(71 days)
Not Found
No
The description focuses on electromechanical and software control for fluid delivery, with no mention of AI or ML terms or functionalities.
Yes
The device is described as an "infusion pump" intended for "parenteral, enteral, and epidural therapies and the administration of whole blood and blood products," which are all forms of medical treatment.
No
The device description indicates it is an infusion pump used to meter and deliver IV fluids. Its intended use is for therapies and the administration of blood products, not for diagnosing medical conditions.
No
The device description explicitly states it is an "electromechanical infusion pump" that uses a "stepper motor" and "inline cassette" to meter and deliver fluids, indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "parenteral, enteral, and epidural therapies and the administration of whole blood and blood products." This describes the delivery of substances into the body, not the testing of samples from the body to diagnose conditions.
- Device Description: The description details an "electromechanical infusion pump" that meters and delivers fluids. This is consistent with a device used for administering treatments, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the device is an infusion pump, which is a therapeutic device used for administering fluids and medications, not a diagnostic device used for testing samples outside the body.
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
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
The proposed device is the Hospira Plum A+ Infusion Pump is a single channel software controlled, electromechanical infusion pump that operates on a volumetric, piston-driven, fluid displacement principle. The infuser uses a stepper motor in conjunction with an inline cassette to meter and deliver IV fluids through sterile intravenous administration sets designed to be used exclusively with both the Plum A+. The infuser can be pole mounted. This pump is IEC/EN 60601-1-2:2001 compliant.
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)
The proposed modifications have been evaluated using bench testing in which the results met the acceptance criteria and do not raise new issues of safety and/or effectiveness.
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.
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
February 2007
510(k) Summary
Plum A+® Infusion Pump
510K Summary
- Submitted by:
APR 24 2007
-
Hospira, Inc. D-389 Bldg. H2 275 N. Field Drive Lake Forest, IL 60045
Contact: Nicohl R. Wilding Phone:(224) 212-5270 Fax: (224) 212-5401 February 6, 2007 -
- Date Prepared:
Infusion Pump 21 CFR 880.5725, Pump, infusion Class II. Product code FRN Plum A+ ® Infusion Pump
- Date Prepared:
-
- Trade Name of Proposed Device:
- Name/Classification of Device:
6. Manufacturer and Establishment Registration Number:
Manufacturer Site: Hospira, Inc. - Morgan Hill 755 Jarvis Drive Morgan Hill, CA 95037
Sterilization Site: N/A
Registration # 2921482
7. 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.
8. Intended Use / Indications for Use:
Intended for use in parenteral, enteral, and epidural therapies and the administration of whole blood and blood products
The intended use is the same as for the predicate devices.
9. Proposed Device Description:
The proposed device is the Hospira Plum A+ Infusion Pump is a single channel software controlled, electromechanical infusion pump that operates on a volumetric, piston-driven, fluid displacement principle. The infuser uses a stepper motor in conjunction with an inline cassette to meter and deliver IV fluids through sterile
1
i(070378
510(k) Summary
Plum A+ ® Infusion Pump
X
intravenous administration sets designed to be used exclusively with both the Plum A+. The infuser can be pole mounted. This pump is IEC/EN 60601-1-2:2001 compliant.
10. Summary of Substantial Equivalence
The proposed device is substantially equivalent to the predicate devices in that it has the same
- . intended use,
- operating principle, .
- . materials of construction.
The major difference between the predicate device and the proposed device is that the subject device is compliant with IEC/EN 60601-1-2:2001.
11. Statement of Safety and Effectiveness
The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes. The proposed modifications have been evaluated using bench testing in which the results met the acceptance criteria and do not raise new issues of safety and/or effectiveness.
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 seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized wing segments and a wavy base, representing water. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2007
Ms. Nicohl R. Wilding Manager Global Device Regulatory Affairs Hospira, Incorporated 275 North Field Drive H2-2 Lake Forest, Illinois 60045
Re: K070398
Trade/Device Name: Plum A+® Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 16, 2007 Received: April 4, 2007
Dear Ms. Wilding:
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 - Ms. Wilding
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clair Lise, 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
/ of /
Indications for Use
510(k) Number (if known)
Device Name: Plum A+® Infusion Pump
Indications for Use:
Intended for use in parenteral, enteral, and epidural therapies and the administration of whole blood and blood products
Prescription Use X (Part 21 CFR 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)
Anthony V.2
on of Anesthesiology, General Hospital, on Control, Dental Devices
X(K) Number: K$\phi$70398
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