The Solo™ Insulin Patch Pump 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™ Insulin Patch Pump (Solo™) is a miniature, portable programmable insulin pump, which adheres to the patient's skin. The patch 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 patch is controlled via a remote control unit.

The Solo™ Insulin Patch Pump 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Solo™ Insulin Patch Pump:

Based on the provided text, the device is an Insulin Infusion Pump, and the document is a 510(k) Summary. In the context of 510(k) submissions, the “acceptance criteria” are typically met by demonstrating “substantial equivalence” to legally marketed predicate devices, rather than through a strict set of predefined performance thresholds for a novel device. The “study” that proves the device meets these criteria is the comparison to predicate devices and a series of performance evaluations.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from Substantial Equivalence to Predicate Devices)	Reported Device Performance
Intended Use: Continuous delivery of insulin, at set and variable rates, for management of diabetes mellitus.	"The Solo™ Insulin Patch Pump 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: External, portable insulin infusion pump; remote-controlled; RF communication; worn on user's skin; modular design (disconnection/reconnection); sterilization method and use lifetime of sterile parts.	"The Solo™ Insulin Patch Pump's technological characteristics are the same as those of its predicate devices.""Solo™ communication is by means of radio frequency.""Same as OmniPod, the Solo™ insulin dispensing patch is worn on the user's skin.""Same as Minimed's Paradigm, the Solo™ has a modular design which enables disconnection and reconnection of the insulin dispensing unit from the cannula at the user's discretion.""Sterilization method and use lifetime of the sterile parts is identical to the predicate devices."
Safety and Performance Features: Includes functions, mechanical and software safety features, alarms and alerts comparable to predicate devices.	"Solo™ includes the same functions, mechanical and software safety features, and alarms and alerts as the predicate devices.""Solo™ accuracy and In-house functional performance testing of Solo™ was conducted... based on risk analysis, literature search and requirements of applicable standards."
Biological Safety: Biocompatibility, microbial ingress, insulin compatibility.	"The following studies were conducted in certified contract laboratories: Biocompatibility, Insulin Compatibility, microbial ingress..."
Environmental & Electrical Safety: Electrical Safety, Environmental, EMC and RF Compatibility.	"...cleaning and disinfection verification, Shelf life, Electrical Safety, Environmental, EMC and RF Compatibility."
Software Validation: Software functions correctly and safely.	"Software validation was performed in Medingo by an external software QA contractor."
Overall Equivalence: No new safety or effectiveness issues.	"Medingo believes that... the Solo™ Insulin Patch Pump is substantially equivalent to its predicate devices without raising any new safety or effectiveness issues.""Solo™ and its components successfully passed all performance evaluations according to its performance criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state sample sizes for specific performance tests (e.g., number of pumps tested for accuracy, number of components for biocompatibility). The testing was conducted in Medingo (Israel) for in-house functional performance and by "certified contract laboratories" for other tests. The provenance of this data is prospective, as it involves testing the Solo™ device specifically for this 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 in the summary. For a 510(k) submission of this type (an insulin pump), the "ground truth" is typically defined by engineering specifications, recognized standards (e.g., for infusion pumps), and comparisons to the performance characteristics of predicate devices, rather than expert clinical judgment on a test set of data in the way one might see for an AI diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable and not mentioned. The document describes engineering and laboratory testing against specifications and standards, not a diagnostic interpretation scenario requiring adjudication by multiple experts.

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

This is not applicable and not mentioned. The Solo™ Insulin Patch Pump is a medical device for insulin delivery, not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

This is not applicable in the context of an insulin pump. The device is a physical system with embedded software, intended for use by a patient under a physician's prescription. Its performance is evaluated on its ability to deliver insulin according to programmed settings, not as a standalone diagnostic algorithm. The "functional performance testing" and "software validation" refer to the testing of the device itself.

