The Abbott DataPort PC is an optional computer (PC) software accessory for use exclusively with the Abbott Plum A+ and A+3 Infusion Pumps in a biomedical technical service environment.

The indications for use are the indications for use of the parent devices belonging to the Abbott Plum A+ Infusion Pump family, which are the Abbott Plum A+ and Abbott Plum A+3 Infusion Pumps. Infusion pumps in the Abbott Plum A+ Infusion Pump Family are used in parenteral, enteral and epidural therapies and the administration of whole blood products. The Abbott Plum A+ and A+3 Infusion Pumps are designed to deliver infusions over a broad range of infusion rates from multiple container types.

Device Description

The Abbott DataPort PC software supports data transfer between a single computer (PC) and up to 15 Abbott Plum A+ Infusion Pumps, or up to 4 Abbott Plum A 13 Infusion Pumps. Abbott DataPort PC allows authorized users to retrieve infuser alarm logs, event history logs, and biomedical settings from interfaced infusers, and to edit and send modified biomedical settings to the interfaced infusers from the PC.

AI/ML Overview

The Abbott DataPort PC is an optional software accessory for use with Abbott Plum A+ and A+3 Infusion Pumps. Its primary function is to facilitate data transfer (retrieving alarm/event logs and biomedical settings, and sending modified biomedical settings) between a PC and the infusion pumps in a biomedical technical service environment.

Here's an analysis of the acceptance criteria and supporting study details based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The provided document describes the Abbott DataPort PC as substantially equivalent to existing Abbott Plum A+ and A+3 Infusion Pumps using interface software not supplied by Abbott. The acceptance criteria are framed in terms of substantial equivalence across various aspects, primarily demonstrating that the addition of the Abbott DataPort PC software does not negatively impact the established safety and effectiveness of the parent devices and offers enhanced functionality.

Acceptance Criteria (Demonstrated by Substantial Equivalence)	Reported Device Performance (Summary of Similarities/Capabilities)
Intended Use Remains Unchanged: The device, with the new software, must have the same intended use as the predicate devices.	The Abbott DataPort PC supports the same intended use as the parent Abbott Plum A+ Infusion Pump family, which is for use in parenteral, enteral, and epidural therapies and the administration of whole blood products, used by licensed physicians or certified healthcare professionals.
Indications for Use Remain Unchanged: The specific indications for the use of the infusion pumps should be consistent.	The indications for use are identical to the parent devices (Abbott Plum A+ and A+3 Infusion Pumps), covering parenteral, enteral, and epidural therapies, and administration of whole blood and blood products.
Fundamental Scientific Technology is the Same: The core operating principle of the infusion pump itself should not change.	Both configurations (with and without Abbott DataPort PC) use the same fundamental scientific technology, operating principle (stepper motor with in-line cassette to meter IV fluids), administration sets, fluid contact materials, physical features, environmental features, and performance features (delivery rates, accuracy, modes, etc.).
No Degradation of Physical, Operational, and Performance Specifications: The addition of the software should not negatively impact the established specifications of the infusion pump.	The device maintains the same physical, operational, and performance specifications as the predicate devices, including delivery rates, VTBI range, dose units, and delivery accuracy.
Data Transfer Capability and Protocol Consistency: The software should utilize existing communication methods and protocols securely and effectively.	Both configurations (with Abbott DataPort PC and without) allow data transfer via the infuser data communication ports, use the same communication protocol, and the same accessory hardware for interfacing a PC to the infusers. It supports data transfer to up to 15 Abbott Plum A+ or 4 Abbott Plum A+3 pumps from a standalone PC.
Biomedical Technician Environment Focus: The software's functionality should be appropriate for its intended user environment.	Both configurations are intended for use in a biomedical technician environment.
Restriction on Therapy Programming and Remote Control: The software should not allow unauthorized programming of therapies or remote control of infusions.	Adherence to these restrictions is explicitly stated: "Both configurations do not allow users to program a new therapy into an infuser." and "Both configurations do not allow users to enter infuser keystrokes remotely." Also, "Both configurations do not allow users to monitor infusers that are actively infusing, priming, or being programmed for infusion."
No Hospital Information System/Network Interface: The software should not introduce network connectivity beyond its defined scope.	"Both configurations do not support Hospital Information System / Network interfaces."
New Capabilities without Adverse Impact: The new functionalities (retrieval/editing of BioMed settings) should be achieved without compromising safety or effectiveness.	The Abbott DataPort PC enables additional functionalities: retrieval, saving, and printing of BioMed configuration settings, and editing, saving, and sending modified BioMed configuration settings. These capabilities are not present in systems using non-Abbott supplied interface software but are presented as enhancements without adversely affecting the core safety and performance of the infusion pumps. The submission implicitly asserts these new capabilities are safe and effective through the substantial equivalence argument itself.
Overall Safety and Effectiveness: The device with the software must be as safe and effective as the predicate device without the software.	The "Statement of Safety and Effectiveness" explicitly states: "The Abbott Plum A+ Family of Infusion Pumps (V11.x) with Abbott DataPort PC software, meets the functional claims and intended use as described in the product labeling, and is as safe and effective as, the Abbott Plum A+ Family of Infusion Pumps without the Abbott DataPort PC software."

