(115 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is for collecting blood for in vitro diagnostic testing, not for treating a disease or condition.
No
The device is a non-invasive medical device used for blood collection for in vitro diagnostic testing, but it does not perform the diagnostic test itself; it is a tool for specimen collection.
No
The device description clearly outlines multiple physical components (cannula, sleeve, luer hub, shields, epoxy) and the performance studies focus on physical and material properties, not software validation.
Based on the provided information, the BD Vacutainer® Multiple Sample Luer Adapter is not an IVD (In Vitro Diagnostic) device itself.
Here's why:
- Intended Use: The intended use states that the device is used "to enable blood collection... for the purpose of in vitro diagnostic testing." This indicates that the device is a tool used in the process of collecting samples for IVD testing, but it does not perform the diagnostic test itself.
- Device Description: The description details a mechanical device for connecting to venous access and puncturing blood collection tubes/bottles. It does not describe any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Function: The device's function is purely for sample collection and transfer. It does not analyze the blood or provide any diagnostic results.
In summary, the BD Vacutainer® Multiple Sample Luer Adapter is a medical device used in the pre-analytical phase of IVD testing (sample collection), but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
The BD Vacutainer® Multiple Sample Luer Adapter is a sterile, single-use, non-invasive medical device intended to be connected with BD Vacutainer® brand needle holders, to enable blood collection from venous access devices, such as needles and blood collection sets or catheters with female luer connectors into blood collection tubes or blood culture bottles for the purpose of in vitro diagnostic testing. These devices are intended to be used by healthcare professionals.
Product codes
JKA
Device Description
The BD Vacutainer® Multiple Sample Luer Adapter consists of a luer-slip fitting (male) which mates with the female Luer connector of venous access devices, and an NP (non-patient) cannula, which punctures the stopper of the evacuated tube(s), or the septum of a blood culture bottle(s) to collect blood.
The NP cannula of the device is lubricated and has a sleeve that recovers over the cannula to prevent leakage during blood collection in-between tubes and/or bottles.
Each end of the device is enclosed in a plastic shield, which join together to fully protect the device. A tamper evident label secures the two shields together and allows identification of whether the sterile barrier has been compromised.
The device consists of the following components:
- Non-patient (NP) Cannula
- Sleeve
- Luer Hub
- NP Shield
- IV Shield
- Epoxy
Note: the IV Shield is intended for maintaining sterility of the luer-slip of the device; there is no IV needle component.
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 intended to be used with any specific population.
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)
Non-clinical Performance Testing:
The non-clinical performance tests below were conducted to verify that the subject device met all design specifications and performance standards, and is substantially equivalent to the predicate device.
- Torque to Break
- NP Cannula Pull Test
- Spinout Test
- IV Shield Pull Force Test
- NP Sleeve Pull-off Force Test
- Tube Push Off Test
- Leakage by Pressure Decay Test
- Sub-Atmospheric Pressure Air Leakage Test
- Stress Cracking Test
- Resistance to Axial Separation Test
- Sterile Barrier Microbial Challenge Test
Biocompatibility Testing:
The subject device is classified as a surface medical device that comes in contact with intact skin for a limited (
§ 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
March 21, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Becton Dickinson and Company Eva Zapletal Sawyer Sr. Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K243649
Trade/Device Name: BD Vacutainer® Multiple Sample Luer Adapter Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: February 18, 2024 Received: February 19, 2025
Dear Eva Zapletal Sawyer:
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
(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); 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-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 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
Sincerely,
David Walloschek
David Wolloscheck, Ph.D. 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
3
Indications for Use
Submission Number (if known)
Device Name
BD Vacutainer® Multiple Sample Luer Adapter
Indications for Use (Describe)
The BD Vacutainer® Multiple Sample Luer Adapter is a sterile, single-use, non-invasive medical device intended to be connected with BD Vacutainer® brand needle holders, to enable blood collection from venous access devices, such as needles and blood collection sets or catheters with female luer connectors into blood collection tubes or blood culture bottles for the purpose of in vitro diagnostic testing. These devices are intended to be used by healthcare professionals.
