For the continuous, subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.

Device Description

The Pearl Diabetes Management System is a continuous, programmable insulin delivery system. It consists of a controller, a single use pump body, a single use adapter and associated accessories. The controller unit has a user interface to program delivery parameters for basal and bolus insulin delivery and attaches to the pump body. The pump body provides the drive mechanism and battery power for pre-filled insulin cartridges. The adapter connects the insulin cartridge to the infusion set and contains the occlusion sensor.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Pearl Diabetes Management System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied by successful testing)	Reported Device Performance
Performance Testing	Designed and tested to assure conformance to requirements for intended use.	Accuracy: Verified. Free Fall Drop: Verified. Altitude, altitude shock, and positive and negative elevation: Verified. Environmental Testing: Verified. Occlusion Sensing: Verified. Power Management: Verified. Shipping and Packaging Testing: Verified. Single Fault Condition Testing: Verified. Mechanical & Electrical Safety: Performed in accordance with EN 60601-1 and IEC 60601-2-24. Electromagnetic Compatibility: Performed in accordance with EN 60601-1-2.
User Evaluation/Human Factors	Product understanding, programming modalities, and pump operation verified; performs as designed and intended; safe and effective for intended use.	Usability testing demonstrated the Pearl Diabetes Management System performs as designed and intended, and is safe and effective for its intended use.
Biocompatibility	Flow path materials are non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic, and non-genotoxic. Insulin compatible.	Cytotoxicity MEM Elution Test: Non-cytotoxic. Sensitization (LLNA & Guinea Pig Maximization): Non-sensitizing. Irritation Intracutaneous Reactivity: Non-irritating. Systemic Toxicity (USP/ISO): Not systemically toxic. Genotoxicity (Ames Test & Mouse Lymphoma Assay): Non-genotoxic. Implantation (Rabbit, 7-day): Not specified whether the outcome of this particular test confirmed non-toxicity, but the overall conclusion states non-toxic. Bacterial Endotoxin (LAL) USP Test: Not specified outcome, but overall conclusion states non-toxic. Insulin Compatibility: Confirmed compatible with Humalog®.

Explanation of "Implied Acceptance Criteria": The document states that the system "has been verified for performance and functionality to provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." For each test listed under "Performance Testing" and "Biocompatibility Testing," the successful completion of the test implies that the device met the pre-defined criteria for that specific test, without explicitly listing numerical thresholds for each.

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

The provided text does not specify the sample size used for the test set (e.g., how many devices were tested for accuracy, how many users participated in usability testing, or how many samples were used for biocompatibility tests).

The data provenance is internal to Asante Solutions, Inc. and is generated during the device's development and testing phases as part of its regulatory submission. It is not based on patient data from a specific country or retrospective/prospective studies in the clinical sense. Instead, it's performance and safety testing data.

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

This information is not applicable or not provided in the context of this 510(k) summary. The "ground truth" here is established by engineering specifications, regulatory standards (like EN 60601-1, IEC 60601-2-24, EN 60601-1-2, ISO 10993-1), and laboratory testing protocols, rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in AI performance evaluations where human expert review is involved. The testing described focuses on mechanical, electrical, software, and biological characteristics against pre-defined engineering and regulatory standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as described in the provided text. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Pearl Diabetes Management System is an insulin pump, not a diagnostic AI system, and its evaluation focuses on safety, performance, and usability as a standalone device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The studies described are for a standalone device (the insulin pump itself) acting without a human-in-the-loop for its direct operation during insulin delivery. The "algorithm only" concept usually applies to AI software. While the pump contains software and algorithms for insulin delivery control, occlusion detection, and safety monitoring, the performance testing explicitly evaluates the device's inherent functional capabilities (e.g., accuracy of insulin delivery, occlusion sensing effectiveness) as a standalone system. User evaluation testing, however, does involve humans interacting with the device to program and operate it.

7. Type of Ground Truth Used

The ground truth for the various tests includes:

Engineering specifications and design requirements: For accuracy, power management, physical robustness (drop, altitude), shipping, and single-fault conditions.
International standards: Such as EN 60601-1, IEC 60601-2-24, EN 60601-1-2 for mechanical, electrical safety, and electromagnetic compatibility.
Biocompatibility standards: ISO 10993-1 for biological evaluation, and specific FDA GLP regulations 21 CFR Part 58 for the individual biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, endotoxin).
Usability metrics: Established during human factors validation studies based on user understanding, programming capability, and satisfactory operation.

8. Sample Size for the Training Set

The provided text does not include information on a "training set" in the context of machine learning or AI. The product testing described is for a medical device (insulin pump) that relies on classical engineering principles, software logic, and control algorithms, not on models trained on a dataset of examples. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here.

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

As there is no training set for an AI/ML model mentioned, this question is not applicable. The "ground truth" for the device's design and verification is, as noted above, based on engineering specifications, regulatory standards, and established laboratory testing protocols.

