NIPRO SUREFUSER AMBULATORY INFUSION PUMP

K051828 · Nipro Medical Corporation · MEB · Dec 15, 2005 · General Hospital

Device Facts

• Record ID: K051828
• Device Name: NIPRO SUREFUSER AMBULATORY INFUSION PUMP
• Applicant: Nipro Medical Corporation
• Product Code: MEB · General Hospital
• Decision Date: Dec 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nipro Surefuser Ambulatory Balloon Infuser is intended for continuous and accurate infusion of medications at a predetermined flow rate. Routes of administration include intra-arterial, intravenous, percutaneous, subcutaneous, and epidural. An elastomeric reservoir is used eliminating the need for electrical power. The device is designed for single use in hospital, outpatient, and home care settings.

Device Story

Nipro Surefuser Ambulatory Balloon Infuser is an elastomeric (balloon) infusion pump; provides continuous, accurate medication delivery at predetermined flow rates. Device utilizes elastomeric reservoir to generate pressure; eliminates need for electrical power. Available in 50, 100, and 250 ml models. Designed for single-use in hospital, outpatient, and home care settings. Operated by clinicians or patients/caregivers. Output is medication infusion; assists in therapeutic management of patients requiring continuous drug administration.

Clinical Evidence

Bench testing only; no clinical data provided. Performance, functional, and biocompatibility testing demonstrated safety and suitability for intended use.

Technological Characteristics

Elastomeric balloon infusion pump; 50, 100, and 250 ml reservoir capacities. Operates via mechanical pressure from elastomeric reservoir; no electrical power required. Single-use device.

Indications for Use

Indicated for continuous, accurate medication infusion via intra-arterial, intravenous, percutaneous, subcutaneous, or epidural routes in hospital, outpatient, or home care settings.

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

• Infusor LV (K011317)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Nipro. The logo consists of a stylized, abstract symbol on the left, resembling two interlocked or overlapping shapes, possibly representing the letter 'N'. To the right of the symbol is the word "NIPRO" in bold, sans-serif font. The entire logo is in black against a white background.

3150 N.W. 107 Avenue Miami, Florida 33172 Tel .: [phone] Fax: [phone]

DEC 1 5 2005

Kasi828

## SUMMARY OF SAFETY AND EFFECTIVENESS NIPRO SUREFUSER AMBULATORY BALLOON INFUSER

807.92 (a)(1)

Contact Person:

Date of Summary Preparation:

Luis Candelario President December 5, 2005

807.92 (a)(2) Trade Name: Common Name: Classification Name:

Nipro Surefuser Ambulatory Balloon Infuser Balloon Infusion pump Pump, Infusion, Elastomeric (880.5725)

### 807.92 (a)(3)

Legally Marketed Substantially Equivalent Device: Infusor LV (K011317), Baxter Healthcare Corporation

## 807.92 (a)(4)

Description of Device:

The subject device can be classified as a balloon (elastomeric) infusion pump as described in 21 CFR 880.5725. The following models are included: 50, 100, and 250 ml.

## 807.92 (a)(5)

Intended Use: The Nipro Surefuser Ambulatory Balloon Infuser is intended for continuous and accurate infusion of medications at a predetermined flow rate. Routes of intra-arterial. intravenous. percutaneous, administration include subcutaneous, and epidural. An elastomeric reservoir is used eliminating the need for electrical power. The device is designed for single use in hospital, outpatient, and home care settings.

#### 807.92 (a)(6)

Comparison of Technical Characteristics:

The Nipro subject devices are similar to the predicate devices in materials, design and technological characteristics. Performance (functional), biocompatibility, and appearance tests demonstrated that the subject devices perform as intended and are safe and suitable for human use. They are substantially equivalent to similar legally marketed devices.

510(k) Amendment Nipro® Surefuser Ambulatory Balloon Infuser Nipro Medical Corporation December 5, 2005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three heads, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 15 2005

Nipro Medical Corporation C/O Ms. Kaelyn Hadley Consultant 1384 Copperfiled Court Lexington, Kentucky 40514

Re: K051828

Trade/Device Name: Nipro Surefuser Ambulatory Balloon Infuser Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: December 5, 2005 Received: December 7, 2005

Dear Ms. Hadley:

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 - Ms. Hadley

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 DAT has made a aves and regulations administered by other Federal agencies. or the receively 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 and ifsing (21 ce received in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet renie 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) I mo feter notification. The FDA finding of substantial equivalence of your device to a premainter heated 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), rf you donto the Office of Compliance at [phone]. 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 oveans 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 yours,

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

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# Indications for Use

K051828 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Nipro Surefuser Ambulatory Balloon Infuser Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use: The Nipro Surefuser Ambulatory Balloon Infuser is intended for continuous and accurate infusion of medications at a predetermined flow rate. Routes of administration include intra-arterial, intravenous, percutaneous, subcutaneous, and epidural. An elastomeric reservoir is used eliminating the need for electrical power. The device is designed for single use in hospital, outpatient, and home care settings.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton Vimmer

ു. പ്രാപ്രവ on of Anesthesvilogy, General Nospital, Juan Control, Dental Devices

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510(k) Amendment Nipro® Surefuser Ambulatory Balloon Infuser Nipro Medical Corporation December 5, 2005