(42 days)
The DECap™ is a non-vented cap that is intended to seal male or female luer locks that are part of typical medical devices such as manifolds, stopcocks or sets.
The DECap™ is a non-vented cap.
The provided document is a 510(k) clearance letter for a medical device called "DECap™". It primarily focuses on the regulatory approval for marketing the device based on its substantial equivalence to a legally marketed predicate device.
Unfortunately, this document does not contain the detailed information necessary to answer your request regarding acceptance criteria and the specifics of a study proving the device meets those criteria.
The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...".
This means the device was cleared because it was shown to be substantially equivalent to an existing device, not necessarily through a new study with explicit acceptance criteria for its performance. The 510(k) pathway often relies on demonstrating that a new device is as safe and effective as a predicate device, which can involve performance data but doesn't always require a comprehensive study against pre-defined acceptance criteria in the same way a PMA (Premarket Approval) might.
Therefore, I cannot provide the requested information from this document. The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, or details of a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and head. The bird is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov - 2 1999
Mr. Gary Werschmidt Vice President The KippGroup 930 Wanamaker Ontario, California 91761
Re: K993147 DECap™ Trade Name: Regulatory Class: II Product Code: FPA September 3, 1999 Dated: Received: September 21, 1999
Dear Mr. Werschmidt:
We have reviewed your Section 510(k) notification of intent to warket the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic ( GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Werschmidt
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 63892041 or (301) 443-6597 or at its internet address "http://www.fida.gov/cdrh/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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K993/47
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: DECap™
Indications for Use:
The DECap™ is a non-vented cap that is intended to seal male or female luer locks that are part of typical medical devices such as manifolds, stopcocks or sets.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ مكيني____________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Page 6
Patricia Cuceroti
§ 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.