(90 days)
No
The summary describes an insulin delivery system and a software updater. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on standard software and hardware verification and validation.
Yes
The device is indicated for the subcutaneous delivery of insulin for the management of diabetes mellitus, which is a therapeutic intervention.
No
The device is an insulin delivery system, indicated for the subcutaneous delivery of insulin and management of diabetes mellitus. It does not perform diagnostic functions.
No
The device description explicitly states that the Tandem Device Updater™ System is comprised of a personal computer application, a web server, an embedded firmware application, and a Tandem pump (t:slim or t:flex). The performance studies also mention hardware changes and hardware verification testing, indicating the device includes hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the t:slim and t:flex systems are for the subcutaneous delivery of insulin. This is a therapeutic function, not a diagnostic one.
- No Mention of Samples or Analysis: The text does not mention the collection or analysis of any biological samples.
- Focus on Insulin Delivery: The entire description revolves around the mechanism and purpose of delivering insulin to manage diabetes.
Therefore, the device described is an insulin delivery system, which is a therapeutic medical device, not an in vitro diagnostic 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 6 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 is comprised of a personal computer application. a web server, an embedded firmware application, and a Tandem pump (t:slim or t:flex). The goal of the Tandem Device Updater System is to provide a secure process for software installation and update.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
t:slim Insulin Delivery System: 6 years of age and greater.
t:flex Insulin Delivery System: 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)
Software verification and validation testing was performed per 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.
Hardware changes were supported by verification testing per previously established acceptance criteria. Testing includes tactile feedback, fluid ingress, performance testing, and simulated use.
Previously completed testing to support substantial equivalence determination included pump software, hardware, EMC testing and electrical safety testing. Software testing was previously performed on the version of software which is the subject of this 510(k). Tandem previously completed validation of the Tandem Device Updater System's user interface through human factor formative and summative studies. Pediatric Human Factors testing was completed for the t:slim Insulin Delivery System to support the use of the device in individuals 6 years of age and greater. Human Factors testing included a validation study for children between ages 6-12 in order to assess the intended user population's ability to identify, interpret, and understand the t:slim Insulin Delivery System's alarms. Labeling, warnings and precautions provide further information regarding the risks of the device for pediatric users.
An updated safety assurance case was provided for the t:slim and t:flex Insulin Delivery System 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 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 arquments 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 ●
Additions to the safety assurance case from the predicate devices' cases included the LCD screen reports, Tandem Device Updater for use with the t:slim pump, updated wake button, updated fuel qauge register, and the updated t:slim indications for use.
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
§ 880.5725 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
October 25, 2016
Tandem Diabetes Care, Inc. Mr. Michael Sarrasin Senior Director of Regulatory Affairs 11045 Roselle Street San Diego, California 92121
Re: K162080
Trade/Device Name: t:slim® Insulin Delivery System, t:flex™ Insulin Delivery System, Tandem® Device Updater™ System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG, MRZ Dated: September 27, 2016 Received: September 28, 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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,
Tina
Kiang-S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K162080 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 melliting insulin, for individuals 6 vears 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) |
|---|
| ---------------------------------------------------------------- |
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY
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: October 25, 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 Devices
Primary Predicate Device: Tandem Diabetes Care, Inc. t:slim Delivery System, t:flex® Insulin Delivery System, Tandem Device Updater (K160428)
Reference Predicate Device: Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System (K160056)
Purpose of the 510(k) notification
The purpose of this 510(k) is to describe modified indications for use of the t:slim® Insulin Delivery System. The indications for use of the t:slim Insulin Delivery System under this 510(k) combines the indications for use of the t:slim Insulin Delivery System cleared under K160056 with the updated software and accessories cleared for the t:slim Insulin Delivery System cleared under K160482. The t:slim Insulin Delivery System was cleared under K160482 with updated software and with the Tandem Device Updater System accessory for ages 12 years and older. The t:slim Insulin Delivery System was cleared under K160056 for ages 6 years and older without the software update or Tandem Device Updater System accessory of K160482. This 510(k) combines the updated
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software, Tandem Device Updater System accessory, and indication for 6 years and older for the t:slim Insulin Delivery System
Minor device hardware modifications were also included for the t:slim Insulin Delivery System and t:flex Insulin Delivery System in this 510(k).
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 is comprised of a personal computer application. a web server, an embedded firmware application, and a Tandem pump (t:slim or t:flex). The goal of the Tandem Device Updater System is to provide a secure process for software installation and update.
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 6 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.
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 syringe and needle (for cartridge filling) an AC power supply and DC car adapter power supply with USB.
Minor technological differences when compared to the primary predicate device include minor modifications to the wake button and updates to the fuel gauge registers. There are no software changes when compared to the primary predicate device.
The Tandem Device Updater ™ System is identical to the previously cleared Tandem Device Updater System. The products both allow for communications between a computer and an infusion pump. The software programs provide software installation and updates.
Performance Data
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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 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. Testing includes tactile feedback, fluid ingress, performance testing, and simulated use.
Previously completed testing to support substantial equivalence determination included pump software, hardware, EMC testing and electrical safety testing. Software testing was previously performed on the version of software which is the subject of this 510(k). Tandem previously completed validation of the Tandem Device Updater System's user interface through human factor formative and summative studies. Pediatric Human Factors testing was completed for the t:slim Insulin Delivery System to support the use of the device in individuals 6 years of age and greater. Human Factors testing included a validation study for children between ages 6-12 in order to assess the intended user population's ability to identify, interpret, and understand the t:slim Insulin Delivery System's alarms. Labeling, warnings and precautions provide further information regarding the risks of the device for pediatric users.
An updated safety assurance case was provided for the t:slim and t:flex Insulin Delivery System 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 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 arquments 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 ●
Additions to the safety assurance case from the predicate devices' cases included the LCD screen reports, Tandem Device Updater for use with the t:slim pump, updated wake button, updated fuel qauge register, and the updated t:slim indications for use.
Substantial Equivalence
Tandem t:slim and t:flex™ Insulin Delivery Systems have the same intended use, the same principles of operation, and the same technological characteristics as the previously cleared predicate devices. The purpose of this 510(k) is to introduce minor hardware changes to t:slim and t:flex Systems and to include individuals 6 vears of age and greater in the indications for use for the t:slim Insulin Delivery System. The t:slim Insulin Delivery System was cleared under K160056 with indications for 6 years and greater, but was cleared separately under K150482 with an updated
6
version of software and the Tandem Device Updater System accessory. This 510(k) merges the indications for use of 6 years and greater with the updated software and Tandem Device Updater accessory for the t:slim Insulin Delivery System. 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.