The DANA Diabecare® IIS is an external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump is not intended for use with blood or blood products.
The DANA Diabecare® IIS insulin pump is an external digitally controlled syringe pump that is intended for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. It is not intended for use with blood or blood products.

Device Description

The DANA Diabecare® IIS insulin pump is a modification of the device described in K022317, the DANA Diabecare® II Insulin Pump.
The DANA Diabecare® IIS insulin pump is a digitally controlled syringe pump that provides precise insulin delivery and monitoring of device functions. The DANA Diabecare® IIS insulin pump has two insulin delivery modes, the basal infusion rate and meal bolus injections. The user can program up to 24 basal infusion dosages in one-hour increments and three bolus injections daily. The basal infusion rate can be temporarily increased or reduced to accommodate changes in activity levels.
The DANA Diabecare® IIS insulin pump is battery powered, water resistant, compact, and lightweight. The pump is equipped with safety systems, acoustic signals, and an LCD display that reads "SE" for a system error. The data that can be stored and retrieved from the DANA Diabecare® IIS insulin pump software includes the following: 100 alarms, 500 bolus doses, 500 daily insulin dosages, and 500 prime histories. The pump also has an error log.
DANA Diabecare® IIS is intended to be used with a proprietary insulin reservoir and the infusion set. The insulin reservoir is a 3mL plastic syringe with a 300-unit insulin capacity. Accessories for the device include the SUPERLINE, SUPERLINE-Easy Release, Soft-Release-R and Soft-Release-ST, which are identical to those included with the DANA Diabecare® II Insulin Pump, and consist of a 55cm/(70cm)/110cm length of tubing with a luer-lock connector on the proximal end for attachment to the insulin syringe and a 27G needle on the distal end. Additional accessories necessary for operation and maintenance of the pump, syringe, and infusion set are provided with the DANA Diabecare® IIS pump.

AI/ML Overview

The provided document is a 510(k) summary for the DANA Diabecare® IIS Insulin Pump. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, or accuracy that are typically found in studies for diagnostic or AI-driven medical devices.

Instead, the "Performance Testing" section states: "Module and system verification and validation testing was performed on the modified software for the DANA Diabecare® IIS insulin pump. The verification and validation testing confirmed that all new and modified subroutines performed as designed and conformed to the software requirement specifications. The modified software is safe and effective for controlling and monitoring the operation of the DANA Diabecare® IIS insulin pump. A risk analysis was also performed in accordance with the requirements of Medical Device Directive 93/42/EEC and ISO 14971 which confirmed that the modified DANA Diabecare® IIS insulin pump is safe and effective for its intended use for the subcutaneous delivery of insulin for the treatment of diabetes mellitus."

This indicates that the "acceptance criteria" were related to software requirements and safety standards, not statistical performance metrics against a medical ground truth in the way a diagnostic AI would be evaluated. The "study" mentioned is the internal verification and validation testing and risk analysis, which confirmed compliance with these engineering and regulatory standards.

Therefore, many of the requested elements for a deep learning/AI device evaluation cannot be extracted from this document because it describes an insulin pump, not an AI or diagnostic tool.

Here's a breakdown of the information that can be extracted and an explanation for why other requested information is not present:

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

Acceptance Criteria (Implied from text)	Reported Device Performance (Implied from text)
New and modified software subroutines perform as designed.	Confirmed: All new and modified subroutines performed as designed.
Software conforms to specifications.	Confirmed: Software conformed to the software requirement specifications.
Software is safe and effective for controlling and monitoring the pump.	Confirmed: Modified software is safe and effective for controlling and monitoring the operation of the DANA Diabecare® IIS insulin pump.
Device complies with risk analysis requirements (e.g., ISO 14971, MDD 93/42/EEC).	Confirmed: Risk analysis performed, confirming safety and effectiveness for intended use.
Device maintains substantial equivalence to predicate device.	Confirmed by FDA 510(k) clearance (K063126).

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

Not Applicable / Not Provided: This device is an insulin pump, not a diagnostic AI system that uses patient data for a "test set" in the common AI sense. The "verification and validation testing" would have involved internal software testing and hardware testing, not a clinical study on a patient test set in the same way.

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)

Not Applicable / Not Provided: Ground truth in the context of an insulin pump's software validation would relate to whether the code executed correctly and met specifications, not to clinical diagnoses requiring expert medical review.

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

Not Applicable / Not Provided: As above, this concept does not apply to the software verification and validation of an insulin pump.

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

No: This is not an AI-assisted diagnostic device, so an MRMC study is not relevant or described.

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

Not Applicable / Not Provided: The device is an insulin pump; its function is to deliver insulin, not to provide an algorithm-only diagnostic output. Its performance is inherent in its operation, which is always with a human user in the loop providing inputs and monitoring. The "algorithm" here refers to the pump's control software, not a diagnostic AI.

