(324 days)
The EASy So Aspirator PROVIDES A PORTABLE, BATTERY POWER MEDICAL VALUAM SOLICE. THE EXELLIGO ASPIRATOR CAN ALSO BE POWERED FRIM A STANDARD WALL GUTLET WITH THE USE OF IN AC POWER ADAPTER. IT IS INTENDED FOR USE IN THE HOME CARE OF HOSPITAL ENVIRONMENT
Not Found
I am sorry, but without a study or performance data, I cannot provide information on acceptance criteria or device performance. The provided document is a 510(k) clearance letter from the FDA for a device called "EasyGo Aspirator" and does not contain the details of a study or performance metrics. It indicates that the device is substantially equivalent to legally marketed predicate devices, but it does not include a table of acceptance criteria or reported device performance.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with a single snake winding around a staff, which is a common symbol associated with medicine and healthcare organizations.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 1998
Mr. Conley Wallace Quality Assurance Manager Precision Medical 300 Held Drive Northampton, Pennsylvania 18067
K971749 Re: Trade Name: EasyGo Aspirator Regulatory Class: II Product Code: BTA March 12, 1998 Dated: Received: March 17, 1998
Dear Mr. Wallace:
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, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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. Wallace
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 diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 gener 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. Galik, M. Witter, Ph.D., M.
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page / _ of
510(k) Number (if known): K971749
Device Name: EASYGO ASPIRATOR
Indications For Use:
(Per 21 CFR 801. 09)
The EASy So Aspirator PROVIDES A PORTABLE, BATTERY POWER MEDICAL VALUAM SOLICE. THE EXELLIGO ASPIRATOR CAN ALSO BE POWERED FRIM A STANDARD WALL GUTLET WITH THE USE OF IN AC POWER ADAPTER. IT IS INTENDED FOR USE IN THE HOME CARE OF HOSPITAL ENVIRONMENT
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K971749 |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
(Optional Format 1-2-96)
ﭘﺴﺮ
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.