(189 days)
Not Found
No
The device description and performance studies focus on the mechanical function and material properties of a needle-free connector, with no mention of AI or ML.
No.
The device is a connector for IV lines, facilitating the administration and aspiration of fluids, but it does not directly treat or diagnose a disease or condition. It is a component of a therapy delivery system, not a therapeutic device itself.
No
The device is a needle-free connector for IV therapy, designed for administering fluids and aspirating blood, not for diagnosing medical conditions.
No
The device description clearly outlines a physical connector with a silicone valve, indicating it is a hardware device, not software only.
Based on the provided information, the BD SmartSite™ Needle-Free Connector is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the IV line and/or IV catheter for the administration and aspiration of fluids, drugs, and blood products. This is a direct interaction with the patient's circulatory system for therapeutic purposes.
- Device Description: The description details a mechanical connector with a valve for fluid pathway control. It does not involve the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The BD SmartSite™ NFC is a medical device used in the delivery of therapy, not for diagnostic purposes.
N/A
Intended Use / Indications 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 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.
Product codes
FPA
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.
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
Not Found
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)
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.
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
Particulate Testing:
The BD SmartSite™ NFC was tested to demonstrate the product meets particulate requirements of United States Pharmacopeia, National Formulary (USP), General Chapter , 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 , Bacterial Endotoxins Test
- . United States Pharmacopeia, National Formulary (USP), General Chapter , 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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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)
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.
| 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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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
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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.
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.
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| Attributes | Subject:
BD SmartSite™ Needle-Free
Connector | SmartSite Needle Free Valve
(K061285) | Equivalence Discussion |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Reg.
Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| FDA Regulation
Name | Intravascular Administration Set | Intravascular Administration Set | Same |
| FDA Class | Class II | Class II | Same |
| FDA Product
Code | FPA | FPA | Same |
| 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. | The SmartSite Needle Free Valve
Administration Sets are intended for
use in today's growing professional
healthcare environment including
healthcare facilities, home care, and
medical transport that utilize infusion
systems for the delivery of fluids,
medication, blood and blood products.
The SmartSite valve allows the user to
add medication into the primary line
without the use of a needle. The
SmartSite valve also be used with low
pressure power injectors rated for a
maximum setting of 325 psi. | Different – mechanical
hemolysis and blood
compatibility was
conducted to verify blood
aspiration claim |
| Attributes | Subject:
BD SmartSite™ Needle-Free
Connector | SmartSite Needle Free Valve
(K061285) | Equivalence Discussion |
| Device
Components /
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): Silicone
fluid (FS-1265 Fluorosilicone Fluid) | Lubricant (piston opening): Silicone
fluid (FS-1265 Fluorosilicone Fluid) | |
| | Lubricant: Silicone fluid (550 Silicone
Fluid) | Lubricant: Silicone fluid (550 Silicone
Fluid) | |
| Packaging
Configuration | Each device is individually packaged in
pouches. Fifty (50) pouches and one
(1) Directions for Use per dispenser
box. Two (2) dispenser boxes per
shipper box. | Each device is individually packaged in
pouches. Fifty (50) pouches and one
(1) Directions for Use per dispenser
box. Two (2) dispenser boxes per
shipper box. | Same |
| Sterilization
Method | Radiation (SAL 10-6) | Radiation (SAL 10-6) | Same |
| Sterilization
Claim | Content Sterile | Fluid Path Sterile | Different - Package
integrity testing was
conducted to verify sterile
barrier claim. |
| Biocompatibility | Biocompatible for the intended use
per ISO 10993-1 | Biocompatible for the intended use
per ISO 10993-1 | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Non-DEHP | Yes | Yes | Same |
| No Natural
Rubber Latex | Yes | Yes | Same |
| Attributes | Subject:
BD SmartSite™ Needle-Free
Connector | SmartSite Needle Free Valve
(K061285) | Equivalence Discussion |
| Duration of Use | 7 days (168 hours) | 72 hours; 24 hours for infusions of
blood, blood products or lipids
emulsions | Different - All intended
fluids per indications
extended to 7 day
duration. verification
testing was conducted to
extend the device
duration. See Section 18
for Harsh Infusate
testing. |
| Priming Volume | 0.1 mL | 0.11 mL | Equivalent - the priming
volume is within the
specification of the
predicate and has no
impact on functional or
performance
characteristics. |
| Residual
Volume | 0 mL | 0 mL | Same |
| Number of
Valve
Activations | 200 | 100 | Different – verification
conducted to extend
number of valve
activations. |
| Method of
Disinfection | Prior to every access, swab top of NFC
access surface for 2 - 5 seconds with
70% isopropyl alcohol and allow to
dry | Prior to every access, swab top of
Needle-Free Valve port with 70%
isopropyl alcohol (1 – 2 seconds) and
allow to dry (approximately 30
seconds) | Different - the longer
swab time does not raise
new or different
questions of safety or
effectiveness. |
| Power Infusion
Flow 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 |
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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".
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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.
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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
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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 :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 , 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 , Bacterial Endotoxins Test
- . United States Pharmacopeia, National Formulary (USP), General Chapter , 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.