(21 days)
K98159
No
The description focuses on electromechanical function, networking capabilities, and software enhancements for drug libraries and user interface, with no mention of AI or ML terms or functionalities.
Yes
The device is indicated for use in parenteral, enteral, and epidural therapies, and the administration of whole blood and blood products, which are therapeutic interventions.
No
Explanation: The device is an infusion system designed for administering fluids and medications, not for diagnosing medical conditions. Its function is to meter and deliver substances, as indicated by "parenteral, enteral and epidural therapies and the administration of whole blood and blood products."
No
The device description explicitly states that the Plum A+® and A+®3 Infusion Systems are "electromechanical infusion pumps" and mentions hardware components like a "stepper motor" and "inline cassette." While the submission describes software modifications and enhancements, the core device is a hardware infusion pump.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "parenteral, enteral and epidural therapies and the administration of whole blood and blood products." These are all related to administering substances into the body, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details an "electromechanical infusion pump" that meters fluids through administration sets. This aligns with the function of delivering substances to a patient, not analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
Therefore, the Plum A+® and Plum A+®3 Infusion System with Hospira MedNet™ Software is a medical device used for administering fluids and substances to patients, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Plum A+® and Plum A+®3 Infusion System with Hospira MedNet™ Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Product codes
FRN
Device Description
The Plum A+® and A+®3 Infusion Systems with MedNet™ Software are electromechanical infusion pumps that use a stepper motor in conjunction with an inline cassette to meter IV fluids through dedicated intravenous administration sets. The infusion pumps and administration sets are manufactured and distributed by Hospira, Inc. The Plum A+® Infusion System is a single channel pump and Plum A+®3 Infusion System is a triple channel pump.
The subject devices are modifications of the predicate infusion pumps. The modifications provide networked (Ethernet wired and wireless) communication capability through new input/output (I/O) modules as well as enhancement of the optional drug library software (on CD-ROMs) to include an asset management function and have resident server software capability. In addition, enhancements are being made to the user interface of the infusion pumps. These enhancements include adding additional dose units, eliminating trailing zeros after a decimal point, dynamic font sizing to allow longer drug and clinical care area (CCA) names and allowing the clinician to change the CCA as required.
In addition, the Plug 'n Play (I/O) Module is backwards compatible so that the modifications described above can be applied to existing Plum A+® pumps. The I/O Modules and peripheral modules are backwards compatible to existing Plum A+3™ pumps and can be inserted at a factory-authorized site.
All new factory released infusion systems will be in compliance with IEC 60601-1-2 2nd Edition.
Both the predicate and the proposed devices can be used for standard, piggyback, or concurrent fluid delivery using the dedicated administration sets currently marketed under K98159. No changes to these dedicated administration sets have been made or are required in order to be used with the subject devices.
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)
K98159
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
AUG 2 4 2004
K$\phi$42081 (f. 102)
5 510(k) SUMMARY
-
- Submitted by: Hospira, Inc. Phone:(224) 212-4803 D-389 Bldg. H2 Fax: (224) 212-5401 275 N. Field Drive Lake Forest, IL 60045 Contact: Thomas Kozma, Ph.D. 2. Date Prepared: June 30, 2004 3. Name/Classification Infusion Pump, Class II of Device: 80 FRN - 21 CFR Parts 880.5725 4. Trade Name of Plum A+® Infusion System with Hospira MedNet™ Proposed Device: Software Plum A+ 3 Infusion System with Hospira MedNet™ Software Abbott Plum A+® Infusion Pump with HPL/RS Plug-and-5. Predicate Devices: Play Module (K031185) Abbott Plum A+3™ Multichannel Infusion Pump (K021350)
6. Proposed Device Description:
The Plum A+® and A+®3 Infusion Systems with MedNet™ Software are electromechanical infusion pumps that use a stepper motor in conjunction with an inline cassette to meter IV fluids through dedicated intravenous administration sets. The infusion pumps and administration sets are manufactured and distributed by Hospira, Inc. The Plum A+® Infusion System is a single channel pump and Plum A+®3 Infusion System is a triple channel pump.
The subject devices are modifications of the predicate infusion pumps. The modifications provide networked (Ethernet wired and wireless) communication capability through new input/output (I/O) modules as well as enhancement of the optional drug library software (on CD-ROMs) to include an asset management function and have resident server software capability. In addition, enhancements are being made to the user interface of the infusion pumps. These enhancements include adding additional dose units, eliminating trailing zeros after a decimal point, dynamic font sizing to allow longer drug and clinical care area (CCA) names and allowing the clinician to change the CCA as required.
In addition, the Plug 'n Play (I/O) Module is backwards compatible so that the modifications described above can be applied to existing Plum A+® pumps. The I/O
1
K442431 (P.2 of 2)
Modules and peripheral modules are backwards compatible to existing Plum A+3™ pumps and can be inserted at a factory-authorized site.
All new factory released infusion systems will be in compliance with IEC 60601-1-2 2nd Edition.
Both the predicate and the proposed devices can be used for standard, piggyback, or concurrent fluid delivery using the dedicated administration sets currently marketed under K98159. No changes to these dedicated administration sets have been made or are required in order to be used with the subject devices.
7. Statement of Intended Use:
The Plum A+® and Plum A+®3 Infusion System with Hospira MedNet™ Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
These are the same indications for use as the predicate devices.
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 effectiveness. Therefore, these infusion systems are substantially equivalent to the predicate infusion pumps.
The claim for substantial equivalence is supported by the information provided in the 510(k) submission.
2
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2004
Hospira, Incorporated C/O Mr. Ned E. Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue SE Grand Rapids, Michigan 49548
Re: K042081
Trade/Device Name: Plum A+® Infusion System with Hospira MedNet™ Software and Plum A+6'3 Infusion System with Hospira MedNet™ Software Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: August 12, 2004 Received: August 16, 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 merodice comments, 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 approvisions 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 (1 writ) it har 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 Ecderal 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 mean that I DA nas made a decemmaries and regulations administered by other Federal agencies. of the Act of ally I ederal states and reguirements, including, but not limited to: registration 1 ou inust comply with an are labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF R Part 067), abouting systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualifical 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) ITIS letter whilanow yourse of substantial equivalence of your device of your device to a premarket notification. - 11 vevice 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), 11 you desire specific at 100 Tompliance at (301) 594-4618. 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 may obtain 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,
Chiu 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
510(k) Number (if known)
Plum A+® Infusion System with Hospira MedNet™ Software Device Name:
Plum A+®3 Infusion System with Hospira MedNet™ Software
Indications for Use:
Plum A+® and Plum A+ 3 Infusion Systems with Hospira MedNet™ Software . Tam A . administration of whole blood and blood products.
Prescription Use × (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)
inta Lilian
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
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