(189 days)
Not Found
No
The device description and performance studies focus on mechanical, chemical, and biological aspects of insulin delivery, with no mention of AI or ML for decision-making or data analysis.
Yes
The device is described as an "On-Demand Insulin Delivery System" intended for "subcutaneous, bolus delivery of insulin for the management of diabetes mellitus," which directly indicates a therapeutic purpose.
No
Explanation: The device is described as an "On-Demand Insulin Delivery System" intended for "subcutaneous, bolus delivery of insulin for the management of diabetes mellitus." Its components and function are solely focused on the delivery of insulin, which is a therapeutic action, not a diagnostic one. There is no mention of it measuring, analyzing, or interpreting any biological signals or data to identify a disease, condition, or risk.
No
The device description explicitly lists multiple hardware components including an Insulin Delivery Device (Patch), Inserter, Fill Syringe, Dose Count Reminder Card, and Change by Stickers.
Based on the provided information, the One Touch Via™ On-Demand Insulin Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the delivery of insulin for the management of diabetes. This is a therapeutic action, not a diagnostic one.
- Device Description: The description details a system for physically delivering a substance (insulin) into the body. It does not describe any components or processes for analyzing samples (like blood, urine, etc.) to provide diagnostic information.
- Lack of Diagnostic Function: The device's function is to administer a bolus dose of insulin based on user input. It does not perform any tests or measurements on biological samples to diagnose, monitor, or screen for a condition.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for diagnostic, monitoring, or screening purposes. The One Touch Via™ system does not perform this type of function.
N/A
Intended Use / Indications for Use
The One Touch Via™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
Product codes (comma separated list FDA assigned to the subject device)
OPP, LZG
Device Description
The OneTouch Via™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyrogenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch," "the Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 72 hours using a biocompatible adhesive.
The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the patient during the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The OneTouch Via™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
adult persons
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)
Appropriate verification activities were completed as recommended by the FDA Guidance for Industry and FDA Staff: Total Product Life Cycle: Infusion Pump (Issued December 2, 2014) and other applicable guidance. The following performance testing was identified by appropriate risk management activities conducted in accordance with ISO 14971:2007: Medical devices – Application of risk management to medical devices.
Insulin compatibility and stability studies have demonstrated the chemical, physical, and microbiological stability of insulin in the IDD for the period of time specified in the labeling.
The biocompatibility evaluation for the OneTouch Via™ IDS was conducted per FDA Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Issued June 16, 2016). The following Biocompatibility Testing was completed as part of this evaluation:
- Cytotoxicity testing
- Sensitization testing
- Intracutaneous reactivity testing
- Acute systemic toxicity testing
- Subacute/Subchronic Toxicity
- Genotoxicity
- Implantation
- Material Mediated Pyrogen
- Hemolysis
Design verification studies per test methods and acceptance criteria previously established for the predicate device were conducted on finished devices which were representative of commercial device have demonstrated the function, wear and mechanical reliability of the device for the intended period of time. Testing included dimensional inspection, IDD performance testing (at nominal and extreme environmental conditions), alarm function, leak testing, cannula function, needle function, chemical compatibility, packaging testing, fluid ingress, and adhesive performance. Design verification studies including chemical exposure, cleanability and functional testing have also demonstrated the function and reliability of the Inserter accessory. Design verification testing has also been conducted demonstrating the function and reliability of the Fill Syringe accessory. Human factors studies have been completed that demonstrate labeling comprehension and usability.
The results from this non-clinical performance testing demonstrate that the technological characteristics and performance criteria of the proposed device are comparable to the predicate device and that the proposed device performs in a manner equivalent to the predicate device (K111924).
No clinical performance data is required to validate the intended uses and user needs of the system.
In accordance with the FDA guidance for Industry and FDA Staff: Infusion Pumps Total Product Life Cycle (Issued December 2, 2014), a Safety Assurance Case has been developed for the IDS. The Safety Assurance Case (SAC) provides a structured argument in Goal Structuring Notation (GSN) format, which presents a top level claim, supported by a body of valid scientific evidence, and context that provides an organized case that the IDS adequately addresses hazards associated with its intended use within its environment of use. The scope of the Safety Assurance Case is to demonstrate that the IDS is acceptably safe for the intended use.
The following three top level argument structures were used to support the top level claim:
- Argue through the claim and evidence process that risks to health associated with the use of the IDS have been adequately mitigated.
