(184 days)
The Amigo® Insulin Pump is intended for the subcutaneous infusion of insulin.
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.
The Nipro Amigo® Insulin Pump's acceptance criteria and performance are detailed in the provided 510(k) summary. The submission argues for substantial equivalence to predicate devices based on non-clinical performance data.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it compares the proposed Amigo® Insulin Pump's performance characteristics directly against three predicate devices. The implicit acceptance criterion is that the new device performs "similarly" or "favorably" compared to the predicate devices, with noted minor differences not being clinically significant.
The table below summarizes key relevant performance characteristics from the comparison table (Table 2 in the original document) that relate to device functionality and safety. The values for the "New Amigo® Insulin Pump (This Submission)" column indicate the reported device performance.
| Characteristic | New Amigo® Insulin Pump (This Submission) | Predicate Device (Animas IR1250) (for comparison) | Predicate Device (Amigo® Insulin Pump K050312) | Predicate Device (Smiths Medical Deltec Cozmo®) | Discussion/Implicit Acceptance |
|---|---|---|---|---|---|
| Flow Rate Accuracy Bolus | +/- 5% | +/- 5% | +/- 5% | +/- 15% at 0.1 U, +/- 1.5% at 25 U | Similar to Animas & Amigo, favorable vs. Cozmo (at low U) |
| Flow Rate Accuracy Basal | +/- 5% (0.5 U/hr or greater) | +/- 5% (0.1 U/hr or greater) | +/- 5% (0.1 U/hr or greater) | +/-2% (nominal) except at low delivery rates | Considered similar, with Animas being slightly better at lower flow rates, and Deltec's nominal % not directly comparable. |
| Basal Rate Adjustment Range | 0.00 - 30.00 U/hr in .05 U/hr steps | 0.025 - 25U/hr in .025 U/hr steps | 0.00 - 30.00U/hr in .05U/hr steps | 0.00 - 35.00 U/hr in 0.05 U/hr steps | Similar range to predicate devices. |
| Bolus Adjustment Range | 0.05 to 30.00U in 0.05U steps | 0.05U - 35 U in 0.05U steps | 0.05 to 30.00U in 0.05U steps | 0.00 - 75.00 U in 0.05 to 5.00 U steps | Similar range to predicate devices. |
| Delivery Rates - Bolus | 0.2 U/sec | 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 | Fixed rate matches an allowed rate within predicate device ranges. |
| Max. Volume infused under single fault conditions | Max 1.5 U | Max 2.0U | Not available | Less than 2 units | Compares favorably with predicate devices. |
| Occlusion Pressure Threshold | Low (15 psi nominal), High (35 psi maximum) (104 kPa, 241.5 kPa) | 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) | Similar to Animas and previous Amigo (two settings), maximum below 35 psi. |
| Bolus Volume after Occlusion Release | 0.65 U (low pressure), 0.79 U (high pressure) (1.0U/hr basal) | 1.0 U (high sens), 3.0 U (low sens) (1.0U/hr basal) | Not available | Approx. 4 U | Compares favorably with predicate devices (lower volume released). |
| Battery capacity | Minimum of 22 days based on typical use | 6-8 week life | Not available | Up to 30 days | Shorter battery life, but not clinically significant due to user-replaceable battery and multiple warnings. |
| Environmental (IPX8) | Yes | Yes | Yes | Yes | Meets IPX8 standard, similar to predicates. |
The study supporting these claims is described under "NON-CLINICAL PERFORMANCE DATA" and involved testing against various IEC and ISO standards.
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance data based on engineering tests, not human subject testing. Therefore, there is no "test set" in the context of patient data or clinical trials, nor is there data provenance (e.g., country of origin, retrospective/prospective). The tests were conducted on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical, engineering-based performance assessment against established standards, not a ground truth established by experts for a test set.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical, engineering-based performance assessment, not requiring adjudication of human expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical specifications and non-clinical performance testing of the device itself, not on human-in-the-loop performance or reader improvement.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was done. The "NON-CLINICAL PERFORMANCE DATA" section describes the testing of the Amigo® Insulin Pump for its electrical safety and infusion pump performance and safety according to various international standards (IEC and ISO). This testing evaluates the device's inherent functional characteristics without human intervention beyond setting up the tests.
