(452 days)
The cautery is a battery-powered medical device used in Ophthalmologic surgical procedures to cause blood vessels to constrict and produce blood loss and keep the surgical field clear. Use for controlling diffuse bleeding and sculpting woven grafts.
The cautery is a battery-powered medical device used in Ophthalmologic surgical procedures to cause blood vessels to constrict and produce blood loss and keep the surgical field clear.
I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Disposable Battery Powered Cautery). It establishes substantial equivalence to a predicate device and provides regulatory information.
However, this document does not contain any information regarding acceptance criteria, device performance results, study design, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.
Therefore, I cannot extract the information required to answer your request.
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Public Health Service
JAN 1 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Modern Medical Equipment Mfg., Ltd. c/o Roger Strube E&M Engineering, Inc. 1705 Dabney Rd. Richmond, VA 23230
Re: K023506
Trade/Device Name: Disposable Battery Powered Cautery Regulation Number: 21 CFR 886.4115 Regulation Name: Thermal Cautery Unit Regulatory Class: Class II Product Code: HQP Dated: October 17, 2003 Received: October 20, 2003
Dear Mr. Strube:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your becally by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in the encreated of the Medical Device Amendments, or to devices that prof to way 20, 1970, the character 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, Act (Act) that ao flor require applect to the general controls provisions of the Act. The general therefore, mance the device, acofov arequirements for annual registration, listing of devices, good controls provibits or willibitions against misbranding and adulteration.
If your device is classificd (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be inay of subject to sublicitions. 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 mcan 1 lease be advised mate 1 177 b issuality t your device complies with other requirements of the Act or mul 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 an the Act s requirements, mortains; but manufacturing practice requirements as set forth in the our); adoning (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 - Roger Strube
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), please contact the Office of Compliance at (301) 594-4613. 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,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) NUMBER (IF KNOWN) K023506
DEVICE NAME: DISPOSABLE CAUTERY (SURGICAL DEVICE)
INDICATIONS FOR USE:
Description:
The cautery is a battery-powered medical device used in Ophthalmologic surgical I he cautery is a battery porrers on one preduce blood loss and keep the proceadios to causes blood. Use for controlling diffuse bleeding and sculpting woven grafts.
(PLEASE DO NOT WRITTE BELOW THIS LINE- USE ADDITIONAL PAGES IN NECESSARY /
N NECESSARY
Afleem
Concurrence of CDRH, Office of Device Evaluation (ODE)
Or
Prescription Use 'V (Per 21 CFR 801.109) Over the -Counter - Use (Optional Format 1-2-96)
Dennis L. McCarthy
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K023506
§ 886.4115 Thermal cautery unit.
(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.