- Argue through the claim and evidence process that design requirements and specifications are adequate for the IDS.
- Argue through the claim and evidence process that IDS is reliable throughout the normal life of the product.
No additional hazards or harms were identified during the construction and review of the Safety Assurance Case. This process did, however, provide clarity between the linkages and safety aspects of the Design History File. In conclusion, the Safety Assurance Case presents claims, arguments and evidence to collectively substantiate the top-level argument that the system is acceptably safe for its intended use.
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.
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2017
Lifescan Europe, A Division Of Cilag Gmbh % Kirsten Franco Sr. Regulatory Affairs Program Lead Lifescan Inc. 965 Chesterbrook Blvd Wayne, Pennsylvania 19087
Re: K163357
Trade/Device Name: One Touch Via™ On-Demand Insulin Delivery System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: OPP, LZG Dated: May 3, 2017 Received: May 5, 2017
Dear Kirsten Franco:
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 (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/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,
Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". There is also a dash followed by the letter "s" below the name. The signature is complex and illegible, consisting of loops and curves.
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
2
Indications for Use
510(k) Number (if known)
Device Name
One Touch Via™ On-Demand Insulin Delivery System
Indications for Use (Describe)
The One Touch Via™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5 - 510(k) Summary
This 510(k) summary is provided as part of this Premarket Notification in compliance with 21 CFR Section 807.92.
| 510(k) Submitter: | LifeScan Europe, a division of Cilag GmbH
Gubelstrasse 34
CH-6300 Zug
Switzerland | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Contact: | Kirsten Stowell Franco
Sr. Regulatory Affairs Program Lead
965 Chesterbrook Blvd
Wayne, PA 19087 | |
| | Phone: | 484-328-6043 |
| | Fax: | 855-261-4885 |
| | Email: | kfranco5@its.jnj.com |
| Date Prepared: | May 2, 2017 | |
| Device trade name: | OneTouch Via™ On-Demand Insulin Delivery System | |
| Device Common
Name: | Disposable Insulin Infusion Pump | |
| Device classification: | Infusion Pump
Product Code: OPP (primary); LZG (secondary)
21 CFR 880.5725
Class II
80 - General Hospital | |
| Legally marketed
predicate device: | K111924 | FINESSE™ Personal Insulin Delivery System |
| Predicate device
classification: | Infusion Pump
Product Code: OPP (primary); LZG (secondary)
21 CFR 880.5725
Class II | |
Device Description
4
Section 5 - 510(k) Summarv
The OneTouch Via™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyrogenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch," "the Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 72 hours using a biocompatible adhesive.
The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the patient during the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The OneTouch Via™ IDS is constructed from biocompatible plastics, elastomers, and
stainless steel.
Indications for Use
The OneTouch Via™ On-Demand Insulin Delivery System is indicated for the subcutaneous bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
Comparison to the Predicate Device
The purpose of this submission is to describe minor modifications in component design for improved manufacturability associated with the relocation and increased automation of the manufacturing of the OneTouch Via™ On-Demand Insulin Delivery System. This manufacturing relocation required no major changes in manufacturing process technologies. Additional minor changes from the predicate device include minor changes to labeling content and format, including product trade name and branding changes. The changes from K111924 include:
Design Changes:
- Fill Syringe & Needle material and design changes; ●
- Packaging design and material change
- Internal component dimensional changes ●
- Needle Handle/Clip Design Change; ●
- . Minor material grade changes and/or supplier change;
5
-
Minor changes to labeling content and format, including product trade name and ● branding changes.
Process / Tooling / Supplier Changes: -
. Component mold tool changes;
-
Contract sterilization supplier change .
The intended use and Indications for Use of the subject device, as described in the labeling, are identical to the predicate device; there is no change since clearance under K111924. The System technological characteristics, performance characteristics, and the user interface remain unchanged.
Technological Characteristics
The OneTouch Via™ IDS meets the FDA description of a pump, infusion, insulin bolus as established in product codes 80-OPP, and pump, infusion, insulin as established in product code 80-LZG. The IDD is identical to other insulin delivery devices in that it uses a positive volume displacement type of manual piston to precisely deliver discrete doses of insulin from the internal reservoir. The IDD does not contain any power sources; it is non-electrically powered. The IDD piston is actuated by the mechanical action of the user's fingers pressing on the buttons. It contains a reservoir to hold insulin. The IDD has a single lumen flexible catheter/cannula that delivers the insulin to the subcutaneous tissues. The IDD may be worn for up to 72 hours. The IDD is used by a patient to deliver rapid acting insulin, i.e., insulin delivery requires competent human interaction to actuate the buttons to deliver insulin.
The proposed OneTouch Via™ IDS is substantially equivalent to the Calibra Medical FINESSE™ Personal Insulin Delivery System cleared under 510(k) K111924, as both devices share the following:
- Intended Use / Indications for use
- Fundamental Scientific Technology ●
- Principles of Operation ●
- Conditions of Use ●
Additionally, the labeling and device materials are similar between the proposed and marketed devices.
6
Non-Clinical Performance Data
Appropriate verification activities were completed as recommended by the FDA Guidance for Industry and FDA Staff: Total Product Life Cycle: Infusion Pump (Issued December 2, 2014) and other applicable guidance. The following performance testing was identified by appropriate risk management activities conducted in accordance with ISO 14971:2007: Medical devices – Application of risk management to medical devices.
Insulin compatibility and stability studies have demonstrated the chemical, physical, and microbiological stability of insulin in the IDD for the period of time specified in the labeling.
The biocompatibility evaluation for the OneTouch Via™ IDS was conducted per FDA Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Issued June 16, 2016). The following Biocompatibility Testing was completed as part of this evaluation:
- Cytotoxicity testing ●
- Sensitization testing ●
- Intracutaneous reactivity testing ●
- Acute systemic toxicity testing ●
- Subacute/Subchronic Toxicity ●
- Genotoxicity
- Implantation ●
- Material Mediated Pyrogen ●
- Hemolysis ●
Design verification studies per test methods and acceptance criteria previously established for the predicate device were conducted on finished devices which were representative of commercial device have demonstrated the function, wear and mechanical reliability of the device for the intended period of time. Testing included dimensional inspection, IDD performance testing (at nominal and extreme environmental conditions), alarm function, leak testing, cannula function, needle function, chemical compatibility, packaging testing, fluid ingress, and adhesive performance. Design verification studies including chemical exposure, cleanability and functional testing have also demonstrated the function and reliability of the Inserter accessory. Design verification testing has also been conducted demonstrating the
7
Section 5 - 510(k) Summary
function and reliability of the Fill Syringe accessory. Human factors studies have been completed that demonstrate labeling comprehension and usability.
The results from this non-clinical performance testing demonstrate that the technological characteristics and performance criteria of the proposed device are comparable to the predicate device and that the proposed device performs in a manner equivalent to the predicate device (K111924).
No clinical performance data is required to validate the intended uses and user needs of the system.
In accordance with the FDA guidance for Industry and FDA Staff: Infusion Pumps Total Product Life Cycle (Issued December 2, 2014), a Safety Assurance Case has been developed for the IDS. The Safety Assurance Case (SAC) provides a structured argument in Goal Structuring Notation (GSN) format, which presents a top level claim, supported by a body of valid scientific evidence, and context that provides an organized case that the IDS adequately addresses hazards associated with its intended use within its environment of use. The scope of the Safety Assurance Case is to demonstrate that the IDS is acceptably safe for the intended use.
The following three top level argument structures were used to support the top level claim:
-
Argue through the claim and evidence process that risks to health associated with the use of the IDS have been adequately mitigated.
-
Argue through the claim and evidence process that design requirements and specifications are adequate for the IDS.
-
Argue through the claim and evidence process that IDS is reliable throughout the normal life of the product.
No additional hazards or harms were identified during the construction and review of the Safety Assurance Case. This process did, however, provide clarity between the linkages and safety aspects of the Design History File. In conclusion, the Safety Assurance Case presents claims, arguments and evidence to collectively substantiate the top-level argument that the system is acceptably safe for its intended use.
Substantial Equivalence Conclusion
The proposed OneTouch Via™ On-Demand Insulin Delivery System uses the same technology, indications for use, and modes of operation as the predicate FINESSE™
8
Section 5 - 510(k) Summary
Personal Insulin Delivery System (K111924). The proposed modifications do not affect the intended use or technological characteristics of the predicate device. Performance bench testing demonstrated that the subject device met all the existing device specifications, thereby demonstrating that the device is as safe, as effective, and performs as well as the predicate device (K111924).