(29 days)
The BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient's vascular system for short term use to sample blood 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 (IV) catheters. These devices have a radiopaque BD Vialon™ catheter material with three 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. A BD MaxZero™ device with protective cover is provided in the unit package.
This document is a 510(k) Premarket Notification from the FDA regarding the BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector. It determines that the device is substantially equivalent to a legally marketed predicate device.
The request asks for information about the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically related to an AI/Machine Learning device. However, this document does not describe an AI/Machine Learning device or any AI/ML performance studies. It pertains to a physical medical device (an IV catheter system).
Therefore, I cannot provide the requested information for acceptance criteria and study proving device meets criteria in the context of an AI/ML device from this document.
The document primarily focuses on demonstrating substantial equivalence of the new catheter system to a previously cleared predicate device (K173354) by comparing technological characteristics and outlining performance tests conducted on the physical device.
Here's what can be extracted, specific to the physical device, but it's important to reiterate that this is NOT about an AI/ML system's performance.
1. A table of acceptance criteria and the reported device performance:
The document broadly states that "the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device." However, it does not provide specific numerical acceptance criteria or detailed reported performance values for each test. Instead, it lists the types of tests conducted:
| Test Category | Specific Tests Mentioned | Reported Device Performance |
|---|---|---|
| Compliance Testing | Sterilization Residuals (ISO 10993-7) | Met predetermined acceptance criteria. |
| Biocompatibility (ISO 10993-1) | Met predetermined acceptance criteria. | |
| Packaging Testing | ISO 11607-1 (General Compliance) | Met predetermined acceptance criteria. |
| Aseptic Presentation Test (ISO 11607-1, Section 7) | Met predetermined acceptance criteria. | |
| Simulated Shipping Conditioning (ISO 11607-1, Section 8) | Met predetermined acceptance criteria. | |
| Bubble Leak Detection (Package Integrity) (ISO 11607-1, Section 8) | Met predetermined acceptance criteria. | |
| Package Peel Force Pouch Seal Strength (ISO 11607-1, Section 5.1.8 and 5.1.9c) | Met predetermined acceptance criteria. | |
| Packaging Materials Microbial Barrier (ISO 11607-1, Annex C) | Met predetermined acceptance criteria. | |
| Ink Permanency/Text Legibility (ISO 11607-1, Section 5.4) | Met predetermined acceptance criteria. | |
| Seal Width (ISO 11607-1, Section 5.1.6d; 5.1.8c and 5.1.9d) | Met predetermined acceptance criteria. | |
| Packaging must protect the product from damages (Damage to Device) ISO 11607-1) | Met predetermined acceptance criteria. | |
| Device Performance | Testing in accordance with ISO 10555-1 (General Compliance for Catheters) | Met predetermined acceptance criteria. |
| Gravity Flow Rate (ISO 10555-1, Section 4.9) | Met predetermined acceptance criteria. | |
| Catheter Burst Pressure (ISO 10555-1, Section 4.10) | Met predetermined acceptance criteria. | |
| Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) (ASTM F 2096-11) | Met predetermined acceptance criteria. | |
| Standard Test Method for Seal Strength of Flexible Barrier Materials (ASTM F88/F88M-15) | Met predetermined acceptance criteria. | |
| Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM D4169-16) | Met predetermined acceptance criteria. | |
| Open flow pressure (BD Internal Requirement) | Met predetermined acceptance criteria. | |
| Power injection peak pressure (BD Internal Requirement) | Met predetermined acceptance criteria. | |
| Catheter stability (BD Internal Requirement) | Met predetermined acceptance criteria. |
2. Sample size used for the test set and the data provenance:
The document states, "When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device." This implies that new testing was primarily conducted for the modified aspects (e.g., the longer length catheter configurations and the addition of the MaxZero™ Needle-free Connector). Specific sample sizes for these tests are not provided in this document. The data provenance would be from manufacturing and testing labs of Becton Dickinson. It's a regulatory submission for a physical device, so the data is likely prospective testing conducted to demonstrate product safety and performance. No country of origin of data is specified beyond "Becton Dickinson Infusion Therapy Systems Inc. Sandy, Utah 84070 USA."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as this is a submission for a physical device, not an AI/ML device relying on expert interpretation for ground truth. The "ground truth" for a physical device would be its measurable physical properties and performance under specific test conditions, established by engineering and quality control procedures, adhering to relevant ISO and ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically relevant for human interpretation of imaging or other medical data in AI/ML validation studies. For physical device testing, the "adjudication" is compliance with documented, objective test procedures and acceptance criteria.
