The OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df are used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with a 510k-clearance ESU generator. The device is disposable and supplied sterile with an electrode tip.

Device Description

The OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df are used for the cutting and coagulation of soft tissue and have a connector attached to a 3M conductive cable and are designed for use with 510K-clearance generator. The connector or pluq fits into the mono-polar side of a 510K-clearance generator. The handpieces (OBS-Db or OBS-Dr) are made of plastic with two buttons or a rocker switch toward the distal part of the pencil in the case of the hand-controlled pencils, while the foot-controlled pencils(OBS-Df) that is activated by a monopolar footswitch connected to the generator (the footswitch is an accessory of the generator). One button or switch is to control the CUT mode of the ESU while the other controls the COAG mode.

AI/ML Overview

This document describes the premarket notification (510(k)) for the OBS Disposable Electrosurgical Pencils. The primary evidence presented is a comparison to legally marketed predicate devices and non-clinical performance and safety testing.

Here's an analysis of the provided text in relation to your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or provide a table outlining specific performance metrics with PASS/FAIL values as one would expect for a detailed performance study like an MRI co-existence test or a drug-delivery device's accuracy. Instead, the approach is focused on demonstrating substantial equivalence to predicate devices through a battery of general safety and performance tests.

The document lists the following non-clinical tests performed:

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC60601-1:1988 (Electrical safety)	"None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards."
Compliance with IEC60601-2-2:2006 (Particular safety for electrosurgical devices)	"None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards."
Compliance with ANSVAAMMSO10993-5:1999 (Biocompatibility - Cytotoxicity)	"None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards."
Compliance with ANSVAAMIISO10993-10:2002 (Biocompatibility - Irritation and sensitization)	"None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards."
Compliance with ANSVAAMMSO10993-7:1995 (Ethylene Oxide sterilization residuals)	"None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards."
Compliance with ANSVAAMIISO11135-12007 (Sterilization of health care products - Ethylene oxide)	"None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards."
Compliance with ANSVAAMIISO11737-1:2006 (Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products)	"None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards."
Compliance with ANSVAAMIISO11737-2:1998 (Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process)	"None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards."
Compliance with USP31:2008 & <71> (Sterility Tests - likely referencing general sterility)	"None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards."
Compliance with BSEN ISO11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems)	"None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards."
Compliance with ISO 15223 (Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied)	"None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards."
Compliance with ASTM F1980-07 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices)	"None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards."
Electrical Safety Test	Performed, implying satisfactory results to relevant standards.
Mechanical Performance Test	Performed, implying satisfactory results to relevant standards.
Biocompatibility Test	Performed, implying satisfactory results to relevant standards.
EO Residue Test	Performed, implying satisfactory results to relevant standards.
Equivalence to predicate devices in intended use, appearance, essential components, materials, and performance specifications	Claimed: "substantially equivalent to predicated devices and is safe and effective in their intended use."

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any of the tests conducted. It only states that "Tests were conducted on the OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df." There is no information provided regarding the data provenance (e.g., country of origin of the data, retrospective or prospective). Given the nature of the tests (standardized performance and safety testing), they would likely be conducted in a laboratory setting by the manufacturer JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO.,LTD, which is based in GuangDong, People's Republic of China. The tests are inherently prospective as they are performed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For these types of non-clinical, standardized tests, "ground truth" is typically established by compliance with the specified international standards (e.g., IEC, ISO, ASTM). The "experts" would be the technical staff or engineers performing the tests and comparing results against the standard's requirements, rather than clinical experts establishing a medical "ground truth."

4. Adjudication method for the test set

This is not applicable to the types of non-clinical tests described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. The tests here are objective measurements against engineering and safety standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an electrosurgical pencil, which is a surgical tool, not an AI-powered diagnostic or assistive technology. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. Again, this device is a physical electrosurgical tool, and the submission focuses on its physical and electrical safety and performance, not on algorithmic accuracy.

7. The type of ground truth used

The "ground truth" for the tests performed is the compliance with established international and national standards for electrical safety, mechanical performance, biocompatibility, sterilization, and packaging. The successful completion of these tests (i.e., results showing no violation of requirements or safety hazards) serves as proof of acceptable performance for a 510(k) submission.

8. The sample size for the training set

This information is not applicable. This is not an AI/Machine Learning device and therefore does not have a "training set."

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this device.

