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.

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

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the BD Intelliport™ System (K243062) describes the performance testing conducted to demonstrate substantial equivalence to its predicate device (K182092). However, it does not provide specific acceptance criteria or reported device performance values in a quantifiable table format, nor does it detail a standalone study with quantitative results, or a multi-reader multi-case (MRMC) comparative effectiveness study.

The document primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics and a list of performance tests completed.

Here's an attempt to structure the answer based on the available information, with caveats where data is missing:

Acceptance Criteria and Device Performance

The 510(k) summary states that "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." However, the specific numerical acceptance criteria and the quantitative reported device performance values for most tests are not explicitly stated in the provided document.

The only quantitative performance criteria and reported values mentioned are for "Volume measurement accuracy" and "Volume Measurement Resolution."

Acceptance Criteria	Reported Device Performance (Subject Device)
Volume measurement accuracy:
For volumes >1.0 mL	± 10%
For volumes 0.4 – 1.0 mL	± 0.2mL
Volume Measurement Resolution	Uniform increments of 0.5 mL

Note: The document states these are "Identical" to the predicate device, implying the reported performance matches the specified criteria.

Study Information

Due to the nature of a 510(k) summary, detailed study reports with specific quantitative results (beyond volume measurement accuracy) are not included. The document generally refers to "performance testing" and "human factors evaluation."

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each test. For "Volume Measurement Performance Window," the volume range tested was 0.5ml to 30ml, and average push speed 10ml/min to 400 ml/min. This implies tests were conducted across this range, but the number of injections or trials is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be non-clinical (laboratory-based) and human factors studies. The human factors testing likely involved simulated clinical environments.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided within the scope of this 510(k) summary. These types of details are usually found in full study reports, not the summary itself, especially for a device that primarily automates record-keeping and measurement, rather than making diagnostic assessments that require expert ground truth. The human factors testing involved "intended device users," but their specific qualifications or roles in establishing "ground truth" (in a diagnostic sense) are not outlined.
Adjudication method for the test set:
- Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where there is disagreement in expert interpretation of diagnostic data. This device automates measurements and record-keeping, so such a method is not relevant.
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:
- No, an MRMC comparative effectiveness study was not explicitly reported or appears not to have been the primary method for demonstrating substantial equivalence. The device's primary function is "automated record keeping" and facilitating "documentation of the medications." It improves efficiency and accuracy of recording medication administration, rather than assisting human readers in interpreting medical images or data. The human factors evaluation assessed "critical tasks completed by intended device users," implying usability and user performance with the system, not a comparison of expert diagnostic accuracy with and without AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that standalone (algorithm-only) performance testing was conducted for various technical attributes. For example, "Bolus volume measurement accuracy," "Sensor flow rate," "Decoding response time," "Wifi functionality," and "Dose transmission time" are intrinsic functions of the system and its algorithms, which would have been tested independently of a human operator to verify their technical specifications. The "Flow Algorithm" itself was updated and "qualified through verification testing." However, explicit, detailed results from a standalone study with acceptance criteria are not presented in a formal table like format for all algorithm-driven functions.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical performance tests (e.g., volume measurement), the "ground truth" would have been established using calibrated instruments and reference standards (e.g., known volumes, known flow rates) in a laboratory setting.
- For the human factors evaluation, the "ground truth" would be defined optimal task performance and safety outcomes as determined by medical device standards and clinical best practices.
The sample size for the training set:
- The document does not provide information on a training set size. The BD Intelliport System involves embedded software and algorithms (e.g., flow algorithm, RFID reading, EMR communication). While such systems often involve development and testing cycles, the summary does not detail a specific "training set" like one would find for a machine learning or AI algorithm that learns from data in a traditional sense. The "Flow Algorithm" was updated and "qualified through verification testing," which implies validation against known physical models or experimental data, rather than a statistical "training set" in the context of deep learning.
How the ground truth for the training set was established:
- As no "training set" is explicitly mentioned for a machine learning model, this question is not applicable in the context of the provided information. The "ground truth" for verifying the updated flow algorithm would have been established through physical experiments and engineering measurements with known parameters (e.g., precise drug volumes, flow rates) to ensure the algorithm accurately processes the sensor data.

Summary

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"

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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).

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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

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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 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."

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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 880.572521 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 880.572521 CFR 880.5440
Classification	Product codes: PHC, FPA
Device Classification Name	Infusion Safety Management Software; Set, Administration, Intravascular
Review Panel	General Hospital

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Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
BD Intelliport™ System Traditional 510(k) Premarket Notification
Page 2 of 12

Device Description

• 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 intended for patients with body weights >20 kg.

Do not use the BD Intelliport™ System with blood, blood products, biologics, or chemotherapeutics.

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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

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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.	DifferentThe 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.

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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)	DifferentModifications 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	DifferentBoth 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.	DifferentThe 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.

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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)	DifferentModifications 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	DifferentBoth 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.	DifferentThe 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.DifferentThe 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.

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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	DifferentThe 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™ connectorPort: 3-way stopcock with integrated BD SmartSite™ needle free valveUseful Life: >24hrs to 30 daysSensor Dead Volume: ≤0.12 mL following injection.Port Capacity: 120 Injections	Fluid Connection: 1 ports, BD Luer-Lok™ type fittingPort: BD Q-Syte™ needle free valveUseful Life: >24hrs to 30 daysSensor Dead Volume: <0.3 mLPort Capacity: 100 Injections	DifferentDifferences in tolerances and dimensions between the subject device and predicate device are made to accommodate improved design features.Design verification and validation testing demonstrates that the subject device performs as intended.
Injection Site: Reader
Function	Reader decodes drug information from sensor, displays information on screen, and communicates drug information to the gateway. Serves as user interface for clinician.	Tablet decodes drug information from sensor, displays information on screen, and communicates drug information to the gateway. Serves as user interface for clinician.	IdenticalAlthough the tablet component has been changed to the reader their function is identical.

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Becton, Dickinson and Company
Franklin Lakes, New Jersey 07417
BD Intelliport™ System Traditional 510(k) Premarket Notification
Page 8 of 12

Attribute	Subject Device (BD Intelliport System)	Predicate Device (K182092– BD Intelliport System)	Significance to Substantial Equivalence
Computing Platform Operating Systems	Modified proprietary embedded software	Proprietary embedded software	DifferentThe updated operating systems have been qualified through software, cybersecurity and design verification activities.
Volume measurement accuracy	± 10% (for volumes >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/minVolume Range: 0.5ml to 30ml	Average Push Speed: 10ml/min to 400 ml/minVolume Range: 0.5ml to 60ml	DifferentThe 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 ConcentrationVisual and auditory notification on the screenAlerts for allergy, antibiotic dosing reminder, and expired medication alerts	Includes Drug Name and ConcentrationAlerts for allergy and antibiotic dosing reminderVisual and auditory notification on the screen	DifferentAddition of expired medication alerts has been qualified through design verification and validation testing.
Dose History List	Contains doses sent to the EMRContains doses missing drug name and concentrationContains doses flagged with a potential volume error message	Contains doses sent to the EMRContains doses missing drug name and concentrationContains doses flagged with a potential volume error message	Identical

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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 ReadersInput Voltage: 100-240 VAC, 50 – 60HzOutput Voltage: 5VOutput Current: 3A	Storage Capacity: 5 BasesInput Voltage: 100-240 VAC, 50 – 60 HzOutput Voltage: 5VOutput Current: 4A	DifferentThe 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)	DifferentThe 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	DifferentThe 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	IdenticalThe 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
Page 10 of 12

Attribute	Subject Device (BD Intelliport System)	Predicate Device (K182092– BD Intelliport System)	Significance to Substantial Equivalence
Biocompatibility	Biocompatible per ISO 10993-1Sensor: 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 10993-1Sensor: 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	IdenticalBoth 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 toIEC 60601-1IEC 60601-2	Conformity toIEC 60601-1IEC 60601-2	IdenticalThe updated design of the subject device has been tested for electrical safety and electromagnetic compatibility.
Sterilization	Sensor: Sterile, Single Use, e-beam, SAL 10⁻⁶Reader: Non-sterile, ReusableMount: Non-sterile, ReusableCharger: Non-sterile, Reusable	Sensor: Sterile, Single Use, Ethylene Oxide, SAL 10⁻⁶Base: Non-sterile, ReusableTablet: Non-sterile, ReusableCharger: Non-sterile, Reusable	DifferentBoth 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.

Regulation Number and Section

§ 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).