(26 days)
Not Found
No
The summary describes a standard electromechanical infusion pump with software control, but there is no mention of AI, ML, or related concepts in the device description, intended use, or other sections. The predicate devices are also standard infusion pumps.
No.
The device is an infusion pump used for administering therapies, not directly a therapeutic device itself.
No
Explanation: The device description states that the infusion pump systems "meter and deliver IV fluids," indicating a therapeutic rather than a diagnostic function. The "Intended Use / Indications for Use" also describes administration of therapies and blood products, not diagnosis.
No
The device description explicitly states it is a "software controlled, electromechanical infusion pump" and describes hardware components like a stepper motor, inline cassette, and the ability to be pole mounted.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for administering fluids (parenteral, enteral, epidural) and blood products directly to a patient. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details an electromechanical pump that meters and delivers fluids. This aligns with a therapeutic device, not a device used to examine specimens from the body to diagnose diseases or conditions.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to diagnose diseases or conditions. This device operates in vivo (within the body) to deliver substances.
N/A
Intended Use / Indications for Use
Intended for use in parenteral, enteral, and epidural therapies and the administration of whole blood and blood products.
Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
The Hospira Plum A+ and Hospira Plum A+ 3 Infusion Pump Systems are a family of single channel and triple channel software controlled, electromechanical infusion pumps that operate on a volumetric, piston-driven, fluid displacement principle. The infusers use a stepper motor in conjunction with an inline cassette to meter and deliver IV fluids through sterile intravenous administration sets desirent to be used exclusively with both the Plum A+ and Plum A+ 3. The infusers can be pole nounted.
As of May 03, 2004, both the infusers and the dedicated PlumSet® Administration Sets are manufactured and distributed by Hospira Incorporated, formerly the Hospital Products Division of Abbott Laboratories.
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): 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.
K042081, K024084, K021350, K011442
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).
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AUG 2 4 2005
510(K) Summary
- Name of Submitter: Hospira, Inc. 275 North Field Drive Lake Forest, Illinois 60045
Owner/Operator # 9063339
2. Manufacturer and Establishment Registration Number:
Hospira, Inc. - Morgan Hill 755 Jarvis Drive Morgan Hill, CA 95037
Establishment Registration # 2921482
3. Proprietary or Trade Name of Proposed Devices:
Hospira Plum A+ Infusion Pump System, v11.5
Hospira Plum A+ 3 Infusion Pump System, v11.5
- Common Name: Infusion Pump with IV Administration Sets
-
- Device Classification, Pancode and ProCode: Class II, FRN (Infuser) Class II, FPA (IV Administration Sets)
-
- Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for intravenous infusion pumps. Infusion pumps are listed in 21 CFR 880.5725.
7. Intended Use:
Intended for use in parenteral, enteral, and epidural therapies and the administration of whole blood and blood products.
8. Indications for Use:
Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
9. Proposed Device Description:
The Hospira Plum A+ and Hospira Plum A+ 3 Infusion Pump Systems are a family of single channel and triple channel software controlled, electromechanical infusion pumps that operate on a volumetric, piston-driven, fluid displacement principle. The infusers use a stepper motor in conjunction with an inline cassette to meter and deliver IV fluids through sterile intravenous administration sets desirent to be used exclusively with both the Plum A+ and Plum A+ 3. The infusers can be pole nounted.
As of May 03, 2004, both the infusers and the dedicated PlumSet® Administration Sets are manufactured and distributed by Hospira Incorporated, formerly the Hospital Products Division of Abbott Laboratories.
