IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K

K052973 · Baxter Healthcare Corp · FRN · Jan 25, 2007 · General Hospital

Device Facts

• Record ID: K052973
• Device Name: IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
• Applicant: Baxter Healthcare Corp
• Product Code: FRN · General Hospital
• Decision Date: Jan 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

External infusion pump for delivery of analgesic, sedative, and anesthetic solutions. Modalities: PCA, PCA plus basal, and continuous. Input: user-programmed delivery parameters via keypad. Mechanism: linear peristaltic pumping with DC motor; powered by 9V battery or AC adapter. Features: air sensor, upstream/downstream occlusion detectors, real-time clock, and data logging. Used in clinical settings; operated by healthcare professionals. Output: controlled medication infusion. Benefits: precise, programmable medication delivery for pain management. System includes custom tubing sets and reservoir bags.

Clinical Evidence

Bench testing only. Evidence includes electrical safety, EMC, environmental, performance, and software verification/validation. Biocompatibility confirmed via comparison to predicate materials and manufacturing methods.

Technological Characteristics

Linear peristaltic pump; DC motor; 9V battery or AC power. Features: air sensor, occlusion detectors, LCD, keypad. Connectivity: data transfer capability. Software: system, unit, and integration level testing performed. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-24.

Indications for Use

Indicated for patients requiring controlled delivery of analgesic, sedative, and anesthetic solutions via intravenous, subcutaneous, epidural, or regional routes.

Regulatory Classification

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.

Predicate Devices

• IpumpTM Pain Management System (K993387)

Submission Summary (Full Text)

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KOS2973

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## 510(k) SUMMARY

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JAN 2 5 2007

| Date | 19 October 2005 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner | Baxter Healthcare Corporation |
| Contact Person | John Manarik<br>1620 Waukegan Road<br>McGaw Park, IL 60085<br>Manager, Global Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| 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 on<br>01 November 1999 |

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### 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.

#### 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.

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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.

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| Assessment of<br>Non-clinical Data | A summary and assessment of the non-clinical performance data<br>relied upon to support substantial equivalence follows: |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Electrical safety: Ipump was evaluated against the applicable<br>requirements contained within IEC 60601-1 with successful results. |
| | Electromagnetic Compatibility (EMC): The Ipump characteristics<br>were evaluated against the applicable requirements contained within<br>IEC 60601-1-2 second edition, augmented by the IEC 60601-2-24<br>clause 36 requirements, with sucessful results. |
| | The Ipump performance during environmental testing, such as the |
| | The performance characteristics of the Ipump were evaluated<br>against the applicable requirements contained within<br>IEC 60601-2-24 with successful results. |
| | Software testing was performed at the system level, unit level and<br>integration level to demonstrate that the design changes satisfy the<br>various Ipump™ Pain Management System requirements.<br>Regression testing was performed to demonstrate that the design<br>changes have not adversely affected those parts of the system not<br>changed. The data recorded from the software testing has been<br>determined to meet its acceptance criteria. |
| | A comparison of the predicate device with the subject Ipump shows<br>that the same components come into direct and indirect contact with<br>the patient. These components are processed by the same<br>manufacturing methods, and are of the same patient contact duration<br>and material type. Biocompatibility requirements are therefore<br>satisfied. |
| | The data supports the subject Ipump has shown equivalent<br>characteristics in its electrical safety, EMC, environmental,<br>performance, software and biocompatibility testing. |
| Conclusion | Baxter Healthcare Corporation concludes that the results obtained<br>during non-clinical performance testing for Ipump™ Pain<br>Management System supports a determination of substantial<br>equivalence. |

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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

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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 [phone]. 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 [phone] or [phone] 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:

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND / OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

K452973

KoS2973

Baxter Confidential