(194 days)
No
The description focuses on standard insulin pump technology and user-programmed delivery, with no mention of AI or ML capabilities.
Yes
The device is described as an "Insulin Delivery System" intended for "subcutaneous delivery of insulin" for the "management of diabetes mellitus," which directly indicates a therapeutic purpose.
No
This device is an insulin delivery system designed for therapeutic purposes (delivering insulin), not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as the insulin infusion pump, disposable cartridge, infusion set, syringe, needle, and AC power supply. The performance studies also include hardware, mechanical, and environmental testing of the pump and cartridge.
Based on the provided text, the t:slim™ Insulin Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the subcutaneous delivery of insulin for the management of diabetes. This is a therapeutic action, not a diagnostic one.
- Device Description: The description details a pump that delivers insulin, a cartridge to hold insulin, and an infusion set to deliver insulin into the body. None of these components are designed to perform tests on samples taken from the body (in vitro).
- Lack of IVD Characteristics: The text does not mention any components or functions related to analyzing biological samples (like blood, urine, etc.) to diagnose, monitor, or screen for a disease or condition.
Therefore, the t:slim™ Insulin Delivery System is a therapeutic device for insulin delivery, not an IVD.
N/A
Intended Use / Indications for Use
The t:slim™ Insulin Delivery System is intended 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.
Product codes (comma separated list FDA assigned to the subject device)
LZG
Device Description
The t:slim™ Insulin Delivery System ("t:slim System") consists of the following components and accessories:
-
- a software-controlled, programmable insulin infusion pump ("t:slim Pump" or "Pump").
-
- a dedicated, disposable 3mL (300 unit) insulin cartridge ("cartridge");
-
- an UnoMedical Comfort™ Infusion Set (K051264), or an equivalently FDA cleared infusion set ("infusion set"); and
-
- accessories, including a Becton Dickenson 3mL sterile syringe and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply with USB for charging the Pump's internal battery, cartridge Instructions for Use, and User's Guide.
The t:slim Pump is a battery operated infusion pump capable of both basal and bolus delivery of insulin. It utilizes a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient's subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the end user (i.e., the patient). The graphical user interface on the t:slim Pump is a capacitive touch screen that is overlaid on an organic light emitting diode ("OLED") screen that displays information used to control the t:slim System. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge. Cartridges are individually packaged and sealed, and provided sterile. The cartridge attaches to the t:slim Pump and is designed to hold up to 3 mL, or 300 units, of insulin. The cartridge has been tested for insulin compatibility with two types of rapid-acting U-100 insulin (Humalog® and NovoLog®) and determined to be insulin compatible as demonstrated by the performance data submitted in this 510(k) application.
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)
Tandem Diabetes Care™, Inc. ("Tandem") completed the appropriate validation and verification activities required by the Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump -- Premarket Notification [510(k)] Submissions Draft Guidance, issued on April 23, 2010 ("Draft Guidance"). Pump validation and verification activities included: software, hardware, mechanical, environmental conditioning, water ingress, simulated aging testing, electrical safety and electromagnetic compatibility testing. Cartridge verification activities included: mechanical testing, environmental conditioning, simulated aging, biocompatibility and insulin compatibility testing. System performance testing was conducted to ensure that the t:slim System meets its intended requirements. Tandem completed verification of the t:slim System's user interface through a series of Formative Studies. Testing was completed to relevant standards, as applicable.
The following performance and safety tests were conducted to evaluate the t:slim System:
- Pump Flow Rate Accuracy
- Pump Bolus Accuracy
- Battery Indication Performance
- Cartridge Depletion and Low Insulin Alert
- Summative Human Factors Study
- Cartridge Performance Validation
- Pump Environmental and Operational Life Validation
- Flow Rate Accuracy for Minimum Flow Rate
- Flow Rate Accuracy after Change in the Infusion Rate or Bolus Dose
- Insulin Stability Study
- Minimum Bolus Accuracy
- Occlusion Alarm Test
- Free Fall Test and Vibration Tests.
In all instances, the t.slim Insulin Delivery System functioned as intended and testing results observed were as expected.
Human Factors Validation: Validation of the User interface was accomplished through a prospective non-randomized, multicenter Investigational Human Factors Summative Study. In this Summative Study, a total of 53 patients ranging in age from 12-74 years old participated in representative training, then exercised all tasks critical for the safe operation of the t:slim System in the home use ambulatory environment. This Study demonstrated that the t.slim System can be used without critical errors that could lead to user harm. Through this comprehensive series of tests and system risk analysis, the Company has demonstrated that the t:slim System satisfies all functional performance, safety requirements, and user meets its intended use, and is safe for the intended user population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Medtronic MiniMed's 508 Insulin Pump (K990801), Nipro Diabetes Systems, Inc.'s Amigo Insulin Pump (K071613)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
UnoMedical Comfort™ Infusion Set (K051264)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
NOV - 9 2011
510(k) SUMMARY Tandem Diabetes Care, Inc.'s t:slim™ Insulin Delivery System
Submitter's Name, Address, Telephone Number, Contact Person, Contact Email Address and Date Prepared
Tandem Diabetes Care™, Inc. 11045 Roselle Street, Suite 200 San Diego, California 92121 Phone: (858) 366-6963 Facsimile: (858) 202-6707
Contact Person: Don Canal Contact Email Address: dcanal@tandemdiabetes.com
Date Prepared: August 3, 2011
Common or Usual Name / Classification Regulation
Insulin Pump / 21 C.F.R. 880.5725
Predicate Devices
Medtronic MiniMed's 508 Insulin Pump (K990801)
Nipro Diabetes Systems, Inc.'s Amigo Insulin Pump (K071613)
Intended Use / Indications for Use
The t:slim™ Insulin Delivery System is intended 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.
