The Solo™ MicroPump Insulin Delivery System is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The Solo™ Insulin Patch Pump is for prescription use only.

Device Description

The Solo™ MicroPump Insulin Delivery System (Solo™) is a miniature, portable programmable insulin pump, which adheres to the patient's skin. The MicroPump is comprised of two connected parts: a disposable reservoir, in which the insulin is stored and a reusable pump, which includes the pumping mechanism and electronic components. The MicroPump is controlled via a remote control unit.
The Solo™ is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician, and includes the features available in the predicate devices.

AI/ML Overview

The document provided is a 510(k) summary for the Solo™ MicroPump Insulin Delivery System. It describes the device, its intended use, and its substantial equivalence to predicate devices. It also mentions performance testing in the context of usability studies. However, the document does not contain detailed acceptance criteria, specific reported device performance metrics against those criteria, or the methodology of a study that directly proves the device meets such criteria in terms of clinical efficacy or diagnostic accuracy.

The provided text focuses on demonstrating substantial equivalence, primarily by addressing a change in the age contraindication.

Therefore, much of the requested information cannot be extracted from this specific document.

Here's a breakdown of what can be inferred or directly stated, and what is missing:

Acceptance Criteria and Reported Device Performance

This document does not define specific acceptance criteria (e.g., accuracy of insulin delivery, specific safety thresholds) nor does it present a table of reported device performance against such criteria. The "Performance Testing" section refers to usability studies rather than objective performance metrics.

Study Information

The document describes two simulated clinical use studies to support the 510(k) submission, specifically for non-adult users and sharps injury prevention features.

Sample size used for the test set and the data provenance: Not specified in terms of numbers. The studies were "simulated clinical use studies" for "non-adults and their caregivers." The provenance is Medingo Ltd., Israel. These studies appear to be prospective usability studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were usability studies, not diagnostic accuracy studies using ground truth established by experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned.
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. This is not an AI/diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for insulin delivery.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for usability studies. The "ground truth" for usability would be successful completion of tasks and user feedback, not clinical outcomes or expert consensus on diagnosis.
The sample size for the training set: Not applicable. This describes usability studies, not machine learning model training.
How the ground truth for the training set was established: Not applicable.

Summary of Available Information

Category	Information from Document
Acceptance Criteria & Reported Performance	Not provided. The document does not list specific technical or clinical acceptance criteria (e.g., insulin delivery accuracy, occlusion detection time) and corresponding device performance data. It briefly mentions that "Study results clearly demonstrated that Solo™ is safe for use by non-adults and their caregivers," addressing a usability and safety aspect related to the expanded indications.
Study Type & Purpose	Two simulated clinical use studies were conducted for usability: 1. Operation by Non-Adults (Summative Usability Study). 2. Simulated Clinical Use of the Sharps Injury Prevention Features. These were conducted to support the deletion of the age contraindication (under 18).
Sample Size (Test Set)	Not specified numerically. The studies involved "non-adult users" and "caregivers."
Data Provenance	Medingo Ltd., Yoqneam, Israel. The studies were described as "simulated clinical use studies" and appear to be prospective, focusing on usability and safety.
Number & Qualifications of Experts for Ground Truth	Not applicable. These were usability studies, not studies requiring expert-established ground truth for diagnostic accuracy.
Adjudication Method	Not applicable. Not mentioned for usability studies.
MRMC Comparative Effectiveness Study	Not applicable. This is an insulin pump, not an AI/diagnostic imaging device where human readers are involved in diagnosis.
Standalone Performance (Algorithm only)	Not applicable. This is a medical device; its performance is always in the context of its function (insulin delivery) and user interaction.
Type of Ground Truth Used	Not applicable. For usability studies, the "ground truth" would relate to successful task completion, user errors, and user satisfaction, not clinical outcomes or expert diagnoses. The studies aimed to demonstrate safety for use by non-adults and their caregivers.
Sample Size (Training Set)	Not applicable. The document describes usability studies, not the training of a machine learning model.
How Ground Truth for Training Set was Established	Not applicable.