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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4
BD Vacutainer® Multiple Sample Luer Adapter Traditional 510(k) Integrated Diagnostic Solutions Becton, Dickinson and Company
510(K) SUMMARY - K243649
Summary Preparation Date: March 20, 2025
Submitted by:
Becton Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885 Phone: (201) 847-6800
Contact:
Eva Zapletal Sawyer Senior Regulatory Affairs Specialist Email: Eva.Sawyer@bd.com Work: (410) 372- 7244
Proprietary Names:
BD Vacutainer® Multiple Sample Luer Adapter
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:
BD Vacutainer® Multiple Sample Luer Adapter (K991088)
Performance Standards:
- . EN ISO 13485:2016+A11:2021 Medical devices quality management systems requirements for regulatory purposes
- EN ISO 14971:2019 Medical devices application of risk management to medical devices
- EN ISO15223-1:2021 Medical devices - Symbols to be used with medical devices labels, labeling, and information to be supplied - Part 1: General requirements
5
- EN ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications-Connectors for intravascular or hypodermic applications
- . EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
- EN ISO 15223-1:2021 Medical devices Symbols to be used with information to be supplied . by the manufacturer - Part 1: General requirements
- 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
- EN 556-1:2024 Sterilization of medical devices Requirements for medical devices to be ● designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
- EN ISO 11137-1:2015 /A2:2019 Sterilization of health care products Radiation Part 1: . Requirements for development, validation, and routine control of a sterilization process for medical devices
- EN ISO 11137-2:2015+A1:2023 Sterilization of health care products Radiation Part 2: ● Establishing the sterilization dose
- EN ISO 11737-1:2018 /A1:2021 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- ISO 11737-2:2019 Sterilization of health care products. Microbiological methods-Tests of ● sterility performed in the definition, validation and maintenance of a sterilization process
- EN ISO 10993-1:2020 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process
- . EN ISO 10993-2:2022 Biological evaluation of medical devices – Part 2: Animal welfare requirements
- EN ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests . for interactions with blood
- EN ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
- EN ISO 10993-10:2023 Biological evaluation of medical devices Part 10: Tests for . irritation and skin sensitization
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- EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- . EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- EN ISO 10993-17:2009 Biological evaluation of medical devices Part 17: Establishment of ● allowable limits for leachable substances
- EN ISO 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical ● characterization of medical device materials within a risk management process
- . EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
Device Description
The BD Vacutainer® Multiple Sample Luer Adapter consists of a luer-slip fitting (male) which mates with the female Luer connector of venous access devices, and an NP (non-patient) cannula, which punctures the stopper of the evacuated tube(s), or the septum of a blood culture bottle(s) to collect blood.
The NP cannula of the device is lubricated and has a sleeve that recovers over the cannula to prevent leakage during blood collection in-between tubes and/or bottles.
Each end of the device is enclosed in a plastic shield, which join together to fully protect the device. A tamper evident label secures the two shields together and allows identification of whether the sterile barrier has been compromised.
The device consists of the following components:
- Non-patient (NP) Cannula ●
- Sleeve
- Luer Hub ●
- NP Shield
- IV Shield
- . Epoxy
Note: the IV Shield is intended for maintaining sterility of the luer-slip of the device; there is no IV needle component.
Indications for Use
The BD Vacutainer® Multiple Sample Luer Adapter is a sterile, single-use, non-invasive medical device intended to be connected with BD Vacutainer® brand needle holders, to enable blood collection from venous access devices, such as needles and blood collection sets or
7
catheters with female luer connectors into blood collection tubes or blood culture bottles for the purpose of in vitro diagnostic testing. These devices are intended to be used by healthcare professionals.
The proposed and predicate device have the same basic indication for use, the collection of a blood sample from venous access devices. The clarification of compatible blood collection devices does not raise new questions of safety or effectiveness.
Substantial Equivalence
This Premarket Notification is for the BD Vacutainer® Multiple Sample Luer Adapter which is substantially equivalent to the predicate given that it:
- Has a similar intended use
- Incorporates similar design
- Is manufactured from similar materials ●
- Is similarly provided sterile for single use and with the same sterility assurance level of 10°
- Uses similar scientific technology and operating principles ●
- . Has the same shelf life (3 years)
The subject and predicate device are substantially equivalent as described in Table 1.
