(425 days)
The BD Intima II™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.
The BD Intima II PLUS™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. 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.
The BD Intima II™ and Intima II PLUS™ Closed IV Catheter Systems are closed system IV catheters designed to keep blood contained within the device throughout the insertion process. The system consists of a radiopaque Vialon™ material catheter, a notched needle for flashback visualization, a septum to remove visible blood from the needle tubing, a pinch clamp, extension tubing (4.0 IN), and a Luer connector. The 24G and 26G products are also provided with 2.8 IN extension tubing. The system incorporates an integrated extension set which is available in multiple configurations: 1) Y connection (dual port) with a PRN adapter or needleless connector (MaxZero) and end cap; 2) Y connection (dual port) with two PRN adapters or two needleless connectors (MaxZero); 3) Y connection (dual port) with one PRN adapter and one needleless connector (MaxZero); and 4) Straight connection (single port) with a PRN adapter or needleless connector (MaxZero). The Luer connectors are color-coded to indicate catheter gauge size.
This is a 510(k) premarket notification for a medical device (intravascular catheter), not an AI/ML device. Therefore, the requested information categories concerning AI/ML device performance (such as sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, and how ground truth was established) are not applicable to this document.
However, based on the provided text, I can infer the acceptance criteria and the study that proves the device meets them for the BD Intima II™ Closed IV Catheter System and BD Intima II PLUS™ Closed IV Catheter System.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that "the subject devices met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices."
The acceptance criteria are implicitly derived from the types of tests conducted, which are standard for intravascular catheters and needleless connectors. The "reported device performance" is a general statement of compliance rather than specific numerical results.
| Acceptance Criteria Category (Derived from Tests) | Reported Device Performance (Summary from Document) |
|---|---|
| Needleless Connector Performance | Met predetermined design requirements. |
| Needleless Connector Removal Torque | Met predetermined design requirements. |
| Needleless Connector Leakage Pressure | Met predetermined design requirements. |
| Needleless Connector Microbial Ingress | Met predetermined design requirements. |
| Needleless Connector EtO Sterilization Compatibility | Met predetermined design requirements. |
| Catheter System Performance | Met predetermined design requirements. |
| Flow rate | Met predetermined design requirements. |
| Back pressure | Met predetermined design requirements. |
| Insertion force | Met predetermined design requirements. |
| Droplet size | Met predetermined design requirements. |
| Droplet separation | Met predetermined design requirements. |
| Activations | Met predetermined design requirements. |
| Shelf-Life | Met predetermined design requirements. |
| Qualification of 26G catheters | Met predetermined design requirements. |
| Lie distance (ISO 10555-1, §4.4.2) | Met predetermined design requirements. |
| Needle tip sharpness (ISO 10555-5, §4.3.3.2) | Met predetermined design requirements. |
| Joint strength (ISO 10555-5, §4.3.3.4) | Met predetermined design requirements. |
| Flow rate (ISO 10555-1, §4.9) | Met predetermined design requirements. |
| Pressure Withstand (300psi for specific configs) | Verified to withstand pressure up to 300psi. |
| Burst and leaking testing (ISO 10555-1, §4.10) | Met predetermined design requirements. |
| Material/Biocompatibility | Met predetermined design requirements. |
| Particulate Matter testing per USP <788> | Met predetermined design requirements. |
| Microbial Ingress testing | Met predetermined design requirements. |
| MR Compatibility per ASTM F2182-19 | Met predetermined design requirements. |
| Biocompatibility (various ISO 10993-1 tests) | Met predetermined acceptance criteria. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. It generally refers to "performance tests" being completed.
The data provenance is internal to Becton Dickinson, as indicated by "BD internal" next to several tests. The studies are prospective in the sense that they are conducted to verify design changes for market approval. The country of origin is not explicitly stated for the test execution, but the submitter is based in Sandy, Utah, USA.
The studies relate to the subject devices (BD Intima II™ Closed IV Catheter System and BD Intima II PLUS™ Closed IV Catheter System with new configurations and modifications) in comparison to predicate devices.
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 the device is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests are objective, measurable physical properties and performance characteristics defined by engineering specifications and international standards (e.g., ISO, ASTM, USP).
