Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical and basic software control systems, with no mention of AI/ML terms or capabilities.

Therapeutic

Yes.
The device is specifically designed for the "subcutaneous infusion of insulin," which is a medical treatment.

Diagnostic

No

The device is an insulin pump, which is used for the subcutaneous infusion of insulin (treatment), not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly details numerous hardware components including a stepper-motor, gear reduction assembly, lead-screw, linear piston, syringe, keypad, LCD display, battery, speaker, and vibrator motor. While it mentions software systems, it is clearly a physical device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided text, the Amigo® Insulin Pump is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is "subcutaneous infusion of insulin." This describes a device that delivers medication directly into the body, not a device used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
Device Description: The description details a mechanical pump that dispenses insulin. It focuses on the physical delivery of a substance, not on analyzing biological samples.
Lack of IVD Characteristics: The text does not mention any components or functions related to:
- Analyzing biological specimens.
- Detecting or measuring substances in biological samples.
- Providing diagnostic information based on in vitro testing.

Therefore, the Amigo® Insulin Pump is a medical device for drug delivery, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

80LZG

Device Description

The proposed Amigo® Insulin Pump is a small, lightweight, battery-operated programmable insulin infusion pump. The pump houses a replaceable single-use insulin syringe containing up to 300 units (3mL) 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.

Various hardware and software systems monitor the pump's operation and provide a method of control and monitor function to keep the pump within safe parameters. A hierarchy of alarms based on IEC 60601-1-8 criteria and priorities notifies the user to possible error conditions. Notifications are via visual, audible, and vibration means through the use of the LCD backlight, the audio speaker, and a vibrator motor, respectively. If the alarm priority warrants, the system is put into a safe state with infusion stopped.

Power is provided by a user-replaceable primary battery (CR2), allowing for a minimum of 22 days of typical usage. An internal, rechargeable backup battery is used for primary battery end-of-life alarms and for operating redundancy.

Provision is made for an infrared communications port, which is accessible only to Nipro for manufacturing use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Amigo® Insulin Pump was tested for electrical safety and infusion pump performance and safety according to:

IEC 60601-1 (1988): Medical electrical equipment Part 1: General . requirements for safety, including Amendment 1 (1991) and Amendment 2 (1995)
IEC 60601-2-24:1998 Medical Electrical Equipment Part 2-24: ● Particular Requirements For The Safety Of Infusion Pumps And Controllers

The Amigo® Insulin Pump was tested for electromagnetic compatibility according to:

IEC 60601-1- 2 Medical Electrical Equipment -- Part 1: General . Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests (Second Edition, 2001).
The Amigo® Insulin Pump also meets:
IEC 60601-1-4:2000 Medical Electrical Equipment Part 1-4: General . Requirements For Safety - Collateral Standard: Programmable Electrical Medical Systems.
ISO 14971:2000 Medical devices Application of risk management to . medical devices.

The Amigo Insulin Pump has passed the above testing regimens, including specific testing for flow rates, accuracy, occlusion detection, water ingress, and alarms.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Animas IR1250 Insulin Infusion Pump K042873, Nipro Amigo® Insulin Pump K050312, Smiths Medical Deltec Cozmo® Insulin Pump K062323

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

K071613 f. lot 12

3361 Enterprise Way Miramar, Florida 33025 Tel: (954) 435-5665 Fax: (954) 435-9295 www.niprodiabetes.com

Image /page/0/Picture/2 description: The image shows the logo for Nipro Diabetes Systems. The word "NIPRO" is in large, bold, black letters on the top line. Below that, the words "DIABETES SYSTEMS" are in smaller, bold, black letters.

DEC 1 4 2007

"510(k) Summary"

Amigo® Insulin Pump

Owner: Address:

Phone: FAX: Name of contact person: Date prepared:

Submission type: Proprietary name: Common name(s): Classification name: Device class: Panel: Product code: Regulation:

Establishment registration:

Predicate device(s)

Nipro Diabetes Systems, Inc 3361 Enterprise Way Miramar, FL 33025

(954)-435-5665 (954)-272-0438 Harry Russell November 5, 2007

Traditional 510(k) Amigo® Insulin Pump Insulin pump Pump, infusion, insulin 11 80 (General hospital and personal use devices) 80LZG 21 CFR § 880.5725

Nipro Diabetes Systems, Inc. #1066380

Animas IR1250 Insulin Infusion Pump K042873 Nipro Amigo® Insulin Pump K050312 Smiths Medical Deltec Cozmo® Insulin Pump K062323

1

DEVICE DESCRIPTION

The proposed Amigo® Insulin Pump is a small, lightweight, battery-operated programmable insulin infusion pump. The pump houses a replaceable single-use insulin syringe containing up to 300 units (3mL) 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.

