The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.

Device Description

Both predicate and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Olympus ESG-400 Generator.

The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy.

AI/ML Overview

This document describes a 510(k) premarket notification for the PK AIM electrosurgical cutting and coagulation device. The submission aims to demonstrate substantial equivalence to existing predicate devices, specifically for the additional claim of sealing vessels up to 3.0 mm in diameter.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" with numerical thresholds, as would be common for diagnostic AI/ML devices with performance metrics like sensitivity, specificity, or AUC. Instead, the performance testing focuses on demonstrating that the subject PK AIM is substantially equivalent to its predicates, particularly for the new vessel sealing claim, meaning its performance is comparable and raises no new safety or effectiveness concerns.

However, we can infer some performance metrics from the Summary of Performance Testing section:

Performance Aspect	Acceptance Criteria (Inferred/Implied)	Reported Device Performance (PK AIM)
Vessel Sealing Capability	Seal arteries within a certain size range.	Sealed 1.00 mm to 3.49 mm size arteries.
Burst Pressure of Sealed Arteries	Statistically equivalent burst pressures to the predicate device and exceed a certain threshold (e.g., 360 mmHg).	Burst pressures of sealed arteries were statistically equivalent to the predicate PKS OMNI. Burst pressure of sealed arteries exceeded 360 mmHg.
Thermal Spread (Acute Study)	Qualitative assessment of thermal damage comparable to predicate.	Evaluated thermal spread in a swine model. (No specific quantitative metric provided, but implied to be acceptable given the "no differences" conclusion in the chronic study).
Qualitative Sealing Characteristics (Acute Study)	Sealing characteristics comparable to predicate.	Evaluated qualitative sealing characteristics in a swine model. (No specific quantitative metric provided, but implied to be acceptable).
Thermal Imaging (Acute Study)	Collection of thermal imaging data.	Provided collection of thermal imaging while sealing vessels. (No performance metric, but rather a data collection).
Thermal Spread (Chronic Study)	Negligible or acceptable thermal damage/collateral effects after 21 days, comparable to predicate.	Evaluated thermal spread in a swine model. Necropsy pathology of post-splenectomy and ovariectomy sealed vessel sites showed no differences between sealing performed by test and control devices. This indicates acceptable long-term thermal effects.
Qualitative Sealing Characteristics (Chronic Study)	Sealing characteristics maintained for 21 days, comparable to predicate.	Evaluated qualitative sealing characteristics. Necropsy pathology showed no differences between sealing performed by test and control devices.
Animal Survival (Chronic Study)	Animals survive a minimum of 21 days with acceptable health.	11 animals survived a minimum of 21-days following the surgical procedure. Their health was deemed acceptable prior-to, during, and following the 21-day survival period at which time they were euthanized and grossly examined.
Overall Comparison	Demonstrated similar functionality to control device for sealing arteries, veins, & AV bundles up to 3mm.	The test results concluded that the subject PK AIM test article demonstrated similar functionality to the control article (Gyrus ACMI (PKS) OMNI) for sealing arteries, veins and artery vein bundles up to 3mm in diameter. The device was found to be substantially equivalent with no new issues of safety or effectiveness.

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

The studies described are in vivo animal studies and ex vivo bench testing, not human patient data.

Ex Vivo Bench Testing:
- Sample Size: Not explicitly stated as a total number of vessels, but it confirmed sealing of 1.00 mm to 3.49 mm size arteries.
- Data Provenance: Laboratory bench testing. (No country of origin specified, but typically conducted internally or at specialized testing facilities).
- Retrospective/Prospective: Prospective.
Acute GLP Study (Swine Model):
- Sample Size: Quantities of 11 and 12 blood vessels were sealed by the subject PK AIM and predicate PK OMNI, respectively.
- Data Provenance: Swine model, likely a controlled laboratory setting (GLP - Good Laboratory Practice implies a standardized, prospective study).
- Retrospective/Prospective: Prospective.
Chronic GLP Study (Swine Model):
- Sample Size: 11 animals survived a minimum of 21 days. The number of vessels sealed per animal is not specified but would be multiple.
- Data Provenance: Swine model, controlled laboratory setting (GLP).
- Retrospective/Prospective: Prospective.

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

The document does not describe the use of human experts to establish "ground truth" in the context of diagnostic performance (e.g., radiologists reviewing images). Instead, the studies involve direct observation, measurement, and pathological analysis by scientific personnel.

Ex Vivo Bench Testing: Ground truth is established by objective measurements (e.g., visual confirmation of sealing, burst pressure measurements using pressure gauges/equipment). This does not involve expert consensus in the human interpretation sense.
Acute and Chronic GLP Studies:
- Histopathology Report: A Histopathology Report is attached to the acute study, implying pathological assessment. This would typically be performed by a veterinary pathologist or similar qualified expert in animal tissue analysis. The number of pathologists is not specified.
- Necropsy Pathology: A necropsy pathology of post-splenectomy and ovariectomy sealed vessel sites was performed in the chronic study. This would also be conducted by a veterinary pathologist. The number of pathologists is not specified.
- Animal Health Report: An Animal Health Report attached to the chronic study, suggesting assessment by a veterinarian or animal care expert.
- Qualifications: "GLP Study" implies that all personnel involved in the study (including pathologists and veterinarians) would meet specific qualifications and adhere to good laboratory practice standards.