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

Software Requirements Specifications / Engineering Standards: The "ground truth" for the performance testing of the pump's software would have been the predefined requirements and specifications outlined during its development, as well as relevant safety and performance standards (e.g., ISO 14971, Medical Device Directive 93/42/EEC).

8. The sample size for the training set

Not Applicable / Not Provided: This device is not an AI system that undergoes "training" on a data set. Its software is programmed and validated.

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

Not Applicable / Not Provided: As above, the concept of a training set and its ground truth does not apply to this type of device.

Summary

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10F 2

510(k) Summary for DANA Diabecare® IIS

SPONSOR SOOIL Development Co, Ltd. 196-1, Dogok-dong, Kangnam-gu Seoul 135-270 Korea

FEB - 2 2007

Contact Person:	Soo Bong Choi
Telephone:	82-2-3463-0041
Fax:	82-2-3463-7077
E-mail:	sbchoi@kku.edu

Local contact person: Jeremy Kim
Telephone:	(858) 404-0659
Fax:	(858) 404-0747
E-mail:	jeremy@sooil.com

Date of Preparation: October 13, 2006

DEVICE NAME

Proprietary Name: Common/Usual Name: Classification Name: Class Type:

DANA Diabecare® IIS Insulin Infusion pump Infusion pump Class II

PREDICATE DEVICE

DANA Diabecare® II Insulin Pump (SOOIL Development Co., Ltd., K022317, cleared for marketing August 2, 2002).

DEVICE DESCRIPTION

The DANA Diabecare® IIS insulin pump is a modification of the device described in K022317, the DANA Diabecare® II Insulin Pump.

The DANA Diabecare® IIS insulin pump is a digitally controlled syringe pump that provides precise insulin delivery and monitoring of device functions. The DANA Diabecare® IIS insulin pump has two insulin delivery modes, the basal infusion rate and meal bolus injections. The user can program up to 24 basal infusion dosages in one-hour increments and three bolus injections daily. The basal infusion rate can be temporarily increased or reduced to accommodate changes in activity levels.

The DANA Diabecare® IIS insulin pump is battery powered, water resistant, compact, and lightweight. The pump is equipped with safety systems, acoustic signals, and an

િયુ

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LCD display that reads "SE" for a system error. The data that can be stored and retrieved from the DANA Diabecare® IIS insulin pump software includes the following: 100 alarms, 500 bolus doses, 500 daily insulin dosages, and 500 prime histories. The pump also has an error log.

DANA Diabecare® IIS is intended to be used with a proprietary insulin reservoir and the infusion set. The insulin reservoir is a 3mL plastic syringe with a 300-unit insulin capacity. Accessories for the device include the SUPERLINE, SUPERLINE-Easy Release, Soft-Release-R and Soft-Release-ST, which are identical to those included with the DANA Diabecare® II Insulin Pump, and consist of a 55cm/(70cm)/110cm length of tubing with a luer-lock connector on the proximal end for attachment to the insulin syringe and a 27G needle on the distal end. Additional accessories necessary for operation and maintenance of the pump, syringe, and infusion set are provided with the DANA Diabecare® IIS pump.

INTENDED USE

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The modifications made to the predicate DANA Diabecare® II insulin pump to create the proposed DANA Diabecare® IIS insulin pump were implemented to enhance the convenience and ease of use of the device. The modifications were limited to software modifications, including changes to the insulin delivery modes and information storage feature, and one minor change in the material used for the microcontroller of the Main Program. In addition, a carbohydrate counting bolus calculator, a button scroll, and a display language setting were added, and the proposed DANA Diabecare® IIS allows for automatic configuration of insulin dosage, extended meal bolus delivery, and dual pattern bolus delivery.

PERFORMANCE TESTING

Module and system verification and validation testing was performed on the modified software for the DANA Diabecare® IIS insulin pump. The verification and validation testing confirmed that all new and modified subroutines performed as designed and conformed to the software requirement specifications. The modified software is safe and effective for controlling and monitoring the operation of the DANA Diabecare® IIS insulin pump. A risk analysis was also performed in accordance with the requirements of Medical Device Directive 93/42/EEC and ISO 14971 which confirmed that the modified DANA Diabecare® IIS insulin pump is safe and effective for its intended use for the subcutaneous delivery of insulin for the treatment of diabetes mellitus

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the body and wings. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sooil Development Company, Limited C/O Mr. Jeremy Kim Sooil, LLC 5677 Oberlin Drive, Suite 101 San Diego, California 92121

FEB - 2 2007

Re: K063126

Trade/Device Name: DANA Diabecare™ IIS Insulin Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: January 24, 2007 Received: January 24, 2007

Dear Mr. Kim:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 -- Mr. Kim

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chr. Lüscher, PD Dr.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K063126

Device Name: DANA Diabecare® IIS Insulin Pump

Indications for Use:

The DANA Diabecare® IIS insulin pump is an external digitally controlled syringe pump that is intended for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. It is not intended for use with blood or blood products.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Canto V) m

K463126

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).