Various hardware and software systems monitor the pump's operation and provide a method of control and monitor function to keep the pump within safe parameters. A hierarchy of alarms based on IEC 60601-1-8 criteria and priorities notifies the user to possible error conditions. Notifications are via visual, audible, and vibration means through the use of the LCD backlight, the audio speaker, and a vibrator motor, respectively. If the alarm priority warrants, the system is put into a safe state with infusion stopped.

Power is provided by a user-replaceable primary battery (CR2), allowing for a minimum of 22 days of typical usage. An internal, rechargeable backup battery is used for primary battery end-of-life alarms and for operating redundancy.

Provision is made for an infrared communications port, which is accessible only to Nipro for manufacturing use.

INTENDED USE

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

COMPARISON WITH THE PREDICATE DEVICE

The following table compares the Amigo® Insulin Pump with its predicate devices, the Animas IR1250 Insulin Infusion Pump, the Nipro Amigo® Insulin Pump, and the Smiths Medical Deltec Cozmo® Insulin Pump.

Areas of minor difference are shaded, with discussion on the difference(s) immediately to the right.

2

| Characteristic | | Animas IR1250
Insulin Infusion
Pump
(Predicate Device) | Amigo® Insulin
Pump
(Predicate Device) | Smiths Medical
Deltec Cozmo
Pump
(Predicate Device) | New Amigo®
Insulin Pump
(This Submission) | Discussion |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | 510(k) Number | K042873 | K050312 | K062323 | N/A | |
| General | Intended Use | Intended to provide
subcutaneous
delivery of insulin
at programmable
basal and bolus
rates for the daily
management of
diabetes mellitus in
insulin dependent
patients | Intended for the
subcutaneous
infusion of insulin. | Designed for
Continuous
Subcutaneous
Insulin Infusion
(CSII) for the control
of diabetes. | Intended for the
subcutaneous
infusion of insulin. | |
| | Pump Type | Linear Piston | Linear Piston | Pushrod | Linear Piston | |
| | Power
transmission | Plastic gears | Stainless steel gears | Not available | Stainless steel gears | |
| | Dimensions | 2.9 x 2.0 x 0.76
inches | Less than 3.54 x
2.36 x 1.18 inches | 3.2 x 1.8 x 0.95
inches | 3.28 x 2.18 x 0.93
inches | |
| | Weight | 3.13 ounces | Less than 3.2
ounces | Approx. 3.2 ounces | 3.1 ounces | |
| Characteristic | Animas IR1250
Insulin Infusion
Pump
(Predicate Device) | Amigo® Insulin
Pump
(Predicate Device) | Smiths Medical
Deltec Cozmo
Pump
(Predicate Device) | New Amigo®
Insulin Pump
(This Submission) | Discussion | |
| Control
Technology | Microprocessor | Microprocessor | Microprocessor | Microprocessor | The new Amigo pump has a backup battery for redundancy, and mitigation of end-of-primary-battery-life issues. | |
| Insulin
Reservoir) | 2 mL (200 Units) | 3 mL (300 Units) | (300 Units) | 3 mL (300 Units) | | |
| Insulin Type | Rapid-acting U-100
insulin or regular
(short-acting) U-
100 insulin | U100 | | Rapid-acting or
short-acting U-100
insulin | | |
| Power Source | One 1.5 Volt
lithium battery | One 3 Volt lithium
primary battery | One AAA alkaline
battery | One 3 Volt lithium
primary battery
(replaceable); one
lithium cell backup
battery (internal) | | |
| Programmable
Basal Delivery | Yes | Yes | Yes | Yes | | |
| Programmable
Bolus Delivery | Yes | Yes | Yes | Yes | | |
| User
Notification | Audible, visual,
and vibration | Audible, visual, and vibration | Audible and
vibration | Audible, visual, and vibration | | |
| Characteristic | Animas IR1250
Insulin Infusion
Pump
(Predicate
Device) | Amigo® Insulin
Pump
(Predicate Device) | Smiths Medical
Deltec Cozmo
Pump
(Predicate Device) | New Amigo®
Insulin Pump
(This Submission) | Discussion | |
| Visual Display | LCD | LCD | LCD | LCD | | |
| Insulin Syringe /
reservoir | Animas disposable
cartridge | GlucoPro syringe,
single-use reservoir
(K014114) | Deltec Cozmo 3 ml
Insulin Cartridge
(21-1750) | GlucoPro syringe,
single-use reservoir
(K014114) | | |
| Infusion Set
Connector | Standard luer lock | Standard luer lock | Standard luer lock | Standard luer lock | | |
| Flow Rate
Accuracy
