PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

K081412 · Hospira, Inc. · FRN · Dec 17, 2008 · General Hospital

Device Facts

• Record ID: K081412
• Device Name: PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
• Applicant: Hospira, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Dec 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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 with monoplace (Class A and B) chambers.

Device Story

Electromechanical infusion pump; uses stepper motor and inline cassette to meter IV fluids. Subject device modified from predicate for hyperbaric environment; includes distal pressure compensation for monoplace chamber pressurization; features green-colored flow regulators for identification. Used in hospital settings and hyperbaric chambers; operated by clinicians. Provides controlled fluid delivery; output monitored by clinicians to manage therapy. Benefits include safe, accurate infusion delivery during hyperbaric treatment.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, materials, and technological characteristics compared to predicate devices.

Technological Characteristics

Electromechanical infusion pump; stepper motor; inline cassette; dedicated administration sets. Features distal pressure compensation for hyperbaric environments. Green-colored flow regulators for hyperbaric identification. Software-controlled (Hospira MedNet).

Indications for Use

Indicated for patients requiring parenteral, enteral, or epidural therapies, or administration of whole blood/blood products. Suitable for use in normal atmospheric hospital settings and hyperbaric conditions (multiplace and monoplace Class A and B chambers).

Regulatory Classification

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.

Predicate Devices

• Plum A+ Infusion System with Hospira MedNet Software (K042081)
• Abbott LifeCare® Model 3 HB Pump (K890282)

Submission Summary (Full Text)

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Kψ814R (P. 10AR)

#### 510(k) SUMMARY 5

DEC 1 7 2008

- Phone:[phone]. Submitted by: Hospira, Inc. Fax: [phone] 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

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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.

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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.

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#### 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 [phone]. 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 [phone] or [phone] 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

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# 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

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510(k) Number: _______________________________________________________________________________________________________________________________________________________________