(10 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard pump functionality and interoperability with external automated insulin dosing software, not AI/ML within the pump itself.
Yes
The device is intended for the management of diabetes mellitus by delivering insulin, which is a therapeutic intervention.
No
This device is an insulin pump designed for therapeutic delivery of insulin, not for diagnosing a medical condition. While it can receive data from a CGM, its primary function is treatment.
No
The device description clearly states that the system includes a physical insulin pump ("Tandem Mobi insulin pump with interoperable technology") which is a hardware component responsible for delivering insulin. While the system also includes a mobile app for control, the core medical device function is performed by the hardware pump.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the subcutaneous delivery of insulin for the management of diabetes. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is described as an infusion pump that delivers insulin. While it can communicate with devices that might provide diagnostic data (like a CGM), its primary function is to administer a substance to the body.
- Lack of Diagnostic Function: There is no mention of the device performing any tests on samples taken from the body (like blood, urine, etc.) to diagnose a condition or provide information about a physiological state.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This insulin pump does not fit that description.
N/A
Intended Use / Indications for Use
The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
The pump is intended for single patient, home use and requires a prescription.
The pump is indicated for use in individuals six years of age and greater.
Product codes
QFG
Device Description
The Subject Device, Tandem Mobi insulin pump with interoperable technology ("Mobi pump", "the pump"), is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. The Tandem Mobi insulin pump with interoperable technology ("pump") is screenless and includes visual LED, sound, and vibratory indicators to alert the user of the pump status. The Tandem Mobi insulin pump with interoperable technology system also includes: the t:connect mobile app and a 2mL (200 insulin unit) Tandem Mobi cartridge and a compatible FDA cleared infusion set. The t:connect mobile app (* Mobile app") displays all information from, and is the primary controller of, the pump. Through the Mobile app, users will program all aspects of basal and bolus insulin delivery therapy including managing personal profiles, viewing pump and CGM data, and actively acknowledging all pump and mobile app alerts, alarms, reminders, notifications and messages. The t:connect mobile app will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The t:connect mobile app will be made available via the Apple® App Store for iOS compatible smartphones based on completed device verification and validation. The Tandem Mobi cartridge is a disposable insulin cartridge only with the Tandem Mobi pump.
The Tandem Mobi ACE pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.
The pump may be used in combination with a compatible continuous glucose monitor (CGM) system, such as the Dexcom G6 Continuous Glucose Monitoring System (DEN170088). Use of CGM is optional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
six years of age and greater
Intended User / Care Setting
single patient, home use and requires a prescription.
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)
Appropriate testing was performed to confirm the Subject Device met specified requirements and performed as intended. Summaries include:
Usability/Human Factors: No new Usability or Human Factors testing was performed to support this 510(k) Notification.
Software Verification and Validation: No new Software testing was performed to support this 510(k) Notification.
Electrical Safety/ EMC: No new Electrical and Electromagnetic Compatibility (EMC) was performed to support this 510(k) Notification.
Insulin Compatibility and Biocompatibility: No new insulin compatibility testing was performed to support this 510(k) Notification.
Sterilization and Shipping: Shipping testing was conducted to ensure the Subject device met the requirements. Results confirm the sterilization and shipping integrity of the system.
Special Controls: Evaluation and adherence to the Special Controls of the Predicate Device (K223213) demonstrates continued assurance of the safety and effectiveness of the Subject Device.
Clinical Testing: No new clinical testing was performed to support this 510(k) Notification.
Conclusion: The Subject Device serves the same function as the Predicate Device. Furthermore, the Subject Device performs insulin therapy functions that are the same as that of the Predicate Device. The required technical documentation provided in this Special 510(k) demonstrates the Subject Device is as safe and as effective as the Predicate Device. Therefore, the Subject Device has been evaluated to be substantially equivalent to the Predicate Device and does not raise new or different questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5730 Alternate controller enabled infusion pump.
(a)
Identification. An alternate controller enabled infusion pump (ACE pump) is a device intended for the infusion of drugs into a patient. The ACE pump may include basal and bolus drug delivery at set or variable rates. ACE pumps are designed to reliably and securely communicate with external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. ACE pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Evidence demonstrating that device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions.
