(425 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functionality of a closed IV catheter system, with no mention of AI or ML technologies.
No.
The device administers fluids and monitors blood pressure, but does not provide a therapeutic effect on its own.
No
This device is designed for administering fluids and monitoring blood pressure, not for diagnosing medical conditions. While it monitors a physiological parameter (blood pressure), its primary function is for intervention (fluid administration) rather than diagnosis.
No
The device description clearly outlines multiple physical components made of materials like Vialon™, including a catheter, needle, septum, clamp, tubing, and connectors. The performance studies also focus on physical characteristics and interactions of these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for insertion into a patient's vascular system to monitor blood pressure or administer fluids intravascularly. This is a direct interaction with the patient's body for therapeutic or monitoring purposes.
- Device Description: The description details a catheter system designed for insertion into blood vessels.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of samples or diagnostic purposes.
The device is clearly intended for direct patient care within the vascular system, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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 population 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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ, FPA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices. A risk analysis was conducted to assess the impact of the proposed 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 devices. The performance tests listed below were conducted to ensure that the subject 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 System single 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
• Microbial Ingress testing
• Evaluation of MR Compatibility per ASTM F2182-19
In addition, a biocompatibility evaluation was conducted in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process and the FDA's guidance Use of International 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 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 performance testing, the subject BD Intima II™ and Intima II PLUS™ Closed IV Catheter Systems have been demonstrated to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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
| Submitter
| Information | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. |
|---|---|---|
| Submitter Address: | 9450 South State Street | |
| Sandy, Utah 84070 | ||
| Contact Person: | Kimberly Geisler | |
| Sr. Manager, Regulatory Affairs | ||
| kimberly.geisler@bd.com | ||
| (801) 565-2422 (phone) | ||
| Date of Preparation: | June 2, 2021 | |
| Subject Device | Trade Name: | BD Intima IITM Closed IV Catheter System |
| BD 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 Needleless | |
| Connector | ||
| Regulation Number: | 21 CFR §880.5440 | |
| Regulation Name: | Intravascular Administration Set | |
| Regulatory Class: | II | |
| Product Code: | FPA | |
| Classification Panel: | General Hospital | |
| Reason for | ||
| Submission | The reason for this submission is to expand the product offerings within the | |
| BD Intima II™ and Intima II PLUS™ Closed IV Catheter System product | ||
| lines, add a performance specification for the BD Intima II PLUS™ Closed | ||
| IV Catheter System single port 20G – 24G configurations to withstand | ||
| pressure up to 300psi, submit modifications to various system components, | ||
| and modify the sterilization method for the MaxZero™ Needleless | ||
| Connector. | ||
| Device Description | 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. | ||
| Indications for Use | ||
| (21 CFR | ||
| §807.92(a)(5)) | 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 population | ||
| 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. | |
| Technological
Characteristics | The BD Intima™ II and Intima II PLUS™ Closed IV Catheter Systems
achieve their intended uses based on the same technology and principles of
operation as the predicate BD Intima II™ and Intima II PLUS™ Closed IV
Catheter Systems, as well as the MaxZero™ Needleless Connector. The
subject devices have been modified from the predicate devices as listed
below. The changes to device design did not alter final product performance
specifications and the results of design verification demonstrate that the
subject devices are substantially equivalent to the predicate devices. All
other aspects of the subject device are identical to those of the predicate
devices. Tables comparing the subject and predicate devices are provided
below. 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. | |
4
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| Attribute | SUBJECT DEVICE
BD Intima™ II Closed IV Catheter System and
BD Intima II PLUSTM Closed IV Catheter
System | PREDICATE DEVICE 1
BD Intima II™ Closed IV
Catheter System (K143610) | PREDICATE DEVICE 2
BD Intima II PLUSTM Closed
IV Catheter System (K172204) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental Scientific Technology | 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. | 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. |
| 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 DEVICE
BD Intima™ II Closed IV Catheter System and
BD Intima II PLUSTM Closed IV Catheter
System | PREDICATE DEVICE 1
BD Intima IITM Closed IV
Catheter System (K143610) | PREDICATE DEVICE 2
BD Intima II PLUSTM Closed
IV Catheter System (K172204) |
| (Extension Tubing/Catheter Adapter
Adhesive) | (no change to material, general term used for
adhesive) | | |
| Needle Adhesive (Cannula Bonding
Adhesive) | Epoxy
(no change to material, general term used for
adhesive) | UV-Cured Epoxy | |
| Septum Adhesive | Epoxy
(no change to material, general term used for
adhesive) | UV-Cured Epoxy | |
| Paddle Hub | Polystyrene and White Colorant | Polystyrene (colorant not specified) | |
| Physical / Mechanical Specifications | Catheter Diameters
18G, 20G, 22G, 24G, 26G
Catheter Lengths
0.56 IN (Intima II PLUS only), 0.75 IN, 1.00 IN,
1.16 IN | Catheter Diameters
18G, 20G, 22G, 24G
Catheter Lengths
0.75IN, 1.00IN, 1.16IN | Catheter Diameters
18G, 20G, 22G, 24G
Catheter Lengths
0.56IN, 0.75IN, 1.00IN, 1.16IN |
| Product
Configurations | • Y connection (dual port) with PRN adapter and
end cap
• Y connection (dual port) with two PRN
adapters
• 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 two
MaxZero™ Needleless Connectors
• Straight connection (single port) with PRN
adapter
• Straight connection (single port) with
MaxZero™ Needleless Connector | • Y Connection (dual port)
with PRN and end cap
• Straight Connection (single
port) with PRN adapter | • Y Connection (dual port)
with PRN adapter and end
cap
• Y Connection (dual port)
with two PRN adapters
• Straight Connection (single
port) with PRN adapter |
| Attribute | SUBJECT DEVICE
BD Intima™ II Closed IV Catheter System and
BD Intima II PLUSTM Closed IV Catheter
System | PREDICATE DEVICE 1
BD Intima II™ Closed IV
Catheter System (K143610) | PREDICATE DEVICE 2
BD Intima II PLUSTM Closed
IV 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 |
7
8
Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE 3
MaxZero™ 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 |
9
Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070 USA
| Summary of
Safety and
Performance
Tests | Performance tests completed on the subject devices were limited to those tests
required to support a determination of substantial equivalence to the predicate
devices. A risk analysis was conducted to assess the impact of the proposed
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
devices. The performance tests listed below were conducted to ensure that the
subject 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 System
single 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 • Microbial Ingress testing • Evaluation of MR Compatibility per ASTM F2182-19 In addition, a biocompatibility evaluation was conducted in accordance with ISO
10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and
Testing Within a Risk Management Process and the FDA's guidance Use of
International 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 |
| -------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
10
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.