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

The "ground truth" for the Solo™ Insulin Patch Pump's performance is established by:

Engineering Specifications and Design Requirements: The device must meet its own design requirements for accuracy, safety features, and functional operations.
Applicable Standards: Compliance with recognized industry standards for insulin infusion pumps.
Predicate Device Performance: Demonstrating that the Solo™ device performs similarly to or better than its predicate devices in relevant aspects (e.g., insulin delivery accuracy, safety mechanisms).
Laboratory Test Results: Measurable outcomes from mechanical, electrical, biocompatibility, and software tests.

8. The sample size for the training set

This is not applicable. The Solo™ Insulin Patch Pump is a hardware-based medical device with fixed functions and embedded software, not a machine learning model that requires a "training set" of data in the typical sense. Software validation ensures the software functions as intended, but it's not a learning algorithm.

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

This is not applicable, as there is no "training set" for an insulin pump in the context of AI/machine learning. The "ground truth" for software validation would be the functional and performance specifications that the software is designed to meet.

Summary

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510(K) Summary

Solo™ Insulin Patch Pump 510(k) Number K090245

Date Prepared: July 21, 2009.

Applicant's Name:

Medingo Ltd.

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

Contact Person:

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

Trade Name:

Solo™ Insulin Patch Pump

Classification Name:

Insulin infusion pump

Classification:

Requlation # (21 CFR 880.5725), FDA has classified insulin infusion pumps as class II devices (product code LZG) and they are reviewed by the General Hospital panel.

Predicate Devices:

iXL Diabetes Management System (Insulet Corp.), product code LZG, cleared for marketing under K031373, K042792
Solo™ Insulin Patch Pump - Page 5-2

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Paradiam Model 515 (Medtronic Minimed), product code LZG, cleared for marketing under K073356.

Intended Use:

The Solo™ Insulin Patch Pump 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:

Technological Characteristics:

The Solo™ Insulin Patch Pump's technological characteristics are the same as those of its predicate devices. Same as its predicates, Solo™ is an external, portable insulin infusion pump controlled by a hand-held controller. Same as Insulet's OmniPod, Solo™ communication is by means of radio frequency.

Same as OmniPod, the Solo™ insulin dispensing patch is worn on the user's skin. Same as Minimed's Paradigm, the Solo™ has a modular design which enables disconnection and reconnection of the insulin dispensing unit from the cannula at the user's discretion.

Sterilization method and use lifetime of the sterile parts is identical to the predicate devices.

Solo™ includes the same functions, mechanical and software safety features, and alarms and alerts as the predicate devices.

Solo™ Insulin Patch Pump - Page 5-3

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Performance Tests:

Solo™ accuracy and In-house functional performance testing of Solo™ was conducted in Medingo according to a verification and validation plan based on risk analysis, literature search and requirements of applicable standards.

The following studies were conducted in certified contract laboratories: Biocompatibility, Insulin Compatibility, microbial ingress, cleaning and disinfection verification, Shelf life, Electrical Safety, Environmental, EMC and RF Compatibility. Software validation was performed in Medingo by an external software QA contractor.

Solo™ and its components successfully passed all performance evaluations according to its performance criteria.

Conclusion:

Medingo believes that, based on the information provided in this submission, the Solo™ Insulin Patch Pump is substantially equivalent to its predicate devices without raising any new safety or effectiveness issues.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with stylized wings and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

CIUL 2 8 2009

Re: K090245

Trade/Device Name: Solo™ Insulin Patch Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: July 8, 2009 Received: July 15, 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,

Cenam E. Anster br
Saml. Preston, D.D.S., M.A.

Susan Runner, D.D.S., M.A. Acting 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 STATEMENT

510(k) Number (if known): K090245

Device Name:

Solo™ Insulin Patch Pump

Indications for Use:

The Solo™ Insulin Patch Pump 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.

510(k) Number: K090245

OR Prescription Use _ ﮨﮯ (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: K010245

Solo™ Insulin Patch Pump - Page 4-1

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).