4. Adjudication Method for the Test Set:

Not applicable in the AI/ML diagnostic sense. The studies rely on objective measurements and pathological assessments, where "adjudication" between human readers is not a concept employed. Discrepancies in pathological findings, if any, would be resolved through standard pathology practices (e.g., review by a senior pathologist, consensus discussion).

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:

Not applicable. This device is an electrosurgical instrument, not an AI/ML diagnostic tool intended to assist human readers in interpreting data. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this submission.

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

Not applicable. The PK AIM is a physical surgical device, not a software algorithm. Its performance is inherent to the device itself.

7. The Type of Ground Truth Used:

Ex Vivo Bench Testing:
- Direct Physical Measurement: Burst pressure of sealed arteries, direct observation of sealing, measurement of artery size.
Acute and Chronic GLP Studies (Swine Model):
- Pathology: Gross examination, histopathology (microscopic examination of tissue samples), necropsy pathology.
- Outcomes Data: Animal survival, qualitative assessment of health, comparison of sealed vessel sites to control.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "training" for the device's functionality comes from its engineering design and manufacturing.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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

September 26, 2016

Gyrus ACMI Inc. Mr. Graham Baillie Regulatory Affairs Manager 136 Turnpike Road Southborough, Massachusetts 01772

Re: K161825

Trade/Device Name: PK AIM Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 12, 2016 Received: September 13, 2016

Dear Mr. Baillie:

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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth

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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 Parts 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161825

Device Name PK AIM

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Notification June 27, 2016

510(k) Summary Gyrus ACMI, Inc.

Olympus PK AIM

General Information

Manufacturer:	Gyrus ACMI, Inc.9600 Louisiana Ave NorthBrooklyn Park, MN 55445Phone: 508-804-2690
Establishment Registration Number:	3011050570
510(k) Submitter:	Gyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104
Establishment Registration Number:	3003790304
Contact Person:	Graham A. L. Baillie MSRegulatory Affairs Manager508-804-2738Graham.baillie@olympus-osta.com
Date Prepared:	June 27, 2016
Device Description
Classification Name:	Electrosurgical cutting and coagulationdevice and accessories
Regulation number	21 CFR 878.4400
Product code	GEI
Regulatory class	Class II
Review Panel	General and Plastic Surgery
Trade Name:	Olympus - PK AIM
Generic/Common Name:	Electrosurgical cutting and coagulationdevice

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Predicate Devices

K152219	Olympus PK AIM
K081766	(Gyrus ACMI, Inc.) PKS OMNI Instrument

Comparison to Predicate Devices:

The Olympus PK AIM has been compared to predicate Olympus PK AIM and PKS OMNI with respect to intended use, design, and fundamental scientific technology. The comparisons and testing results presented in this 510(k) notification to FDA show this device to be substantially equivalent to predicate devices and raises no new concerns or safety or effectiveness.

Like the predicate PK AIM, the proposed PK AIM is intended for mono polar cutting and coagulation, grasping, bipolar coagulation of selected soft tissues, and like its predicate PKS OMNI the proposed PK AIM is also intended to seal vessels up to and including 3.0 mm in diameter during electro surgery. Both predicate and proposed PK AIM devices are not intended to be used for tubal ligation or female sterilization.

Product Description

The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy. The predicate Olympus PK AIM passed all applicable biocompatibility testing and additional information was provided within in K152219 for any patient contacting materials that contain colorants. The subject Olympus PK AIM and predicate Olympus PK AIM are physically identical - no design or material changes whatsoever.

Technological Characteristics

The proposed Olympus PK AIM uses monopolar energy in order to cut and bipolar energy in order to coagulate soft tissue in general surgical procedures. For safety and convenience the ESG-400 generator recognizes the proposed Olympus PK AIM when it is connected and limits generator settings to those dedicated for use with the proposed Olympus PK AIM device. These settings are called out in the IFU.

The Olympus PK AIM can be activated using buttons located on the device handle, or via a foot pedals which are sold separately. The hand activation allows the physician to activate either cut or coagulation (coag) mode without taking their eyes off the surgical site. A sliding toggle switch located on the handle allows the user to switch between using the device as a pencil or forceps.

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Material

No material changes were made to the predicate PK AIM cleared under K152219.

