(98 days)
The SmartSet Insulin Infusion Device is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump.
Indication for Use: Intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump
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 Its introducer needle is inserted at a right angle into the subcurtaneous tissue of the infusion site and then withdrawn to leave the indwelling catheter in place.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.
The provided text is a 510(k) summary for the SmartSet Insulin Infusion Device. It explicitly states that "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."
Therefore, based on the provided document, there are no clinical study findings, acceptance criteria, or performance data available to address the requested points. The device's substantial equivalence was determined based on its similarity to a predicate device and non-clinical data (biocompatibility and sterilization).
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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
- Contact Person: George R. Lynch President (800) 746-7505 (972) 446-8406
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- Date Summary Prepared: July 16, 2001
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- Device Name: SmartSet Insulin Infusion Device
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- Predicate Devices: MiniMed Sof-Set Micro QR Infusion Set (K991979)
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- 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 Its introducer needle is inserted at a right angle into the subcurtaneous tissue of the infusion site and then withdrawn to leave the indwelling catheter in place.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.
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- 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.
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- 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.
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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
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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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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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 .
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.