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 medications to patients.

The BD Intelliport System allows the clinician to record anesthesia related medication events in the pre-op, intra-op, and PACU areas. 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.

Device Description

The BD Intelliport System is used for automated documentation of medication, concentration, dose, volume and time of each IV injection for when intravenous bolus injections of medication are given to a patient.

During treatment, the clinician connects an intelligent injection port, called the Intelliport device, to a patient's fluid-delivery line and performs standard drug-delivery activities. The health practitioner injects the drug; the Intelliport reads the 2-D barcode adhered to the syringe containing the drug such as Becton Dickinson syringe K110771. This barcode contains the drug name and concentration. As the drug is injected, the Intelliport measures the volume of the injected drug and the time the drug was administered. Once the drug has been administered, the Intelliport transmits all of the information to an electronic record maintained by the Computer.

AI/ML Overview

The provided text describes the BD Intelliport System, its indications for use, and a comparison to a predicate device (DocuSys Anesthesia Information and Digital-Drug Management System) to establish substantial equivalence. It also mentions performance testing. However, it does not provide a detailed study report that proves the device meets specific acceptance criteria with the level of detail requested in the prompt.

Therefore, I cannot fully complete all sections of your request based solely on the provided text. I will extract the information that is present and note where details are missing.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Explicitly Stated for Intelliport)	Reported Device Performance (BD Intelliport System)
Accuracy of Drug Delivery	Not explicitly stated as "acceptance criteria", but compared to predicate and manual activation.	$\pm$ 5% for bolus volumes > 1.0 mL to 55 mL
		$\pm$ 20% for bolus volumes of 0.4 to 1.0 mL
Additional Functional Features (Implied Acceptance by presence)
Automated record keeping system	Present	Present
Patient safety features aligned with hospital records/protocols	Present	Present
Identification, measurement, alerting, documentation of medication administration	Present	Present
Record anesthesia related events (pre-op, intra-op, PACU)	Present	Present
Use by healthcare professionals in hospital/medical center	Present	Present
Facilitate documentation of manually administered bolus IV injections	Present	Present
Measures volume of injected drug	Present	Uses ultrasonic sensor
Allergy data notification	Present	Provides notice of patient allergies
Medication history record	Present	Provides a record of drug delivery related events
Drug formulary	Present	Provides drug formulary to select drugs
Narcotics tracking	Present	Provides database for tracking narcotics
External data interface	Present	Provides interface to hospital information system
Provides ability to edit drug formulary	Present	Provides ability to edit drug formulary

Note: The document explicitly states the accuracy of the BD Intelliport System, but it doesn't frame it as a "pre-defined acceptance criterion" in the same way a study protocol would. Instead, it justifies this performance by comparison to the predicate's reported accuracy (with a clarification on calculation methods) and manual syringe activation.

2. Sample Size Used for the Test Set and the Data Provenance

The document mentions "performance testing for the BD Intelliport System includes software unit testing and code reviews (verification), system validation testing, and testing to compliance standards for electrical and electromagnetic safety."

Sample Size: Not specified for any specific test set.
Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective). The tests likely occurred in a lab or simulated environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not specified in the provided text. The performance testing described appears to be technical in nature (software, electrical, volumetric accuracy) rather than requiring expert clinical assessment for ground truth.

4. Adjudication Method for the Test Set

Not specified.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an automated record-keeping system with measurement capabilities, not an AI-assisted diagnostic tool that would typically involve human "readers" or interpretations. The comparison is between the BD Intelliport System and a predicate system, both of which are automated.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

The accuracy testing for drug delivery (± 5% for bolus volumes > 1.0 mL to 55 mL and ± 20% for bolus volumes of 0.4 to 1.0 mL) can be considered standalone performance, as it quantifies the device's measurement capability independent of a human's interpretation of that measurement. The device itself is designed to automate aspects of medication administration documentation, which is inherently a "standalone" function in terms of data capture and measurement.

7. The Type of Ground Truth Used

For the accuracy testing of drug delivery, the ground truth would likely be established by controlled laboratory measurements using highly accurate reference instruments or gravimetric methods to determine the actual volume delivered, against which the BD Intelliport System's reported volume is compared. This is implied by the statement "Testing of the BD Intelliport System syringe delivery is conducted in accordance with the bolus delivery requirements as defined in IEC 60601-2-24 (Particular requirements for the safety of infusion pumps and controllers)."

