BECTON DICKINSON INTELLIPORT SYSTEM

K141474 · Becton, Dickinson & CO · PHC · Dec 18, 2014 · General Hospital

Device Facts

• Record ID: K141474
• Device Name: BECTON DICKINSON INTELLIPORT SYSTEM
• Applicant: Becton, Dickinson & CO
• Product Code: PHC · General Hospital
• Decision Date: Dec 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Intended 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 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 Story

System automates documentation of IV bolus medication administration; comprises intelligent injection port and software. Clinician connects port to patient fluid-delivery line; injects medication via syringe. Port reads 2-D barcode on syringe (drug name/concentration); uses ultrasonic sensor to measure volume and time of injection. Data transmitted to electronic record system. Used in pre-op, intra-op, and PACU by healthcare professionals. Facilitates accurate medication logging; replaces manual entry; improves documentation efficiency and patient safety.

Clinical Evidence

Bench testing only. Includes software unit testing, code reviews (verification), system validation testing, and electrical/electromagnetic safety testing. Validation covered user interface, usability, wireless communication, and volume delivery accuracy (±5% for >1.0-55 mL; ±20% for 0.4-1.0 mL).

Technological Characteristics

System includes intelligent injection port and software. Uses ultrasonic sensor for volume measurement. Connectivity via wireless communication to hospital information system. Accuracy: ±5% for bolus >1.0 mL to 55 mL; ±20% for 0.4 to 1.0 mL. Complies with IEC 60601-2-24 for bolus delivery.

Indications for Use

Indicated for healthcare professionals in hospital/medical center settings to document manually administered bolus intravenous injections for patients in pre-op, intra-op, and PACU areas.

Regulatory Classification

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.

Predicate Devices

• DocuSys Anesthesia Information and Digital-Drug Management System (K062388)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

### Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### 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 Drive<br>Franklin Lakes, NJ 07417 |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Contact person: | Daniel Olivier |
| Phone number: | [phone] |
| Fax number: | [phone] |
| 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:

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.

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# 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 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.

| | BD<br>Intelliport System | DocuSys Anesthesia Information &<br>Digital-Drug Management System |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Becton Dickinson | DocuSys |
| 510(k) | NA | K062388 |
| Indications for<br>use | The BD Intelliport System is an<br>automated record keeping system<br>that incorporates patient safety<br>features that are aligned with<br>hospital patient records and<br>protocols. The system is comprised<br>of an injection port and software that<br>enables the identification,<br>measurement, alerting and<br>documentation of the administration<br>of medications to patients.<br><br>The BD Intelliport System allows the<br>clinician to record anesthesia<br>related events in the pre-op, intra-<br>op, and PACU areas. The system is<br>indicated for use by healthcare<br>professionals in a hospital or<br>medical center setting with patients<br>who are receiving manually<br>administered bolus intravenous<br>injections as part of their care to<br>facilitate documentation of the<br>medications. | The DocuSys Anesthesia Information<br>and Digital-Drug Management System<br>offers anesthesia a comprehensive<br>record keeping system with advanced<br>patient safety features. The clinician<br>begins interacting with the system<br>through the electronic anesthesia pre-<br>operative assessment in which patient<br>data relative to anesthesia is<br>recorded. Electronic documentation of<br>the patient's allergies and home<br>medications allows for proactive<br>adverse drug event screening when<br>the patient is in the operating room<br>prior to anesthesia delivering drugs.<br>The DocuSafe electronic anesthesia<br>information system allows the clinician<br>to record anesthesia related events in<br>the pre-op, intra-op, and PACU areas.<br>The DocuSafe software receives<br>physiologic data from various patient<br>monitoring devices. Clinicians enter<br>drug information onto the anesthesia<br>record in one of two methods: a)<br>manually selecting the drug from a list<br>of drugs in the formulary, or b)<br>through the use of DocuSys' optional<br>digital-Drug Management System. If<br>the optional d-DMS is used, the<br>clinician may scan a barcode affixed<br>to a Syringe Label Cradle or use |
| | BD<br>Intelliport System | DocuSys Anesthesia Information &<br>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 |
| Drug<br>interactions | NA | Adverse drug event screening |
| Medication<br>history 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 |
| Measuring<br>drug delivery | Measures volume of the injected drug using an ultrasonic sensor | Measures the syringe plunger displacement |
| Accuracy of<br>drug delivery | $\pm$ 5% for bolus volumes > 1.0 mL to 55 mL<br>$\pm$ 20% for bolus volumes of 0.4 to 1.0 mL<br>(at nominal conditions) | Calculated as a percent of total syringe volume not volume of drug delivered so not used for comparison. |
| Formulary<br>database | Provides ability to edit drug formulary | Provides a Formulary Reference module |
| Narcotics<br>tracking | Provides database for tracking narcotics | Provides database for tracking narcotics |
| External data<br>interface | 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.