(206 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties for safe blood transfer, with no mention of AI/ML or data processing.
No.
The devices are intended for the collection and transfer of blood for in vitro diagnostic testing, not for treating a disease or medical condition.
No
The devices are described as tools for collecting and transferring blood samples for in vitro diagnostic testing, but they do not perform the diagnostic testing themselves.
No
The device description clearly indicates it is a physical, sterile, single-use device for blood collection and transfer, featuring Luer lock connections. There is no mention of software components.
Based on the provided text, these devices are not IVDs themselves, but they are intended to be used in conjunction with IVD testing.
Here's why:
- Intended Use: Both devices explicitly state their purpose is to collect or transfer blood "for in vitro diagnostic testing." This indicates they are a tool used in the process of obtaining a sample for IVD analysis, but they don't perform the diagnostic test themselves.
- Device Description: The description reinforces that they are for the "safe transfer of blood... for in vitro diagnostic testing."
- Lack of Diagnostic Function: The descriptions focus on the physical mechanism of blood collection and transfer (Luer connections, closed system, needleless). There is no mention of any analytical or diagnostic capabilities within the devices themselves.
- Performance Studies: The performance studies listed are related to the physical integrity and functionality of the devices (torque, leakage, compatibility), not their ability to diagnose or analyze a sample.
In summary, these devices are accessories or tools used in the pre-analytical phase of IVD testing. They facilitate the collection and transfer of the sample that will then be used in an IVD test.
N/A
Intended Use / Indications for Use
BD Vacutainer® Luer-Lok™ Access Device:
The BD Vacutainer® Luer-Lok™ Access Device is a sterile, single-use, noninvasive device intended to be used by healthcare professionals for safe, closed-system venous blood collection from a female Luer of a catheter port or blood collection set, directly into an evacuated blood collection tube(s) for in vitro diagnostic testing. This device may also be used with a blood collection set with a female Luer to collect blood cultures.
BD Vacutainer® Blood Transfer Device:
The BD Vacutainer® Blood Transfer Device is a sterile, single use, noninvasive medical device intended to be used by healthcare professionals for the safe, closed-system, needleless transfer of venous blood from a BD Luer-Lok™ tip syringe into evacuated blood collection tube(s) or blood culture bottle(s) for in vitro diagnostic testing.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The BD Vacutainer® Luer-Lok™ Access Device and the BD Vacutainer® Blood Transfer Device are sterile, single use, non-invasive devices for the safe transfer of blood into an evacuated BD Vacutainer® blood collection tube or BD BACTEC™ blood culture bottle for in vitro diagnostic testing. The only difference between the devices is the BD Vacutainer® Luer-Lok™ Access device features a male Luer lock connection with compatible female Luer catheter port (blood collection set) and the BD Vacutainer® Blood Transfer Device features a female Luer lock for connection with BD Luer-Lok™ syringes.
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
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)
The non-clinical performance tests below were conducted to verify that the proposed devices met all design specifications and performance standards and are each Substantially Equivalent (SE) to the predicate device.
- Torque to Break
- . Torque to Unseat
- NP Cannula Pull Test •
- Air Leakage Test
- Torque to Break .
- Torque to Unseat
- NP Sleeve Function
- Package Integrity test ●
- Peel Strength Test .
- Luer Compatibility as per ISO 594/80369-7.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 10, 2023
Becton Dickinson and Company Sravan Rajamani Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K222478
Trade/Device Name: BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: December 9, 2022 Received: December 12, 2022
Dear Sravan Rajamani:
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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 (OS) 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,
Daniel Walloschek
David Wolloscheck, Ph.D. Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222478
Device Name
BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device
Indications for Use (Describe)
BD Vacutainer® Luer-Lok™ Access Device:
The BD Vacutainer® Luer-Lok™ Access Device is a sterile, single-use, noninvasive device intended to be used by healthcare professionals for safe, closed-system venous blood collection from a female Luer of a catheter port or blood collection set, directly into an evacuated blood collection tube(s) for in vitro diagnostic testing. This device may also be used with a blood collection set with a female Luer to collect blood cultures.
