(83 days)
Not Found
No
The summary describes a standard laparoscopic system with a video image output and a dongle for display conversion. There is no mention of AI, ML, image processing beyond basic display conversion, or any performance metrics typically associated with AI/ML algorithms. The performance studies focus on functional and safety testing, not algorithmic performance.
Yes
The intended use statement explicitly states that the device is intended for use in "diagnostic and therapeutic procedures".
Yes
The 'Intended Use / Indications for Use' states the device is "intended to be used in diagnostic and therapeutic procedures".
No
The device description explicitly states that the system contains two separate functioning components: the Xenoscope™ Laparoscope Device (a physical laparoscope) and the Xenoscope™ Dongle (a physical component that converts the image). This indicates the device includes hardware components and is not software-only.
Based on the provided information, the Xenoscope™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Xenoscope™ is used in "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 for visualization and surgical intervention.
- Device Description: The description details a laparoscope and a dongle that converts a camera image for display. This is consistent with a surgical visualization tool used in vivo.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro). IVDs are typically used to analyze biological samples like blood, urine, tissue, etc., in a laboratory setting.
- Anatomical Site: The specified anatomical sites (thoracic and peritoneal cavities) are internal to the patient, reinforcing its use in vivo.
Therefore, the Xenoscope™ is a surgical endoscope used for visualization and intervention within the patient's body, not an IVD used for testing samples outside the body.
N/A
Intended Use / 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.
Product codes
GCJ, HET
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.
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
- Rigid Shaft: 30 Fr (10mm) in diameter, and approximately 10 36 cm long
- Ergonomic handle
- Video cable attached to scope to connect to the Dongle (Micro-HDMI D).
- Inserted through a trocar/port
- Packaged sterile and designed for single-use only
- 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:
- Protective case
- Internal PCB board
- Cable connections:
- Power (5V, 1A)
- Micro-HDMI D (connect to scope)
- HDMI v1.3 (connect to display monitor)
- USB 3.0 service port (Manufacturing)
Mentions image processing
Yes, the device description states it is a "high-definition video image" and that the dongle "converts the camera image onto the video display screen".
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Thoracic and peritoneal cavities including the female reproductive organs.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained surgeon, clinical settings.
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)
Functional/Safety Testing:
- Biocompatibility - Per ISO 10993-1 for External communicating device, direct tissue contact, duration ≤ 24 hours.
- Electrical Safety and Essential Performance Requirements - Tested to 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; IEC 62366:2007 + A1:2014; IEC 62304:2006 + A1:2015.
- Electromagnetic Compatibility (EMC) - Tested to 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).
- Software Testing - Firmware on a processor in the dongle that converts the digital video signal into an HDMI signal. Level of concern determined to be moderate.
- Design Validation - evaluation by three (3) trained surgeons using a simulated use model in an environment that simulated the intended clinical settings.
Key results: All data met pre-determined acceptance criteria. The Xenoscope™ Laparoscopic System met all acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K935279 - Karl Storz, Hopkins Rigid Autoclavable Telescope; K993045 - Stryker, Bariatric Laparoscope; K150633 - Olympus Winter & Ibe GmbH, ULTRA Telescope
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 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 right, stacked on top of each other.
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
1
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
2
Statement of Indications for Use
Indications for Use
510(k) Number (if known): K161838
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 × (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)
3
| 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: | June 30, 2016 |
| Trade Name: | Xenocor® Xenoscope™ Laparoscopic System |
| Classification Name: | Endoscope and Accessories |
| 21 CFR §876.1500, Product Code GCJ, Class II | |
| Predicate Device(s): | Gynecologic Laparoscope and Accessories |
| 21 CFR §884.1720, Product Code HET, Class II | |
| • K935279 - Karl Storz, Hopkins Rigid Autoclavable | |
| Telescope; | |
| • K993045 - Stryker, Bariatric Laparoscope; | |
| • K150633 - Olympus Winter & Ibe GmbH, ULTRA | |
| Telescope; |
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.
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
4
- 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:
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™ 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.
5
- . 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.