Laparoscopic surgical manual instruments are designed to be used endoscopically through cannula to perform cutting, grasping, dissecting, retracting, and manipulating functions. The Ergonomic handle is intended to be used with 5mm inserts available from K&W and previously cleared under K973259.

Device Description

Symmetry® laparoscopic surgical manual instruments consist of a handle and a 5mm shaft, which hold various 5 mm inserts cleared under K973259. The shaft comes in two lengths: 33 cm and 45 cm. One handle can be used in combination with a variety of different 5 mm inserts. The handles have monopolar posts which allow them to be used for electrosurgery.

The ergonomic laparoscopic handles have an adjustable grip. They may be used in one of the three handle positions: pistol grip, hybrid, and inline. To change the handle position, retract the position adjustment button and lock the grip in the chosen position. The handle comes in two sizes.

AI/ML Overview

This document describes the Ergonomic Handle (K173272), which is an accessory to laparoscopic surgical manual instruments. The device allows for adjustable grip angles to improve surgeon comfort. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Biocompatibility	ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 (for External Communicating Devices: Tissue/Bone/Dentin with limited contact duration <24 hours)	Cytotoxicity, Intracutaneous Reactivity, Sensitization, and Acute Systemic Toxicity tested. All acceptance criteria of the standards were met through testing or justified through risk assessment.
Sterilization Validation	ISO 17665-1 (for Pre-vacuum steam sterilization cycles of 132°C for 4 minutes and 134°C for 3 minutes)	Testing was done to validate common cycles to achieve a Sterility Assurance Level of 10⁻⁶.
Electrical Safety	ANSI/AAMI ES60601-1 (General Requirements for Basic Safety and Essential Performance) and IEC 60601-2-2 (Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories)	The proposed devices comply with these standards for safety.
Mechanical Testing	Not explicitly stated, but included testing for shaft deflection and electrical safety after simulated use.	Reliability testing was conducted, including shaft deflection and electrical safety after simulated use. (Implied to have met performance needs for substantial equivalence).

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

The provided document does not specify sample sizes for any of the testing conducted (biocompatibility, sterilization, electrical safety, mechanical testing).

The data provenance is not explicitly stated beyond the testing being performed in support of the substantial equivalence determination for the device. Given the context of a 510(k) submission, this typically refers to testing conducted by the manufacturer or a contracted lab under their direction, likely within the US, but this is an inference. It is retrospective in the sense that the testing was performed on completed device designs to demonstrate compliance, rather than in a prospective clinical trial.

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

This document describes pre-market testing for a medical device (laparoscopic handle). These types of tests (biocompatibility, sterilization, electrical safety, mechanical) do not typically involve human experts establishing "ground truth" in the way it's understood for AI/diagnostic studies. The "ground truth" here is defined by compliance with established scientific standards and regulatory requirements. The experts involved would be the testers and engineers conducting the studies, and potentially external auditors or consultants specializing in those regulatory standards. Their qualifications would be in their respective fields (e.g., microbiology for sterilization, toxicology for biocompatibility, electrical engineering for safety, mechanical engineering for mechanical testing). No specific number or qualifications of such experts are provided in this document.

4. Adjudication Method for the Test Set

As mentioned above, the tests are primarily objective measurements against established standards, not subjective assessments requiring adjudication. Therefore, no adjudication method like 2+1 or 3+1 is applicable or mentioned for the described testing. The assessments are based on whether predefined metrics (e.g., bacterial kill rate, material toxicity, electrical leakage) meet specified limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done or is mentioned. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to compare human performance with and without AI. This device is a surgical instrument handle, not an interpretive medical device.

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

N/A. This device is a manual surgical instrument handle, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance assessment of this ergonomic handle is defined by:

Compliance with recognized international and national standards: ISO 10993 series (biocompatibility), ISO 17665-1 (sterilization), ANSI/AAMI ES60601-1 and IEC 60601-2-2 (electrical safety).
Engineering specifications and test protocols: for mechanical reliability (shaft deflection, electrical safety after simulated use).
Demonstration of substantial equivalence to a predicate device (K150127) through comparing technological characteristics and ensuring no new issues of safety or effectiveness are raised.

