(142 days)
UnoMedical's Comfort™ Infusion Set (K051264)
No
The summary describes a standard insulin pump system and a software updater. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on insulin delivery, software updates, and cybersecurity.
Yes
The device is an insulin delivery system, indicated for the management of diabetes mellitus, which is a therapeutic purpose.
No
The device is an insulin delivery system designed for the management of diabetes, not for diagnosing it. Its function is to deliver insulin, not to detect or identify a medical condition.
No
The 510(k) submission describes both the t:slim and t:flex Insulin Delivery Systems, which are hardware devices (insulin pumps), and the Tandem Device Updater System, which is software. While the Tandem Device Updater System is software, the overall submission covers a system that includes hardware components (the pumps). The performance studies also include hardware verification testing for the insulin delivery systems.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "subcutaneous delivery of insulin" for the "management of diabetes mellitus." This describes a therapeutic device that delivers medication into the body.
- Device Description: The description focuses on the mechanical and software components involved in delivering insulin and updating the pump's software. There is no mention of analyzing biological samples (blood, urine, etc.) or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
The device is an insulin pump system, which is a therapeutic medical device. The Tandem Device Updater is an accessory for managing the software of this therapeutic device.
N/A
Intended Use / Indications for Use
The t:slim® Insulin Delivery System is indicated for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater. The device is indicated for use with NovoLog or Humalog U-100 insulin.
The t:flex™ Insulin Delivery System is indicated for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater. The device is indicated for use with NovoLog or Humalog U-100 insulin.
The Tandem® Device Updater™ System consists of software which allows for communication between a computer and a t:slim® or t:flex™ Insulin Delivery System. It allows for remote software installation and update of a Tandem Insulin Delivery System.
Product codes
LZG, MRZ
Device Description
The t:slim® and t:flex™ Insulin Delivery Systems facilitate the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The accessory Tandem Device Updater™ System consists of software which allows for communications between a computer and a Tandem Diabetes Care. Inc. Insulin Delivery System. The Tandem Device Updater™ allows for software installation and update.
The Tandem Device Updater System is comprised of a personal computer application, a web server (HAL), an embedded firmware application (Homer), and a Tandem pump (t.slim or t.flex). The goal of the Tandem Device Updater System is to provide a process for the user to perform updates to the firmware components of a Tandem pump. The Tandem Device Updater System provides communication security consisting of message authentication and encryption, two commonly used methods to secure communication protocols (i.e. USB). Communication between the pump and the Tandem Device Updater System can only occur while the pump is connected to a computer via USB cable.
The HAL Web Server (HAL) is a web server that is responsible for storing and delivering the firmware components of a pump.
The Homer Firmware Application (Homer) is a software application which is part of Tandem Device Updater System that runs on the main MCU incorporated in the pump. Homer is used to update the Bootloader Software in each MCU, essentially rewriting the contents in the flash memory of the MCU. In addition to updating the Bootloader Software, Homer will provide an interface for the secure exchange of security keys during the enabling of communication security. Homer authenticates critical messages received from the PC application.
The Tandem pumps (i.e., t.flex and t:slim described above) incorporate three separate microcontroller units (MCUs), and each MCU runs two separate pieces of firmware, known as the Bootloader Software, and Application Software. The Application Software running on the main MCU, utilizes a graphics library to generate the screens for the pump display. The Tandem Device Updater downloads files from Tandem and installs them on the pump. All binary images for use on the pump transmitted by the Tandem Device Updater are encrypted.
The software components on the pump that may be updated by the Tandem Device Updater System include: the Bootloader Software stored in each MCU, the Application Software stored in each MCU, and the graphics library files stored in the nonvolatile flash memory module.
The software version of the t:slim and t:flex Insulin Delivery Systems for this submission is version 4.3.5.1. The software version of the Tandem Device Updater System for this submission is version 1.0.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
12 years of age and greater
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)
Performance data provided an assurance case for the t:slim and t:flex Insulin Delivery Systems and the Tandem Device Updater System accessory, as recommended by FDA guidance.