Bolus | +/- 5% | +/- 5% | +/- 15% at 0.1 U
+/- 1.5% at 25 U | +/- 5% | | |
| Basal | +/- 5% (0.1 U/hr
or greater) | +/- 5% (0.1 U/hr or
greater) | +/-2% (nominal)
except at low
delivery rates | +/- 5% (0.5 U/hr or
greater) | The Animas maintains
+/- 5% accuracy at
slightly lower flow
rates; (The Deltec unit
nominal % does not
compare to the
absolute % of Animas
and Amigo). | |
| Basal
Basal rate
adjustment
range | 0.025 - 25U/hr in
.025 U/hr steps | 0.00 - 30.00U/hr in
.05U/hr steps
Normal, Temporary | 0.00 - 35.00 U/hr in
0.05 U/hr steps
Normal / Temporary | 0.00 - 30.00U/hr in
.05U/hr steps
Normal, Temporary | | |
| Basal Profiles
Basal Rates | 4
Up to 12 basal
rates | 1 to 4
48 available per
profile in 15 minute
increments | 4
48 available per
profile in 30 minute
increments | 1 to 4
48 available per
profile in 15 minute
increments | | |
| Characteristic | Animas IR1250
Insulin Infusion
Pump
(Predicate
Device) | Amigo® Insulin
Pump
(Predicate Device) | Smiths Medical
Deltec Cozmo
Pump
(Predicate Device) | New Amigo®
Insulin Pump
(This Submission) | Discussion | |
| Temporary,
Basal Mode | 30 min - 24 hr
Adjusted in 30
minute intervals; | 15 min - 24 hr
Adjusted in 15
minute intervals; | 30 min - 72 hr
Adjusted in 30
minute intervals; | 15 min - 24 hr
Adjusted in 15
minute intervals; | Ranges are
substantially
equivalent. | |
| Basal Insulin
Delivery
Frequency | -90% to 200% in
10% increments
3 minutes | As a Percent (%) of
active profile;
10 - 200% in 10%
increments
3 or 15 minutes | As a Percent (%) of
active profile;
0 - 250% in 5%
increments
3 minutes (0.1 U/h
or higher);
significantly longer
for rates less than
0.1 U/h) | As a Rate in U/h or
as a Percent (%) of
active profile;
10 - 200% in 10%
increments
3 or 15 minutes | The new Amigo Insulin
Pump also allows
programming as a rate
in U/hr | |
| Bolus
Adjustment
Range | 0.05U - 35 U in
0.05U steps | 0.05 to 30.00U in
0.05U steps
Normal, Extended
and Layered | 0.00 - 75.00 U in
0.05 to 5.00 U steps
(steps are settable)
Meal, Extended, and
Combination | 0.05 to 30.00U in
0.05U steps
Normal, Extended
and Layered | | |
| Direct Bolus
Increment | 0.1 - 2.0U in 0.1 U
steps
0.5 - 10.0U in 0.5
U steps
1.0 - 20.0U in 1.0
U steps
5.0 - 35.0U in 5.0
U steps | 0.1 to 5.0U in 0.1 U
steps | 0.05, 0.10, 0.50,
1.00, 2.00, or 5.00
U. | 0.1 to 5.0U in 0.1 U
steps | | |
| Bolus Estimator | Yes | Yes | Yes | Yes | | |
| Characteristic | Animas IR1250
Insulin Infusion
Pump
(Predicate
Device) | Amigo® Insulin
Pump
(Predicate Device) | Smiths Medical
Deltec Cozmo
Pump
(Predicate Device) | New Amigo®
Insulin Pump
(This Submission) | Discussion | |
| Delivery Rates -
Bolus | 0.2 U/sec to 2.2
U/sec | 0.07 U/sec to 0.2
U/sec | 0.01 U / sec to 2.5
U/sec | 0.2 U/sec | The Amigo pump has a
fixed bolus rate that
matches an allowed
rate within the ranges
of all of the predicate
devices. | |
| Delivery Rates -
Prime | 1.8 - 2.9 U/sec | Not available | 1.0 U / sec | 1.0 U/sec | | |
| Max. Volume
infused under
single fault
conditions | Max 2.0U | Not available | Less than 2 units | Max 1.5 U | | |
| Occlusion
Detection Time
to Alarm | | | | | | |
| Basal | 72 hrs - 120 hrs
(0.025 U/h basal)
Typical - Maximum | Not available | 37 hours - 74 hours
(0.05 U/h)
Minimum -
Maximum | 58 hours 20 min -
88 hours 40 minutes
(0.10 U/h basal)
Minimum -
Maximum | | |
| Basal | 90 min - 3 hours
(1.0 U/h basal)
Typical - Maximum | Not available | 60 min - 3.9 hours
(2.0 U/h basal)
Minimum -
Maximum | 85 min - 88 minutes
(1.00 U/h basal)
Minimum -
Maximum | | |
| Characteristic | Animas IR1250
Insulin Infusion
Pump
(Predicate Device) | Amigo® Insulin
Pump
(Predicate Device) | Smiths Medical
Deltec Cozmo
Pump
(Predicate Device) | New Amigo®
Insulin Pump
(This Submission) | Discussion | |
| Occlusion
Pressure
Threshold | 75 kPa – 241kPa | 15 psi, 25 psi, 35 psi
(104 kPa, 172.5
kPa, 241.5 kPa) | 18 psi +/- 5 psi (13
psi to 23 psi) | Low (15 psi
nominal), High (35
psi maximum)
(104 kPa, 241.5
kPa) | The Cozmo has one
setting, Animas and
Amigo have two.
Maximum (see below)
are all below 35 psi. | |
| Maximum
Occlusion
Pressure | 241kPa (35 psi) | 35 psi | 23 psi | 35 psi | | |
| Bolus Volume
after Occlusion
Release | 1.0 U with
occlusion
sensitivity set to
high

