SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN

K020990 · Sterling Medivations, Inc. · FPA · Apr 10, 2002 · General Hospital

Device Facts

• Record ID: K020990
• Device Name: SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
• Applicant: Sterling Medivations, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Apr 10, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use is to provide a means to infuse or inject insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.

Device Story

Simplicity Soft QD II Infusion Set; subcutaneous insulin delivery interface. Connects to external infusion pumps providing continuous or intermittent flow. Facilitates insulin administration; enables patient self-management of insulin therapy. Device consists of tubing and cannula assembly for subcutaneous access. Used in home or clinical settings by patients or caregivers. Output is physical delivery of insulin to subcutaneous tissue; clinical decision-making relies on pump settings and patient glucose monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Subcutaneous infusion set; includes tubing and cannula. Class II device (Product Code FPA). Intended for use with external insulin infusion pumps.

Indications for Use

Indicated for subcutaneous insulin infusion or injection in patients requiring continuous or intermittent insulin delivery via compatible infusion devices.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 0 2002

Mr. Joel Douglas Chief Technology Officer Sterling Medivations, Incorporated 25285 La Loma Drive Los Altos Hills, California 94022-4583

Re: K020990

Trade/Device Name: Simplicity Soft OD II Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Regulatory Class: II Product Code: FPA Dated: March 26, 2002 Received: March 27, 2002

Dear Mr. Douglas:

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 of the Act or any Federal statutes and regulations administered by other Federal agencies.

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## Page: 2 - Mr. Douglas

You must comply with all the Act's requirements, including, but not limited to: registration 1 od inust comply with a807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 807), and lity systems (QS) regulation (21 CFR Part 820); and if requirents as bet form in are qt 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 This tetter will and w you to cognized a finding of substantial equivalence of your device to 310(k) promained no adicate 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 If you debire up of the are 809.10 for in vitro diagnostic devices), please contact the and additionally in the at [phone]. Additionally, for questions on the promotion and office of coffyour 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

Timothy Ulatowski

Timo 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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510(k) Number (if known):

Device Name: Simplicity Soft QD II Infusion Set

Indications For Use:

The intended use is to provide a means to infuse or inject insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻟﺴﻴ Prescription Use (PER 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Patricia Ciccone

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F10(k) Number __ A Oo

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