The BD SmartSite™ Needle-Free Connector (NFC) is a sterile, single patient use connector for needle free access to the IV line and/or IV catheter during IV therapy. The BD SmartSite™ NFC can be used for direction, intermittent infusion and/or the continuous infusion of fluids, drugs, IV nutrition, lipids, and/or blood/blood products or the aspiration of blood. The BD SmartSite™ NFC may be used with power injector procedures to a maximum pressure of 325 psi up to a flow rate of 10 mL per second.

Device Description

The BD SmartSite™ NFC allows the user to add medication into the primary line without the use of a needle. It consists of a female luer on one side and a male luer connection on the other side. Both connections have locking threads. The connector has a silicone valve inside which is in an expanded position in the free state. When the male luer end of a compatible vascular access device is attached securely to the female luer of the SmartSite connector, the valve/piston is compressed which opens the fluid pathway. This open pathway allows administration of fluids as well as aspiration through the connector without the use of a needle.

AI/ML Overview

This FDA 510(k) summary describes the BD SmartSite™ Needle-Free Connector (NFC) and its equivalence to a predicate device. The information provided is for a medical device (intravascular administration set) and does not involve AI or algorithms, human readers, or image analysis. Therefore, many of the requested categories in your prompt are not applicable to this document.

However, I can extract and present the relevant information that is available:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly list "acceptance criteria" alongside "reported device performance" in a direct table format for each performance claim. Instead, it describes "equivalence discussion" which implies the subject device met the criteria established by the predicate device or a new test. The performance attributes and the testing conducted to support them are discussed.

Performance Attribute	Predicate Device Performance (K061285)	Subject Device Claim (BD SmartSite™ NFC)	Equivalence Discussion / Supporting Study
Duration of Use	72 hours; 24 hours for infusions of blood, blood products or lipids emulsions	7 days (168 hours) or 200 activations, whichever occurs first	Different. Verification testing was conducted to extend the device duration (to 7 days) and include all intended fluids per indications. See Section 18 for Harsh Infusate testing.
Sterilization Claim	Fluid Path Sterile	Content Sterile	Different. Package integrity testing was conducted to verify the sterile barrier claim.
Number of Valve Activations	100	200	Different. Verification conducted to extend the number of valve activations.
Disinfection Swab Time	Swab top of port for 1-2 seconds with 70% IPA, allow 30 seconds to dry	Swab top of access surface for 2-5 seconds with 70% IPA, allow to dry	Different. The longer swab time does not raise new or different questions of safety or effectiveness.
Priming Volume	0.11 mL	0.1 mL	Equivalent. The priming volume is within the specification of the predicate and has no impact on functional or performance characteristics.
Indication for Use (Blood Aspiration)	Includes fluids, medication, blood and blood products	Includes aspiration of blood (in addition to fluids, drugs, IV nutrition, lipids, and/or blood/blood products)	Different. Mechanical hemolysis and blood compatibility testing was conducted to verify the blood aspiration claim.
Particulate Testing	(Not explicitly stated for predicate)	Meets USP <788> requirements	Tested to demonstrate the product meets particulate requirements of United States Pharmacopeia, National Formulary (USP), General Chapter <788>, Particulate Matter in Injections.
Biocompatibility	Biocompatible per ISO 10993-1	Biocompatible for the intended use per ISO 10993-1	Evaluated for biocompatibility appropriate to the contact characterization (externally communicating, blood path (indirect) for prolonged duration). Testing performed according to ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23, ISO 8536-4, USP <788>.
Sterilization	Radiation (SAL 10-6)	Radiation (SAL 10-6)	Same. Sterilization and shelf-life testing completed in accordance with ISO 11137-1, ISO 11137-2, USP <85>, USP <161>, ANSI/AAMI ST72.
Shelf-Life	3 years	3 years	Same. Data supports a shelf-life claim of 3 years. Shelf-life testing includes packaging tests (ASTM F1886, ASTM F88/F88M-21, ASTM F2096, ASTM F1929, internal tests for Seal Transfer Width, Ink Legibility, Label Adhesion) and ISO 11607-1, ISO 11607-2.
General Performance	(Implied by predicate clearance)	Complies with ISO 8536-4, ISO 594-1, ISO 594-2	Performance testing was conducted to verify compliance with relevant sections of ISO 8536-4, ISO 594-1, ISO 594-2.
Microbial Ingress	(Implied by predicate clearance)	Meets FDA guidance	Microbial ingress testing performed based on FDA guidance document "Intravascular Administration Sets Premarket Notification Submissions [510(k)], July 11, 2008".
Harsh Infusates	(Not explicitly stated for predicate)	Device tests for multiple days with worst case infusates	Additional performance testing was conducted to simulate use with fluids, specifically Harsh Infusates testing. This supports the extended duration of use claim.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document is a 510(k) summary for a medical device. It does not provide specific sample sizes for test sets (e.g., number of devices tested for each performance criterion) or data provenance details like country of origin or retrospective/prospective nature. This level of detail is typically found in the full submission, not the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes a physical medical device, not an AI/algorithm-based diagnostic tool requiring expert ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reasons as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the document describes a physical medical device and does not involve AI or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the document describes a physical medical device and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given this is a physical medical device, "ground truth" as typically defined for AI/diagnostic studies is not directly applicable. The "truth" for device performance is established through adherence to recognized standards (e.g., ISO, USP, ASTM) and successful completion of specific verification and validation tests as outlined. For instance:

