacuated, sterile, single use, in vitro diagnostic medical devices."
N/A
Intended Use / Indications for Use
BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are plastic, evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used in settings where venous blood specimens are collected by trained healthcare professionals for the collection, and processing of blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are used for trace element testing (e.g., Arsenic, Cadmium, Chromium, Copper, Lead, Manganese, Mercury, Selenium, and Zinc).
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The BD Vacutainer® Trace Element K2EDTA Tube is an evacuated plastic blood collection tube. It consists of closure assembly, a plastic tube, and EDTA coating (dipotassium) and is available in two draw sizes, 6 mL (13 x 100 mm) and 3 mL (13 x 75 mm). The plastic tube is manufactured from PET (polyethylene terephthalate) plastic, which enhances user safety and disposal because of the reduced risk of tube breakage and the use of incineration as a method of disposal compared to glass. The EDTA anticoagulant coating is spray-dried on the walls of the tube in the dipotassium (K2) form.
The BD Vacutainer® Trace Element Serum Tube is also an evacuated plastic blood collection tube consisting of a closure assembly, a plastic tube and contains a silica clot activator additive which is spray-dried on the interior walls of the tube. It is available in one draw size, 6 mL (13 x 100 mm). The plastic tube is manufactured from PET (polyethylene terephthalate) plastic.
All of these plastic tubes are closed with a BD Hemogard™ Closure, which consists of a rubber stopper and protective plastic shield to help reduce user exposure to blood. The stopper/closures are color coded to reflect the intended use (Royal Blue for trace element tubes).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
To be used in settings where venous blood specimens are collected by trained healthcare professionals.
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)
Non-clinical performance testing was conducted following defined protocols and with established acceptance criteria to evaluate the following attributes of the BD Vacutainer® Trace Element K2EDTA Tubes and BD Vacutainer® Trace Element Serum Tubes at time-zero and over the proposed shelf life: Draw Volume, X-Value, Second Stopper Pullout, Stopper/Shield Separation, Stopper Leakage, Tube Leakage, Breakage Resistance During Centrifugation, Breakage Resistance During Drop Testing, and Trace Metal Content Testing. Additionally, Ship Testing was conducted to assess the functional performance of the packaging materials. The BD Vacutainer® Trace Element K2EDTA Tubes and BD Vacutainer® Trace Element Serum Tubes 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 substantial equivalence of the subject devices to the predicate devices.
Clinical testing was conducted on whole blood collected in the subject devices (BD Vacutainer® Trace Element K2EDTA Tubes and BD Vacutainer® Trace Element Serum Tubes) and a legally marketed comparator device to demonstrate Clinical Equivalence. Additional clinical testing was completed to evaluate Within-Tube Stability, Shelf-Life Performance, and Repeatability/Reproducibility. Clinical testing results confirmed the devices' functional clinical equivalence in the identification of clinically relevant levels of Arsenic, Cadmium, Chromium, Copper, Lead, Manganese, Mercury, Selenium, and Zinc using these tubes. Results based on pre-determined acceptance criteria demonstrated the BD Vacutainer® Trace Element K2EDTA Tubes and BD Vacutainer® Trace Element Serum Tubes are suitable for use in trace element testing.
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.
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
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July 17, 2023
Becton, Dickinson and Company Angela Mariani Senior Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K213953
Trade/Device Name: BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: March 28, 2023 Received: March 29, 2023
Dear Angela Mariani:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-torres -S
Marianela Perez-Torres, PhD Acting 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
Enclosure
2
Indications for Use
510(k) Number (if known) K213953
Device Name
BD Vacutainer® Trace Element K2EDTA Tube and BD Vacutainer® Trace Element Serum Tube
Indications for Use (Describe)
BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are plastic, evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used in settings where venous blood specimens are collected by trained healthcare professionals for the collection, and processing of blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are used for trace element testing (e.g., Arsenic, Cadmium, Chromium, Copper, Lead, Manganese, Mercurv, Selenium, and Zinc).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY K213953
1.1 Device Name:
BD Vacutainer® Trace Element K2EDTA Tubes and,
BD Vacutainer® Trace Element Serum Tubes
1.2 Summary Preparation Date:
July 7, 2023
1.3 Submitted bv:
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885
Phone: (201) 847-6800
1.4 Contact:
Angela M Mariani Senior Staff Regulatory Affairs Specialist email: angela.mariani(@bd.com
Phone: (201) 847-6800 Work: (240) 704-3084
1.5 Alternate Contact:
Matthew Trachtenberg Associate Director Regulatory Affairs email: matthew.trachtenberg(@bd.com
Phone: (201) 847-6337 Work: (201) 847-6800
Proprietary Names: 1.6
BD Vacutainer® Trace Element K2EDTA Tubes and,
BD Vacutainer® Trace Element Serum Tubes
1.7 Common or Usual Names:
Tubes, Vials, Systems, Serum Separators, Blood Collection
4
1.8 Regulatory Information
Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection Classification Regulation: 21 CFR § 862.1675 Regulatory Class: Class II Product Code: JKA
1.9 Predicate Device
BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K2EDTA Plus Tube (K041071)
Device Establishment 1.10
Becton, Dickinson and Company
Registration Number: 1.11
2243072
1.12 Performance Standards:
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
ANSI/AAMI/ISO 11137-1:2006, A1: 2013, A2 2018 Sterilization of health care products -Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 11137-2: 2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ANSI/AAMI/ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
ANSI/AAMI/ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ANSI/AAMI/ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods -Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ANSI AAMI ST67:2019 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices
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1.13 Intended Use
BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are plastic, evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used in settings where venous blood specimens are collected by trained healthcare professionals for the collection, transportation, and processing of blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are used for trace element testing (e.g., Arsenic, Cadmium, Chromium, Copper, Lead, Manganese, Mercury, Selenium, and Zinc).
