SURESET INFUSION SET, MODEL 8023

K012429 · Applied Diabetes Research, Incorporated · FPA · Nov 6, 2001 · General Hospital

Device Facts

• Record ID: K012429
• Device Name: SURESET INFUSION SET, MODEL 8023
• Applicant: Applied Diabetes Research, Incorporated
• Product Code: FPA · General Hospital
• Decision Date: Nov 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump

Device Story

Subcutaneous insulin infusion set; connects external infusion pump to patient. Introducer needle inserted at right angle into subcutaneous tissue; needle withdrawn leaving indwelling catheter. Tubing primed with medication; SmartSet hub locked to tubing. Used in clinical or home settings; operated by patient or healthcare provider. Facilitates continuous delivery of insulin from external pump to patient.

Clinical Evidence

No clinical data. Biocompatibility and sterilization testing submitted.

Technological Characteristics

Subcutaneous infusion set; includes introducer needle and indwelling catheter. Biocompatible materials; sterilized. Manual operation; no energy source or software.

Indications for Use

Indicated for subcutaneous infusion of medicine, including insulin, from an external infusion pump.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MiniMed Sof-Set Micro QR Infusion Set (K991979)

Submission Summary (Full Text)

{0}------------------------------------------------

NOV 0 6 2001

## 510(k) Summary

Applied Diabetes Research, Inc. 1. Name/Address of Submitter: 1740 South IH 35E Suite 112 Carrollton, TX 75006

2. Contact Person: George R. Lynch President [phone] [phone]

- 3. Date Summary Prepared: July 16, 2001
- 4. Device Name: SmartSet Insulin Infusion Device
- 5. Predicate Devices: MiniMed Sof-Set Micro QR Infusion Set (K991979)
- 6. Device Description and Intended Use: The SmartSet Insulin Infusion Device is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. Its introducer needle is inserted at a right angle into the subcurtaneous tissue of the infusion site and then withdrawn to leave the indwelling catheter in place. The pump end of the Smart-Set tubing is attached to an external infusion pump. Following the pump manufacturer's instructions, the tubing is primed until medication drips from the connector needle. The SmartSet end of the tubing is aligned with the SmartSet hub and then firmly locked together.
- 7. Brief Description of Nonclinical and Clinical Testing: Appropriate information relative to the biocompatibility of the device's components and the sterilization of the finished device, but not clinical study findings, were submitted.
- 8. Conclusions Drawn: The intended use of the SmartSet Insulin Infusion Device 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.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 6 2001

Applied Diabetes Research, Incorporated C/O Mr. Charles H. Kyper Kyper & Associates 103 Nolen Lane Church Hill, North Carolina 27516

Re: K012429

Trade/Device Name: Sureset Infusion Set, Model 8023 Regulation Number: 880.5440 Regulation Name: FPA Set, Administration, Intravascular Regulatory Class: II Product Code: FPA Dated: August 28, 2001 Received: August 29, 2001

Dear Mr. Kyper:

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.

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

{2}------------------------------------------------

## Page 2 - Mr. Kyper

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Susan Runnes

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

NOV 0 6 2001

## Indication for Use

4012429 510(k) Number ( if known):

Device Name:

Indication for Use: Intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump

Concurrence of CDRH Office of Device Evaluation

Prescription Use _1 (per 21 CFR 801.109) OR

Over-the-counter Use _________________________________________________________________________________________________________________________________________________________

Patricia Cassatt

: Non Sian-Off sion of Dental, Infection Control, General Hospital De (k) Number .