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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the One Touch Via™ On-Demand Insulin Delivery System (K163357). This document focuses on demonstrating substantial equivalence to a predicate device (FINESSE™ Personal Insulin Delivery System, K111924) rather than presenting a study to prove acceptance criteria for a novel device's performance characteristics.

Therefore, the information requested can only be partially addressed based on the provided text. The document states that the new device has "minor modifications in component design for improved manufacturability associated with the relocation and increased automation of the manufacturing" and "minor changes to labeling content and format". It explicitly states that "The System technological characteristics, performance characteristics, and the user interface remain unchanged" and "No clinical performance data is required to validate the intended uses and user needs of the system."

Given these statements, the "acceptance criteria" discussed are primarily related to ensuring the modified device performs comparably to the predicate device and meets established safety and performance standards for infusion pumps.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with numerical targets and corresponding performance results for the device itself in a typical "device meets acceptance criteria" format. Instead, it states that "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."

It also states: "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)."

This implies that the acceptance criteria are the "existing device specifications" (presumably inherited from the predicate device) and the "test methods" used to verify them. However, these specific criteria and the detailed performance against them are not provided in this summary.

The document lists categories of testing performed:

Insulin compatibility and stability studies
Biocompatibility testing (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Subacute/Subchronic Toxicity, Genotoxicity, Implantation, Material Mediated Pyrogen, Hemolysis)
Design verification studies for function, wear, and mechanical reliability (including 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 for Inserter and Fill Syringe accessories (including chemical exposure, cleanability, and functional testing)
Human factors studies (labeling comprehension and usability)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the "test set" (i.e., the samples used for the non-clinical performance data). It only mentions that "finished devices which were representative of commercial device" were used.

The data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the study described is non-clinical performance testing (bench testing, biocompatibility, human factors) and does not involve "ground truth" derived from expert review in the context of clinical observations or diagnostics. Human factors studies are mentioned, which would involve users, but details on "experts" for ground truth are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the study described is non-clinical performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an insulin delivery system, not an AI-assisted diagnostic or imaging device. The document explicitly states: "No clinical performance data is required to validate the intended uses and user needs of the system."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a mechanical insulin delivery system, not an algorithm. It is a "manual, user filled, positive volume displacement, bolus dosing pump" and "insulin delivery requires competent human interaction to actuate the buttons to deliver insulin."

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This is not applicable for this type of non-clinical device testing. The "ground truth" for non-clinical performance testing would be established engineering specifications, physical/chemical standards, and recognized biological response criteria (e.g., for biocompatibility).

8. The sample size for the training set

This is not applicable. There is no mention of a "training set" for an algorithm, as the device is a mechanical insulin delivery system.

9. How the ground truth for the training set was established

This is not applicable as there is no "training set."

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence of a modified medical device (an insulin delivery system) to an existing predicate device. It relies heavily on non-clinical performance data (bench testing, biocompatibility, human factors) to show that the modifications do not negatively impact safety or effectiveness. The specific numerical acceptance criteria and detailed performance results are not included, nor are clinical trial details or AI-related study design elements.

Summary

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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.

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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 (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,

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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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Indications for Use

510(k) Number (if known)

K163357

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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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 GmbHGubelstrasse 34CH-6300 ZugSwitzerland
Contact:	Kirsten Stowell FrancoSr. Regulatory Affairs Program Lead965 Chesterbrook BlvdWayne, 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 CommonName:	Disposable Insulin Infusion Pump
Device classification:	Infusion PumpProduct Code: OPP (primary); LZG (secondary)21 CFR 880.5725Class II80 - General Hospital
Legally marketedpredicate device:	K111924	FINESSE™ Personal Insulin Delivery System
Predicate deviceclassification:	Infusion PumpProduct Code: OPP (primary); LZG (secondary)21 CFR 880.5725Class II

Device Description

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Section 5 - 510(k) Summarv

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;

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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.

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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

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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™

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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).

Regulation Number and Section

§ 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).