(34 days)
Like the predicate devices, the BAHO autoclavable Cystoscope is indicated for use in the visual examination of body cavities, hollow organs and canals and using additional accessories, to perform various diagnostic and therapeutic procedures.
The BAHO autoclavable Cystoscope has a basic design similar to those legally available for sale in the U.S.A. Like others legally sold in the U.S.A.,it consists of an evepiece.body and insertion tube. The insertion tube is double walled surgical steel with illumination fibers in between. The insertion tube contains the optical rod lens system. ( identical to BAHO autoclavable Laparoscope 510(k) Number K982276 )
The provided text describes a 510(k) submission for a medical device (BAHO Autoclavable Cystoscope) and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data and acceptance criteria from a study.
Therefore, many of the requested data points (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not available in the provided text, as they are not typically part of a 510(k) submission that relies on demonstrating equivalence through material and design similarity to already approved devices.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Design Equivalence | Basic design similar to legally available devices in the U.S.A. (eyepiece, body, insertion tube, double-walled surgical steel with illumination fibers, optical rod lens system). | "The BAHO autoclavable Cystoscope has a basic design similar to those legally available for sale in the U.S.A. Like others legally sold in the U.S.A., it consists of an eyepiece, body and insertion tube. The insertion tube is double walled surgical steel with illumination fibers in between. The insertion tube contains the optical rod lens system." (identical to K982276) |
| Material Equivalence | Selection of materials demonstrating appropriate levels of biocompatibility, similar or identical to predicate devices and other approved BAHO endoscopes. | "The biological safety of the BAHO autoclavable Cystoscope has been defined through the selection of materials that demonstrated appropriate levels of biocompatibility which constitute the building blocks of the proposed device. These materials are similar or identical to those used for the manufacturing of the predicate devices as well as other brands legally sold in the U.S.A. and other approved BAHO endoscopes (Arthroscope, Laparoscope)" |
| Functional Equivalence | Biocompatibility, function, indications, and designs developed to ensure safety and substantial equivalence to commercially approved cystoscopes. | "In summary : biocompatibility, function, indications and designs have been developed to ensure the safety of this device. It is substantially equivalent to commercially approved cystoscopes available for sale in the U.S.A." |
| Indication for Use | Indicated for visual examination of body cavities, hollow organs, and performing diagnostic/therapeutic procedures with accessories. | "Like the predicate devices the BAHO autoclavable Cystoscope is indicated for use in the visual examination of body cavities, hollow organs and using additional accessories, to perform various diagnostic and therapeutic procedures." |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable/Not provided. The submission relies on claiming substantial equivalence based on material and design similarity to existing predicate devices, not on a new testing study with a "test set" in the context of performance metrics for an AI/diagnostic device.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No dedicated "test set" requiring expert-established ground truth is mentioned. The submission is about device design and materials.
4. Adjudication method for the test set
- Not applicable/Not provided.
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 is not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a physical, optical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The "ground truth" for this submission is the established safety and efficacy of the predicate devices and the biocompatibility of the materials used in the new device, rather than diagnostic accuracy.
8. The sample size for the training set
- Not applicable/Not provided. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 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.