Conclusion based on the provided text: The document provides excellent detail regarding the regulatory submission (510(k)), device description, and predicate devices. However, it does not include the detailed performance study information with acceptance criteria that would typically be associated with clinical efficacy or technical performance specifications for the device's primary function (insulin delivery). The "performance testing" described is specifically related to usability and safety for an expanded user population (non-adults), rather than comprehensive performance metrics.

Summary

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510(K) Summary

JAN 2 5 2010

Solo™ MicroPump Insulin Delivery System

510(k) Number Kog 3364

Applicant's Name:

Medingo Ltd. Yoqneam Industrial Park Building 7 - 3rd Floor P.O. Box 261 Yoqneam, Israel, 20692 Phone: (+972) 73-713-1313 (+972) 73-713-1314 Fax:

Contact Person:

Name: Arava HaCohen VP Quality and Regulatory Affairs Title: (+972) 73-713-1303 Tel: (+972) 73-713-1314 Fax: Email: arava@medingo.com

Trade Name:

Solo™ MicroPump Insulin Delivery System

Classification Name:

Insulin infusion pump

Classification:

FDA has classified insulin infusion pumps as class II devices (product code LZG) and they are reviewed by the General Hospital panel.

Solo™ MicroPump Insulin Delivery System - Page 5-2

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Predicate Devices:

Medingo Solo™ Insulin Patch Pump, insulin infusion pump, product code A LZG, cleared for marketing under K090245 ("Solo™")
iXL Diabetes Management System (Insulet Corp.), product code LZG, cleared for marketing under K031373, K042792

Intended Use:

The Solo™ MicroPump Insulin Delivery System is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Device Description:

The Solo™ is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician, and includes the features available in the predicate devices.

Technological Characteristics:

The Solo™ MicroPump Insulin Delivery System is identical to the predicate Solo™ approved under K090245 except for some minor modifications, none of which individually, or in aggregate, require the submission of a new 510(k).

Solo™ MicroPump Insulin Delivery System - Page 5-3

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Performance Testing:

Two simulated clinical use studies were conducted to support the current 510(k) submission :

1. Operation of the Solo™ MicroPump Insulin Delivery System by Non-Adults- A Summative Usability Study.
1. Simulated Clinical Use of the Solo™ MicroPump Sharps Injury Prevention Features.

These studies, with the non-adult user population, were designed and executed according to FDA guidance and international standards (HE74-2001 and IEC 60601-1-6), as presented in Section 20 of the 510(k) packet. Study results clearly demonstrated that Solo™ is safe for use by non-adults and their caregivers.

Conclusion:

The Solo™ MicroPump Insulin Delivery System presented in this 510(k) submission is the same as the predicate cleared Solo™, except for the deletion of the contraindication for use by persons under the age of 18.

By deleting the age contraindication, the Solo™ MicroPump Insulin Delivery System is substantially equivalent to the predicate iXL Diabetes Management System. Based on the information provided in this submission, Medingo believes that Solo™ is substantially equivalent to its predicate devices without raising any new safety or effectiveness issues.

Solo™ MicroPump Insulin Delivery System - Page 5-4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

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

Ms. Arava Hacohen Vice President Quality and Regulatory Affairs Medingo Limited Yoqneam Industrial Park Building 7 -- 3rd Floor P.O. Box 261 Yoqneam 20692 ISRAEL

JAN 9 5 2010

Re: K093364

Trade/Device Name: Solo™ MicroPump Insulin Delivery System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: October 21, 2009 Received: October 28, 2009

Dear Ms. Hacohen:

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 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. Hacohen

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Rh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K042264

Device Name:

Solo™ MicroPump Insulin Delivery System

Indications for Use:

The Solo™ MicroPump Insulin Delivery System is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

The Solo™ Insulin Patch Pump is for prescription use only.

Prescription Use _ X (Per 21 CFR 801.109)

Over the Counter Use

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

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K093364

Solo™ MicroPump Insulin Delivery System - Page 4-2

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).