(30 days)
DEN 180058
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a programmable pump that can receive commands from other interoperable devices, but does not indicate that the pump itself uses AI/ML for decision-making. The AI/ML functionality is likely within the compatible "Interoperable Automated Glycemic Controllers" mentioned as separate devices.
Yes
The device is intended for the management of diabetes mellitus by delivering insulin, which is a therapeutic intervention.
No
The device is an insulin pump designed for the delivery of insulin, which is a therapeutic function. While it can communicate with other devices that might have diagnostic capabilities (like iCGM systems), the pump itself does not diagnose diabetes or assess the patient's condition for diagnostic purposes.
No
The device description explicitly states it is an "ambulatory, battery operated, rate-programmable infusion pump" and includes a "disposable cartridge which is motor driven to deliver patient programmed basal rates and boluses through an infusion set into subcutaneous tissue." This clearly indicates a hardware component for insulin delivery, not a software-only device.
Based on the provided text, the t:slim X2 insulin pump with interoperable technology is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is the subcutaneous delivery of insulin for diabetes management. This is a therapeutic action, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description focuses on the mechanical and software aspects of delivering insulin. It describes a pump, cartridge, and infusion set, all involved in delivering a substance into the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is designed to work with other devices that might involve diagnostic information (like iCGM systems), but the pump itself is the delivery mechanism, not the diagnostic tool.
N/A
Intended Use / Indications for Use
The t:slim X2 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 with NovoLog or Humalog U-100 insulin. The Pump is indicated for use in individuals 6 years of age and greater.
Product codes
QFG, OFG
Device Description
The Subject 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. The desired timing and quantity of insulin delivery (bolus or basal) is programmed by the patient based on their healthcare provider's recommendations.
The Subject Device can send and receive data to and from other interoperable devices and is designed to act on commands from other authorized digital pump controller devices to adjust insulin dosing. The Subject Device is designed to be able to receive and display alerts and alarms to users based on information received from other interoperable devices. The Subject Device is compatible with Interoperable Automated Glycemic Controllers, such as Basal-IQ Technology (K193483) and Control IQ Technology (DEN190034) to aid in diabetes management. In addition, the Subject Device is compatible with iCGM systems cleared under 21 CFR 862.1355 and marketed separately from the ACE Pump and Interoperable Automated Glycemic Controllers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
6 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
Human factors and software verification and validation tests were conducted to confirm that the User Settable Max Basal Limit software update feature met specified requirements and performed as intended.
Human factors validation testing was conducted to demonstrate the intended users can effectively use the Subject Device for its' intended purpose in expected use environments. Usability tasks were evaluated in accordance to ANSI AAMI HE 75:2009 (R) 2013 Human Factors Engineering- Design of Medical Devices, ANSI/AAMI/IEC 62366-1:2015 Medical devices - Part 1: Application of Usability Engineering To Medical Devices and Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices – February 3, 2016.
Software verification and validation testing was carried out in accordance with ISO 14971-2012 Medical Devices - Application of Risk Management to Medical Devices, ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes and FDA guidance General Principles of Software Validation: Final Guidance for Industry and FDA Staff.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Human factors and software verification and validation tests were conducted to confirm that the User Settable Max Basal Limit software update feature met specified requirements and performed as intended. The results from the human factors study demonstrates users can safely and effectively use the feature of the Subject Device. Software development activities included establishing detailed software requirements with associated verification and validation activities, software code inspection, software code walkthrough, static code analysis, unit testing, and system level testing to ensure that the software conforms to patient needs and intended uses. No new clinical testing was required for this Special 510(k) notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DEN 180058
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 of 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 4, 2020
Tandem Diabetes Care, Inc. Ashley Reynolds Regulatory Affairs Specialist II 11075 Roselle Street San Diego, CA 92121
Re: K201214
Trade/Device Name: t:slim X2 Insulin Pump with Interoperable Technology Regulation Number: 21 CFR 880.5730 Regulation Name: Alternate Controller Enabled (Ace) Infusion Pump Regulatory Class: Class II Product Code: OFG Dated: May 5, 2020 Received: May 5, 2020
Dear Ashley Reynolds:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201214
Device Name
t:slim X2 insulin pump with interoperable technology
Indications for Use (Describe)
The t:slim X2 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 melliting 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 with NovoLog or Humalog U-100 insulin. The Pump is indicated for use in individuals 6 years of age and greater.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
Page 1 of 1
Tandem Diabetes Care Inc.
Confidential
3
Image /page/3/Picture/0 description: The image contains the logo for Tandem Diabetes Care. On the left is a blue square with rounded corners, inside of which is a white "T". To the right of the square are the words "TANDEM" in large, bold, black letters, with a registered trademark symbol next to the "M". Below "TANDEM" are the words "DIABETES CARE" in smaller, thinner, black letters.
510(k) Summary 510(k) Number: K201214 Prepared: 04 May 2020
| I. | Company | Tandem Diabetes Care, Inc.
11075 Roselle Street
San Diego, CA 92121 |
|-------|-----------------------------|----------------------------------------------------------------------------------------------------------------|
| II. | Contact | Ashley Reynolds, M.S.
Regulatory Affairs Specialist II
areynolds@tandemdiabetes.com
+1 (858) 401-1725 |
| III. | Product Trade Name | t:slim X2 Insulin Pump with Interoperable Technology |
| IV. | Common Name | Insulin Pump |
| V. | Classification Name | Alternate Controller Enabled Infusion Pump |
| VI. | Regulation Number | 21 CFR 880.5730 |
| VII. | Device Class | Class II |
| VIII. | Classification Product Code | QFG |
| IX. | Predicate Device | DEN 180058 t:slim X2 Insulin Pump with Interoperable
Technology |
X. Purpose of Special 510(k) Notification
The User Settable Max Basal Limit feature is a software update to the current t:slim X2 ACE Pump software to enhance the existing safety measures that prevent the user from setting an excessively high basal rate or temporary basal rate. This software feature allows the user to establish a limit to the basal insulin rate that can be set within the Personal Profiles, as well as the amount of insulin that can be delivered when using a temporary rate. The software feature prevents the user from setting a basal insulin rate or a temporary basal insulin rate higher than the user set Basal Limit.
The User Settable Max Basal Limit software update does not impact the automated dosing algorithms of Interoperable Automated Glycemic Controllers used with the Subject Device.
XI. Indications for Use/ Intended Use
The t:slim X2 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, 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 with NovoLog or Humalog U-100 insulin. The Pump is indicated for use in individuals 6 years of age and greater.
4
XII. Device Description and Technological Characteristics
The Subject Device is identical to the predicate device- with the exception of the software updates discussed within this submission. The Subject Device is an ambulatory, battery operated, rateprogrammable 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. The desired timing and quantity of insulin delivery (bolus or basal) is programmed by the patient based on their healthcare provider's recommendations.
The Subject Device can send and receive data to and from other interoperable devices and is designed to act on commands from other authorized digital pump controller devices to adjust insulin dosing. The Subject Device is designed to be able to receive and display alerts and alarms to users based on information received from other interoperable devices. The Subject Device is compatible with Interoperable Automated Glycemic Controllers, such as Basal-IQ Technology (K193483) and Control IQ Technology (DEN190034) to aid in diabetes management. In addition, the Subject Device is compatible with iCGM systems cleared under 21 CFR 862.1355 and marketed separately from the ACE Pump and Interoperable Automated Glycemic Controllers.
5
| | Predicate Device
DEN 180058 | Subject Device |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use/
Intended Use | The t:slim X2 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 with NovoLog or
Humalog U-100 insulin. The Pump is
indicated for use in individuals 6 years of age
and greater. | Identical |
| Prescription
Use | Yes | Identical |
| Principles of
Operation | Delivery of insulin (Bolus and Basal)
programmed by the patient based on health
care provider recommendations. | Identical |
| Materials and
Accessories | Alternate Controller Enabled Infusion Pump
cleared under 21 CFR 880.5730 | Identical |
| Insulin Basal
Rate Delivery
Range | 0 units /hour- 15units/hour | Identical |
| Insulin Basal
Rate Default | Not applicable | 3 units/hour for users without
established Personal Profile
OR
2x (twice) the users highest
programmed Basal Rate for users
with an established Personal Profile |
| User Settable
Max Basal
Limit Feature | None | Yes |
| User Settable
Max Basal
Rate Range | None | 0.2 units /hour- 15 units/hour |
| Temporary
Basal Insulin
Rate (Temp
Rate) | A Temporary Rate set higher than 15
units/hour is capped at the pump's
maximum basal rate. | A Temporary Rate cannot be set
higher than the maximum rate set by
the user. |
6
XIIII. Discussion of the Non-Clinical Testing
Human factors and software verification and validation tests were conducted to confirm that the User Settable Max Basal Limit software update feature met specified requirements and performed as intended.
Human factors validation testing was conducted to demonstrate the intended users can effectively use the Subject Device for its' intended purpose in expected use environments. Usability tasks were evaluated in accordance to ANSI AAMI HE 75:2009 (R) 2013 Human Factors Engineering- Design of Medical Devices, ANSI/AAMI/IEC 62366-1:2015 Medical devices - Part 1: Application of Usability Engineering To Medical Devices and Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices – February 3, 2016. The results from the human factors study demonstrates users can safely and effectively use the feature of the Subject Device.
Software verification and validation testing was carried out in accordance with ISO 14971-2012 Medical Devices - Application of Risk Management to Medical Devices, ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes and FDA guidance General Principles of Software Validation: Final Guidance for Industry and FDA Staff. Software development activities included establishing detailed software requirements with associated verification and validation activities, software code inspection, software code walkthrough, static code analysis, unit testing, and system level testing to ensure that the software conforms to patient needs and intended uses.
Adherence of the Special Controls listed in the Predicate Device (DEN180058), and present in the Subject Device, show continued assurance of the safety and effectiveness of the Subject Device.
XIV. Discussion of Clinical Testing
No new clinical testing was required for this Special 510(k) notification.
XV. Conclusions
The addition of the User Settable Max Basal Limit software update feature has been evaluated to be as safe and effective, and performs as well as, the Predicate Device. The addition of this software feature does not raise any new or different questions of safety or effectiveness.