(41 days)
The sterilization wrap (pouch) is a device intended to be used to enclose another medical device that is to be sterilized using ethylene oxide or steam by a health care provider. It is intended to allow sterilization via ethylene oxide or steam of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Sterilization Wrap (pouch)
I am sorry, but based on the provided FDA letter and accompanying documents, there is no information available regarding the acceptance criteria, study details, or performance of the "Global Healthcare Self-Sealing Sterilization Pouch."
The documents primarily consist of:
- An FDA 510(k) clearance letter for the device, confirming its substantial equivalence to a predicate device.
- An "Indications for Use" statement for the sterilization wrap (pouch).
These documents do not contain the type of technical study data, performance metrics, or statistical analysis typically found in a clinical or validation study report. Therefore, I cannot provide the requested information.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1999 APR
Mr. Alam Ahmed Global Healthcare 130 Brantley Road Atlanta, Georgia 30350
K990567 Re : Global Healthcare Self-Sealing Sterilization Trade Name: Pouch Requlatory Class: II Product Code: FRG Dated: February 19, 1999 February 23, 1999 Received:
Dear Mr. Ahmed:
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, 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, qood 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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 Reqister. Please note: this response to your premarket notification submission does not affect any 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.
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Page 2 - Mr. Ahmed
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdafpov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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| 03/24/1999 13:37 | 770-4519409 |
|---|---|
| 03-24-99 02:09 PM | FROM UNISPLINT 4044400343 |
Page 1 of 1
| 510(k) NUMBER (IF KNOWN): | K990567 |
|---|---|
| DEVICE NAME: | Sterilization Wrap |
| INDICATIONS FOR USE: |
The sterilization wrap (pouch) is a device intended to be used
to enclose another medical device that is to be sterilized using
ethylene oxide or steam by a health care provider. It is intended
to allow sterilization via ethylene oxide or steam of the
enclosed medical device and also to maintain sterility of the
enclosed device until used.
(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)
Chin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K990567 |
|---|---|
| --------------- | --------- |
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§ 880.6850 Sterilization wrap.
(a)
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.(b)
Classification. Class II (performance standards).