BD Vacutainer® Blood Transfer Device:
The BD Vacutainer® Blood Transfer Device is a sterile, single use, noninvasive medical device intended to be used by healthcare professionals for the safe, closed-system, needleless transfer of venous blood from a BD Luer-Lok™ tip syringe into evacuated blood collection tube(s) or blood culture bottle(s) for in vitro diagnostic testing.
| 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
K222478 - 510(K) SUMMARY
Summary Preparation Date
03/10/2023
Submitted by:
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885
Phone: (201) 847-6800
Contact:
Sravan Rajamani Senior Regulatory Affairs Specialist email: sravan.rajamani@bd.com Work: (201) 847 4719
Proprietary Names:
BD Vacutainer® Luer-Lok™ Access Device BD Vacutainer® Blood Transfer Device
Common or Usual Names:
Blood Collection Tubes, Vials, Systems, Serum Separators
Regulatory Information
Classification Name: Blood specimen collection device Classification Regulation: 21 CFR §862.1675 Review Panel: Clinical Chemistry Class: II Product Code: JKA
Predicate Device(s)
Luer Access Device-holder with Preattached Multiple Sample Adapter (K200027)
4
Device Description
The BD Vacutainer® Luer-Lok™ Access Device and the BD Vacutainer® Blood Transfer Device are sterile, single use, non-invasive devices for the safe transfer of blood into an evacuated BD Vacutainer® blood collection tube or BD BACTEC™ blood culture bottle for in vitro diagnostic testing. The only difference between the devices is the BD Vacutainer® Luer-Lok™ Access device features a male Luer lock connection with compatible female Luer catheter port (blood collection set) and the BD Vacutainer® Blood Transfer Device features a female Luer lock for connection with BD Luer-Lok™ syringes.
| Proposed Device
BD Vacutainer® Luer-LokTM
Access Device | Proposed Device
BD Vacutainer® Blood Transfer
Device | K200027
Luer Access Device-holder with
preattached multiple sample
adapter | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The BD Vacutainer® Luer-LokTM Access Device is a sterile, single- use, noninvasive device intended to be used by healthcare professionals for safe, closed-system venous blood collection from a female Luer of a catheter port or blood collection set, directly into an evacuated blood collection tube(s) for in vitro diagnostic testing. This device may also be used with a blood collection set with a female Luer to collect blood cultures. | The BD Vacutainer® Blood
Transfer Device is a sterile, single use, noninvasive medical device intended to be used by healthcare professionals for the safe, closed-system, needleless transfer of venous blood from a BD Luer-LokTM tip syringe into evacuated blood collection tube(s) or blood culture bottle(s) for in vitro diagnostic testing. | The Luer access device- holder with preattached multiple sample adapter is a sterile, non-invasive device used to connect devices with male or female Luer connectors to blood collection tubes for the collection of blood. | |
| Characteristic | Subject Device | Predicate Device | Comparison |
| | BD Vacutainer® Luer-Lok™
Access Device, BD
Vacutainer® Blood Transfer | Luer Access Device-holder
with preattached multiple
sample adapter | |
| | Device | K200027 | |
| Product Code | JKA | JKA | Same |
| Regulation
Number | 21 CFR 862.1675 | 21 CFR 862.1675 | Same |
| Class | II | II | Same |
| Number of Uses | Single Use | Single Use | Same |
| Material | Hub (Polycarbonate)
Non-patient (NP) Cannula
(Stainless Steel)
Rubber Sleeve (Isoprene
Rubber)
Holder (Polypropylene (PP))
Bonding agent/adhesive* | Luer Lock Male Hub (MABS)
Non-patient Needle/Tube
(Stainless Steel)
Rubber Sleeve (Isoprene
Rubber)
Holder (PP) | Difference in Hub
Material. The use of a
different polymer for
the hub component
does not raise new
questions of safety or
effectiveness of the
device. |
| Label/Labeling | Conform with 21 Part 801 | Conform with 21 Part 801 | Same |
| Length | BTD: 61.98 mm (2.44 in),
LLAD: 63.42 mm (2.50 in) | 60.8±0.2mm | Difference in Length.
