DANA DIABECARE IIS

K063126 · Sooil Development Co., Ltd. · LZG · Feb 2, 2007 · General Hospital

Device Facts

• Record ID: K063126
• Device Name: DANA DIABECARE IIS
• Applicant: Sooil Development Co., Ltd.
• Product Code: LZG · General Hospital
• Decision Date: Feb 2, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

DANA Diabecare® IIS is a digitally controlled, battery-powered, portable syringe infusion pump for subcutaneous insulin delivery. Device accepts user input via button interface to program basal infusion rates (up to 24 hourly increments) and bolus injections. Features include carbohydrate counting bolus calculator, extended meal bolus, and dual pattern bolus delivery. Pump stores history logs (alarms, bolus, daily dosage, prime, error). Used by patients for diabetes management; provides precise insulin delivery to assist in glycemic control. Safety systems include acoustic alarms and LCD error indicators. Device utilizes proprietary 3mL insulin reservoirs and infusion sets with luer-lock connectors.

Clinical Evidence

Bench testing only. Module and system verification and validation testing performed on modified software to confirm conformance to requirements. Risk analysis conducted per ISO 14971 and Medical Device Directive 93/42/EEC.

Technological Characteristics

Digitally controlled syringe pump; 3mL plastic reservoir; 27G needle infusion set; battery-powered; water-resistant; compact form factor. Software-controlled insulin delivery modes (basal/bolus). Microcontroller-based architecture.

Indications for Use

Indicated for subcutaneous insulin delivery in patients with diabetes mellitus requiring insulin therapy. Not for use with blood or blood products.

Regulatory Classification

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.

Predicate Devices

• DANA Diabecare® II Insulin Pump (K022317)

Submission Summary (Full Text)

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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: | [e-mail] |

| Local contact person: Jeremy Kim | |
|-----------------------------------|------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

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

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.

### 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 [phone]. 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 [phone] or [phone] 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)

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K463126