SURESET 3.0 ML RESERVOIR, MODEL 24-103

K024056 · Applied Diabetes Research, Incorporated · FRN · Jan 17, 2003 · General Hospital

Device Facts

• Record ID: K024056
• Device Name: SURESET 3.0 ML RESERVOIR, MODEL 24-103
• Applicant: Applied Diabetes Research, Incorporated
• Product Code: FRN · General Hospital
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SureSet 3.0 ml Reservoir is indicated for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not indicated for use with blood or blood products.

Device Story

SureSet 3.0 ml Reservoir is a single-use piston syringe; consists of hollow barrel, movable plunger with O-rings, and male Luer lock fitting. Used in conjunction with external infusion pumps and infusion sets (e.g., SmartSet Insulin Infusion Device) to deliver medications subcutaneously. Reservoir placed in external pump; male Luer lock connects to infusion set. Available with or without 22 gauge cannula. Device facilitates medication delivery for patients requiring external pump therapy.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparison.

Technological Characteristics

Single-use 3.0 ml piston syringe; materials include barrel, plunger, and O-rings; features male Luer lock fitting. Available with or without 22 gauge cannula. Mechanical device; no energy source, software, or electronic components.

Indications for Use

Indicated for patients requiring subcutaneous infusion of medication, including insulin, via an external infusion pump. Not indicated 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

• MiniMed 3.0 ml Reservoir (K991936)

Reference Devices

• SmartSet Insulin Infusion Device (K012429)

Submission Summary (Full Text)

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JAN 1 7 2003

Infusion Pump Syringe

510(k) Summary (As required by 21 CFR 807.92(a))

- A. Submitter Information
Applied Diabetes Research, Inc. 1740 South IH 35E. Suite 112 Carrollton, TX 75006

| Phone Number: | 972-446-8406 |
|----------------------------------|------------------|
| Fax Number: | 972-446-9397 |
| Contact: Rick Lynch<br>President | |
| Date: | December 9, 2002 |

- Device Information B.
SureSet 3.0 ml Reservoir Trade/Proprietary Name:

Common name of device:

Pump, Infusion Classification Name:

- C: MiniMed 3.0 ml Reservoir Predicate Device:
Predicate 510(k) #:

- D. Device Description:
The SureSet Reservoir is a single use 3.0 ml piston syringe. It consists of a hollow barrel, movable plunger with O-rings for sealing and a male Luer lock fitting at the distal end. This device is used in conjunction with an external infusion pump and infusion set (e.g. SmartSet Insulin Infusion Device cleared under K012429) to deliver medications, including insulin, subcutaneously. The male Luer lock fitting of the reservoir is connected to the female Luer fitting of an infusion set. The reservoir is placed in an external infusion pump. The SureSet Reservoir is available with a 22 gauge cannula (Model 24-103) or without a cannula (Model 24-104).

K991936

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- E. Intended Use:
The SureSet 3.0 ml Reservoir is indicated for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not indicated for use with blood or blood products.

- ட் Comparison of Required Technological Characteristics:
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the SureSet 3.0 ml Reservoir and the cited predicate device.

- G. Summary and Conclusion of Nonclinical and Clinical Tests:
The intended use of the SureSet 3.0 ml Reservoir is identical to that of the cited predicate device. Any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness.

Conclusion:

The SureSet 3.0 ml Reservoir is substantially equivalent to the MiniMed 3.0 ml Reservoir in indications for use and technological characteristics.

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Image /page/2/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized graphic of what appears to be an abstract representation of a human figure or symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

Applied Diabetes Research, Incorporated C/O Mr. James Barley JB & Associates 28481 LaFalda Laguna Niguel, California 92677

Re: K024056

Trade/Device Name: SureSet 3.0 ml Reservoir Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: December 9, 2002 Received: December 9, 2002

Dear Mr. Barley:

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. Barley

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 vour 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timot Ulatowski 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

The SureSet 3.0 ml Reservoir is indicated for use for the infusion of medicine, including insulin, from an external pump. The reservoir is not intended for use with blood or blood products.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricx Cusente

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

510(k) Number ._______________________________________________________________________________________________________________________________________________________________

(Optional Format 3-10-98)