1.14 Device Description
The BD Vacutainer® Trace Element K2EDTA Tube is an evacuated plastic blood collection tube. It consists of closure assembly, a plastic tube, and EDTA coating (dipotassium) and is available in two draw sizes, 6 mL (13 x 100 mm) and 3 mL (13 x 75 mm). The plastic tube is manufactured from PET (polyethylene terephthalate) plastic, which enhances user safety and disposal because of the reduced risk of tube breakage and the use of incineration as a method of disposal compared to glass. The EDTA anticoagulant coating is spray-dried on the walls of the tube in the dipotassium (K2) form.
The BD Vacutainer® Trace Element Serum Tube is also an evacuated plastic blood collection tube consisting of a closure assembly, a plastic tube and contains a silica clot activator additive which is spray-dried on the interior walls of the tube. It is available in one draw size, 6 mL (13 x 100 mm). The plastic tube is manufactured from PET (polyethylene terephthalate) plastic.
All of these plastic tubes are closed with a BD Hemogard™ Closure, which consists of a rubber stopper and protective plastic shield to help reduce user exposure to blood. The stopper/closures are color coded to reflect the intended use (Royal Blue for trace element tubes).
1.15 Substantial Equivalence
The subject and predicate device are substantially equivalent as described in Table 1.
6
| Characteristic | BD Vacutainer® Trace
Element K2EDTA Tubes
and
BD Vacutainer® Trace
Element Serum Tubes
(K213953) | BD Vacutainer® Trace
Element Serum Plus
Tubes
and
BD Vacutainer® Trace
Element K2EDTA Tubes
(K041071) | Comparison |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | BD Vacutainer® Trace
Element Serum Tubes and
BD Vacutainer® Trace
Element K2EDTA Tubes are
plastic, evacuated, sterile,
single use, in vitro diagnostic
medical devices. They are
intended to be used in settings
where venous blood
specimens are collected by
trained healthcare
professionals for the
collection, transportation, and
processing of blood in a
closed tube. Blood collected
in the BD Vacutainer® Trace
Element Serum Tubes and
BD Vacutainer® Trace
Element K2EDTA Tubes are
used for trace element testing
(e.g., Arsenic, Cadmium,
Chromium, Copper, Lead,
Manganese, Mercury,
Selenium, and Zinc). | The BD Vacutainer®
Trace Element Serum Plus
Tube and BD Vacutainer®
Trace Element K2EDTA
Tube and are plastic
evacuated blood collection
tubes that provide a means
of collecting, transporting,
and processing blood in a
closed tube. Blood
collected in the BD
Vacutainer® Trace
Element Serum Plus Tube
and BD Vacutainer® Trace
Element K2EDTA Tube is
used for trace element
testing (e.g., Arsenic,
Cadmium, Calcium,
Chromium, Copper, Iron,
Lead, Magnesium,
Manganese, Mercury,
Selenium, and Zinc). | The indications for use
of the subject device is
identical to the cleared
indication for the
predicate device except
that the subject device
indication 1) reduces the
indication scope to
remove Calcium, Iron,
and Magnesium from
trace element testing
because they are not
present in the blood in
trace amounts, and 2)
includes additional
information related to
the intended use setting
and intended user of the
devices. The subject
indication is intended to
be cleared for a subset of
the previously cleared
predicate trace element
indication.
