(26 days)
Not Found
No
The document describes a standard laparoscope and a signal converter. There is no mention of AI, ML, image processing, or any algorithms that would suggest the use of such technologies. The performance studies focus on basic device functionality and biocompatibility.
No
The device is described as being used in diagnostic procedures for endoscopy and endoscopic surgery, and it converts a digital signal for display. It does not perform any therapeutic function.
Yes
The Intended Use / Indications for Use section explicitly states that "The SaberScope5 Laparoscope is intended to be used in diagnostic procedures for endoscopy and endoscopic surgery".
No
The device description explicitly states it contains two separate functioning components: a physical, single-use, sterile laparoscope device (hardware) and a XenoBox™ which converts the digital signal (also hardware). This is not a software-only device.
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 procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs." This describes a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The device is a laparoscope with a camera and a system to display the video. This is a surgical/diagnostic instrument used for visualization inside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct visualization within the body.
N/A
Intended Use / Indications for Use
The SaberScope5 Laparoscope is intended to be used in diagnostic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.
Product codes
GCJ, HET, GCQ
Device Description
The Articulating Xenoscope™ System is being renamed the SaberScope5 Laparoscope. The subject device contains two separate functioning components. First is the single-use, sterile SaberScope5 Laparoscope Device, which includes a 0° camera on 5 mm rigid shaft with a ± 90° articulating tip, 10 - 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.
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)
Verification activities were performed on the subject laparoscope to demonstrate substantial equivalence to the predicate device:
- Biocompatibility No new patient contacting materials were introduced therefore . additional biocompatibility testing was not conducted for this modification.
- . Design Verification – Performance bench testing was conducted to ensure that the subject device met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system. The following performance testing was performed or fulfilled with the subject SaberScope5 Laparoscope.
- Fixed Lens Focus Testing o
- Focus Range Testing O
- Packaging The proposed changes to the subject device did not affect the packaging ● or its configuration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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/0 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.
April 20, 2022
Xenocor, Inc % Spencer Walker CEO/ Managing Partner Peak Regulatory Consulting, LLC 370 S. 300 E. Salt Lake City, Utah 84111
Re: K220872
Trade/Device Name: Saberscope5 Laparoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, HET, GCQ Dated: March 24, 2022 Received: March 25, 2022
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/cfpm/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.
1
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-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 (QS) 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 medical devices and radiation-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
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Indications for Use
510(k) Number (if known) K220872
Device Name Xenocor® SaberScope5 Laparoscope
Indications for Use (Describe)
The SaberScope5 Laparoscope is intended to be used in diagnostic 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 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Xenocor. The logo consists of a circular graphic on the left and the word "XENOCOR" on the right. The graphic is made up of three sections, one dark blue, one light gray, and one white, with a light gray circle in the center. The text "K220872" is located in the bottom left corner of the image.
510(K) SUMMARY
(21 CFR 807.92)
GENERAL INFORMATION
| Submitter: | Xenocor, Inc. |
|---|---|
| Contact Person: | Spencer Walker, MSc – |
| Peak Regulatory Consulting | |
| 370 S. 300 E. | |
| Salt Lake City, UT 84111 | |
| (801) 708-2238 | |
| Spencer@PeakRegulatory.com | |
| Date Prepared: | March 24, 2022 |
| Trade Name: | Xenocor® SaberScope5 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: | 510(k) No.: K193315 |
| Model: Xenocor® Articulating Xenoscope™ Laparoscope | |
| Manufacture: Xenocor, Inc. | |
| Classification: GCJ, GCQ & HET |
Device Description:
The Articulating Xenoscope™ System is being renamed the SaberScope5 Laparoscope. The subject device contains two separate functioning components. First is the single-use, sterile SaberScope5 Laparoscope Device, which includes a 0° camera on 5 mm rigid shaft with a ± 90° articulating tip, 10 - 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.
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Image /page/4/Picture/0 description: The image shows the logo for Xenocor. The logo consists of a circular graphic to the left of the company name. The graphic is divided into three sections, with the top section being blue and the other two sections being gray. The text "K220872" is located in the bottom left corner of the image.
| Table 1: SaberScope5 Model Numbers | |||
|---|---|---|---|
| Product Family | Model No. | Description | |
| Xenoscope | XSA-0-0510 | SaberScope5 Laparoscope (0°, 5mm shaft, | |
| 10cm length) | |||
| XSA-0-0536 | SaberScope5 Laparoscope (0°, 5mm shaft, | ||
| 36cm length) |
Indications for Use:
The Indications for Use is the same as the predicate device, which is:
The SaberScope5 Laparoscope 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 modified SaberScope5 System is comparable to the predicate device in intended use, fundamental scientific technology, design, materials, principles of operation and functional performance evaluations and is substantial equivalent as summarized in Table 2. The SaberScope5 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 device.
| Table 2: Table of Substantial Equivalence | ||
|---|---|---|
| Product | ||
| Attribute | Predicate Device: | |
| Articulating Xenoscope Laparoscope | ||
| (K193315) | Subject Device: | |
| SaberScope5 Laparoscope | ||
| 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. | The SaberScope5 Laparoscope | |
| 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. | ||
| Classification | ||
| Info. | 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
Class II | Same |
| Table 2: Table of Substantial Equivalence | | |
| Product
Attribute | Predicate Device:
Articulating Xenoscope Laparoscope
(K193315) | Subject Device:
SaberScope5 Laparoscope |
| Single Use | Yes | Same |
| Sterile | Provided Sterile (EO gas) | Same |
| Prescription | Yes | Same |
| Anatomical
Access | Thoracic and abdominal body cavities,
hollow organs, and canals, including female
reproductive organs. | Same |
| Fundamental
Scientific
Technology | The tip has an imaging sensor that sends
digital video information, which the Xenobox
coverts to an HDMI output for display on
commonly used HD monitors. | Same as predicate with the
additional manual focus
capability |
| Part No. | XSA-0-0510, XSA-0-0536 | Same |
| Design | 0° camera angle, 5 mm rigid shaft, with
articulating tip with fixed focus. | Same, but with manual focus
buttons on handle |
| Shaft Diameter
(OD) | 5 mm | Same |
| Shaft Tip | Articulating Tip (± 90°) | Same |
| Shaft Lengths | 10 cm,
36 cm | Same |
| Shaft Material | Carbon Fiber, covered with heat shrink
sheathing | Same |
| Field of View | 65°-75°
(Nominal 69º) | Same |
| HD Resolution | 1080p | Same |
| Camera Focus | Fixed Focus | 3-10cm |
| Focus Control
Buttons | N/A | 3 buttons:
- forward (manual mode)
- backward (manual mode)
- manual/auto toggle |
| Frame Rate | 30 fps | Same |
| Exposure/Gain
Control | Automatic (no user adjustments) | Same |
| Latency