DECAP

K993147 · The Kipp Group · FPA · Nov 2, 1999 · General Hospital

Device Facts

• Record ID: K993147
• Device Name: DECAP
• Applicant: The Kipp Group
• Product Code: FPA · General Hospital
• Decision Date: Nov 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended 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.

Device Story

DECap™ is a non-vented cap designed to seal male or female luer locks on medical devices (e.g., manifolds, stopcocks, sets). Device functions as a physical barrier to maintain system integrity. Used in clinical settings by healthcare professionals. Provides a secure closure for luer-connected medical equipment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-vented cap; designed for male or female luer lock interfaces.

Indications for Use

Indicated for sealing male or female luer locks on medical devices such as manifolds, stopcocks, or sets. No specific patient population or contraindications described.

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)

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

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

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

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 [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" (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 [phone] 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

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

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