The Xenoscope™ is intended to be used in diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.

Device Description

The Xenoscope™ System contains two separate functioning components. First, the Xenoscope™ Laparoscope Device is a 0°, 30 Fr (10mm), 10 - 36 cm long, single-use, high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. Second, the Xenoscope™ Dongle, which converts the camera image onto the video display screen for the surgeon to use, is provided with the Xenoscope™. Together, the Xenoscope™ and the Xenoscope™ Dongle comprise the Xenoscope™ Laparoscopic System and work synergistically together.

AI/ML Overview

The Xenocor® Xenoscope™ Laparoscopic System is a medical device intended for diagnostic and therapeutic procedures within the thoracic and peritoneal cavities, including female reproductive organs. The provided text outlines the acceptance criteria and supporting studies for its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Biocompatibility	ISO 10993-1 for External communicating device, direct tissue contact, duration ≤ 24 hours.	All data met pre-determined acceptance criteria. (Implied compliance with ISO 10993-1)
Electrical Safety and Essential Performance	IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012, EN 60601-1:2006 / A1:2013 / A11:2011 / A12:2014, CAN/CSA-C22.2 No. 60601-1:14, AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, IEC 60601-1-6:2010 + A1:2013, IEC 60601-2-18:2009.	All data met pre-determined acceptance criteria. (Implied compliance with listed standards)
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 Medical Device (2007), IEC 61000-4-2 (2008), IEC 61000-4-3 (2006), A1(2007), A2(2010), IEC 61000-4-4 (2012), IEC 61000-4-5 (2005), IEC 61000-4-6 (2008), IEC 61000-4-8 (2009), IEC 61000-4-11 (2004), CISPR 11 Emissions Class A (2009), A1(2010), IEC 61000-3-2 AC Current Harmonic Emissions (2006), A1(2009), A2(2009), IEC 61000-3-3 Voltage Fluctuations Emissions (2008).	All data met pre-determined acceptance criteria. (Implied compliance with listed standards)
Software Testing	Assessment of "moderate" level of concern for firmware in the dongle, ensuring no harm or misdiagnosis when used by a trained surgeon.	The software level of concern has been determined to be moderate, and is deemed to not result in harm to the patient or misdiagnosis of the patient condition when the device is used by a trained surgeon. (Implied that the software meets safety and performance expectations)
Design Validation	Evaluation of the Xenoscope™ System by trained surgeons in a simulated clinical setting.	Evaluated by three (3) trained surgeons (intended users) using a simulated use model in an environment that simulated the intended clinical settings. The system met all acceptance criteria.

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

Sample Size for Design Validation (Usability/Performance Test Set): 3 trained surgeons.
Data Provenance: Not explicitly stated, but the "simulated use model in an environment that simulated the intended clinical settings" suggests a prospective, controlled study specifically for device validation. The "country of origin of the data" is not mentioned. For the other tests (Biocompatibility, Electrical Safety, EMC, Software), the data provenance is from laboratory testing adhering to international standards, not derived from clinical data sets.

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

Number of Experts: 3.
Qualifications of Experts: Described as "trained surgeons (intended users)". Specific experience levels (e.g., "10 years of experience") are not provided, but being "trained surgeons" implies relevant clinical expertise for evaluating a laparoscopic system.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the design validation study (e.g., 2+1, 3+1). It states that the "three (3) trained surgeons" performed the evaluation and the system "met all acceptance criteria." This implies a consensus or individual satisfaction with performance, but the process for resolving any potential disagreements among the three is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The documentation focuses on demonstrating substantial equivalence primarily through technical specifications and functional/safety testing against standards, along with a design validation study. There is no mention of comparing human reader performance with or without AI assistance. The device itself is an endoscope system, not an AI diagnostic tool that assists human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable in the context of this device. The Xenocor Xenoscope is a laparoscopic system that is inherently designed for human-in-the-loop operation by a surgeon, not a standalone AI algorithm. The only "software" mentioned is firmware that converts a digital video signal for display, which does not operate as a standalone diagnostic algorithm.

7. Type of Ground Truth Used

The ground truth for the design validation study was based on the expert evaluation and feedback of the three trained surgeons using the device in a simulated clinical setting. For the other tests (Biocompatibility, Electrical Safety, EMC, Software), the ground truth was adherence to established international and national performance and safety standards.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI algorithm or model development. The Xenoscope is a hardware device with supporting firmware, not a machine learning system that requires a training set of data.

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

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable to the information provided in the document.

Summary

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

September 26, 2016

Xenocor, Inc Mr. Spencer Walker Director, Regulatory Affairs 630 Komas Dr., Suite 200 Salt Lake City, Utah 84108

Re: K161838

Trade/Device Name: Xenocor Xenoscope Laparoscopic System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, HET Dated: August 23, 2016 Received: August 29, 2016

Dear Mr. Walker:

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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth

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in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 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/ResourcesforYou/Industry/default.htm. 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.

