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/sectioning 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 (PKSTM BiLL™) is-a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Gyrus ACMI G400 Workstation Generator. The PKSTM BiLL™ is a laparoscopic instrument. It is available in an 88mm x 215mm loop. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10°0

AI/ML Overview

Here's an analysis of the provided text regarding the PKS™ BiLL™ device, focusing on the requested acceptance criteria and study information:

PKS™ BiLL™ Device Study Analysis

The provided 510(k) summary for the PKS™ BiLL™ device does not contain detailed acceptance criteria and a specific study proving the device meets those criteria in the typical sense of a clinical trial. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and pre-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria with numerical targets are provided in the document. The performance assessment is primarily qualitative, stating that:

Acceptance Criterion (Implied)	Reported Device Performance
Electrical Safety (IEC 60601)	Compliant to electrical standards, specifically applicable sections of IEC 60601 incorporating electrical, thermal safety, and Electromagnetic Interference.
Biocompatibility (ISO 10993)	Full biocompatibility testing on all patient contacting parts has been performed in compliance with the relevant requirements of ISO-10993.
Packaging and Sterilization (ISO 11607, ISO 11137)	Packaged and sterilized as a sterile single-use device and tested to comply with ISO 11607 and ISO11137.
Mechanical Design / Usability / Software Selection for Cut & User Performance	Preclinical testing has been undertaken to validate the mechanical design, usability considerations, and software selection to provide the desired cut and user performance requirements. Performance was compared against the predicate LiNA Loop. Bench and preclinical testing demonstrated that the performance requirements were met, and that the PKSTM BiLLTM exhibited comparable performance characteristics to the LiNA Loop.

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

The document mentions "Preclinical testing" and "Bench and preclinical testing". It states that this testing was done to validate mechanical design, usability, and software selection, and the performance was compared against the predicate LiNA Loop.

Sample Size for Test Set: Not specified. The document does not provide a number of devices or subjects used in this testing.
Data Provenance: The nature of the "preclinical testing" suggests in-house laboratory or animal testing. The country of origin of this data is not explicitly stated, but being a US-based manufacturer, it's reasonable to infer the testing was conducted in the US or by its contracted facilities. The testing is prospective in nature, as it's being conducted to validate the new device.

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

Not applicable. The "preclinical testing" described for this device focuses on engineering performance characteristics (electrical, mechanical, sterilization, biocompatibility, and functional "cut and user performance requirements") rather than diagnostic accuracy or clinical outcomes that would typically involve expert ground truth establishment for a test set. There's no mention of experts establishing a ground truth for this type of performance testing.

4. Adjudication Method

Not applicable. As the "preclinical testing" primarily involves engineering and functional performance, clinical adjudication methods like 2+1 or 3+1 for ground truth are not relevant to the described studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The evaluation focuses on substantial equivalence based on technological features and in-vitro/pre-clinical performance compared to predicates, not on the improvement of human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable/Not relevant. This device is an electrosurgical instrument, not an AI algorithm. Its performance is inherent to its design and how it interacts with the G400 Workstation Generator, meaning "standalone" performance without human interaction (as in, no one is operating the laparoscopic loop) is not a practical concept for this device type. The "cut and user performance requirements" inherently involve human interaction for usability.

7. Type of Ground Truth Used

For the described preclinical testing, the "ground truth" implicitly refers to:

Engineering specifications and regulatory standards: (e.g., IEC 60601, ISO 10993, ISO 11607, ISO 11137).
Performance characteristics of the predicate device (LiNA Loop): The new device's performance was "compared against the performance characteristics of the predicate LiNA Loop" and found to "exhibit comparable performance characteristics."

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its function is based on established electrosurgical principles and mechanical design.

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

Not applicable. See point 8.

Summary

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PKS™ BiLL™ Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

SEP - 1 2011

Traditional 510(k) Notification

K111059 page 1 of 3

510(k) Summary

General Information

Manufacturer:

Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104

Establishment Registration Number:

Contact Person:

Date Prepared:

3003790304

Terrence E. Sullivan Executive Director, Regulatory Affairs

August 31, 2011

Device Description

Classification Name:

Bipolar endoscopic coagulator-cutter and accessories (21 CFR 884.4150), Class II Obstetrics and Gynecology Panel

PKSTM (Plasmakinetic System) BiLLTM

(Bipolar Laparoscopic Loop)

Trade Name:

Generic/Common Name:

BiLap Loop / Bipolar Laparoscopic Loop

Predicate Devices

The predicate devices include: 1. LiNA Loop K070315 2. Gyrus ACMI PlasmaCision Spatula K041633 3. Gyrus ACMI G400 Workstation Generator (and 9-pin PKSTM PlasmaSpatula) K050550

Indications for Use

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Traditional 510(k) Notification

KIII059 page 2 of 3

Product Description

Performance Data, Technological Features and Substantial Equivalence

The PKSTM BiLL™ utilizes features incorporated into the following legally marketed predicate devices:

The bipolar PKSTM BiLL™ connects to the same electrosurgical generator, . the Gyrus ACMI G400 Workstation Generator (K050550) as the predicate 9-pin PKSTM PlasmaSpatula (K050550).
The PKSTM BiLL™ uses Bipolar PK technology and contains an � identification capacitor embedded in the single use connector cable, which will be recognized by the generator to set default optimal power output parameters for the subject instrument, as does the PKS™ PlasmaSpatula (K050550)
The mechanical design features of the PKSTM BiLL™ are similar to that of the predicate LiNA Loop (K070315).

The PKSTM BiLLTM has the same intended use as the predicates PKSTM PlasmaSpatula and LiNA Loop.

The PKS™ BiLL ™ 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 and the LiNA Loop. Full biocompatibility testing on all patient contacting parts has been performed in compliance to the relevant requirements of ISO-10993.

The PKSTM BiLL™ instrument is packaged and sterilized as a sterile single use device and tested to comply with ISO 11607 and ISO11137.

Preclinical testing has been undertaken to validate the mechanical design, usability considerations and software selection to provide the desired cut and user performance requirements. The performance was compared against the performance characteristics of the predicate LiNA Loop. Bench and preclinical testing demonstrated that the

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Traditional 510(k) Notification

K111059 page 3 of 3

performance requirements were met, and that the PKSTM BiLLTM exhibited comparable performance characteristics to the LiNA Loop.

Summary

The Gyrus ACMI Inc. Bipolar Laparoscopic Loop (PKS™ BiLL™), as described in this submission, is substantially equivalent to the predicates in intended use, materials, principles of operation and fundamental scientific technology and raises no new issues of safety and effectiveness. The evidence included within this submission supports the conclusion that the PKS™ BiLL™ instrument is substantially equivalent to the identified predicates and is safe and effective for its intended purpose.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Mr. Terrence E. Sullivan Executive Director. Regulatory Affairs Gyrus ACMI Inc. 136 Turnpike Road SOUTHBOROUGH MA 01772

2011

Re: K111059

Trade/Device Name: PKSTM (Plasmakinetic System) BiLLTM (Bipolar Laparoscopic Loop) instrument Regulation Number: 21 CFR8 884.4150 Regulation Name: Bipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: HIN Dated: August 17. 2011 Received: August 18, 2011

Dear Mr. Sullivan:

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 10 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 of medical device-related

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Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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.

http://www.fda.gov/MedicalDevices/ResourcestoYou/Industry/default.htm.

Sincerely yours,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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Traditional 510(k) Notification

PKS™ BiLL™ Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

510(k) Number: K111059

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

Statement of Intended use:

Prescription Use:

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)

Heidi Heun

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111059

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.