(57 days)
Not Found
No
The description focuses on the electrosurgical mechanism and does not mention any AI/ML components or functionalities.
Yes
Explanation: The device is used to deliver high frequency current to target tissue for cutting and coagulation, which is a therapeutic action aimed at treating or alleviating a medical condition (e.g., by removing tissue or stopping bleeding).
No
The device is described for cutting and coagulation of soft tissue during electrosurgical procedures, which are therapeutic actions, not diagnostic ones.
No
The device description clearly describes a physical, disposable electrosurgical pencil with an electrode, which is a hardware component used to deliver electrical current to tissue. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is used to deliver high-frequency current directly to target tissue for cutting and coagulation during an electrosurgical procedure. This is an in vivo (within the living body) procedure.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens or providing diagnostic information based on such analysis.
The device is an electrosurgical tool used for surgical intervention, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The device is to be used in combination with a standard electrosurgical generator to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Disposable electrosurgical pencil uses high density and high frequency current on local tissue thermal effect, the tissue or tissue components vaporization or burst, the medical operation so as to achieve the cutting and coagulation. Therefore, it may not only replace surgical knife for a variety of surgical procedures, and obviously reduce the bleeding or no bleeding. This can significantly reduce the labor intensity of the medical staff, and also shorten the operation time, and is good for patient to recover after surgery.
Disposable electrosurgical pencil is the applied parts of high frequency electrosurgical equipment/generator, when the high-frequency generator outputs a certain waveform of highfrequency current, which passes through the electrosurgical electrode and applies to the tissue of patient for cutting or coagulation, then the residual current returns back to the high-frequency generator through a neutral electrode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Performance testing was conducted for the proposed device in accordance with requirements of FDA's Guidance: Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (issued on March 9, 2020).
A study was performed to compare the penetrating thermal tissue effects of the Mecun disposable electrosurgical pencil. Tissues of porcine kidney and porcine muscle were used for thermal effect testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
October 11, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of a human figure, while the FDA name on the right is written in blue and consists of the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
Shenzhen Mecun Medical Supply Co., Ltd. Mr. Bo Zheng General Manager 2nd Level, 2nd Building, Fuqiang S&T Park 6 Ailian Industrial Park,Zhugushi,Wulian Community, Longgang District Shenzhen, Guangdong 518000 China
Re: K232460
Trade/Device Name: Disposable electrosurgical pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 15, 2023 Received: August 15, 2023
Dear Mr. Zheng:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Colin K. Chen -S
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232460
Device Name Disposable electrosurgical pencil
Indications for Use (Describe)
The device is to be used in combination with a standard electrosurgical generator to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
(K232460)
This summary of 510(K) safety and effectiveness information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1. Submitter
| Submitter's Name | Shenzhen Mecun Medical Supply Co., Ltd. |
|---|---|
| Address | 2nd Level, 2nd Building, Fuqiang S&T Park, 6 Ailian |
| Industrial Park, Zhugushi, Wulian Community, Longgang | |
| Street, Longgang District, Shenzhen City, China | |
| Telephone | +86-755-86062204 |
| Fax number | +86-755-86062204 |
| First Contact person | Name: Mr. Zheng Bo |
| Title: General manager | |
| E-mail: manager@mecun.com | |
| Second contact person | Name: Mr. James Cai |
| Title: Regulatory manager | |
| E-mail: james@szcsqy.com | |
| Data preparation | October 09, 2023 |
2. Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Disposable electrosurgical pencil |
| Classification name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | II |
| Review Panel: | General & Plastic Surgery |
| Product Code: | GEI |
| Regulation Number: | 878.4400 |
3. Predicate Device Information
| Trade Name | Single use electrosurgical pencil with electrode |
|---|---|
| 510(k) Number | K213786 |
| Classification name | Electrosurgical cutting and coagulation device and |
| accessories | |
| Classification: | II |
| Review Panel: | General & Plastic Surgery |
| Product code | GEI |
5
Regulation No. 878.4400
4. Device Descriptions
Disposable electrosurgical pencil uses high density and high frequency current on local tissue thermal effect, the tissue or tissue components vaporization or burst, the medical operation so as to achieve the cutting and coagulation. Therefore, it may not only replace surgical knife for a variety of surgical procedures, and obviously reduce the bleeding or no bleeding. This can significantly reduce the labor intensity of the medical staff, and also shorten the operation time, and is good for patient to recover after surgery.
Disposable electrosurgical pencil is the applied parts of high frequency electrosurgical equipment/generator, when the high-frequency generator outputs a certain waveform of highfrequency current, which passes through the electrosurgical electrode and applies to the tissue of patient for cutting or coagulation, then the residual current returns back to the high-frequency generator through a neutral electrode.
5. Intended Use/Indications for Use
Intended use: The monopolar electrosurgical pencil with electrode is used to deliver high frequency current to target tissue for cutting and coagulation.
