(272 days)
Not Found
No
The device description and performance studies focus on the physical properties and electrical performance of a standard electrosurgical electrode, with no mention of AI or ML.
Yes
The device is used to cut and/or coagulate soft tissues during an electrosurgical procedure, which are therapeutic actions.
No
The device is described as being used to "cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly details physical components (conductive electrode tip, insulated shaft, conductive post) and its function involves delivering electrical current for cutting and coagulation, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure." This describes a surgical intervention performed directly on the patient's body.
- Device Description: The description details a surgical electrode that delivers electrical current to tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device described is a surgical tool used for electrosurgery, which is a medical procedure performed directly on a patient.
N/A
Intended Use / Indications for Use
The electrode is used to cut and / or coagulate soft tissues 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 General Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is categorized by three families: Blade, Needle and Ball. Each electrode family offers three series S, M and L in length and different insulation designs. The conductive post of electrode is inserted into the nozzle of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in electrosurgical procedure. This device is used in conjunction with a compatible monopolar electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.
The proposed Disposable General Electrode is a stainless steel shaft insulted by wrapping different electrical insulation materials included of Polyolefin Shrink Wrap, Teflon Shrink Wrap or ABS/HIPS overmold or their combinations. The shaft diameter is about 2.36mm. One end of shaft acts as the electrode tip which is shaped as Blade, Needle or Ball and the other end as conductive post which insert into the nozzle of electrosurgical pencil from which it receives the electrical current.
The conductive electrode tip delivers high frequency current onto a target tissue for cutting and/or coagulation during an electro-surgery. The insulation material prevents accidental conduction of the electrosurgical current from this point to the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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)
Validation and Verification testing was performed on the device and packaging. Simulation Tests include comparative testing was performed on porcine kidney, liver, and muscle for both Cut mode at 50W, 100W, 200W and 300W output power and Coagulation mode at 50W and 100W. It demonstrates that the performance result of device operation and amount of eschar buildup on the tip of electrode are no significant difference between proposed device and predicate device.
Safety Testing was performed to comply with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC60601-2-2: 2009 (Fifth Ed).
EO and ECH residue test was performed in accordance to ISO10993-7 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals after aeration in ETO sterilization process.
The biological evaluation was performed in accordance with ISO10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. Below tests verified that the material use of the proposed electrode is biocompatibility with intended use:
- Intracutaneous Reactivity Test
- In vitro Cytotoxicity Test
- Skin sensitization tests
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2016
Modern Medical Equipment Manufacturing Limited Thomas Chan Tsz Fung Regulatory Supervisor 35-41 Tai Lin Pai Rd., Unit F, 4th Fl., Gold King Ind. Bldg, Kwai Chung, N.T. Hong Kong, China
Re: K152059
Trade/Device Name: Disposable General Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: July 24, 2015 Received: July 24, 2015
Dear Thomas Chan Tsz Fung:
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152059
Device Name Disposable General Electrode
Indications for Use (Describe)
The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| 1. 510(k) Owner | |
|---|---|
| Name: | Modern Medical Equipment Manufacturing Limited |
| Address: | Modern Medical Equipment Mfg., Ltd. |
| 35-41 Tai Lin Pai Rd., Unit F, | |
| 4th Fl., Gold King Ind. Bldg | |
| Kwai Chung, N.T. Hong Kong, China | |
| Telephone: | (852) 2420 9068 |
| Fax: | (852) 2481 1234 |
| Contact person: | Thomas, Chan Tsz Fung |
| Date of preparation: | 20 Jul, 2015 |
| 2. Device | |
| Name of Device: | Disposable General Electrode |
| Trade or proprietary name: | Disposable General Electrode |
| Common or usual name: | Disposable General Electrode |
| Classification name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification Panel: | General & Plastic Surgery |
| Product Code: | GEI |
| Class: | II |
3. Device description
Disposable General Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is categorized by three families: Blade, Needle and Ball. Each electrode family offers three series S, M and L in length and different insulation designs. The conductive post of electrode is inserted into the nozzle of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in electrosurgical procedure. This device is used in conjunction with a compatible monopolar electrosurgical generator and patient grounding pad and complies with IEC60601-1
4
and IEC60601-2-2.
4. Indication for Use
The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure.
5. Predicate device
Disposable Electrode Series with 510(k) number K091672.
6. Technological characteristic
The proposed Disposable General Electrode is a stainless steel shaft insulted by wrapping different electrical insulation materials included of Polyolefin Shrink Wrap, Teflon Shrink Wrap or ABS/HIPS overmold or their combinations. The shaft diameter is about 2.36mm. One end of shaft acts as the electrode tip which is shaped as Blade, Needle or Ball and the other end as conductive post which insert into the nozzle of electrosurgical pencil from which it receives the electrical current..
The conductive electrode tip delivers high frequency current onto a target tissue for cutting and/or coagulation during an electro-surgery. The insulation material prevents accidental conduction of the electrosurgical current from this point to the patient.
The construction of proposed electrode and the predicted device is identical. There are no new questions raised regarding to effectiveness and safety.
7. Substantial Equivalence
The technological characteristic in both proposed device and predicate device is identical. Moreover, performance testing data showed that operation result by using proposed device and predicate device shall be the same.
8. Performance Testing Data
Validation and Verification testing was performed on the device and packaging.
5
Simulation Tests include comparative testing was performed on porcine kidney, liver, and muscle for both Cut mode at 50W, 100W, 200W and 300W output power and Coagulation mode at 50W and 100W. It demonstrates that the performance result of device operation and amount of eschar buildup on the tip of electrode are no significant difference between proposed device and predicate device.
- Safety and Biocompatibility testing data Safety Testing was performed to comply with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC60601-2-2: 2009 (Fifth Ed)
EO and ECH residue test was performed in accordance to ISO10993-7 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals after aeration in ETO sterilization process. The residue level on the patient contact portion of device shall be met below standard
EO residue ≤ 4 mg per device ECH residue ≤ 10 mg per device
The biological evaluation was performed in accordance with ISO10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. Below tests verified that the material use of the proposed electrode is biocompatibility with intended use.
- Intracutaneous Reactivity Test
- In vitro Cytotoxicity Test
- Skin sensitization tests
6
10. Conclusion
Based on comparing technological characteristic and performance testing data, we believe the proposed device, Disposable General Electrode is substantial equivalence to predicate device (K091672).