(238 days)
Not Found
No
The summary describes a passive dispersive electrode for electrosurgery, with no mention of AI/ML terms, image processing, or data sets for training/testing.
No
The device, a dispersive electrode, is intended to provide a return path for electrosurgical current, which is an accessory function during a surgical procedure, not a therapeutic action itself.
No
This device is an electrosurgical dispersive electrode, which is used to provide a return path for RF current during electrosurgical procedures. It does not perform any diagnostic function.
No
The device description clearly details physical components like a conductive area covered with hydro-gel, PE Foam, Texture Fabric, and medical-grade adhesive. It also mentions different sizes and shapes, indicating a physical product, not software.
Based on the provided information, Wandy's Dispersive Electrode is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide a path for RF current to leave the patient during electrosurgical procedures. This is a direct interaction with the patient's body for a therapeutic/surgical purpose, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the physical components and function of the electrode in facilitating the flow of electrical current through the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. Wandy's Dispersive Electrode is a medical device used on the patient during a surgical procedure.
N/A
Intended Use / Indications for Use
Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator
Product codes
ODR
Device Description
Wandy Dispersive Electrode is designed to provide a safe return path Electrosurgical current between Generator, to active electrode and to patient without cord. And able to use to any patient if full skin contact available. non sterilized and to use only one time.
The surface of the conductive area is covered with a Bio-compatible Hydro-gel and the surface of the non-conductive area made of PE Foam and Texture Fabric is covered with Medical grade adhesive for maximum skin adhesion. This device are non sterilized and one time use only, available 3 sizes with various shape for Adult / Pediatric
Proposed device are single use, non-sterilized with connector to use with any Electrosurgical device. And designed with PE form or Textile fabric on non conductive area and self-adhesive Hydro-gel on conductive area, with Rectangle shape. This device has same indication for use, same output power (300W, 700mA @615 ohms for less than 60 seconds )as predicate cleared electrode device in the market.
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 / Pediatric
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
Bench test done by manufacturer accordance, IEC 60601-2-2: 2006-59.104.5 / 104.79b(b).(c) / and attached report ISO10993-5 Invitro Cytotoxicity 2002 10 Skin Sensitization / Irritation 2009
The biological safety of used components of Wandy's Dispersive Electrode was conformed by the guidance of ISO 10993-1: Biological Evaluation of Medical Device
Key Metrics
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
Summary of safety and effectiveness
DEC 2 0 2012
In accordance with Section 513 (1) of the SMDA as defined in 21CFR part 807.3 this summary is submitted to obtain Pre-Market 510 (K) notification.
1. Submitter / Contact person.
Mr. Young Chi, President Bio-Med USA Inc. ( Reg Nr. 2246683) 111 Ellison Street, Paterson, NJ 07505. U.S.A. Tel: 1 973 278 5222 Fax: 201 934 6030 e mail : biomedusa@msn.com
2. Manufacturer
Wandy Rubber Industrial Co., Ltd ( Reg Nr. 3003749270) 48, Lane 392, Fu Teh 1st RD Xi-Zhi dist 221, New Taipei City, Taiwan, R.O.C. Tel: 886 2 2694 3184 Fax: 2 2694 4574
3. Name of Device
| Trade name | Wandy Dispersive Electrode |
|---|---|
| Classification name : | Electrosurgical, Cutting, Coagulation & Accessories |
| Panel | Plastic and General Surgery |
| Common name | Grounding Pad |
| Regulation | 878.4400 |
| Class II | |
| Product Code | ODR |
4. Legally marketed Predicate Device
K100686 Conmed Corp Macrolyte Dispersive Electrode
5. Device Description
Wandy Dispersive Electrode is designed to provide a safe return path Electrosurgical current between Generator, to active electrode and to patient without cord. And able to use to any patient if full skin contact available. non sterilized and to use only one time.
The surface of the conductive area is covered with a Bio-compatible Hydro-gel and the surface of the non-conductive area made of PE Foam and Texture Fabric is covered with Medical grade adhesive for maximum skin adhesion. This device are non sterilized and one time use only, available 3 sizes with various shape for Adult / Pediatric
Manufactured in accordance with both mandatory and voluntary standards
1
IEC 60601-2.2 Medical Electrical equipment part 2-2 Ed 5/9 2009-02 General requirement for safety Performing, Bench test done by manufacturer accordance, IEC 60601-2-2: 2006-59.104.5 / 104.79b(b).(c) / and attached report ISO10993-5 Invitro Cytotoxicity 2002 10 Skin Sensitization / Irritation 2009
6. Intended use
. Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator
7. Technological Characteristic.
Proposed device are single use, non-sterilized with connector to use with any Electrosurgical device. And designed with PE form or Textile fabric on non conductive area and self-adhesive Hydro-gel on conductive area, with Rectangle shape. This device has same indication for use, same output power (300W, 700mA @615 ohms for less than 60 seconds )as predicate cleared electrode device in the market.
7. Bio-Compatibility
The biological safety of used components of Wandy's Dispersive Electrode was conformed by the guidance of ISO 10993-1: Biological Evaluation of Medical Device
Test Report attached
8. Safety and Effectiveness.
Wandy's Dispersive Electrode is substantially equivalent to several predicate devices that have already been cleared in respect to Intended use. Main function, Technology, Principal operation and performance.
So, it does not raise any additional concerns regarding safety and effectiveness.
Wandy's Rubber Industry will include in this summary with updates on any other information deemed seasonally necessary by the FDA.
End of summary
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of the usual two.
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
December 20, 2012
Bio-Med USA, Incorporated % Mr. Young Chi President 111 Ellison Street Paterson, New Jersey 07505
Re: K121268
Trade/Device Name: Wandy Dispersive Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: ODR Dated: November 15, 2012 Received: November 20, 2012
Dear Mr. Chi:
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 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. 1
3
Page 2 - Mr. Young Chi
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/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 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 D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Wandy Rubber
Dispersive Electrode
Indication for use statement
510 (K ) number : 121268
Device name : Wandy's Dispersive Electrode
Indication for use : Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator
or/and Over the Counter use Prescription use XX (Part 21CFR 801 Sub part C) (Part 21 CFR 801 Sub part D )
Please do not write below line-continued an another pages if needed Concurrence of CDRH, office of Device Evaluation ( ODE )
Brian DN 6
Division of Surgical Devices 510(k) Number: K121268