(321 days)
Peng's Multifunctional Operative Dissector consists of various types of disposable electrosurgical pencils which are adaptable to common brands of electrosurgical generators for cutting and coagulation to remove tissue and control bleeding by use of high frequency current. Several main models of the electrosurgical pencils can be utilized for suction, and blood, tissue debris, smoke can be removed from the surgical field.
Peng's Multifunctional Operative Dissector (PMOD) consists of various types of disposable electrosurgical pencils which are adaptable to common brands of electrosurgical generators for cutting and coagulation to remove tissue and control bleeding by use of high frequency current. Several main models of the electrosurgical pencils can be utilized for suction, and blood, tissue debris, smoke can be removed from the surgical field.
The provided document is a 510(k) premarket notification letter from the FDA regarding the Peng's Multifunctional Operative Dissector (PMOD). It confirms substantial equivalence to predicate devices but does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on regulatory approval and indications for use, without detailing performance metrics or study designs.
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FEB 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hangzhou Shuyou Medical Instrument Company, Ltd. c/o Jian Chen, M.D. 6868 Colony Drive West Bloomfield, Michigan 48323
Re: K040780
K040760
Trade/Device Name: Peng's Multifunctional Operative Dissector (PMOD) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 3, 2005 Received: January 6, 2005
Dear Dr. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars manat date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food. Drug. devices that have been recuire approval of a premarket approval apploval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applic and Cosment Act (Act) that do not require approvise the general controls provisions of the Act. The You may, therefore, market the devreet, basyer rements for annual registration, listing of general controls provisions of the 120 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 if your device is classifica (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controls. Extronic only of the 21, 2011 addition, FDA may be found in the Outs in the Outserning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a baller requirements of the requirements of the Act
that FDA has made a determination that your device complies with other requirem that FDA has made a determination and Journer Federal agencies. You must or any Pederal statutes and regulations daminderer of a mot limited to: registration and listing (21 comply with an the Act 3 requirements, n.e.; good manufacturing practice requirements as senses as sense CFK Part 807), labeling (21 CFR Part 807), good if applicable, the clectronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Jian Chen, M.D.
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 (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/industry/support/index.html.
Sincerely yours,
Mark A. Wilkerson
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: K040780
Device Name: Peng's Multifunctional Operative Dissector (PMOD)
Indications for Use:
Peng's Multifunctional Operative Dissector consists of various types of disposable electrosurgical pencils which are adaptable to common brands of electrosurgical generators for cutting and coagulation to remove tissue and control bleeding by use of high frequency current. Several main models of the electrosurgical pencils can be utilized for suction, and blood, tissue debris, smoke can be removed from the surgical field.
Prescription Use V
And/Or
Over-the-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_
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§ 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.