(142 days)
The Pearl™ Diabetes Management 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.
The Pearl™ Diabetes Management System is a continuous, programmable insulin delivery system. It consists of a controller, a single use pump body and an infusion set adapter. The controller unit has a user interface to program delivery parameters for basal and bolus insulin delivery. It attaches to the pump body. The pump body provides the drive mechanism and battery power and holds the pre-filled insulin cartridges. The infusion set adapter is the conduit from the insulin cartridge to the final delivery tubing.
The document provided does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets those criteria.
However, based on the available text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document mentions several tests performed, but it does not list specific quantitative acceptance criteria or detailed results. It generally states that the system "performs reliably and delivers insulin as intended" and "design verification testing confirmed that no new questions of safety or effectiveness were identified."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Insulin delivery accuracy | "The system performs reliably and delivers insulin as intended." |
| Altitude and altitude shock resistance | Verified and found acceptable (no specific metrics provided). |
| Free fall resistance | Verified and found acceptable (no specific metrics provided). |
| Liquid ingress protection | Verified and found acceptable (no specific metrics provided). |
| Positive and negative elevation performance | Verified and found acceptable (no specific metrics provided). |
| System occlusion detection/performance | Verified and found acceptable (no specific metrics provided). |
| Software validation | Verified and found acceptable (no specific metrics provided). |
| Overall safety and effectiveness | "No new questions of safety or effectiveness were identified." |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified. The document only states "the major tests that were performed on the Pearl Pump System to support the modifications." It does not provide the number of devices or data points used in these tests.
- Data Provenance: Not specified. It does not mention the country of origin or if the study was retrospective or prospective. Given it is a device modification, the testing would typically be internal "design verification testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the "Pearl™ Diabetes Management System" is an insulin infusion pump, a hardware device, not an AI/ML-based diagnostic or prognostic tool that would require expert-established ground truth for a test set in the same manner. The "ground truth" for this device would be its physical and software performance against engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable for this type of medical device as it's not a diagnostic system requiring human 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:
This is not applicable. The Pearl™ Diabetes Management System is an insulin pump, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable in the context of AI/ML algorithm performance. The device itself (the pump) operates in a standalone manner to deliver insulin based on programmed parameters, but this is not an "algorithm-only" performance study in the AI sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance would be derived from engineering specifications, established performance standards (e.g., for accuracy, occlusion detection), and regulatory requirements for insulin infusion pumps. The document explicitly mentions "assure conformance to the requirements for its intended use" and "design verification testing confirmed that no new questions of safety or effectiveness were identified."
8. The sample size for the training set:
This is not applicable. The Pearl™ Diabetes Management System is not an AI/ML device that uses a "training set" in the conventional machine learning sense. Its functionality is based on pre-programmed logic and mechanical engineering, not learned from data.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above for question #8.
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K 122483
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Asante Solutions Inc. Pearl™ Diabetes Management System
Special 510(k) August 10, 2012
510(k) Summary Section 1.2
Submitter Information
JAN 0 3 2013
| Company: | Asante Solutions |
|---|---|
| 352 East Java Drive | |
| Sunnyvale, CA 94089 | |
| (408) 716-5600 | |
| Robin Bush | |
| Regulatory Project Manager | |
| Summary Date: | August 10, 2012 |
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 existing established technology also known as Continuous Subcutaneous Insulin Infusion (CSII).
- Pearl Diabetes Management System (#K100567, Asante Solutions) a)
Reference Devices
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Intended Use
The Pearl Diabetes Management 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.
Description of Device
The Pearl Diabetes Management System is a continuous, programmable insulin delivery system. It consists of a controller, a single use pump body and an infusion set adapter. The controller unit has a user interface to program delivery parameters for basal and bolus insulin delivery. It attaches to the pump body. The pump body provides the drive mechanism and battery power and holds the pre-filled insulin cartridges. The infusion set adapter is the conduit from the insulin cartridge to the final delivery tubing.
Summary of Technological Characteristics
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 (#K100567) to apply controlled and accurate force to move the plunger in the insulin cartridge. The microprocessor based controller is unchanged.
Performance Testing
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.
The following are the major tests that were performed on the Pearl Pump System to support the modifications:
- . accuracy
- altitude and altitude shock .
- . free fail
- . liquid ingress
- positive and negative elevation .
- system occlusion .
- software validation .
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Conclusion
Performance testing on the modified device demonstrated that the Pearl Diabetes Management System performs reliably and delivers insulin as intended through the Asante Infusion Sets, and is safe for its intended use. 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 modified Pearl Diabetes Management System is substantially equivalent to the predicate Pearl System in design, features, performance, fundamental scientific technology, and indications for use.
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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 features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 3, 2013
Mr. Robin Bush Project Manager, Regulatory Affairs Asante Solutions, Incorporated 352 East Java Drive SUNNYVALE CA 94089
Re: K122483
Trade/Device Name: Pearl™ Diabetes Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: December 18, 2012 Received: December 18, 2012
Dear Mr. Bush:
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.
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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 devicerelated 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthong La m
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Asante Solutions Inc. Pearl" Diabetes Management System
Special 510(k) August 10, 2012
Indications for Use Section 1.1
510(k) Number:
. asante
4122483
Device Name:
Pearl™ Diabetes Management System
Indications for Use: The Pearl Diabetes Management System is indicated for the continuous subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.
Prescription Use ﮯ (Part 21 CFR 801 Subpart D) Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
and/or
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Anesthesiology, General Hospital |
| Infection Control, Dental Devices |
| 510(k) Number: | K122483 |
|---|---|
| ---------------- | --------- |
| Keith G. Marin | Digitally signed by Keith G. Marin DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Keith G. Marin, 0.9.2342.19200300.100.1.1=00112 50397 Date: 2013.01.03 16:07:51 -05:00 |
|---|---|
| ---------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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§ 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).