(244 days)
Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.
Flexible Overtube™ provides an access for repeated insertion and withdrawal of an endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations. Prior to inserting an endoscope into a patient, the user passes the endoscope through Flexible Overtube™. Flexible Overtube™ is placed after the endoscope is inserted into the patient. The endoscope can be inserted and withdrawn through properly placed Flexible Overtube™.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:
Crucially, the provided text describes a 510(k) submission for a medical device (Flexible Overtube™) seeking substantial equivalence to a predicate device. This type of submission generally does not involve clinical studies with human subjects to prove a device meets specific performance criteria in the way a de novo or PMA submission would. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through technological comparison, material biocompatibility testing, and functional bench testing.
Therefore, many of the typical questions for AI/diagnostic device performance studies (like sample sizes for test sets, expert ground truth, MRMC studies, etc.) are not applicable to this document. The focus here is on the "acceptance criteria" for establishing substantial equivalence, which are different from those for proving a diagnostic algorithm's accuracy.
The "study" here refers to the testing and comparisons done to support the claim of substantial equivalence.
Understanding the Context: 510(k) Premarket Notification
This submission (K182520) is a 510(k) Traditional Premarket Submission. The FDA review process for 510(k)s focuses on demonstrating substantial equivalence to a predicate device. This means the new device is:
- Intended for the same use as a predicate device.
- Has the same technological characteristics as the predicate device, OR
- Has different technological characteristics, but the information submitted by the applicant demonstrates that the device is as safe and effective as a legally marketed predicate device, and does not raise different questions of safety and effectiveness.
This is different from proving absolute performance against a set of clinical criteria for a diagnostic/AI device.
Analysis of the Provided Information:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" in this context are not quantitative performance metrics for a diagnostic algorithm, but rather the criteria for demonstrating substantial equivalence to the predicate device. The "reported device performance" is mainly shown through qualitative comparisons and results of bench tests.
| Acceptance Criterion (for Substantial Equivalence) | Reported Device "Performance" (Evidence from the Submission) |
|---|---|
| Similar Indications for Use | Met: Flexible Overtube™ is used "for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations." This is stated to be "identical to that of the Predicate device (Disposable Overtube K040836)." |
| Similar Principles of Operation | Met: Both devices facilitate repeated insertion/withdrawal of an endoscope. The predicate device also uses a similar principle to reduce mucosal pinching (albeit with a two-tube system vs. single tube for the subject device). |
| Technological Characteristics - Overtube Design | Met (with justification): Subject device uses a single tube with a soft, beveled distal end and lengthwise slit to reduce mucosal pinching. Predicate uses a two-tube system (inner/outer) with a tapered distal end for similar purpose. Justification: "both the proposed and the predicate devices provides an access for repeated insertion and withdrawal of an endoscope with reduced potential for mucosal pinching." |
| Technological Characteristics - Seal Unit | Met (with justification): Subject device has a detachable seal unit. Insufflation seal testing showed internal pressure >4.0 kPa, which "is much more than the average of stomach pressure during insufflation." (No direct comparison to predicate seal performance provided, but the functionality appears to be similar and adequate). |
| Technological Characteristics - Mouthpiece | Met (with justification): Subject device includes a detachable mouthpiece. Justification: "It is recommended that a minimum 60FR bite block be used with the predicate device. Therefore, the use of the Flexible Overtube™ with the Mouthpiece is not different from the use of the predicate device." |
| Technological Characteristics - Length | Met (with justification): Subject device is 205 mm. Justification: This length is "within the range" (20-25 cm) recommended by ASGE for protection. The predicate has 250 mm and 500 mm models, with the 250 mm model also in range. |
| Technological Characteristics - Diameter | Met (with comparison): |
| Inner diameter: Subject - 16.0 mm. Predicate - 16.7 mm (Outer), 8.6 mm or 10.2 mm (Inner). | |
| Outer diameter: Subject - 19.0 mm. Predicate - 19.5 mm (Outer tube). | |
| Endoscope OD range: Subject - 9.0-12.0 mm. Predicate - 8.6-10.0 mm (for 8.6mm ID inner tube), 10.0-11.7 mm (for 10.2mm ID inner tube). The differences are noted but not presented as raising new questions of safety/effectiveness, implying clinical equivalence in use. | |
| Technological Characteristics - Sterility | Improved (advantage for subject device): Subject device is EO sterilized (Sterility Assurance Level 10-6 achieved, residual EO/ECH/endotoxin within limits). Predicate device is non-sterile. This is considered a positive difference, not a new QSE. |
| Biocompatibility | Met: Contact with mucosal membrane (Surface device, Mucosal, Contact A-limited). Tests performed: Cytotoxicity, Sensitization, Acute systemic toxicity, Irritation reactivity. "No biocompatibility concern was raised." |
| Mechanical Performance | Met: Tensile strength test conducted, showed "enough for actual use." Simulated use test showed "bendability and stiffness... were kept during endoscopic treatment." |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set for diagnostic performance. The "test set" here would refer to the physical devices used for bench testing (tensile strength, simulated use, insufflation seal, biocompatibility). The number of samples tested is not specified in the provided summary, but device submissions typically outline these in detailed test reports.
- Data Provenance: Not applicable. This is not clinical data from patients. The data comes from in vitro (bench) testing of the device itself and its materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" to establish for a diagnostic decision in this context. The testing is physical and chemical verification of device characteristics and safety.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No human adjudication of results is mentioned or would typically be required for this type of physical/material testing.
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
- No. An MRMC study is not relevant for this device. This is a physical medical device (an overtube for endoscopy), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this device, "ground truth" refers to established engineering standards, material safety standards (e.g., ISO, AAMI), and the functional requirements for an overtube. For example, the ground truth for biocompatibility is whether the materials elicit an adverse biological response when tested against ISO 10993 standards.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/machine learning product.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
In summary, the provided document details a 510(k) submission for a physical medical device (Flexible Overtube™). The "acceptance criteria" and "proof" relate to demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics, confirmed by various bench tests (e.g., biocompatibility testing, tensile strength, seal testing). It does not involve clinical studies with human subjects or the evaluation of an AI algorithm's diagnostic performance.
§ 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.