(266 days)
Not Found
No
The description of the device and its functionalities (identification, measurement, alerting, and documentation) does not mention any AI, DNN, or ML technologies. The system relies on RFID for medication identification, volume measurement, and wireless transmission, which are conventional automation technologies rather than AI.
No
The device is an automated record-keeping system for medication administration, not a therapeutic device. It facilitates documentation, but does not diagnose, treat, or prevent a disease or condition.
No
The device is described as an "automated record keeping system" that identifies, measures, alerts, and documents the administration of medications, primarily to facilitate documentation. It does not provide any diagnostic information or analysis about a patient's medical condition.
No
The device is not a software-only medical device because its description explicitly includes hardware components like the "BD Intelliport™ Injection Site" (comprised of a Sensor and a Reader), "BD Intelliport™ Mount," and "BD Intelliport™ 2-Bay Charger." The "Software validation & cybersecurity assessment" is only one part of extensive testing that also covers various hardware components, indicating the device is a system with both hardware and software.
No.
This device is an automated record-keeping system for medication administration. It measures the volume of drugs administered and transmits this information to the patient's EMR. It does not perform tests on specimens derived from the human body to provide information for diagnostic, monitoring or screening purposes.
N/A
Intended Use / Indications for Use
The BD Intelliport™ System is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients.
The BD Intelliport™ System allows the clinician to record anesthesia-related medication administration events during pre-procedure, intra-procedure and recovery phase. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.
The BD Intelliport™ System is intended for patients with body weights >20 kg.
Do not use the BD Intelliport™ System with blood, blood products, biologics, or chemotherapeutics.
Product codes (comma separated list FDA assigned to the subject device)
PHC, FPA
Device Description
BD Intelliport™ System integrates into an intravenous line and automatically captures information about the anesthesia medications administered to the patient. It wirelessly transmits anesthesia medication administration information to the patient's Electronic Medical Record (EMR) via hospital server applications (Gateway software). The BD Intelliport™ System provides core technologies that enable key functions of the system:
• Medication Identification: Informs clinician of medication and concentration along with any informational notifications such as patient allergy and expired medication reminders. This occurs when syringes with the correct type of RFID encoded label are attached.
• Dose Measurement: Measures volume of drug administered to the patient through the system, then calculates dose weight.
• Automatic Charting: Wirelessly transmits measured doses to the EMR.
The following are the main system components:
• BD Intelliport™ Injection Site which is comprised of the following two components:
- BD Intelliport™ Sensor
- BD Intelliport™ Reader
• BD Intelliport™ Mount (optional accessory)
• BD Intelliport™ 2-Bay Charger (accessory)
• BD Intelliport™ Gateway
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals in a hospital or medical center setting
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)
To demonstrate substantial equivalence of the subject device to the predicate device, non-clinical testing was conducted. Using FDA Guidance, recognized consensus standards, and internal requirements the following tests were conducted on the subject device:
• Sensor Testing
- Bolus volume measurement accuracy
- Sensor barcode scan
- Sensor flow rate
- Sensor readiness
- Sensor detect
- Detachment force of sensor from reader
- Sensor tensile and leak testing
- Syringe attachment and detachment detection
- Smartvalve detection
- Sensor IV Port ISO 80369-7 Testing
- SmartsiteTM 80369-7 Testing
- Particulate Testing per USP 788 & ISO 8536-4
• Reader Testing
- Cleaner compatibility
- Charging initiation
- Audio test
- User reader touchscreen interaction
- Decoding barcode symbology
- Sensor detect
- Reader Sensor Barcode Scan
- Smartvalve Detection
- Syringe attachment and detachment detection
- Reader syringe decoding coverage test
- Reader false read
- Decoding response time
- Wifi functionality
- Dose transmission time
- Bolus volume measurement under operating environmental conditions
- Battery charging test
• Mount Testing
- Positive indication upon injection site attachment
- Retention force of injection site to mount
- Usage life
• Charger Testing
- Charger stays in place during use
- One handed insertion and removal
