(435 days)
No
The description focuses on the mechanical and electrical aspects of insulin delivery and does not mention any AI/ML components or capabilities.
Yes
The device is described as a "continuous, subcutaneous delivery of insulin...for the management of diabetes mellitus," which directly treats a medical condition.
No
The device is an insulin delivery system which administers insulin; it does not diagnose medical conditions.
No
The device description explicitly states it consists of hardware components including a controller, pump body, adapter, and associated accessories, and describes mechanical and electrical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of insulin for the management of diabetes. This is a therapeutic action, not a diagnostic one.
- Device Description: The description focuses on the mechanical and electronic components for delivering insulin (pump body, controller, adapter, infusion set). It does not mention any components or processes for analyzing biological samples (like blood, urine, etc.) to diagnose or monitor a condition.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis.
The device is an insulin pump, which is a medical device used for drug delivery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
For the continuous, subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.
Product codes
LZG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
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 regulations 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®.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary
Submitter Information
| Company: | Asante Solutions
1012 Stewart Drive
Sunnyvale. CA 94085
(408) 716-5600 |
|-----------------|---------------------------------------------------------------------------------|
| Contact Person: | Naghmeh Nouri
Vice 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.
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
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.
1
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.
2
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.
3
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
વ્
·
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
4
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
5
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