(81 days)
This camera head has been designed to be used with the CV-180 EXERA II video system center or OTV-S7Pro VISERA Pro video system center, endoscopes, light sources, video monitors and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.
HD CAMERA HEAD OTV-S7ProH-HD-L08E is an imaging device used with specified HD CAMERA FILAD OTV-811 1011 1017 1072 120 120 0ther ancillary equipment for observation of endoscopic image on a video monitor.
The new camera head is basically identical to predicate device shown in Table 14-1 in intended use, and similar in specifications, performance.
The provided text is a 510(k) summary for a medical device (HD CAMERA HEAD OTV-S7ProH-HD-L08E). It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and study results in the typical format of a device performance study.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not explicitly present in the provided document. The document primarily compares the new device's specifications to a predicate device to argue for substantial equivalence.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance targets that were tested against. Instead, it provides a "Comparison of Specifications" between the subject device and its predicate. The implication is that the subject device's performance, as outlined in these specifications, is considered acceptable because it is similar to the legally marketed predicate device.
| Item | Specifications (Predicate Device) | Reported Device Performance (Subject Device) | Implied Acceptance |
|---|---|---|---|
| Dimension | O.D. 21mm x 83mm (from mount surface) L-shape | ||
| Camera Head | O.D. 40mm x 104mm (from mount surface) Straight shape | The size differences (smaller, L-shape vs. straight) are presented as design changes, not deviations from a performance requirement. These are acceptable as long as they don't negatively impact intended use or safety, which is claimed in the conclusion by stating no "significant changes in intended use, method of operation, or design." | |
| Cable | O.D. 6.6mm x 4m | O.D. 3.3mm x 4m | Similar to above, smaller cable diameter is a design change. |
| Weight | 100g (excluding cable) | 60g (excluding cable) | Lighter weight is a design change. |
| Video plug | Round shape type connector | Card-edge type connector | A different type of connector, indicating a design change, but functional equivalence is implied. |
| Remote control switches | Separated | Embedded | Design change for convenience, still providing the function. |
| Observation | |||
| Pickup System | Interline type CCD solid-state image pickup | Interline type CCD solid-state image pickup | Identical, thus meeting the implied standard of the predicate device. |
| Auto Iris | Available | Not available | The absence of Auto Iris is a functional difference. Its acceptability hinges on the overall system performance and whether manual control is sufficient or if the NBI feature compensates. The submission implies it's acceptable. |
| Narrow Band Imaging (NBI) function | Not available | Available | This is an added feature. Its presence is considered an enhancement, not a failure to meet criteria. |
| Operating Environment | |||
| Ambient Temperature | 10 to 40°C | 10 to 40°C | Identical, meeting the implied standard. |
| Relative Humidity | 30 to 85% | 30 to 85% | Identical, meeting the implied standard. |
| Atmospheric Pressure | 700 to 1060 hPa | 700 to 1060 hPa | Identical, meeting the implied standard. |
| Reprocessing | |||
| Cleaning | Immersible in detergent solution with a water-resistant cap | Immersible in detergent solution without water-resistant cap | This indicates an improvement in design for ease of cleaning, implicitly acceptable. |
| Disinfection | Immersible in disinfectant solution with a water-resistant cap | Immersible in disinfectant solution without water-resistant cap | This indicates an improvement in design for ease of disinfection, implicitly acceptable. |
| Sterilization | Ethylene oxide gas sterilization | Ethylene oxide gas sterilization | Identical, meeting the implied standard. |
| Patient contacting material | No patient contacting material | No patient contacting material | Identical, ensuring no new biocompatibility concerns. |
Study Details:
The document describes a comparison to a predicate device for the purpose of demonstrating "substantial equivalence" to obtain 510(k) clearance, not a clinical performance study with specific acceptance criteria and detailed statistical analysis of performance metrics.
Therefore, most of the following information is not available in the provided text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document does not describe a clinical study with a "test set" of patient data. The comparison is based on device specifications and design characteristics.
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)
- Not applicable / Not provided. No ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method is mentioned.
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
- Not applicable / Not provided. This device is a camera head, not an AI-assisted diagnostic tool. No MRMC study is referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a camera head, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth for a clinical study is referenced. The "truth" in this submission is the established safety and effectiveness of the predicate device, against which the new device's specifications are compared.
8. The sample size for the training set
- Not applicable / Not provided. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No ground truth for a training set is mentioned.
Summary of the Document's Conclusion:
The document concludes that the HD CAMERA HEAD OTV-S7ProH-HD-L08E is "basically identical to the predicate device in intended use" (with some limitation of application to specific anatomical regions) and "similar in specifications." It highlights the addition of Narrow Band Imaging (NBI) and embedded remote control switches, as well as an L-shaped configuration and smaller dimensions, as design changes. The key statement for regulatory purposes is: "When compared to the predicate device, the HD CAMERA HEAD OTV-S7ProH-HD-L08E does not incorporate any significant changes in intended use, method of operation, or design of the device." This statement, along with the detailed specification comparison, forms the basis for the FDA's substantial equivalence determination.
§ 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.