These minor changes do
not result in a new
intended use of the
subject device. |
| Evacuated Blood
Collection Tube | Yes | Yes | Identical |
| Characteristic | BD Vacutainer® Trace
Element K2EDTA Tubes
and
BD Vacutainer® Trace
Element Serum Tubes
(K213953) | BD Vacutainer® Trace
Element Serum Plus
Tubes
and
BD Vacutainer® Trace
Element K2EDTA Tubes
(K041071) | Comparison |
| Tube Dimensions
and Draw Volume | BD Vacutainer® Trace
Element Serum Tube:
13 x 100 mm, 6 mL
BD Vacutainer® Trace
Element K2EDTA Tube:
13 x 100 mm, 6 mL and
13 x 75 mm, 3 mL | BD Vacutainer® Trace
Element Serum Plus Tube:
13 x 100mm, 6 mL
BD Vacutainer® Trace
Element K2EDTA Tube:
13 x 100mm, 6 mL | The predicate tubes were
only available in 13 x
100mm 6 mL draw
volumes. The proposed
devices include a
product line extension to
include a 13 x 75mm 3
mL draw volume version
of the BD Vacutainer®
Trace Element K2EDTA
Tube to meet customer
needs.
This product line
expansion does not raise
new questions of safety
and effectiveness. |
| Sample Type | BD Vacutainer® Trace
Element Serum Tube:
Serum
BD Vacutainer® Trace
Element K2EDTA Tube:
Whole Blood | BD Vacutainer® Trace
Element Serum Plus Tube:
Serum
BD Vacutainer® Trace
Element K2EDTA Tube:
Whole Blood | Identical |
| Additive Type | BD Vacutainer® Trace
Element Serum Tube:
Serum Clot Activator
BD Vacutainer® Trace
Element K2EDTA Tube:
K2EDTA | BD Vacutainer® Trace
Element Serum Plus Tube:
Serum Clot Activator
BD Vacutainer® Trace
Element K2EDTA Tube:
K2EDTA | Identical |
| Additive
Application/Quantity | BD Vacutainer® Trace
Element Serum Tube:
Spray Dried Silica Additive
BD Vacutainer® Trace
Element K2EDTA Tube:
K2EDTA Spray Dried
10.8 mg, 13 x 100 mm, 6 mL
5.4 mg, 13 x 75 mm, 3 mL | BD Vacutainer® Trace
Element Serum Plus Tube:
Spray Dried Silica
Additive
BD Vacutainer® Trace
Element K2EDTA Tube:
K2EDTA Spray Dried
10.8 mg, 13 x 100 mm, 6
mL | The new 3mL K2EDTA
Trace Element tube has a
lower quantity of
K2EDTA, but an
identical additive-to-
blood ratio.
This product line
expansion does not raise
new questions of safety
and effectiveness. |
| Tube Material | PET (polyethylene
terephthalate) plastic | PET (polyethylene
terephthalate) plastic | Identical |
| Tube Closure | BD Hemogard™ /Royal Blue | BD Hemogard™ /Royal
Blue | Identical |
| Characteristic | BD Vacutainer® Trace
Element K2EDTA Tubes
and
BD Vacutainer® Trace
Element Serum Tubes
(K213953) | BD Vacutainer® Trace
Element Serum Plus
Tubes
and
BD Vacutainer® Trace
Element K2EDTA Tubes
(K041071) | Comparison |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Identical |
| Sterility Assurance
Level (SAL) | 10-6 | 10-6 | Identical |
| Shelf Life | 6 mL BD Vacutainer® Trace
Element Serum Tube and
6mL BD Vacutainer® Trace
Element K2EDTA Tube
12 months
3 mL BD Vacutainer® Trace
Element K2EDTA Tube
10 months | 12 months | Shelf-life durations are
based on test data
currently available and
additional testing is
ongoing to support
future shelf-life
extensions. This
difference does not raise
new questions of safety
or effectiveness. |
| Packaging | Unit - tube and closure
Shelf – shrink wrapped
polystyrene tray
Case - corrugated cardboard | Unit - tube and closure
Shelf – shrink wrapped
polystyrene tray
Case - corrugated
cardboard | Identical |
Table 1: Substantial Equivalence Comparison
7
8
Substantial Equivalence Discussion 1.16
Intended Use
The intended use of the subject BD Vacutainer® Trace Element K2EDTA Tubes and BD Vacutainer® Trace Element Serum Tubes is substantially equivalent to the prior cleared indications for use of the BD Vacutainer® Trace Element Serum Plus Tubes and BD Vacutainer® Trace Element K2EDTA Tubes under K041071. They are intended to be used for the collection, transportation, and processing of blood in a closed tube for trace element testing.
