(119 days)
The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-ileum using during diagnostic and therapeutic upper GI endoscopy and enteroscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).
The device described in this 510(k) consists of a modified sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the lower GI tract.
The provided 510(k) summary document focuses on establishing substantial equivalence for the Spirus Medical, Inc. Endo-Ease Endoscopic Overtube based on a clinical study and physical comparison to a predicate device.
Here's an analysis of the requested information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds for device approval. Instead, it relies on a clinical study to "demonstrate the device's effectiveness." The primary effectiveness metric reported is the ability to reach the ileum.
| Performance Metric | Reported Device Performance | Acceptance Criteria (Explicitly Stated in Document) |
|---|---|---|
| Ability to reach the ileum | Successfully reached the ileum in 48% of patients | Not explicitly stated (implied "effectiveness demonstrating") |
| Ability to reach the mid-ileum | Successfully reached the mid-ileum in 6% of cases | Not explicitly stated (implied "effectiveness demonstrating") |
| Aid endoscopic insertion & advancement | Indicated to aid endoscopic insertion and advancement | Not explicitly stated (functional claim) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 101 patients
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, although the phrasing "In a study involving the treatment of 101 patients" suggests a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the clinical study. The "user" successfully reaching the ileum implies a determination made by the endoscopist performing the procedure.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. The outcome simply reports what the "user" (presumably the treating physician) achieved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information about a multi-reader multi-case (MRMC) comparative effectiveness study is present in the document. The study described is a single-arm study focused on the performance of the device itself, not a comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance
This device is an endoscopic overtube, a mechanical medical device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.
7. Type of Ground Truth Used
The ground truth used appears to be clinical observation/outcome as determined by the endoscopist during the procedure (i.e., whether the ileum or mid-ileum was successfully reached).
8. Sample Size for the Training Set
This device is a physical medical device, not a machine learning model. Therefore, the concept of a "training set" is not applicable in this context. The 101 patients mentioned are part of the clinical study to demonstrate effectiveness for regulatory submission, not for training an algorithm.
9. How Ground Truth for the Training Set Was Established
As this is not an AI/ML device, there is no training set and thus no ground truth establishment for a training set.
§ 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.