2. Sample Size for Test Set and Data Provenance

The document does not specify a separate test set or sample size for the Abbott DataPort PC software itself. The submission is a Special 510(k) for a modification to a previously cleared device. The "study" for this submission focuses on demonstrating substantial equivalence to the predicate devices (existing Abbott Plum A+ and A+3 infusion pumps).

The data provenance for the underlying infusion pumps (K024084, K021350, K011442, K982159) is not detailed in this specific document, as those were previously cleared devices. The substantial equivalence argument relies on the inherent safety and efficacy of those predicate devices, with the new software being an accessory that does not alter these core characteristics.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set related to the DataPort PC software. The submission focuses on design control and verification/validation activities demonstrating that the software performs its intended functions (e.g., correctly transfers data, retrieves logs, sends settings) in the biomedical technical service environment without introducing new risks or compromising existing safety features of the infusion pumps.

4. Adjudication Method

No adjudication method is described, as there is no explicit clinical or performance study with a test set requiring expert review or ground truth establishment in the traditional sense for this Special 510(k). The focus is on technical verification (e.g., does the data transfer work as designed?) rather than diagnostic accuracy or clinical outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or reported. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI is intended to assist in that interpretation. The Abbott DataPort PC is an accessory for an infusion pump, facilitating data management for biomedical technicians, not a diagnostic tool requiring human interpretation for clinical decision-making at the point of care.

6. Standalone (Algorithm Only) Performance Study

A standalone performance evaluation of the Abbott DataPort PC software itself was implicitly conducted through design validation and verification activities, as is standard for medical device software. However, the document does not describe specific metrics like sensitivity, specificity, accuracy, etc., as would be common for diagnostic algorithms. Instead, the "performance" is demonstrated by its ability to reliably retrieve, save, print, edit, and send the specified data (alarm logs, event history logs, and biomedical settings) correctly, without errors, and maintaining the integrity of the infuser's operation.

The "Statement of Safety and Effectiveness" indicates that the software "meets the functional claims and intended use as described in the product labeling." This implies internal testing was performed to verify these functional claims.

7. Type of Ground Truth Used

For the Abbott DataPort PC, the "ground truth" would be the expected and verified behavior of the software and the infusion pump hardware working together. This would involve:

Functional Verification: Confirming that the software correctly retrieves the exact data (e.g., alarm codes, event timestamps, current biomedical settings) from the infuser.
Data Integrity: Verifying that modified biomedical settings sent from the PC are accurately received and implemented by the infuser without corruption or unintended alterations.
System Responsiveness: Ensuring the communication and data transfer occur within acceptable timeframes.
Failure Mode Testing: Confirming that the system handles errors or disconnections gracefully without endangering patient safety or corrupting infuser settings.

This ground truth is typically established through engineering specifications, direct observation, and comparison against expected values or states during testing (e.g., comparing a retrieved log to the actual log stored in the infuser, or comparing a sent setting to the setting actually applied by the infuser).

8. Sample Size for the Training Set

The document does not specify a training set sample size. The Abbott DataPort PC is a software application for data transfer and configuration management, not a machine learning or AI algorithm that requires a training set in the typical sense. Its functionality is rules-based and deterministic, derived from programming rather than learned from data.

