The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.

Device Description

The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the G400 generator. It is available in an 88mm x 227mm loop size. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10-6.

AI/ML Overview

The provided text describes a Special 510(k) Notification for the Gyrus ACMI PKS™ BiLL™ (Bipolar Laparoscopic Loop). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than a de novo clinical study establishing new performance metrics. Therefore, the information requested about acceptance criteria and a study proving device performance in the context of AI-driven diagnostics is not fully applicable. However, I will extract and present the available information regarding performance and evaluation, interpreting "acceptance criteria" as successful completion of the described evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device	- Identical Indications for Use.	The proposed PKS™ BiLL™ has the identical Indications for Use as the predicate PKS™ BiLL™.
	- Connects to the same electrosurgical generator (G400).	The bipolar PKS™ BiLL™ connects to the same electrosurgical generator, G400.
	- Uses Bipolar PK (Plasma Kinetic) technology with an identification capacitor recognized by the generator for optimal power output.	The PKS™ BiLL™ uses Bipolar PK (Plasma Kinetic) technology and contains an identification capacitor embedded in the single use connector cable will be recognized by the generator to set default optimal power output parameters for the subject instrument. This remained unchanged and identical to the predicate.
	- Mechanical design features similar to the predicate.	The mechanical design features of the PKS™ BiLL™ are similar to that of the predicate PKS™ BiLL™.
Electrical Safety	- Compliance to electrical standards (specifically applicable sections of IEC 60601 incorporating electrical, thermal safety and Electromagnetic Interference).	The PKS™ BiLL™ instrument is compliant to electrical standards specifically to those applicable sections of IEC 60601 incorporating electrical, thermal safety and Electromagnetic Interference. Electrical testing was also carried out to IEC 60601 and passed as well.
Biocompatibility	- Materials used are well-established and used in other FDA-cleared medical devices.	The PKS™ BiLL™ instrument uses materials that are well established and used in other GYRUS ACMI FDA cleared medical devices.
	- Biocompatibility testing on all patient contacting parts performed in compliance with ISO-10993.	Biocompatibility testing on all patient contacting parts has been performed in compliance to the relevant requirements of ISO-10993. In addition the representative final product was tested to and passed ISO-10993-1. The product has been determined to be biocompatible.
Sterilization & Packaging	- Packaged and sterilized as a sterile single use device.	The PKS™ BiLL™ instrument is packaged and sterilized as a sterile single use device (sterilized by gamma irradiation to an SAL of 10-6).
Design Verification & Validation (Bench Test)	- Device meets product specifications (design verification).	Design verification testing was carried out to ensure the device meets the product specifications, and design validation was carried out to ensure the product meets the user requirements. All testing was completed successfully.
	- Product meets user requirements (design validation).	Design verification testing was carried out to ensure the device meets the product specifications, and design validation was carried out to ensure the product meets the user requirements. All testing was completed successfully.
Pre-clinical Evaluation (User Acceptance)	- Physicians' satisfaction with ease of understanding the Instructions for Use (IFU).	All three physicians were happy with the proposed device and felt it met their needs and performed to their expectations regarding their experience after a mock procedure and answering 32 questions, which included questions about the ease of understanding the IFU.
	- Physicians' satisfaction with performance related questions specific to the procedure (e.g., meeting needs, performing to expectations).	All three physicians were happy with the proposed device and felt it met their needs and performed to their expectations after they carried out a mock procedure using the proposed device and answered 32 questions, which included performance-related questions.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- Pre-clinical Evaluation: Three (3) physicians participated in the pre-clinical evaluation. The evaluation used "extirpated tissue (Human Uterine)." While the number of tissue samples isn't explicitly stated, the context implies mock procedures were performed.
- Other tests (Bench, Biocompatibility, Electrical): These tests typically involve discrete units of the device or its components. Specific sample sizes are not provided but are generally determined by established engineering and regulatory standards for each test type (e.g., a certain number of devices for electrical safety, specific material samples for biocompatibility).
Data Provenance: Not explicitly stated, but the submission is from "Olympus Surgical Technologies of America · Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772" (USA) and "Gyrus Medical, Ltd. Fortran Road, St. Mellons Cardiff CF3 OLT" (ERN: 9617070, indicating UK/European entity). Given the submission to the FDA, it is processed for the US market. The tissue used was "Human Uterine" but the exact source (country, hospital) is not specified. The study is retrospective in the sense that it evaluates a device not intended to gather new diagnostic insights but to confirm its performance against a predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Three (3) physicians.
Qualifications of Experts: Their specific qualifications (e.g., years of experience, specialty) are not detailed beyond being described as "Physicians." They were involved in the pre-clinical evaluation.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable in the traditional sense of diagnostic interpretation or a consensus-building process for ground truth. In the pre-clinical evaluation, each of the three physicians individually completed 32 questions after a mock procedure. The "adjudication" or decision on user acceptance was based on the collective positive feedback: "All three physicians were happy with the proposed device and felt it met their needs and performed to their expectations." There's no indication of a formal 2+1 or 3+1 adjudication for conflicting opinions as would be seen in a diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This submission is for an electrosurgical device, not an AI-driven diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device's evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is an electrosurgical device, not an algorithm. There is no "standalone" algorithmic performance to evaluate. The device itself is a tool operated by a human.