4. Adjudication method for the test set
Not applicable in the context of this device type. Performance is measured against predefined engineering and regulatory specifications, not subject to human adjudication for accuracy or diagnosis.
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.
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
The ground truth used for these performance tests is based on:
- Established engineering specifications and design requirements for the device's physical and functional performance.
- International standards such as ISO 10555-1, ISO 10555-5, ASTM F2182-19.
- Pharmacopeial standards such as USP <788> for particulate matter testing.
- Biocompatibility standards guidance from ISO 10993-1:2009 and FDA guidance.
These are objective, measurable outcomes rather than expert consensus, pathology, or outcomes data in the clinical diagnostic sense.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device and therefore does not have a "training set" in the context of AI/ML.
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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 in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
June 2, 2021
Becton, Dickinson and Company Kimberly Geisler Sr. Manager, Regulatory Affairs 9450 South State Street Sandy, Utah 84070
Re: K200891
Trade/Device Name: BD Intima II™ Closed IV Catheter System, BD Intima II PLUS™ Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ, FPA Dated: April 30, 2021 Received: May 3, 2021
Dear Kimberly Geisler:
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
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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 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 (OS) 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,
Payal Patel 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
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Indications for Use
510(k) Number (if known) K200891
Device Name
BD Intima II™ Closed IV Catheter System and BD Intima II PLUSTM Closed IV Catheter System
Indications for Use (Describe)
The BD Intima II™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.
The BD Intima II PLUS™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. 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.
| 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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Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA
bd.com
Image /page/3/Picture/2 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a circular orange symbol on the left and the letters "BD" in blue on the right. The orange symbol features a stylized sun-like design with rays emanating from a central point, while the letters "BD" are bold and rounded.
510(k) Summary (21 CFR §807.92) - K200891 BD Intima II™ Closed IV Catheter System and
BD Intima II PLUS™ Closed IV Catheter System
| SubmitterInformation | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. |
|---|---|---|
| Submitter Address: | 9450 South State StreetSandy, Utah 84070 | |
| Contact Person: | Kimberly GeislerSr. Manager, Regulatory Affairskimberly.geisler@bd.com(801) 565-2422 (phone) | |
| Date of Preparation: | June 2, 2021 | |
| Subject Device | Trade Name: | BD Intima IITM Closed IV Catheter SystemBD Intima II PLUSTM Closed IV Catheter System |
| Common Name: | Peripheral Intravascular or IV Catheter | |
| Regulation Number: | 21 CFR §880.5200 | |
| Regulation Name: | Intravascular Catheter | |
| Regulatory Class: | II | |
| Product Code: | FOZ (primary); FPA (secondary) | |
| Classification Panel: | General Hospital | |
| Predicate Device 1 | Trade Name: | BD Intima IITM Closed IV Catheter System |
| 510(k) Reference: | K143610, cleared 09 April 2015 | |
| Common Name: | Peripheral Intravascular or IV Catheter | |
| Regulation Number: | 21 CFR §880.5200 | |
| Regulation Name: | Intravascular Catheter | |
| Regulatory Class: | II | |
| Product Code: | FOZ | |
| Classification Panel: | General Hospital | |
| Predicate Device 2 | Trade Name: | BD Intima II PLUSTM Closed IV Catheter System |
| 510(k) Reference: | K172204, cleared 17 August 2017 | |
| Common Name: | Peripheral Intravascular or IV Catheter | |
| Regulation Number: | 21 CFR §880.5200 | |
| Regulation Name: | Intravascular Catheter | |
| Regulatory Class: | II | |
| Product Code: | FOZ | |
| Classification Panel: | General Hospital | |
| Predicate Device 3 | Trade Name: | MaxZero™ Needleless Connector (MZ1000) |
| 510(k) Reference: | K132413, cleared 29 August 2013 | |
| Common Name: | Intravascular Administration Set or NeedlelessConnector | |
| Regulation Number: | 21 CFR §880.5440 | |
| Regulation Name: | Intravascular Administration Set | |
| Regulatory Class: | II | |
| Product Code: | FPA | |
| Classification Panel: | General Hospital | |
| Reason forSubmission | The reason for this submission is to expand the product offerings within theBD Intima II™ and Intima II PLUS™ Closed IV Catheter System productlines, add a performance specification for the BD Intima II PLUS™ ClosedIV Catheter System single port 20G – 24G configurations to withstandpressure up to 300psi, submit modifications to various system components,and modify the sterilization method for the MaxZero™ NeedlelessConnector. | |
| Device Description | The BD Intima II™ and Intima II PLUS™ Closed IV Catheter Systems areclosed system IV catheters designed to keep blood contained within thedevice throughout the insertion process. The system consists of aradiopaque Vialon™ material catheter, a notched needle for flashbackvisualization, a septum to remove visible blood from the needle tubing, apinch clamp, extension tubing (4.0 IN), and a Luer connector. The 24G and26G products are also provided with 2.8 IN extension tubing. The systemincorporates an integrated extension set which is available in multipleconfigurations: 1) Y connection (dual port) with a PRN adapter orneedleless connector (MaxZero) and end cap; 2) Y connection (dual port)with two PRN adapters or two needleless connectors (MaxZero); 3) Yconnection (dual port) with one PRN adapter and one needleless connector(MaxZero); and 4) Straight connection (single port) with a PRN adapter orneedleless connector (MaxZero). The Luer connectors are color-coded toindicate catheter gauge size. | |
| Indications for Use(21 CFR§807.92(a)(5)) | The BD Intima II™ Closed IV Catheter System is inserted into a patient'svascular system for short-term use to monitor blood pressure or administerfluids intravascularly. These devices may be used for any patient populationwith consideration given to adequacy of vascular anatomy, procedure beingperformed, fluids being infused, and duration of therapy.The BD Intima II PLUS™ Closed IV Catheter System is inserted into apatient's vascular system for short-term use to monitor blood pressure oradminister fluids intravascularly. These devices may be used for any patientpopulation with consideration given to adequacy of vascular anatomy,procedure being performed, fluids being infused, and duration of therapy. | |
| TechnologicalCharacteristics | The BD Intima™ II and Intima II PLUS™ Closed IV Catheter Systemsachieve their intended uses based on the same technology and principles ofoperation as the predicate BD Intima II™ and Intima II PLUS™ Closed IVCatheter Systems, as well as the MaxZero™ Needleless Connector. Thesubject devices have been modified from the predicate devices as listedbelow. The changes to device design did not alter final product performancespecifications and the results of design verification demonstrate that thesubject devices are substantially equivalent to the predicate devices. Allother aspects of the subject device are identical to those of the predicatedevices. Tables comparing the subject and predicate devices are providedbelow. Qualification of new product configurations: Y connection (dual port) with MaxZero™ Needleless Connector and end cap; Y connection (dual port) with dual MaxZero™ Needleless Connectors; Y connection (dual port) with PRN adapter and MaxZero™ Needleless Connector; Straight Connection (single port) with MaxZero™ Needleless Connector; 26G needle configuration (with 2.8 IN and 4.0 IN extension tubing); and 2.8 IN extension tubing for 24G products. Addition of a performance specification for the BD Intima II PLUS™ Closed IV Catheter System single port 20G – 24G configurations to withstand pressure up to 300psi. Design modifications to various components of the BD Intima II™ and Intima II PLUS™ Closed IV Catheter Systems including: modification of the paddle hub dimensions and reduction of colorant concentration; reduction of luer connector colorant concentration; modification to cannula profile and dimensions; modification to 18G Y luer connector dimensions; update to luer component torque off specification; qualification of new packaging bottom web material; and introduction of slim pinch clamp. Modification to catheter tipping lubricant and catheter lubricant to remove HCFC solvent and modification to catheter lubricant application process. Change in sterilization method for MaxZero™ Needleless Connector. |
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| Attribute | SUBJECT DEVICEBD Intima™ II Closed IV Catheter System andBD Intima II PLUSTM Closed IV CatheterSystem | PREDICATE DEVICE 1BD Intima II™ Closed IVCatheter System (K143610) | PREDICATE DEVICE 2BD Intima II PLUSTM ClosedIV Catheter System (K172204) |
|---|---|---|---|
| Fundamental Scientific Technology | A single-winged, polyurethane IV catheter with anintegrated extension set incorporating either a singleport or Y (dual)-port injection site. Incorporates BDInstaflash™ technology to assist with flashbackvisualization. | A single-winged, polyurethane IV catheter with an integratedextension set incorporating either a single port or Y (dual)-portinjection site. Incorporates BD Instaflash technology to assist withflashback visualization. | A single-winged, polyurethane IV catheter with an integratedextension set incorporating either a single port or Y (dual)-portinjection site. Incorporates BD Instaflash technology to assist withflashback visualization. |
| Catheter Tubing | BD Vialon™ Polyurethane | BD Vialon™ Polyurethane | BD Vialon™ Polyurethane |
| Catheter Tipping Lubricant | Silicone Fluid(no change to material, "fluid" added for clarity) | Silicone | Silicone |
| Catheter Lubricant | Silicone Fluid(no change to material, “fluid" added for clarity) | Silicone | Silicone |
| Metal Wedge | Stainless Steel | Stainless Steel | Stainless Steel |
| Y-Adapter (Catheter Adapter) | Propionate | Propionate | Propionate |
| Septum/Sleeve Stopper | Polyisoprene | Polyisoprene | Polyisoprene |
| Needle (Cannula) | Stainless Steel | Stainless Steel | Stainless Steel |
| Needle (Cannula) Lubricant | Silicone Fluid | Not specified | Not specified |
| Needle Cover | Polyethylene | Polyethylene | Polyethylene |
| Extension Tubing | Polyvinyl Chloride (Intima II only) | Polyvinyl Chloride | N/A |
| Thermoplastic Polyurethane (Intima II PLUS only) | N/A | Thermoplastic Polyurethane | |
| Pinch Clamp Material | Polyoxymethylene (POM) | Polyoxymethylene | Polyoxymethylene |
| Pinch Clamp Design | Standard and Slim | Standard | Standard |
| Slide Clamp | Polystyrene (Intima II only) | Polystyrene | N/A |
| Luer Connection Site | Polypropylene with gauge-specific colorant | Polypropylene (colorant not specified) | Polypropylene (colorant not specified) |
| PRN Adapter Body | Polycarbonate | Polycarbonate | Polycarbonate |
| PRN Adapter Injection Port | Polyisoprene | Polyisoprene | Polyisoprene |
| PRN Adapter Shrink Wrap Band | Polyvinyl Chloride (Intima II only) | Polyvinyl Chloride | N/A |
| Polyethylene Terephthalate (Intima II PLUS only) | N/A | Polyethylene Terephthalate | |
| End Cap | Acrylonitrile Butadiene Styrene | Acrylonitrile Butadiene Styrene | Acrylonitrile Butadiene Styrene |
| Extension Tubing Adhesive | Epoxy | UV-Cured Epoxy | UV-Cured Epoxy |
| Attribute | SUBJECT DEVICEBD Intima™ II Closed IV Catheter System andBD Intima II PLUSTM Closed IV CatheterSystem | PREDICATE DEVICE 1BD Intima IITM Closed IVCatheter System (K143610) | PREDICATE DEVICE 2BD Intima II PLUSTM ClosedIV Catheter System (K172204) |
| (Extension Tubing/Catheter AdapterAdhesive) | (no change to material, general term used foradhesive) | ||
| Needle Adhesive (Cannula BondingAdhesive) | Epoxy(no change to material, general term used foradhesive) | UV-Cured Epoxy | |
| Septum Adhesive | Epoxy(no change to material, general term used foradhesive) | UV-Cured Epoxy | |
| Paddle Hub | Polystyrene and White Colorant | Polystyrene (colorant not specified) | |
| Physical / Mechanical Specifications | Catheter Diameters18G, 20G, 22G, 24G, 26GCatheter Lengths0.56 IN (Intima II PLUS only), 0.75 IN, 1.00 IN,1.16 IN | Catheter Diameters18G, 20G, 22G, 24GCatheter Lengths0.75IN, 1.00IN, 1.16IN | Catheter Diameters18G, 20G, 22G, 24GCatheter Lengths0.56IN, 0.75IN, 1.00IN, 1.16IN |
| ProductConfigurations | • Y connection (dual port) with PRN adapter andend cap• Y connection (dual port) with two PRNadapters• Y connection (dual port) with MaxZero™Needleless Connector and end cap• Y connection (dual port) with MaxZero™Needleless Connector and PRN adapter• Y connection (dual port) with twoMaxZero™ Needleless Connectors• Straight connection (single port) with PRNadapter• Straight connection (single port) withMaxZero™ Needleless Connector | • Y Connection (dual port)with PRN and end cap• Straight Connection (singleport) with PRN adapter | • Y Connection (dual port)with PRN adapter and endcap• Y Connection (dual port)with two PRN adapters• Straight Connection (singleport) with PRN adapter |
| Attribute | SUBJECT DEVICEBD Intima™ II Closed IV Catheter System andBD Intima II PLUSTM Closed IV CatheterSystem | PREDICATE DEVICE 1BD Intima II™ Closed IVCatheter System (K143610) | PREDICATE DEVICE 2BD Intima II PLUSTM ClosedIV Catheter System (K172204) |
| Extension Tubing Length | 2.8 IN (24G and 26G only)4.0 IN | 4.0 IN | |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
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Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE 3MaxZero™ Needleless Connector (K132413) |
|---|---|---|
| MaxZero Housing Top | Polycarbonate | Polycarbonate |
| MaxZero Housing Bottom | Polycarbonate | Polycarbonate |
| MaxZero Valve | Silicone Rubber and Blue Colorant | Silicone Rubber and Blue Colorant |
| MaxZero Valve Lubricant | Silicone Fluid | Silicone Fluid |
| Sterilization Method | Ethylene Oxide | E-beam |
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Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070 USA
| Summary ofSafety andPerformanceTests | Performance tests completed on the subject devices were limited to those testsrequired to support a determination of substantial equivalence to the predicatedevices. A risk analysis was conducted to assess the impact of the proposedmodifications to the subject devices. When technological characteristics betweenthe subject and predicate devices were found to be identical, results ofperformance testing conducted on the predicate devices were applied to the subjectdevices. The performance tests listed below were conducted to ensure that thesubject devices meet pre-determined design requirements:• Needleless Connector Removal Torque (BD internal) • Needleless Connector Leakage Pressure (BD internal) • Needleless Connector Microbial Ingress • Needleless Connector EtO Sterilization Compatibility • Flow rate (BD internal) • Back pressure (BD internal) • Insertion force (BD internal) • Droplet size (BD internal) • Droplet separation (BD internal) • Activations (BD internal) • Shelf-Life (BD internal) • Qualification of 26G catheters • Lie distance (ISO 10555-1, §4.4.2) • Needle tip sharpness (ISO 10555-5, §4.3.3.2) • Joint strength (ISO 10555-5, §4.3.3.4) • Flow rate (ISO 10555-1, §4.9) • Verification of the BD Intima II PLUS™ Closed IV Catheter Systemsingle port 20G – 24G configurations to withstand pressure up to 300psi • Flow rate (ISO 10555-1, §4.9) • Burst and leaking testing (ISO 10555-1, §4.10) • Particulate Matter testing per USP <788> • Microbial Ingress testing • Evaluation of MR Compatibility per ASTM F2182-19 In addition, a biocompatibility evaluation was conducted in accordance with ISO10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation andTesting Within a Risk Management Process and the FDA's guidance Use ofInternational Standard ISO 10993-1, “Biological evaluation of medical devices –Part 1: Evaluation and testing within a risk management process" (issued June 16,2016). Biocompatibility data submitted in support of the predicate devices was |
|---|---|
| -------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070 USA
bd.com
leveraged and the following biocompatibility studies were conducted to support the design changes within the scope of this submission: · Cytotoxicity · Sensitization · Intracutaneous Reactivity · Acute Systemic Toxicity
- · Pyrogenicity (Material-Mediated Rabbit Pyrogen)
- Subacute/Subchronic Toxicity .
- · Haemocompatibility
Per the design control requirements specified in 21 CFR §820.30, the subject devices met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices. Based on the indications for use, technological characteristics, and safety and Summary of performance testing, the subject BD Intima II™ and Intima II PLUSTM Closed IV Substantial Equivalence Catheter Systems have been demonstrated to be substantially equivalent to the predicate devices.
§ 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).