The Abbott Plum A+ Infusion Pump is an electromechanical infusion pump that uses a stepper motor in conjunction with an in-line cassette to meter IV fluids through a dedicated intravenous administration set that is also manufactured and distributed by Abbott Laboratories.

The subject and predicate devices have identical indications for use. Abbott proposes to modify the predicate device through software changes, minor changes to mechanical parts and labeling changes.

The featured software changes include: providing users with a choice to select the manufacturer's recommended units of measure for drug administration, updating the drug list, adding a confirmation screen before allowing therapy to begin, including a standby function and adding a password protected keypad.

These proposed changes along with the updated drug list are intended to potentially aid in medication error reduction by highlighting the drug to be infused and the units of measure for drug administration as shown in the manufacturer's package insert.

The user interface of the infusion pump allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units such as micrograms/kq/hour, grams/hr and other delivery specifications.

Like the predicate device. the proposed device includes: a nurse call function, a computer data port, a druq list, and a bar code wand. The display on the pump provides visible indication of several functions including active pump operations, alarm and program status and the parameters of fluid flow for one or both incoming fluid lines.

Both the predicate and the proposed devices can be used for standard, piggyback, or concurrent fluid delivery.

AI/ML Overview

The provided text from the 510(k) submission for the Abbott Plum A+® Infusion Pump (K024084) describes a device modification and its substantial equivalence to a predicate device. However, it does not contain the detailed information requested for acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, or detailed study designs like MRMC or standalone performance.

The document is a summary for a Special 510(k) submission, which typically focuses on demonstrating that modifications do not raise new issues of safety or effectiveness. The information regarding studies is very general.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Implicit Acceptance Criteria:	General Statement:
No new issues of safety and effectiveness raised by the modifications.	"The results of testing conducted to validate and verify the design modifications demonstrate acceptable performance of the device. There are no new issues of safety or effectiveness raised by the Plum A+® with version 11.3 software." (Section 9, Page 3)
Device performance equivalent to the predicate device.	"Both pumps use the same software lanquage. The proposed pump has similar design, materials of construction, components, labeling and manufacturing processes as the currently marketed Abbott Plum A+® Infusion Pump. These differences do not raise new issues of safety and effectiveness nor do they alter the fundamental technology of the predicate device." (Section 8, Page 2)
Software changes (choice of units, drug list update, confirmation screen, standby function, password-protected keypad) function as intended.	"The featured software changes include: providing users with a choice to select the manufacturer's recommended units of measure for drug administration, updating the drug list, adding a confirmation screen before allowing therapy to begin, including a standby function and adding a password protected keypad... These proposed changes along with the updated drug list are intended to potentially aid in medication error reduction by highlighting the drug to be infused and the units of measure for drug administration..." (Section 6, Pages 1-2)

Missing Information: Specific quantitative acceptance criteria (e.g., flow rate accuracy within X%, alarm response time within Y seconds) and the specific, measured performance values from the tests are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document only mentions "Data regarding the functional performance of the proposed Abbott Plum A+ Infusion Pump has been generated and reviewed." There is no indication of the number of devices, tests, or data points used.
Data Provenance: Not specified. It can be inferred that the testing was conducted by Abbott Laboratories, a U.S.-based company, but the specific location or nature (retrospective/prospective) of the data collection is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document describes functional and design verification/validation, which typically does not involve "ground truth" establishment by experts in the way an AI diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable in the context of this device's testing as described. The testing appears to be engineering verification and validation against performance specifications, not human interpretation of data requiring adjudication.

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

No MRMC study was done or mentioned. This type of study is relevant for AI-assisted diagnostic devices, which this infusion pump is not.

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

This concept is not directly applicable to a modified infusion pump. The "algorithm" (software) is integral to the pump's function. The functional performance tests described are inherently a standalone evaluation of the device's operation. No "human-in-the-loop" performance impact is discussed as it's a device modification, not a diagnostic aid.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied in AI/diagnostic device studies is not applicable here. The "ground truth" for an infusion pump's performance would be its adherence to engineering specifications and safe operation, as validated through various functional and safety tests.

8. The sample size for the training set

This information is not provided. As this is a software modification to an existing electromechanical device, and not an AI or machine learning algorithm in the typical sense, there would not be a "training set" in the context of fitting a model to data. The "training" for the software would involve traditional software development, coding, and debugging.

9. How the ground truth for the training set was established

This information is not provided and is not applicable for the reasons stated in point 8.

Summary

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Koz 4084

DEC 31 2002

Special 510(k): Device Modification Abbott Plum A+® Infusion Pump Page 1 of 3

510(k) SUMMARY Abbott Plum A+® Infusion Pump

1. Submitted by:

Frank Pokrop Associate Director, Requlatory Affairs Abbott Laboratories D-389. Bldg. LFJ45 Abbott Park, IL 60064

2. Date Prepared:

December 10, 2002

3. Name/Classification of Device:

Infusion Pump. Class II 80 FRN -- 21 CFR Parts 880.5725

4. Proposed Device:

Abbott Plum A+® Infusion Pump, List Number, 12391

5. Predicate Device:

Abbott Plum A+® Infusion Pump

6. Proposed Device Description:

The subject and predicate devices have identical indications for use. Abbott proposes to modify the predicate device through software changes, minor changes to mechanical parts and labeling changes.

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Special 510(k): Device Modification Abbott Plum A+® Infusion Pump Page 2 of 3

6. Proposed Device Description: (cont'd)

Both the predicate and the proposed devices can be used for standard, piggyback, or concurrent fluid delivery.

7. Statement of Intended Use:

The pump is intended for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

This is the same intended use as the predicate device.

The pump must be used with sterile, dedicated, intravenous PlumSet® administration sets.

8. Summary of Technological Characteristics of New Device Compared to Predicate Device

Both pumps use the same software lanquage. The proposed pump has similar design, materials of construction, components, labeling and manufacturing processes as the currently marketed Abbott Plum A+® Infusion Pump.

These differences do not raise new issues of safety and effectiveness nor do they alter the fundamental technology of the predicate device.

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Special 510(k): Device Modification
Page 3 of 3

9. Discussion and Conclusions from Nonclinical Tests:

Data regarding the functional performance of the proposed Abbott Plum A+® Infusion Pump has been generated and reviewed.

The results of testing conducted to validate and verify the design modifications demonstrate acceptable performance of the device. There are no new issues of safety or effectiveness raised by the Plum A+® with version 11.3 software.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol that resembles a stylized caduceus or a series of flowing lines, possibly representing health and well-being.

DEPARTMENT OF HEALTH & HUMAN SERVICES

od and Drug Administrat 9200 Corporate Boulevaro Rockville MD 20850

DEC 3 1 2002

Mr. Frank Pokrop Associate Director, R/A Abbott Laboratories 200 Abbott Park Road Dept. 0389, Bldg. LFJ45 Abbott Park, Illinois 60064-6133

Re: K024084

Trade/Device Name: Abbott Plum A+® Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: December 10, 2002 Received: December 11, 2002

Dear Mr. Pokrop:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Pokrop

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 legally marketed 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Jo. Albert Louise for,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

510(k) Number (if known)	12024084
Device Name:	Abbott Plum A+ ® Infusion Pump
Indications For Use:	Abbott Plum A+ ® Infusion Pump has the following indications for use:
	Indicated for use 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__________________________________________________________________________________________________________________________________________________________

Kittie Cucenite

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

510(k) Number. K024084

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).