Xenocor Xenoscope Laparoscopic System

K171344 · Xenocor, Inc. · GCJ · Jun 1, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K171344
• Device Name: Xenocor Xenoscope Laparoscopic System
• Applicant: Xenocor, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 1, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Xenoscope™ Laparoscopic System consists of a single-use, high-definition video laparoscope (0° or 30°, 10mm diameter, 10-36cm length) and a Xenobox™ (dongle) image processor. System captures endoscopic video images; Xenobox™ converts and transmits signals to a standard video display for surgeon visualization. Used in OR/clinical settings for diagnostic and therapeutic procedures in thoracic and peritoneal cavities. Surgeon uses real-time visual feedback to guide surgical instruments and perform procedures. System provides high-definition visualization to assist in minimally invasive surgery, potentially reducing patient trauma compared to open procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 for external communicating devices with direct tissue contact (≤ 24 hours). Software verification performed for image rotation feature. Shaft bending tests confirmed mechanical integrity and functionality.

Technological Characteristics

Single-use laparoscope (10mm, 10-36cm, 0° or 30°); Xenobox™ image processing dongle. Biocompatibility per ISO 10993-1. Connectivity via video output to display. Software-based image rotation feature.

Indications for Use

Indicated for diagnostic and therapeutic endoscopic procedures within the thoracic and peritoneal cavities, including female reproductive organs.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Gynecologic Laparoscope and Accessories (K161838)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002

June 1, 2017

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

Re: K171344

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: May 5, 2017 Received: May 8, 2017

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 Actinclude 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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Jennifer R. Stevenson -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): K171344

Device Name: Xenocor® Xenoscope™ Laparoscopic System

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.

Prescription Use X_____________________________________________________________________________________________________________________________________________________________________________ (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 Affairs<br>630 Komas Dr. Suite 200<br>Salt Lake City, UT 84108<br>[phone] |
| Date Prepared: | May 05, 2017 |
| Trade Name: | Xenocor® Xenoscope™ Laparoscopic System |
| Classification Name: | Endoscope/ Ureteroscope and Accessories<br>21 CFR §876.1500, Product Code GCJ, FGB, Class II |
| Predicate Device(s): | Gynecologic Laparoscope and Accessories<br>21 CFR §884.1720, Product Code HET, Class II |
| | ● K161838 - Xenocor®, Xenoscope™ Laparoscopic System |

#### Device Description:

The Xenoscope™ System contains two separate functioning components. First, the Xenoscope™ Laparoscope Device is a 0° or 30°, 30 Fr (10mm), 10 - 36 cm long, singleuse, 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 (now termed as the Xenobox™), 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 Xenobox™ comprise the Xenoscope™ Laparoscopic System and work synergistically together.

# 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.

# 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™

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Laparoscopic System has been fully assessed within the Xenocor® Risk Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria to confirm safety and efficacy.

# Functional/Safety Testing:

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

- o Biocompatibility - Per ISO 10993-1 for External communicating device, direct tissue contact, duration ≤ 24 hours.
- Software Verification Verification of modifications for image rotation feature of . the 30° scope. The Xenoscope™ Laparoscope software level of concern is not changed.
- Shaft Bending Inspection of the laparoscope shaft to confirm functionality after . bending the shaft.

# Conclusion:

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