(123 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a software-controlled pump with user-programmed insulin delivery, not an AI/ML-driven system.
Yes.
The device is indicated for the management of diabetes mellitus, which is a therapeutic purpose.
No
The device is described as an insulin delivery system for managing diabetes, not for diagnosing a condition.
No
The device description explicitly lists multiple hardware components, including an insulin infusion pump, a disposable insulin cartridge, an infusion set, and accessories like syringes and power supplies. The 510(k) submission also includes hardware verification and validation testing.
Based on the provided text, the t:slim® Insulin Delivery System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The t:slim system delivers insulin into the body (subcutaneously) for the management of diabetes. It does not analyze blood, urine, or other bodily fluids.
- The intended use is for insulin delivery. The description clearly states its purpose is to deliver insulin at set and variable rates.
- The components are for insulin delivery. The pump, cartridge, infusion set, syringe, and needle are all designed to facilitate the subcutaneous delivery of insulin.
Therefore, the t:slim® Insulin Delivery System is a therapeutic 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 12 years of age and greater.
Product codes
LZG
Device Description
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. The scope of this 510(k) is limited to a new software version and minor changes to the pump component of the t:slim System.
The modified t:slim System, like the predicate device, 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 (K941562) and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply and DC car adapter 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-driver 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 user (i.e., the patient). The graphical user interface ("GUI") of the t:slim Pump is a capacitive touch 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.
The t:slim cartridge is a single-use device. individually packaged 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 delivery of insulin is accomplished through a micro-syringe within the head of the cartridge. The Pump has a pressure measurement sensor to estimate the volume of insulin in the insulin reservoir by measuring air pressure in the cartridge. This information is used to provide feedback to the software to determine the insulin volume, detect occlusions and cartridge removal.
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)
Software verification and validation testing was performed per FDA's quidance document. 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"). Hardware changes were supported by verification testing per previously established acceptance criteria. Completed testing to support substantial equivalence determination included software, hardware, mechanical, environmental conditioning, water ingress, simulated aging testing, electrical safety and electromagnetic compatibility testing. Tandem completed verification of the t:slim System's user interface through a series of human factor formative and summative studies.
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2014
Tandem Diabetes Care, Incorporated c/o Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 1910
Re: K141758
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: October 1, 2014 Received: October 1, 2014
Dear Ms. Hogan:
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.
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
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. 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 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,
Susan Runner DDS, MA
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
t:slim® Insulin Delivery 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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510(k) SUMMARY
Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Tandem Diabetes Care, Inc. 11045 Roselle Street, Suite 200 San Diego, CA 92121 Phone: 858-366-6900 Facsimile: 858-362-7070
Contact Person: John Sheridan Contact Email: jsheridan@tandemdiabetes.com
Date Prepared: June 30, 2014
Common or Usual Name
Insulin infusion pump
Classification Name
Infusion Pump per 21 CFR 880.5725
Predicate Devices
Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System (K111210, K133593)
Purpose of the 510(k) notification
The t:slim® Insulin Delivery System is a modification to the previously cleared t:slim® Insulin Delivery System.
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.
Device Description
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. The scope of this 510(k) is limited to a new software version and minor changes to the pump component of the t:slim System.
The modified t:slim System, like the predicate device, consists of the following components and accessories:
4
-
- 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 (K941562) and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply and DC car adapter 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-driver 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 user (i.e., the patient). The graphical user interface ("GUI") of the t:slim Pump is a capacitive touch 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.
The t:slim cartridge is a single-use device. individually packaged 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 delivery of insulin is accomplished through a micro-syringe within the head of the cartridge. The Pump has a pressure measurement sensor to estimate the volume of insulin in the insulin reservoir by measuring air pressure in the cartridge. This information is used to provide feedback to the software to determine the insulin volume, detect occlusions and cartridge removal.
Technological Characteristics
The modified t:slim Insulin Delivery System has the same technological characteristics as the predicate device. 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 including a sterile syringe and needle (for cartridge filling) and AC power supply and DC car adapter power supply with USB. The new software version and minor changes to the pump component of the t:slim System were verified and/or validated per Tandem's design control process and shown to meet design requirements.
Performance Data
Software verification and validation testing was performed per FDA's quidance document. 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"). Hardware changes were supported by verification testing per previously established acceptance criteria. Completed testing to support substantial equivalence determination included software, hardware, mechanical, environmental conditioning, water ingress, simulated aging testing, electrical safety and electromagnetic compatibility testing. Tandem completed verification of the t:slim System's user interface through a series of human factor formative and summative studies.
5
Substantial Equivalence
The modified t:slim System has the same intended use and indications for use, the same principles of operation, and same technological characteristics as the previously cleared predicate t:slim System. The purpose of this 510(k) is to introduce a new software version and minor hardware changes to the pump component of the System. The verification and validation testing, including human factors testing, confirms that the modified t:slim System is substantially equivalent to its predicate.