(63 days)
This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or incision.
The NovaCyte Micro endoscope is a semi-rigid fiberscope intended for limited reuse (not to exceed 10 procedures) and is provided non-sterile. The NovaCyte Micro endoscope must be sterilized prior to use. Refer to the Handling, Cleaning and Sterilization instructions. The NovaCyte Accessory Pack is comprised of a solid obturator (dilator) and an Introducer (Cannula). It is intended for single use and is provided sterile.
This response is based on the provided text, which is a 510(k) premarket notification. 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with detailed acceptance criteria and performance metrics as might be found in a PMA.
Therefore, many of the requested data points (e.g., specific acceptance criteria for performance, sample sizes for test/training sets, expert qualifications, MRMC studies) are not provided in this type of document. The document primarily focuses on technical specifications, intended use, and comparison to predicate devices to establish safety and effectiveness.
Here's an analysis based on the available information:
Acceptance Criteria and Study for NovaCyte™ Microendoscope and Accessories
The provided document, a 510(k) premarket notification, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against pre-defined acceptance criteria through a standalone clinical study. Therefore, formal "acceptance criteria" in the sense of specific performance thresholds for a clinical outcome are not explicitly stated in this document.
The "study" conducted to meet the requirements of the 510(k) process is a comparison of the NovaCyte™ Microendoscope and Accessories to established predicate devices (Acueity Microendoscope (K011189) and Davlite Microendoscope (K020310)). The premise is that if the new device is substantially equivalent in intended use, design, materials, physical characteristics, and geometry, it is considered as safe and effective as the predicate devices, which are already legally marketed.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, explicit acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity) for clinical outcomes are not detailed in this 510(k) submission.
Instead, the "acceptance criteria" for a 510(k) are implicitly met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is largely inferred from its similarity to the predicate devices and its ability to perform its intended function of "viewing an interior cavity of the human body."
| Criterion Type | Acceptance Criteria (Implicit from 510(k) Submission) | Reported Device Performance (Inferred from Submission) |
|---|---|---|
| Intended Use | The intended use of the NovaCyte™ Microendoscope and Accessories must be the same as or very similar to the predicate devices. | Match: "This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or incision." This matches the general intended use of endoscopes and is substantially equivalent to the predicates. |
| Technological Characteristics | The design, materials, physical characteristics, and geometry of the NovaCyte™ Microendoscope and Accessories must be substantially equivalent to the predicate devices, not raising new questions of safety or effectiveness. This includes mechanical properties, optical performance (e.g., field of view, resolution – though not quantified in this summary), and compatibility with accessories. | Demonstrated by Comparison: The submission states, "Establishment of equivalence is based on similarities of intended use, design, and materials, physical characteristics and geometry between the Cytyc Surgical NovaCyte Microendoscope and the Acueity Microendoscope (Viaduct) (K011189) and the Davlite Microendoscope (K020310) among other marketed visualization products." Specific technical data would be in the full submission, but the conclusion is that these characteristics are substantially equivalent. Key characteristics mentioned: semi-rigid fiberscope, limited reuse (not to exceed 10 procedures), non-sterile (must be sterilized), accessory pack (obturator, introducer) for single use and sterile. |
| Safety & Effectiveness | The device must not raise new questions of safety or effectiveness compared to the predicate devices. This implies satisfactory biocompatibility, structural integrity, and appropriate sterilization methods. | Inferred from Equivalence: By demonstrating substantial equivalence in design, materials, and intended use, the device is deemed to have a similar safety and effectiveness profile to the legally marketed predicate devices. The document highlights the need for sterilization prior to use for the main device and states the accessories are sterile and single-use, indicating consideration for infection control. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: This 510(k) summary does not report a specific "test set" sample size in the context of a clinical performance study with human subjects. The device comparison is primarily a technical and design comparison to predicate devices, not a clinical trial.
- Data Provenance: Not applicable in the context of a clinical study test set here. The data provenance relevant to the 510(k) includes the technical specifications and design features of the NovaCyte device and its predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts & Qualifications: Not applicable. The 510(k) process for this device did not involve establishing ground truth through expert consensus on a clinical test set. The regulatory review process involves FDA experts evaluating the submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable as there was no clinical test set with associated ground truth to adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, the provided summary does not indicate that an MRMC comparative effectiveness study was performed. Such studies are generally not required for 510(k) submissions unless there are significant new questions of effectiveness.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Not applicable. This device is a microendoscope, a hardware device for direct visual viewing by a physician (human-in-the-loop). There is no "algorithm only" component.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of clinical performance data. The "ground truth" for the 510(k) submission relates to the established safety and effectiveness of the predicate devices based on their prior marketing and regulatory clearance.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is a hardware device; there is no "training set" in the machine learning sense. The design and manufacturing process would involve internal testing and validation, but not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no training set for an algorithm.
§ 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.