(198 days)
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No
The summary describes an automated record-keeping system that uses barcode scanning and volume measurement, with no mention of AI or ML algorithms for analysis, prediction, or decision-making.
No.
The device is an automated record-keeping system for medications, designed to facilitate documentation and enhance patient safety by accurately recording drug administration details, rather than directly treating a disease or condition.
No
The BD Intelliport System is described as an automated record keeping system for medication administration, focusing on identification, measurement, alerting, and documentation of medications. It facilitates precise recording of drug information (name, concentration, volume, time) during intravenous injections. While it tracks events related to medical treatment, it does not analyze patient data or body parameters to establish a diagnosis, monitor a disease, or predict health status. Its primary function is documentation and record-keeping, not diagnostic assessment.
No
The device description explicitly states the system is comprised of an "injection port" (Intelliport device) which is a hardware component that reads barcodes, measures volume, and transmits data. This is not a software-only device.
Based on the provided text, the BD Intelliport System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to automate the record-keeping of manually administered intravenous bolus injections of medications to patients. This involves identifying, measuring, alerting, and documenting the administration of drugs within the patient's body.
- Device Description: The device measures the volume and time of injected drugs as they are administered to the patient. It reads barcodes on syringes and transmits this information to an electronic record.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) outside of the body to provide information about a patient's health. The BD Intelliport System does not perform any analysis on patient specimens. It is focused on the administration and documentation of substances into the patient.
The BD Intelliport System is a device used in the clinical setting for medication management and documentation, not for diagnostic testing of patient samples.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
PHC, FPA
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.
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
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Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of drug delivery: +/- 5% for bolus volumes > 1.0 mL to 55 mL, +/- 20% for bolus volumes of 0.4 to 1.0 mL (at nominal conditions)
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.
DocuSys Anesthesia Information and Digital-Drug Management System K062388
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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)
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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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 |
| Franklin 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:
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
Intelliport System | DocuSys Anesthesia Information &
Digital-Drug Management System |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Becton Dickinson | DocuSys |
| 510(k) | NA | K062388 |
| 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. | The DocuSys Anesthesia Information
and Digital-Drug Management System
offers anesthesia a comprehensive
record keeping system with advanced
patient safety features. The clinician
begins interacting with the system
through the electronic anesthesia pre-
operative assessment in which patient
data relative to anesthesia is
recorded. Electronic documentation of
the patient's allergies and home
medications allows for proactive
adverse drug event screening when
the patient is in the operating room
prior to anesthesia delivering drugs.
The DocuSafe electronic anesthesia
information system allows the clinician
to record anesthesia related events in
the pre-op, intra-op, and PACU areas.
The DocuSafe software receives
physiologic data from various patient
monitoring devices. Clinicians enter
drug information onto the anesthesia
record in one of two methods: a)
manually selecting the drug from a list
of drugs in the formulary, or b)
through the use of DocuSys' optional
digital-Drug Management System. If
the optional d-DMS is used, the
clinician may scan a barcode affixed
to a Syringe Label Cradle or use |
| | BD
Intelliport 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 |
| Drug
interactions | NA | Adverse drug event screening |
| Medication
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
drug delivery | Measures volume of the injected drug using an ultrasonic sensor | Measures the syringe plunger displacement |
| Accuracy of
drug 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. |
| Formulary
database | Provides ability to edit drug formulary | Provides a Formulary Reference module |
| Narcotics
tracking | Provides database for tracking narcotics | Provides database for tracking narcotics |
| External data
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.