Device Description
The t:slim™ Insulin Delivery System ("t:slim System") consists of the following components and accessories:
-
- a software-controlled, programmable insulin infusion pump ("t:slim Pump" or "Pump").
-
- a dedicated, disposable 3mL (300 unit) insulin cartridge ("cartridge");
-
- an UnoMedical Comfort™ Infusion Set (K051264), or an equivalently FDA cleared infusion set ("infusion set"); and
-
- accessories, including a Becton Dickenson 3mL sterile syringe and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply with USB for charging the Pump's internal battery, cartridge Instructions for Use, and User's Guide.
The t:slim Pump is a battery operated infusion pump capable of both basal and bolus delivery of insulin. It utilizes a motor-driven mechanism to deliver insulin from within a
1
disposable cartridge, through an infusion set, into a patient's subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the end user (i.e., the patient). The graphical user interface on the t:slim Pump is a capacitive touch screen that is overlaid on an organic light emitting diode ("OLED") screen that displays information used to control the t:slim System. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge.
Cartridges are individually packaged and sealed, and provided sterile. The cartridge attaches to the t:slim Pump and is designed to hold up to 3 mL, or 300 units, of insulin. The cartridge has been tested for insulin compatibility with two types of rapid-acting U-100 insulin (Humalog® and NovoLog®) and determined to be insulin compatible as demonstrated by the performance data submitted in this 510(k) application.
Technological Characteristics
The t:slim System consists of: (1) a software-controlled, programmable insulin infusion pump capable of both basal and bolus delivery of insulin ("t:slim Pump"): (2) a dedicated disposable 3mL (300 unit) insulin cartridge; (3) UnoMedical's Comfort™ Infusion Set (K051264), or an equivalently cleared set; and (4) additional device accessories. The t:slim System and the cartridge materials of construction are commonly used in electromechanical medical equipment.
Performance Data
Tandem Diabetes Care™, Inc. ("Tandem") completed the appropriate validation and verification activities required by the Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump -- Premarket Notification [510(k)] Submissions Draft Guidance, issued on April 23, 2010 ("Draft Guidance"). Pump validation and verification activities included: software, hardware, mechanical, environmental conditioning, water ingress, simulated aging testing, electrical safety and electromagnetic compatibility testing. Cartridge verification activities included: mechanical testing, environmental conditioning, simulated aging, biocompatibility and insulin compatibility testing. System performance testing was conducted to ensure that the t:slim System meets its intended requirements. Tandem completed verification of the t:slim System's user interface through a series of Formative Studies. Testing was completed to relevant standards, as applicable.
The following performance and safety tests were conducted to evaluate the t:slim System:
- Pump Flow Rate Accuracy, .
- . Pump Bolus Accuracy.
- Battery Indication Performance, .
- Cartridge Depletion and Low Insulin Alert, .
- t Summative Human Factors Study,
- . Cartridge Performance Validation,
- Pump Environmental and Operational Life Validation, .
- . Flow Rate Accuracy for Minimum Flow Rate,
- Flow Rate Accuracy after Change in the Infusion Rate or Bolus Dose, .
- t Insulin Stability Study,
2
- Minimum Bolus Accuracy, .
- . Occlusion Alarm Test, and
- . Free Fall Test and Vibration Tests.
In all instances, the t.slim Insulin Delivery System functioned as intended and testing results observed were as expected.
Human Factors Validation
Validation of the User interface was accomplished through a prospective non-randomized, multicenter Investigational Human Factors Summative Study. In this Summative Study, a total of 53 patients ranging in age from 12-74 years old participated in representative training, then exercised all tasks critical for the safe operation of the t:slim System in the home use ambulatory environment. This Study demonstrated that the t.slim System can be used without critical errors that could lead to user harm. Through this comprehensive series of tests and system risk analysis, the Company has demonstrated that the t:slim System satisfies all functional performance, safety requirements, and user meets its intended use, and is safe for the intended user population.
Assurance Case Reports
Tandem has demonstrated the t:slim System is safe and effective as intended, through the use of Assurance Case Reports as recommended in the Draft Guidance.
Substantial Equivalence
The t:slim System is as safe and effective as Medtronic MiniMed's 508 Insulin Pump (K990801) and Nipro Medical Corporation's Amigo Insulin Pump (K071613), as demonstrated by performance data. It has the same intended use/indications for use, and similar technological characteristics and principles of operation, and the minor technological differences between the t.slim System and its predicate devices raise no new issues of safety or effectiveness. Thus, the t:slim System is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Don Canal Vice President, Quality and Regulatory Tandem Diabetes Care, Incorporated 11045 Roselle Street Suite 200 San Diego, California 92121
NOV - 9 2011
Re: K111210
Trade/Device Name: t:slim Insulin Delivery System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG Dated: November 7, 2011 Received: November 7, 2011
Dear Mr. Canal:
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.
4
Page 2 - Mr. Canal
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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Antman 20. nute
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K111210
Device Name: t:slim™ Insulin Delivery System
Indications for Use:
The t:slim™ Insulin Delivery System is intended 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.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111210