(75 days)
Not Found
No
The document describes a passive electrosurgical pad and its intended use in completing an electrical circuit. There is no mention of any computational analysis, learning, or adaptive capabilities that would indicate the presence of AI or ML. The performance studies focus on electrical safety, EMC, and biocompatibility, not algorithmic performance.
No
The device is described as a "Neutral Electrode" or "dispersive electrode" used to complete an electrical circuit during electrosurgery, rather than providing therapy itself. It facilitates the function of an electrosurgical generator, which is the therapeutic device.
Name of the Device: OBS Disposable Electrosurgical Pads
Is this device a diagnostic device? No
Explanation: The device is a neutral electrode used in electrosurgery to complete an electrical circuit. Its function is to provide a return path for current and it does not gather or interpret data for medical diagnosis.
No
The device description clearly states it is a disposable, non-sterile dispersive electrode, which is a physical hardware component used in electrosurgery. The performance studies also focus on electrical safety, electromagnetic compatibility, and biocompatibility, all related to the physical properties of the pad.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Neutral Electrode" used to "complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient." This describes a device used on the patient during a surgical procedure, not a device used to test samples in vitro (outside the body).
- Device Description: The description reinforces its use as a "disposable, non-sterile dispersive electrode" that adheres to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
OBS Disposable Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient. Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System(CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS(i.e.REM,ARM,NESSY etc.).
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
OBS Disposable Electrosurgical Pads are disposable, non-sterile dispersive electrode with or without a pre-attached cord and available in a comprehensive range of shapes and sizes(adult and pediatric). OBS disposable electrosurgical pads, Solid (Model:GBS-Dm) are for use with generators that do not have a Contact Quality Monitoring System(CQMS).OBS disposable electrosurgical pads, Split (Model:GBS-Db) are for use with generators that have a Contact Quality Monitoring System(i.e. REM,ARM,NESSY etc.).
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 and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety test, Electromagnetic compatibility test and Biocompatibility test have been done to demonstrate the safety and performance of subject devices. Tests was conducted on the OBS Disposable Electrosurgical Pads, model GBS-Db and GBS-Dm, in accordance with the "510(k) Guidance Document for General Surgical Electrosurgical Devices".
Safety test: Standard:1) IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General) 2) IEC 60601-2-2- 2006, Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment. (General Plastic Surgery/General Hospital ) Test result: For the Safety test, all the testing items pass the above standards, it demonstrates that the subject devices OBS Disposable Electrosurgical Pads, model GBS-Db and GBS-Dm, comply with the safety and performance requirements.
EMC test: Standard: 1) IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004). (General) Test result: For the EMC test, the testing items Emission and Immunity, Harmonic Current Emissions, Voltage changes, Voltage Fluctuations and Flicker, pass the above standard, it demonstrates that the subject devices OBS Disposable Electrosurgical Pads, model GBS-Db and GBS-Dm, comply with the safety and performance requirements.
Biocompatibility test: Standard: 1) AAMI / ANSI / ISO 10993-1:2003, Biological evaluation of medical devices --Part 1: Evaluation and testing. (Biocompatibility) 2) AAMI / ANSI / ISO 10993-5:1999, Biological evaluation of medical devices --Part 5: Tests for In Vitro cytotoxicity. (Biocompatibility) 3) AAMI / ANSI / ISO 10993-10:2002, Biological evaluation of medical devices -Part 10: Tests for irritation and delayed-type hypersensitivity. (Biocompatibility) 4) AAMI / ANSI / ISO 10993-12:2007, Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials. (Biocompatibility) Test result: For the Biocompatibility test, the testing items Delayed Hypersensitivity, Skin Irritation and In Vitro Cytotoxicity, pass the above standard, the test result is no sensitization, no skin irritation and no cytotoxicity, it demonstrates that the subject devices OBS Disposable Electrosurgical Pads, both aged and unaged samples, comply with the safety and performance requirements.
Summary of test results: Through the above Safety test, EMC test and Biocompatibility test, none of the testing items were demonstrated to violate the requirements of the above mentioned standards or result in any safety hazards.
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/0 description: The image shows a logo with the letters "OBS" in a stylized font. Below the letters, there are two Chinese characters, which are "百生". The logo is black and white and appears to be a company logo.
