Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and signal conversion aspects of the device, and explicitly states that mentions of AI, DNN, or ML were "Not Found".

Therapeutic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used in diagnostic and therapeutic procedures."

Diagnostic

Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used in diagnostic and therapeutic procedures".

SaMD (Software as a Medical Device)

No

The device description clearly outlines two hardware components: the Articulating Xenoscope™ Laparoscope Device (a physical scope with a camera and articulating tip) and the XenoBox™ (a hardware component that converts the digital signal). This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities". This describes a device used directly on or within the patient's body for visualization and surgical intervention.
Device Description: The description details a laparoscope (a surgical instrument with a camera) and a system to display the video feed. This is consistent with a surgical imaging and access device, not a device used to test samples in vitro (outside the body).
Anatomical Site: The specified anatomical sites are within the patient's body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose a condition.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Articulating 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.

Product codes (comma separated list FDA assigned to the subject device)

GCJ, HET, GCQ

Device Description

The Articulating Xenoscope™ System contains two separate functioning components. First is the single-use, sterile Articulating Xenoscope™ Laparoscope Device, which includes a 0° camera on 5 mm rigid shaft with a ± 30° articulating tip, 10 cm or 36 cm long shaft, and 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. The second is the XenoBox™, which converts the digital signal from the camera to HDMI signal for display onto the HD video screen for the surgeon to view. Together, the Xenoscope™ and the Xenobox™ comprise the Xenoscope™ Laparoscopic System and work synergistically together.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracic and peritoneal cavities including the female reproductive organs.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Biocompatibility - Biocompatibility testing was done due to the new shaft materials. All tests were done per the same protocol and acceptance criteria as the predicate device, and per ISO 10993-1 and in accordance with the 2016 FDA guidance document "Use of International Standard ISO 10993-1 for External communicating device, direct tissue contact, duration ≤ 24 hours, the following tests were performed and passed:
- Cytotoxicity o
- Sensitization o
- Irritation/ Intracutaneous Toxicity O
- Systemic Injection O
- Material Mediated Pyrogenicity о
. Shaft Bend Strength Testing - Due to the smaller 5 mm shaft diameter and shaft material change to carbon fiber with addition of the heat shrink sheath, per internal requirements, and based on the risk evaluation for this change, the inspection of the laparoscope shaft to confirm functionality after bending the shaft was done. The protocol and acceptance criteria were the same as the predicate device. All devices tested passed.
. Accelerated Aging - Per internal requirements and based on the risk evaluation for this device, all devices were mechanically functional after 1-year shelf life testing. The protocol and acceptance criteria were the same as the predicate device with the added visual examination of the heat shrink materials and the ≥ 30° articulation in both the X and Y axis.
. Software Validation – The software for the Xenobox and the subject device has not changed. The subject and predicate devices use the same software.
. Packaging - The proposed changes to the Xenoscope Laparoscope did not affect the packaging or its configuration.
Design Validation - The modified design was validated by intended users (trained surgeons) through an evaluation of the Articulating Xenoscope™. The study protocol & acceptance criteria were the same as the predicate, with the only deviation being the predicate was evaluated by 3 physicians, and the subject device was evaluated by 10 physicians).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161838 - Xenocor®, Xenoscope™ Laparoscopic System

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K171344

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 27, 2020

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

Re: K193315

Trade/Device Name: Xenocor Articulating Xenoscope Laparoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, HET, GCQ Dated: November 26, 2019 Received: November 29, 2019

Dear Spencer 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193315

Device Name

Xenocor Articulating Xenoscope Laparoscope

Indications for Use (Describe)

The Articulating 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.

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 O)

| X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary
Submitter:		Xenocor®, Inc
Contact Person:		Spencer Walker, MSC - Director Regulatory Affairs
630 Komas Dr. Suite 200
Salt Lake City, UT 84108
(801) 581-5080
Date Prepared:		Jan. 4, 2020
Trade Name:		Xenocor® Articulating Xenoscope™ Laparoscope
Classification Name:		Endoscope and Accessories
21 CFR §876.1500, Product Code(s) GCJ, GCQ,
Gynecologic Laparoscope and Accessories
21 CFR §884.1720, Product Code HET,
Device Class:		Class II
Predicate Device(s):	●	K161838 - Xenocor®, Xenoscope™ Laparoscopic System

Device Description:

The Articulating Xenoscope™ System contains two separate functioning components. First is the single-use, sterile Articulating Xenoscope™ Laparoscope Device, which includes a 0° camera on 5 mm rigid shaft with a ± 30° articulating tip, 10 cm or 36 cm long shaft, and 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. The second is the XenoBox™, which converts the digital signal from the camera to HDMI signal for display onto the HD video screen for the surgeon to view. Together, the Xenoscope™ and the Xenobox™ comprise the Xenoscope™ Laparoscopic System and work synergistically together.