Summary

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DEC - 1 2009 FDA-Electrosurgical-D-05

Chapter 05

PREMARKET NOTIFICATION 510(K) Summary

OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df

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'sRepublic of China
Phone:	+86-750-6628113
Fax:	+86-750-6616122
Contact:	Mr. Chen Xi
E-mail:	renzheng@bs0750.com
Date	June 1, 2008

OBS Disposable Electrosurgical Pencils Proprietary Name: 2.0 Model: OBS-Db, OBS-Dr, OBS-Df
Electrosurgical Pencil Common Name :

Classification Name: Electrosurgical, cutting & coagulation & accessories Class II Classification: Product Code: GEI

3.0 Predicate Device Information:

SHINING WORLD HELTH CARE CO.,LTD

Company Name: SHINING WORLD HELTH CARE CO.,LTD

Address: 6F, No.8, Lane 7, Wu-Chun Road, Wu-Ku Industrial Park, Taipei, China(Taiwan)
SHINMED various models of electro-surgical pencils model : Proprietary Name: SW12200,SW12202, SW12300

lt's 510(K) number is K033027

Code: FDA-005

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Image /page/1/Picture/1 description: The image shows a logo with the letters "OBS" in a stylized font. Below the letters, there are two Chinese characters, which may represent the name of the company or brand associated with the logo. The logo is black and white, with the letters and characters appearing in black against a white background. The overall design is simple and modern, with a focus on readability and visual impact.

Unimed Surgical Products, Inc.

Company Name: Unimed Surgical Products, Inc.

Address: 10401 Belcher Road Largo, Florida 33777

Proprietary Name: Disposable Hand and Foot-Switching Pencil

lt's 510(K) number is K993647

Tecno Instruments(PVT) Ltd

Company Name: Tecno Instruments(PVT) Ltd

Address: 316-C Small Industrial Estate Sialkot-51340 Pakistan

Proprietary Name: Tecno Disposable Fingerswitch Pencil

Model: 150-100

lt's 510(K) number is K002257

4.0 Device Description

Indications for Use: 5.0

Comparison to Predicate Devices 6.0

OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df, 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 size, it won't affect safety and effectiveness of subject devices. In addition, performance and safety have been done to validate the performance and safety of the device. testing

Code: FDA-005	Version: A/0	Page 2 of 3	Issuing Date: 10.2009
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Image /page/2/Picture/0 description: The image shows a logo with the letters "OBS" stacked above the Chinese characters "百生". The letters "OBS" are in a bold, sans-serif font, with the "O" resembling a water droplet. The Chinese characters are in a traditional font and are stacked vertically below the letters.

FDA-Electrosurgical-D-05

Discussion of Non-Clinical Tests Performed for Determination of Substantial 7.0 Equivalence are as below:
Electrical safety test, Mechanical performance test, Biocompatibility test and EO Residue 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.

Tests were conducted on the OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr. OBS-Df as per the requirements of IEC60601-1:1988 . IEC60601-2-2:2006, ANSVAAMMSO10993-5:1999, ANSVAAMIISO10993-10:2002 ,ANSVAAMMSO10993-7:1995, ANSVAAMIISO11135-12007 and ANSVAAMIISO11737-1:2006, ANSVAAMIISO11737-2: 1998., USP31:2008, <71>, BSEN ISO11607-1:2006, ISO 15223, ASTM F1980-07. 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 to the FDA show that the OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df are substantially equivalent to predicated devices and is safe and effective in their intended use.

Code:	FDA-005
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Version:	A/0
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Page	3 of 3
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Issuing Date:	10.2009
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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Jiangmen City Xinhui BaiSheng Medical Equipment Co., Ltd. % Intertek Testing Services NA, Inc. Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087 DEC - 1 2009

Re: K092634

Trade/Device Name: OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df

Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical cutting and coagulation device and accessories, Regulatory Class: Class II Product Code: GEI Dated: November 13, 2009 Received: November 16, 2009

Dear Mr. Lehtonen:

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.

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

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Page 2- Mr. Daniel W. Lehtonen

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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FDA-Electrosurgical-D-04

OBS

百生

Chapter 04 PREMARKET NOTIFICATION Indications for Use

510(k) Number (if known): Device Name: OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df Indications For Use:

Prescription Use (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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Yauvence N. Ceying FOR M. MELKERSON

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092634

Regulation Number and Section

§ 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.