The proposed device is the Hospira Plum A+ Infusion Pump is a single channel software controlled, electromechanical infusion pump that operates on a volumetric, piston-driven, fluid displacement principle. The infuser uses a stepper motor in conjunction with an inline cassette to meter and deliver IV fluids through sterile intravenous administration sets designed to be used exclusively with both the Plum A+. The infuser can be pole mounted. This pump is IEC/EN 60601-1-2:2001 compliant.

AI/ML Overview

The Plum A+® Infusion Pump is a medical device and therefore the acceptance criteria are not clinical performance measures but rather safety and effectiveness measures, which are assessed through bench testing and comparison to predicate devices.

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Intended Use	Same as predicate devices.
Operating Principle	Same as predicate devices.
Materials of Construction	Similar to predicate devices.
Compliance with IEC/EN 60601-1-2:2001	The proposed device is compliant.
Safety and Effectiveness	Bench testing results met acceptance criteria and did not raise new issues of safety and/or effectiveness.

Study Details:

Sample size used for the test set and the data provenance: Not applicable. The evaluation was primarily based on bench testing of the device itself, rather than a test set of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of device evaluation relates to meeting engineering and safety standards, which are assessed via bench testing against predetermined specifications, not expert consensus on interpretations of data.
Adjudication method for the test set: Not applicable. The "adjudication" is inherent in the bench testing results meeting pre-defined engineering and safety criteria.
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 infusion pump, not an AI-assisted diagnostic or interpretive tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone electromechanical infusion pump. Its performance is evaluated intrinsically through bench testing to ensure it meets its specifications for fluid delivery. There is no "algorithm only" performance in the context of an AI system.
The type of ground truth used: The ground truth was established through bench testing against predetermined engineering specifications, safety standards, and performance criteria for infusion pumps, along with a direct comparison to the predicate devices' characteristics.
The sample size for the training set: Not applicable. This device is an electromechanical pump, not a machine learning model that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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February 2007

K070398

510(k) Summary
Plum A+® Infusion Pump

510K Summary

Submitted by:

APR 24 2007

Hospira, Inc. D-389 Bldg. H2 275 N. Field Drive Lake Forest, IL 60045
Contact: Nicohl R. Wilding Phone:(224) 212-5270 Fax: (224) 212-5401 February 6, 2007
1. Date Prepared:
  Infusion Pump 21 CFR 880.5725, Pump, infusion Class II. Product code FRN Plum A+ ® Infusion Pump
1. Trade Name of Proposed Device:

Name/Classification of Device:

1. Predicate Devices:
  K052052 Hospira Plum A+ Infusion Pump System v11 Cleared 08/24/2005 K024084 Abbott Plum A- Infusion Pump. Model 12391 Cleared 12/31/2002

6. Manufacturer and Establishment Registration Number:

Manufacturer Site: Hospira, Inc. - Morgan Hill 755 Jarvis Drive Morgan Hill, CA 95037

Sterilization Site: N/A

Registration # 2921482

7. 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.

8. Intended Use / Indications for Use:

Intended for use in parenteral, enteral, and epidural therapies and the administration of whole blood and blood products

The intended use is the same as for the predicate devices.

9. Proposed Device Description:

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i(070378
510(k) Summary
Plum A+ ® Infusion Pump

intravenous administration sets designed to be used exclusively with both the Plum A+. The infuser can be pole mounted. This pump is IEC/EN 60601-1-2:2001 compliant.

10. Summary of Substantial Equivalence

The proposed device is substantially equivalent to the predicate devices in that it has the same

. intended use,
operating principle, .
. materials of construction.

The major difference between the predicate device and the proposed device is that the subject device is compliant with IEC/EN 60601-1-2:2001.

11. Statement of Safety and Effectiveness

The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes. The proposed modifications have been evaluated using bench testing in which the results met the acceptance criteria and do not raise new issues of safety and/or effectiveness.

The claim for substantial equivalence is supported by the information provided in the 510(k) submission.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized wing segments and a wavy base, representing water. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2007

Ms. Nicohl R. Wilding Manager Global Device Regulatory Affairs Hospira, Incorporated 275 North Field Drive H2-2 Lake Forest, Illinois 60045

Re: K070398

Trade/Device Name: Plum A+® Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 16, 2007 Received: April 4, 2007

Dear Ms. Wilding:

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 - Ms. Wilding

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 (240) 276-0115. Also, please note the regulation entitled, "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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clair Lise, Ph.D.

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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K070398

/ of /

Indications for Use

510(k) Number (if known)

Device Name: Plum A+® Infusion Pump

Indications for Use:

Intended for use in parenteral, enteral, and epidural therapies and the administration of whole blood and blood products

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony V.2

on of Anesthesiology, General Hospital, on Control, Dental Devices

X(K) Number: K$\phi$70398

Page 1 of 1

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).