(A) Design input requirements must include delivery accuracy specifications under reasonably foreseeable use conditions, including ambient temperature changes, pressure changes (
e.g., head-height, backpressure, atmospheric), and, as appropriate, different drug fluidic properties.(B) Test results must demonstrate that the device meets the design input requirements for delivery accuracy under use conditions for the programmable range of delivery rates and volumes. Testing shall be conducted with a statistically valid number of devices to account for variation between devices.
(ii) Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration (
e.g., occlusions, air in line, etc.) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Hazard detection must be appropriate for the intended use of the device and testing must validate appropriate performance under the conditions of use for the device.(iii) Validation testing results demonstrating compatibility with drugs that may be used with the pump based on its labeling. Testing must include assessment of drug stability under reasonably foreseeable use conditions that may affect drug stability (
e.g., temperature, light exposure, or other factors as needed).(iv) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. This shall include chemical and particulate characterization on the final, finished, fluid contacting device components demonstrating that risk of harm from device-related residues is reasonably low.
(v) Evidence verifying and validating that the device is reliable over the ACE pump use life, as specified in the design file, in terms of all device functions and in terms of pump performance.
(vi) The device must be designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements in the intended use environment.
(vii) For any device that is capable of delivering more than one drug, the risk of cross-channeling drugs must be adequately mitigated.
(viii) For any devices intended for multiple patient use, testing must demonstrate validation of reprocessing procedures and include verification that the device meets all functional and performance requirements after reprocessing.
(2) Design verification and validation activities must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following:
(i) Risk control measures shall be implemented to address device system hazards and the design decisions related to how the risk control measures impact essential performance shall be documented.
(ii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design.
(3) The device shall include validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to external devices.
(ii) Secure, accurate, and reliable means of data transmission between the pump and connected devices.
(iii) Sharing of necessary state information between the pump and any digitally connected alternate controllers (
e.g., battery level, reservoir level, pump status, error conditions).(iv) Ensuring that the pump continues to operate safely when data is received in a manner outside the bounds of the parameters specified.
(v) A detailed process and procedure for sharing the pump interface specification with digitally connected devices and for validating the correct implementation of that protocol.
(4) The device must include appropriate measures to ensure that safe therapy is maintained when communications with digitally connected alternate controller devices is interrupted, lost, or re-established after an interruption (
e.g., reverting to a pre-programmed, safe drug delivery rate). Validation testing results must demonstrate that critical events that occur during a loss of communications (e.g., commands, device malfunctions, occlusions, etc.) are handled appropriately during and after the interruption.(5) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the system must, at a minimum, include:
(i) A record of all drug delivery
(ii) Commands issued to the pump and pump confirmations
(iii) Device malfunctions
(iv) Alarms and alerts and associated acknowledgements
(v) Connectivity events (
e.g., establishment or loss of communications)(6) Design verification and validation must include results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(7) Device labeling must include the following:
(i) A prominent statement identifying the drugs that are compatible with the device, including the identity and concentration of those drugs as appropriate.
(ii) A description of the minimum and maximum basal rates, minimum and maximum bolus volumes, and the increment size for basal and bolus delivery, or other similarly applicable information about drug delivery parameters.
(iii) A description of the pump accuracy at minimum, intermediate, and maximum bolus delivery volumes and the method(s) used to establish bolus delivery accuracy. For each bolus volume, pump accuracy shall be described in terms of the number of bolus doses measured to be within a given range as compared to the commanded volume. An acceptable accuracy description (depending on the drug delivered and bolus volume) may be provided as follows for each bolus volume tested, as applicable: Number of bolus doses with volume that is 250 percent of the commanded amount.
(iv) A description of the pump accuracy at minimum, intermediate, and maximum basal delivery rates and the method(s) used to establish basal delivery accuracy. For each basal rate, pump accuracy shall be described in terms of the amount of drug delivered after the basal delivery was first commanded, without a warmup period, up to various time points. The information provided must include typical pump performance, as well as worst-case pump performance observed during testing in terms of both over-delivery and under-delivery. An acceptable accuracy description (depending on the drug delivered) may be provided as follows, as applicable: The total volume delivered 1 hour, 6 hours, and 12 hours after starting delivery for a typical pump tested, as well as for the pump that delivered the least and the pump that delivered the most at each time point.
