(24 days)
Not Found
No
The document describes a standard laparoscopic system with image processing for rotation, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is intended for use in diagnostic and therapeutic procedures, but it is described as a high-definition video image laparoscope used for visualization and image display, which are diagnostic functions. It does not exert a therapeutic effect on the patient.
Yes
The intended use explicitly states that "The Xenoscope™ is intended to be used in diagnostic and therapeutic procedures".
No
The device description explicitly states the system contains two separate functioning components: the Xenoscope™ Laparoscope Device (a physical laparoscope) and the Xenoscope™ Dongle (Xenobox™), which are hardware components. While there is mention of software verification for an image rotation feature, the core device is a hardware system for endoscopy.
Based on the provided information, the Xenoscope™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device 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's body for visualization and surgical intervention.
- Device Description: The description details a laparoscope (a surgical instrument) and a system to display the video image from that laparoscope. This aligns with a surgical/endoscopic device, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The Xenoscope™ does not perform this function.
The Xenoscope™ is a surgical/endoscopic device used for visualization and potentially assisting in surgical procedures in vivo.
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 (comma separated list FDA assigned to the subject device)
GCJ, HET
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.
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)
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.
- 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.
All necessary verification steps met pre-determined acceptance criteria to confirm safety and efficacy.
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.
Not Found
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
§ 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/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
1
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 (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,
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)
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: | May 05, 2017 |
| Trade Name: | Xenocor® Xenoscope™ Laparoscopic System |
| Classification Name: | Endoscope/ Ureteroscope and Accessories |
| 21 CFR §876.1500, Product Code GCJ, FGB, Class II | |
| Predicate Device(s): | Gynecologic Laparoscope and Accessories |
| 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™
4
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.