3.0 U with
occlusion
sensitivity set to
low
(1.0U/hr basal) | Not available | Approx. 4 U | 0.65 U with
occlusion pressure
set to low

3

KC71613 p. 4 of 12

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NON-CLINICAL PERFORMANCE DATA

The Amigo® Insulin Pump was tested for electrical safety and infusion pump performance and safety according to:

IEC 60601-1 (1988): Medical electrical equipment Part 1: General . requirements for safety, including Amendment 1 (1991) and Amendment 2 (1995)
IEC 60601-2-24:1998 Medical Electrical Equipment Part 2-24: ● Particular Requirements For The Safety Of Infusion Pumps And Controllers

The Amigo® Insulin Pump was tested for electromagnetic compatibility according to:

IEC 60601-1- 2 Medical Electrical Equipment -- Part 1: General . Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests (Second Edition, 2001).
The Amigo® Insulin Pump also meets:
IEC 60601-1-4:2000 Medical Electrical Equipment Part 1-4: General . Requirements For Safety - Collateral Standard: Programmable Electrical Medical Systems.
ISO 14971:2000 Medical devices Application of risk management to . medical devices.

The Amigo Insulin Pump has passed the above testing regimens, including specific testing for flow rates, accuracy, occlusion detection, water ingress, and alarms.

SUBSTANTIAL EQUIVALENCE

A review of the above chart shows that the Amigo® Insulin Pump compares similarly with the predicate devices in all features, with minor differences, as noted, not clinically significant.

. The devices have similar intended uses, use the same insulin type and infusion set, and share similar operating and technological principles.
All devices have similar physical properties and offer similar software . features of bolus and basal combinations and rates.
All devices have nearly identical environmental specifications. .

11

07/6/3 p. 12 of 12.

The above-referenced performance testing data supports the claims of
substantial equivalence, that the Amigo® Insulin pump is as safe, as effective, substantial equivalorios, than the predicate devices.

12

Image /page/12/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2007

Mr. Harry Russell Director of Quality and Regulatory Affairs Nipro Diabetes Systems, Incorporated 3361 Enterprise Way Miramar, Florida 33025

Re: K071613

Trade/Device Name: The Amigo® Insulin Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: November 8, 2007 Received: December 3, 2007

Dear Mr. Russell:

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 Eederal Register.

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

13

Page 2 - Mr. Russell

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 (OS) 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 Office of Compliance 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 Division of Small Manufacturers, 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,

Anthony D. Watson for

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

14

Indications for Use

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

K071613 Amigo® Insulin Pump

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

Prescription Use _ X ___

AND/OR

Over-The-Counter Use

(Part21 CFR 801 Subpart D)

(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)

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Anthony D. Watt

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

02-0002 10(k) Number: