(26 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Xenocor® SaberScope5 Laparoscope, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table (Table 2) between the predicate device (Articulating Xenoscope™ Laparoscope, K193315) and the subject device (SaberScope5 Laparoscope). The acceptance criteria implicitly are that the subject device's performance attributes are "Same" as the predicate device or demonstrate equivalent performance, with some notable differences.
| Attribute | Predicate Device Performance (K193315) | SaberScope5 Laparoscope Performance | Acceptance Criteria Met? | Notes |
|---|---|---|---|---|
| Indications for Use | Diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. | Same | Yes | Maintained same Indications for Use. |
| Classification Info. | GCJ, GCQ, HET; Class II | Same | Yes | Maintained same classification. |
| Single Use | Yes | Same | Yes | |
| Sterile | Provided Sterile (EO gas) | Same | Yes | |
| Prescription | Yes | Same | Yes | |
| Anatomical Access | Thoracic and abdominal body cavities, hollow organs, and canals, including female reproductive organs. | Same | Yes | |
| Fundamental Scientific Technology | Imaging sensor that sends digital video, converted to HDMI by Xenobox. | Same as predicate with the additional manual focus capability | Yes (with enhancement) | The addition of manual focus is highlighted as an improvement, not a deviation from acceptance. |
| Part No. | XSA-0-0510, XSA-0-0536 | Same | Yes | These are the model numbers for existing lengths. |
| Design | 0° camera angle, 5 mm rigid shaft, articulating tip with fixed focus. | Same, but with manual focus buttons on handle | Yes (with enhancement) | The addition of manual focus buttons is an enhancement. |
| Shaft Diameter (OD) | 5 mm | Same | Yes | |
| Shaft Tip | Articulating Tip (± 90°) | Same | Yes | |
| Shaft Lengths | 10 cm, 36 cm | Same | Yes | |
| Shaft Material | Carbon Fiber, covered with heat shrink sheathing | Same | Yes | |
| Field of View | 65°-75° (Nominal 69º) | Same | Yes | |
| HD Resolution | 1080p | Same | Yes | |
| Camera Focus | Fixed Focus | 3-10cm | Yes (improved) | This is a key difference. The SaberScope5 moves from "Fixed Focus" to a "3-10cm" focus range, which implies user-adjustable focus. The associated design change is the addition of focus control buttons. This is presented as an improvement that meets acceptance. |
| Focus Control Buttons | N/A | 3 buttons: forward (manual mode), backward (manual mode), manual/auto toggle | N/A | This is a new feature introduced in the SaberScope5. It's not a "met" or "not met" criteria against the predicate, but a feature leading to the "3-10cm" focus range. |
| Frame Rate | 30 fps | Same | Yes | |
| Exposure/Gain Control | Automatic (no user adjustments) | Same | Yes | |
| Latency (<100ms) | No buffering more than 3 frames | Same | Yes | |
| Light Source | 6 LED (ring) | Same | Yes | |
| White Balance | Fixed | Same | Yes | |
| LED Color Brightness Range | 2500k to 7000k | Same | Yes | |
| Handle | Handle with articulation mechanism | Handle with articulation mechanism and focus buttons | Yes (with enhancement) | The addition of focus buttons is an enhancement. |
| Packaging | Double Pouched Tyvek/ Mylar Pouch, and backer card | Same | Yes | Confirmed explicitly in the "Functional/Safety Testing" section that changes did not affect packaging. |
| Sterilization | EO Sterile (SAL 10-6) | Same | Yes | |
| Shelf Life | 1 years | Same | Yes | |
| Biocompatibility | Patient contacting components meet ISO 10993 standard | Same | Yes | Confirmed explicitly in "Functional/Safety Testing" that no new materials were introduced. |
| Applied Part Class | Type CF | Same | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Design Verification – Performance bench testing was conducted".
- Sample Size: Not specified. The document only mentions "performance bench testing" was conducted, implied to be on the SaberScope5 Laparoscope.
- Data Provenance: Not specified, but generally, bench testing results for FDA submissions are generated by the manufacturer or a contracted lab. There's no indication of country of origin of data or whether it was retrospective or prospective in the clinical sense, as it was bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This type of information is not applicable to this submission. The submission pertains to a medical device (laparoscope) that aids human physicians, not an AI or diagnostic software that requires expert-established ground truth for its own performance evaluation in a clinical context. The performance verification here relates to engineering and functional parameters rather than diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is a hardware device undergoing performance bench testing, not an AI or diagnostic algorithm requiring clinical adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done. This is not an AI-assisted diagnostic or imaging interpretation device. It is a surgical viewing device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm, but a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implicitly uses engineering specifications and performance standards as "ground truth" derived from the predicate device and relevant industry standards. For example, the "Field of View" (65°-75°) or "HD Resolution" (1080p) are objective, measurable performance characteristics. The term "ground truth" in the context of diagnostic accuracy is not directly applicable here.
8. The sample size for the training set
Not applicable. This is a hardware device; there is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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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.
