AMIGO INSULIN PUMP

K050312 · Nipro Diabetes Systems, Inc. · LZG · May 9, 2005 · General Hospital

Device Facts

• Record ID: K050312
• Device Name: AMIGO INSULIN PUMP
• Applicant: Nipro Diabetes Systems, Inc.
• Product Code: LZG · General Hospital
• Decision Date: May 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Amigo Insulin Pump is intended for the subcutaneous infusion of insulin.

Device Story

Amigo Insulin Pump is a small, battery-operated, programmable infusion pump for subcutaneous insulin delivery. Device uses a microcomputer to control a stepper-motor and gear reduction assembly, which drives a linear piston to depress a Nipro GlucoPro single-use syringe (up to 300 units of U-100 insulin). User programs delivery via keypad and LCD display. Pump provides basal and bolus delivery; includes audible, visual, and vibration notifications. Device is intended for patient use to manage insulin administration, potentially improving glycemic control. Output is delivered through a standard luer lock connector to an infusion set.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparisons to the predicate device.

Technological Characteristics

Linear piston infusion pump; microprocessor-controlled stepper motor; 3 mL (300 unit) reservoir capacity; powered by one 3V lithium battery; LCD interface; standard luer lock infusion set connector; audible, visual, and vibration alarm system.

Indications for Use

Indicated for subcutaneous insulin infusion in patients requiring insulin therapy.

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

• GlucoPro EVA Pump (K013309)

Submission Summary (Full Text)

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K 0503/2

## MAY - 9 2005 510(k) Summary

- 1.0 Date Prepared
January 14, 2005

- 2.0 Submitter (Contact)
Clarence Odem, III General Manager Nipro Diabetes Systems, Inc. Miramar, FL 32205 [phone]

- 3.0 Device Name
Proprietary / Trade Name: Amigo Insulin Pump Insulin pump Common Name(s):

- 4.0 Device Classification
Classification Name: P Pump, Infusion, Insulin Procode: 80LZG Class II

21 CFR § 880.5725

- 5.0 Device Description
The Amigo Insulin Pump is a small, lightweight, battery-operated programmable Insulin infusion pump. The pump houses a replaceable Nipro GlucoPro™ single-use insulin syringe containing up to 300 units of U-100 insulin. Programming is accomplished via a keypad and LCD display. A microcomputer controls the rotation of a stepper-motor which is connected to a gear reduction assembly. The output of the reduction assembly turns a lead-screw which moves a linear piston. The piston mechanically engages the plunger of the insulin syringe, and the programmed amount of insulin is dispensed through an external seal and luer lock connector to an infusion set.

- 6.0 Indications for Use
The Amigo Insulin Pump is intended for the subcutaneous infusion of insulin.

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#### 7.0 Substantial Equivalence

The Amigo Insulin Pump is substantially equivalent in the intended use, operating principle, overall design, performance, technology, features, functions, and materials to the GlucoPro EVA Pump as described in K013309.

| Characteristic | Amigo Insulin Pump<br>(This Submission) | GlucoPro EVA<br>(K013309) |
|-----------------------------|------------------------------------------------------|------------------------------------------------------|
| Intended Use | Intended for the subcutaneous<br>infusion of insulin | Intended for the subcutaneous<br>infusion of insulin |
| Pump Type | Linear Piston | Linear Piston |
| Control Technology | Microprocessor | Microprocessor |
| Insulin Reservoir | 3 mL (300 Units) | 3 mL (300 Units) |
| Insulin Type | U-100 | U-100 |
| Power Source | One 3 Volt lithium battery | One 3 Volt lithium battery |
| Programmable Basal Delivery | Yes | Yes |
| Programmable Bolus Delivery | Yes | Yes |
| User Notification | Audible, visual, and vibration | Audible, visual, and vibration |
| Visual Display | LCD | LCD |
| Insulin Syringe / reservoir | Nipro GlucoPro | Nipro GlucoPro |
| Infusion Set Connector | Standard luer lock | Standard luer lock |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2005

Mr. Clarence Odom, III General Manager NIPRO Diabetes Systems, Incorporated 3361 Enterprise Way Miramar, Florida 33025

Re: K050312

Trade/Device Name: Amigo Insuliñ Pump Regulation Number: 880.5275 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: January 31, 2005 Received: February 8, 2005

Dear Mr. Odom:

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 morender editions or to devices that have been reclassified in accordance with the provisions of / Including of to corrend Cosmetic Act (Act) that do not require approval of a premarket the reachar F over, 2008, 1998, 1herefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include controls provisions 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 wr 1), its 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. Odom

Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe advisod that 1 Dr. 5 leadines on that your device complies with other requirements mean that I DA mas made a autes and regulations administered by other Federal agencies. of the Act of ally rederal states and right.
You must comply with all the Act s requirements, including, but not limited to: registration 1 ou must comply with and are labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 007), labeling systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality sion 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 mis letter will and if you to be objects.
premarket notification. The FDA finding of substantial equivalence of your device to a premiarket nothreation. THE PDF 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), If you desire specific at not to for Joinese 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 outmit one. Echerwracturers, 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,

Gylette H. Michie Oms.

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

510(k) Number (if known): Amigo Insulin Pump Device Name: Indications for Use:

The Amigo Infusion Pump is intended for the subcutaneous infusion of insulin

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

.

AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

i.K. Jone

. ... Sistan Sign-Off) · Liston or Anesthesiology, General Hospital, Theation Control, Dental Devices

10(k) Number_KAS 9312

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