The assurance cases defined the device systems, including indications for use, patient types, users, use conditions, environments of use, and list of specific devices.
Supporting arguments covered acceptability of risk mitigations, adequate device reliability, and adequate design verification and validation of device specifications.
The assurance cases included mitigations of risks related to operational, environmental, electrical, hardware, software, mechanical, biological and chemical, and use hazards.
Evidence included software verification and validation testing, hardware verification testing, EMC testing, and electrical safety testing.
Cybersecurity information including encryption, authentication, threat detection, penetration testing, operating system support, and a risk analysis were provided for the Tandem Device Updater.
Validation of the Tandem Device Updater System’s user interface was completed through human factor formative and summative studies.
The t:slim/t:flex safety assurance cases include risk mitigation strategies addressing pump interaction with other software/devices, including the Tandem Device Updater System. The Tandem Device Updater System safety assurance case includes risk mitigations involving all interactions between the Tandem Device Updater System and the Tandem Pumps (i.e. t:slim and t:flex) and the user.
The verification and validation testing, including human factors testing, confirms that the t:slim® and t:flex™ Insulin Delivery Systems and Accessories are substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System (K141758), Tandem Diabetes Care, Inc. t:flex™ Insulin Delivery System (K143189), Medfusion® Model 4000 Syringe Infusion Pump with the PharmGuard® Toolbox2 Medication Safety Software (K111386)
Reference Device(s)
UnoMedical's Comfort™ Infusion Set (K051264)
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2016
Tandem Diabetes Care, Inc. Mr. Michael Sarrasin Senior Director of Regulatory Affairs 11045 Roselle Street San Diego, California 92121
Re: K160482
Trade/Device Name: t:slim® Insulin Delivery System, t:flex™ Insulin Delivery System, The Tandem® Device Updater™ System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG, MRZ Dated: June 13, 2016 Received: June 13, 2016
Dear Mr. Sarrasin:
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.
1
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 (OS) 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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
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for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160482
Device Name
t:slim® Insulin Delivery System, t:flex™ Insulin Delivery System, The Tandem® Device Updater™ System
Indications for Use (Describe)
The t:slim® Insulin Delivery System is indicated for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater. The device is indicated for use with NovoLog or Humalog U-100 insulin.
The t:flex™ Insulin Delivery System is indicated for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater. The device is indicated for use with NovoLog or Humalog U-100 insulin.
The Tandem® Device Updater™ System consists of software which allows for communication between a computer and a t:slim® or t:flex™ Insulin Delivery System. It allows for remote software installation and update of a Tandem Insulin Delivery System.
| 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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3
510(k) SUMMARY K160482
Tandem® Diabetes Care, Inc.
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego, CA 92121 Phone: 858-366-6900 Facsimile: 858-362-7070
Contact Person: Michael Sarrasin Contact Email: MSarrasin@tandemdiabetes.com
Date Prepared: July 13, 2016
Name of Device
t:slim® Insulin Delivery System, t:flex™ Insulin Delivery System, The Tandem® Device Updater™ System
Common or Usual Name
Insulin infusion pump
Classification Name
Infusion Pump per 21 CFR 880.5725
Product Codes
LZG, Insulin Infusion Pump MRZ, Infusion Pump Accessories
Predicate Device
Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System (K141758) Tandem Diabetes Care, Inc. t:flex™ Insulin Delivery System (K143189) Medfusion® Model 4000 Syringe Infusion Pump with the PharmGuard® Toolbox2 Medication Safety Software (K111386).
Device Description
The t:slim® and t:flex™ Insulin Delivery Systems facilitate the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
4
The accessory Tandem Device Updater™ System consists of software which allows for communications between a computer and a Tandem Diabetes Care. Inc. Insulin Delivery System. The Tandem Device Updater™ allows for software installation and update.