Biocompatibility: Demonstrated by passing tests defined in ISO 10993 series.
Sterilization: Demonstrated by meeting requirements of ISO 11137 series and USP chapters.
Performance: Demonstrated by compliance with ISO 8536-4, ISO 594-1, ISO 594-2, and internal test protocols for specific claims (e.g., Harsh Infusates, Microbial Ingress, Valve Activations).
Particulate Matter: Demonstrated by meeting USP <788>.
Package Integrity/Shelf Life: Demonstrated by passing tests defined in ISO 11607 series and ASTM standards.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device and does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This is not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

April 7, 2023

CareFusion Jacob Lee Sr. Manager Regulatory Affairs 10020 Pacific Mesa Blvd San Diego, California 92121

Re: K223088

Trade/Device Name: BD SmartSite™ Needle-Free Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: March 8, 2023 Received: March 8, 2023

Dear Jacob Lee:

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 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

{1}------------------------------------------------

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.

David 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) K223088

Device Name BD SmartSite™ Needle-Free Connector

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the word "CareFusion" in gray text. Below the word "CareFusion" are the words "has joined BD" in a smaller, lighter font.

K223088 -0(k) Summarv

Submitter Information

Submitter:

Contact Person: Phone: Email: Date Prepared:

CareFusion 10020 Pacific Mesa Blvd. San Diego, CA 92121, USA Jacob Lee 385-255-0184 iacob.lee@bd.com April 7, 2023

Subject Device Identification

Trade Name:
Common Name:
Classification Name:
Classification Panel:
Regulation Number:
Regulatory Class:
Product Code:

BD SmartSite™ Needle-Free Connector Intravascular Administration Set Intravascular Administration Set General Hospital 21 CFR 880.5440 Class II FPA

Predicate Device Identification

SmartSite™ Needle-Free Valve Trade Name: Common Name: Intravascular Administration Set Classification Name: Intravascular Administration Set Classification Panel: General Hospital Regulation Number: 21 CFR 880.5440 Regulatory Class: Class II Product Code: FPA CareFusion, Inc. Manufacturer: 510k Number: K061285 510K Clearance Date: July 26, 2006

Reason for Submission

The objective of this submission is to introduce new labeling claims. Specifically, the following claims are proposed to be added to the labeling:

Duration of use to 7 days (168 hours) or 200 activations, whichever occurs first ●
Sterility claim from fluid path sterile to content sterile ●
. Update disinfection swab time

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for CareFusion. The logo features an orange circle with a white shield-like shape inside, with a small orange accent in the upper right corner. To the right of the circle is the name "CareFusion" in a dark gray, sans-serif font. Below the name, in smaller, lighter gray font, is the phrase "has joined BD".

Device Description

Indication for Use

The BD SmartSite™ Needle-Free Connector (NFC) is a sterile, single patient use connector for needle free access to the IV line and/or IV catheter during IV therapy. The BD SmartSite™ NFC can be used for direct injection, intermittent infusion and/or the continuous infusion of fluids, drugs, IV nutrition, lipids, and/or blood/blood products or the aspiration of blood. The BD SmartSite™ NFC may be used with power injector procedures to a maximum pressure of 325 psi up to a flow rate of 10 mL per second.

Technological Characteristics

The following table presents an overview of comparisons between the subject device and the predicate device.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the logo for CareFusion. The logo features an orange circle with a white shield inside on the left. To the right of the logo is the name "CareFusion" in a sans-serif font. Below the name, in smaller letters, is the phrase "has joined BD".