This difference does
not affect the
intended use or
performance of the
device or raise new
questions of safety or
effectiveness. |
| ISO 594 | Compliant | Compliant | Same |
| Biocompatibility | ISO 10993 Compliant including:
In vitro toxicitySkin sensitizationIntracutaneous
ReactivityAcute System ToxicityHemocompatibility | ISO 10993 Compliant including:
In vitro toxicitySkin sensitizationIntracutaneous
ReactivityAcute System ToxicityHemocompatibility | Same |
| Sterilization
Method | EO | EO | Same |
| Sterilization
Assurance Level
(SAL) | 10-6 | 10-6 | Same |
| Connector Type | Luer-Lok™ Access Device -
Male Luer
Blood Transfer Device - Female
Luer | Male & Female Luers | Same |
| Characteristic | Subject Device
BD Vacutainer® Luer-Lok™
Access Device and BD
Vacutainer® Blood Transfer
Device | Predicate Device
Luer Access Device-holder
with preattached multiple
sample adapter
K200027 | Comparison |
| Sample Collected | Blood | Blood | Same |
Table 1: Indications for Use
The proposed and predicate device have the same basic indication for use, the collection of a blood sample using a male or female Luer connector on a multiple sample adapter with a preattached holder. All devices use an ISO 594 connector of various gender (male/female) connected to a compatible 6% Luer to transfer blood into an evacuated container (blood collection tube, blood culture bottle) for in vitro diagnostic testing. The differences in the indications statement are in language and do not pose new questions of safety or effectiveness.
Substantial Equivalence
The subject and predicate device are substantially equivalent as described in Table 3.
5
Substantial Equivalence Comparison Table 2:
6
*The clearance for the predicate K200027 did not list the bonding agent used.
Difference in Hub Material: The materials of hub from proposed device are different with predicate device. However, the biocompatibility test for proposed device has been tested and the results comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantial equivalence or safety/effectiveness.
Difference in Length: The length of between the proposed device and predicate device is different. This difference in length is not substantial. This difference does not affect intended use or the performance of the device. Therefore, this difference does not affect substantial equivalence or safety/effectiveness.
Difference in precautions: The proposed Luer-Lok™ Access Device has an added precaution for use in urinalysis to address reported adverse events associated with reasonably foreseeable misuse. This difference does not affect substantial equivalence or safety/effectiveness. This difference does not affect the Blood Transfer Device.
Conclusion: The differences between proposed device and predicated device include materials of manufacture, product length and device labeling. These differences do not raise any question regarding its safety and effectiveness. The differences in technological characteristics may be evaluated through performance testing.
Non-clinical Performance Testing:
1. Performance Testing
ISO 594-1-1986 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
ISO 594-2-1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -Part 2: Lock fittings
EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
EN ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied
EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices
2. Sterilization, Package Integrity, Shipping and Shelf Life
7
EN ISO 11135:2014 Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization Residuals
EN ISO 11737-1:2019 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
3. Biocompatibility
BD Vacutainer® Luer-Lok™ Access Device and BD Vacutainer® Blood Transfer Device are classified as a surface medical devices that comes in contact with intact skin for a limited (≤24 hours) duration.
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 10993-7:2008/AC:2009 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
8
ISO 10993-12:2012 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
ISO 10993-23:2021, Biological Evaluation of Medical Devices - Part 23: Tests for irritation.
Non-clinical Performance Summary
The non-clinical performance tests below were conducted to verify that the proposed devices met all design specifications and performance standards and are each Substantially Equivalent (SE) to the predicate device.
- Torque to Break
- . Torque to Unseat
- NP Cannula Pull Test •
- Air Leakage Test
- Torque to Break .
- Torque to Unseat
- NP Sleeve Function
- Package Integrity test ●
- Peel Strength Test .
- Luer Compatibility as per ISO 594/80369-7.
Clinical Data
Not applicable
Conclusion
Based on the comparison and analysis above and the performance testing conducted, each of the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.