PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE by HOSPIRA, INC.

The Plum A+® and Plum A+®3 Infusion System with Hospira MedNet™ Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Device Description

The Plum A+® and A+®3 Infusion Systems with MedNet™ Software are electromechanical infusion pumps that use a stepper motor in conjunction with an inline cassette to meter IV fluids through dedicated intravenous administration sets. The infusion pumps and administration sets are manufactured and distributed by Hospira, Inc. The Plum A+® Infusion System is a single channel pump and Plum A+®3 Infusion System is a triple channel pump.

The subject devices are modifications of the predicate infusion pumps. The modifications provide networked (Ethernet wired and wireless) communication capability through new input/output (I/O) modules as well as enhancement of the optional drug library software (on CD-ROMs) to include an asset management function and have resident server software capability. In addition, enhancements are being made to the user interface of the infusion pumps. These enhancements include adding additional dose units, eliminating trailing zeros after a decimal point, dynamic font sizing to allow longer drug and clinical care area (CCA) names and allowing the clinician to change the CCA as required.

AI/ML Overview

The provided text is a 510(k) summary for the Plum A+® and Plum A+®3 Infusion Systems with Hospira MedNet™ Software. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the fashion typical for AI/ML medical devices.

Therefore, much of the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not present in this type of submission.

This 510(k) summary primarily addresses:

Device Description: The Plum A+® and A+®3 Infusion Systems with MedNet™ Software are electromechanical infusion pumps that use a stepper motor and inline cassette to meter IV fluids. The MedNet™ software adds networked communication capability (Ethernet wired and wireless), enhances the optional drug library software to include an asset management function, and enables resident server software capability. User interface enhancements are also described.
Intended Use: Indicated for use in parenteral, enteral, and epidural therapies, and the administration of whole blood and blood products. This is the same as the predicate devices.
Technological Characteristics Comparison: The proposed and predicate devices are similar in design, materials, components, intended use, labeling, and manufacturing processes. The modifications (networked communication, drug library enhancements, UI changes) do not raise new safety or effectiveness concerns.
Substantial Equivalence: The claim is that the device is substantially equivalent to the Abbott Plum A+® Infusion Pump with HPL/RS Plug-and-Play Module (K031185) and the Abbott Plum A+3™ Multichannel Infusion Pump (K021350).

Detailed breakdown of the requested information based on the provided text:

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

Acceptance Criteria (Explicitly stated)	Reported Device Performance (Implied by Substantial Equivalence)
Preamble: This document (a 510(k) summary) does not explicitly state acceptance criteria in a quantitative format typical for an AI/ML device study. Instead, the "acceptance criteria" for a 510(k) center around demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Functionality of networked communication (Ethernet wired and wireless)	Claimed to not raise new issues of safety and/or effectiveness; implies successful implementation and operation.
Functionality of enhanced drug library software (asset management, resident server)	Claimed to not raise new issues of safety and/or effectiveness; implies successful implementation and operation.
Functionality of user interface enhancements (dose units, no trailing zeros, dynamic font, CCA changes)	Claimed to not raise new issues of safety and/or effectiveness; implies successful implementation and operation.
Safety and effectiveness given new modifications	Substantially equivalent to predicate devices; modifications do not raise new issues of safety and/or effectiveness; compliance with IEC 60601-1-2 2nd Edition.
Compatibility with existing Plum A+® and Plum A+3™ pumps and administration sets	Plug 'n Play (I/O) Module is backwards compatible; I/O Modules and peripheral modules are backwards compatible; no changes to administration sets required.
Adherence to IEC 60601-1-2 2nd Edition	"All new factory released infusion systems will be in compliance with IEC 60601-1-2 2nd Edition."

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

Not applicable / Not present. This document does not describe a clinical study with a test set of data. The submission relies on a comparison of technical specifications and intended use to predicate devices, and likely in-house testing to verify new functionalities, but no clinical data with a "test set" in the context of an AI/ML evaluation.

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)

Not applicable / Not present. This type of ground truth establishment is not relevant for an infusion pump 510(k) submission focused on technical modifications.

