The Bipolar Forceps device is a single use hand held insulated medical device approximately 295mm in overall length featuring a 190mm distance from the user's grasp to the tip. The bayonet offset is 1.5cm. The tips are Titanium Nitride coated and have polished contact surfaces 1.5mm wide by 1cm long. The device is offered in straight and 20 degree angled tips. The Bipolar Forceps are sold as a single use sterile packaged device used in general surgical procedures. The Bipolar Forceps are limited to maximum 70 watts and shall be used only by personnel with training in electrosurgical procedures and with compatible generators compliant with IEC 60601 requirements. The Bipolar Forceps are rated at 1000V peak and can be used with a compatible reusable pin plug cable (1.8mm pin, 5.8mm spacing). The Bipolar Forceps are single use disposable devices packaged in double blisters with Tyvek lid.

AI/ML Overview

The provided text describes the 510(k) submission for the Boston Endo Surgical Technologies (division of Lacey Manufacturing) Bipolar Forceps. However, it does not contain a study explicitly designed to prove device performance against specific acceptance criteria in the manner typically seen for complex diagnostic or AI-driven medical devices.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (K032327 Modern Medical Bipolar Forceps) through a comparison of technological characteristics and performance testing to ensure safety and basic functionality.

Here's an breakdown of the information that is present, and what is absent from the provided text, in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicitly stated numerical "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy) or device performance beyond general functional and safety standards. The performance section focuses on safety and biocompatibility.

Test	Acceptance Criteria (Implied)	Reported Device Performance
Cytotoxicity	Non-cytotoxic	Non-cytotoxic
Irritation	Non-irritating	Non-irritating
Sensitization	Non-sensitizing	Non-sensitizing
Electrosurgical Function	Proper cutting and coagulation	The device properly cut and coagulated the tissue. (Animal tissue testing)
Electrical Safety	Met standards	No issues found
Packaging Validation	Met standards	No issues found
Shipping & Transportation	Met standards	No issues found
Aging Shelf Life	Met standards	No issues found
Hi-Pot	Met standards	No issues found

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

Test Set Sample Size: The text mentions "animal tissue of various diameters" for the electrosurgical function testing. No specific sample size (number of animals, number of tissue samples) or details about the tissue types or conditions (e.g., healthy vs. diseased) are provided.
Data Provenance: Not specified. It's internal company testing, likely conducted in a lab setting rather than clinical data from a specific country.
Retrospective/Prospective: Not applicable in the context of this device's performance testing. The biocompatibility and safety tests are laboratory-based, and the functional testing on animal tissue is a controlled experimental setup.

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

Number of Experts: Not applicable. The "ground truth" for these types of tests (biocompatibility, electrical safety, functional cutting/coagulation) is typically determined objectively by laboratory measurements and observation against established standards, not by expert consensus on clinical findings.
Qualifications of Experts: Not applicable beyond the implicit assumption that the testers were qualified laboratory personnel.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1 for clinical image interpretation) is not relevant for the type of testing described for this device.

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

MRMC Study: No. This is a basic surgical instrument, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant to this submission.

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

Standalone Performance: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground Truth: For biocompatibility tests, the ground truth is defined by the results of the specific ISO 10993 tests (e.g., presence/absence of cytotoxic effects, irritation, sensitization). For electrical safety, it's compliance with electrical standards. For functional testing, "properly cut and coagulated" acts as the objective ground truth against the expected performance of an electrosurgical device on tissue.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no training set in the typical sense.

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

Ground Truth for Training Set: Not applicable.

Summary of the Study Demonstrated in the K131058 Submission:

The submission for the Bipolar Forceps primarily relies on design and material equivalence to a predicate device (K032327 Modern Medical Bipolar Forceps), coupled with benchtop and laboratory testing to ensure safety, biocompatibility, and basic functional performance.

The "study" that proves the device meets (implied) acceptance criteria consists of:

Biocompatibility Testing: Performed according to ISO 10993 guidelines, FDA General Program Memorandum No. G95-1, and ODE Bluebook Memorandum G95-1. These tests (Cytotoxicity, Irritation, Sensitization) concluded the device was non-cytotoxic, non-irritating, and non-sensitizing.
Performance Testing: Conducted after sterilization, using "animal tissue of various diameters" to simulate vessels at different power settings. The conclusion was that "The device properly cut and coagulated the tissue."
Safety and Efficacy Testing: This included Electrical safety, Biocompatibility (reiterated), Packaging validation, Shipping & transportation, Aging Shelf Life, and Hi-Pot tests. All testing "found no issues of safety or effectiveness."