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:
Not applicable. This is not an AI/ML device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this physical device, the "ground truth" is based on:
- Engineering specifications and design requirements: How the device is designed to perform.
- Measurement and testing against recognized standards: Compliance with ISO (e.g., 10993 for biocompatibility, 10555 for catheters, 11607 for packaging) and ASTM standards (e.g., F2096, F88/F88M-15, D4169-16).
- Internal BD requirements: Specific performance parameters defined by the manufacturer (e.g., open flow pressure, power injection peak pressure, catheter stability).
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
Not applicable. This is a physical device, not an AI/ML model.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2023
Becton Dickinson Infusion Therapy Systems Inc. Sunny Patel Senior Regulatory Affairs Specialist 9450 South State Street Sandy, Utah 84070
Re: K233529
Trade/Device Name: BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: November 1, 2023 Received: November 2, 2023
Dear Sunny Patel:
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).
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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, 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) K233529
Device Name
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
Indications for Use (Describe)
The BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient's vascular system for short term use to sample blood or administer fluids. These devices may 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) |
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bd.com
Image /page/4/Picture/2 description: The image shows the BD logo. The logo consists of two parts: a stylized sun-like symbol in orange and the letters "BD" in blue. The sun-like symbol is on the left, and the letters "BD" are on the right.
K233529- 510(k) Summary
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
| SubmitterInformation | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. | ||
|---|---|---|---|---|
| Submitter Address: | 9450 South State Street, Sandy, Utah 84070 | |||
| Contact Person: | Sunny Patel, Senior Regulatory Affairs Specialist | |||
| Email Address: | sunny.patel@bd.com | |||
| Phone Number: | (817) 609-9594 | |||
| Subject Device | Trade Name: | BD Nexiva™ Diffusics™ Closed IV Catheter Systemwith BD MaxZero™ Needle-free Connector | ||
| Common Name: | Peripheral Intravascular or IV Catheter | |||
| 510(k) Reference: | K233529 | |||
| Regulation Number: | 21 CFR §880.5200 | |||
| Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 days | |||
| Regulatory Class: | II | |||
| Product Code: | FOZ | |||
| Classification Panel: | General Hospital | |||
| Predicate Device | Trade Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System | ||
| Common Name: | Peripheral Intravascular or IV Catheter | |||
| 510(k) Reference: | K173354 | |||
| Regulation Number: | 21 CFR §880.5200 | |||
| Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 days | |||
| Regulatory Class: | II | |||
| Product Code: | FOZ | |||
| Classification Panel: | General Hospital | |||
| Reason forSubmission | The purpose of this submission is to introduce the BD Nexiva™ Diffusics™ Closed IVCatheter System with BD MaxZero™ Needle-free Connector. | |||
| DeviceDescription | BD Nexiva™ Diffusics™ Closed IV Catheter Systems are over-the-needle, intravascular(IV) catheters. These devices have a radiopaque BD Vialon™ catheter material withthree side holes located near the tip of the catheter which are designed to optimize powerinjection 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 maximumpower injector pressure limit setting. The needle and catheter are protected by a needlecover. An end cap with protective cover is provided in the unit package. A BDMaxZero™ device with protective cover is provided in the unit package. |
Date: December 1, 2023
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bd.com
| Indications for Use(21 CFR §807.92(a)(5)) | The BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted intoa patient's vascular system for short term use to sample blood or administer fluids. Thesedevices may be used for any patient population with consideration given to adequacy ofvascular anatomy, procedure being performed, fluids being infused, and duration oftherapy. These devices are suitable for use with power injectors set to a maximumpressure of 325 psi (2240 kPa) when access ports not suitable for use with powerinjectors are removed. | ||