Indication for use: The device is to be used in combination with a standard electrosurgical generator to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
6. Comparisons of technological characteristics with the predicate device
The subject device and the predicate device are similar in intended use, compositions, functions, scientific technology, sterilization and method of operation, the following table provides a comparison summary:
| Comparison
| item | Subject Device (K232460) | Predicate Device (K213786) | Remark |
|---|---|---|---|
| Manufacturer | Shenzhen Mecun Medical | ||
| Supply Co., Ltd. | Ningbo Shun Ye Medical | ||
| Company, Ltd. | Remark | ||
| Product name | Disposable electrosurgical | ||
| pencil | Single use electrosurgical | ||
| pencil with electrode | |||
| Product Code | GEI | GEI | Same |
| Regulation | |||
| Number | 878.4400 | 878.4400 | Same |
| Classification | II | II | Same |
| Intended | |||
| use | The monopolar electrosurgical | ||
| pencil with electrode is used to | |||
| deliver high frequency current | |||
| to target tissue for cutting and | |||
| coagulation. | The monopolar electrosurgical | ||
| pencil with electrode is used to | |||
| deliver high frequency current | |||
| to target tissue for cutting and | |||
| coagulation. | Same | ||
| Indications for | |||
| Use | The device is to be used in | ||
| combination with a standard | |||
| electrosurgical generator to cut | |||
| and coagulate soft tissue by | |||
| means of high frequency | |||
| electrical current during an | |||
| electrosurgical procedure. | The device is to be used in | ||
| combination with a standard | |||
| electrosurgical generator to cut | |||
| and coagulate soft tissue by | |||
| means of high frequency | |||
| electrical current during an | |||
| electrosurgical procedure. | Same | ||
| Prescription or | Prescription | Prescription | Same |
| OTC | |||
| Energy delivery | High frequency electrical | ||
| current/energy | High frequency electrical | ||
| current/energy | Same | ||
| User interface | Hand | Footswitch/Hand | Same |
| Structure | Electrode (with a cap), | ||
| insulating sleeve, plastic | |||
| handle, manual controlled | |||
| buttons, cables and plug | Pencil handpiece: a plastic | ||
| handle, electrical cable and a | |||
| plug; | |||
| Electrode: a conductive | |||
| electrode tip, an insulated shaft | |||
| and a conductive post | Same | ||
| Material | Pencil: | ||
| -Housing: ABS; | |||
| -Cable: PVC | |||
| -Switching: ABS | |||
| -Cap: PVC | |||
| Electrode: |
- Stainless steel:
- Coating: Teflon coat; | Pencil:
-Housing: ABS;
-Cable: PVC
-Switching: ABS
Electrode: - Stainless steel;
- Coating: Teflon coat; | Same |
| Switching type | Push button | Push button, rocker switch &
foot control; | Same
(included) |
| Shape of
electrode tip | Blade | Blade, Needle, Ball | Same
(included) |
| Diameter of
electrode tip | 2.36 mm | 2.36 mm | Same |
| Length of
electrode tip | Blade: 69mm, 100mm, 150mm | Blade: 66mm, 70mm, 101mm,
152mm;
Angled blade: 65mm;
Needle: 72mm, 101mm,
152mm;
Angled needle: 60mm, 66mm;
Dermal tip: 60mm;
Ball: 49mm, 50mm, 51mm,
132mm, 133mm, 134mm; | Similar
(Note 1) |
| Rated
accessory
voltage | 4kVp | 4kVp | Same |
| Sterilization | EO sterile | EO sterile | Same |
| Shelf-life | 3 years | 3 years | Same |
| Biocompatibility | Comply with ISO10993-5,
ISO10993-10 & 10993-11 | Comply with ISO10993 | Same |
| Electrical
Performance
and Safety | Comply with IEC60601-1,
IEC60601-1-2,
ISO60601-2-2 | Comply with IEC60601-1,
IEC60601-1-2,
ISO60601-2-2 | Same |
6
Note 1:
The length of the electrode tip is different, the subject device has been tested the safety test, EMC test, and thermal effect test, the difference will not affect the safety and effectiveness of the subject device.
7. Performance data
The subject device conforms to the following standards and guidance:
7.1 Biocompatibility testing
7
The biocompatibility evaluation for Neutral electrode was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The subject device is contacted with patient's breached or compromised surface during the electrosurgery operation for duration of less than 24 hours. The biocompatibility testing includes the following:
- . Cytotoxicity
- . Intracutaneous Reactivity
- Skin Sensitization ●
- . Acute systemic toxicity
- . Pyrogen
7.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the following standards:
- . IEC 60601-1: 2005 + A1:2012 + A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2014 + A1:2020 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC
- IEC 60601-2-2:2017 Medical electrical equipment Part 2-2: Particular requirements for . the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
7.3 Performance testing
Performance testing was conducted for the proposed device in accordance with requirements of FDA's Guidance: Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (issued on March 9, 2020).
A study was performed to compare the penetrating thermal tissue effects of the Mecun disposable electrosurgical pencil. Tissues of porcine kidney and porcine muscle were used for thermal effect testing.
7.4 EO sterilization
The proposed device is also provided for sterilization validation is performed as the standard of ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
8. Conclusions
Based on device comparison information and performance data, the subject device is as safety and effectiveness as predicate device, and the differences do not raise any new issue of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.