(338 days)
The devices are used to cut and cauterize soft tissue.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for the "Mini Lap Electrocautery Instruments." This document primarily indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.
However, the document does NOT contain information about acceptance criteria, specific device performance metrics, clinical studies, sample sizes for testing or training sets, expert qualifications, or adjudication methods.
The FDA clearance process for a 510(k) submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device. This often involves comparing device features, intended use, technological characteristics, and performance data (which may include bench testing, non-clinical studies, and sometimes limited clinical data, but not always a full-scale clinical trial with the detailed information you're asking for).
Therefore, based solely on the provided text, I cannot complete the requested information. The document focuses on the regulatory clearance aspect rather than detailed performance study results.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (often submitted as part of the 510(k) but not fully reproduced in this clearance letter) or a clinical study report.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mini-Lap Technologies, Inc. % Orchard Design Mr. Joseph M. Azary 80 Shelton Technology Center Shelton, Connecticut 06484
NOV 2 0 2009
Re: K083754
Trade/Device Name: Mini Lap Electrocautery Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 6, 2009 Received: November 13, 2009
Dear Mr. Azary:
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 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 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
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Page 2 - Mr. Joseph Azary
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KO 83754 510(k) Number (if known):
Device Name: MINI LAP Instruments
Indications For Use:
The devices are used to cut and cauterize soft tissue.
Prescription Use X (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) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
1
Orchid Design
-510(k)-Number K083754
A Division of Orchid Orthopedic Solutions www.orchid-orthopedics.com
80 Shelton Technology Center Shelton, Connecticut 06484 USA
Phone: +1 (203) 922-0105 +1 (203) 922-0130 Fax:
§ 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.