The Laparoscopic Handles with PEEK Insulation are indicated for use in endoscopic surgical procedures through cannulae to perform cutting, dissecting, retracting, and manipulating functions.

Device Description

Laparoscopic surgical manual instruments (containing a Laparoscopic Handle with PEEK Insulation and manual instrument insert) are intended for cutting, holding, grasping and manipulation of tissue, organ areas, and surgical auxiliaries such as suturing material. Some instruments have radiofrequency (RF) ports which allow them to be used for electrosurgery. The Laparoscopic Handles with PEEK Insulation (herein referred to as 'proposed device') can be used in combination with the predicate 5 mm inserts cleared in K973259. The proposed devices are designed to be sterilized by the end user using either the US or EU standard pre-vacuum sterilization cycles.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Laparoscopic Handles with PEEK Insulation). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study or AI model performance evaluation. Therefore, most of the information requested in your prompt is not available in these documents.

Here's the information that can be extracted, and an explanation of why other requested information is not present:

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

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Biocompatibility	- Criteria: Adherence to FDA Blue Book Memorandum #G95-1, ISO 10993-1:2009, ISO 10993-5 (In vitro cytotoxicity), ISO 10993-10 (Irritation and skin sensitization), ISO 10993-11 (Systemic toxicity). Device considered External Communicating Devices: Tissue/Bone/Dentin with limited contact duration (<24 hours).
	- Performance: Cytotoxicity, Intracutaneous Reactivity, Sensitization, and Acute Systemic Toxicity testing was performed on finished devices that had undergone simulated use and reprocessing. All biocompatibility testing had passing results.
Sterilization Validation	- Criteria: Compliance with ISO 17665-1:2006 "Sterilization of Health Care Products Moist Heat Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices". Requirement for a Sterility Assurance Level (SAL) of $10^{-6}$.
	- Performance: Sterilization has been validated to ensure a Sterility Assurance Level of 10-6.
Electrical Safety	- Criteria: Compliance with ANSI/AAMI ES60601-1:2005 + A2 (R2012) +A1 "Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance" and IEC 60601-2-2:2009 "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'.
	- Performance: The proposed devices comply with the specified electrical safety standards.
Mechanical Testing	- Criteria: Evaluation of Shaft deflection and Monopolar cycling (Reliability of electrical insulation through repeated firing of monopolar energy). Specific quantitative criteria are not listed in the provided text.
	- Performance: Mechanical testing was conducted for Shaft deflection and Monopolar cycling. Specific quantitative results or passing values are not detailed in this summary.

The following information is NOT available in the provided document:

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

This document describes engineering and biocompatibility testing, not a clinical study with a "test set" in the context of an AI model or diagnostic device. Therefore, this information is not applicable.

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 as this is not a diagnostic device or AI model study.

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

Not applicable.

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 a surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable.

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

For the physical tests (biocompatibility, sterilization, electrical, mechanical), the "ground truth" is defined by the specific requirements and methods of the referenced international standards (e.g., ISO, ANSI/AAMI). Passing these established and standardized tests serves as the "ground truth" for compliance.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device.

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

February 4, 2015

Stryker Endoscopy % Mr. Dave Yungvirt Third Party Review Group, LLC 45 Rockafeller Plaza New York, New York 10111

Re: K150127

Trade/Device Name: Laparscopic Handles with PEEK Insulation Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: January 19, 2015 Received: January 20, 2015

Dear Mr. Yungvirt:

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, Jennifer R. Stevenson -A 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) K150127

Device Name

Laparoscopic Handles with PEEK Insulation

Indications for Use (Describe)

The Laparoscopic Handles with PEEK Insulation are indicated for use in endoscopic surgical procedures through cannulae to perform cutting, dissecting, retracting, and manipulating functions.

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)

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FOR FDA USE ONLY

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

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I. SUBMITTER

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138

Phone: 408-855-6377 Fax: 408-754-2969

Contact Person: Rebecca Goldberg Date Prepared: January 16, 2015

II. DEVICE

Name of Device: Laparoscopic Handles with PEEK Insulation Common or Usual Name: Endoscopic Forceps/Graspers/Scissors Classification Name: Endoscope and Accessories (21 CFR 876.1500) Regulatory Class: II Product Code: GCJ

III. PREDICATE DEVICE

K&W 2-Piece Take-Apart Instruments, K973259

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

INDICATIONS FOR USE V.

The Laparoscopic Handles with PEEK Insulation are indicated for use in endoscopic surgical procedures through cannulae to perform cutting, dissecting, and manipulating functions.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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Manipulation and cutting of tissue using mechanical or electrosurgical means is the technological principle for both the proposed and predicate devices. These functions are based on using surgical tools to access internal tissues and organs within the abdominal cavity.

The following differences exist between the proposed and predicate devices:

Use of different shaft insulation material .
. Use of different glue between the shaft and shaft insulation

VII. PERFORMANCE DATA

The following performance data are provided in support of the substantial equivalence determination.

Biocompatibility Testing:

The biocompatibility evaluation and testing of the Laparoscopic Handles with PEEK Insulation was conducted in accordance with the following as recognized by the FDA:

. FDA Blue Book Memorandum #G95-1 "Use of International Standard 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" May 1, 1995,
ISO 10993-1:2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process,"
. ISO 10993-5. Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
ISO 10993-11, Biological evaluation of medical devices- Part 11: Tests for systemic ● toxicity.

The Laparoscopic Handles with PEEK Insulation are considered External Communicating Devices: Tissue/Bone/Dentin with limited contact duration (<24 hours). Cytotoxicity, Intracutaneous Reactivity, Sensitization and Acute Systemic Toxicity testing was performed on the finished devices which had undergone simulated use and reprocessing per the Instructions for Use. All biocompatibility testing had passing results.

Sterilization Validation:

The Laparoscopic Handles with PEEK Insulation are provided to user non-sterile and must be sterilized prior to the initial and each subsequent use. Sterilization was conducted in accordance with ISO 17665-1:2006 "Sterilization of Health Care Products Moist Heat Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices". Sterilization has been validated to ensure a Sterility Assurance Level of 10-6.

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Electrical Safety:

Electrical safety testing was conducted on the Laparoscopic Handles with PEEK Insulation. The proposed devices comply with the ANSI/AAMI ES60601-1:2005 + A2 (R2012) +A1 "Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance" standard for safety and the IEC 60601-2-2:2009 "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:

Shaft deflection
Monopolar cycling (Reliability of electrical insulation through repeated firing of monopolar energy)

VIII. CONCLUSIONS

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 Laparoscopic Handles with PEEK Insulation raise no new questions of safety or effectiveness and can be considered to be substantially equivalent to the predicate devices.

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.