The core argument for substantial equivalence is that the new device is almost identical to the predicate, with the only significant difference being that the subject device is sterile and single-use, while the predicate is reusable. This difference does not alter the fundamental mechanism of action or intended use.

Summary

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K131058

510(k) Summary for Boston Endo Surgical Technologies (division of Lacey Manufacturing) Bipolar Forceps

SUBMITTER/510(K) HOLDER 1.

Boston Endo Surgical Technologies (division of Lacey Manufacturing) 1146 Barnum Avenue Bridgeport, CT 06610

Contact Name: James Rogers. Email: JRogers@peplacey.com Telephone: (203) 336-7453

Date Revised: July 1, 2013

Prepared By: JA

2. DEVICE NAME

Proprietary Name:	Bipolar Forceps
Common/Usual Name:	Bipolar Forceps
Classification:	Class 2, 21 CFR 878.4400
Classification Name:	Electrosurgical Cutting and Coagulation Accessories
Product Code:	GEI

3. PREDICATE DEVICES

K032327 Modern Medical Bipolar Forceps .

DEVICE DESCRIPTION 4.

The Bipolar Forceps are limited to maximum 70 watts and shall be used only by personnel with training in electrosurgical procedures and with compatible generators compliant with IEC 60601 requirements. The Bipolar Forceps are rated at 1000V peak and can be used with a compatible reusable pin plug cable (1.8mm

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pin, 5.8mm spacing). The Bipolar Forceps are single use disposable devices packaged in double blisters with Tyvek lid.

INTENDED USE 5.

Tissue grasping and control of bleeding of small vessels by bipolar coagulation.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Bipolar Forceps substantially equivalent to the Modern Medical Bipolar Forceps cleared under 510(k) K032327. The only difference between the devices is that the subject device is provided sterile and is for one time use, whereas the predicate device is reusable. The materials and design are identical.

7. PERFORMANCE TESTING

Biocompatibility testing for the intended application of the Bipolar Forceps was performed as suggested by the International Standards Organization (ISO) 10993 Guidelines, FDA General Program Memorandum No. G95-1 and the Office of Device Evaluation (ODE) Bluebook Memorandum G95-1 "Use of ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".

Test	Conclusion
Cytotoxicity	Non-cytotoxic
Irritation	Non-irritating
Sensitization	Non-sensitizing

The device was also subjected to performance testing after sterilization using animal tissue of various diameters to simulate vessels at different power settings. The device properly cut and coagulated the tissue.

8. SAFETY AND EFFICACY

The subject device was subjected to testing including:

Electrical safety .
Biocompatibility .
Packaging validation .
Shipping & transportation .
. Aging Shelf Life
. Hi-Pot

The testing found no issues of safety or effectiveness.

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9. CONCLUSION

Boston Endo Surgical Technologies believes that based on the indications for use, technological characteristics, and comparison to predicate devices the Bipolar Forceps has been shown to be substantially equivalent to the predicate and is safe and effective for its intended use.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

October 25, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Boston Endo Surgical Technologies, Incorporated Mr. James Rogers Regulatory Affairs, Manager 1146 Barnum Avenue Bridgeport, Connecticut 06610.

Re: K131058

Trade/Device Name: Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 14, 2013 Received: August 16, 2013

Dear Mr. Rogers:

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

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Page 2 - Mr. James Rogers

forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 vours.

Mark Nijelkerson -S

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

Enclosure

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Indications for Use Form

510(k) Number (if known): K131058

Device Name: Bipolar Forceps

Indications for Use:

Tissue grasping and control of bleeding of small vessels by bipolar coagulation.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH)

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0.9.2342.19200300.100.1.1=13300369056
Date: 2013.11.05 06:44.29 -05:00 I

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(Division Sign-off) Division of Surgical Devices 510(k) Number: K131058

Page 1 of 1

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.