(24 days)
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.
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 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.
The provided text describes a 510(k) submission for the Ipump™ Pain Management System. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on the accuracy of fluid delivery.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Defined by IEC 601-2-24 standard | "demonstrate acceptable performance of the device" |
Note: The exact quantitative acceptance criteria from the IEC 601-2-24 standard are not detailed in this document. The submission only states that the testing was conducted according to this standard and the results were acceptable.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "testing conducted to verify the design modifications" but does not give a number for the test samples (e.g., number of pumps tested, number of infusion runs).
- Data Provenance: Not explicitly stated. Based on the context of a 510(k) submission by Baxter Healthcare Corporation (a U.S.-based company), it is highly likely the testing was conducted domestically. The study would be prospective as it's for verifying design modifications of a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this submission. The "ground truth" for infusion pump accuracy is determined by objective physical measurements (e.g., gravimetric analysis or flow sensors) against a defined standard, not by human expert opinion or consensus.
4. Adjudication Method for the Test Set
Not applicable. As the "ground truth" is based on objective physical measurements and not expert consensus, there is no need for an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study is not applicable for this device. This type of study is used for diagnostic devices where human readers interpret medical images or data. The Ipump™ is an infusion pump, and its effectiveness is determined by its mechanical performance and accuracy, not by human interpretation.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes. The tests described are inherently a standalone performance study. The "Accuracy data was generated in accordance with the testing methodology defined by the IEC 601-2-24 standard." This typically involves automated or highly controlled experimental setups to measure the infusion pump's performance (e.g., fluid delivery rate) against the programming, without human intervention affecting the outcome of the measurement itself.
7. Type of Ground Truth Used
The ground truth used is based on objective physical measurements (e.g., gravimetric analysis to measure delivered fluid volume over time) as defined by the IEC 601-2-24 standard for infusion pumps.
8. Sample Size for the Training Set
Not applicable. The Ipump™ Pain Management System is a hardware device (infusion pump) with embedded software controlling its mechanical functions. It does not use machine learning or AI algorithms that would require a "training set" in the conventional sense of AI/ML models. Its control logic and algorithms are typically pre-programmed based on engineering design and validated through testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, there is no "training set" in the context of AI/ML for this device.
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special 210(K): Device Mountation Ipump™ Pain Management System
NOV - I -1998
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 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).