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.

Christopher J. Ronk -S

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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Statement of Indications for Use

Indications for Use

510(k) Number (if known): K161838

Device Name: Xenocor® Xenoscope™ Laparoscopic System

Prescription Use × (Per 21 CFR 801.109)

OR Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office Of Device Evaluation (ODE)

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510(k) Summary
Submitter:	Xenocor®, Inc
Contact Person:	Spencer Walker, MSC - Director Regulatory Affairs630 Komas Dr. Suite 200Salt Lake City, UT 84108(801) 581-5080
Date Prepared:	June 30, 2016
Trade Name:	Xenocor® Xenoscope™ Laparoscopic System
Classification Name:	Endoscope and Accessories21 CFR §876.1500, Product Code GCJ, Class II
Predicate Device(s):	Gynecologic Laparoscope and Accessories21 CFR §884.1720, Product Code HET, Class II
	• K935279 - Karl Storz, Hopkins Rigid AutoclavableTelescope;
	• K993045 - Stryker, Bariatric Laparoscope;
	• K150633 - Olympus Winter & Ibe GmbH, ULTRATelescope;

Device Description:

Xenoscope™ Laparoscope .

The Xenoscope™ Device is used like other laparoscopes, and has the following features:

Camera Housing: 0°lens, sensor and a single LED light, o
Rigid Shaft: 30 Fr (10mm) in diameter, and approximately 10 36 cm long o
Ergonomic handle o

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Video cable attached to scope to connect to the Dongle (Micro-HDMI D). o
Inserted through a trocar/port o
Packaged sterile and designed for single-use only o
o High-definition video image

. Xenoscope™ Dongle

The Xenoscope™ Dongle is a multi-use device and is provided with the Xenoscope™ and has multiple connections. The Dongle converts the digital information into a video image displayed on an HDMI monitor that the surgeon uses. The Xenoscope™ connects to the Dongle via a cable with a micro-HDMI connector. The Dongle connects to the viewing screen via an HDMI cord. The Dongle portion of the Xenoscope™ consists of the following parts:

o Protective case
Internal PCB board o
Cable connections o
- Power (5V, 1A),
- . Micro-HDMI D (connect to scope),
- HDMI v1.3 (connect to display monitor), 트
- USB 3.0 service port (Manufacturing)

Indications For Use:

Comparative Analysis:

It has been demonstrated that the Xenoscope™ Laparoscopic System is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The Xenoscope™ Laparoscopic System has been fully assessed within the Xenocor® Risk Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria.

Functional/Safety Testing:

The following functional tests were performed. All data met pre-determined acceptance criteria.

. Biocompatibility - Per ISO 10993-1 for External communicating device, direct tissue contact, duration ≤ 24 hours.

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. Electrical Safety and Essential Performance Requirements - The Xenoscope™ Laparoscope and the Xenoscope™ Donale were tested to verify safety and essential performance requirements to the following standards:
- o IEC 60601 1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012
- o EN 60601-1:2006 / A1:2013 / A11:2011 / A12:2014: CAN/CSA-C22.2 No. 60601-1:14;
- o AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; IEC 60601-1-6:2010 + A1:2013; IEC 60601-2-18:2009:
- o IEC 62366:2007 + A1:2014; IEC 62304:2006 + A1:2015
. Electromagnetic Compatibility (EMC) – The (EMC) series of test demonstrates the EMC characteristics of the Xenoscope™. The Xenoscope™ Laparoscope was tested to the requirements of the following standards:
- IEC 60601-1-2 Medical Device (2007) o
- IEC 61000-4-2 (2008) o
- IEC 61000-4-3 (2006), A1(2007), A2(2010) O
- IEC 61000-4-4 (2012) IEC 61000-4-5 (2005) O
- IEC 61000-4-6 (2008) IEC 61000-4-8 (2009) O
- IEC 61000-4-11 (2004) O
- CISPR 11 Emissions Class A (2009), A1(2010) O
- Radiated Emissions Conducted Emissions о
- IEC 61000-3-2 AC Current Harmonic Emissions (2006), A1(2009), o A2(2009)
- o IEC 61000-3-3 Voltage Fluctuations Emissions (2008)
. Software Testing - The only software in the Xenoscope™ system is in the form of firmware on a processor in the dongle that converts the digital video signal into an HDMI signal that displays the video image on commonly used HD monitors. The Xenoscope™ Laparoscope software level of concern has been determined to be moderate, and is deemed to not result in harm to the patient or misdiagnosis of the patient condition when the device is used by a trained surgeon.
Design Validation Design was validated through an evaluation of the . Xenoscope™ System by three (3) trained surgeons (intended users) using a simulated use model in an environment that simulated the intended clinical settinas.

Conclusion:

The Xenoscope™ Laparoscopic System is substantially equivalent to the cited predicate device. Additionally, the Xenoscope™ Laparoscopic System met all acceptance criteria.

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.