Attributes	Subject:BD SmartSite™ Needle-FreeConnector	SmartSite Needle Free Valve(K061285)	Equivalence Discussion
FDA Reg.Number	21 CFR 880.5440	21 CFR 880.5440	Same
FDA RegulationName	Intravascular Administration Set	Intravascular Administration Set	Same
FDA Class	Class II	Class II	Same
FDA ProductCode	FPA	FPA	Same
Indication foruse	The BD SmartSite™ Needle-FreeConnector (NFC) is a sterile, singlepatient use connector for needle freeaccess to the IV line and/or IVcatheter during IV therapy. The BDSmartSite™ NFC can be used fordirect injection, intermittent infusionand/or the continuous infusion offluids, drugs, IV nutrition, lipids,and/or blood/blood products or theaspiration of blood. The BDSmartSite™ NFC may be used withpower injector procedures to amaximum pressure of 325 psi up to aflow rate of 10 mL per second.	The SmartSite Needle Free ValveAdministration Sets are intended foruse in today's growing professionalhealthcare environment includinghealthcare facilities, home care, andmedical transport that utilize infusionsystems for the delivery of fluids,medication, blood and blood products.The SmartSite valve allows the user toadd medication into the primary linewithout the use of a needle. TheSmartSite valve also be used with lowpressure power injectors rated for amaximum setting of 325 psi.	Different – mechanicalhemolysis and bloodcompatibility wasconducted to verify bloodaspiration claim
Attributes	Subject:BD SmartSite™ Needle-FreeConnector	SmartSite Needle Free Valve(K061285)	Equivalence Discussion
DeviceComponents /Materials	SmartSite Body and Male Luer:Acrylic Multi-polymer (GS90)	SmartSite Body and Male Luer:Acrylic Multi-polymer (GS90)	Same
	SmartSite Female Luer:Isoplast (2530 Polyeurethane)	SmartSite Female Luer:Isoplast (2530 Polyeurethane)
	Piston: Silicone (Elastosil LR3003/80)	Piston: Silicone (Elastosil LR3003/80)
	Lubricant (piston opening): Siliconefluid (FS-1265 Fluorosilicone Fluid)	Lubricant (piston opening): Siliconefluid (FS-1265 Fluorosilicone Fluid)
	Lubricant: Silicone fluid (550 SiliconeFluid)	Lubricant: Silicone fluid (550 SiliconeFluid)
PackagingConfiguration	Each device is individually packaged inpouches. Fifty (50) pouches and one(1) Directions for Use per dispenserbox. Two (2) dispenser boxes pershipper box.	Each device is individually packaged inpouches. Fifty (50) pouches and one(1) Directions for Use per dispenserbox. Two (2) dispenser boxes pershipper box.	Same
SterilizationMethod	Radiation (SAL 10-6)	Radiation (SAL 10-6)	Same
SterilizationClaim	Content Sterile	Fluid Path Sterile	Different - Packageintegrity testing wasconducted to verify sterilebarrier claim.
Biocompatibility	Biocompatible for the intended useper ISO 10993-1	Biocompatible for the intended useper ISO 10993-1	Same
Non-Pyrogenic	Yes	Yes	Same
Non-DEHP	Yes	Yes	Same
No NaturalRubber Latex	Yes	Yes	Same
Attributes	Subject:BD SmartSite™ Needle-FreeConnector	SmartSite Needle Free Valve(K061285)	Equivalence Discussion
Duration of Use	7 days (168 hours)	72 hours; 24 hours for infusions ofblood, blood products or lipidsemulsions	Different - All intendedfluids per indicationsextended to 7 dayduration. verificationtesting was conducted toextend the deviceduration. See Section 18for Harsh Infusatetesting.
Priming Volume	0.1 mL	0.11 mL	Equivalent - the primingvolume is within thespecification of thepredicate and has noimpact on functional orperformancecharacteristics.
ResidualVolume	0 mL	0 mL	Same
Number ofValveActivations	200	100	Different – verificationconducted to extendnumber of valveactivations.
Method ofDisinfection	Prior to every access, swab top of NFCaccess surface for 2 - 5 seconds with70% isopropyl alcohol and allow todry	Prior to every access, swab top ofNeedle-Free Valve port with 70%isopropyl alcohol (1 – 2 seconds) andallow to dry (approximately 30seconds)	Different - the longerswab time does not raisenew or differentquestions of safety oreffectiveness.
Power InfusionFlow Rate	≤ 325 psi; 10 mL/s	Maximum 325 psi	Equivalent
Use	Single Patient Use	Single Patient Use	Same
Shelf Life	3 years	3 years	Same

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in dark gray. Below the text, there is a smaller text that says "has joined BD".

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside on the left. To the right of the circle is the word "CareFusion" in gray text. Below the word "CareFusion" are the words "has joined BD" in a smaller, lighter gray font.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. Below the text, there is smaller text that says "has joined BD".

