(211 days)
The Plum A+® Hyperbaric 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.
Additionally, the Plum A+ Hyperbaric Infusion System with Hospira MedNet Software can be used under hyperbaric conditions in multiplace and with monoplace (Class A and B) chambers.
The Plum A+ Hyperbaric Infusion System with Hospira MedNet® Software is an electromechanical infusion pump that uses a stepper motor in conjunction with an inline cassette to meter IV fluids through dedicated intravenous administration sets in normal atmospheric Hospital settings and in Hyperbaric conditions. The infusion pump and administration sets are manufactured and distributed by Hospira. Inc. The Plum A+® Hyperbaric Infusion System is a single channel pump.
The subject device is based on modifications of the predicate infusion pumps. The modifications allow for distal pressure increases due to monoplace hyperbaric chamber pressurization and include distinct coloring to identify the purmp as a hyperbaric device.
Additionally, the sets were changed so that they could be used under hyperbaric conditions. The flow regulator is colored green to identify them as hyperbaric administration sets.
In normal atmospheric conditions, both the predicate and the proposed device can be used for standard, piggyback, or concurrent fluid delivery using the dedicated administration sets currently marketed. No changes to these dedicated administration sets have been made or are required in order to be used with the subject devices. However, new sets have been designed for administration with monoplace hyperbaric chambers.
This document is a 510(k) summary for the Plum A+® Hyperbaric Infusion System with Hospira MedNet® Software. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria.
Therefore, much of the requested information (like specific acceptance criteria, detailed study results, sample sizes, expert qualifications, and ground truth methodologies) is not explicitly present in the provided text. The submission describes modifications to an existing device to allow for hyperbaric use and emphasizes the similarities to the predicate device.
However, based on the information provided, here's what can be inferred or stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics. Its primary goal is to establish "substantial equivalence" to a predicate device, meaning its safety and effectiveness are similar to a device already legally marketed.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not specified directly in this summary, as the submission focuses on substantial equivalence to a predicate device. | The modifications allow for distal pressure increases due to monoplace hyperbaric chamber pressurization and include distinct coloring to identify the pump as a hyperbaric device. Additionally, the sets were changed so that they could be used under hyperbaric conditions. The flow regulator is colored green to identify them as hyperbaric administration sets. |
2. Sample Size Used for the Test Set and Data Provenance
No information regarding a "test set" sample size or data provenance (country of origin, retrospective/prospective) is provided. The submission likely relies on engineering testing and comparison to the predicate device's established performance rather than a clinical study with a specific test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable based on the provided text. The document does not describe a "ground truth" establishment process by experts for a test set in the context of clinical performance.
4. Adjudication Method for the Test Set
Not applicable based on the provided text. No test set requiring expert adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is an infusion pump, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device operates independently, the concept of a "standalone algorithm" performance typically refers to AI/software analysis. This device is an electromechanical infusion pump, and its performance would be assessed through engineering and functional testing rather than a standalone algorithm study in the AI sense. The document does not detail such testing.
7. The Type of Ground Truth Used
No specific "ground truth" (e.g., pathology, outcomes data) is mentioned in relation to the device's performance. The "ground truth" in this context would likely be engineering specifications and established performance characteristics of the predicate device under various conditions, including hyperbaric.
8. The Sample Size for the Training Set
Not applicable. This device is an electromechanical infusion pump and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.
{0}------------------------------------------------
Kψ814R (P. 10AR)
510(k) SUMMARY 5
DEC 1 7 2008
- Phone:(224)212-5316 1. Submitted by: Hospira, Inc. Fax: (224) 212-5401 D-389 Bldg. H2 275 N. Field Drive Lake Forest, IL 60045 Contact: Daniela Weksler March 20, 2008 2. Date Prepared: 3. Name/Classification Infusion Pump, Class II 80 FRN - 21 CFR Parts 880.5725 of Device: Administration Sets, Class II 80 FPA - 21 CFR Parts 880.5440 Plum A+® Hyperbaric Infusion System with Hospira 4. Trade Name of Proposed Device: MedNet® Software 5. Predicate Devices: Plum A+ Infusion System with Hospira MedNet Software (K042081) Abbott LifeCare® Model 3 HB Pump (K890282)
6. Proposed Device Description:
The Plum A+ Hyperbaric Infusion System with Hospira MedNet® Software is an electromechanical infusion pump that uses a stepper motor in conjunction with an inline cassette to meter IV fluids through dedicated intravenous administration sets in normal atmospheric Hospital settings and in Hyperbaric conditions. The infusion pump and administration sets are manufactured and distributed by Hospira. Inc. The Plum A+® Hyperbaric Infusion System is a single channel pump.
The subject device is based on modifications of the predicate infusion pumps. The modifications allow for distal pressure increases due to monoplace hyperbaric chamber pressurization and include distinct coloring to identify the purmp as a hyperbaric device.
Additionally, the sets were changed so that they could be used under hyperbaric conditions. The flow regulator is colored green to identify them as hyperbaric administration sets.
In normal atmospheric conditions, both the predicate and the proposed device can be used for standard, piggyback, or concurrent fluid delivery using the dedicated administration sets currently marketed. No changes to these dedicated administration sets have been made or are required in order to be used with the
{1}------------------------------------------------
\u03c881412 (l. a of\u03bb)
subject devices. However, new sets have been designed for administration with monoplace hyperbaric chambers.
7. Statement of Intended Use:
The Plum A+® Hyperbaric 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.
Additionally, the Plum A+ Hyperbaric Infusion System with Hospira MedNet Software can be used under hyperbaric conditions in multiplace and with monoplace (Class A and B) chambers.
The indications for use of the subject devices and predicate devices are identical, with the addition of Hyperbaric Capabilities in the subject device
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, this infusion system 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 consists of a stylized graphic of an abstract human figure with three flowing lines extending from its side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hospira, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
DEC 1 7 2008
Re: K081412
Trade/Device Name: Plum A+ Hyperbaric Infusion System with Hospira MedNet® Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: November 25, 2008 Received: December 2, 2008
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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Chiu S. Liu, Ph.D.
Chiu S. Lin, Ph. D Division 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) | K481412 |
|---|---|
| Device Name: | Plum A+® Hyperbaric Infusion System with Hospira MedNet® Software |
Indications for Use:
The Plum A+ Hyperbaric 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.
Additionally, the Plum A+ Hyperbaric Infusion System with Hospira MedNet Software can be used under hyperbaric conditions in multiplace and monoplace (Class A and B) chambers.
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)
Centry me me
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
§ 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).