7. The type of ground truth used
The "ground truth" for this submission are the performance specifications and safety requirements defined by international standards (IEC 60601-1, IEC 60601-2-24, IEC 60601-1-2, IEC 60601-1-4, ISO 14971) and the performance characteristics of legally marketed predicate devices. The new device's performance was measured against these established benchmarks.
8. The sample size for the training set
Not applicable. This is a medical device submission based on product engineering and testing, not an AI/algorithm submission that would involve a "training set" of data for machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set."
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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
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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.
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| Characteristic | Animas IR1250Insulin InfusionPump(Predicate Device) | Amigo® InsulinPump(Predicate Device) | Smiths MedicalDeltec CozmoPump(Predicate Device) | New Amigo®Insulin Pump(This Submission) | Discussion | |
|---|---|---|---|---|---|---|
| 510(k) Number | K042873 | K050312 | K062323 | N/A | ||
| General | Intended Use | Intended to providesubcutaneousdelivery of insulinat programmablebasal and bolusrates for the dailymanagement ofdiabetes mellitus ininsulin dependentpatients | Intended for thesubcutaneousinfusion of insulin. | Designed forContinuousSubcutaneousInsulin Infusion(CSII) for the controlof diabetes. | Intended for thesubcutaneousinfusion of insulin. | |
| Pump Type | Linear Piston | Linear Piston | Pushrod | Linear Piston | ||
| Powertransmission | Plastic gears | Stainless steel gears | Not available | Stainless steel gears | ||
| Dimensions | 2.9 x 2.0 x 0.76inches | Less than 3.54 x2.36 x 1.18 inches | 3.2 x 1.8 x 0.95inches | 3.28 x 2.18 x 0.93inches | ||
| Weight | 3.13 ounces | Less than 3.2ounces | Approx. 3.2 ounces | 3.1 ounces | ||
| Characteristic | Animas IR1250Insulin InfusionPump(Predicate Device) | Amigo® InsulinPump(Predicate Device) | Smiths MedicalDeltec CozmoPump(Predicate Device) | New Amigo®Insulin Pump(This Submission) | Discussion | |
| ControlTechnology | Microprocessor | Microprocessor | Microprocessor | Microprocessor | The new Amigo pump has a backup battery for redundancy, and mitigation of end-of-primary-battery-life issues. | |
| InsulinReservoir) | 2 mL (200 Units) | 3 mL (300 Units) | (300 Units) | 3 mL (300 Units) | ||
| Insulin Type | Rapid-acting U-100insulin or regular(short-acting) U-100 insulin | U100 | Rapid-acting orshort-acting U-100insulin | |||
| Power Source | One 1.5 Voltlithium battery | One 3 Volt lithiumprimary battery | One AAA alkalinebattery | One 3 Volt lithiumprimary battery(replaceable); onelithium cell backupbattery (internal) | ||
| ProgrammableBasal Delivery | Yes | Yes | Yes | Yes | ||
| ProgrammableBolus Delivery | Yes | Yes | Yes | Yes | ||
| UserNotification | Audible, visual,and vibration | Audible, visual, and vibration | Audible andvibration | Audible, visual, and vibration | ||
| Characteristic | Animas IR1250Insulin InfusionPump(PredicateDevice) | Amigo® InsulinPump(Predicate Device) | Smiths MedicalDeltec CozmoPump(Predicate Device) | New Amigo®Insulin Pump(This Submission) | Discussion | |
| Visual Display | LCD | LCD | LCD | LCD | ||
| Insulin Syringe /reservoir | Animas disposablecartridge | GlucoPro syringe,single-use reservoir(K014114) | Deltec Cozmo 3 mlInsulin Cartridge(21-1750) | GlucoPro syringe,single-use reservoir(K014114) | ||