Substantial Equivalence Discussion:

Design verification testing was performed to demonstrate that the subject device is equivalent to the predicate device. All test results met their acceptance criteria and support that the BD SmartSite™ NFC is safe and effective and is substantially equivalent to the predicate SmartSite Needle Free Valve. The subject device and the predicate have the equivalent indications for use and intended use. Both devices are sterilized via irradiation and are single patient use devices.

Both the subject and predicate devices have the same principle of operation. The primary technological differences between the subject device and the predicate are similar. The BD SmartSite™ NFC has a longer duration of use (up to 7 days or 200 activations, whichever comes sooner). The BD SmartSite™ NFC is also claiming content sterile and the predicate claims fluid path sterile.

The BD SmartSite™ NFC contains minor differences in technological characteristics when compared to the predicate device, these differences do not change the intended use and do not raise new questions of safety and effectiveness as supported by verification testing.

Discussion of Non-Clinical Tests:

The BD SmartSite™ NFC, like the predicate device, was evaluated for biocompatibility appropriate to the contact characterization (externally communicating, blood path (indirect) for prolonged duration (> 24 hours to 30 days)). Testing is performed in accordance with the requirements of ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and the FDA Guidance for Industry - Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Specific testing included:

. ISO 10993-4:2017 Biological evaluation of medical device - Part 4: Selection of tests for interactions with blood
. ISO 10993-5:2009 Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2021 Biological evaluation of medical device – Part 10: Tests for skin sensitization
. ISO 10993-11:2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity
. ISO 10993-23:2021 Biological evaluation of medical device - Part 23: Test for irritation

Other standards followed included:

ISO 8536-4:2019 Infusion equipment for medical use Part 4: Infusion Sets for . Single Use Gravity Feed, Section 8 Chemical and Biological Requirements

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image contains the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in a dark gray sans-serif font. Below the text, in a smaller font, it says "has joined BD".

USP <788>:2021 Particulate Matters in Injection

Particulate Testing:

The BD SmartSite™ NFC was tested to demonstrate the product meets particulate requirements of United States Pharmacopeia, National Formulary (USP), General Chapter <788>, Particulate Matter in Injections (Current Standard).

Sterilization and Shelf Life:

The subject device is radiation sterilized and data supports a shelf-life claim of 3 years. Sterilization and shelf-life testing were completed in accordance with the following FDA recognized guidelines:

Sterilization:

. ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
ISO 11137-2:2013 Sterilization of health care products Radiation Part 2: ● Establishing the sterilization dose
United States Pharmacopeia, National Formulary (USP), General Chapter <85>, Bacterial Endotoxins Test
. United States Pharmacopeia, National Formulary (USP), General Chapter <161>, Medical Devices - Bacterial Endotoxin and Pyrogen Tests
ANSI/AAMI ST72:2019 - Bacterial endotoxins - Test methods, routine monitoring and alternatives to batch testing

Shelf-Life:

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
Package testing included:
- Standard Test Method for Determining Integrity of seals for Flexible o Packaging by Visual Inspection: ASTM F1886
- Standard Test Method for Seal Strength of Flexible Barrier Materials: ASTM o F88/F88M-21
- Seal Transfer Width: Internal testing O
- Bubble Leak Detection Test: ASTM F2096 and ASTM F2096-11 O
- Ink Legibility: Internal testing O
- Standard Test Method for Thickness Measurement of Flexible Packaging o Material: ASTM F2251-13

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. Below the text, in smaller font, it says "has joined BD".

O Label Adhesion: Internal Testing
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging O by Dye Penetration: ASTM F1929

Performance Testing:

The BD SmartSite™ NFC was tested to verify compliance with the relevant sections of the following standards:

ISO 8536-4:2019 Infusion equipment for medical use Part 4: Infusion sets for . single use, gravity feed
ISO 594-1: 1986 Conical fittings with a 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

Microbial Ingress Testing:

Microbial ingress was performed based on the following FDA quidance document:

Guidance for Industry and FDA staff; Intravascular Administration Sets Premarket . Notification Submissions [510(k)], July 11, 2008
Additional performance testing was conducted to simulate use with fluids:
Harsh Infusates testing: Device tests for multiple days with worst case infusates ●

Clinical Data:

There are no clinical data included in this submission.

Conclusion:

The information in this submission supports the safety and efficacy of the subject device for its intended use and demonstrates substantial equivalence with the predicate device. The BD SmartSite™ NFC differences in geometry, materials and sterilization claim do not raise new questions of safety and effectiveness.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.