(81 days)
For debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds.
Not Found
This document is a 510(k) clearance letter for "Medical Maggots" and does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter confirms substantial equivalence to a predicate device for specific indications for use, but it does not detail any performance metrics or clinical study results.
Therefore, I cannot provide the requested information based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2004
Mr. Ronald A. Sherman 36 Urey Court Irvine, California 92612
Re: K033391
Trade/Device Name: Medical Maggots Regulatory Class: Unclassified Product Code: NQK Dated: October 16, 2003 Received: October 23, 2003
Dear Mr. Sherman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revea your your your determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the Merce , 1976, the enactment date of the Medical Device Amendments, or to econniser that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmotic 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 r ou may, are every, include requirements for annual registration, listing of general controll pro receive, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Spccial Controls) or class III (PMA), it rr your device to such additional controls. Existing major regulations affecting your device can may be fanyott to back at Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Foderal 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 that - Direderal statutes and regulations administered by other Foderal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CHR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Crick 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. Ronald A. Sherman
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) 594-4659. 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Medical Maggots
indications For Use:
For debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Page 1 of _ 1
vision Sign-Off) Division of General, Restorative and Neurological Devices
Number K63339/
N/A