| Infusion SetConnector | Standard luer lock | Standard luer lock | Standard luer lock | Standard luer lock | ||
| Flow RateAccuracyBolus | +/- 5% | +/- 5% | +/- 15% at 0.1 U+/- 1.5% at 25 U | +/- 5% | ||
| Basal | +/- 5% (0.1 U/hror greater) | +/- 5% (0.1 U/hr orgreater) | +/-2% (nominal)except at lowdelivery rates | +/- 5% (0.5 U/hr orgreater) | The Animas maintains+/- 5% accuracy atslightly lower flowrates; (The Deltec unitnominal % does notcompare to theabsolute % of Animasand Amigo). | |
| BasalBasal rateadjustmentrange | 0.025 - 25U/hr in.025 U/hr steps | 0.00 - 30.00U/hr in.05U/hr stepsNormal, Temporary | 0.00 - 35.00 U/hr in0.05 U/hr stepsNormal / Temporary | 0.00 - 30.00U/hr in.05U/hr stepsNormal, Temporary | ||
| Basal ProfilesBasal Rates | 4Up to 12 basalrates | 1 to 448 available perprofile in 15 minuteincrements | 448 available perprofile in 30 minuteincrements | 1 to 448 available perprofile in 15 minuteincrements | ||
| Characteristic | Animas IR1250Insulin InfusionPump(PredicateDevice) | Amigo® InsulinPump(Predicate Device) | Smiths MedicalDeltec CozmoPump(Predicate Device) | New Amigo®Insulin Pump(This Submission) | Discussion | |
| Temporary,Basal Mode | 30 min - 24 hrAdjusted in 30minute intervals; | 15 min - 24 hrAdjusted in 15minute intervals; | 30 min - 72 hrAdjusted in 30minute intervals; | 15 min - 24 hrAdjusted in 15minute intervals; | Ranges aresubstantiallyequivalent. | |
| Basal InsulinDeliveryFrequency | -90% to 200% in10% increments3 minutes | As a Percent (%) ofactive profile;10 - 200% in 10%increments3 or 15 minutes | As a Percent (%) ofactive profile;0 - 250% in 5%increments3 minutes (0.1 U/hor higher);significantly longerfor rates less than0.1 U/h) | As a Rate in U/h oras a Percent (%) ofactive profile;10 - 200% in 10%increments3 or 15 minutes | The new Amigo InsulinPump also allowsprogramming as a ratein U/hr | |
| BolusAdjustmentRange | 0.05U - 35 U in0.05U steps | 0.05 to 30.00U in0.05U stepsNormal, Extendedand Layered | 0.00 - 75.00 U in0.05 to 5.00 U steps(steps are settable)Meal, Extended, andCombination | 0.05 to 30.00U in0.05U stepsNormal, Extendedand Layered | ||
| Direct BolusIncrement | 0.1 - 2.0U in 0.1 Usteps0.5 - 10.0U in 0.5U steps1.0 - 20.0U in 1.0U steps5.0 - 35.0U in 5.0U steps | 0.1 to 5.0U in 0.1 Usteps | 0.05, 0.10, 0.50,1.00, 2.00, or 5.00U. | 0.1 to 5.0U in 0.1 Usteps | ||
| Bolus Estimator | Yes | Yes | Yes | Yes | ||
| Characteristic | Animas IR1250Insulin InfusionPump(PredicateDevice) | Amigo® InsulinPump(Predicate Device) | Smiths MedicalDeltec CozmoPump(Predicate Device) | New Amigo®Insulin Pump(This Submission) | Discussion | |
| Delivery Rates -Bolus | 0.2 U/sec to 2.2U/sec | 0.07 U/sec to 0.2U/sec | 0.01 U / sec to 2.5U/sec | 0.2 U/sec | The Amigo pump has afixed bolus rate thatmatches an allowedrate within the rangesof all of the predicatedevices. | |
| Delivery Rates -Prime | 1.8 - 2.9 U/sec | Not available | 1.0 U / sec | 1.0 U/sec | ||
| Max. Volumeinfused undersingle faultconditions | Max 2.0U | Not available | Less than 2 units | Max 1.5 U | ||
| OcclusionDetection Timeto 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 IR1250Insulin InfusionPump(Predicate Device) | Amigo® InsulinPump(Predicate Device) | Smiths MedicalDeltec CozmoPump(Predicate Device) | New Amigo®Insulin Pump(This Submission) | Discussion | |
| OcclusionPressureThreshold | 75 kPa – 241kPa | 15 psi, 25 psi, 35 psi(104 kPa, 172.5kPa, 241.5 kPa) | 18 psi +/- 5 psi (13psi to 23 psi) | Low (15 psinominal), High (35psi maximum)(104 kPa, 241.5kPa) | The Cozmo has onesetting, Animas andAmigo have two.Maximum (see below)are all below 35 psi. | |
