(27 days)
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 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 a closed system IV catheter 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 and Luer connector. The system incorporates an integrated extension set which is available in three configurations: 1) Y Connection (dual port) with PRN adapter and end cap; 2) Y Connection (dual port) with two PRN adapters; and 3) Straight Connection (single port) with PRN adapter. The Luer connector is color-coded to indicate catheter gauge size. The system is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6. The package system is able to maintain product sterility during its specified shelf life of 3 years.
The provided document is a 510(k) summary for the BD Intima II PLUS Closed IV Catheter System, seeking substantial equivalence to the predicate device, BD Intima II Closed IV Catheter System (K143610). The submission focuses on modifications to materials, the removal of a clamp option, and the addition of new configurations.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Test | Reported Device Performance |
|---|---|
| Extension Tubing / Catheter Adapter Pull Force | Met predetermined acceptance criteria. |
| Extension Tubing / Catheter Adapter Joint Leakage Pressure | Met predetermined acceptance criteria. |
| Extension Tubing Pull Out Force | Met predetermined acceptance criteria. |
| Clamp Seal Pressure | Met predetermined acceptance criteria. |
| Package Integrity | Met predetermined acceptance criteria. |
| Biocompatibility (Cytotoxicity) | Met predetermined acceptance criteria, in accordance with ISO 10993-1:2009. |
| Biocompatibility (Sensitization) | Met predetermined acceptance criteria, in accordance with ISO 10993-1:2009. |
| Biocompatibility (Intracutaneous Reactivity) | Met predetermined acceptance criteria, in accordance with ISO 10993-1:2009. |
| Biocompatibility (Systemic Toxicity - Acute) | Met predetermined acceptance criteria, in accordance with ISO 10993-1:2009. |
| Biocompatibility (Haemocompatibility) | Met predetermined acceptance criteria, in accordance with ISO 10993-1:2009. |
| Biocompatibility (Pyrogenicity - Material-Mediated Rabbit Pyrogen) | Met predetermined acceptance criteria, in accordance with ISO 10993-1:2009. |
| Particulate Analysis (Surface and Fluid Path) | Demonstrated that the device met acceptance criteria (implies acceptable levels of particulates). |
| Overall Design Requirements (as per 21 CFR §820.30, Design Controls) | The subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices. This indicates that the new design (materials, configurations) performs equivalently to the predicate and doesn't raise new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each performance test. It mentions that "Performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate devices." It also 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 suggests that some testing may have been done on the new configurations and materials, while for other aspects, reliance was placed on the predicate's testing.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for mechanical and material changes, the data would typically be generated in a laboratory setting by the manufacturer, rather than clinical trials with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
Not applicable. This is a medical device submission focused on physical and mechanical performance, and biocompatibility, not a diagnostic or AI-based device requiring expert interpretation for ground truth establishment. The "ground truth" here is objective measurement against specified engineering and biological standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not a study involving human interpretation or subjective assessments that would require an adjudication method. The testing involves objective measurements against predefined 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 device is an IV catheter system, not a diagnostic device or an AI-assisted system. Therefore, an MRMC study is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests conducted on the BD Intima II PLUS Closed IV Catheter System relies on:
- Engineering Specifications: Predetermined requirements for physical and mechanical properties (e.g., pull force, leakage pressure, clamp seal pressure).
- Standardized Biocompatibility Protocols: Adherence to international standards like ISO 10993-1:2009 for biological evaluation, where acceptance criteria are defined for various biological responses (cytotoxicity, sensitization, etc.).
- Manufacturing Quality Standards: Requirements for package integrity and particulate analysis.
Essentially, the ground truth is established by objective, measurable standards and tests designed to ensure the device performs safely and effectively according to its intended use.
8. The Sample Size for the Training Set
Not applicable. There is no AI or machine learning component to this device; therefore, no "training set" exists.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2017
Becton, Dickinson and Company % Mark Job Responsible Third Party Official Regulatory Technology Services. LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K172204
Trade/Device Name: 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 Dated: July 19, 2017 Received: July 21, 2017
Dear 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.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 (DICE) 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 (DICE) 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.
Tara A. Ryan -S
for
Lori Wiggins 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)
Device Name
BD Intima II PLUS Closed IV Catheter System
Indications for Use (Describe)
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 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) |
|X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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K172204 510(k) Summary
21 CFR §807.92
BD Intima II PLUS™ Closed IV Catheter System
| SubmitterInformation | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. | |
|---|---|---|---|
| Submitter Address: | 9450 South State StreetSandy, UT 84070 | ||
| Contact Person: | Henry BolandStaff Regulatory Affairs Specialisthenry.boland@bd.com(801) 565-2550 (phone) | ||
| Date of Preparation: | June 30, 2017 | ||
| Subject Device | Trade Name: | BD Intima II PLUS™ 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 | ||
| Classification Panel: | General Hospital | ||
| PredicateDevice | Trade Name: | BD Intima II™ Closed IV Catheter System | |
| 510(k) Reference: | K143610 | ||
| 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 | ||
| Reason forSubmission | The reason for his submission is to notify CDRH of modifications to the BD Intima II™ Closed IV Catheter System, including: 1) a change to extension tubing and PRN shrink wrap band from PVC to non-PVC materials; 2) the removal of the slide clamp option (only a pinch clamp option will be available); 3) the addition of new Y connection (dual port) with dual PRN adapter configurations; 4) the addition 0.56" length catheter configurations. | ||
| DeviceDescription | The BD Intima II PLUS™ Closed IV Catheter System is a closed system IV catheter 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 and Luer connector. The system incorporates an integrated extension set which is available in three configurations: 1) Y Connection (dual port) with PRN adapter and end cap; 2) Y Connection (dual port) with two PRN adapters; and 3) Straight Connection (single port) with PRN adapter. The Luer connector is color-coded to indicate catheter gauge size. The system is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6. The package system is able to maintain | ||
| SUBJECT DEVICE | PREDICATE DEVICE (K143610) | ||
| Indications forUse(21 CFR§807.92(a)(5)) | The subject device Indications for Use is the same as the predicate BD Intima IIClosed IV Catheter System (K143610), with the exception of the device tradename. As such, the differences between the subject and predicate deviceIndications for Use do not change the intended use of the predicate devices orraise different questions of safety and effectiveness. | ||
| product sterility during its specified shelf life of 3 years. |
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| SUBJECT DEVICE | PREDICATE DEVICE (K143610) |
|---|---|
| The BD Intima II PLUS™ Closed IVCatheter System is inserted into a patient'svascular system for short-term use tomonitor blood pressure or administer fluidsintravascularly. These devices may be usedfor any patient population with considerationgiven to adequacy of vascular anatomy,procedure being performed, fluids beinginfused, and duration of therapy. | The BD Intima II™ Closed IV CatheterSystem is inserted into a patient's vascularsystem for short-term use to monitor bloodpressure or administer fluids intravascularly.These devices may be used for any patientpopulation with consideration given toadequacy of vascular anatomy, procedurebeing performed, fluids being infused, andduration of therapy. |
Technological Technological characteristics of the subject device are substantially equivalent to Characteristics the predicate device. The subject BD Intima II PLUS™ Closed IV Cather System achieves its intended use based on the same technology and principles of operation as the predicate BD Intima IITM Closed IV Cather System. The subject device has been modified from the predicate device as listed below. The results of design verification demonstrate that these changes are substantially equivalent to the predicate device. All other aspects of the subject device are identical to those of the predicate device.
- · Change to Extension Tubing and PRN Shrink Wrap Band materials from PVC to non-PVC materials
- · Removal of slide clamp component (only pinch clamp provided)
- · Qualification of new product configurations:
- o Y Connection (dual port) with two pre-attached PRN adapters
- o 0.56" length catheter configuration
- o Y Connection (dual port) with two pre-attached PRN adapters
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE (K143610) |
|---|---|---|
| Design | A single-winged, polyurethane IV catheter with an integrated extension set incorporating either a single port or Y (dual)-port injection site. Incorporates BD Instaflash™ technology to assist with flashback visualization. | A single-winged, polyurethane IV catheter with an integrated extension set incorporating either a single port or Y (dual)-port injection site. Incorporates BD Instaflash™ technology to assist with flashback visualization. |
| Materials | Component | PREDICATE DEVICE |
| Catheter Tubing | BD Vialon™ Polyurethane | |
| Catheter Tipping Lubricant | Silicone | |
| Catheter Lubricant | Silicone | |
| Metal Wedge | Stainless Steel | |
| Y-Adapter | Propionate | |
| Septum/Sleeve Stopper | Polyisoprene | |
| Needle | Stainless Steel |
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| Needle Cover | Same as predicate | Polyethylene | |
|---|---|---|---|
| Extension Tubing | Thermoplastic Polyurethane | Polyvinyl Chloride | |
| Pinch Clamp | Same as predicate | Polyoxymethylene | |
| Slide Clamp | No slide clamp option | Polystyrene | |
| Luer Connection Site | Same as predicate | Polypropylene | |
| PRN Body | Same as predicate | Polycarbonate | |
| PRN Injection Port | Same as predicate | Polyisoprene | |
| PRN Shrink Wrap Band | Polyethylene Terephthalate | Polyvinyl Chloride | |
| Cap | Same as predicate | Acrylonitrile Butadiene Styrene | |
| Extension Tubing Adhesive | Same as predicate | UV-Cured Epoxy | |
| Needle Adhesive | Same as predicate | UV-Cured Epoxy | |
| Septum Adhesive | Same as predicate | UV-Cured Epoxy | |
| Paddle Hub | Same as predicate | Polystyrene | |
| Physical /MechanicalSpecifications | SUBJECT DEVICE | PREDICATE DEVICE | |
| Catheter Diameters18G, 20G, 22G, 24G1.16" | Catheter Lengths0.56", 0.75", 1.00", | Catheter DiametersCatheter Lengths18G, 20G, 22G, 24G0.75", 1.00", 1.16" | |
| ProductConfigurations | • Y Connection (dual port) with PRNadapter and end cap• Y Connection (dual port) with two PRNadapters• Straight Connection (single port) withPRN adapter | • Y Connection (dual port) with PRN adapterand end cap• Straight Connection (single port) with PRNadapter |
Summary of Performance tests completed on the subject device were limited to those tests Performance required to support a determination of substantial equivalence to the predicate devices. A risk analysis was conducted to assess the impact of the proposed Tests modifications to the subject devices. 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 identified to ensure that specified design requirements were met:
- Extension Tubing / Catheter Adapter Pull Force .
- . Extension Tubing / Catheter Adapter Joint Leakage Pressure
- Extension Tubing Pull Out Force .
- Clamp Seal Pressure ●
- Package Integrity .
In addition, the following biocompatibility testing was conducted in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.
- . Cytotoxicity
- Sensitization .
- . Intracutaneous Reactivity
- Systemic Toxicity (Acute) .
- . Haemocompatibility
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| Pyrogenicity (Material-Mediated Rabbit Pyrogen) | |||
|---|---|---|---|
| -- | -- | ------------------------------------------------- | -- |
Finally, particulate analysis of the surface and fluid path was conducted.
Per the 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 devices.
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and performancetesting, the subject BD Intima II PLUS™ Closed IV Catheter meets all pre-determined requirements in accordance with 21 CFR §820.30, Design Controls,and demonstrates that the subject device is substantially equivalent to thepredicate BD Intima II™ Closed IV Catheter System. |
|---|---|
| ------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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).