The subject device indication for use is for a subset of the previously cleared predicate trace element indications. The subject indication for use statement reduces the scope of trace elements to remove Calcium, Iron, and Magnesium from trace element testing because they are not present in the blood in trace amounts. In addition to this change, there is a minor language change in the subject indications for use which expands on the cleared indication for use to better clarify the intended setting and user of the devices, e.g., to be in settings where venous blood samples would be collected by trained healthcare professionals. These minor changes do not result in a new intended use of the subject device.
Both the subject and predicate device have the same intended use and substantially similar indications for use, meeting the first criteria for a finding of substantial equivalence.
9
Technological Characteristics
Both the subject and predicate tubes have similar technological characteristics. They are plastic, evacuated, sterile, single use, in vitro diagnostic medical devices with Royal Blue BD Hemogard™ closures. There is no change in sterilization method or sterility assurance level for these tubes.
The subject BD Vacutainer® Trace Element Serum Tubes and predicate tubes are available in 6 mL draw volumes and contain the same quantity of spray dried silica additive to ensure clot formation.
The one minor change to the technological characteristics is the introduction of a 3 mL draw BD Vacutainer® Trace Element K2EDTA Tube as an extension to the BD Trace Element Tube line. This new tube size does not introduce any new questions of safety or effectiveness. The additive types and application methods are unchanged. In alignment with this new size offering, the K2EDTA blood-to-additive ratio for the tubes, which is related to the draw volume to ensure adequate anticoagulation of the sample, remains unchanged. This is technologically equivalent and allows for testing on an anticoagulated sample.
Furthermore, performance testing demonstrates that the modifications do not impact the safety or effectiveness of the device over the indicated shelf life and that the subject BD Trace Element tubes continue to perform as intended.
Principles of Operation
Both the subject and predicate tubes are used for the collection of venous whole blood for trace element testing. BD Vacutainer® Trace Element K2EDTA Tubes are designed to provide an anticoagulated sample for trace element testing and BD Vacutainer® Trace Element Serum Tubes are designed to ensure clot formation for trace element testing on serum. The principles of operation are unchanged compared to the predicate device.
1.17 Performance Testing - Bench Summarv
Non-clinical performance testing was conducted following defined protocols and with established acceptance criteria to evaluate the following attributes of the BD Vacutainer® Trace Element K2EDTA Tubes and BD Vacutainer® Trace Element Serum Tubes at time-zero and over the proposed shelf life: Draw Volume, X-Value, Second Stopper Pullout, Stopper/Shield Separation, Stopper Leakage, Tube Leakage, Breakage Resistance During Centrifugation, Breakage Resistance During Drop Testing, and Trace Metal Content Testing. Additionally, Ship Testing was conducted to assess the functional performance of the packaging materials.
The BD Vacutainer® Trace Element K2EDTA Tubes and BD Vacutainer® Trace Element Serum Tubes 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 substantial equivalence of the subject devices to the predicate devices.
10
1.18 Performance Testing - Animal Summary
No animal studies were performed in support of this submission.
1.19 Performance Testing - Clinical Summary
Clinical testing was conducted on whole blood collected in the subject devices (BD Vacutainer® Trace Element K2EDTA Tubes and BD Vacutainer® Trace Element Serum Tubes) and a legally marketed comparator device to demonstrate Clinical Equivalence. Additional clinical testing was completed to evaluate Within-Tube Stability, Shelf-Life Performance, and Repeatability/Reproducibility. Clinical testing results confirmed the devices' functional clinical equivalence in the identification of clinically relevant levels of Arsenic, Cadmium, Chromium, Copper, Lead, Manganese, Mercury, Selenium, and Zinc using these tubes.
Results based on pre-determined acceptance criteria demonstrated the BD Vacutainer® Trace Element K2EDTA Tubes and BD Vacutainer® Trace Element Serum Tubes are suitable for use in trace element testing.
1.20 Conclusion
The technical performance characteristics of the subject device are unchanged. The proposed BD Vacutainer® Trace Element K2EDTA Tubes and BD Vacutainer® Trace Element Serum Tubes and predicate devices have the same intended use, principle of operation, and technological characteristics. Non-Clinical and Clinical Performance Testing sufficiently support the determination of substantial equivalence of the BD Vacutainer® Trace Element K2EDTA Tubes and BD Vacutainer® Trace Element Serum Tubes. Based on information provided in this submission the proposed device is substantially equivalent to the predicate device.