(41 days)
Providing access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals.
The SOPRO 162 is a high resolution, digital processing camera system utilizing a CCD image sensor. It provides high quality images with excellent resolution and color contrast. Its contour enhancer gives the impression of a 3D image. This makes the camera a multidisciplinary tool. The SOPRO 162 is a modification of the SOPRO 61D previously cleared on 510(k) K031593. The modifications are the addition of a USB2 port option, the addition of a foot control that allows for the freezing of an image when using the USB2 port option, and the addition of a stand-by board (electronic board). The SOPRO 162 requires the operator to initially turn on a master switch before turning on the unit with a button on the front panel.
This 510(k) submission (K070102) for the SOPRO 162 camera does not contain a detailed study proving the device meets specific acceptance criteria in terms of performance metrics.
Instead, this submission is a "Substantial Equivalence" determination, which aims to demonstrate that the new device (SOPRO 162) is as safe and effective as a legally marketed predicate device (SOPRO 61D, K031593) without requiring new clinical trials or extensive performance data beyond what was established for the predicate.
Here's why the requested information isn't fully available in this document:
- No specific acceptance criteria or quantitative performance metrics are listed for the SOPRO 162. The submission focuses on functional equivalence and safety.
- No dedicated clinical study or performance data comparing the SOPRO 162 to the predicate is presented. The substantial equivalence argument rests on the minor nature of the modifications.
However, I can extract and infer information based on the premise of substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
Since no specific quantitative performance criteria are provided for the SOPRO 162, we must infer that the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, SOPRO 61D (K031593). The "performance" is implicitly considered equivalent to the cleared predicate.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (SOPRO 162) |
|---|---|
| Provides high quality images | Provides high quality images |
| Excellent resolution | Excellent resolution |
| Excellent color contrast | Excellent color contrast |
| Contour enhancer provides impression of 3D image | Contour enhancer gives the impression of a 3D image |
| Multidisciplinary tool | Multidisciplinary tool |
| Functionally similar to SOPRO 61D | Modifications (USB2 port, foot control, stand-by board) do not affect safety and effectiveness compared to SOPRO 61D |
| Safe for intended use | Safe for intended use |
| Effective for intended use | Effective for intended use |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable / Not provided. This type of submission does not typically involve a new, independent test set for performance evaluation in the same way a de novo or PMA submission might. The evaluation relies on the known performance and safety profile of the predicate device.
- Data Provenance: Not applicable / Not provided. The submission focuses on the technical specifications and modifications rather than new data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth establishment with experts is not part of this substantial equivalence demonstration. The device's functionality is assessed against that of the predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / None. No formal adjudication process for a test set is described.
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. This device is a digital camera system for endoscopy, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (camera system), not an algorithm or software requiring standalone performance testing in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The ground truth, in an indirect sense, refers to the established safety and effectiveness of the predicate device (SOPRO 61D), which had already met FDA requirements based on typical medical device testing and clinical use practices for endoscopic cameras at the time it was cleared (K031593).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/machine learning device.
In summary:
The document describes a 510(k) submission arguing for substantial equivalence of the SOPRO 162 camera to a previously cleared predicate device (SOPRO 61D). The "study" demonstrating that the device meets acceptance criteria is the comparison of its technical specifications and intended use against those of the predicate, along with the assertion that the modifications (USB2 port, foot control, stand-by board) are minor and do not alter its fundamental safety or effectiveness. Such submissions typically do not include new performance studies, test sets, or expert ground truth adjudication as would be found for novel devices or AI solutions.
§ 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.