Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are intended for use in open or thoracoscopic surgical procedures. They are designed for cutting, manipulating, grasping, clamping, dissecting or suction.

Device Description

Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are designed for cutting, manipulating, grasping, clamping, dissecting, or suction during open, or thoracoscopic surgical procedures. The instruments are reusable and are made from Stainless Steel with monopolar capabilities. The instruments are modular, consisting of a jaw insert and insulated outer tube with interchangeable ratcheting and non-ratcheting handles. The instruments are 250mm in length with a 7mm diameter. The instruments can be used interchangeably with either a ratcheting or non-ratcheting handle. The handles are made from PEEK with a HF connection that fits any standard monopolar cable. The instruments can be used with a visualization system to allow for better visibility during the procedure. This is an independent system and is not system specific. No new visualization systems are being introduced by Aesculap® in this submission.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for surgical instruments, specifically "Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments." It describes the device, its intended use, and a comparison to predicate devices, along with performance data.

However, the request asks for information relevant to the acceptance criteria and study that proves a device meets those criteria, particularly for an AI/ML-enabled medical device. The document provided does NOT describe an AI/ML-enabled medical device. It describes traditional surgical instruments and their performance testing (design verification, electrical safety, biocompatibility, cleaning/sterilization).

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from the provided text. The document does not contain:

A table of acceptance criteria and reported device performance for an AI/ML device. The performance data tables are for mechanical and electrical properties of surgical instruments.
Sample size used for the test set or data provenance for an AI/ML device.
Number of experts used to establish ground truth or their qualifications for an AI/ML device.
Adjudication method for an AI/ML device.
MRMC comparative effectiveness study or human reader improvement for an AI/ML device.
Standalone (algorithm only) performance for an AI/ML device.
Type of ground truth (expert consensus, pathology, outcomes data) for an AI/ML device.
Sample size for the training set of an AI/ML device.
How ground truth for the training set was established for an AI/ML device.

The document describes standard engineering and biological safety tests for physical medical devices.

Summary

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February 20, 2018

Aesculap, Inc. Jessica Stigliano Regulatory Affairs Associate 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K170683

Trade/Device Name: Aesculap Video Assisted Thoracic Surgery (VATS) Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopes and Accessories Regulatory Class: Class II Product Code: GCJ Dated: January 12, 2018 Received: January 16, 2018

Dear Jessica Stigliano:

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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Page 2 - Jessica Stigliano

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) K170683

Device Name

Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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510(k) SUMMARY (as required by 21 CFR 807.92)

Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Jessica Stigliano 610-984-9063 (phone)610-791-6882 (fax)jessica.stigliano@Aesculapimplants.com
TRADE NAME:	Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments
COMMON NAME:	Laparoscope, General & Plastic Surgery/Minimally Invasive SurgicalInstruments
REGULATION NUMBER:	876.1500 – Endoscope and accessories
PRODUCT CODE:	GCJ
REVIEW PANEL:	Gastroenterology and Urology

PRIMARY PREDICATE

Aesculap® Thoracoscopic Instruments K944955 ●

REFERENCE DEVICE

AdTec® K160393 ●
IntegraTMJarit® Video Assisted Thoracic Instruments K120012 ●

DEVICE DESCRIPTION

The instruments can be used interchangeably with either a ratcheting or non-ratcheting handle. The handles are made from PEEK with a HF connection that fits any standard monopolar cable.

The instruments can be used with a visualization system to allow for better visibility during the procedure. This is an independent system and is not system specific. No new visualization systems are being introduced by Aesculap® in this submission.

INDICATIONS FOR USE

Aescular® Video Assisted Thoracic Surgery (VATS) Instruments are intended for use in open or thoracoscopic surgical procedures. They are designed for cutting, manipulating, grasping, clamping, dissecting or suction.

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TECHNOLOGICA InCHARACTERISTICS (compared to Primary Predicate and reference devices)

Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are substantially equivalent to the primary predicate Aesculap® Thoracoscopic Instruments (K944955) and comparable to the reference devices, AdTec® (K160393) and Integra™Jarit® Video Assisted Thoracic Surgery (VATS) Instruments (K120012). The table below provides a comparison between the subject device and primary predicate and reference devices. The minor differences in technological characteristics do not raise questions of safety or effectiveness, as confirmed by the testing and validation activities described in the submission.