8. The Sample Size for the Training Set

N/A. This device is a physical surgical instrument, not an AI/machine learning system, so there is no "training set."

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

N/A. Since there is no training set, this question is not applicable.

Summary

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February 9, 2018

Symmetry Surgical Inc. Christopher Smith Sr. Director of Regulatory Compliance 3034 Owen Drive Antioch, Tennessee 37013

Re: K173272

Trade/Device Name: Ergonomic Handle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: October 9, 2017 Received: October 12, 2017

Dear Christopher Smith:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer R. Stevenson -S3

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) K173272

Device Name Ergonomic Handle

Indications for Use (Describe)

Laparoscopic surgical manual instruments are designed to be used endoscopically through camula to perform cutting, grasping, dissecting, retracting, and manipulating functions.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 4: 510(k) SUMMARY

Submitter's Name:	Symmetry Surgical Inc.
Address:	3034 Owen Drive, Antioch, TN 37013 USA
Telephone:	1-800-251-3000
Fax:	1-800-342-3272
Submitter:	Christopher Smith
Date Prepared:	February 8, 2018
Device Trade Name:	Ergonomic Handle
Common Name:	Ergonomic Handle
Device Classification:	Class II
Classification Name:	Endoscope and Accessories
Regulation:	21 CFR 876.1500
Device Regulation Panel:	General and Plastic Surgery
Device Product Code:	GCJ
Predicate Device:	K150127 Laparoscopic Handles with PEEK Insulation

Device Description:

Intended Use:

Indications For Use:

Laparoscopic surgical manual instruments are designed to be used endoscopically through cannula to perform cutting, grasping, dissecting, retracting, and manipulating functions.

Technological Characteristics of the Device Compared to the Predicate Device:

Indications between the predicate and subject device are equivalent. Both devices are intended to be used endoscopically to perform cutting, dissecting, and manipulating functions.

The subject device has additional ability to adjust the handle position to allow for better ● surgeon comfort but this does not affect the function of the device.
The subject device allows the devices to be disassembled for easier cleaning and ● sterilization.

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The subject device is only available in a 5mm option and does not introduce a new worstcase scenario.
The subject device adjustable grip angle allows the surgeon to use the device in a more comfortable manner depending on the procedure and does not affect the performance of the device for its indicated uses.

There are no technological characteristics that raise new issues of safety or effectiveness. Based upon the similarities of the Ergonomic Handle and the predicate device studied, the safety and effectiveness of the Ergonomic Handle is substantially equivalent to the predicate device referenced.

Assessment of Performance Data:

Design verification and validation testing including biocompatibility, sterilization, cleaning, electrical safety, and mechanical testing was performed in support of the substantial equivalence determination.

Biocompatibility Testing

The Ergonomic handles are considered External Communicating Devices: Tissue/Bone/Dentin with limited contact duration (<24 hours). Cytotoxicity, Intracutaneous Reactivity, Sensitization and Acute Systemic Toxicity tested was performed on the finished devices. Biocompatibility testing was completed per ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11. All acceptance criteria of the standards were met through testing or justified through risk assessment.

Sterilization Validation

The Ergonomic handles are provided to the user non-sterile and must be sterilized prior to the initial use and each subsequent use. Sterilization testing was conducted in accordance with ISO 17665-1. Testing was done to validate common Pre-vacuum steam sterilization cycles of 132°C for 4 minutes and 134° for 3 minutes to achieve a Sterility Assurance Level of 10°.

Electrical Safety

The proposed devices comply with the ANSI/AAMI ES60601-1 "Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential

Performance" standard for safety and the IEC 60601-2-2 "Medical Electrical Equipment -Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories" for high frequency devices.

Mechanical Testing

Reliability testing was conducted that included both shaft deflection and electrical safety testing after simulated use. There are additional tests performed for internal use to characterize surgeon satisfaction with the device over the lifetime of the product and those tests are not applicable to the safety or efficacy of the product for its intended use.

Based off the previously mentioned tests the subject device is substantially equivalent to the predicate device.

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Conclusion:

The submitted information in this premarket notification is complete, and based on the indications for use, technological characteristics, performance testing and comparison to the predicate devices, the Ergonomic Handle raises no new questions of safety or effectiveness and can be considered to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.