- Charge bay keyed for installation
- Bay powered when reader installed
- Output current
- Operating temperature
- Cleaning chemical compatibility
- LED light indicator
- Reader screen visibility
- Verify charger does not scratch reader
- Dimensions/weight
- Surface temperature limits
- Reverse input polarity protection
- Wear resistance
- Drop test
- Power supply cord length
• Software validation & cybersecurity assessment
• Reprocessing/cleaning validation
• Electromagnetic Compatibility, Wireless, and Electrical, Mechanical, and Thermal (EMT) Safety Testing
• Biocompatibility
• Packaging Testing
Human factors evaluation, including formative and summative usability studies were conducted to assess critical tasks completed by intended device users while operating the device. Testing was conducted in accordance with FDA guidance "Applying Human Factors and usability Engineering to medical devices" (2016). The results of the studies and the analysis of residual risk, show that the use-related risks associated with the Intelliport™ System have been mitigated to acceptable levels and support that the subject device does not raise different questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Volume measurement accuracy: ± 10% (for volumes >1.0 mL), ± 0.2mL (for volumes 0.4 – 1.0 mL)
Volume Measurement Resolution: Uniform increments of 0.5 mL
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
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 20, 2025
Becton Dickinson
Tim Wade
Associate Director, Regulatory Affairs
1 Becton Drive
Franklin Lakes, New Jersey 07417
Re: K243062
Trade/Device Name: BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)
Regulation Number: 21 CFR 880.5725
Regulation Name: Infusion Pump
Regulatory Class: Class II
Product Code: PHC, FPA
Dated: May 23, 2025
Received: May 23, 2025
Dear Tim Wade:
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"
Page 2
K243062 - Tim Wade Page 2
(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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K243062 - Tim Wade Page 3
Sincerely,
Kyran R. Gibson -S
for
Shruti Mistry
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K243062
Device Name:
BD Intelliport System;
BD Intelliport Reader (516230);
BD Intelliport Sensor (516229);
BD Intelliport Gateway (516232);
BD Intelliport Mount (516233);
BD Intelliport Charger (516231)
Indications for Use (Describe)
The BD Intelliport™ System is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients.
The BD Intelliport™ System allows the clinician to record anesthesia-related medication administration events during pre-procedure, intra-procedure and recovery phase. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.
The BD Intelliport™ System is intended for patients with body weights >20 kg.
Do not use the BD Intelliport™ System with blood, blood products, biologics, or chemotherapeutics.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
BD Intelliport™ System
Traditional 510(k) Premarket Notification
Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
Page 1 of 12
BD Intelliport™ System 510(k) Summary
21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
Submitter Information:
Becton Dickinson (BD)
One Becton Drive
Franklin Lakes, NJ USA 07417
Contact Person: Tim Wade, Associate Regulatory Affairs Director
Tel: 602.830.5330
Date Prepared:
June 17, 2025
Subject Device:
| Device Trade Name | BD Intelliport™ System |
|---|---|
| 510(k) Number | K243062 |
| Regulation Number | 21 CFR 880.5725 |
| 21 CFR 880.5440 | |
| Classification | Product codes: PHC, FPA |
| Device Classification Name | Infusion Safety Management Software; Set, Administration, Intravascular |
| Review Panel | General Hospital |
Predicate Device:
| Device Trade Name | BD Intelliport™ System |
|---|---|
| 510(k) Number | K182092 |
| Regulation Number | 21 CFR 880.5725 |
| 21 CFR 880.5440 | |
| Classification | Product codes: PHC, FPA |
| Device Classification Name | Infusion Safety Management Software; Set, Administration, Intravascular |
| Review Panel | General Hospital |
Page 6
Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
BD Intelliport™ System Traditional 510(k) Premarket Notification
Page 2 of 12
Device Description
BD Intelliport™ System integrates into an intravenous line and automatically captures information about the anesthesia medications administered to the patient. It wirelessly transmits anesthesia medication administration information to the patient's Electronic Medical Record (EMR) via hospital server applications (Gateway software). The BD Intelliport™ System provides core technologies that enable key functions of the system:
• Medication Identification: Informs clinician of medication and concentration along with any informational notifications such as patient allergy and expired medication reminders. This occurs when syringes with the correct type of RFID encoded label are attached.
