(22 days)
The intended use of the Simplicity Soft QD Micro Infusion Set is to provide a means to infuse insulin subcutaneously from a pump or syringe.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Simplicity Soft QD Micro Infusion Set." It details the regulatory classification and approval process, but it does not contain any information about acceptance criteria or specific study data to prove the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for market entry. However, substantial equivalence typically relies on demonstrating that the new device performs as intended and is as safe and effective as a predicate device, which may involve various tests, but the results of those tests and associated acceptance criteria are not included in this document.
Therefore, I cannot provide the requested information based on the text provided.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 2001
Mr. Joel S. Douglas Chief Technology Officer Sterling Medivations, Incorporated 25285 La Loma Drive Los Altos Hills, California 94022-4583
Re: K012845
Trade/Device Name: Simplicity Soft QD Micro Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 22, 2001 Received: August 23, 2001
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 ou must compry with as a 807); labeling (21 CFR Part 801); good manufacturing practice and lisung (21 OF Revel 007), assility systems (QS) regulation (21 CFR Part 820); and if requirements as bet rortir in adiation control provisions (section 531-542 of the Act, 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 510(k) This feter wification. The FDA finding of substantial equivalence of your device to a promation nowned on a 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 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 807.97). Other general information on your responsibilities under the nothreadon (210) 16 00191). Only & 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,
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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510(k) Number (if known):
Device Name: Simplicity Soft QD Micro Infusion Set
Indications For Use:
The intended use of the Simplicity Soft QD Micro Infusion Set is to provide a means to infuse insulin subcutaneously from a pump or syringe.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (PER 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Patrizio Cucente
Consion of Dental, Infection Control Seneral Hospita ETC(k) Number
Page 7 of 98
§ 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.