The packaging tray is intended to be used as a non-reusable protective pack, which allows EO sterilization of the product and maintains sterility for a specified length of time, and protects the product from damage during transport, delivery and storage.
Device Story
Packaging tray functions as a non-reusable protective container for medical devices; facilitates ethylene oxide (EO) sterilization; maintains sterility post-sterilization; provides physical protection against damage during transport, delivery, and storage. Used in clinical or hospital settings by healthcare personnel to house medical devices prior to use. Device ensures integrity of sterile barrier system.
Clinical Evidence
Bench testing only.
Technological Characteristics
Non-reusable protective packaging tray; designed for ethylene oxide (EO) sterilization compatibility; maintains sterile barrier; physical form factor serves as a protective enclosure for medical devices.
Indications for Use
Indicated for use as a non-reusable protective packaging tray for medical devices to facilitate ethylene oxide (EO) sterilization, maintain sterility, and provide physical protection during transport, delivery, and storage.
Regulatory Classification
Identification
A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Submission Summary (Full Text)
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2004
Ms. Courtney Smith Regulatory Consultant Vygon US LLC 2495 General Armstcad Avenue Norristown, Pennsylvania 19403
Re: K040707
Trade/Device Name: Packaging Tray and Accessories Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: II Product Code: FRG Dated: March 9, 2004 Received: March 19, 2004
Dear Ms. Smith:
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 interstatc commerce prior to May 28, 1976, the cnactment 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 (sce 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 Codc 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 I'DA 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. 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.
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Page 2 - Ms. Courtney Smith
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and h your e FDA finding of substantial equivalence of your device to a legally premarket notineted more 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
L. Mark A. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
K040707 510(k) Number (if known):
Device Name: Packaging Tray
Indications For Use:
The packaging tray is intended to be used as a non-reusable protective pack, which allows EO sterilization of the product and maintains sterility for a specified length of time, and protects the product from damage during transport, delivery and storage.
Prescription Use
(Part 21 CFR 801 Subpart D)
✓
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Millum
Division of General, Restorative, and Neurological Devices
310(k) Number K040707