| MaximumOcclusionPressure | 241kPa (35 psi) | 35 psi | 23 psi | 35 psi | ||
| Bolus Volumeafter OcclusionRelease | 1.0 U withocclusionsensitivity set tohigh3.0 U withocclusionsensitivity set tolow(1.0U/hr basal) | Not available | Approx. 4 U | 0.65 U withocclusion pressureset to low0.79 U withocclusion pressureset to high(1.0U/hr basal) | The Amigo InsulinPump comparesfavorably with thepredicate devices. | |
| MiscellaneousInfraredCommunicationPort | Yes | Yes (formanufacturing useonly) | Yes | Yes (formanufacturing useonly) | ||
| Characteristic | Animas IR1250Insulin InfusionPump(Predicate Device) | Amigo® InsulinPump(Predicate Device) | Smiths MedicalDeltec CozmoPump(Predicate Device) | New Amigo®Insulin Pump(This Submission) | Discussion | |
| Battery capacity | 6-8 week life | Not available | Up to 30 days | Minimum of 22 daysbased on typical use | The Amigo pump has ashorter battery life.This is not clinicallysignificant, as the userhas the ability tochange batteries andthe pump givesmultiple warnings. | |
| Infusion Set | 23" Comfort | 23" UnomedicalComfort infusion setK972135 | Unomedical Comfortinfusion set | 23" UnomedicalComfort infusion setK972135 | ||
| Low InsulinAlarm Setting | 10-50 U in 10 UnitSteps | 10-50 U in 10 UnitSteps | 5-50 U in 1 UnitSteps | 10-50 U in 10 UnitSteps | ||
| EnvironmentalIPX8 | Yes | Yes | Yes | Yes | ||
| Shipping /Storage RangeTemperature | -20 to +60 C / -4to +140 F | -20 to +60 C / -4 to+140 F | -20 to +60 C / -4 to+140 F | 0 to +60 C / 32 to+140 F | The new Amigo pumphas a higher minimumstorage temperature. | |
| Humidity | 10 to 100% RH,includingcondensing | 10 to 100% RH,includingcondensing | Maximum 90% RH,non-condensing | 10 to 100% RH,includingcondensing | ||
| Pressure /Altitude | 50-106 kPa /18281 to -1253feet | 50-106 kPa /18281 to -1253 feet | 70-106 kPa / to10,000 feet abovesea level | 50-106 kPa /18281 to -1253 feet | ||
| Characteristic | Animas IR1250Insulin InfusionPump(Predicate Device) | Amigo® InsulinPump(Predicate Device) | Smiths MedicalDeltec CozmoPump(Predicate Device) | New Amigo®Insulin Pump(This Submission) | Discussion | |
| OperatingRangeTemperature | +5 to +40 C / +40to +104 F | +5 to +40 C / +40 to+104 F | 2 to +40 C / 35.6 to+104 F | +10 to +40 C / +50to +104 F | ||
| Humidity | 20 to 90% RH,includingcondensing | 20 to 90% RH,includingcondensing | Maximum 90% RH,non-condensing | 20 to 90% RH,includingcondensing | ||
| Pressure /Altitude | 70 – 106 kPa /9878 feet above to1253 feet belowsea level | 70 – 106 kPa /9878 feet above to1253 feet below sealevel | 70 – 106 kPa / to10,000 feet abovesea level | 70 – 106 kPa /9878 feet above to1253 feet below sealevel | The new Amigo pumphas a slightly higherminimum operatingtemperature. This isnot a clinical issue, asthe pump is typicallyworn against the body,under clothing, in coldweather. |
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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. .
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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.
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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
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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
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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:
§ 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).