(166 days)
Vial access devices with SmartSite™ are standalone, single-vial use, disposable devices which provide access to a medication vial without the use of a needle during medication preparation. BD standalone vial access devices are not intended to be used on a patient.
Vial access devices with SmartSite™ are standalone, single-vial use, disposable devices which permit access to a medication vial without the use of a needle during medication preparation. Vial access devices with needle-free connectors are available in two configurations: 13 mm or 20 mm.
The provided text describes a 510(k) premarket notification for a medical device, the "BD SmartSite™ 13mm Vial Access Device" and "BD SmartSite™ 20mm Vial Access Device." This document focuses on demonstrating substantial equivalence to a predicate device rather than outright performance against specific acceptance criteria for a novel device or AI algorithm.
Therefore, the typical structure for acceptance criteria and human-in-the-loop studies for AI algorithms is not applicable to this document. This submission details the safety and performance testing to show that a new version of a device (subject device) is comparable to an already cleared device (predicate device).
Here's an analysis of the provided information, framed within the context of demonstrating substantial equivalence, and noting where the requested AI-specific information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of a specific table for acceptance criteria vs. device performance for a novel AI device, this document lists various bench and non-clinical tests performed according to recognized consensus standards. The "acceptance criteria" here implicitly refer to meeting the specifications of these standards to demonstrate safe and effective performance, thus supporting substantial equivalence.
| Acceptance Criteria (Implicitly, meeting standard specifications) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: | Met applicable test specifications. |
| - Cytotoxicity (ISO 10993-5) | |
| - Genotoxicity (ISO 10993-3) | |
| - Sensitization (ISO 10993-10) | |
| - Irritation / Intracutaneous Reactivity (ISO 10993-23) | |
| - Acute Systemic Toxicity (ISO 10993-11) | |
| - Sub-acute/ Sub-chronic Toxicity (ISO 10993-11) | |
| - Material Mediated Pyrogenicity (ISO 10993-11) | |
| - Hemolysis Indirect (ISO 10993-4) | |
| - Chemical Requirements (ISO 8536-4) | |
| Physical/Functional Performance: | Met applicable test specifications. |
| - Conical fittings (ISO 594-1, ISO 594-2, ISO 80369-7) | |
| - Transfer set requirements (ISO 22413) | |
| - Particulate requirements (USP <788>) | Met particulate requirements. |
| - Microbial Ingress (FDA guidance, Harsh Infusates testing) | |
| - Packaging Integrity (ISO 11607-1, ISO 11607-2, ASTM F2096) | |
| Sterilization: | Met applicable test specifications. |
| - Radiation sterilization (ISO 11137-1, 11137-2, 11137-3) | |
| - Microbiological methods (ISO 11737-1, 11737-2) |
The document states: "All test results met their acceptance criteria and support that the BD SmartSite™ Vial Access Device is substantially equivalent to the predicate SmartSite Access Pin."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test. It lists the standards followed (e.g., ISO, ASTM, USP), which inherently define the methodologies and often the sample sizes for such tests.
Data provenance isn't described in terms of "country of origin" or "retrospective/prospective" as typical for clinical data or AI training data. Instead, the tests were conducted according to recognized international standards and FDA guidance documents.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is not an AI algorithm requiring expert ground truth for image interpretation or similar tasks. The "ground truth" for these tests are the objective measurements against the specified performance parameters in the standards (e.g., proper fitting, no leaks, meeting particulate limits, etc.).
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3. Testing involves objective measurements and adherence to specified standard protocols, not subjective expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is an intravenous administration set component, not an AI algorithm, and therefore no MRMC study or AI assistance evaluation was performed or required.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical and bench testing presented in this submission is based on objective measurements defined by the referenced national and international consensus standards (e.g., ISO, ASTM, USP). Examples include:
- Measurement of luer taper conformance.
- Detection of leaks using specific pressure tests.
- Counting particulate matter within specified limits.
- Assessment of biological responses in accordance with biocompatibility standards (e.g., cytotoxicity, sensitization).
- Validation of sterilization efficacy.
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as point 8.
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March 6, 2024
CareFusion Stefanee Smith Senior Regulatory Affairs Specialist 10020 Pacific Mesa Blvd. San Diego, California 92121
Re: K233021
Trade/Device Name: BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device
Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: February 5, 2024 Received: February 5, 2024
Dear Stefanee Smith:
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"
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(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.
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).
Sincerely.
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,
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General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K233021
Device Name
BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device
Indications for Use (Describe)
Vial access devices with SmartSite™ are standalone, single-vial use, disposable devices which provide access to a medication vial without the use of a needle during medication preparation. BD standalone vial access devices are not intended to be used on a patient.
| 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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K233021-510(k) Summary
Submitter Information
Submitter:
| Contact Person: |
|---|
| Phone: |
| Email: |
| Date Prepared: |
CareFusion 10020 Pacific Mesa Blvd. San Diego, CA 92121, USA Stefanee Smith 717-330-6037 stefanee smith@bd.com March 6, 2024
Subject Device Identification
| Trade Name: | BD SmartSite™ 13mm Vial Access Device |
|---|---|
| BD SmartSite™ 20mm Vial Access Device | |
| Common Name: | IV Fluid Transfer Set |
| Regulation Name: | Intravascular Administration Set |
| Review Panel: | General Hospital |
| Regulation Number: | 21 CFR 880.5440 |
| Regulatory Class: | Class II |
| Product Code: | LHI |
Predicate Device Identification
| Trade Name: | SmartSite Access Pin |
|---|---|
| Common Name | IV Fluid Transfer Set |
| Regulation Name: | Intravascular Administration Set |
| Review Panel: | General Hospital |
| Regulation Number: | 21 CFR 880.5440 |
| Regulatory Class: | Class II |
| Product Code: | LHI and FPA |
| Manufacturer: | IVAC Holdings, Incorporated (Now BD) |
| 510k Number: | K970485 |
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Device Description
Vial access devices with SmartSite™ are standalone, single-vial use, disposable devices which permit access to a medication vial without the use of a needle during medication preparation. Vial access devices with needle-free connectors are available in two configurations: 13 mm or 20 mm.
Intended Use
The BD SmartSite™ Vial Access Device is for use with medication vials and mating luer access devices for withdrawal and/or injection of fluid.
Indications for Use
Vial access devices with SmartSite™ are standalone, single-vial use, disposable devices which provide access to a medication vial without the use of a needle during medication preparation. BD standalone vial access devices are not intended to be used on a patient.
Technological Characteristics
The BD SmartSite™ Vial Access Device was shown to be substantially equivalent to the predicate device cleared under K970485. Differences in technological characteristics such as the material were addressed through biocompatibility and performance testing. The following table presents an overview of comparisons between the subject and predicate device.
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Technological Characteristics and Substantial Equivalence
The following table provides an overview of comparisons between the subject and the predicate device.
| Attributes | Subject Device:BD SmartSite™ 13mm VialAccess Device;BD SmartSite™ 20mm VialAccess Device | Predicate Device:SmartSite Access Pin | Equivalence Discussion |
|---|---|---|---|
| 510(k) Status | K233021 | K970485Clearance date April 21, 1997 | N/A |
| Applicant | CareFusion (Now BD) | IVAC Holdings, Incorporated(Now BD) | N/A |
| ModelNumber(s) | 2203E and 2205E | 2202E | N/A |
| Indications foruse | Vial Access devices withSmartsite™ are standalone,single-vial use, disposabledevices which provide accessto a medication vial withoutthe use of a needle duringmedication preparation. BDstandalone vial accessdevices are not intended tobe used on a patient. | The SmartSite Access Pin isintended to be used forintravenous administration ofdrugs and fluids (e.g., blood,lipids, saline, and dextrose). | Similar – The exception being the subjectdevice is only used for medicationpreparation and not intended to be usedon a patient. The difference does notraise different questions of safety andeffectiveness. |
| Attributes | Subject Device:BD SmartSite™ 13mm VialAccess Device;BD SmartSite™ 20mm VialAccess Device | Predicate Device:SmartSite Access Pin | Equivalence Discussion |
| DeviceComponents /Materials | Vial Adaptor Body & Spike:Makrolon (PolycarbonateRX2530- 451118) | Access Pin Body:Makrolon (PolycarbonateRX2530- 451118) | Biocompatibility results on the subjectdevices show that the materials are safeper the intended use. |
| SmartSite FemaleLuer: Isoplast (2530Polyeurethane) | SmartSite FemaleLuer: Isoplast (2530Polyeurethane) | ||
| Piston: Silicone (ElastosilLR3003/80) with 3% DOWCorning 550 Fluid | Piston: Silicone (ElastosilLR3003/80) | ||
| Lubricant (piston opening):Silicone fluid (FS-1265Fluorosilicone Fluid) | Spike Plastic: Valox(Polybutylene TerephthalateHX420HP-1H1001) | ||
| Lubricant (piston opening):Silicone fluid (FS-1265Fluorosilicone Fluid) | |||
| Lubricant: Silicone fluid (550Silicone Fluid) | |||
| Piercing Spike | Single Lumen | Single Lumen | Same |
| Vial Adapter Fit | Snap Fit to Vial | Spring Clip | Different-There is a difference in vialadapter fit for the two devices. Thesubject device has 4 tabs on the vialadapter body and the predicate devicehas 2 tabs on the access pin body tosecure the device to the vial. The 4 tabs |
| Attributes | Subject Device:BD SmartSite™ 13mm VialAccess Device;BD SmartSite™ 20mm VialAccess Device | Predicate Device:SmartSite Access Pin | Equivalence Discussion |
| facilitate a more secure connection withthe vial due to the higher surface area ofPerformance bench testing demonstratesthe difference does not raise differentquestions of safety and effectiveness. | |||
| Compatible vialsize | 13mm and 20mm | Variable | Different - The predicate device is auniversal adapter designed to fit differentvial sizes. The subject device is designedto fit a 13mm or 20mm vial size.Performance bench testing demonstratesthe difference does not raise differentquestions of safety and effectiveness. |
| Prescription Use | Yes | Yes | Same |
| PackagingConfiguration | Each device is individuallypackaged in pouches. Fifty(50) pouches and one(1) Directions for Use perdispenser box. Two (2)dispenser boxes pershipper box. | Each device is individuallypackaged in pouches. Fifty(50) pouches and one(1) Directions for Use perdispenser box. Two (2)dispenser boxes per shipperbox. | Same |
| Packaging Type | Peelable Tyvek/Film Pouch | Peelable Tyvek/Film Pouch | Same |
| SterilizationMethod | Radiation (SAL 10-6) | Radiation (SAL 10-6) | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Attributes | Subject Device:BD SmartSite™ 13mm VialAccess Device;BD SmartSite™ 20mm VialAccess Device | Predicate Device:SmartSite Access Pin | Equivalence Discussion |
| Residual Volume | 0.07 mL | Unknown | Residual volume has no impact on thesafety and effectiveness of the device. It isprovided as an additional input for the enduser to inform the amount of drug volumethat could be potentially left in the subjectdevice. |
| Method ofDisinfection | Prior to every access, swabtop of NFC access surfacefor 2 - 5 seconds with70% isopropyl alcohol andallow to dry | Prior to every access, swabtop of Needle-Free Valve portwith 70% isopropyl alcohol(1 - 2 seconds) andallow to dry (approximately 30seconds) | Different - the longer swab time does notraise new or different questions of safetyand effectiveness. |
| Use | Single Vial Use | Single Vial Use | Same |
| Shelf Life | 3 years | 3 years | Same |
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Substantial Equivalence Discussion:
Design verification testing was performed to demonstrate that the subject device is substantially equivalent to the predicate device. All test results met their acceptance criteria and support that the BD SmartSite™ Vial Access Device is substantially equivalent to the predicate SmartSite Access Pin. The subject device and the predicate have equivalent indications for use and intended use. Both devices are sterilized via irradiation and are single vial use devices.
Both the subject and predicate devices have the same principle of operation. The BD SmartSite™ Vial Access Device 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.
Safety and Performance Testing
Nonclinical Testing:
The BD SmartSite™ Vial Access Device was evaluated via non-clinical safety and performance testing to demonstrate that the subject device is substantially equivalent to the predicate device.
The bench and nonclinical testing on the BD SmartSite™ Vial Access Device were conducted according to the following FDA recognized consensus standards listed below. The subject device met the applicable test specifications and acceptance criteria as described in the submission.
- ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and . certain other medical equipment - Part 1: General requirements (FDA Recognition Number 6-11)
- ISO 594-2:1998, Conical fittings with a 6% (Luer) taper for syringes, needles and . certain other medical equipment - Part 2: Lock fittings (FDA Recognition Number 6-129)
- . ISO 80369-7:2021, Small-bore connectors for liquids and gases in healthcare
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applications – Part 7: Connectors for intravascular or hypodermic applications (FDA Recognition Number 5-133)
- ISO 22413:2021, Transfer sets for pharmaceutical preparations Requirements and . test methods
- 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)] (FDA Recognition Number 14-528)
- ISO 11137-2:2013, Sterilization of health care products Radiation Part 2: . Establishing the sterilization dose (FDA Recognition Number 14-409)
- ISO 11137-3:2017, Sterilization of health care products Radiation Part 3: . Guidance on dosimetric aspects (FDA Recognition Number 14-510)
- . ISO 11737-1:2018, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including: Amendment 1 (2021)] (FDA Recognition Number 14-577)
- ISO 11737-2:2019 Sterilization of health care products - Part 2: Microbiological methods – Tests of sterility performed in the definition, validation and maintenance of a sterilization process (FDA Recognition Number 14-540)
- . ISO 11607-1:2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (FDA Recognition Number 14-530)
- . ISO 11607-2:2019, Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forminq, Sealing and Assembly Processes (FDA Recognition Number 14-531)
- ASTM F2096 and ASTM F2096-11, Standard Test Method for Detecting Gross Leaks ● in Packaging by Internal Pressurization (Bubble Test) (FDA Recognition Number 14-359)
Biocompatibility:
Biocompatibility tests for the subject device were performed in accordance with ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process as recognized by the FDA. The BD SmartSite™ Vial Access Device is categorized as an externally communicating tissue contacting (indirect) prolonged (> 24 hours to 30 days) device in accordance with ISO 10993-1 and FDA Guidance, Use of
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International Standard 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process." The battery of tests included the following:
- Cytotoxicity (ISO 10993-5:2009, FDA Recognition Number 2-245) .
- Genotoxicity (ISO 10993-3:2014, FDA Recognition Number 2-228) ●
- Sensitization (ISO 10993-10:2021, FDA Recognition Number 2-296) ●
- Irritation / Intracutaneous Reactivity (ISO 10993-23:2021, FDA Recognition ● Number 2-291)
- Acute Systemic Toxicity (ISO 10993-11:2017, FDA Recognition Number 2-255) ●
- Sub-acute/ Sub-chronic Toxicity (ISO 10993-11:2017, FDA Recognition Number 2-● 255)
- Material Mediated Pyrogenicity (ISO 10993-11:2017, FDA Recognition Number 2-● 255)
- Hemolysis Indirect (ISO 10993-4:2017, FDA Recognition Number 2-248)
- Chemical Requirements; Section 8 (ISO 8536-4:2019, FDA Recognition Number 6-447)
Particulate Testing:
The BD SmartSite™ Vial Access Device 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).
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 evaluation was conducted to simulate use with fluids: -
Harsh Infusates testing .
Clinical Data:
Not Applicable. Clinical data was not considered necessary to demonstrate substantial equivalence to the predicate device.
Conclusion:
The information provided in this submission, including the non-clinical safety and performance testing, adequately demonstrates substantial equivalence of the BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device to the predicate device, cleared under K970485. The BD SmartSite™ 13mm Vial Access Device; Page 9 of 10
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BD SmartSite™ 20mm Vial Access Device and the predicate device have similar indications for use, the same intended use, and similar technological characteristics. Any differences between the subject and predicate device do not raise new questions of safety and effectiveness.
§ 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.