DANA 3CC SYRINGE INSULIN RESERVOIR

K071418 · Sooil Development Co., Ltd. · MRZ · Sep 4, 2007 · General Hospital

Device Facts

• Record ID: K071418
• Device Name: DANA 3CC SYRINGE INSULIN RESERVOIR
• Applicant: Sooil Development Co., Ltd.
• Product Code: MRZ · General Hospital
• Decision Date: Sep 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DANA 3cc Syringe Insulin Reservoir is an accessory to the DANA Diabecare® Insulin Pumps. The DANA 3cc Syringe Insulin Reservoir is intended for the delivery of insulin from the DANA Diabecare® Insulin Pumps using specified insulin administration sets. The DANA 3cc Syringe Insulin Reservoir is intended exclusively for use with the DANA Diabecare® Insulin Pumps. The DANA Diabecare® Insulin Pumps external programmable syringe infusion pumps used for the are subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pumps are not intended for use with blood or blood products.

Device Story

DANA 3cc Syringe Insulin Reservoir is a sterile, single-use, 3 ml polypropylene syringe; 300-unit insulin capacity; includes 22 gauge, 12.7 mm needle. Designed as accessory for DANA Diabecare® insulin pumps; features silicone ring-shaped gasket. User fills reservoir like standard insulin syringe; removes air; inserts into pump; attaches to pump linking screw. Used in clinical or home settings by patients or caregivers. Provides insulin storage and delivery interface for pump; ensures compatibility with specific DANA pump models. Benefits patient by enabling precise, programmable subcutaneous insulin administration.

Clinical Evidence

Bench testing only. Design verification activities included evaluation of physical and functional characteristics and shelf-life testing to confirm compatibility with DANA Diabecare® insulin pumps.

Technological Characteristics

3 ml piston syringe; 300-unit insulin capacity; polypropylene body; silicone ring-shaped gasket; 22 gauge, 12.7 mm needle. Sterile, single-use, non-pyrogenic. Mechanical interface with DANA Diabecare® pump via linking screw.

Indications for Use

Indicated for patients with diabetes mellitus requiring subcutaneous insulin delivery via DANA Diabecare® external programmable syringe infusion pumps. 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® (K001604)
• SimpleChoice 3.0 ml Reservoir Pro (K051045)
• SureSet 3.0 ml Reservoir (K024056)
• Simplicity Infusion Reservoir (K013767)
• 3.0 ml Reservoir Model 103/193 (K991936)

Submission Summary (Full Text)

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## 510(k) Summary for DANA 3cc Syringe Insulin Reservoir

### 1. SPONSOR

- 4 2007

Sooil Development Co., Ltd. 196-1, Dogok-dong, Kangnam-gu Seoul, 135-270, KOREA

Soo Bong Choi, CEO Contact: (82) 2-3463-0041 Telephone: [phone] Facsimile:

Date Prepared: July 9, 2007

#### 2. DEVICE NAME

| Proprietary Name: | DANA 3cc Syringe Insulin Reservoir |
|----------------------|------------------------------------|
| Common/Usual Name: | Insulin reservoir |
| Classification Name: | Accessories, infusion pump |

#### 3. PREDICATE DEVICES

- SOOIL Development Co., Ltd., DANA Diabecare® (K001604)*
- Spectrx, Inc., SimpleChoice 3.0 ml Reservoir Pro (K051045)
- Applied Diabetes Research, Inc., SureSet 3.0 ml Reservoir (K024056)
- Sterling Medivations, Inc., Simplicity Infusion Reservoir (K013767)
- Medtronic MiniMed, Inc., 3.0 ml Reservoir Model 103/193 (K991936)
- *Insulin reservoir accessory included in K001604

## DEVICE DESCRIPTION

The DANA 3cc Syringe Insulin Reservoir is a sterile, single-use, non-pyrogenic, syringe that is designed for use with all versions of the DANA Diabcare® Insulin pump that have been cleared for marketing in the U.S. (K001604, K022317, and K063126). The syringe reservoir is a 3 ml polypropylene syringe with a 300 unit insulin capacity that is supplied with a 22 gauge, 12.7 mm straight needle. The

SOOIL Development Co., Ltd. Additional Information - K071418

August 20, 2007

510(k) Summary, Page 1 of 3

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reservoir is filled similarly to filling an insulin syringe. Once filled and inspected for reservoir is filled similariy to fining an insume syringer esservor is inserted into the distal entrapped air, the needle is Tentoved and the syringe has groves cut into the distal.
DANA Diabecare® Insulin pump. The syringe thas grooves cut into the DANA Diabecare® Insulin punip. The syrings pringer has g
end for attachment to the linking screw that connects the syringe reservoir to the end Tor attachmont - A Diabecare® Insulin Pump.

The proposed DANA 3cc Syringe Insulin Reservoir is a modification of the insulin
t the insults the first to 1001604 the wriving 510(k) premarket notification The proposed DANA 3CC Syringe Insumi Reserver and 510(k) premarket notification
reservoir accessory described in K001604, the woldfied to a change reservoir accessory described in Rocroor, the modification was limited to a change
for the DANA Diabecare® Insulin Pump. The moresal DANA 3cc Syringe Insulin for the DANA Diabecare@ Insumil Tamp. The monneed DANA 3cc Syringe Insulin
in the gasket configuration and material. The proposed DANA 3cc Syringe Insulin
Systems on igurati in the gasket contriguration and material.
Reservoir has a ring shape gasket that is manufactured from silicone.