• Dose Measurement: Measures volume of drug administered to the patient through the system, then calculates dose weight.
• Automatic Charting: Wirelessly transmits measured doses to the EMR.
The following are the main system components:
• BD Intelliport™ Injection Site which is comprised of the following two components:
- BD Intelliport™ Sensor
- BD Intelliport™ Reader
• BD Intelliport™ Mount (optional accessory)
• BD Intelliport™ 2-Bay Charger (accessory)
• BD Intelliport™ Gateway
Indications for Use:
The BD Intelliport™ System is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients.
The BD Intelliport™ System allows the clinician to record anesthesia-related medication administration events during pre-procedure, intra-procedure and recovery phase. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.
The BD Intelliport™ System is intended for patients with body weights >20 kg.
Do not use the BD Intelliport™ System with blood, blood products, biologics, or chemotherapeutics.
Page 7
Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
BD Intelliport™ System Traditional 510(k) Premarket Notification
Page 3 of 12
Comparison to Predicate Device:
The subject BD Intelliport System has the following similarities to the predicate BD Intelliport System (K182092):
• Same intended use
• Same patient population and users
• Same fundamental scientific technology
• Same mechanism of action
• Same sterility assurance levels
• Similar materials
The subject and predicate devices have the following differences:
• Improved flow algorithm
• Modified indications for use
• Modifications to system components and design
• RFID reading capability
• Updated Cybersecurity profile
Page 8
Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
BD Intelliport™ System Traditional 510(k) Premarket Notification
Page 4 of 12
A detailed comparison of technological characteristics is provided in the table below:
| Attribute | Subject Device (BD Intelliport System) | Predicate Device (K182092– BD Intelliport System) | Significance to Substantial Equivalence |
|---|---|---|---|
| Intended Use/Indications for Use | |||
| Intended Use | The BD Intelliport System is intended to automate the record keeping of bolus intravenous injections. | The BD Intelliport system is intended to automate the record keeping of bolus intravenous injections. | Identical |
| Indications for Use | The BD Intelliport system is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients. |
The BD Intelliport system allows the clinician to record anesthesia-related medication administration events during pre-procedure, intra-procedure, and recovery phase. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications. | The BD Intelliport system is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients.
The BD Intelliport system allows the clinician to record anesthesia-related medication administration events during preop, intra-op, and PACU. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications. | Different
The indications for use remain unchanged between the subject device and the predicate device except for the change from preop, intra-op, and PACU to pre-procedure, intra-procedure and recovery phase to clarify that the subject device can be used in different use environments, by qualified clinicians as substantiated by the human factors testing.
The removal of the contraindication "The BD Intelliport System is not intended for use with refrigerated medications (excluding cefazolin)" is appropriately substantiated by the verification and validation testing. |
Page 9
Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
BD Intelliport™ System Traditional 510(k) Premarket Notification
Page 5 of 12
| Attribute | Subject Device (BD Intelliport System) | Predicate Device (K182092– BD Intelliport System) | Significance to Substantial Equivalence |
|---|---|---|---|
| The BD Intelliport™ system is intended for patients with body weights >20 kg. |
Do not use the BD Intelliport™ System with blood, blood products, biologics, or chemotherapeutics. | The BD Intelliport™ system is intended for patients whose body weights are >20kg.
The BD Intelliport™ system is not intended for use with blood, blood products, biologics, or chemotherapeutics.
The BD Intelliport™ system is not intended for use with refrigerated medications (excluding cefazolin). | |
| Technology and Design | | | |
| Components | • Intelliport Injection Site which consists of:
- Intelliport Reader
- Intelliport Sensor
• Intelliport Gateway (software)
• Intelliport 2-Bay Charger (accessory)
• Intelliport Mount (optional accessory) | • Intelliport Injection Site which consists of: - Intelliport Base
- Intelliport Sensor
• Intelliport Tablet
• Intelliport Radio
• Intelliport Gateway (software)
• Intelliport 5-Bay Charger (accessory) | Different
Modifications have been made to the subject device design to allow for improved user interaction.