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| Characteristic | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | Becton, Dickinson and Company | Same | |
| Device Name | BD Vacutainer® Multiple Sample Luer Adapter | Same | |
| 510(k) No. | Pending | K991088 | N/A |
| Regulation No. | 21 CFR 862.1675 | Same | |
| Product Code | JKA | Same | |
| Device Class | Class II | Same | |
| Regulation Description | Blood Specimen Collection Device | Same | |
| Indications for Use | The BD Vacutainer® Multiple Sample Luer | ||
| Adapter is a sterile, single-use, non-invasive | |||
| medical device intended to be connected with | |||
| BD Vacutainer® brand needle holders, to enable | |||
| blood collection from venous access devices, | |||
| such as needles and blood collection sets or | |||
| catheters with female luer connectors into blood | |||
| collection tubes or blood culture bottles for the | |||
| purpose of in vitro diagnostic testing. These | |||
| devices are intended to be used by healthcare | |||
| professionals. | The Vacutainer® Brand Luer Adapter is a | ||
| sterile, non-invasive device used to | |||
| connect venous access devices such as | |||
| needles, blood collection sets, and | |||
| infusion sets to blood collection tubes. | |||
| They are also used in connection with | |||
| non-needle devices for collection of blood | |||
| from catheters. The Vacutainer® Brand | |||
| Luer Adapter is sold by itself and as a | |||
| component of other Vacutainer® Brand | |||
| devices. | Different; clarification of | ||
| compatible devices does | |||
| not raise questions of | |||
| safety or effectiveness. | |||
| Hub Material | Polystyrene (MIPS 0415) | Same | |
| Cannula Material | Stainless Steel | Same | |
| Non-Patient Sleeve | |||
| Material | Isoprene Rubber (7403/45) | Same | |
| IV Shield Material | Polypropylene (PF511) | Same | |
| Non-Patient Shield | |||
| Material | High Density Polyethylene with | ||
| Hexane Resin (9018) | High Density Polyethylene | Different; No changes | |
| have been made to the | |||
| base resin. Additive | |||
| qualification did not raise | |||
| any questions of safety or | |||
| effectiveness. | |||
| Non-Patient Cannula | |||
| Lubricant | Polydimethylsiloxane (PDMS) –Medical grade silicone | Same | |
| Adhesive | Epoxy | Same | |
| Characteristic | Subject Device | Predicate Device | Comparison |
| Population | Not intended to be used with any specific population. | Same | |
| Nature of Body Contact | Intact Skin and Blood (Indirect Blood Path) | Same | |
| Duration of Use | Transient (Less than 60 minutes) | Same | |
| Condition of Use | Sterile, Single-use | Same | |
| Sterilization Method | Gamma Irradiation | Ethylene Oxide | Different; the device is |
| irradiated to obtain the | |||
| same Sterility Assurance | |||
| Level (10-6) | |||
| Sterility Assurance Level | 10-6 | Same | |
| Shelf Life | 3 years | Same | |
| Biocompatibility | Cytotoxicity, Skin sensitization, Intracutaneous Reactivity, Acute System Toxicity, | ||
| pyrogenicity, hemocompatibility | Same | ||
| Packaging/Sterile Barrier | NP and IV Shield Caps joined at hub; sterility indicated by tamper-evident label | Same |
Table 1. Substantial Equivalence Comparison
9
10
Performance Testing-Bench Summary
Results of the following non-clinical performance, biocompatibility, and sterilization testing validate that the subject device performs as intended over the course of the product shelf life and demonstrates acceptable performance:
Non-clinical Performance Testing:
The non-clinical performance tests below were conducted to verify that the subject device met all design specifications and performance standards, and is substantially equivalent to the predicate device.
- . Torque to Break
- NP Cannula Pull Test
- Spinout Test ●
- IV Shield Pull Force Test ●
- NP Sleeve Pull-off Force Test ●
- Tube Push Off Test ●
- Leakage by Pressure Decay Test ●
- Sub-Atmospheric Pressure Air Leakage Test ●
- Stress Cracking Test ●
- Resistance to Axial Separation Test ●
- Sterile Barrier Microbial Challenge Test
Biocompatibility Testing:
The subject device is classified as a surface medical device that comes in contact with intact skin for a limited (