## 5. INTENDED USE

The DANA 3cc Syringe Insulin Reservoir is an accessory to the DANA Dibecare@
in the DANA 3cc Syringe In Decemeir is interveir is intended for the delivery The DANA 3cc Syringe Insumit Reservor is intended for the delivery
Insulin Pumps. The DANA 3cc Syringe Insulin Reservor is unsuling specified, insulin Insulin Pumps. The DANA See Syrings Insulin Pumps using specified insulin administration sets.

The DANA 3cc Syringe Insulin Reservoir is intended exclusively for use with the The DANA 3cc Syringe Insulin Reserver 10 mm Diabecare® Insulin Pumps are DANA Diabecare® Insular Fumps. "The Subcutaneous delivery of
external programmable syringe infusion pumps are not intended for use external programmable syringe midslow painfor and intended for use with blood or blood products.

# 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The material components and technological characteristics of the proposed DANA The material colliponents and the predicate devices are similar. The proposed devices are 3.0 ml piston syringes with a 300 unit insulin capacity. The proposed devices are 3.0 In piston syringes what a comments are supplied sterile and are indicated for single use.

The proposed DANA 3cc Syringe Insulin Reservoir and the predicate devices are indicated for use only with a specified insulin pump. As stated elsewhere, the indicated for use only with a spection on the predicate insulin reservoir reservoir proposed DANA SCC Syringe modial research for use with the DANA Diabecare®
described in K001604 are designed specifically for use with the Bearner The other predicate reservoirs (SimpleChoice 3.0 ml Reservoir Insulin Pump. (K051045), Sureset 3.0 ml Reservoir (K024056), Simplicity Infusion Reservoir (K031043), Surcher 5.0 ml Reservoir (K991936)) are designed exclusively for use with the Medtronic MiniMed® pumps.

SOOIL Development Co., Ltd. Additional Information - K071418 August 20, 2007

510(k) Summary, Page 2 of 3

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| Item for Comparison | DANA 3cc Syringe<br>Insulin Reservoir<br>(Proposed) | DANA<br>Insulin Reservoir<br>(K001604) | Simplicity Infusion<br>Reservoir<br>(K013767) | MiniMed 3.0 ml<br>Reservoir<br>(K991936) |
|-----------------------------|------------------------------------------------------------------------------|----------------------------------------|-----------------------------------------------|------------------------------------------|
| Intended Use | Infusion reservoirs for use to infuse insulin from an external infusion pump | | | |
| Insulin Pump | DANA Diabecare®<br>Insulin Pumps | DANA Diabecare®<br>Insulin Pumps | Medtronic<br>MiniMed® Pumps | Medtronic<br>MiniMed® pumps |
| Technical<br>Specifications | • 3 ml syringe<br>• 300 unit capacity | • 3 ml syringe<br>• 300 unit capacity | • 3 ml syringe<br>• 300 unit capacity | • 3 ml syringe<br>• 300-unit capacity |
| Sterility Status | • Supplied sterile<br>• Single use | • Supplied sterile<br>• Single use | • Supplied sterile<br>• Single use | • Supplied sterile<br>• Single use |

# Comparison Chart for Determination of Substantial Equivalence

## 7. PERFORMANCE TESTING

Design verification activities for the DANA 3cc Syringe Insulin Reservoir included Design vermeanon avon evaluation of physical and functional characteristics, and shelf-life testing. The results confirm that the DANA 3cc Syringe Insulin Reservoir showing to may insulin reservoir for all legally marketed versions of the DANA Diabecare® Insulin Pumps and support the claimed shelf life.

Deleted: a three-yea

SOOIL Development Co., Ltd. Additional Information - K071418

August 20, 2007

510(k) Summary, Page 3 of 3

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sooil Development Company, Limited C/O Cynthia J.M. Nolte, Ph.D., RAC Senior Regulatory Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

SEP - 4 2007

Re: K071418

Trade/Device Name: DANA 3cc Syringe Insulin Reservoir Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: July 9, 2007 Received: July 10, 2007

Dear Dr. Nolte:

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 - Dr. Nolte

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,

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

510(k) Number (if known): K071418

Device Name: DANA 3cc Syringe Insulin Reservoir

Indications for Use:

The DANA 3cc Syringe Insulin Reservoir is an accessory to the DANA Diabecare® Insulin Pumps. The DANA 3cc Syringe Insulin Reservoir is intended for the delivery of insulin from the DANA Diabecare® Insulin Pumps using specified insulin administration sets.

The DANA 3cc Syringe Insulin Reservoir is intended exclusively for use with the DANA Diabecare® Insulin Pumps. The DANA Diabecare® Insulin Pumps external programmable syringe infusion pumps used for the are subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pumps are 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) хаанаа

מחלק מערב משמעות המועד המונח של המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המונח של המועד המועד המועד המועד המוזיקה המועד המוזיקה המועד המוזיקה המועד המוזיק

מאמיני

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

id. OQ. for Chulin
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: Lo 7 148