(224 days)
The EndoFLIP® EF-800 is an external channel for an endoscope (9.0 to 12.2 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures. The EndoFLIP® ECD is single patient use, disposable. Environments of use - Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.
The EndoFLIP® ECD EF-800 External Channel Device (ECD) is an endoscopic accessory designed to provide an additional channel external to the endoscope for inserting, advancing, and removing endoscopic devices thereby preserving the working channel of the endoscope for other instruments.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EndoFLIP® ECD EF-800, structured as requested.
The provided document is a 510(k) Summary, which is typically a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. In many cases, for devices of this type (an accessory to an endoscope), the "acceptance criteria" are demonstrating equivalence in technical characteristics and performance to predicate devices, rather than establishing new clinical thresholds. The "study" often refers to non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the K110531 submission, the "acceptance criteria" are implied by the comparison to predicate devices, focusing on demonstrating similar functional, material, and safety characteristics. The performance reported is primarily through compatibility and age testing to ensure the device performs as expected for its intended use.
| Acceptance Criteria (Implied from Predicate Comparison) | Reported Device Performance (EndoFLIP® ECD EF-800) |
|---|---|
| Indications for Use Equivalence | Identified as equivalent to predicate K100081 (US Endoscopy overtube) for aiding insertion, advancement, and removal of endoscopic devices during procedures in the upper GI tract, including small intestine. |
| Technology Similarity | Similar to predicate K060923 (Smart Medical NaviAID BGE) – a simple double lumen tube with a tapered tip. Note: without the balloon accessory present in the predicate. |
| Material Biocompatibility | Materials in contact were tested to ISO 10993-1 (Cytotoxicity, Irritation, and Sensitization). |
| Environment of Use Equivalence | Identical to predicate K060923 (Smart Medical NaviAID BGE) – Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices. |
| Patient Population Equivalence | Identical to predicate K060923 (Smart Medical NaviAID BGE) – Patients undergoing endoscopic procedures. |
| Shelf Life | Age testing performed. (Details of specific duration or passing criteria are not provided in this summary.) |
| Compatibility with Endoscopes | Compatibility testing performed to verify its ability to slide over endoscopes. (Details of specific compatibility parameters are not provided.) |
| Safety and Efficacy Concerns | The device "raises no new safety or efficacy concerns" compared to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
For the "Performance Testing" mentioned (Age testing and Compatibility testing), the document does not specify:
- The exact sample size used for these tests.
- The origin of data (e.g., country of origin).
- Whether the data was retrospective or prospective.
These tests are typically bench or lab-based rather than clinical studies with human participants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts for ground truth) is typically relevant for studies involving subjective assessment (e.g., image interpretation). For a device like an endoscopic accessory undergoing performance testing (age testing, compatibility testing), the "ground truth" would be established by objective measurements and standardized test protocols, not by expert consensus on, for example, image interpretation. Therefore, this information is not applicable in the context of the provided regulatory submission.
4. Adjudication Method for the Test Set
As the performance testing described is objective (age testing, compatibility with endoscopes), there is no mention of an adjudication method (like 2+1 or 3+1). Such methods are typically used when subjective expert assessments need to be reconciled, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically clinical trials designed to compare the diagnostic performance of different methods (e.g., AI vs. human readers, or human readers with vs. without AI assistance) across multiple readers and cases. This submission focuses on demonstrating substantial equivalence of a physical medical device accessory through comparison of technical specifications and non-clinical performance tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not applicable. The EndoFLIP® ECD EF-800 is a physical medical device accessory (an external channel for an endoscope), not a diagnostic algorithm or an AI-powered system. Therefore, the concept of "standalone algorithm performance" (without human-in-the-loop) does not apply.
7. The Type of Ground Truth Used
For the performance tests mentioned:
- Age testing: The "ground truth" would be the stability and integrity of the device materials and function over a specified period, verified by empirical observation/measurement (e.g., material degradation, functional checks after accelerated aging) against predefined engineering specifications.
- Compatibility testing: The "ground truth" would be the successful and unimpeded sliding of the device over various endoscope diameters, verified by direct observation/measurement (e.g., successful navigation, absence of damage to either device) against specified dimensional and functional tolerances.
This is based on engineering specifications and objective physical measurements, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical accessory, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this device does not utilize a training set in the context of machine learning.
§ 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.