9. How Ground Truth for the Training Set Was Established

As there is no training set for this type of deterministic software, the concept of establishing ground truth for a training set is not applicable. The software's design and functionality are based on established communication protocols and the functional requirements of managing data for the Abbott Plum A+/A+3 Infusion Pumps.

Summary

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Abbott DataPort PCTM

Special 510(k) / January 2004

JAN 2 9 2004

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Special 510(K) Summary

1. Name of Submitter:
  Abbott Laboratories Hospital Products Division 200 Abbott Park Road Abbott Park, Illinois 60064-6133

Establishment Registration # 1415939

2. Manufacturer and Establishment Registration Number:

Abbott Laboratories Hospital Products Division 755 Jarvis Drive Morgan Hill, CA 95037

Establishment Registration # 2921482

1. Proprietary or Trade Name: Abbott DataPort PC TM

Common Name: Infusion Pump

5. Device Classification, Pancode and ProCode: Class II, 80, FRN

1. Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for intravenous infusion pumps. Infusion pumps are listed in 21 CFR 880.5725.

7. Intended Use:

The Abbott DataPort PC is an optional computer (PC) software accessory for use exclusively with the Abbott Plum A+ and A+3 Infusion Pumps in a biomedical technical service environment.

8. Indications for Use:

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9. Device Description:

10. Statement of Substantial Equivalence:

Infusion pumps in the Abbott Plum A+ Infusion Pump Family using the optional Abbott DataPort PC software for data transfer are substantially equivalent to infusion pumps in the Abbott Plum A+ Infusion Pump Family using software programmed by the facility, or a facility contracted software developer, for data transfer.

The Abbott Plum A+ and Abbott Plum A+3 infusers with optional Abbott DataPort PC software are substantially equivalent to currently marketed Abbott Plum A+ and Abbott Plum A+3 infusers using interface software not supplied by Abbott in that:

Similarities:

1. Both configurations have the same intended use and indications for use.
Both configurations use the same fundamental scientific technology. 2)
1. Both configurations have the same physical, operational, and performance specifications.
1. Both configurations allow for data transfer via the infuser data communication ports.
1. Both configurations use the same communication protocol for data transfer.
Both configurations use the same accessory hardware for interfacing a PC to the infusers. 6)
1. Both configurations allow for data transfer from a standalone PC to up to 15 Abbott Plum A+ Infusion Pumps or up to 4 Abbott Plum A+3 Infusion Pumps.
1. Both configurations are intended for use in a biomedical technician environment.
1. Both configurations allow for authorized users to retrieve, save, and print alarm and event history logs from connected infusers.
1. Both configurations do not allow users to program a new therapy into an infuser.
1. Both configurations do not allow users to enter infuser keystrokes remotely.
1. Both configurations do not allow users to monitor infusers that are actively infusing, priming, or being programmed for infusion.
1. Both configurations do not support Hospital Information System / Network interfaces.

Differences:

The retrieval, saving, and printing of BioMed configuration settings is possible through the infuser l ) communication dataport with a PC that has the Abbott DataPort PC software installed. BioMed configuration settings cannot be accessed through the infuser communication dataport with a PC using interface software not supplied by Abbott,
The editing, saving, and sending of modified BioMed configuration settings is possible through the 2) infuser communication dataport using a PC that has the accessory software installed. BioMed configuration settings cannot be accessed through the infuser communication dataport with a PC using interface software not supplied by Abbott.

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11. Predicate Device Information:

Information for Abbott Plum A+/A+3 Infusion Pumps previously cleared for commercial distribution and determined to be appropriate for use as predicates is provided below.

510(k) #	Product Name	Clearance Date
K024084	Abbott Plum A+ Infusion Pump	12/31/02
K021350	Abbott Plum A+3 Multichannel Infusion Pump	05/14/02
K011442	Abbott Plum A+ Infusion Pump	06/05/01
K982159	Abbott Plum A+ Infusion Pump	01/12/99

