(185 days)
Reusable Hook, Coagulator is a electrical surgical instrument used in arthroscopic and laparoscopic surgical procedures.
Reusable Hook, Coagulator is a electrical surgical instrument
The provided text is a 510(k) clearance letter from the FDA for a device named "Fire Stick," which is described as a "Reusable Hook, Coagulator" used in arthroscopic and laparoscopic surgical procedures. This document is a regulatory approval and does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed study results with acceptance criteria and performance metrics in the way a clinical study report or a more comprehensive premarket approval (PMA) document would.
Therefore, I cannot provide the requested information based on the text provided.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 19 2009
H.S. International Co., Inc. % Mr. Henry Shapiro President 5040 Commercial Circle, Unit A Concord, California 94520
Re: K973197 Trade/Device Name: Fire Stick Regulatory Class: II Product Code: GEI, HRX Dated: December 15, 1998 Received: December 29, 1998
Dear Mr. Shapiro:
This letter corrects our substantially equivalent letter of February 27, 1998.
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 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 (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 additional controls. Existing major regulations affecting your device can 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.
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. 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 - Mr. Henry Shapiro
This letter will allow you to continue 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), please 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html .
Sincerely vours.
Daniel Keane
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):___K 97 3197
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indication For Use:
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Reusable Hook, Coagulator is a electrical surgical instrument used in arthroscopic and laparoscopic surgical procedures.
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Image /page/2/Picture/5 description: This image shows a form titled "Concurrence of CDRH, Office of Device Evaluation (ODE)". The form includes a signature and the division is listed as "General Restorative Devices". The 510(k) Number is K973197 and there is a checkmark next to "Prescription Use".
§ 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.