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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 Consulting370 S. 300 E.Salt Lake City, UT 84111(801) 708-2238Spencer@PeakRegulatory.com |
| Date Prepared: | March 24, 2022 |
| Trade Name: | Xenocor® SaberScope5 Laparoscope |
| Classification Name: | Endoscope and Accessories21 CFR §876.1500, Product Code(s) GCJ, GCQ,Gynecologic Laparoscope and Accessories21 CFR §884.1720, Product Code HET, |
| Device Class: | Class II |
| Predicate Device: | 510(k) No.: K193315Model: Xenocor® Articulating Xenoscope™ LaparoscopeManufacture: 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 | ||
|---|---|---|
| ProductAttribute | Predicate Device:Articulating Xenoscope Laparoscope(K193315) | Subject Device:SaberScope5 Laparoscope |
| Indications forUse | The Articulating Xenoscope is intended to beused in diagnostic and therapeuticprocedures for endoscopy and endoscopicsurgery within the thoracic and peritonealcavities including the female reproductiveorgans. | The SaberScope5 Laparoscopeis intended to be used indiagnostic and therapeuticprocedures for endoscopy andendoscopic surgery within thethoracic and peritoneal cavitiesincluding the femalereproductive organs. |
| ClassificationInfo. | Gastroenterology-Urology Devices -Endoscope and Accessories(21 CFR §876.1500),Product code: GCJ & GCQObstetrical and Gynecological DiagnosticDevices - Gynecologic Laparoscope andAccessories(21 CFR §884.1720),Product code: HETClass II | Same |
| Table 2: Table of Substantial Equivalence | ||
| ProductAttribute | Predicate Device:Articulating Xenoscope Laparoscope(K193315) | Subject Device:SaberScope5 Laparoscope |
| Single Use | Yes | Same |
| Sterile | Provided Sterile (EO gas) | Same |
| Prescription | Yes | Same |
| AnatomicalAccess | Thoracic and abdominal body cavities,hollow organs, and canals, including femalereproductive organs. | Same |
| FundamentalScientificTechnology | The tip has an imaging sensor that sendsdigital video information, which the Xenoboxcoverts to an HDMI output for display oncommonly used HD monitors. | Same as predicate with theadditional manual focuscapability |
| Part No. | XSA-0-0510, XSA-0-0536 | Same |
| Design | 0° camera angle, 5 mm rigid shaft, witharticulating tip with fixed focus. | Same, but with manual focusbuttons 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 shrinksheathing | Same |
| Field of View | 65°-75°(Nominal 69º) | Same |
| HD Resolution | 1080p | Same |
| Camera Focus | Fixed Focus | 3-10cm |
| Focus ControlButtons | N/A | 3 buttons:- forward (manual mode)- backward (manual mode)- manual/auto toggle |
| Frame Rate | 30 fps | Same |
| Exposure/GainControl | Automatic (no user adjustments) | Same |
| Latency<100ms | No buffering more than 3 frames | Same |
| Table 2: Table of Substantial Equivalence | ||
| ProductAttribute | Predicate Device:Articulating Xenoscope Laparoscope(K193315) | Subject Device:SaberScope5 Laparoscope |
| Light Source | 6 LED (ring) | Same |
| White Balance | Fixed | Same |
| LED ColorBrightnessRange | 2500k to 7000k | Same |
| Handle | Handle with articulation mechanism | Handle with articulationmechanism and focus buttons |
| Packaging | Double Pouched Tyvek/ Mylar Pouch, andbacker card | Same |
| Sterilization | EO Sterile (SAL 10-6) | Same |
| Shelf Life | 1 years | Same |
| Biocompatibility | Patient contacting components meet ISO10993 standard | Same |
| Applied PartClass (per IEC60601-2-18;(2009)) | Type CF | Same |
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Image /page/5/Picture/0 description: The image contains the logo for Xenocor, a medical device company. The logo features a stylized circular design with a blue and gray color scheme, accompanied by the company name in blue text. Below the logo, the alphanumeric code "K220872" is displayed.
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Image /page/6/Picture/0 description: The image shows the logo for Xenocor. The logo consists of a blue and gray circular design to the left of the company name, which is written in blue, sans-serif font. The text "K220872" is located in the bottom left corner of the image.
Functional/Safety Testing:
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
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Image /page/7/Picture/1 description: The image contains the logo for Xenocor. The logo consists of a blue and gray circular design on the left, followed by the company name "XENOCOR" in blue, sans-serif font. Below the logo, the text "K220872" is printed in black.
- Packaging The proposed changes to the subject device did not affect the packaging ● or its configuration.
Conclusion:
The subject SaberScope5 Laparoscope is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate device. The minor differences between the subject SaberScope5 Laparoscope and the predicated device have no effect on safety or effectiveness, as established through various performance tests.
The modifications to the SaberScope5 Laparoscope were made per Xenocor's procedures and quality system. The SaberScope is substantially equivalent to the cited predicate device. Additionally, the SaberScope met all acceptance criteria to confirm safety and effectiveness.
§ 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.