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FDA-Electrosurgical-GBS-05
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| K102372 | |
|---|---|
| Chapter 05 | |
| PREMARKET NOTIFICATION | |
| 510(K) Summary | |
| NOV - 3 2010 | |
| OBS Disposable Electrosurgical Pads, Solid (Model: GBS-Dm) | |
| OBS Disposable Electrosurgical Pads, Split (Model: GBS-Db) | |
| This summary of 510(k) safety and effectiveness information is being submitted in accordance, with the requirements of SMDA and 21 CFR §807.92 | |
| 1.0 Submitter's Name: | JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO.,LTD |
| Address: | Building 1 No.1,Huimin East Road, Huicheng Town, XinHui District JiangMen City, GuangDong, People's Republic of China |
| Phone: | +86-750-6628113 |
| Fax: | +86-750-6616122 |
| Contact: | Mr. Chen Xi |
| E-mail: | renzheng@bs0750.com |
| Date | December 28, 2009 |
| 2.0 Proprietary Name: | OBS Disposable Electrosurgical Pads, Solid (Model: GBS-Dm) |
| OBS Disposable Electrosurgical Pads, Split (Model: GBS-Db) | |
| Common Name : | Electrosurgical Pad |
| Regulation Number: | 21 CFR 878.4400 |
| Classification Name: | Electrosurgical, cutting & coagulation & accessories |
| Classification: | Class II |
| Product Code: | GEI |
| Panel: | General & Plastic Surgery |
| 3.0 Predicate Device Information: | |
| 1) Leonhard Lang GmbH | |
| Company Name: | Leonhard Lang GmbH |
| Address: | Archenweg 56 6010 Innsbruck Austria |
| Proprietary Name: | Skintact® Cool Contact Electrosurgical Grounding Plates |
| It's 510(K) number is | K030362 |
| Code: FDA-005 | Version: A/0 Page 1 of 4 Issuing Date: 2009-12-28 |
1
Image /page/1/Picture/1 description: The image shows a logo with the letters "OBS" stacked on top of two Chinese characters. The letters "OBS" are in a bold, sans-serif font, with the "O" resembling a water droplet. The Chinese characters below the letters are smaller in size and appear to be a different font. The logo is black and white.
2) ConMed Corporation
Company Name: ConMed Corporation
Address: 310 Broad Street Utica, New York 13501
Proprietary Name: SureFit™ Dual Dispersive Electrode (410-2000)
lt's 510(K) number is K002002
3) Valleylab
Company Name: Valleylab,INC.
Address: 5910 Longbow Drive Boulder CO 80301
Proprietary Name: PolyHesive II Patient Return Electrode(Mode E7506:solid,with cable.Model E7507:REM,with cable.Model E7509:REM,without cable)
lt's 510(K) number is K861036
4.0 Device Description
OBS Disposable Electrosurgical Pads are disposable, non-sterile dispersive electrode with or without a pre-attached cord and available in a comprehensive range of shapes and sizes(adult and pediatric). OBS disposable electrosurgical pads, Solid (Model:GBS-Dm) are for use with generators that do not have a Contact Quality Monitoring System(CQMS).OBS disposable electrosurgical pads, Split (Model:GBS-Db) are for use with generators that have a Contact Quality Monitoring System(i.e. REM,ARM,NESSY etc.).
5.0 Indications for Use:
OBS Disposable Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient. Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System(CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS(i.e.REM,ARM,NESSY etc.).
Comparison to Predicate Devices 6.0
OBS Disposable Electrosurgical Pads have 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 shape, 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.
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Image /page/2/Picture/1 description: The image shows a logo or symbol with two lines of text below it. The top line of the logo consists of three distinct shapes or characters, with the first resembling a water droplet or an eye, the second appearing to be the letters 'BS', and the third being a curved shape similar to a crescent or a reversed 'C'. The bottom line of text is in a different font and appears to be two Chinese characters. The overall design is simple and bold, with a clear contrast between the shapes and the background.
7.0 Summary of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as below:
Electrical safety test, Electromagnetic compatibility test and Biocompatibility test have been done to demonstrate the safety and performance of subject devices. Tests was conducted on the OBS Disposable Electrosurgical Pads, model GBS-Db and GBS-Dm, in accordance with the "510(k) Guidance Document for General Surgical Electrosurgical Devices", which outlines safety and performance requirements. The test details as follow:
Safety test: FDA-Electrosurgical-GBS-Appendix-01 Safety and Performance Test FDA-Electrosurgical-GBS-Appendix-05 Safety and Performance Test
- Standard:1) IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General)
- 2) IEC 60601-2-2- 2006, Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment. (General Plastic Surgery/General Hospital )
- Test result: For the Safety test, all the testing items pass the above standards, it demonstrates that the subject devices OBS Disposable Electrosurgical Pads, model GBS-Db and GBS-Dm, comply with the safety and performance requirements.
