The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.

Device Description

The PK Spatula is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgery. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The instrument is to be used only with the ESG-400 electrosurgical generator. The generator and device make up a medical electrical system. The instrument is to be used only with the Gyrus ESG-400 Generator and associated 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment.

AI/ML Overview

This document describes the PK Spatula, an electrosurgical device, and its substantial equivalence to a predicate device. Detailed acceptance criteria and extensive study information (like sample sizes for test and training sets, expert qualifications, and specific ground truth methods) as typically found in an AI/software device submission are not provided in this type of 510(k) submission for a physical medical device. This submission focuses on comparing the new device to an existing one to demonstrate similar safety and effectiveness.

Here's a breakdown of the requested information based on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" and "device performance" are typically defined by engineering specifications and functional testing, rather than metrics like sensitivity, specificity, or AUC as seen in AI/software. The document states the new device is "substantially equivalent" to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence in cutting and coagulation performance to predicate.	"Cutting and Coagulation equivalency to predicate" met.
Dimensional compliance.	"Dimensional Measurements" met.
Withstand expected forces.	"Expected forces on devices" met.
Proper design feature functionality (rotation, button activation).	"Design feature testing (rotation and button activation)" met.
Sterility and specified shelf life.	"Sterilization" and "Shelf Life" testing results are satisfactory.
Biocompatibility.	"Biocompatibility testing has been carried out with passing results."
Compliance with relevant voluntary standards.	Device "complies with the following standards" (listed).

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

This information is not explicitly provided in the document. The "performance tests" mentioned (dimensional, cutting/coagulation equivalency, forces, design features, shelf life, sterilization, biocompatibility) are laboratory-based engineering and bench tests, not clinical studies with "test sets" in the context of data analysis.

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

This information is not applicable and not provided. "Ground truth" in the context of expert consensus is typically for diagnostic/interpretive devices (e.g., radiologists reviewing images). For an electrosurgical tool, "ground truth" refers to established engineering principles and objective measurements of its physical and functional properties.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, which is not relevant to the physical and functional testing of an electrosurgical 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

This information is not applicable and not provided. An MRMC study is relevant for AI-assisted diagnostic or interpretive devices. The PK Spatula is a surgical tool, not an AI-based diagnostic system.

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

This information is not applicable and not provided. Standalone algorithm performance is a concept for AI/software devices; the PK Spatula is a physical electrosurgical instrument.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the performance testing is based on:

Engineering specifications and objective measurements: For dimensional measurements, expected forces, and design feature testing.
Established laboratory-based testing protocols: For cutting and coagulation equivalency (likely measured on tissue surrogates or ex vivo tissue), sterilization effectiveness, shelf life stability, and biocompatibility.
Compliance with recognized standards: Such as ISO and IEC standards for medical devices.

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" is a term used for machine learning. This device's development involves engineering design and validation, not model training.

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

This information is not applicable and not provided for the same reasons as #8.

Summary of the K142289 Submission:

The provided document is a 510(k) premarket notification for a traditional medical device (PK Spatula, an electrosurgical instrument). The core of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (Gyrus PlasmaCision Laparoscopic Spatula K041633).

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

Bench Testing: A series of laboratory tests confirm the device's physical dimensions, mechanical strength, functionality (rotation, button activation), and performance characteristics (cutting and coagulation equivalency to the predicate).
Biocompatibility Testing: To ensure patient safety with the materials used.
Sterilization and Shelf Life Validation: To confirm the device remains sterile and functional over its stated shelf life.
Compliance with Voluntary Standards: Adherence to recognized medical device standards (ISO, IEC).

The document asserts that these tests, along with a detailed comparison of intended use, design, and technological characteristics, ensure the PK Spatula is "substantially equivalent" to the predicate and "raises no new concerns or safety or effectiveness."

Summary

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

December 31, 2014

Gyrus ACMI, Incorporated Mr. Neil Kelly MBA, RAC Senior Regulatory Affairs Specialist 6655 Wedgwood Road Maple Grove, Minnesota 55311

Re: K142289

Trade/Device Name: PK Spatula Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 4, 2014 Received: December 5, 2014

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. 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

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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 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/Resourcesfor You/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 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 yours,

David Krause -S

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) TBD K142289

Device Name PK Spatula

Indications for Use (Describe)

The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc.

Olympus PK Spatula

General Information

Manufacturer:	Gyrus ACMI, Inc.6655 Wedgwood RoadMaple Grove, MN 55311Phone: 508-804-2600
Establishment Registration Number:	2183680
510(k) Submitter:	Gyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104
Establishment Registration Number:	3003790304
Contact Person:	Neil KellyRegulatory Affairs Specialist508-804-2690Neil.kelly@olympus-osta.com
Date Prepared:	August 15, 2014
Device Description
Classification Name:Regulation NumberProduct CodeRegulatory ClassReview Panel	Electrosurgical cutting and coagulationdevice and accessories21 CFR 878.4400GEIClass IIGeneral and Plastic Surgery
Trade Name:	PK Spatula
Generic/Common Name:	Spatula Electrode

Predicate Devices

Gyrus PlasmaCision Laparoscopic Spatula K041633

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Comparison to Predicate Devices:

The PK Spatula has been compared to our own legally marketed Gyrus PlasmaCision Laparoscopic Spatula (K041633) with respect to intended use and technological characteristics. The comparison and testing results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and raises no new concerns or safety or effectiveness.

Product Description

Technological Characteristics

The PK Spatula uses bipolar energy in order to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgical procedures. The PK Spatula is activated using buttons located on the device handle. This allows the physician to activate either cut or coagulation (coag) mode without taking their eyes off the surgical site. Historically foot pedals have been used for such devices and are also available for the proposed device. A nosecone located at the distal end of the handle and at the proximal end of the device shaft allows the physician to alter the orientation of the electrode tip without altering the orientation of the handle.

Material

The predicate and proposed devices share many common materials. The two patient contact material differences are the sheath, which is now flouropolymer rather than Polyimide tubing, and a new ink was added on the device shaft as well. Biocompatibility testing has been carried out with passing results. As for the electrode tip and insulation all materials remain the same as the predicate.

Intended Uses

The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.

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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

The Olympus PK Spatula is delivered 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 three(3) years.

Summary of Performance Testing

The following performance tests were conducted:

Dimensional Measurements ●
Cutting and Coagulation equivalency to predicate
Expected forces on devices ●
Design feature testing (rotation and button activation)
Shelf Life
Sterilization ●
Biocompatibility ●

Substantial Equivalence

The proposed PK Spatula has the same intended use, design, and scientific technology as the Predicate PlasmaCision Laparoscopic Spatula (K041633). Both devices are of the same design, intended for the same patient population, have the identical indications for use, and use the same scientific technology. In addition there were no new issues of safety or effectiveness found with the proposed device.

Conclusion:

In summary, the PK Spatula is substantially equivalent to the predicate device 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.