(415 days)
Indications For Use: The Smoke Evacuation Attachment is intended to remove smoke and aerosols from the surgical site.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Smoke Evacuation Attachment." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment as typically found in clinical validation studies.
The letter explicitly states: "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 relevant indications for use and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the device was approved based on its substantial equivalence to a predicate device, not on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria. The FDA determined that the new device is as safe and effective as the predicate device.
Therefore, I cannot provide the requested information from the given text.
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Image /page/0/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 2004
Mr. David Lou Senior Project Engineer Modern Medical Equipment Manufacturing Limited 5F, Gold King Ind. Bldg., 35 Tai Lin Pai Road Kwai Chung, HONG KONG
Re: K033095
Trade/Device Name: Smoke Evacuation Attachment Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: October 29, 2004 Received: November 1, 2004
Dear Mr. Lou:
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 releveloca dooro and in the enclosure) to legally marketed predicate 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) 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 (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 writ), it may of each be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Lou
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA 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. or mo rot or myly 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 and insting (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirely as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), 11 you contact the Office of Compliance at (240) 276-0115. 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,
Chiu, Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K033095
Device Name: Smoke Evacuation Attachment
Indications For Use:
Indications For Ges surgical site.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
arrer of not write below this line-continue on another page if NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DIVIS
Division
Infection
510(k) Number K033095
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.