7. The Type of Ground Truth Used

Pre-clinical Evaluation: The ground truth for the user acceptance aspect of the pre-clinical evaluation was the individual and collective professional opinion/satisfaction of the three evaluating physicians. For the device performance within the mock procedure, it was based on the physicians' subjective assessment against their expectations and needs.
Other Tests (Bench, Biocompatibility, Electrical): The "ground truth" for these tests is defined by established engineering standards, regulatory requirements (e.g., IEC 60601, ISO 10993), and the device's own pre-defined product specifications and user requirements. Successful adherence to these standards and specifications serves as the "ground truth."

8. The Sample Size for the Training Set

Not applicable. This device itself is not an AI algorithm that requires a training set. The "training set" concept does not apply here.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI algorithm, determining its ground truth is not relevant here.

Summary

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Olympus Surgical Technologies of America · Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

510(K) SUMMARY
----------------

PKS" BiLL""

General Information

Manufacturer:

510(k) Submitter:

Contact Person:

Date Prepared:

Classification Name:

Trade Name:

Generic/Common Name:

Bipolar Loop / Bipolar Laparoscopic Loop

Predicate Device

Gyrus ACMI PKS™ BiLLTM

K11059

Indications for Use

Product Description

Page 10

Special 510(k) Notifi

DEC 0 5 2012

Special 510(k) Notification

(508) 804-2690 neil.kelly@Olympus-OSTA.com

Neil Kelly

Gyrus Medical, Ltd. Fortran Road, St. Mellons

Cardiff CF3 OLT ERN: 9617070

Gyrus ACMI Inc. 136 Turnpike Rd.

ERN: 3003790304

Southborough, MA 01772-2104

August 24, 2012

Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Obstetrics/Gynecology HIN 21 CFR 884.4150 Class II

PKSTM BILLTM

BiLap Loop / Bipolar Laparoscopic Loop

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Olympus Surgical Technologies of America Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

Performance Data Technological features and Substantial Equivalence

The PK STM BiLL™ utilizes features incorporated into the following legally marketed predicate device:

The bipolar PKS™ BiLL™ connects to the same electrosurgical generator, G400 . (K050550) as the predicate PKSTM BiLLTM (K111059).
The PKSTM BiLL™ uses Bipolar PK (Plasma Kinetic) technology and contains . an identification capacitor embedded in the single use connector cable will be recognized by the generator to set default optimal power output parameters for the subject instrument. This remained unchanged and identical to the predicate PKS™ BiLLTM (K111059).
. The mechanical design features of the PKS™ BiLL™ are similar to that of the predicate PKSTM BiLLTM (K111059).

The proposed PKS™ BiLL™ has the identical Indications for use as the predicate PKSTM BiLLTM.

The PKS™ BiLLTM instrument is compliant to electrical standards specifically to those applicable sections of IEC 60601 incorporating electrical, thermal safety and Electromagnetic Interference. .

The PKSTM BiLLTM instrument uses materials that are well established and used in other GYRUS ACMI FDA cleared medical devices. Biocompatibility testing on all patient contacting parts has been performed in compliance to the relevant requirements of ISO-10993.

The PKS™ BiLL™ instrument is packaged and sterilized as a sterile single use device.

Bench, Biocompatibility, and General Safety Summary

Design verification testing was carried out to ensure the device meets the product specifications, and design validation was carried out to ensure the product meets the user requirements. All testing was completed successfully. Electrical testing was also carried out to IEC 60601 and passed as well.

In addition the representative final product was tested to and passed ISO-10993-1. The product has been determined to be biocompatible.

Pre-clinical Evaluation Summary

In addition a pre-clinical evaluation was carried out using extirpated tissue (Human Uterine), and three (3) Physicians. Thirty-two (32) questions were asked of each of the three physicians after they carried out a mock procedure using the proposed device. These questions ranged from ease of understanding the IFU, to performance related questions specific to the

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Olympus Surgical Technologies of Američa Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

procedure. All three physicians were happy with the proposed device and felt it met their needs and performed to their expectations.

ﺎ

Summary

The proposed Gyrus ACMI Inc. Bipolar Laparoscopic Loop (PKS™ BiLL™), as described in this submission, is substantially equivalent to the predicate in intended use, materials, principles of operation and fundamental scientific technology and raises no new issues of safety and effectiveness.

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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a person embracing another person.

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 5, 2012

Gyrus ACMI, Inc. % Mr. Neil Kelly Regulatory Affairs Specialist 136 Turnpike Road SOUTHBOROUGH MA 01772

Re: K122605

Trade/Device Name: Gyrus ACMI® Bipolar Laparoscopic Loop (PKSTM BILLTM) Regulation Number: 21 CFR§ 884.4150 Regulation Name: Bipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: HIN Dated: November 2, 2012 Received: November 5, 2012

Dear Mr. Kelly:

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.

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Page 2 - Mr. Neil Kelly

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/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.

Herbert R. Lerner

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

: K122605

Device Name: Gyrus ACMI® Bipolar Laparoscopic Loop (PKS™ BiLL™)

Indications for Use:

Prescription Use: X

OR Over-the-Counter Use:

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number	K22605

Regulation Number and Section

§ 884.4150 Bipolar endoscopic coagulator-cutter and accessories.

(a)
Identification. A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and
(iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),”
(2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,”
(3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,”
(4) Labeling:
(i) Indication: For female tubal sterilization, and
(ii) Instructions for use:
(A) Destroy at least 2 centimeters of the fallopian tubes,
(B) Use a cut or undampened sinusoidal waveform,
(C) Use a minimum power of 25 watts, and
(D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction.