(29 days)
BD Nexiva Diffusics closed IV catheter systems are intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter with side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package.
The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.
These devices have BD Instaflash needle technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. The stabilization platform and Luer connector are color coded to indicate catheter gauge size (24 GA [0.7 mm]=Yellow, 22 GA [0.9 mm] =Blue, 20 GA [1.1 mm]=Pink, 18 GA [1.3 mm]=Green).
The provided text is an FDA 510(k) summary for a medical device (BD Nexiva Diffusics Closed IV Catheter System) and does not contain information about an AI/ML-driven medical device, nor does it detail a study proving such a device meets acceptance criteria.
The document is a premarket notification to the FDA for a medical device (intravenous catheter), asserting its substantial equivalence to a legally marketed predicate device. The "performance tests" mentioned are engineering tests to ensure the physical integrity and function of the catheter after a minor design modification, not clinical studies of an AI algorithm.
Therefore, I cannot extract the requested information related to AI/ML device acceptance criteria and study details from the provided text. The questions refer to concepts like "test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "ground truth," and "training set," which are relevant to evaluating AI/ML models, but not to the type of device and submission described in the document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2017
Becton, Dickinson and Company c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street North West Buffalo, Minnesota 55313
Re: K170283
Trade/Device Name: BD NexivaTM Diffusics™ Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: January 13, 2017 Received: January 30, 2017
Dear Mr. Mark Job:
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. 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.
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Page 2 - Mr. Mark Job
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170283
Device Name BD Nexiva Diffusics Closed IV Catheter System
Indications for Use (Describe)
BD Nexiva Diffusics closed IV catheter systems are intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary (21 CFR §807.92)
BD Nexiva™ Diffusics™ Closed IV Catheter System
| SubmitterInformation | Submitter Name:Submitter Address: | Becton Dickinson Infusion Therapy Systems Inc.9450 South State StreetSandy, UT 84070 |
|---|---|---|
| Contact Person:Email Address:Phone Number:Fax NumberDate of Preparation: | Amy HoneyRegulatory Affairs Specialistamy.honey@bd.com(801) 304-3908(801) 304-3963January 13, 2017 | |
| Subject Device | Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD Nexiva™ Diffusics™ Closed IV Catheter SystemPeripheral Intravascular or IV Catheter21 CFR §880.5200Intravascular CatheterIIFOZGeneral Hospital |
| PredicateDevice | Trade Name:510(k) Reference:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD Nexiva™ Diffusics™ Closed IV Catheter SystemK161777Peripheral Intravascular or IV Catheter21 CFR §880.5200Intravascular CatheterIIFOZGeneral Hospital |
| DeviceDescription | BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascularcatheters. These devices have a radiopaque BD Vialon catheter with side holeslocated near the tip of the catheter which are designed to optimize power injectionprocedures. These devices also have a needle, needle shield, septum,stabilization platform, integrated extension tubing, clamp, Luer connector, and ventplug. The Luer connector displays gauge-specific maximum flow rate and themaximum power injector pressure limit setting. The needle and catheter areprotected by a needle cover. An end cap with protective cover is provided in theunit package.The closed system is designed to keep blood contained within the devicethroughout the insertion process. The septum is designed to wipe visible bloodfrom the needle surface as the needle is withdrawn from the catheter, furtherreducing the risk of blood exposure. The needle tip is passively protected when | |
| the needle is removed, reducing the risk of accidental needlestick injury. | ||
| These devices have BD Instaflash needle technology, allowing for immediatevisualization of blood along the catheter. Continuous blood return is seen in theextension tubing. The vent plug prevents blood leakage from the extension tubingduring insertion. The stabilization platform and Luer connector are color coded toindicate catheter gauge size (24 GA [0.7 mm]=Yellow, 22 GA [0.9 mm] =Blue, 20GA [1.1 mm]=Pink, 18 GA [1.3 mm]=Green). | ||
| Indications forUse | BD Nexiva Diffusics closed IV catheter systems are intended to be inserted into apatient's vascular system for short term use to sample blood, monitor bloodpressure, or administer fluids. These devices may be used for any patientpopulation with consideration given to adequacy of vascular anatomy, procedurebeing performed, fluids being infused, and duration of therapy. These devices aresuitable for use with power injectors set to a maximum pressure of 325 psi (2240kPa) when access ports not suitable for use with power injectors are removed. | |
| TechnologicalCharacteristics | Technological characteristics of the subject and predicate devices are substantiallyequivalent with respect to the basic design and materials, and the subject BDNexiva™ Diffusics™ Closed IV Catheter System achieves its intended use basedon the same technology and principles of operation as the predicate BD Nexiva™Diffusics™ Closed IV Cather System. Design modifications have been made to thesubject device Luer adapter internal geometry to move the extension tubing / Lueradapter bond location away from the extension tubing bend point. Performancetesting conducted to support the design modification are as follows: | |
| No Leak after Repeated Bending Cycles |
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- Luer Adapter Pull Force
All pre-determined acceptance criteria were met.
