(10 days)
Not Found
No
The description focuses on electromechanical components, software for programmed parameters, and networked communication, with no mention of AI or ML terms or functionalities.
Yes
The device is used for the "infusion of analgesic drugs" which is a medical treatment.
No
This device is an infusion pump, used for administering analgesic drugs to a patient, not for diagnosing a condition or disease.
No
The device description explicitly states it is an "electromechanical infusion pump" and lists hardware components such as a stepper motor, bar code reader, Nurse Call Port, and networked communication hardware. While it includes software (Hospira MedNet™ Software), it is an integral part of a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The LifeCare PCA® Infusion System is an infusion pump. Its function is to deliver medication (analgesic drugs) directly into a patient's bloodstream. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use clearly states "accurate, volumetric, infusion of analgesic drugs... by intravenous administration." This describes a therapeutic delivery system, not a diagnostic test.
Therefore, the LifeCare PCA® Infusion System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LifeCare PCA® Infusion System with Hospira MedNet™ Software is indicated for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System with Hospira MedNet™ Software is also indicated for short-term (less than 96 hours) continuous administration of analgesic drugs.
Product codes
MAE
Device Description
The LifeCare PCA® Infusion System with Hospira MedNet™ Software is an electromechanical infusion pump that uses a stepper motor that exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser is pole-mounted and includes an attached patient pendant that allows a patient to self-administer analgesia within physician-prescribed, programmed parameters that include delivery mode, PCA dose, lockout interval, and/or dose limits.
The LifeCare PCA® Infusion System with MedNet™ Software consists of:
- an infuser that is compliant with IEC 60601-1-2 2nd Edition requirements .
- a bar code reader that recognizes Hospira- or Abbott-manufactured drug . vials as well as hospital pharmacy-generated bar codes
- . a Nurse Call Port
- networked communication capability (Ethernet wired and wireless) with . Medication Management compatible hospital information systems
- hardware that is compatible with Hospira MedNet™ Software. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 1 8 2004
510(k) SUMMARY 5
| 1. Submitted by: | Hospira, Inc.
D-389 Bldg. H2
275 N. Field Drive
Lake Forest, IL 60045
Contact: Thomas Kozma, Ph.D. | Phone:(224) 212-4803
Fax: (224) 212-5401 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| 2. Date Prepared: | September 14, 2004 | |
| 3. Name/Classification
of Device: | Infusion Pump, Class II
80-MAE - 21 CFR Parts 880.5725 | |
| 4. Trade Name of
Proposed Devices: | LifeCare PCA® Infusion System
with Hospira MedNet™ Software | |
| 5. Predicate Devices: | Abbott LifeCare® PCA 3 Infuser (K022203) and
Hospira Plum A+® Infusion System with Hospira
MedNet™ Software (K042081) | |
6. Proposed Device Description:
The LifeCare PCA® Infusion System with Hospira MedNet™ Software is an electromechanical infusion pump that uses a stepper motor that exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser is pole-mounted and includes an attached patient pendant that allows a patient to self-administer analgesia within physician-prescribed, programmed parameters that include delivery mode, PCA dose, lockout interval, and/or dose limits.
The LifeCare PCA® Infusion System with MedNet™ Software consists of:
- an infuser that is compliant with IEC 60601-1-2 2nd Edition requirements .
- a bar code reader that recognizes Hospira- or Abbott-manufactured drug . vials as well as hospital pharmacy-generated bar codes
- . a Nurse Call Port
- networked communication capability (Ethernet wired and wireless) with . Medication Management compatible hospital information systems
- hardware that is compatible with Hospira MedNet™ Software. .
7. Statement of Intended Use:
The LifeCare PCA® Infusion System with Hospira MedNet™ Software is indicated for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System with Hospira MedNet™ Software is also indicated for short-term (less than 96 hours) continuous administration of analgesic drugs.
1
8. Summary of Technological Characteristics of New Device Compared to Predicate Device
The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes. The proposed modifications do not raise new issues of safety and/or Frio proposou moome, the LifeCare PCA® Infusion System with Hospira™ MedNet Software is substantially equivalent to the predicate infusion pumps.
The claim for substantial equivalence is supported by the information provided in the 510(k) submission.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2004
Hospira, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated World Headquarters 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K042800
Trade/Device Name: LifeCare PCA® Infusion System with Hospira MedNet™ Software Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: October 8, 2004 Received: October 8, 2004
Dear Mr. Devine:
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.
3
Page 2 - Mr. Devine
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 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 (OS) 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/dsma/dsmamain.html
Sincerely yours,
Susan Runne
Chin 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
4
Indications for Use
. . . .
| 510(k) Number (if known) | K042800 |
|---|---|
| Device Name: | LifeCare PCA® Infusion System with Hospira MedNet™ Software |
Indications for Use:
The LifeCare PCA® Infusion System with Hospira MedNet™ Software is indicated for
accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded
(PCA) intravenous administration. It is also indicated for short-term (less than 96
hours) continuous administration of analgesic drugs.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X AND/OR | Over-The-Counter Use
(Part 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)
| | (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices | Page 1 of 1 |
|----------------|-----------------------------------------------------------------------------------------------------------|-------------|
| 510(k) Number: | K042300 | |