The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue.

Device Description

OLSEN Medical® Electrosurgical Monopolar and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate, cut or coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (bipolar or monopolar) to the specified output terminal of an electrosurgical generator. The bipolar forceps are intended for use with a maximum voltage of 500 volts while the monopolar forceps have a maximum voltage of 2000 volts. The forceps are offered either as single (disposable) or multiple-use (reuseable).

AI/ML Overview

This document is a 510(k) Premarket Notification for Olsen Medical Bipolar and Monopolar Forceps. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study to prove acceptance criteria for a novel artificial intelligence or software-as-a-medical-device (SaMD) product.

Therefore, many of the requested categories for AI/SaMD performance studies (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this 510(k) submission.

However, I can extract the relevant information regarding acceptance criteria and the type of studies performed to show device safety and equivalence.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance / Outcome
Electrical Safety	IEC 60601-2-2 (High Frequency Surgical Equipment)	Successful outcome
Sterilization	ANSI/AAMI/ISO 11137-2 (Radiation Sterilization Dose)	Successful outcome
Biocompatibility	ISO 10993 Part 5 (In vitro cytotoxicity)	Successful outcome
Electrosurgical Device Standards	ANSI/AAMI HF18-1993 (Electrosurgical Devices)	Successful outcome
Intended Use Equivalence	To be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue.	"The subject devices also have the same intended use and performance characteristics as their predicates. No new technological characteristics were introduced..."
Design Equivalence	Similar in design to predicates	"The proposed Olsen Bipolar and Monopolar Forceps is similar in design as its predicates."
Materials/Processes Equivalence	Sterilized using equivalent materials and processes as predicates.	"The Olsen Forceps are sterilized using equivalent materials and processes as its predicates."
Safety and Effectiveness	No new types of safety and effectiveness issues compared to predicates.	"...the proposed forceps do not raise new types of safety and effectiveness issues as compared to the predicates."

2. Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes a 510(k) submission for conventional medical devices (bipolar and monopolar forceps), not an AI/SaMD. The "testing" refers to compliance with established international and national standards for medical device safety and performance (e.g., electrical safety, sterilization, biocompatibility), rather than a clinical study with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. See point 2. Ground truth in the context of AI/SaMD studies involves expert interpretations of data. For these forceps, "ground truth" is adherence to engineering and safety standards.

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

Not applicable. See point 2.

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. This type of study is specifically for evaluating AI/SaMD performance in a clinical setting involving human readers/interpreters. It's not relevant for assessing electrosurgical forceps.

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

No. This is not software or an algorithm.

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

The "ground truth" for these devices is adherence to established engineering, electrical, biological, and sterilization standards for electrosurgical equipment (e.g., IEC 60601-2-2, ISO 10993, ANSI/AAMI HF18, ANSI/AAMI/ISO 11137-2). The ultimate validation is "substantial equivalence" to legally marketed predicate devices, meaning they function and are as safe and effective as existing, cleared devices.

8. The sample size for the training set

Not applicable. No AI model is being trained.

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

Not applicable. No AI model is being trained.

Summary

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510(k) Premarket Notification Olsen Medical Bipolar and Monopolar Forceps

510(k) Summary Pursuant to 21 CFR 807.92

General Company Information

Company Name:	Olsen Medical®
Company Address:	3230 Commerce Center PlaceLouisville, Kentucky 40211
Company Telephone:	(502) 772-4280
Contact:	Dalene T. Binkley
Contact Address:	1927 N. Arthur DriveColumbia City, Indiana 46725(260) 244-4189
Date:	October 7, 2013DEC 0 6 2013
Device Trade Name:	Olsen Medical Bipolar and Monopolar Forceps(Single and Multiple-Use)
Common Name:	Single Use Bipolar and Monopolar Forceps;Multiple-Use Bipolar and Monopolar Forceps
Classification Nameand Reference:	GEI – 878.4400, Electrosurgical cutting andcoagulation device and accessories
Predicate Device:	Bipolar Forceps:
	Dermacare (now Olsen Medical) DisposableBipolar Cord and Bipolar Forcep, K884656,cleared November 25, 1988
	Olsen Medical Midas Touch Bipolar Forceps,K982705, cleared September 8, 1998
	Stryker Bipolar Forceps, K093108, cleared June22, 2010

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510(k) Premarket Notification Olsen Medical Bipolar and Monopolar Forceps

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Monopolar Forceps:

Boston Surgical Products Reusable Monopolar Forceps, K950877, cleared March 9, 1995

Device Description:

Intended Use:

Comparison to Predicate Device:

The proposed Olsen Bipolar and Monopolar Forceps is similar in design as its predicates. The Olsen Forceps are sterilized using equivalent materials and processes as its predicates. The subject devices also have the same intended use and performance characteristics as their predicates. No new technological characteristics were introduced and as such, the proposed forceps do not raise new types of safety and effectiveness issues as compared to the predicates.

Testing and Technological Characteristics:

The Olsen Medical Bipolar and Monopolar Forceps are active electrosurgical devices that provide an electrical current that is fired through the tips of the forceps. The devices are hand-held and provided sterile for the single use forceps and non-sterile for the multiple use forceps. The forceps connect to a corresponding power cord (bipolar or monopolar).

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510(k) Premarket Notification Olsen Medical Bipolar and Monopolar Forceps

The following testing was conducted with successful outcome to establish device safety and equivalence:

IEC 60601-2-2 Medical Electrical Equipment/Part 2-2: Particular . Requirements for Safety of High Frequency Surgical Equipment
. ANSI/AAMI/ISO 11137-2:2006: Sterilization of Health Care Products -Radiation - Part 2: Establishing the sterilization dose
ISO 10993: Biological evaluation of medical devices Part 5: Tests for in . vitro cytotoxicity
ANSI/AAMI HF18-1993 American National Standard for Electrosurgical . Devices

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Olsen Medical % Ms. Dalene T. Binkley FDC Services, LLC 1927 N. Arthur Drive Columbia City, Indiana 46725

December 6, 2013

Re: K130669

Trade/Device Name: Olsen Medical® Bipolar and Monopolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 7, 2013 Received: October 11, 2013

Dear Ms. Binkley:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & nove 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 10 use sured in the enorse. 976, 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). and Cosinction room in the device, subject to the general controls provisions of the Act. The r ou may, merelory, manss of the Act include requirements for annual registration, listing of general ookies provision 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 It may be subject to additions, 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 r lease of advised that I Dr 3 lesaants or our device complies with other requirements of the Act that I DA has Indo a dolorimians administered by other Federal agencies. You must or any I collares and regulances and regulations but not limited to: registration and listing (21 Comply will an the Fee 316quirements (1); medical device reporting (reporting of medical CrK Fall 807), labeling (21 OFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Dalene T. Binkley

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 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 yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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ктзоева

510(k) Number (if Known):

Device Name: Device Name: Olsen Medical® Bipolar and Monopolar Forceps

Indications For Use: The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue.

Prescription Use: _ X

OR Over-The-Counter Use: (Part 21 CFR 807.109)

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-off) Division of Surgical Devices 510(k) Number: K130669 17

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.