EMC test: FDA-Electrosurgical-GBS-Appendix-02 EMC Test Report
FDA-Electrosurgical-GBS-Appendix-06 EMC Test Report
- Standard: 1) IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004). (General)
- Test result: For the EMC test, the testing items Emission and Immunity, Harmonic Current Emissions, Voltage changes, Voltage Fluctuations and Flicker, pass the above standard, it demonstrates that the subject devices OBS Disposable Electrosurgical Pads, model GBS-Db and GBS-Dm, comply with the safety and performance requirements.
3
Image /page/3/Picture/1 description: The image shows a logo with the letters "OBS" stacked on top of the Chinese characters "Ri Sheng". The letters "OBS" are in a bold, sans-serif font, with the "O" being a perfect circle and the "B" and "S" having a slightly stylized appearance. The Chinese characters "Ri Sheng" are in a traditional font and are smaller in size compared to the "OBS" letters.
Biocompatibility test: FDA-Electrosurgical-GBS-Appendix-03 Biocompatibility Test
FDA-Electrosurgical-GBS-Appendix-07 Biocompatibility Test
Standard: 1) AAMI / ANSI / ISO 10993-1:2003, Biological evaluation of medical devices --Part 1: Evaluation and testing. (Biocompatibility)
-
- AAMI / ANSI / ISO 10993-5:1999, Biological evaluation of medical devices --Part 5: Tests for In Vitro cytotoxicity. (Biocompatibility)
-
AAMI / ANSI / ISO 10993-10:2002, Biological evaluation of medical devices -Part 10: Tests for irritation and delayed-type hypersensitivity. (Biocompatibility)
-
AAMI / ANSI / ISO 10993-12:2007, Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials. (Biocompatibility)
Test result: For the Biocompatibility test, the testing items Delayed Hypersensitivity, Skin Irritation and In Vitro Cytotoxicity, pass the above standard, the test result is no sensitization, no skin irritation and no cytotoxicity, it demonstrates that the subject devices OBS Disposable Electrosurgical Pads, both aged and unaged samples, comply with the safety and performance requirements.
Summary of test results:
Through the above Safety test, EMC test and Biocompatibility test, none of the testing items were demonstrated to violate the requirements of the above mentioned standards or result in any safety hazards.
8.0 Conclusions:
OBS Disposable Electrosurgical Pads, model GBS-Dm and GBS-Db, have been carefully compared to legal marketed predicated 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 shape, it won't affect safety and effectiveness of subject devices. And the Safety test, EMC test and Biocompatibility test have been done to validate the performance and safety of the subject device. The comparison, validation and test results presented in this 510k notification to the FDA show that the OBS Disposable Electrosurgical Pads, Solid (Model:GBS-Dm) and OBS Disposable Electrosurgical Pads, Split (Model:GBS-Db) are substantially equivalent to predicated devices and effective in their intended use.
4
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Jiangmen City Xinhui Baisheng Medical Equipment Co., LTD % Intertek Testing Services NA, Inc. Mr. William J. Sammons 2307 E. Aurora Road Unit B7 Twinsburg, OH 44087
NOV - 3 2010
Re: K102372
Trade/Device Name: OBS Disposable Electrosurgical Pads, Solid (Model: GBS-Dm) OBS Disposable Electrosurgical Pads, Split (Model: GBS-Db) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 15, 2010 Received: October 19, 2010
Dear Mr. Sammons:
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
5
Page 2 - Mr. William J. Sammons
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.
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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Mellon
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
FDA-Electrosurgical-GBS-04
Image /page/6/Picture/1 description: The image shows a logo with the letters "OBS" stacked on top of the Chinese characters "日生". The letters "OBS" are in a bold, sans-serif font. The Chinese characters "日生" are in a traditional font and are smaller than the letters "OBS". The logo is black and white.
Chapter 04 PREMARKET NOTIFICATION Indications for Use
NOV - 3 2010
510(k) Number (if known):
Device Name: OBS Disposable Electrosurgical Pads, Solid (Model: GBS-Dm) OBS Disposable Electrosurgical Pads, Split (Model: GBS-Db)
Indications For Use:
OBS Disposable Electrosurgical Pads are Neutral Electrode which is also known as plate, plate, plate, electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient. Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System(CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS(i.e.REM,ARM,NESSY etc.).
| Prescription Use | √ | AND/OR Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER NEEDED) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K102372 |
|---|---|
| --------------- | --------- |
| Code: FDA-004 | Version: A/0 | Page 1 of 1 | Issuing Date: 12.2009 |
|---|---|---|---|
| --------------- | -------------- | ------------- | ----------------------- |