The Asante Snap Insulin Pump System is indicated for continuous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.

Device Description

The Snap™ Insulin Pump System is a wearable, continuous, programmable insulin delivery system. It is a portable, battery-powered system capable of delivering insulin at fixed and variable rates. The Snap system consists of the following components and accessories:

1. a software-controlled, programmable, reusable Controller module;
1. a single-use, disposable Pump Body;
1. an Unomedical Asante Comfort™ or Asante Conset™ Infusion Set (K120872), or an equivalently FDA-cleared infusion set with Luer fitting using the Asante sterile, single-use disposable Infusion Set Adapter; and
1. accessories, including the AsanteSync™ download cradle with USB cable, and a fabric Case and plastic Clip that provide a means of attaching the Snap system to the user's belt or other clothing.
  The Controller module has a user interface to program delivery parameters for basal and bolus insulin delivery and the Pump Body provides the drive mechanism and battery power and holds the pre-filled insulin cartridges. The user obtains Eli Lilly Humalog fast-acting U100 insulin from their pharmacy and inserts the pre-filled glass cartridge into the Asante Pump Body. The Pump Body is connected to the Controller module and either (a) an Unomedical Asante Comfort or Asante Conset infusion set with proprietary connector, or (b) an Asante Infusion Set Adapter with Luer fitting that connects to commercially available Luered infusion sets to allow delivery of insulin for the management of diabetes.

AI/ML Overview

The Snap Insulin Pump System is a wearable, continuous, programmable insulin delivery system. It is indicated for continuous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the device itself (e.g., insulin delivery accuracy ranges, battery life). Instead, it describes a series of tests performed to ensure the device's safety, functionality, and equivalence to a predicate device. The general acceptance criterion for all tests was "All testing met the acceptance criteria."

Acceptance Criteria Category	Reported Device Performance
Risk Analysis	Identification of hazards and evaluation, estimation, and control of associated risks performed in accordance with ANSI/AAMI/ISO 14971. The changes made to the device were assessed to ensure all risks were sufficiently mitigated and no new risks were introduced.
Physical Characteristics	Performed (details not specified, but implicitly met acceptance criteria).
Software	Documentation prepared for a "major" Level of Concern device per FDA guidance. Software verified and validated according to IEC 62304:2006 and FDA's General Principles of Software Validation.
Electrical Safety	Successfully passed relevant sections of IEC 60601-1 (General requirements for safety), IEC 60601-1-2 (Electromagnetic Compatibility), and IEC 60601-2-24 (Particular requirements for infusion pumps and controllers).
Water Ingress	Tested for protection of equipment inside Controller and Pump Body enclosures against harmful effects due to water ingress in accordance with IEC 60529 (Degrees of protection provided by enclosures (IP Code)). The Pump Body's rating increased from IPX5 to IPX7.
Electromagnetic Interference (EMI)	Successfully passed relevant sections of IEC 61000-4-2 (Electrostatic discharge immunity test), IEC 61000-4-3 (Radiated, radio-frequency, electromagnetic field immunity test), and IEC 61000-4-8 (Power frequency magnetic field test).
Overall Performance & Safety	Demonstrated reliable performance, delivered insulin as intended, and was as safe and effective as the predicate. Design verification confirmed no new safety or effectiveness questions were identified.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample sizes used for the various tests (e.g., how many units were subjected to electrical safety testing, water ingress testing, etc.).
The data provenance is not explicitly mentioned in terms of country of origin or whether it was retrospective or prospective. However, given that these are pre-market verification and validation activities for a medical device, the studies are inherently prospective in nature, conducted specifically to demonstrate compliance with regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to the studies described. The "tests" here are engineering and technical verification and validation studies based on international standards (e.g., IEC standards, ISO 14971) and FDA guidance, not studies involving human interpretation or expert evaluation of data to establish a "ground truth" in the diagnostic sense. The "ground truth" is defined by the physical, electrical, and software specifications and the compliance requirements of the standards themselves.

4. Adjudication Method for the Test Set

Not applicable. As noted above, these are technical verification and validation studies against defined standards and specifications, not studies requiring expert adjudication of results.

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

Not applicable. The Snap Insulin Pump System is an insulin delivery device, not a diagnostic imaging system or an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not relevant to this device.

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

The device itself is an algorithm-driven system (software-controlled, programmable). The performance testing described (software validation, electrical safety, water ingress, EMI, risk analysis) inherently evaluates the "standalone" performance of the device's components and integrated system without human intervention during the testing phase of its technical capabilities. The device is designed for human-in-the-loop operation for insulin delivery, but the tests conducted are about its fundamental functional and safety characteristics.

7. The Type of Ground Truth Used

The "ground truth" for these tests is implicitly defined by:

Engineering Specifications: The design requirements and specifications of the device components and system.
International Standards: Compliance requirements of standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-24, IEC 60529, IEC 61000-4 series, and ISO 14971.
FDA Guidance: Requirements outlined in "Guidance of Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions Draft Guidance" and "FDA's General Principles of Software Validation; Final Guidance for Industry and FDA Staff."

The device must meet these predefined technical and regulatory benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/Machine Learning model that requires a "training set" in the conventional sense. The "training" in manufacturing is related to the calibration and quality control of the physical and software components during production.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of AI/ML for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular pattern around the edge. At the center of the seal is a stylized emblem consisting of three human profiles facing to the right, stacked on top of each other, representing the department's focus on health and human well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18,2014

Asante Solutions, Inc. Edward J. Sinclair Vice President, Regulatory and Quality Affairs 352 East Java Drive Sunnyvale, California 94089

Re: K142619

Trade/Device Name: Snap Insulin Pump System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG Dated: November 20, 2014 Received: November 21, 2014

Dear Mr. Sinclair:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno, DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K142619

Device Name Asante SnapTM Insulin Pump System

Indications for Use (Describe)

The Asante Snap Insulin Pump System is indicated for continuous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

510(k) Summary

Submitter Information

Company:	Asante Solutions352 East Java DriveSunnyvale, CA 94089(408) 716-5600Edward J. SinclairVice President, Regulatory and Quality Affairs
Date Prepared:	December 18, 2014

Device Name and Classification

Common Name:	Insulin Infusion Pump
Proprietary Name:	Snap™ Insulin Pump System
Classification Name:	Pump, Infusion, Insulin
Product Code:	LZG
Regulation Number:	880.5725
Class:	II

Predicate Device

Asante Pearl Diabetes Management System (K122483)

Intended Use

The Snap Insulin Pump System is intended for continuous, subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.

{4}------------------------------------------------

Device Description

1. a software-controlled, programmable, reusable Controller module;
1. a single-use, disposable Pump Body;
1. an Unomedical Asante Comfort™ or Asante Conset™ Infusion Set (K120872), or an equivalently FDA-cleared infusion set with Luer fitting using the Asante sterile, single-use disposable Infusion Set Adapter; and
1. accessories, including the AsanteSync™ download cradle with USB cable, and a fabric Case and plastic Clip that provide a means of attaching the Snap system to the user's belt or other clothing.

The Controller module has a user interface to program delivery parameters for basal and bolus insulin delivery and the Pump Body provides the drive mechanism and battery power and holds the pre-filled insulin cartridges. The user obtains Eli Lilly Humalog fast-acting U100 insulin from their pharmacy and inserts the pre-filled glass cartridge into the Asante Pump Body. The Pump Body is connected to the Controller module and either (a) an Unomedical Asante Comfort or Asante Conset infusion set with proprietary connector, or (b) an Asante Infusion Set Adapter with Luer fitting that connects to commercially available Luered infusion sets to allow delivery of insulin for the management of diabetes.

Summary of Technological Characteristics

The Snap Insulin Pump System has the same technological characteristics as the predicate device. The system uses existing established and unchanged technology and materials, relative to the previously cleared device. The system employs the same drive mechanism as that of the cleared Pearl System (#K122483) to apply controlled and accurate force to move the plunger in the insulin cartridge.

Summary of Changes

The following changes have been made:

Product trade name change from Pearl Diabetes Management System to Snap Insulin Pump System
. Component substitutions in the Controller module to address discontinued parts from the respective manufacturer

{5}------------------------------------------------

. Component additions to the Controller module for added electrical protection during assembly
Increase in the water ingress rating of the Pump Body from IPX5 to IPX7
Addition of a fabric case, plastic clip and download accessories ●
Minor user interface improvements
. Other minor software changes to accommodate componement substitutions. software anomaly resolution and improvements

Performance Testing

Asante completed the appropriate verification and validation activities required by the Guidance of Industry and FDA Staff - Total Product Life Cycle: Infusion Pump -Premarket Notification [510(k)] Submissions Draft Guidance and other guidance, as applicable. The system has been verified for performance and functionality to provide assurance that the device modifications have been designed and tested to assure conformance to the requirements for its intended use, based on an evaluation of risks for the type of change involved. All the changes made to the device were assessed to make sure all the risks were sufficiently mitigated and that no new risks were introduced as a result of these modifications.

The following performance and safety testing has confirmed that the proposed device is substantially equivalent to the predicate device:

Risk Analysis; Identification of the hazards associated with the modified device . in order to evaluate, estimate and control the associated risks was performed in accordance with ANSI/AAMI/ISO 14971 Application of risk analysis to medical devices.
. Physical characteristics.
. Software; documentation was prepared and submitted for a "major" Level of Concern device in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Device software was verified and validated according to IEC 62304:2006 - Medical device software -Software life cycle processes and FDA's General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
Electrical Safety; the modified Snap Insulin Pump System has been tested and . successfully passed all of the relevant sections of the following standards:
- o IEC 60601-1 Medical electrical equipment -- Part 1: General requirements for safety.
- o IEC 60601-1-2 General Requirements for basic safety and essential performance - Collateral standard: Electromagnetic Compatibility -Requirements and Tests.

{6}------------------------------------------------

o IEC 60601-2-24 Medical electrical equipment Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers.
Water Ingress: the modified Snap Insulin Pump System was tested for the ● protection of the equipment inside the Controller and Pump Body enclosures against harmful effects due to the ingress of water, in accordance with IEC 60529 Degrees of protection provided by enclosures (IP Code).
Electromagnetic Interference; the modified device has been tested and . successfully passed all of the relevant sections of the following standards:
- IEC 61000-4-2. Electromagnetic Compatibility (EMC) Part 4-2: Testing o and measurement techniques – Electrostatic discharge immunity test.
- o IEC 61000-4-3, Electromagnetic Compatibility (EMC) Part 4-3: Testing and measurement techniques - - Radiated, radio-frequency, electromagnetic field immunity test.
- IEC 61000-4-8, Electromagnetic Compatibility (EMC) Part 4-8: Testing o and measurement techniques - Power frequency magnetic field test.

All testing met the acceptance criteria.

Conclusion From Data

Performance testing on the modified device demonstrated that the Snap Insulin Pump System performs reliably and delivers insulin as intended through the infusion sets, and is as safe and as effective as the predicate. Design verification testing confirmed that no new questions of safety or effectiveness were identified during device testing of the modified device.

Based upon the successful safety and performance tests and the similarities to predicate device, the subject Snap Insulin Pump System is substantially equivalent to the predicate Pearl Diabetes Management System in design, features, performance, fundamental scientific technology, and indications for use.

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).