(231 days)
Not Found
No
The summary describes a passive, disposable electrode with conductive gel, and there is no mention of any computational or algorithmic processing, let alone AI/ML.
No
This device is an accessory for electrosurgical devices, providing a return path for current and preventing burns, rather than directly treating a condition or disease.
No.
The device is described as a neutral electrode used during electrosurgical procedures to provide a return path for high-frequency current, not to diagnose medical conditions.
No
The device description clearly outlines physical components like electrode carrier, conductive gel, aluminum foil, sponge, anti-sticking film, and connecting wire, 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 is as a neutral electrode during electrosurgical procedures, providing a return path for high-frequency current. This is a therapeutic/surgical function, not a diagnostic one.
- Device Description: The description focuses on the physical components and how it functions in an electrosurgical circuit. It does not mention any analysis of biological samples or substances.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific analytes (e.g., glucose, antibodies, DNA).
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is clearly an accessory used during a surgical procedure on the patient's body, not a device used to perform tests on samples outside the body (which is the definition of "in vitro").
N/A
Intended Use / Indications for Use
This disposable neutral electrode for adult patients with conductive adhesive gel is used as neutral reference during electrosurgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Disposable Neutral Electrode, is an accessory for high voltage high frequency electrosurgical devices, connect it to the body of the PATIENT and the HF SURGICAL EQUIPMENT, it can perform it function for provide a return path for the HIGH FREQUENCY current and unwanted burns are avoided.
Construction --- The product consists of Electrode carrier and Clarity PET. It is packed in an al film bag.
The electrode is composed of conductive gel, aluminum foil, sponge, anti-sticking film and connecting wire. Conductive gel is composed of high molecular monomer, glycerinum and water, which is a gel, can be conducted in high frequency and has voltage-sensitive by polymerization.
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
Adult patients
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)
Laboratory testing was conducted to validate and verify that the Disposable Electrosurgical Pencil met all design specifications, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of all consensus standards
Electrical safety test, Mechanical performance test, and Biocompatibility test have been done to demonstrate the safety and performance of subject devices. Tests was conducted in accordance with the "510(k) Guidance Document for General Surgical Electrosurgical Devices", which outlines safety and performance requirements.
The comparison and validation results presented in this 510k notification, show that the GP202 Disposable Neutral Electrode is substantially equivalent to predicated devices and are safe and effective in their intended use.
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.
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| 510(k) Summary | |
|---|---|
| Sponsor: | Company: CATHAY MANUFACTURING CORP. |
| Address: No.328, Xishe Road, Maogang Town, Songjiang Area, Shanghai City, China | |
| Contact Name: Ren Ren | |
| Title: Assistant | |
| Telephone: (86) 021- 57878328 | |
| E-mail: rubyfantasy@qq.com | |
| Consultant: | Taizhou EBO information Technology Co., Ltd |
| Contact person: Zhang Hui | |
| Telephone: (86) 010-59795724 | |
| Fax: (86) 010-52214567-5514 | |
| Email: itczhanghui@gmail.com | |
| AUG 2 2 2013 | |
| 1. Device information: | |
| Proprietary Name: | Disposable Neutral Electrode |
| Model: | GP202 |
| Regulation Description | Electrosurgical cutting and coagulation device and accessories |
| Product Code | GEI |
| Submission Type | 510(k) |
| Regulation Number | 21 CFR 878.4400 |
| Device Class | 2 |
| 2. Predicate Devices |
ﻬﺎ
Trade/Device Name: OBS Disposable Electrosurgical Pads Models: GBS-Db, GBS-Dm Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories, Regulatory Class: Class II Product Code: GEI
Manufactured by:
Jiangmen City Xinhui BaiSheng Medical Equipment Co., Ltd.
3. Description of the device
The Disposable Neutral Electrode, is an accessory for high voltage high frequency electrosurgical devices, connect it to the body of the PATIENT and the HF SURGICAL
1
EQUIPMENT, it can perform it function for provide a return path for the HIGH FREQUENCY current and unwanted burns are avoided.
Construction --- The product consists of Electrode carrier and Clarity PET. It is packed in an al film bag.
The electrode is composed of conductive gel, aluminum foil, sponge, anti-sticking film and connecting wire. Conductive gel is composed of high molecular monomer, glycerinum and water, which is a gel, can be conducted in high frequency and has voltage-sensitive by polymerization.
4. Indications for Use
This disposable neutral electrode for adult patients with conductive adhesive gel is used as neutral reference during electrosurgical procedures.
5. Testing
Laboratory testing was conducted to validate and verify that the Disposable Electrosurgical Pencil met all design specifications, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of all consensus standards
6. Compared to the predicate device
Disposable Neutral Electrode has been carefully compared to legally marketed devices with respect to intended use, appearance, essential components, materials and performance specifications.
They are similar in intended use, appearance, essential components, materials and performance specifications. Although they may differ from the predicate devices in color and size, it won't affect safety and effectiveness of subject devices.
In addition, performance and safety testing have been done to validate the performance and safety of the device.
7.0 Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as below:
Electrical safety test, Mechanical performance test, and Biocompatibility test have been done to demonstrate the safety and performance of subject devices. Tests was conducted in accordance with the "510(k) Guidance Document for General Surgical Electrosurgical Devices", which outlines safety and performance requirements.
The proposed device is equivalent to the identified predicate device with respect to technological characteristics and function. The device has been designed to comply with the applicable sections of ANSI/AAMI American National Standard for Electrosurgical Devices:
The International Standard for electrical medical device: IEC60601-1; the International
2
Standard for Electrosurgical Devices: IEC 60601-2-2; Biocompatibility: ISO 10993-5 and ISO 10993-10.
None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards.
8.0 Conclusions:
The comparison and validation results presented in this 510k notification, show that the GP202 Disposable Neutral Electrode is substantially equivalent to predicated devices and are safe and effective in their intended use.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 22, 2013
Cathay Manufacturing Corporation % Taizon EBO Information Technology Co., Ltd. Zhang Hui No. 328, Xishe Road, Maogang Town, Songhang Area Shanghai, China 201607
Re: K130027
Trade/Device Name: Disposable Neutral Electrode GP202 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 15, 2013 Received: July 25, 2013
Dear Zhang Hui:
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
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Page 2 - Zhang Hui
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/MedicalDevices/Safetv/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 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter DJRuimm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K130027 Disposable Neutral Electrode Device Name:
Indications for Use:
This disposable neutral electrode for adult patients with conductive adhesive gel is used as neutral reference during electrosurgical procedures.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua @ Mipper -S
(Division Sign-off) Division of Surgical Devices 510(k) Number K130027