The PK Needle is a bipolar electrosurgical instrument with the capability to resect soft tissue and blood vessels in laparoscopic and general surgical procedures. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The device has an active blunt needle shaped tip and is activated via a button on the handle, or by a foot pedal. 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 Gyrus ESG-400 Generator.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "PK Needle." It's a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to existing legally marketed devices, and it primarily focuses on device safety and performance characteristics for regulatory approval rather than clinical study results establishing diagnostic or therapeutic accuracy against ground truth.

Therefore, many of the requested categories are not applicable to this type of document because it details the physical and functional characteristics of an electrosurgical device, not a diagnostic AI or image analysis system.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document describes several performance tests, but it does not specify explicit "acceptance criteria" in a quantitative, tabular format as one might expect for a diagnostic device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, it states that tests were conducted and the device performed "substantially equivalent" to its predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Dimensional measurements within specifications	Passed: Dimensional Measurements conducted.
Cutting equivalency to predicate device	Passed: Cutting equivalency to predicate demonstrated.
Withstand expected forces	Passed: Expected forces on devices tested.
Proper design feature activation (button)	Passed: Design feature testing (button activation) conducted.
Maintain sterility and functionality over shelf life	Passed: Shelf Life and Sterilization tests conducted. Shelf life of three (3) years confirmed.
Biocompatibility with patient contact materials	Passed: Biocompatibility testing carried out with passing results for new flouropolymer sheath and new ink.
Compliance with relevant voluntary standards (ISO, ANSI/AAMI, IEC)	Passed: Device design complies with listed standards.

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

The document does not detail specific sample sizes for tests like "cutting equivalency" or "expected forces." The tests appear to be bench tests of the device itself rather than studies involving human subjects or clinical data sets on a large scale. Data provenance is not applicable as these are engineering and materials tests, not clinical data studies. The tests are prospective in the sense that they are performed on the manufactured device.

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. This device is an electrosurgical instrument, not a diagnostic device where "ground truth" would be established by experts interpreting medical images or pathology. The "truth" here relates to engineering specifications and performance characteristics.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for bench testing of device functionality.

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 is not an AI-assisted diagnostic or image interpretation device.

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

Not applicable. This is a physical electrosurgical instrument for direct surgical use.

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

The "ground truth" for this device's performance is based on engineering specifications, material science standards (e.g., biocompatibility), and functional tests designed to mimic its intended use (e.g., cutting equivalency). It's not based on clinical "outcomes data" or "pathology" in the context of diagnostic accuracy.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the machine learning sense.

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

Not applicable.

Summary

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

December 19, 2014

Gyrus ACMI Incorporated Mr. Neil Kelly, MBA, RAC Senior Regulatory Affairs Specialist 136 Turnpike Road Southborough, Massachusetts 01772

Re: K142154

Trade/Device Name: PK Needle Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 25, 2014 Received: November 26, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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,

Binita S. Ashar -S

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) K142154

Device Name PK Needle

Indications for Use (Describe)

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

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

Olympus PK Needle

General Information

Manufacturer:	Gyrus ACMI, Inc.6655 Wedgwood RoadMaple Grove, MN 55311Phone: 508-804-2739
Establishment Registration Number:	2183680
510(k) Submitter:	Gyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104
Establishment Registration Number:	3003790304
Contact Person:	Neil KellySenior Regulatory Affairs Specialist508-804-2690Neil.kelly@olympus-osta.com
Date Prepared:	August 1, 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:	Olympus - PK Needle
Generic/Common Name:	Electrosurgical cutting and coagulationdevice
Predicate Devices

Everest Bipolar Needle Electrode Gyrus Bipolar Needle

K031079

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Comparison to Predicate Devices:

The Olympus - PK Needle has been compared to our own legally marketed Everest Bipolar Needle Electrode (K031079) with respect to intended use and technological characteristics. The comparison and testing results presented in this 510(k) notification show that the device is substantially equivalent to predicate devices and raises no new concerns or safety or effectiveness.

Product Description

Technological Characteristics

For safety and convenience the Olympus ESG-400 generator recognizes and automatically presets the default output settings once the proposed PK Needle is connected.

The PK Needle is activated using a button located on the device handle, or via a foot pedal.

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 Needle is indicated for resection of soft tissue 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 Needle 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 equivalency to predicate ●
Expected forces on devices ●
Design feature testing (button activation) ●
Shelf Life .
Sterilization ●
Biocompatibility ●

Substantial Equivalence

The proposed Olympus - PK Needle has the same intended use, design, and scientific technology as the Predicate Everest Bipolar Needle Electrode (K031079). Both devices are of similar design and technology and have been shown to perform substantially equivalent in bench testing. There were no new issues of safety or effectiveness with the proposed device.

Conclusion:

In summary, the Olympus - PK Needle is substantially equivalent to the predicate 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.