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.

AI/ML Overview

This document is a 510(k) summary for the Amigo Insulin Pump. It describes the device and its intended use, and argues for its substantial equivalence to a previously cleared device, the GlucoPro EVA Pump (K013309).

Based on the provided information, the following answers can be given:

1. A table of acceptance criteria and the reported device performance

The document does not provide acceptance criteria or detailed device performance metrics in the way one would typically find for an AI/software device undergoing validation studies with specific performance targets (e.g., sensitivity, specificity, accuracy).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (GlucoPro EVA Pump K013309) by comparing key characteristics. The "performance" in this context refers to the functional equivalence of the Amigo Insulin Pump to the predicate device.

Characteristic	Acceptance Criteria (Predicate's Performance)	Reported Device Performance (Amigo Insulin Pump)
Intended Use	Subcutaneous infusion of insulin	Subcutaneous 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

Study Proving Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria is the 510(k) submission itself, which argues for substantial equivalence. It does so by directly comparing the Amigo Insulin Pump's specifications and features to those of the legally marketed predicate device, the GlucoPro EVA Pump (K013309). The FDA's letter (K050312) confirms that based on this comparison, the device is deemed substantially equivalent. This is not a clinical study in the traditional sense, but rather a regulatory comparison.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/not provided in the given document. The submission is for a physical medical device (an insulin pump), not an AI/software device that would typically rely on a "test set" of data for performance evaluation in the context of AI. The "test" here is the comparison of device specifications to a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. As above, this is a physical device submission, not an AI/software validation involving expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. This type of study is relevant for AI-assisted diagnostic or decision-making tools, not for an insulin pump.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. The device is an insulin pump; it does not perform an "algorithm only" function in the way an AI diagnostic tool would. It is inherently a "human-in-the-loop" device in that a patient or caregiver programs and uses it.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/not provided. In the context of "substantial equivalence" for a physical device, the "ground truth" is established by the predicate device's cleared specifications and performance, which the new device aims to match. There isn't an external "ground truth" in the AI sense.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical insulin pump, not an AI model that undergoes training on a dataset.

9. How the ground truth for the training set was established

This information is not applicable/not provided.

Summary

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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 (954) 435-5665
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(This Submission)	GlucoPro EVA(K013309)
Intended Use	Intended for the subcutaneousinfusion of insulin	Intended for the subcutaneousinfusion 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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)

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

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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).