(24 days)
Not Found
No
The description focuses on standard electronic infusion pump technology, mechanical components, and software configuration options. There is no mention of AI, ML, or related concepts like learning, adaptation, or complex data analysis for decision-making. The modifications listed are typical for updating existing medical devices.
Yes.
The device is an infusion pump indicated for the controlled delivery of parenteral fluids for pain management, which directly implies a therapeutic function.
No
The device is an infusion pump for delivering fluids, not for diagnosing conditions.
No
The device description explicitly details hardware components such as a linear peristaltic pumping mechanism, DC motor, battery, AC adapter, tubing set, and reservoir. It also describes modifications to physical mechanisms like occlusion detection.
Based on the provided information, the Ipump™ Pain Management System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "controlled rate delivery of small volume parenteral fluids as prescribed by a physician." This describes a device that administers substances into the body, not a device that examines specimens from the body to provide diagnostic information.
- Device Description: The description focuses on the mechanical and electronic aspects of a pump designed for fluid delivery. It mentions pumping mechanisms, power sources, modes of operation, and safety features related to infusion. There is no mention of analyzing biological samples or providing diagnostic results.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic, prognostic, or screening information
- Using reagents or assays
The Ipump™ is clearly described as an infusion pump used for delivering medications or fluids directly to a patient. This falls under the category of therapeutic or drug delivery devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural, intravenous or subcutaneous [delivery]
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
APII Infusion Pump, K926385
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
357
OCT 7 1999
\data02\rashare\510k\ipump\special\sum 11.doc
1
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.
\data02\rashare\510k\ipump\special\sum_r1.doc
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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
3
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
4
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)
Image /page/4/Picture/9 description: The image shows the number 289 in large font at the top. Below that, the text "OCT 7 1999" is visible, indicating a date. The text is slightly blurry, but the numbers are still legible. The image appears to be a scan or a photograph of a document.
Baxter Confidential s:\510k\ipump\special\indication.doc