(v) A description of delivery hazard alarm performance, as applicable. For occlusion alarms, performance shall be reported at minimum, intermediate, and maximum delivery rates and volumes. This description must include the specification for the longest time period that may elapse before an occlusion alarm is triggered under each delivery condition, as well as the typical results observed during performance testing of the pumps.
(vi) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(vii) For any infusion pumps intended for multiple patient reuse, instructions for safely reprocessing the device between uses.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
October 5, 2023
Tandem Diabetes Care Inc. Louise Focht Director, Regulatory Affairs 12400 High Bluff Drive San Diego, California 92130
Re: K233044
Trade/Device Name: Tandem Mobi insulin pump with interoperable technology Regulation Number: 21 CFR 880.5730 Regulation Name: Alternate Controller Enabled Infusion Pump Regulatory Class: Class II Product Code: QFG Dated: September 22, 2023 Received: September 25, 2023
Dear Louise Focht:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K233044
Device Name
Tandem Mobi insulin pump with interoperable technology
Indications for Use (Describe)
The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
The pump is intended for single patient, home use and requires a prescription.
The pump is indicated for use in individuals six years of age and greater.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| K233044 | |
|---|---|
| Company | Tandem Diabetes Care, Inc |
| 12400 High Bluff Drive | |
| San Diego, CA 92130 | |
| Prepared | 22 September, 2023 |
| Contact | Louise Focht |
| Director Regulatory Affairs | |
| +1 (858) 255 6363 | |
| lfocht@tandemdiabetes.com | |
| Trade Name | Tandem Mobi insulin pump with interoperable technology |
| Common Name | Ambulatory Insulin Pump |
| Classification Product Code | QFG |
| Classification Name | Alternate Controller Enabled Infusion Pump |
| Regulation Number | 21 CFR 880.5730 |
| Device Class | Class II |
| Predicate Device | K223213, Tandem Mobi Insulin Pump with interoperable technology |
510(k) SUMMARY K733044
I. Device Under Review
The Subject Device, Tandem Mobi insulin pump with interoperable technology ("Mobi pump", "the pump"), is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. The Tandem Mobi insulin pump with interoperable technology ("pump") is screenless and includes visual LED, sound, and vibratory indicators to alert the user of the pump status. The Tandem Mobi insulin pump with interoperable technology system also includes: the t:connect mobile app and a 2mL (200 insulin unit) Tandem Mobi cartridge and a compatible FDA cleared infusion set. The t:connect mobile app (* Mobile app") displays all information from, and is the primary controller of, the pump. Through the Mobile app, users will program all aspects of basal and bolus insulin delivery therapy including managing personal profiles, viewing pump and CGM data, and actively acknowledging all pump and mobile app alerts, alarms, reminders, notifications and messages. The t:connect mobile app will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The t:connect mobile app will be made available via the Apple® App Store for iOS compatible smartphones based on completed device verification and validation. The Tandem Mobi cartridge is a disposable insulin cartridge compatible only with the Tandem Mobi pump.
The Tandem Mobi ACE pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.
The pump may be used in combination with a compatible continuous glucose monitor (CGM) system, such as the Dexcom G6 Continuous Glucose Monitoring System (DEN170088). Use of CGM is optional.
4
II. Intended Use/ Indications for Use
The Tandem Mob Insulin Pumip with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
The pump is intended for single patient, home use and requires a prescription.
The pump is indicated for use in individuals six years of age and greater.
| | Predicate Device
K223213 | Subject
Device |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Indications for
Use/ Intended
Use | The Tandem Mobi Insulin Pump with interoperable
technology (the pump) is intended for the
subcutaneous delivery of insulin, at set and variable
rates, for the management of diabetes mellitus in
persons requiring insulin. The pump is able to
reliably and securely communicate with
compatible, digitally connected devices, including
automated insulin dosing software, to receive,
execute, and confirm commands from these
devices.
The pump is intended for single patient, home use
and requires a prescription.