A comparison of the subject and predicate device technological characteristics is provided in the table below.
| Attribute | SUBJECTBD Nexiva™ Diffusics™Closed IV Catheter System | PREDICATEBD Nexiva™ Diffusics™ Closed IV Catheter System(K161777) |
|---|---|---|
| Classification | Same as predicate | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter |
| Indications forUse | Same as predicate | BD Nexiva Diffusics closed IV catheter systems areintended to be inserted into a patient's vascularsystem for short term use to sample blood, monitorblood pressure, or administer fluids. These devicesmay be used for any patient population withconsideration given to adequacy of vascularanatomy, procedure being performed, fluids beinginfused, and duration of therapy. These devices aresuitable for use with power injectors set to amaximum pressure of 325 psi (2240 kPa) whenaccess ports not suitable for use with power injectorsare removed. |
| FundamentalScientific | Same as predicate | Closed peripheral intravascular catheter systems aredesigned with an integrated extension set incorporating |
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| Attribute | SUBJECTBD Nexiva™ Diffusics™Closed IV Catheter System | PREDICATEBD Nexiva™ Diffusics™ Closed IV Catheter System(K161777) |
|---|---|---|
| Technology | either a single port or Y (dual)-port injection site.Incorporates BD Instaflash technology to assist withflashback visualization.In addition, the catheter tip includes diffuser holes toreduce the velocity of contrast media exiting the cathetertip during CT scans. | |
| Primary DeviceMaterials | Same as predicate | Needle:Stainless SteelCatheter:PolyurethaneCatheter Wings:TPECatheter Adapter:CopolyesterNeedle Hub:PolycarbonateTip Shield:PolycarbonateExtension Tubing:PolyurethaneLuer Adapter:CopolyesterPinch Clamp:Acetal |
| Physical /MechanicalSpecifications | Same as predicate | Catheter Diameters18G, 20G, 22G, 24GCatheter Lengths0.75", 1.00", 1.25" |
| Sterility | Same as predicate | Provided sterile (EO) |
| Summary ofPerformanceTests | Performance tests completed on the subject device were limited to those testsrequired to support a determination of substantial equivalence to the predicatedevice. A risk analysis was conducted to assess the impact of the proposedmodifications to the subject device, and the performance tests listed below wereidentified to ensure that specified design requirements were met:No Leak after Repeated Bending Cycles Luer Adapter Pull Force When technological characteristics between the subject and predicate device werefound to be identical, results of performance testing conducted on the predicatedevice were applied to the subject device.Per the design control requirements specified in 21 CFR 820.30, the subjectdevice met all predetermined acceptance criteria for the above-listed performancetests, demonstrating substantial equivalence to the predicate device. |
|---|---|
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and results ofperformance testing, the subject BD Nexiva™ Diffusics™ Closed IV CatheterSystem has been demonstrated to be substantially equivalent to the predicatedevice. |
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).