The ACCU-CHEK Ultraflex is an ethylene oxide sterilized, single-use, disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The infusion set includes a stainless steel introducer needle to facilitate insertion of the soft cannula into the dermis. The unit is designed to interface with commercially available insulin infusion pumps with suitable luer connections. The insulin infusion pump systems are designed to control the delivery of U100 insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.

AI/ML Overview

The provided text describes the ACCU-CHEK® Ultraflex Infusion Set and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria for device performance or the details of a study proving the device meets specific performance criteria.

The document states that "Non-clinical testing of the modified ACCU-CHEK Ultraflex Infusion Set demonstrated that the device meets the requirements for its intended use" and "Non-clinical testing included: soft cannula length confirmation, introducer needle length confirmation, insertion force, and system functional verification testing."

It also explicitly states: "Clinical testing was not required to validate the device modification or support substantial equivalence."

Therefore, I cannot populate the table or answer most of your detailed questions because the information is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device through material and design similarities and non-clinical testing, rather than a clinical performance study with detailed acceptance criteria and expert-adjudicated ground truth.

Here's what I can extract based on the provided text, along with what is explicitly missing:

Acceptance Criteria and Device Performance

Criteria	Acceptance Criteria (Required Performance)	Reported Device Performance	Study Proving Compliance
Soft Cannula Length	(Not specified in document)	Confirmed (implicitly meets design specifications)	Non-clinical testing
Introducer Needle Length	(Not specified in document)	Confirmed (implicitly meets design specifications)	Non-clinical testing
Insertion Force	(Not specified in document)	Meets requirements (implicitly within acceptable range)	Non-clinical testing
System Functional Verification	(Not specified in document)	Meets requirements (implicitly functions as intended)	Non-clinical testing
Substantial Equivalence (Overall)	Device is as safe and effective as the predicate device (K101196 ACCU-CHEK Ultraflex Infusion Set)	Demonstrated through similar materials, design, indications for use, intended use, sterilization, packaging, and non-clinical testing.	Non-clinical testing and comparison to predicate.

Detailed Study Information (Based on what is NOT in the document)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document refers to "non-clinical testing" without detailing sample sizes for specific tests. No clinical test set.
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)
- Not applicable. No clinical test set with expert-established ground truth was reported.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set with expert adjudication was reported.
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
- Not applicable. This device is an infusion set, not an AI or imaging device that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an infusion set; it does not involve algorithms or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established as clinical testing was not required. Non-clinical testing would rely on engineering specifications and measurement standards.
The sample size for the training set
- Not applicable. No "training set" in the context of machine learning or AI is relevant here. If referring to design verification or validation, it's not specified.
How the ground truth for the training set was established
- Not applicable.

In summary, the provided K122686 510(k) summary focuses on demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical engineering tests (soft cannula length confirmation, introducer needle length confirmation, insertion force, and system functional verification). It explicitly states that clinical testing was not required for this submission.

Summary

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K122686

510(k) Summary Page 1 of 2

ACCU-CHEK®Ultraflex Infusion Set

510(k) Summary

Date of Summary:	August 29, 2012
Submitter:	Roche Diabetes Care AGKirchbergstrasse 190CH-3401 Burgdorf, SwitzerlandNOV 16 2012
Contact Person:	Catherine GreenRegulatory Affairs ManagerRoche Diabetes Care AGKirchbergstrasse 190, CH-3401 Burgdorf, SwitzerlandTel: +41-34-424 2272, catherine.green@roche.com
Device Trade Name:	ACCU-CHEK® Ultraflex Infusion Set
Device Common Name:	Subcutaneous infusion set
Classification name:	Intravascular administration set
Regulation Number:	21 CFR 880.5440
Product Code and Class:	FPA, Class II
Predicate Device	K101196 ACCU-CHEK Ultraflex Infusion Set

Device Description

Intended Uses

The ACCU-CHEK Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

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Technological Characteristics

The modified ACCU-CHEK Ultraflex infusion set uses the same materials and design as the predicate device. The modified ACCU-CHEK Ultraflex infusion set provides a 6mm cannula length variant. The predicate device includes cannula lengths of 8mm and 10mm. There are no other significant differences between the modified ACCU-CHEK Ultraflex and the predicate ACCU-CHEK Ultraflex. The fundamental scientific technology, indications for use, intended use, materials, design, sterilization and packaging are identical between the proposed and predicate devices.

Dimensional characteristics of the predicate compared to the modified device are listed below. ·

Feature	Predicate	Modified
Cannula length	8mm, 10mm	6mm, 8mm, 10mm
Tube Length	30, 60, 80, 110 cm	30, 60, 80, 110 cm
Tubing ID/OD	0.39 mm x 1.46 mm	0.39 mm x 1.46 mm
Priming Volume(average for tube set + 1IU for priming head set)	69μl, 104μl, 128μl, 163μl	69μl, 104μl, 128μl, 163μl

Performance Standards

To date, no performance standards that affect this device have been finalized under Section 514 of the Act.

FDA has published a guidance document for review of intravascular administration sets entitled, Guidance on Premarket Notification for Intravascular Administrations Sets. FDA has also published a guidance document for review of external infusion pumps entitled. Guidance On The Content Of Premarket Notification [510(k)] Submissions For External Infusion Pumps and a draft update entitled, Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions. FDA has published a guidance document for review of medical devices with sharps entitled, Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features: Guidance for Industry and FDA. Roche has evaluated this modified device according to the recommendations provided in these guidance documents and our internal system development guidelines and standard operating procedures.

Testing Conclusions

Non-clinical testing of the modified ACCU-CHEK Ultraflex Infusion Set demonstrated that the device meets the requirements for its intended use. The data also demonstrates that the ACCU-CHEK Ultraflex Infusion Set is substantially equivalent to the predicate device. Non-clinical testing included: soft cannula length confirmation, introducer needle length confirmation, insertion force, and system functional verification testing.

Clinical testing was not required to validate the device modification or support substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 16, 2012

Ms. Catherine Green Regulatory Affairs Manager Roche Diabetes Care AG Kirchbergstrasse 190 Burgdorf, Switzerland CH-3401

Re: K122686

Trade/Device Name: ACCU-CHEK® Ultraflex Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 18, 2012 Received: October 19, 2012

Dear Ms. Green:

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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Page 2 - Ms. Green

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 (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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours,

( Le trans ": Weter -

DN: c=US, o=U.S. Government, ou=HHS. ou=FDA. ou=People cn=Anthony D. Watson, 0.9.2342.19200300.100.1.1=13000 92402

Anthony D. Watson, B.S., M.S., M.B.A. 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): K 122686

Device Name: ACCU-CHEK® Ultraflex Infusion Set

Indications For Use:

The ACCU-CHEK® Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

Digitally signed by Richard C.
Chapman
Date: 2012.11.16 08:33:21 -05'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

·K 122686 510(k) Numbar:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.