Additional offering of optional mount accessory. |
| Syringe reading capability | RFID labeled drug syringes | 2D Barcode labeled drug syringes | Different
Both devices utilize electronically encoded medication syringes. Differences have been qualified through verification testing. |
| Compatible Accessories | • 1 mL-30 mL luer lock syringes
• Intravenous (IV) administration tubing and IV extension sets and accessories having luer lock connectors. | • 1 mL-60 mL luer lock syringes
• Intravenous (IV) administration tubing and IV extension sets and accessories having luer lock connectors. | Different
The subject device has limited the size of luer lock syringes within the range of the predicate devices. Differences have been qualified through verification and human factors testing. |
Page 10
Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
BD Intelliport™ System Traditional 510(k) Premarket Notification
Page 6 of 12
| Attribute | Subject Device (BD Intelliport System) | Predicate Device (K182092– BD Intelliport System) | Significance to Substantial Equivalence |
|---|---|---|---|
| The BD Intelliport™ system is intended for patients with body weights >20 kg. |
Do not use the BD Intelliport™ System with blood, blood products, biologics, or chemotherapeutics. | The BD Intelliport™ system is intended for patients whose body weights are >20kg.
The BD Intelliport™ system is not intended for use with blood, blood products, biologics, or chemotherapeutics.
The BD Intelliport™ system is not intended for use with refrigerated medications (excluding cefazolin). | |
| Technology and Design | | | |
| Components | • Intelliport Injection Site which consists of:
- Intelliport Reader
- Intelliport Sensor
• Intelliport Gateway (software)
• Intelliport 2-Bay Charger (accessory)
• Intelliport Mount (optional accessory) | • Intelliport Injection Site which consists of: - Intelliport Base
- Intelliport Sensor
• Intelliport Tablet
• Intelliport Radio
• Intelliport Gateway (software)
• Intelliport 5-Bay Charger (accessory) | Different
Modifications have been made to the subject device design to allow for improved user interaction.
Additional offering of optional mount accessory. |
| Syringe reading capability | RFID labeled drug syringes | 2D Barcode labeled drug syringes | Different
Both devices utilize electronically encoded medication syringes. Differences have been qualified through verification testing. |
| Compatible Accessories | • 1 mL-30 mL luer lock syringes
• Intravenous (IV) administration tubing and IV extension sets and accessories having luer lock connectors. | • 1 mL-60 mL luer lock syringes
• Intravenous (IV) administration tubing and IV extension sets and accessories having luer lock connectors. | Different
The subject device has limited the size of luer lock syringes within the range of the predicate devices. Differences have been qualified through verification and human factors testing.
Both devices utilize electronically encoded medication syringes. Differences have been qualified through verification testing.
Different
The subject device has limited the size of luer lock syringes within the range of the predicate devices. Differences have been qualified through verification and human factors testing. |
Page 11
Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
BD Intelliport™ System Traditional 510(k) Premarket Notification
Page 7 of 12
| Attribute | Subject Device (BD Intelliport System) | Predicate Device (K182092– BD Intelliport System) | Significance to Substantial Equivalence |
|---|---|---|---|
| Flow Algorithm | Algorithm calculates velocity based on transit time, the speed of sound of the material and the fluid path length | Algorithm calculates velocity based on transit time, the speed of sound of the material and the fluid path length | Different |
The fundamental design of the algorithm between the predicate and subject devices is the same. The subject device calculations have been updated to allow for broader range of drugs, including refrigerated medications. This has been qualified through verification testing. |
| Injection Site: Sensor | | | |
| Physical/ Mechanical Specifications(Sensor) | Fluid Connection: 2 ports, BD Luer-Lok™ connector
Port: 3-way stopcock with integrated BD SmartSite™ needle free valve
Useful Life: >24hrs to 30 days
Sensor Dead Volume: ≤0.12 mL following injection.
