The Aviator Insulin Pump is indicated for continuous delivery of insulin, at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin.

Device Description

The Aviator insulin pump is a microprocessor controlled, battery powered, insulin pump system. The pump continuously delivers insulin according to an individualized software plan. A proprietary, disposable syringe is used as the insulin reservoir. The other component of the system is a disposable infusion set. There are two modes of delivery: basal and bolus. Basal delivery is a continuous infusion providing insulin the body needs to maintain target blood glucose levels under fasting conditions. To conserve power, basal delivery occurs in discrete pulses that are spaced nominally three minutes apart.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical or performance study report. Instead, it describes a 510(k) submission for the Aviator Insulin Pump, focusing on substantial equivalence to a predicate device.

Here's an analysis based on the information provided, addressing the requested points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results. It states in general terms:

Acceptance Criteria Mentioned (Implicit): Requirements stated in the "specification documents."
Reported Device Performance:
- "Bench testing and software validation verified the requirements stated in the specification documents."
- "A Human Factors Study was conducted to validate the overall design of the Aviator insulin pump in the hands of the user."
- "Environmental testing includes testing for electromagnetic compatibility."
- "The performance data demonstrates substantial equivalence between the Aviator infusion pump and the Abbott Diabetes Care infusion pump."

Without specific numerical targets for flow rate accuracy, delivery precision, or safety features, an acceptance criteria table cannot be constructed from this document. The focus is on demonstrating equivalence through these tests, rather than meeting novel performance thresholds.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not specified for bench testing, software validation, or environmental testing.
Data Provenance: Implied to be prospective as these are tests conducted as part of the device development and submission process. The country of origin is not explicitly stated, but given "Abbott Diabetes Care Inc." and the submission to the FDA (USA), it's likely primarily US-based or international studies conducted for US regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the disclosed "performance data" refers to bench tests and software validation, not clinical studies requiring expert ground truth for interpretation of outputs like images or diagnoses.
A "Human Factors Study" was conducted, which would involve users, but the specifics of expert involvement or ground truth establishment are not detailed.

4. Adjudication method for the test set

This information is not provided. Adjudication methods are typically relevant for clinical studies involving multiple observers, particularly for subjective assessments. The nature of the performance data (bench testing, software validation) does not typically involve such adjudication.

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

No MRMC comparative effectiveness study is mentioned. This device is an insulin pump, not an AI diagnostic tool that assists human readers/interpreters.

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

This concept is not directly applicable to an insulin pump in the same way it would be for a diagnostic algorithm. The pump is a standalone device in its function of delivering insulin, but it requires human interaction (e.g., setting parameters, bolusing). The described "Human Factors Study" assesses the overall design "in the hands of the user," indicating a human-in-the-loop evaluation rather than a purely standalone algorithm assessment.

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

For the bench testing and software validation, the "ground truth" would be the engineering specifications and design requirements. The device performance is compared against these predetermined, objective standards.
For the Human Factors Study, the "ground truth" would likely relate to usability metrics, user satisfaction, and successful execution of tasks according to predefined criteria, but the specific details are not provided.

8. The sample size for the training set

This information is not applicable as the document describes an insulin pump, which is a hardware and software system, not a machine learning model that requires a "training set" in the conventional sense.

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

This information is not applicable for the same reason as point 8.

Summary based on available information:

The document describes the regulatory submission for an insulin pump, emphasizing substantial equivalence to a predicate device. The "performance data" section outlines various types of engineering and usability testing (bench testing, software validation, human factors, environmental testing), but it does not provide detailed quantitative acceptance criteria or specific study designs (like sample sizes or ground truth establishment methods for clinical evaluations) which would typically be found in reports for AI/diagnostic devices. The focus is on verifying compliance with specifications and demonstrating equivalence rather than presenting novel performance metrics against a clinical ground truth.

Summary

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Abbott Diabetes Care Inc.

Image /page/0/Picture/1 description: The image shows the text "K071788 p. lot of 2" in handwritten font. Below this text is the text "Aviator Insulin Pump" in a printed font. The image appears to be a label or document related to the Aviator Insulin Pump, possibly indicating a lot number or identification code.

JAN 1 1 2008Section 5: 510(k) Summary(as required by 21 CFR 807.92)
Submitted by:	Abbott Diabetes Care1360 South Loop RoadAlameda, CA 94502
Company Contact:	Sarah HarringtonSenior Regulatory Specialist(510) 239-2732sarah.harrington@abbott.com
Date Prepared:	June 29, 2007
Trade Name:	Aviator insulin pump
Common/Usual Name:	External Insulin Infusion Pump
Classification Name:	Class II: Insulin Infusion Pump (LZG)21 CFR 880.5725
Substantially EquivalentDevice:	Abbott Diabetes Care Insulin Pump, K05104-

Device Description

The other component of the system is a disposable infusion set. There are two modes of delivery: basal and bolus. Basal delivery is a continuous infusion providing insulin the body needs to maintain target blood glucose levels under fasting conditions. To conserve power, basal delivery occurs in discrete pulses that are spaced nominally three minutes apart.

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K071788 fr 2042

Aviator Insulin Pump

Intended Use

The Aviator insulin pump is indicated for continuous delivery of insulin, at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin.

Technological Characteristics

The Aviator insulin pump shares the same intended use and indications for use as the predicate device, the Abbott Diabetes Care infusion pump. Both the Aviator infusion pump and the predicate pump have two microprocessors to control and monitor drug delivery. The user interface on the Aviator was enhanced as a result of user needs.

Performance Data

Bench testing and software validation verified the requirements stated in the specification documents. A Human Factors Study was conducted to validate the overall design of the Aviator insulin pump in the hands of the user. Environmental testing includes testing for clectromagnetic compatibility.

The syringe and infusion set materials will undergo biocompatibility testing, if required, in accordance to ISO 10993-1. The syringe will be sterilized to the requirements stated in ISO 11135-1994.

Conclusion

The performance data demonstrates substantial equivalence between the Aviator infusion pump and the Abbott Diabetes Care infusion pump. When compared to the legally marketed Abbott Diabetes Care infusion pump, the Aviator insulin pump is safe and effective for its intended use.

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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 caduceus symbol, which features three abstract human figures connected by flowing lines. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2008

Ms. Sarah Harrington Senior Regulatory Specialist Abbott Diabetes Care, Incorporated 1360 South Loop Road Alameda, California 94502

Re: K071788

Trade/Device Name: Aviator Insulin Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: December 19, 2007 Received: December 20, 2007

Dear Ms. Harrington:

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. Harrington

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 (QS) 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 vours.

Clus

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 Namc:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Aviator Insulin Pump is indicated for continuous delivery of insulin, at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Cun

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

510(k) Number: الأدار الأكل ال

Response to FDA Deficiency Letter

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).