12. Comparison to Legally Marketed Device(s)

Factors	Subject Device(s)Abbott Plum A+/A+3 Infusion Pumps (V11.x)with Abbott DataPort PC	Predicate Device(s)Abbott Plum A+/A+3 Infusion Pumps (V11.x)
Intended Use	Intended for use at the direction of or under thesupervision of licensed physicians or certified healthcareprofessionals for intravenous infusion therapy.	Same
Indications for Use	For use in parenteral, enteral and epidural therapies andthe administration of whole blood and blood products.	Same
Operating Principle	Infusion of intravenous medications to a patient'svascular system using a stepper motor in conjunctionwith an in-line cassette to meter IV fluids throughdedicated IV administration sets.	Same
Administration Sets andFluid Contact Materials	Sterile, dedicated, non-pyrogenic administration sets."Plum" sets.	Same
Physical Features	Size, Weight, Input Lines, Output Lines, Power Sources,Battery Type, Power Cord, Materials	Same
Environmental Features	Operating Temperature, Relative Humidity, Pressure,Storage Temperature	Same
Performance Features	Delivery Rates, VTBI Range, Dose Units, DeliveryAccuracy, Delivery Modes, Distal Occlusion PressureSetting, Default Drug Library	Same
BioMed ConfigurationSettings	Date and Time, Continue Rate, Deliver Together Mode(Concurrent or Piggyback), Enable Delay Start, CallbackDefault (Yes/No), Default Distal Occlusion Pressure,Max Rate Cap, Default Units/Drug (as listed in DefaultDrug Library), Default Dose and Conc Units for Drug	Same
Communication Ports	(1) Serial communication dataport for standalone PCinterface with up to (15) Abbott Plum A+ InfusionPumps or up to (4) Abbott Plum A+3 Infusion Pumps.	Same
Computer InterfaceSoftware	Abbott supplied (optional).	Facility software per theAbbott Plum A+/A+3Programmers Guide.
Computer (PC) InterfaceSoftware Features	Retrieve, save and print alarm and event historylogs from connected infusers.Retrieve, save, and print BioMed Settings fromconnected infusers.Edit, save and send modified BioMed Settings toconnected infusers.	Retrieve, save and printalarm and event historylogs from connectedinfusers.
Other Features	BarCode Wand (optional)	Same

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13. Summary of Substantial Equivalence

The Abbott Plum A+Family of Infusion Pumps with the optional Abbott DataPort PC software as described in this submission are substantially equivalent to the predicate Abbott Plum A+ Family of Infusion Pumps in that all the infuser configurations have:

1. the same intended use,
1. the same indication for use,
1. the same fundamental technology and operating principle,
1. the same physical, environmental and performance features
1. the same or similar materials of construction for all infuser components,
1. the same dataport communication capabilities

14. Statement of Safety and Effectiveness

The Abbott Plum A+ Family of Infusion Pumps (V11.x) with Abbott DataPort PC software, meets the functional claims and intended use as described in the product labeling, and is as safe and effective as, the Abbott Plum A+ Family of Infusion Pumps without the Abbott DataPort PC software.

Prepared and submitted on January 19, 2004 by: Garia Melecal Patricia Melerski Manager Regulatory Affairs Device Registration Abbott Laboratories Hospital Products Division D389, J45-2N 200 Abbott Park Road, IL 60064-6133 Phone: 847/938-3718 Fax: 847/938-7867

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three wavy lines, which is the symbol of the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2004

Abbott Laboratories Ms. Patricia Melerski Manager Regulatory Affairs Device Registration Hospital Product Division Department 0389 Building J45-2N 200 Abbott Park Road Abbott Park, Illinois 60064-6133

Re: K040114

K040114
Trade/Device Name: Abbott Plum A+® Infusion Pump with Abbott DataPort PCTM Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: January 19, 2004 Received: January 20, 2004

Dear Ms. Melerski:

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 mendie oonments, or to devices that have been reclassified in accordance with the provisions of Anchanenene, or to are and Cosmetic Act (Act) that do not require approval of a premarket the rederal F UGA). You may, therefore, market the device, subject to the general approvisions 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.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr.), it may be bacyers in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Eederal Register.

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Page 2 -Ms. Melerski

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a premained hotelled predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entifled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Curls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 510(k) K640114 Number (if known) Device Abbott Plum A+® Infusion Pump with Abbott DataPort PCTM Name: The Abbott Plum A+® Infusion Pump with Abbott DataPort PCTM Indications has the following indications for use: The device is used in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Nicole Dillard, Interim Branch Chief

(Division Sign-Off) General Hospital, (Division of Anesthesiology Division Control, Dental D

510(k) Number: K040114

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).