Port Capacity: 120 Injections | Fluid Connection: 1 ports, BD Luer-Lok™ type fitting
Port: BD Q-Syte™ needle free valve
Useful Life: >24hrs to 30 days
Sensor Dead Volume: 1.0 mL)
± 0.2mL (for volumes 0.4 – 1.0 mL) | ± 10% (for volumes >1.0 mL)
± 0.2mL (for volumes 0.4 – 1.0 mL) | Identical |
| Volume Measurement Resolution | Uniform increments of 0.5 mL | Uniform increments of 0.5 mL | Identical |
| Volume Measurement Performance Window | Average Push Speed: 10ml/min to 400 ml/min
Volume Range: 0.5ml to 30ml | Average Push Speed: 10ml/min to 400 ml/min
Volume Range: 0.5ml to 60ml | Different
The subject device lowers the upper limit of the volume range from 60ml to 30ml. This change has been qualified through verification and human factors testing. |
| Notifications | Includes Drug Name and Concentration
Visual and auditory notification on the screen
Alerts for allergy, antibiotic dosing reminder, and expired medication alerts | Includes Drug Name and Concentration
Alerts for allergy and antibiotic dosing reminder
Visual and auditory notification on the screen | Different
Addition of expired medication alerts has been qualified through design verification and validation testing. |
| Dose History List | Contains doses sent to the EMR
Contains doses missing drug name and concentration
Contains doses flagged with a potential volume error message | Contains doses sent to the EMR
Contains doses missing drug name and concentration
Contains doses flagged with a potential volume error message | Identical |
Page 13
Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
BD Intelliport™ System Traditional 510(k) Premarket Notification
Page 9 of 12
| Attribute | Subject Device (BD Intelliport System) | Predicate Device (K182092– BD Intelliport System) | Significance to Substantial Equivalence |
|---|---|---|---|
| Charger (Hardware) | |||
| Specifications | Storage Capacity: 2 Readers | ||
| Input Voltage: 100-240 VAC, 50 – 60Hz | |||
| Output Voltage: 5V | |||
| Output Current: 3A | Storage Capacity: 5 Bases | ||
| Input Voltage: 100-240 VAC, 50 – 60 Hz | |||
| Output Voltage: 5V | |||
| Output Current: 4A | Different |
The updated charger has been qualified as part of design verification activities. |
| Gateway (Software) | | | |
| EMR connectivity | Send/receive medication data to/from EMR | Send/receive medication data to/from EMR | Identical |
| Encoded drug table (EDT) | 306 drugs on ISDT (Intelliport System Drug Table) | 161 drugs on EDT (Encoded Drug Table) | Different
The subject device algorithm has been updated to allow for additional drugs to be qualified as part of design verification testing. |
| Provisioning | Semi-automated method to provision the device on network | Manual method to provision the device on network | Different
The subject device has been updated to provide a semi-automated way of connecting to Wifi to improve use of the system and has been qualified through software testing. |
| System | | | |
| Software Documentation Level | Enhanced documentation level | Major level of concern – Class C | Identical
The level of concern/documentation level is the same between the predicate and subject devices. |
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Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
BD Intelliport™ System Traditional 510(k) Premarket Notification
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| Attribute | Subject Device (BD Intelliport System) | Predicate Device (K182092– BD Intelliport System) | Significance to Substantial Equivalence |
|---|---|---|---|
| Biocompatibility | Biocompatible per ISO 10993-1 |
Sensor: Externally communicating medical device with blood path, indirect patient contact. Prolonged contact (>24 hr to 30 days)
Reader: Direct contact with intact skin. Prolonged contact (>24 hours to 30 days)
Mount & Charger: No patient contact | Biocompatible per ISO 10993-1
Sensor: Externally communicating medical device with blood path, indirect patient contact. Prolonged contact (>24 hr to 30 days)
Base: Direct contact with intact skin. Prolonged contact (>24 hours to 30 days)
Charger: No patient contact | Identical
Both devices share common contact duration and type of intended tissue contact for the Injection system (reader and sensor).