Indications for Use:

The Indications for Use is the same as the predicate device, which is:

The Articulating 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.

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Technological Characteristics and Substantial Equivalence Comparative Analysis:

Modifications in design and materials of the previously 510(k) cleared Xenoscope Laparoscope device (K161838) resulted in two (2) additional models (XSA-0-0510, XSA-0-0536) which include a smaller 5mm diameter rigid carbon fiber shaft with articulating tip and handle features. The camera is the same as the predicate, and the combined 6 smaller LED's of the subject device equal the 1 larger LED of the predicate in energy and light output.

It has been demonstrated that the modified Xenoscope™ Laparoscopic device is comparable to the predicate and reference device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations and is substantially equivalent as summarized in Table 1. The Articulating Xenoscope™ Laparoscopic System has been fully assessed within the Xenocor® Risk Management and Design Controls systems. The differences raise no additional or different questions of safety or effectiveness from that already identified for the predicate and reference devices.

Table 1: Xenoscope System Table of Substantial Equivalence
Product
Attribute	Predicate Device:
Xenoscope Laparoscope
(K161838)	Reference Device:
Xenoscope Laparoscope
(K171344)	Subject Device:
Articulating Xenoscope
Laparoscope (K193315)
Indications for
Use	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.	Same	Same
Classification
Info.	Gastroenterology-Urology
Devices - Endoscope and
Accessories
(21 CFR §876.1500),
Product code: GCJ

Obstetrical and
Gynecological Diagnostic
Devices - Gynecologic
Laparoscope and
Accessories
(21 CFR §884.1720),
Product code: HET

Class II | Same | Gastroenterology-Urology
Devices - Endoscope and
Accessories
(21 CFR §876.1500),
Product code: GCJ & GCQ

Obstetrical and
Gynecological Diagnostic
Devices - Gynecologic
Laparoscope and
Accessories
(21 CFR §884.1720),
Product code: HET

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Verification and Functional/Safety Testing:

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

Biocompatibility - Biocompatibility testing was done due to the new shaft materials. All tests were done per the same protocol and acceptance criteria as the predicate device, and per ISO 10993-1 and in accordance with the 2016 FDA guidance document "Use of International Standard ISO 10993-1 for External communicating device, direct tissue contact, duration ≤ 24 hours, the following tests were performed and passed:
- Cytotoxicity o
- Sensitization o
- Irritation/ Intracutaneous Toxicity O
- Systemic Injection O
- Material Mediated Pyrogenicity о
. Shaft Bend Strength Testing - Due to the smaller 5 mm shaft diameter and shaft material change to carbon fiber with addition of the heat shrink sheath, per internal requirements, and based on the risk evaluation for this change, the inspection of the laparoscope shaft to confirm functionality after bending the shaft was done. The protocol and acceptance criteria were the same as the predicate device. All devices tested passed.
. Accelerated Aging - Per internal requirements and based on the risk evaluation for this device, all devices were mechanically functional after 1-year shelf life testing. The protocol and acceptance criteria were the same as the predicate

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device with the added visual examination of the heat shrink materials and the ≥ 30° articulation in both the X and Y axis.

. Software Validation – The software for the Xenobox and the subject device has not changed. The subject and predicate devices use the same software.
. Packaging - The proposed changes to the Xenoscope Laparoscope did not affect the packaging or its configuration.
Design Validation - The modified design was validated by intended users (trained surgeons) through an evaluation of the Articulating Xenoscope™. The study protocol & acceptance criteria were the same as the predicate, with the only deviation being the predicate was evaluated by 3 physicians, and the subject device was evaluated by 10 physicians).

Conclusion:

The modifications to the Xenoscope™ were made per Xenocor's quality procedures and design control systems. The Articulating Xenoscope™ Laparoscopic System is substantially equivalent to the cited predicate device. Additionally, the Articulating Xenoscope™ Laparoscopic System met all acceptance criteria to confirm safety and effectiveness.