(321 days)
Not Found
No
The 510(k) summary describes a standard electrosurgical pencil for cutting and coagulation, with optional suction. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The description focuses on the physical function and adaptability of the device.
Yes
The device is used for cutting and coagulation to remove tissue and control bleeding, which are therapeutic actions.
No
The device is described as an electrosurgical tool for cutting, coagulation, tissue removal, and bleeding control during surgery. These are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it consists of "disposable electrosurgical pencils," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is used for "cutting and coagulation to remove tissue and control bleeding by use of high frequency current." This is a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description reinforces its use in surgery for tissue removal, bleeding control, and suction of surgical debris.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely focused on performing a surgical procedure directly on the patient.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
Peng's Multifunctional Operative Dissector (PMOD)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.
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.
1
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
2
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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