The Tandem Device Updater System is comprised of a personal computer application, a web server (HAL), an embedded firmware application (Homer), and a Tandem pump (t.slim or t.flex). The goal of the Tandem Device Updater System is to provide a process for the user to perform updates to the firmware components of a Tandem pump. The Tandem Device Updater System provides communication security consisting of message authentication and encryption, two commonly used methods to secure communication protocols (i.e. USB). Communication between the pump and the Tandem Device Updater System can only occur while the pump is connected to a computer via USB cable.
The HAL Web Server (HAL) is a web server that is responsible for storing and delivering the firmware components of a pump.
The Homer Firmware Application (Homer) is a software application which is part of Tandem Device Updater System that runs on the main MCU incorporated in the pump. Homer is used to update the Bootloader Software in each MCU, essentially rewriting the contents in the flash memory of the MCU. In addition to updating the Bootloader Software, Homer will provide an interface for the secure exchange of security keys during the enabling of communication security. Homer authenticates critical messages received from the PC application.
The Tandem pumps (i.e., t.flex and t:slim described above) incorporate three separate microcontroller units (MCUs), and each MCU runs two separate pieces of firmware, known as the Bootloader Software, and Application Software. The Application Software running on the main MCU, utilizes a graphics library to generate the screens for the pump display. The Tandem Device Updater downloads files from Tandem and installs them on the pump. All binary images for use on the pump transmitted by the Tandem Device Updater are encrypted.
The software components on the pump that may be updated by the Tandem Device Updater System include: the Bootloader Software stored in each MCU, the Application Software stored in each MCU, and the graphics library files stored in the nonvolatile flash memory module.
The software version of the t:slim and t:flex Insulin Delivery Systems for this submission is version 4.3.5.1. The software version of the Tandem Device Updater System for this submission is version 1.0.
Intended Use
The t:slim® Insulin Delivery System is indicated for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater. The device is indicated for use with NovoLog or Humalog U-100 insulin.
The t:flex™ Insulin Delivery System is indicated for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater. The device is indicated for use with NovoLog or Humalog U-100 insulin.
The Tandem® Device Updater™ System consists of software which allows for communication between a computer and a t:slim® or t:flex™ Insulin Delivery System. It allows for remote software installation and update of a Tandem Insulin Delivery System.
Modifications of Intended Use Compared to Predicate
5
The intended use statements of the t:slim and t:flex Insulin Delivery Systems have been modified to include a statement of the drug concentration to be delivered by the pumps. This modification does not change the predicate intended use since the t:slim and t:flex Insulin Delivery System predicate labeling included statements that only NovoLog or Humalog U-100 insulin is to be used with the pumps. No functional characteristics were changed in response to the modification of the intended use statement.
The intended use of the Tandem Device Updater System is very similar to that of the predicate device Medfusion Model 4000 Syringe Infusion Pump with the PharmGuard® Toolbox2 Medication Safety Software. Both the Tandem Device Updater System and the PharmGuard Toolbox2 Medication Safety Software contain software intended to provide software updates to their respective indicated infusion pumps by allowing communication between a computer and an infusion pump.
Technological Characteristics
The t:slim and t:flex Insulin Delivery Systems have the same technological characteristics as the respective predicate devices. Both Systems, like the predicates, consist of: (1) a software-controlled, programmable insulin infusion pump capable of both basal and bolus delivery of insulin ("t:slim and t:flex Pump"); (2) a dedicated disposable 3.0 mL (300 units) and 4.8 mL (480 units) insulin cartridge, respectively: (3) UnoMedical's Comfort™ Infusion Set (K051264), or an equivalently cleared set; and (4) additional device accessories including a sterile svringe and needle (for cartridge filling) an AC power supply and DC car adapter power supply with USB.
Minor technological differences when compared to the predicate device include the addition of an LCD screen, alternate USB cables, and cartridge box quantity of 2. Minor software changes were made to the t:slim and t:flex pumps including an updated homing algorithm, support for the LCD screen, authentication and encryption in the software, reference to the software version by a user friendly name, suppress fuel gauge learning after soft reset (but force after shelf mode emergence), and to address previously identified unresolved software anomalies. The t:slim and t:flex Insulin Delivery Systems software updates are for version 4.3.5.1.
