The Ipump™ Pain Management system is indicated for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, and epidural, and for regional (local) analgesia applications.

Device Description

The Ipump™ Pain Management System is an external infusion pump offering three different modalities for the delivery of medications to a patient. The modalities include Patient Controlled Analgesia (PCA) mode, PCA plus basal (continuous) mode, and continuous mode.

PCA mode delivers a bolus of a medication at a fixed rate of 90 mL/hr at patient-controlled time intervals by pressing the PCA button. PCA plus basal (continuous) mode delivers medication at 90 mL/hr during patient-controlled time intervals in conjunction with the desired basal delivery of between 0.1 mL/hr and 19.9 mL/hr between PCA doses. In continuous mode, the pump delivers medication continuously at a rate adjustable between 0.1 mL/hr and 90.0 mL/hr.

The Ipump operates using a linear peristaltic pumping mechanism and a DC motor with either a 9 volt alkaline battery or an AC adapter power source. The pump's features include an air sensor, an upstream occlusion detector and a down stream occlusion detector. The disposables for the Ipump™ Pain Management System consist of numerous custom tubing sets and flexible non-vented reservoir bags of up to 500 ml.

AI/ML Overview

This KOS submission is for an Infusion Pump, which is a hardware device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test/training sets, ground truth establishment methods, expert involvement, and MRMC studies) are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, primarily related to safety and effectiveness in its mechanical and electrical operation.

Here's an analysis of the provided text based on the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

The submission discusses several performance evaluations against recognized standards. The "acceptance criteria" are implied by successful evaluation against these standards.

Acceptance Criteria (Implied Standard Compliance)	Reported Device Performance
Electrical Safety: Compliance with IEC 60601-1 requirements.	Ipump was evaluated against the applicable requirements contained within IEC 60601-1 with successful results.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 second edition, augmented by IEC 60601-2-24 clause 36 requirements.	The Ipump characteristics were evaluated against the applicable requirements contained within IEC 60601-1-2 second edition, augmented by the IEC 60601-2-24 clause 36 requirements, with successful results.
General Performance: Compliance with IEC 60601-2-24 requirements.	The performance characteristics of the Ipump were evaluated against the applicable requirements contained within IEC 60601-2-24 with successful results.
Software Performance: Software design changes satisfy various requirements; no adverse effects on unchanged parts of the system.	Software testing was performed at the system level, unit level and integration level to demonstrate that the design changes satisfy the various Ipump™ Pain Management System requirements. Regression testing was performed to demonstrate that the design changes have not adversely affected those parts of the system not changed. The data recorded from the software testing has been determined to meet its acceptance criteria.
Biocompatibility: Same patient-contact components, manufacturing methods, duration, and material type as predicate device.	A comparison of the predicate device with the subject Ipump shows that the same components come into direct and indirect contact with the patient. These components are processed by the same manufacturing methods, and are of the same patient contact duration and material type. Biocompatibility requirements are therefore satisfied.
Environmental Performance: Performance during environmental testing (e.g., temperature, humidity, vibration).	The Ipump performance during environmental testing, such as the (specific tests not detailed, but implied successful).

2. Sample Size for the Test Set and Data Provenance

As this is a mechanical/electrical device, the concept of a "test set" in the context of AI/ML (e.g., a set of medical images or patient records) does not apply. The "tests" here refer to engineering verification and validation activities.

Sample Size: Not explicitly stated in terms of "samples" for a specific dataset but rather describes the device being tested against standards. It implies testing was conducted on one or more units of the Ipump™ Pain Management System.
Data Provenance: Not applicable in the AI/ML sense. The testing was conducted internally by Baxter Healthcare Corporation for regulatory submission purposes. It's non-clinical, not from patient studies or retrospective/prospective medical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. "Ground truth" in the AI/ML sense is not relevant for the testing of an infusion pump's mechanical and electrical performance. The "truth" is defined by compliance with engineering standards and specifications.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert labeling of data, which is not relevant for this type of device submission.

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

No. This is not an AI/ML device, nor is it a device that requires human interpretation of outputs in a way that an MRMC study would be relevant. The pump's function is automated delivery of medication.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. Again, this is a hardware device. While it has software, its "performance" is assessed through engineering tests, not through an algorithm-only study in the context of an AI/ML diagnostic or predictive tool.

7. Type of Ground Truth Used

Not applicable in the AI/ML sense. The "ground truth" for this device's performance is established by engineering specifications, regulatory standards (e.g., IEC 60601 series), and the device's own design requirements. The tests verify that the device meets these pre-defined performance and safety criteria.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm.