Indications for Use

Compliance to Voluntary Standards

The design of the proposed device complies with the following standards:

ISO 10993-1. 2009 ISO 10993-5, 2009 ISO 10993-7 2008 ISO 10993-10, 2010 ANSI/AAMI/ISO 11607-1, 2006 ANSI/AAMI/ISO 11135-1, 2007 ISO 14971, 2007 ISO 15223-1; 2012 IEC 60601-1: 2005 IEC 60601-2-2: 2009

Summary of Sterilization and Shelf Life Discussion

Like the predicate Olympus PK AIM, (K152219), the proposed Olympus PK AIM will be distributed in a sterile state and is intended for single patient use only. The sterilization method used is ethylene oxide and has a shelf life of 1 year.

Summary of Performance Testing

The predicate PK AIM (K152219) and proposed PK AIM, are identical in every respect. No physical design changes were made that would require the repeat of performance testing already provided in K152219. Bench and animal testing performance tests were conducted to support the additional 3 mm vessel sealing claim which is the subject of this submission. Performance testing provided in this submission will demonstrate that the 3 mm vessel sealing performance of the proposed PK AIM is substantially equivalent to the predicate Gyrus ACMI PKS OMNI, K081766.

The vessel sealing performance of subject PK AIM and the predicate PKS OMNI were compared via ex vivo bench testing, acute animal testing, and chronic animal testing (porcine model). Protocols, reports and test data for this testing are provided in the appendices of Section 15 and 16 and include:

Bench Testing ex vivo, confirmed that both devices:

Sealed 1.00 mm to 3.49 mm size arteries.
Burst pressures of sealed arteries were statistically equivalent. ●

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and burst pressure of sealed arteries exceeded 360 mmHg. ●
The Acute GLP Study evaluated thermal spread, qualitative sealing characteristics and provided collection of thermal imaging while sealing vessels with the Olympus PK AIM device in a swine model. The predicate Gyrus ACMI (PKS) OMNI device was used as the Control device. During the acute study, quantities of 11 and 12 blood vessels respectively were sealed by subject PK AIM and predicate PK OMNI. A Histopathology Report is attached to this study.

The Chronic GLP Study in a swine model evaluated thermal spread, qualitative sealing characteristics and provided a collection of thermal imaging while sealing vessels with the proposed Olympus PK AIM device. The predicate Gyrus ACMI (PKS) OMNI device was used as the Control device. The Chronic studies demonstrated that 11 animals survived a minimum of 21-days following the surgical procedure. Their health was deemed acceptable prior-to, during, and following the 21day survival period at which time they were euthanized and grossly examined. A necropsy pathology of post-splenectomy and ovariectomy sealed vessel sites showed no differences between sealing performed by test and control devices.

The test results concluded that the subject PK AIM test article demonstrated similar functionality to the control article (Gyrus ACMI (PKS) OMNI) for sealing arteries, veins and artery vein bundles up to 3mm in diameter.

An Animal Health Report and Pathology Report were attached in the appendices of this report.

Substantial Equivalence

The proposed Olympus PK AIM has the same intended use, design, and scientific technology as its predicate Olympus PK AIM device combined into one device. The predicate PK AIM and proposed PK AIM device are both a pencil and a forceps device with a dual cord. The proposed and predicate devices were shown to perform substantially equivalent in bench testing. There were no new issues of safety or effectiveness with the proposed device. Please see the following Substantial

DesignFeature	ProposedOlympus PK AIM	PredicateOlympus PK AIMK152219	PredicatePKS OMNIK081766	Comments
Function ofDevice	Forceps/Pencil	Forceps/Pencil	Forceps	Same aspredicate PKAIM
Tip Size	Forceps1mm tip, 2mm basePencil2mm	Forceps1mm tip, 2mm basePencil2mm		Same
Energy	Monopolar/Bipolar	Monopolar/Bipolar	Bipolar	Same

Equivalence Comparison Table:

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Activation	Hand / Footpedal	Hand / Footpedal	Same
Plug	Dual (mono/bi)	Dual (mono/bi)	Same
ElectrodeMaterials	Stainless Steel	Stainless Steel	Same
Sterility	$10^{-6}$EtO	$10^{-6}$EtO	$10^{-6}$ (Same)
Single Use	Yes	Yes	Same
Intended Use	The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.	The PK AIM device is intended for monopolar cutting as well as grasping, manipulating and bipolar coagulation of selected soft tissues during electrosurgery. This device is not intended to be used for tubal ligation or female sterilization.	The Gyrus ACMI Inc. PKS OMNI Instruments is intended for electrosurgical coagulation, mechanical grasping, and dissection of tissue, and sealing of vessels up to 3mm, during the performance of laparoscopic and general (open) surgical procedures when used in conjunction with the Gyrus ACMI G400 Workstation
			Predicate and proposed PK AIM devices are the same except for the addition of 3 mm vessel sealing to the proposed PK AIM. The PKS OMNI was included as predicate because of its 3 mm vessel sealing.

Conclusion:

In summary, the proposed Olympus PK AIM is substantially equivalent to the predicate Olympus PK AIM and Gyrus ACMI PKS OMNI devices and presents no new questions of safety or efficacy.

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.