The Tandem Device Updater ™ System is similar in design, function and intended use to the Medfusion® 4000 wireless syringe infusion pump with the PharmGuard® Toolbox 2 Medication Safety Software, specifically the SureLink Remote Support Software portion. The products both allow for communications between a computer and an infusion pump. The software programs provide software installation and updates.
Performance Data
An assurance case was provided for the t:slim and t:flex Insulin Delivery Systems as recommended in the FDA's guidance document, Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions Guidance, issued on December 2, 2014.
The stated goal of the t:slim/t:flex assurance case is:
- The safety risk resulting from use of t:slim/t:flex pump is reduced to acceptable levels and is As . Low As Reasonably Practicable (ALARP) through use of mitigating technologies and the risks are substantially equivalent to the predicate device.
6
The assurance case defined the device system, including the indications for use, patient types, users, use conditions, environments of use, and list of specific devices covered by the assurance case with associated design specification and labeling documentation. The supporting assurance arguments covered the following attributes:
- . Demonstrate acceptability of risk mitigations
- Demonstrate adequate device reliability .
- Demonstrate adequate design verification and validation of device specifications .
The assurance case included mitigations of risks related to the following hazards:
- Operational Hazards ●
- Environmental Hazards ●
- Electrical Hazards
- Hardware Hazards
- Software Hazards
- Mechanical Hazards ●
- Biological and Chemical Hazards ●
- . Use Hazards
The following evidence was included in the assurance case:
Software verification and validation testing was performed per FDA's quidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions Guidance, issued on December 2, 2014.
Hardware changes were supported by verification testing per previously established acceptance criteria. Previously completed testing to support substantial equivalence determination included pump software, hardware, EMC testing and electrical safety testing, Software testing was performed on the version of software which is the subject of this 510(k).
An assurance case was provided for the Tandem Device Updater System accessory as recommended in the FDA's guidance document, Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions Guidance, issued on December 2, 2014.
The stated goal of the Tandem Device Updater System assurance case is:
-
The safety risk resulting from use of Tandem Device Updater is reduced to acceptable levels . and is As Low As Reasonably Practicable (ALARP) through use of mitigating technologies and the risks are substantially equivalent to the predicate device.
The assurance case defined the device system, including the indications for use, users, use conditions, environments of use, and list of specific devices covered by the assurance case with associated design specification and labeling documentation. The supporting assurance arguments covered the following attributes: -
Demonstrate acceptability of risk mitigations .
-
Demonstrate adequate device reliability .
-
. Demonstrate adequate design verification and validation of device specifications
The assurance case included mitigations of risks related to the following hazards:
- Software Hazards ●
- . Use Hazards
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Software verification and validation testing was performed per FDA's guidance document, Guidance for Industry and FDA Staff - Total Product Life Cvcle: Infusion Pump - Premarket Notification [510(k)] Submissions Guidance, issued on December 2, 2014.
Tandem completed validation of the Tandem Device Updater System's user interface through human factor formative and summative studies.
Cybersecurity information including encryption, authentication, threat detection, penetration testing, operating system support, and a risk analysis were provided to address the cybersecurity risks of the Tandem Device Updater.
The t:slim/t:flex safety assurance cases include risk mitigation strategies addressing the pump interaction with other software/devices, including the Tandem Device Updater System. The Tandem Device Updater System safety assurance case includes risk mitiqations involving all interactions between the Tandem Device Updater System and the Tandem Pumps (i.e. t:slim and t:flex) and the user.
Substantial Equivalence
Tandem t:slim® and t:flex™ Insulin Delivery Systems have intended use and indications for use (updated to explicitly state the insulin to be used), the same principles of operation, and similar technological characteristics as the previously cleared predicate devices. The purpose of this 510(k) is to introduce minor software changes to t:slim and t:flex as well as to introduce the Tandem Device Updater™. The verification and validation testing, including human factors testing, confirms that the t:slim® and t:flex™ Insulin Delivery Systems and Accessories are substantially equivalent to the predicates.