(193 days)
The products are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body.
The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.
The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes which are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body.
The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.
The submitted devices can be grouped by working length (WL) and direction of view.
The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes with a fixed eyepiece, integrated light guide, optical system, cold light connector, with screw-on adapter for fiber light cables and with color coding ring for direction of view.
The telescopes are constructed of a cladding tube, which is surrounded by a rigid sheath, a fixed eyepiece and an eyecup at the proximal end.
Within the cladding tube, images are transferred via a rod lens system to the fixed eyepiece. Illumination is provided via light guide bundles connected to a light source. Visualization can directly be performed via the fixed eyepiece (direct visualization method) or alternatively via a monitor and user interface (indirect visualization method). For the second option, a camera must be attached to the fixed eyepiece and must be connected to a monitor.
The provided document, K203226, is a 510(k) Premarket Notification for rigid endoscopes (Telescopes) manufactured by Richard Wolf Medical Instruments Corporation. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results that would typically be associated with AI/ML devices or new diagnostic tests.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC studies, AI improvement effect size, training set details) are not applicable (N/A) because this submission pertains to a physical medical device (endoscope) and its manufacturing and performance validation, not a software-driven or AI-based diagnostic tool.
The document describes non-clinical performance testing (bench testing) to demonstrate the safety and effectiveness of the device, primarily by comparing its characteristics and performance to a legally marketed predicate device.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance for Rigid Endoscopes (K203226)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantifiable acceptance criteria with corresponding performance metrics in a way commonly seen for software or AI/ML device clearances. Instead, the acceptance criteria are implicitly or explicitly stated through the validation of various engineering and functional aspects, and performance is demonstrated by meeting these and showing equivalence to the predicate.
| Category | Acceptance Criteria (Implied/Stated in Document) | Reported Device Performance |
|---|---|---|
| Reprocessing | - Manual cleaning process: Must pass all acceptance criteria. |
- Automated cleaning process: Must pass all acceptance criteria.
- Sterilization (moist heat/steam): Must achieve a Sterility Assurance Level (SAL) of 10⁻⁶ (according to AAMI TIR12, Annex B). | - Manual cleaning process: "passed all acceptance criteria."
- Automated cleaning process: "passed all acceptance criteria."
- Sterilization: SAL of 10⁻⁶ "was achieved" (sterility ensured). |
| Biocompatibility | - Biological risk assessment performed according to ISO 10993-1:2018 and FDA guidance. - Biological testing and chemical characterization to demonstrate safety (for materials with direct patient contact: optical glass, stainless steel, glue, soft solder, classified as external communicating device with contact to tissue, bone, and dentin for ≤24h). | - Biological testing and chemical characterization "proved that the PANOVIEW Ultra telescopes are as safe as the predicate devices." |
| Performance Testing (Bench) | - Optical performance validation (according to ISO 8600-1/-3/-5 for parameters like spectral range, working lengths, working distance). - Optical performance validation after simulation of aging.
- Performance testing addressing differences from predicate: different working length, shaft thickness, new material of light guide bundle, focal length, distortion.
- Functionality: ability to visualize inside the body, image transfer via rod lens system, illumination via light guide bundles.
- Packaging validation (specifically for 434 mm working length).
- Stability testing.
- Temperature testing (according to IEC 60601-2-18).
- Overall design, basic safety, and essential performance requirements and specifications met. | - Optical performance validated; parameters compared to predicate devices "to prove equivalence."
- Optical performance after aging validated.
- Confirmed that changed characteristics (e.g., working length) "do not question safety and effectiveness."
- Function as described (e.g., "images are transferred via a rod lens system," "illumination is provided via light guide bundles").
- Packaging validated for the 434mm subset.
- Stability testing performed.
- Temperature testing performed.
- "Testing confirms that the products meet all the requirements and specifications for overall design, basic safety and essential performance, and that the design inputs and specifications are met." |
| Equivalence to Predicate | Functional and safety equivalence to the predicate device (Endoscope 0°/30°/50° Ø 10MM, K993103). | - "the submitted devices are as safe and as effective as the predicate devices." - "submitted devices function as safe as effective as the predicate device"
- "deemed to be substantially equivalent to the legally marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Not explicitly stated as a number of "cases" or "patients" as this is a physical device, not an AI/ML diagnostic. The testing involved various bench tests on the device units themselves. The number of physical units tested for each validation (reprocessing, biocompatibility, optical performance, etc.) is not specified in this summary.
* Data Provenance: Not applicable in the context of patient data (e.g., retrospective/prospective, country of origin). The data comes from internal laboratory/bench testing of the physical medical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
* N/A. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not applicable here. The "truth" for this device's performance is established by objective engineering measurements against established standards (e.g., ISO, IEC) and manufacturer specifications in a laboratory setting. No medical experts were described as establishing a "ground truth" for the test set.
4. Adjudication Method for the Test Set:
* N/A. Given that this is bench testing of a physical device against engineering standards, an "adjudication method" involving human experts is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
* N/A. This device is an endoscope, not an AI/ML-assisted diagnostic tool or software. No MRMC study was performed as it is not relevant to the clearance of this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Performance was Done:
* N/A. This applies to algorithms. The device itself is a standalone physical instrument used by a human operator for visualization. Its "standalone performance" refers to its optical and mechanical integrity, which was evaluated through bench testing.
7. The Type of Ground Truth Used:
* The "ground truth" for this device's performance is based on adherence to engineering specifications, international standards (e.g., ISO 8600-1/-3/-5 for optical performance, AAMI TIR12 for sterilization, ISO 10993-1 for biocompatibility, IEC 60601-2-18 for temperature testing), and validation against the characteristics of a predicate device. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the traditional sense for this type of device clearance.
8. The Sample Size for the Training Set:
* N/A. This document describes a physical medical device, not a software or AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
* N/A. As there is no training set mentioned or implied for this physical device, the concept of establishing ground truth for it is not applicable.
§ 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.