(95 days)
SAPIMED's Sigmoidoscopes are used to examine the rectum and lower bowel and, using additional accessories, perform various diagnostic and/or therapeutic procedures.
The Proctoscopy set consists of a multi-use plastic Grip (Ref. A.4131) and a choice of 3 different single use Insertion Tubes (Ref. A.4113, A.4120, A.4125). Each insertion tube comes with a matching obturator to facilitate the atraumatic insertion of the tube into the rectum. The multi-use plastic Grip (Ref. A.4131) consists of the following elements: 1. A hollow handle designed to connect to the light source (either a fiberoptic cable or a pen-light). 2. A circular frontal opening designed to connect to the Insertion Tube. 3. A posterior hinged closure containing both the lens and the insufflator attachment. The insufflator is a hand squeeze ball with a one-way valve as also used in manual blood pressure measuring devices. The Sigmoidoscope Kit MRP (ref. A.4522) consists of a Rigid Proctosigmoidoscope insertion tube and a plastic grip.
The provided text is a 510(k) summary for a disposable sigmoidoscope. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against predefined acceptance criteria through a clinical study in the way a novel AI algorithm might. Therefore, many of the requested elements (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, HRMC studies, standalone performance) are not typically included or relevant in a 510(k) for a hardware medical device like a sigmoidoscope.
Here's an analysis of the provided text in relation to your request, highlighting what is present and what is not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in this context. For a device like a sigmoidoscope, "acceptance criteria" generally refers to design specifications, material properties, and functional performance benchmarks (e.g., proper illumination, insufflation, dimensional integrity, biocompatibility, shelf-life) rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) that would be relevant for an AI algorithm. The 510(k) focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate, not on meeting external performance targets usually quantified in such a table.
- The document does not provide a table of acceptance criteria for diagnostic performance or a comparison of its performance against such criteria.
2. Sample size used for the test set and the data provenance
- Not applicable. This device is a physical medical instrument, not a diagnostic algorithm that relies on a "test set" of data for performance evaluation. Clinical studies demonstrating a "test set" performance for a sigmoidoscope are not typically part of a 510(k) submission for this type of device.
- The document mentions "Accelerated aging testing" and "Biocompatibility Testing (ISO10993 standards)" but does not specify sample sizes for these tests, nor are they "test sets" in the context of data-driven algorithms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As this is not an AI algorithm being evaluated for diagnostic accuracy against a ground truth, this information is irrelevant.
4. Adjudication method for the test set
- Not applicable. No test set or ground truth adjudication by experts is described as this is a physical medical device.
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 is a hardware device (sigmoidoscope), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant. The information provided is a comparison to a predicate device based on technical characteristics and intended use, not clinical performance improvement over human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. There is no "ground truth" in the context of diagnostic accuracy for this type of physical device. The device's safety and effectiveness are established by demonstrating substantial equivalence to a legally marketed predicate device, focusing on material, design, and intended use similarities.
8. The sample size for the training set
- Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no training set or ground truth for this device.
Summary of Relevant Information from the Provided Text as it Pertains to Device Acceptance/Equivalency:
While not explicitly in the format of acceptance criteria for a diagnostic algorithm, the document effectively outlines the criteria for substantial equivalence to a predicate device, which is the "acceptance" standard for a 510(k) submission.
Predicate Device Comparison (Basis for Acceptance/Equivalency):
| Parameter | Sapimed Disposable Sigmoidoscope (Proposed Device) | Welch Allyn Disposable Sigmoidoscope (Predicate Device) |
|---|---|---|
| Device Name | Disposable Sigmoidoscope/Sigmoidoscope | Welch Allyn Disposable sigmoidoscope |
| Product Code | KOG | KOG |
| K Number | (Not applicable for proposed) | K770291 |
| Common Name | Disposable Sigmoidoscope | Disposable sigmoidoscope |
| Intended Use | SAPIMED's Sigmoidoscopes are used to examine the rectum and lower bowel and, using additional accessories, perform various diagnostic and/or therapeutic procedures. | SAPIMED's Sigmoidoscopes are used to examine the rectum and lower bowel and, using additional accessories, perform various diagnostic and/or therapeutic procedures. |
| Material | Plastic | plastic |
| Single use | Yes | Yes |
| Cleanliness (A.4113, A.4120, A.4125) | Clean, non-sterile | Clean, non-sterile |
| Cleanliness (A.4522 Sigmoidoscope Kit MRP) | Sterile | (Not specified for predicate, implying equivalence or no new questions) |
Studies Demonstrating Safety and Efficacy (for Substantial Equivalency):
- Shelf Life: Accelerated aging testing was performed to substantiate an expiration of 5 years.
- Biocompatibility Testing: Conducted in accordance with ISO10993 standards.
Conclusion from the 510(k) Summary:
The document states: "The Sapimed disposable sigmoidoscopes have a similar intended use, technological characteristics and mode of operation as the predicate products, both disposable and reuseable and presents no new questions concerning safety and efficacy." The FDA's letter confirms: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." This indicates that the device has met the regulatory acceptance criteria for market clearance by demonstrating substantial equivalence to the predicate device through this comparison and the mentioned testing.
§ 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.