8. The Sample Size for the Training Set

Not applicable/Not specified. The BD Intelliport System is described as a system for identification, measurement, alerting, and documentation of medications. It is not presented as an AI/ML device that requires a "training set" in the context of learning algorithms. Its functionality is based on predefined logic, sensors (ultrasonic for volume), and barcode scanning.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set for an AI/ML model is indicated.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18,2014

Becton, Dickinson and Company C/O Mr. Daniel Olivier Certified Compliance Solutions, Inc. President 11665 Avena Place, Suite 203 San Diego, CA 92128

Re: K141474

Trade/Device Name: BD Intelliport System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: PHC, FPA Dated: December 15, 2014 Received: December 16, 2014

Dear Mr. Olivier:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Olivier

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141474

Device Name BD Intelliport System

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5. 510(k) Summary

Submitter:	Becton, Dickinson and Company
Address:	1 Becton DriveFranklin Lakes, NJ 07417
Phone number:	(201) 847-4496
Fax number:	(201) 847-4845
Contact person:	Daniel Olivier
Phone number:	(858) 675-8200
Fax number:	(858) 675-8201
Date prepared:	September 14, 2014
Trade name:	BD Intelliport System
Common name:	Intelliport System
Product Code, Primary:	PHC, Infusion Safety Management Software
Regulation:	21 CFR 880.5725, Infusion Pump, Class II
Product Code, Secondary:	FPA, Set, Administration, Intravascular
Regulation:	21 CFR 880.5440, Intravascular Administration Set, Class II

Substantial equivalence claimed to: DocuSys Anesthesia Information and Digital-Drug Management System

Description:

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Indications for Use:

The BD Intelliport System allows the clinician to record anesthesia related events in the pre-op, intra-op, and PACU areas. 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.

Technological Characteristics

The BD Intelliport System is substantially equivalent to the predicate Device, the DocuSys Anesthesia Information and Digital-Drug Management System.

	BDIntelliport System	DocuSys Anesthesia Information &Digital-Drug Management System
Manufacturer	Becton Dickinson	DocuSys
510(k)	NA	K062388
Indications foruse	The BD Intelliport System is anautomated record keeping systemthat incorporates patient safetyfeatures that are aligned withhospital patient records andprotocols. The system is comprisedof an injection port and software thatenables the identification,measurement, alerting anddocumentation of the administrationof medications to patients.The BD Intelliport System allows theclinician to record anesthesiarelated events in the pre-op, intra-op, and PACU areas. The system isindicated for use by healthcareprofessionals in a hospital ormedical center setting with patientswho are receiving manuallyadministered bolus intravenousinjections as part of their care tofacilitate documentation of themedications.	The DocuSys Anesthesia Informationand Digital-Drug Management Systemoffers anesthesia a comprehensiverecord keeping system with advancedpatient safety features. The clinicianbegins interacting with the systemthrough the electronic anesthesia pre-operative assessment in which patientdata relative to anesthesia isrecorded. Electronic documentation ofthe patient's allergies and homemedications allows for proactiveadverse drug event screening whenthe patient is in the operating roomprior to anesthesia delivering drugs.The DocuSafe electronic anesthesiainformation system allows the clinicianto record anesthesia related events inthe pre-op, intra-op, and PACU areas.The DocuSafe software receivesphysiologic data from various patientmonitoring devices. Clinicians enterdrug information onto the anesthesiarecord in one of two methods: a)manually selecting the drug from a listof drugs in the formulary, or b)through the use of DocuSys' optionaldigital-Drug Management System. Ifthe optional d-DMS is used, theclinician may scan a barcode affixedto a Syringe Label Cradle or use
	BDIntelliport System	DocuSys Anesthesia Information &Digital-Drug Management System
		Formulary Reference module, managed by pharmacy, contains drug specific information used for documenting drugs on the anesthesia record, performing ADE checks, and submitting medication utilization information for billing purposes. The DocuRx pharmacy component of the digital-Drug Management System provides for pre-screening of medications that are ordered by anesthesia to check for any potential adverse drug events. It also provides a methodology for narcotics tracking through its comprehensive medication tracking and wasting feature. Each component of the Anesthesia Information and Digital-Drug Management System plays an integral part in standardizing medication administration techniques and documentation.
Allergy data	Provides notice of patient allergies	Provides notice of patient allergies
Druginteractions	NA	Adverse drug event screening
Medicationhistory record	Provides a record of drug delivery related events	Provides a record of drug delivery related events
Drug formulary	Provides drug formulary to select drugs to be delivered	Provides drug formulary to select drugs to be delivered
Drug delivery	Pre-filled syringe that has a barcode attached to register drug delivered	Pre-filled syringe that has a barcode to register drug delivered and volume
Measuringdrug delivery	Measures volume of the injected drug using an ultrasonic sensor	Measures the syringe plunger displacement
Accuracy ofdrug delivery	$\pm$ 5% for bolus volumes > 1.0 mL to 55 mL$\pm$ 20% for bolus volumes of 0.4 to 1.0 mL(at nominal conditions)	Calculated as a percent of total syringe volume not volume of drug delivered so not used for comparison.
Formularydatabase	Provides ability to edit drug formulary	Provides a Formulary Reference module
Narcoticstracking	Provides database for tracking narcotics	Provides database for tracking narcotics
External datainterface	Provides interface to hospital information system	Provides interface to hospital information system

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Substantial Equivalence Discussion

The BD Intelliport System is substantially equivalent to the DocuSys Anesthesia Information and Digital-Drug Management System based on indications for use and comparison of functional

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capabilities. Both devices are intended to provide the healthcare professional with an electronic record of "anesthesia related events." The BD Intelliport System provides an automated record of the name, concentration, dose, volume of the drug injected into the patient, as well as the time of the injection. Features common to both systems include:

· Medication history record: name, concentration, dose, volume of the drug injected into the patient as well as the time of the injection
· Allergy Alerts
Drug Formularv

The minor differences between the BD Intelliport System and the DocuSys Anesthesia Information and Digital-Drug Management System do not raise new questions of safety or effectiveness. These differences will be discussed in turn.

The DocuSys Anesthesia Information and Digital-Drug Management System provides adverse drug event screening such as notification of potential drug - drug interactions. This feature is not provided by the BD Intelliport System. Failure to provide this feature does not raise safety or efficacy concerns as this screening is currently performed in the hospital setting.

The drug-delivery accuracy of the DocuSys Anesthesia Information and Digital-Drug Management System is ±3%. However, this accuracy measurement is always calculated based on the total syringe volume not the volume of drug delivered to the patient. As stated in the DocuSys Summary Data for DocuJet II Accuracy, "If a user delivers a bolus injection of 2ml using a 20ml syringe and the DocuJet records 2.2ml on the record, that is not considered a discrepancy of 10%. The discrepancy is based on the Nominal Syringe Volume and therefore would be calculated as 0.2ml/20ml, a 1% discrepancy." The term discrepancy, in this case, is tantamount to accuracy. The accuracy of the BD Intelliport System is ± 5% for bolus volumes from 1.0 mL to 55 mL and ± 20% for bolus volumes from 0.4 to 1.0 mL at nominal conditions. This measurement is based on the volume of the drug delivered.

A performance test comparison of the accuracy of the DocuSys Anesthesia Information and Digital-Druq Management System could not be performed as this product is no longer marketed and not available.

Testing of the BD Intelliport System syringe delivery is conducted in accordance with the bolus delivery requirements as defined in IEC 60601-2-24 (Particular requirements for the safety of infusion pumps and controllers). The accuracy of drug delivery for the BD Intelliport System does not raise safety or efficacy concerns as this accuracy is in line with the accuracy currently achieved through manual activation of a syringe.

Test Summary

The performance testing for the BD Intelliport System includes software unit testing and code reviews (verification), system validation testing, and testing to compliance standards for electrical and electromagnetic safety. Traceability has been documented between the system specification to validation test protocols. Validation test procedures also address the user interface, user manual descriptions, usability, wireless communication and general performance including volume delivery accuracy.

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Conclusion:

The performance of the BD Intelliport System is substantially equivalent to that of the DocuSys Anesthesia Information and Digital-Drug Management System and raises no safety or effectiveness issues and performs as well or better than the predicate device.

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).