The pump is indicated for use in individuals six
years of age and greater. | SAME |
| Prescription Use | Prescription is required. | SAME |
| Insulin Type | NovoLog or Humalog U-100 insulin | SAME |
| Infusion Set
Type | Compatible, FDA cleared infusions sets with t:lock
connectors manufactured for Tandem Diabetes
Care. | SAME |
| Pump Type | An Alternate Controller Enabled Infusion Pump (21
CFR 880.5730) | SAME |
| Compatible
Interoperable
Devices | Compatible with:
• DEN170088: Dexcom G6 Continuous
Glucose Monitoring System or other
compatible iCGM
• K193483: Basal-IQ technology
• K200467: Control-IQ technology | SAME |
| Communication | Bluetooth Low Energy (BLE) | SAME |
| | | |
| Interoperable
Devices | | |
| Principles of
Operation | Delivery of Insulin (Bolus and Basal) programmed
by patient based on health care provider
recommendations. | SAME |
| Pump
Technological
Characteristics | The Device is an ambulatory, battery operated, rate-
programmable infusion pump designed for the
subcutaneous delivery of insulin, at set and variable
rates, for the management of diabetes mellitus in
persons requiring insulin. The device includes a
disposable cartridge which is motor driven to
deliver patient programmed basal rates and boluses
through an infusion set into subcutaneous tissue. | SAME |
| Alarm Type | Visual, audible, and vibratory | SAME |
| Bolus Calculator | The Device contains a built-in bolus calculator | SAME |
| Bolus and Basal
Insulin Control | Yes | SAME |
| Display of
Primary Glucose
and Therapy
Information | The Device can display Glucose and Therapy
information and trends from the pump and
compatible interoperable devices.
The pump does not include a graphical user
interface. Instead, Primary Glucose and Therapy
information and trends from the pump and
compatible interoperable devices are displayed in
the t:connect mobile app. | SAME |
| Use of t:connect
Mobile App | The t:connect mobile app is not optional and has
the following functions:
View pump therapy data, trends, alerts,
alarms, and notifications. Program Correction Boluses, Bolus
Override, and Food (Standard) Boluses. Terminate (Cancel or Stop) all bolus types
regardless of origin of bolus request being
made on the Tandem Mobi Insulin Pump or
the t:connect mobile app. Update historical pump data to Tandem
Cloud The t:connect mobile app when paired with
Tandem Mobi Insulin Pump and iOS
compatible smartphone, will be able to
control all aspects of pump therapy. | SAME |
| Sterilization | The pump is provided non-sterile.
The cartridge is provided sterile via Ethylene Oxide
Gas to a Sterility Assurance Level (Sal) 10-6. | SAME |
| Cartridge
Length of Use | Every 3 days for compatible insulins. | SAME |
| | | |
III. Technological Characteristics Compared to Predicate Device K203234
5
6
IV. Overview of Non-Clinical Performance Tests
Appropriate testing was performed to confirm the Subject Device met specified requirements and performed as intended. See summaries below.
Usability/Human Factors:
No new Usability or Human Factors testing was performed to support this 510(k) Notification.
Software Verification and Validation:
No new Software testing was performed to support this 510(k) Notification.
Electrical Safety/ EMC:
No new Electrical and Electromagnetic Compatibility (EMC) was performed to support this 510(k) Notification.
Insulin Compatibility and Biocompatibility:
No new insulin compatibility testing was performed to support this 510(k) Notification.
Sterilization and Shipping:
Shipping testing was conducted to ensure the Subject device met the requirements. Results confirm the sterilization and shipping integrity of the system.
Special Controls:
Evaluation and adherence to the Special Controls of the Predicate Device (K223213) demonstrates continued assurance of the safety and effectiveness of the Subject Device.
Clinical Testing:
No new clinical testing was performed to support this 510(k) Notification.
Conclusion:
The Subject Device serves the same function as the Predicate Device. Furthermore, the Subject Device performs insulin therapy functions that are the same as that of the Predicate Device. The required technical documentation provided in this Special 510(k) demonstrates the Subject Device is as safe and as effective as the Predicate Device. Therefore, the Subject Device has been evaluated to be substantially equivalent to the Predicate Device and does not raise new or different questions of safety or effectiveness.