|---|---|---|---|
| TechnologicalCharacteristics | Technological characteristics of the subject BD Nexiva™ Diffusics™ Closed IVCatheter System with BD MaxZero™ Needle-free Connector are substantiallyequivalent to predicate BD Nexiva™ Diffusics™ Closed IV Catheter System. Thesubject device achieves its intended use based on the same technology and principles ofoperation as the predicate device.A comparison of the subject and predicate device technological characteristics isprovided in the table below. | ||
| SUBJECT | PREDICATE (Κ173354) | ||
| The closed system is designed to keep blood contained within the device throughout theinsertion process. The septum is designed to wipe visible blood from the needle surfaceas 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 ofaccidental needle stick 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 tubing duringinsertion. The stabilization platform and Luer connector are color coded to indicatecatheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1mm) = Pink, 18 GA (1.3 mm) = Green). |
| Attribute | SUBJECTBD Nexiva™ Diffusics™ Closed IVCatheter System with BDMaxZero™ Needle-free Connector | PREDICATE (K173354)BD Nexiva™ Diffusics™ Closed IVCatheter System | Comparison |
|---|---|---|---|
| Classification | 21 CFR 880.5200Class IIFOZ - Intravascular Catheter | 21 CFR 880.5200Class IIFOZ - Intravascular Catheter | Same |
| Indications forUse | The BD Nexiva™ Diffusics™ ClosedIV Catheter Systems are intended tobe inserted into a patient's vascularsystem for short term use to sampleblood or administer fluids. Thesedevices may be used for any patientpopulation with consideration givento adequacy of vascular anatomy,procedure being performed, fluidsbeing infused, and duration oftherapy. These devices are suitablefor use with power injectors set to amaximum pressure of 325 psi (2240kPa) when access ports not suitable | The BD Nexiva™ Diffusics™ ClosedIV Catheter Systems are intended tobe inserted into a patient's vascularsystem for short term use to sampleblood, monitor blood pressure, oradminister fluids. These devices maybe used for any patient populationwith consideration given to adequacyof vascular anatomy, procedure beingperformed, fluids being infused, and duration of therapy. These devices aresuitable for use with power injectorsset to a maximum pressure of 325 psi (2240 kPa) when access ports not | Substantially Equivalent-The subject and predicatedevices are both intendedto sample blood andadminister fluids.The subject deviceIndications for Use hasbeen narrowed to remove"monitor blood pressure"compared to the predicatedevice.Narrowing theIndications for Use doesnot raise any new or |
| Attribute | SUBJECTBD Nexiva™ Diffusics™ Closed IVCatheter System with BDMaxZero™ Needle-free Connector | PREDICATE (K173354)BD Nexiva™ Diffusics™ Closed IVCatheter System | Comparison |
| for use with power injectors areremoved. | suitable for use with power injectorsare removed. | different questions ofsafety or effectiveness. | |
| Intended Use | Intravascular access | Intravascular access | Same |
| FundamentalScientificTechnology | Closed peripheral intravascularcatheter system are designed with anintegrated extension set incorporatinga single port injection site.Incorporates BD Instaflash™technology to assist with flashbackvisualization | Closed peripheral intravascularcatheter system are designed with anintegrated extension set incorporatinga single port injection site.Incorporates BD Instaflash™technology to assist with flashbackvisualization | Same |
| Primary Components Material Composition | |||
| ISO 10993-1BiocompatibilityContact Type andDuration | Body Contact: Externallycommunicating deviceContact: Circulating bloodContact Duration: Limited (A)to Prolonged (B) (≤ 24 hrs to30 days) | Body Contact: Externallycommunicating deviceContact: Circulating bloodContact Duration: Limited (A)to Prolonged (B) (≤ 24 hrs to30 days) | Same |
| Needle (Cannula) | Stainless Steel | Stainless Steel | Same |
| Catheter Tubing | BD Vialon™ Polyurethane withBarium Sulfate | BD Vialon™ Polyurethane withBarium Sulfate | Same |
| Catheter Adapter | Copolyester | Copolyester | Same |
| Catheter AdapterWings | TPE with Gauge-Specific Colorant | TPE with Gauge-Specific Colorant | Same |
| Tip Shield | Polycarbonate with Grey Colorant | Polycarbonate with Grey Colorant | Same |
| Grip/Needle Hub | Polycarbonate with White Colorant | Polycarbonate with White Colorant | Same |