Summary

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510(k) Summary

Submitter Information

Company:	Asante Solutions1012 Stewart DriveSunnyvale. CA 94085(408) 716-5600
Contact Person:	Naghmeh NouriVice President of Quality Assurance and Regulatory Affairs
Summary Date:	May 09, 2011

Name and Classification

Common Name:	Insulin Infusion Pump
Proprietary Name:	Pearl Diabetes Management System
Classification Name:	Pump, Infusion, Insulin
Product Code:	LZG
Regulation Number:	880.5725
Class:	II

Predicate Devices

The Pearl Diabetes Management System has the same intended use as a number of commercially available medical devices, operates within an established range of insulin delivery, and uses technology that is substantially equivalent to the identified predicates.

Disetronic D-TRON and D-TRONplus (K994186, K043000). a)
b) Animas IR1200 (K032257).

Intended Use

The intended use of the Pearl Diabetes Management System is for continuous. subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.

Description of Device

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510(k) #K100567 Pearl Diabetes Management System

Summary of Technological Characteristics

The system uses existing established technology, materials, and construction techniques. The system employs a ratchet drive mechanism to apply controlled and accurate force to the " plunger movement of the insulin cartridge. The dual microprocessor based controller allows safety monitoring for basal and bolus insulin delivery. Occlusion is detected by monitoring an optical based pressure sensor located in the adapter.

Performance Testing

The system has been verified for performance and functionality to provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use

The following tests were performed on the Pearl Pump System:

. accuracy
. free fall drop
. altitude, altitude shock, and positive and negative elevation
environmental testing .
. occlusion sensing
. power management
shipping and packaging testing .
single fault condition testing .
Mechanical and electrical safety testing was performed in accordance to EN 60601-1 . and the specific requirements of IEC 60601-2-24
Electromagnetic compatibility testing was performed in accordance to EN 60601-1-2. .

User EvaluationTesting

User assessment evaluations and human factors validation studies were conducted under simulated use conditions to verify product understanding, programming modalities and pump operation. The users were provided a user manual and were trained by professional diabetic educators. Usability testing demonstrated the Pearl Diabetes Management System performs as designed and intended, and is safe and effective for its intended use.

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Asante Solutions. Inc.

510(k) #K100567 Pearl Diabetes Management System

Biocompatibility Testing

The biocompatibility of the flow path of the Pearl Pump device was assessed in accordance with ISO 10993-1:2009 - Biological evaluation of medical devices, Part 1 - Evaluation and tests within a risk management process.

The biocompatibility tests listed below were conducted in accordance with the provisions of the FDA GLP requlations 21 CFR Part 58.

Cytotoxicity MEM Elution Test using L-929 Mouse Fibroblast cells (ISO) .
Sensitization Local Lymph Node Assay (LLNA) .
Sensitization ISO Guinea Pig Maximization Sensitization Test .
Irritation Intracutaneous Reactivity (Irritation) Test .
Systemic Toxicity USP/ISO Systemic Injection Test .
Systemic Toxicity USP/ISO Systemic Injection .
Genotoxicity Salmonella Typhimurium Reverse Mutation Assay (Ames Test) .
Genotoxicity In Vitro Mouse Lymphoma Assay .
. Implantation -- ISO Intramuscular Implant Test 7-Day Duration in Rabbits
Bacterial Endotoxin (LAL) USP Test .

The biocompatibility test results confirmed that the flow path materials are non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic, and non-genotoxic when evaluated under the respective test conditions.

The flow path material has also been tested for insulin compatibility and was confirmed to be compatible with Humalog®.

Conclusion

Based upon the successful safety and performance tests and the similarities to predicate devices, the Pearl Diabetes Management System is substantially equivalent to the predicate devices in design, features, performance, materials, packaging, fundamental scientific technology, and intended use.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Naghmeh Nouri Vice President, Quality and Regulatory Affairs M2 Group Holdings, Incorporated 1012 Stewart Drive Sunnyvale, California 94085

MAY 1 0 201

Re: K100567

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Trade/Device Name: Pearl Diabetes Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II * Product Code: LZG Dated: April 11, 2011 Received: April 12, 2011

Dear Ms. Nouri:

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

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Page 2 - Ms. Nouri

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 (2) CFR Part 820)
the Act): 21 CFR 1000 1050 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 please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiogical 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/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 Small Manufacturers, International and Consumer Assistance 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,

Wh for

Anthony 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

Enclosure

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Asante Solutions, Inc.

510(k) #K100567 Pearl Diabetes Management System

Indications for Use

510(k) Number: K100567 Device Name: Pearl™ Diabetes Management System

For the continuous, subcutaneous delivery of insulin at Indication for Use: programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.

Prescription Use
(Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhd C. Chapman 5/20/11

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

510(k) Number: K100567

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).