Summary

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KOS2973

510(k) SUMMARY

JAN 2 5 2007

Date	19 October 2005
Owner	Baxter Healthcare Corporation
Contact Person	John Manarik1620 Waukegan RoadMcGaw Park, IL 60085Manager, Global Regulatory AffairsTelephone: (847) 473-6294Fax: (847) 785-5116E-mail: john_manarik@baxter.com
Device name	IpumpTM Pain Management System
Common name	External Infusion Pump
Classification name	Infusion Pump (21 CFR 880.5725, Product Code 80 FRN)
Predicate Device	IpumpTM Pain Management System, K993387 cleared on01 November 1999

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Device Description

Statement of Intended Use

The Ipump™ Pain Management System is indicated for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, and epidural, and for regional (local) analgesia applications.

Technological Characteristics

The subject and predicate devices are similar in operating principle, material composition, energy sources, environmental specifications, performance, dimensional specifications and packaging. A summary of the technological characteristics for the subject and predicate devices follows in Table 1.

KoS2973

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Functional Features	Predicate Ipump	Subject Ipump
Power Sources
9 volt battery	included	included
100-120 VAC, 60 Hz	included	included
220-240 VAC, 50 Hz
Key Features:
Air sensor	included	included
Preventative maintenance alert	included	included
Multilanguage interface	included	included
Detailed history display and printout capability	included	included
Ability to transfer data to another Ipump	included	included
Upstream and downstream occlusion detectors	included	included
Programmable limits for PCA doses	included	included
Record Management:
Tracking of programming, time and history	included	included
Data retained in memory after pump is off	included	included
Real time clock	included	included
Security
Key only	included	included
Code only	included	included
Key plus code	included	included
Setting up of the Pump
PCA cord	included	included
May be IV pole mounted	included	included
Pumping Mechanism:
DC motor	included	included
Linear peristaltic motion	included	included
Display Technology
Liquid crystal display	included	included
Keypad
Keypad with action keys	included	included

Table 1. Ipump™ Pain Management System Technological Characteristics Comparison

The technological characteristics of the subject Ipump™ Pain Management System do not raise new questions of safety or effectiveness.

Baxter Confidential

Ko52973

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Assessment ofNon-clinical Data	A summary and assessment of the non-clinical performance datarelied upon to support substantial equivalence follows:
	Electrical safety: Ipump was evaluated against the applicablerequirements contained within IEC 60601-1 with successful results.
	Electromagnetic Compatibility (EMC): The Ipump characteristicswere evaluated against the applicable requirements contained withinIEC 60601-1-2 second edition, augmented by the IEC 60601-2-24clause 36 requirements, with sucessful results.
	The Ipump performance during environmental testing, such as the
	The performance characteristics of the Ipump were evaluatedagainst the applicable requirements contained withinIEC 60601-2-24 with successful results.
	Software testing was performed at the system level, unit level andintegration level to demonstrate that the design changes satisfy thevarious Ipump™ Pain Management System requirements.Regression testing was performed to demonstrate that the designchanges have not adversely affected those parts of the system notchanged. The data recorded from the software testing has beendetermined to meet its acceptance criteria.
	A comparison of the predicate device with the subject Ipump showsthat the same components come into direct and indirect contact withthe patient. These components are processed by the samemanufacturing methods, and are of the same patient contact durationand material type. Biocompatibility requirements are thereforesatisfied.
	The data supports the subject Ipump has shown equivalentcharacteristics in its electrical safety, EMC, environmental,performance, software and biocompatibility testing.
Conclusion	Baxter Healthcare Corporation concludes that the results obtainedduring non-clinical performance testing for Ipump™ PainManagement System supports a determination of substantialequivalence.

Kos 2973

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES, U.S.A." in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Baxter Healthcare Corporation C/O Ms. Barbara K. Barbeau Senior Director, Global Regulatory Affairs Global Regulatory Affairs 1620 Waukegan Road McGaw Park, Illinois 60085-6730

14 2 5 1007

Re: K052973

Trade/Device Name: Ipump™ Pain Management System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: November 13, 2006 Received: November 15, 2006

Dear Ms. Barbeau:

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.

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

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Page 2 -- Ms. Barbeau

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chih-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

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Indications for Use

510(k) Number (if known): ____ K 052973

Device Name: Jpump™ Pain Management System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND / OR

Over-the-Counter Use (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)

K452973

KoS2973

Baxter Confidential

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).