| Pinch Clamp | Acetal with Blue Colorant | Acetal with Blue Colorant | Same |
| Extension Tubing | Biomerics Polyurethane | Biomerics Polyurethane | Same |
| Luer Adapter | Copolyester with Gauge-SpecificColorant | Copolyester with Gauge-SpecificColorant | Same |
| Luer AdapterOvermold | TPE with Blue Colorant and WhitePrint Ink | TPE with Blue Colorant and WhitePrint Ink | Same |
| End Cap | Polypropylene with White Colorant | Polypropylene with White Colorant | Same |
| End CapProtective Cover | HDPE with Blue Colorant | HDPE with Blue Colorant | Same |
| Vent Plug | Polypropylene and Acrylic-NylonMembrane | Polypropylene and Acrylic-NylonMembrane | Same |
| CatheterDimensions | Catheter Diameters18 GA, 20 GA, 22 GA, 24 GACatheter Lengths0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN | Catheter Diameters18 GA, 20 GA, 22 GA, 24 GACatheter Lengths0.75 IN, 1.00 IN, 1.25 IN | Different-The subject and predicatedevices are substantiallyequivalent. The longerlength (1.75 IN) subjectdevice configurationswere evaluated using theequivalent test methodsas the predicate device. |
| Attribute | SUBJECTBD Nexiva™ Diffusics™ Closed IVCatheter System with BDMaxZero™ Needle-free Connector | PREDICATE (K173354)BD Nexiva™ Diffusics™ Closed IVCatheter System | Comparison |
| This modification did notraise any new or differentquestions of safety andeffectiveness. | |||
| ProductConfigurations | Single Port with BD MaxZero™ Needle-free Connector | Single Port | Different-The subject and predicatedevices are offered in thesame single portconfiguration. The BDMaxZero™ Needle-freeConnector is included asa kit component in thesubject device unitpackage. The addition ofthe BD MaxZero™Needle-free Connector asa kit component does notalter the intended use ofthe subject devicecompared to the predicatedevice. |
| SterilizationModality | Ethylene Oxide | Ethylene Oxide | Same |
| Minimum SAL | $1 x 10^{-6}$ | $1 x 10^{-6}$ | Same |
| Energy Source | User operated | User operated | Same |
| Disposable orReusable | Disposable | Disposable | Same |
| Single Use Only | Yes | Yes | Same |
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Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA
bd.com
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bd.com
A Risk Analysis was conducted in accordance with ISO 14971, Medical Devices - Risk Summary of Management for Medical Devices was conducted to assess the impact of the proposed Performance modifications to the predicate BD Nexiva™ Diffusics™ Closed IV Catheter System. Tests Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate device. A risk analysis was conducted to assess the impact of the proposed modifications to the predicate device. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device. The performance tests listed below were conducted to ensure that the subject device meets predetermined design requirements: 1) Compliance Testing: . Sterilization Residuals (ISO 10993-7) ● Biocompatibility (ISO 10993-1) Packaging Testing ISO 11607-1 . Aseptic Presentation Test (ISO 11607-1, Section 7) -Simulated Shipping Conditioning (ISO 11607-1, Section 8) -Bubble Leak Detection (Package Integrity) (ISO 11607-1, Section 8) -Package Peel Force Pouch Seal Strength (ISO 11607-1, Section 5.1.8 and 5.1.9c) -Packaging Materials Microbial Barrier (ISO 11607-1, Annex C) --Ink Permanency/Text Legibility (ISO 11607-1, Section 5.4) Seal Width (ISO 11607-1, Section 5.1.6d; 5.1.8c and 5.1.9d) -Packaging must protect the product from damages (Damage to Device) ISO 11607-1) ● Testing in accordance with ISO 10555-1 Gravity Flow Rate (ISO 10555-1. Section 4.9) -Catheter Burst Pressure (ISO 10555-1, Section 4.10) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble ● Test) (ASTMF 2096-11) . Standard Test Method for Seal Strength of Flexible Barrier Materials (ASTM F88/F88M-15) Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM D4169-16) ● 2) BD Internal Requirements ● Open flow pressure ● Power injection peak pressure Catheter stability ● Per design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device. Clinical studies are not required to demonstrate substantial equivalence to the predicate device. Summary of Based on the indications for use, technological characteristics, and results of performance testing, Substantial the subject BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-Equivalence free Connector has been demonstrated to be substantially equivalent to the predicate BD NexivaTM Diffusics™ Closed IV Catheter System (K173354).
§ 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).