	New deviceAesculap® VideoAssisted ThoracicSurgery (VATS)Instruments	Primary Predicate deviceAesculap® ThoracoscopicInstruments (K944955)	Reference deviceAdTec®(K160393)	Reference deviceIntegra™Jarit® Video AssistedThoracic Surgery (VATS)Instruments (K120012)
Indications	Aesculap® VATSInstruments areintended for use inopen, mini-open, orthoracoscopic surgicalprocedures. They aredesigned for cutting,manipulation.grasping, clamping,dissecting, or suction.	Aesculap® ThoracoscopicInstruments are intendedfor use in thoracoscopy.They are used to cut,manipulate, grasp, suture,ligate, suction, irrigate,and/or cauterize selectedtissue.	Aesculap®'s AdTec®system is indicated foruse in adult and pediatric(3.5mm instrumentsonly) diagnostic andtherapeutic generalendoscopy andlaparoscopy surgery.	Integra™Jarit® Video AssistedThoracic Surgery (VATS)Instruments are manuallyoperated instruments designed toperform specific functions such ascutting, grasping, clamping,dissecting, probing, draining,aspirating, suturing, or ligatingduring open, mini-open, orthoracoscopic procedures.
Instruments:
Material	Stainless Steel	Stainless Steel	Stainless Steel	Stainless Steel
Features	• Modular• Insulated• Reusable• Monopolarcapability	• Modular & non-• modular• Reusable• Insulated• Selected monopolarcapability	• Modular• Insulated• Reusable/disposable• Monopolar/bipolarcapabilities	• Single or dual pivot• Reusable• Manually operated
Types	• Scissors• Forceps• Needleholders• Clamps• Dissectors• Suction/Irrigation	• Scissors• Forceps• Needleholders• Clamps• Dissectors• Suction/Irrigation	• Scissors• Forceps• Clamps• Suction/Irrigation	• Scissors• Forceps• Clamps• Dissectors• Needleholders• Suction/Irrigation
Dimensions	Length: 250mmDiameter: 7mm	Length: 220mm – 450mmDiameter: 5mm - 10mm	Length: 220 – 420mmDiameter: 3.5, 5, and10mm	Length: 227mm – 500mmDiameter: 5mm - 10mm
Handles:
Style	• Ring Handle• Ratcheted and non-ratcheted	• Ring handle• Ratcheted and non-ratcheted	• Ring handle axial orangled• Ratcheted/non-ratcheted	• Curved and straight• Ratcheted and non-ratcheted
Material	PEEK	Stainless Steel	PEEK	Stainless Steel
Insulation tube:
Material	PEEK	Teflon	PEEK	N/A

PERFORMANCE DATA

Design Verification

The following design verification testing was completed for the Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments:

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Test	Test Purpose	Results
Blocking function	Demonstrates single actuating element allows for temporary actuation	Pass
	of the barrier and latching and unlocking of the barrier
Cutting capacity	Demonstrates a smooth cut and that there is no plucking during the	Pass
	cutting performance
Holding force	Demonstrates a comparable holding force as the reference model	Pass
Preparation	Demonstrates the sufficient stability and ability to hold the maximum	Pass
	load to ensure adequate performance and work properly and safely in
	clinical use

The results of the design verification testing demonstrate that the Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments meet the pre-defined acceptance criteria and intended uses.

Electrical Safety

The Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments conform to the following electrical safety and EMC standards;

· IEC 60601-1:2005 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
· IEC 60601-2-2 International Electrotechnical Commission, 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

Conductivity testing

Conductivity testing according to IEC 60601-2-2 was performed to determine the electrical conductivity of the Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments. Results of the testing show that the instrument design is able to support application of HF current.

Biocompatibility

The contact classification for the Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments is surface contact less than 24 hours. Surgical grade stainless steel (ISO 7153-1) and PEEK have been successfully used in the clinical environment for many years. These materials have also been accepted in other systems marketed by Aesculap®, such as the reference device AdTec® (K160393). No new materials have been added.

The materials in the patient contacting Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments conform to the following standards;

DIN EN ISO 7153-1: Surgical Instruments -- Metallic Materials -- Part 1: Stainless Steel
ISO 10993-5: Biological Evaluation Of Medical Devices Part 5: Tests For In ● Vitro Cytotoxicity
10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

Cleaning/Sterilization

The Video Assisted Thoracic Surgery (VATS) Instruments are provided non-sterile and are intended to be cleaned and sterilized prior to use. Sterilization of instruments is to be

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accomplished by steam autoclave (moist heat) in a standard pre-vacuum cycle. Cleaning and sterilization parameters are provided in the Instructions for Use for the instruments.

The cleaning and sterilizations provided in this submission conform to the following standards and guidance documents:

. AAMI TIR12:2010 Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities. A guide for Device Manufacturers
. AAMI TIR30:2011 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices
. ANSI/AAMI ST81:2004 (R2010) Sterilization of medical devices – Information to be provided by the manufacturer for processing of resterilizable medical devices.
. FDA Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff. March 17, 2015

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believe that the Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are substantially equivalent to the primary predicate, Aesculap® Thoracoscopic Instruments (K944955). As outlined in the comparison table above, the subject device shares similar indications, designs, dimensions, materials, and principals of operation with the primary predicate and reference devices, AdTec® (K160393) and Integra™ Jarit® Video Assisted Thoracic Surgery (VATS) Instruments (K120012).

CONCLUSION

The purpose of this 510(k) premarket notification is to gain marketing clearance for the new Video Assisted Thoracic Surgery (VATS) Instruments presented in this submission. The K170683 device instruments are as and equivalent to the primary predicate indications, design / features, components, dimensional ranges, and fundamental scientific technology.

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.