The biological evaluation, conducted in accordance with ISO10993-1, demonstrated that the subject device (sensor and reader) is biocompatible for its intended use. |
| Electrical Safety & Electromagnetic Compatibility | Conformity to
IEC 60601-1
IEC 60601-2 | Conformity to
IEC 60601-1
IEC 60601-2 | Identical
The updated design of the subject device has been tested for electrical safety and electromagnetic compatibility. |
| Sterilization | Sensor: Sterile, Single Use, e-beam, SAL 10⁻⁶
Reader: Non-sterile, Reusable
Mount: Non-sterile, Reusable
Charger: Non-sterile, Reusable | Sensor: Sterile, Single Use, Ethylene Oxide, SAL 10⁻⁶
Base: Non-sterile, Reusable
Tablet: Non-sterile, Reusable
Charger: Non-sterile, Reusable | Different
Both devices have components delivered sterile or non-sterile and both are sterilized using FDA established methods. The sterility of the subject is supported by sterilization validation testing. |
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Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
BD Intelliport™ System Traditional 510(k) Premarket Notification
Page 11 of 12
Performance Testing
To demonstrate substantial equivalence of the subject device to the predicate device, non-clinical testing was conducted. Using FDA Guidance, recognized consensus standards, and internal requirements the following tests were conducted on the subject device:
• Sensor Testing
- Bolus volume measurement accuracy
- Sensor barcode scan
- Sensor flow rate
- Sensor readiness
- Sensor detect
- Detachment force of sensor from reader
- Sensor tensile and leak testing
- Syringe attachment and detachment detection
- Smartvalve detection
- Sensor IV Port ISO 80369-7 Testing
- Smartsite™ 80369-7 Testing
- Particulate Testing per USP 788 & ISO 8536-4
• Reader Testing
- Cleaner compatibility
- Charging initiation
- Audio test
- User reader touchscreen interaction
- Decoding barcode symbology
- Sensor detect
- Reader Sensor Barcode Scan
- Smartvalve Detection
- Syringe attachment and detachment detection
- Reader syringe decoding coverage test
- Reader false read
- Decoding response time
- Wifi functionality
- Dose transmission time
- Bolus volume measurement under operating environmental conditions
- Battery charging test
• Mount Testing
- Positive indication upon injection site attachment
- Retention force of injection site to mount
- Usage life
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Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
BD Intelliport™ System Traditional 510(k) Premarket Notification
Page 12 of 12
• Charger Testing
- Charger stays in place during use
- One handed insertion and removal
- Charge bay keyed for installation
- Bay powered when reader installed
- Output current
- Operating temperature
- Cleaning chemical compatibility
- LED light indicator
- Reader screen visibility
- Verify charger does not scratch reader
- Dimensions/weight
- Surface temperature limits
- Reverse input polarity protection
- Wear resistance
- Drop test
- Power supply cord length
• Software validation & cybersecurity assessment
• Reprocessing/cleaning validation
• Electromagnetic Compatibility, Wireless, and Electrical, Mechanical, and Thermal (EMT) Safety Testing
• Biocompatibility
• Packaging Testing
Human Factors Evaluation
A human factors evaluation, including formative and summative usability studies were conducted to assess critical tasks completed by intended device users while operating the device. Testing was conducted in accordance with FDA guidance "Applying Human Factors and usability Engineering to medical devices" (2016). The results of the studies and the analysis of residual risk, show that the use-related risks associated with the Intelliport™ System have been mitigated to acceptable levels and support that the subject device does not raise different questions of safety or effectiveness.
Conclusion
The subject device, the BD Intelliport™ System, has met all predetermined acceptance criteria for the non-clinical and human factors testing conducted in accordance with relevant FDA guidance, recognized consensus standards, and internal requirements. The differences in technological characteristics do not change the intended use of the device and the testing conducted supports the technology changes do not raise different questions of safety or effectiveness when compared to the predicate device. Therefore, the subject device is considered substantially equivalent to the predicate BD Intelliport™ System.