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

Not applicable / Not present. Adjudication methods are not described as there is no clinical "test set" in the AI/ML sense.

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, not done. MRMC studies are not applicable to the evaluation of an infusion pump's modifications. The device described does not involve "human readers" interpreting data with or without AI assistance.

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

Not applicable. This device is an infusion pump with software enhancements, not a standalone AI algorithm being evaluated for diagnostic or predictive performance. The software acts as a control and communication system for the pump.

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

Not applicable / Not present. The "ground truth" for this device would be its ability to safely and accurately deliver fluids according to its programming and intended use, verified through engineering bench testing and adherence to standards, rather than clinical ground truth from patient data or expert consensus.

8. The sample size for the training set

Not applicable / Not present. This device does not use machine learning in a way that would require a "training set" of data for an algorithm.

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

Not applicable / Not present. As there is no training set mentioned or implied, this question is not relevant.

Summary

{0}------------------------------------------------

AUG 2 4 2004

K$\phi$42081 (f. 102)

5 510(k) SUMMARY

1. Submitted by: Hospira, Inc. Phone:(224) 212-4803 D-389 Bldg. H2 Fax: (224) 212-5401 275 N. Field Drive Lake Forest, IL 60045 Contact: Thomas Kozma, Ph.D. 2. Date Prepared: June 30, 2004 3. Name/Classification Infusion Pump, Class II of Device: 80 FRN - 21 CFR Parts 880.5725 4. Trade Name of Plum A+® Infusion System with Hospira MedNet™ Proposed Device: Software Plum A+ 3 Infusion System with Hospira MedNet™ Software Abbott Plum A+® Infusion Pump with HPL/RS Plug-and-5. Predicate Devices: Play Module (K031185) Abbott Plum A+3™ Multichannel Infusion Pump (K021350)

6. Proposed Device Description:

In addition, the Plug 'n Play (I/O) Module is backwards compatible so that the modifications described above can be applied to existing Plum A+® pumps. The I/O

{1}------------------------------------------------

K442431 (P.2 of 2)

Modules and peripheral modules are backwards compatible to existing Plum A+3™ pumps and can be inserted at a factory-authorized site.

All new factory released infusion systems will be in compliance with IEC 60601-1-2 2nd Edition.

Both the predicate and the proposed devices can be used for standard, piggyback, or concurrent fluid delivery using the dedicated administration sets currently marketed under K98159. No changes to these dedicated administration sets have been made or are required in order to be used with the subject devices.

7. Statement of Intended Use:

These are the same indications for use as the predicate devices.

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

The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes. The proposed modifications do not raise new issues of safety and/or effectiveness. Therefore, these infusion systems are substantially equivalent to the predicate infusion pumps.

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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2004

Hospira, Incorporated C/O Mr. Ned E. Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue SE Grand Rapids, Michigan 49548

Re: K042081

Trade/Device Name: Plum A+® Infusion System with Hospira MedNet™ Software and Plum A+6'3 Infusion System with Hospira MedNet™ Software Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: August 12, 2004 Received: August 16, 2004

Dear Mr. Devine:

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 merodice comments, 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 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 (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 writ) it har 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 Ecderal Register.

{3}------------------------------------------------

Page 2 - Mr. Devine

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 mean that I DA nas made a decemmaries and regulations administered by other Federal agencies. of the Act of ally I ederal states and reguirements, including, but not limited to: registration 1 ou inust comply with an are labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF R Part 067), abouting systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualifical 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) ITIS letter whilanow yourse of substantial equivalence of your device of your device to a premarket notification. - 11 vevice 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), 11 you desire specific at 100 Tompliance at (301) 594-4618. 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 may obtain 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,

Chiu Lin, 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

{4}------------------------------------------------

510(k) Number (if known)

Plum A+® Infusion System with Hospira MedNet™ Software Device Name:

Plum A+®3 Infusion System with Hospira MedNet™ Software

Indications for Use:

Plum A+® and Plum A+ 3 Infusion Systems with Hospira MedNet™ Software . Tam A . administration of whole blood and blood products.

Prescription Use × (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)

inta Lilian

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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).