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K052052
2 of 3
10. Predicate Device Information:
Devices cleared for commercial distribution and determined to be appropriate for use as predicates are summarized in the following table.
| Submission History | ||
|---|---|---|
| 510(k) # | Title | Decision Date |
| K042081 | Plum A+ Infusion System with Hospira MedNet™ Software (v. 13.x) | 08/24/2004 |
| K024084 | Abbott Plum A+ Infusion Pump, Model 12391 | 12/31/2002 |
| K021350 | Abbott Plum A+3 Multichannel Infusion Pump | 05/14/2002 |
| K011442 | Plum A+ Infusion Pump | 06/05/2001 |
11. Comparison to Legally Marketed Device(s)
| Factors | Subject Device(s) | Primary Predicate
Device(s) |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| | Hospira Plum A+® Infusion Pump System, v11.5
Hospira Plum A+®3 Infusion Pump System, v11.5 | Hospira Plum A+®/
Plum A+®3 Infusion
Pump Systems
V10.3, v11.3, v13.x |
| Intended Use | Intended for use in parenteral, enteral, and epidural therapies
and the administration of whole blood and blood products. | Same |
| Indications | Indicated for use in parenteral, enteral, and epidural therapies
and the administration of whole blood and blood products. | Same |
| Operating
Principle | Volumetric, piston driven, fluid displacement principle.
Stepper motor in conjunction with an in-line cassette to meter
IV fluids through a dedicated intravenous administration set. | Same |
| Administration
Sets and Fluid
Contact
Materials | Sterile, dedicated, non-pyrogenic, PlumSet® Administration
Sets. | Same |
| Physical
Features | Materials, Size, Weight, Input Lines, Output Lines, Power
Sources, Battery Type, Power Cord | Same |
| Environmental
Features | Operating Temperature, Storage Temperature, Relative
Humidity, Pressure | Same |
2
| Factors | Subject Device(s) | Primary Predicate Device(s) |
|---|---|---|
| Performance | ||
| Features | Delivery Rates, VTBI Range, Dose Units, Delivery Accuracy, | |
| Delivery Modes, Therapies, Distal Occlusion Limits, Proximal | ||
| Occlusion Limits, Alarm Types and Conditions, Default Drug | ||
| Library. | Similar | |
| (Improved Battery Charge | ||
| Monitoring Algorithm in | ||
| v11.5 and v13.x only) | ||
| BioMed | ||
| Settings | Configuration settings available for customization. | Similar |
| (Supporting software | ||
| code for optional | ||
| barcode wand | ||
| capability removed in | ||
| v11.5, disabled in | ||
| v13.x) |
12. Statement of Substantial Equivalence:
Compatible Hospira Plum A+ and Hospira Plum A+ 3 Infusion Systems when upgraded with v11.5 software are substantially equivalent to the current predicate devices identified in the submission.
Similarities:
- Same intended use and indications for use. 1)
-
- Same fundamental scientific technology.
- Same physical, operational, and performance specifications. 3)
- Same materials of construction for all infuser components and administration sets. 4)
13. Statement of Safety and Effectiveness
Compatible Hospira Plum A+ and Hospira Plum A+ 3 Infusion Systems, when upgraded to v11.5, meet the functional claims and intended use as described in the product labeling, and are as safe and effective in terms of substantial equivalence as the predicate devices described in this submission.
Prepared and submitted by: Patricia Melerski Manager, Global Device Regulatory Affairs Hospira, Inc. 275 North Field Drive Lake Forest, IL 60045 Phone: 224/212-4880 Fax: 224/212-5401
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures, represented by curved lines, positioned closely together.
Public Health Service
AUG 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Melerski Manager, Global Device Regulatory Affairs Hospira, Incorporated 275 North Field Drive Building H-2, Dept. - 389 Lake Forest, Illinois 60045
Re: K052052
Trade/Device Name: Hospira Plum A+® Infusion Pump System, v11.5 Hospira Plum A+ 3 Infusion Pump System, v11.5 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: July 28, 2005 Received: July 29, 2005
Dear Ms. Melerski:
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.
4
Page 2 - Ms. Melerski
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 (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 (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/industry/support/index.html.
Sincerely yours,
Susan Runner
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
5
Indications for Use Statement
510(k) Number (if known)
Hospira Plum A+ Infusion Pump System, v11.5 Device Name:
Hospira Plum A+ 3 Infusion Pump System, v11.5
Indications for Use:
Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Prescription Use _ X (Part 21 801 Subpart D) 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)
Clint Druk
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K152453