IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K

K993387 · Baxter Healthcare Corp · FRN · Nov 1, 1999 · General Hospital

Device Facts

• Record ID: K993387
• Device Name: IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
• Applicant: Baxter Healthcare Corp
• Product Code: FRN · General Hospital
• Decision Date: Nov 1, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ipump™ Pain Management System is an electronic infusion pump indicated for the controlled rate delivery of small volume parenteral fluids as prescribed by a physician. Delivery may be continuous or intermittent and may be epidural, intravenous or subcutaneous.

Device Story

Ipump™ Pain Management System is an electronic infusion pump for controlled delivery of parenteral fluids; utilizes linear peristaltic pumping mechanism with DC motor; powered by 9V battery or AC adapter. Supports continuous, intermittent, and Patient Controlled Analgesia (PCA) modes. Configurable parameters allow institutions to set infusion modes, units of measure, and safety limits. Includes custom tubing and non-vented reservoir (up to 500 mL). Modifications include upstream occlusion/air detection, enhanced security, expanded alerts, and configuration download features. Operated by clinicians in clinical settings to manage patient pain; output affects clinical decision-making by ensuring precise medication delivery. Benefits include improved safety and flexibility in pain management protocols.

Clinical Evidence

Bench testing only. Accuracy data generated in accordance with IEC 601-2-24 standard. Testing verified design modifications and demonstrated acceptable device performance.

Technological Characteristics

Linear peristaltic pump; DC motor; 9V battery or AC adapter power; configurable infusion modes/limits; upstream/downstream occlusion detection; air detection; non-vented reservoir (up to 500 mL). Testing performed per IEC 601-2-24.

Indications for Use

Indicated for controlled rate delivery of small volume parenteral fluids via epidural, intravenous, or subcutaneous routes as prescribed by a physician.

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

• APII Infusion Pump (K926385)

Submission Summary (Full Text)

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special 210(K): Device Mountation Ipump™ Pain Management System

NOV - I -1998

K993387

### 510(K) SUMMARY

#### Submitted by:

Vicki L Drews Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073

Proposed Device: Ipump™ Pain Management System

#### Predicate Device:

APII Infusion Pump, K926385, cleared 4/18/1994

#### Device Description and Statement of Intended Use:

The Ioump™ Pain Management System is an electronic infusion pump indicated for the controlled rate delivery of small volume parenteral fluids as prescribed by a physician. Delivery may be continuous or intermittent and may be epidural, intravenous or subcutaneous.

The Ipump™ operates using a linear peristaltic pumping mechanism and a DC motor. The power source can be either a 9 Volt battery or an AC adapter. The Ipump™ provides continuous, Patient Controlled Analgesia (PCA), and combined modes of operation. The pumps have configurable input parameters. which allow institutions to pre-select which modes of operation will be available to users and which units of measure will be used for data entry.

The principal modifications described in this submission are: (1) the addition of upstream occlusion and air detection; (2) a modified downstream occlusion mechanism; (3) a modified AC Adapter; (4) addition of a configuration download feature; (5) increased the configurable continuous infusion rate and the configurable bolus volume; (6) expanded alerts and alarms; (7) enhanced security features; (8) additional timed infusion limit and dose/hour limit configuration options; (9) an automatic restart after bolus option; (10) foreign language and international date and time format options; (11) flexible audible alert call back time; (12) option to configure the "Start" key to function as a PCA

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OCT 7 1999

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button; (13) enhanced pump history; (14) option for use of previous prescription the current prescription; (15) updated labeling.

The pump system includes a custom tubing set and a flexible non-vented reservoir (bag) of up to 500 mL in addition to the pump. The disposable accessories are unchanged from the predicate device.

## Summary of Technological Characteristics of New Device to Predicate Devices

The technological features of the Ipump™ Pain Management System do not differ significantly from the APII Infusion Pump. The devices have similar materials, product design, and energy source and have the same intended use.

## Discussion of Non Clinical Tests; Conclusions Drawn from Nonclinical Tests

Accuracy data was generated in accordance with the testing methodology defined by the IEC 601-2-24 standard. The results of testing conducted to verify the design modifications demonstrate acceptable performance of the device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 1999

Ms. Vicki L. Drews Manager, Requlatory Affairs Baxter Healthcare Corporation Route 120 & Wilson Road Round Lake, Illinois 60073-0490

Re : K993387 APII Infusion Pump Trade Name: Requlatory Class: II Product Code: FRN Dated: October 7, 1999 Received: October 8, 1999

Dear Ms. Drews:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturinq Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Drews

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdaa.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

Device Trade Name: Ipump™ Pain Management System

Indications for Use:

The Ipump™ Pain Management System is indicated for the controlled rate delivery of small volume parenteral fluids as prescribed by a physician. Delivery may be continuous or intermittent and may be epidural, intravenous or subcutaneous.

Patrizia Cucurati

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

510(k) Number K992387

**Prescription Use**
(Per 21 CFR 801.109)

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Baxter Confidential s:\510k\ipump\special\indication.doc