FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The ClearCap Distal Attachment has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy. The ClearCap Distal Attachment is intended for the following: Gastrointestinal mucosal resection (endoscopic mucosal resection) Keeping the suitable depth of the endoscope's view field

Device Description

ClearCap Distal Attachment is a sterile distal attachment intended to improve endoscopic control and to help maintain the clear view by keeping a moderate distance from the tissues during endoscopic surgical procedures. The ClearCap Distal Attachment is comprised of three main sections: an attaching portion, a distal portion and draining holes. The attaching portion is connecting portion of the attachment to an applicable endoscope; a distal portion is the ending portion of the attachment and the 2 draining holes on the sidewall are to discharge bleeding and some foreign matter. Applicable lesions are both lower digestive tract (=gastrointestinal (GI) tract) and upper GI tract. The model name FM-EC0001, FM-EC0005, FM-EC0006 and FM-EC0007 are for lower GI Tract, and FM-EC0002, EC0003 and EC0004 are for upper GI tract. It is available in various sizes of diameter to assure the compatibility of various endoscope outer diameters. The average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for a medical device called the "ClearCap Distal Attachment." It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the provided text, the device is not an AI/Software as a Medical Device (SaMD). It is a physical accessory designed to be attached to the distal end of an endoscope. Therefore, the questions related to AI/SaMD acceptance criteria, test sets, ground truth establishment, expert consensus, MRMC studies, and training sets are not applicable to this document.

The document focuses on demonstrating the physical device's safety and effectiveness through non-clinical testing, primarily biocompatibility and performance testing, to show its substantial equivalence to already marketed predicate devices.

Here's a breakdown of the relevant information provided:

Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of "acceptance criteria" in the way one might see for an AI model (e.g., specific thresholds for sensitivity, specificity, or F1-score). Instead, substantial equivalence for this physical device is demonstrated through:

Indications for Use (IFU) comparability: The ClearCap Distal Attachment has the same IFU as its primary predicate device (US Endoscopy Distal Attachment Cap).
Technological Characteristics Comparability: A table compares the subject device to its primary predicate and a reference device across various characteristics like company, device name, classification, product code, regulation number, IFU, appearance, materials, outer diameter, maximum diameter of attaching endoscope, total length, inner diameter of distal end, size and number of the drain, sterility, and reuse.
Non-Clinical Testing Results: The device underwent specific tests to ensure it met relevant standards and performed comparably to expectations for such devices. The "performance" is reported as meeting these standards, rather than numerical metrics for AI performance.

Table of Non-Clinical Testing and Outcome (interpreted as meeting "acceptance"):

Acceptance Criterion (Testing Standard)	Reported Device Performance (Outcome)
Biocompatibility (ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017)	Completed: Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic Toxicity, and Pyrogen Test (Demonstrated biocompatibility and substantial equivalence)
Performance Testing (Finemedix's design control system)	Appearance, Dimension, Extractable Substance, Endoscope Compatibility, and Suction testing (Performed as per system)
EO Sterilization Residuals (ISO 10993-7:2008)	Tested (No specific pass/fail values given, but implies acceptance)
Shelf Life Testing (ASTM F1980)	Tested (No specific duration or pass/fail values given, but implies acceptance)
EO Sterilization Validation (ISO 11737-1:2006, ISO 11737-2:2009)	Tested (Leveraged from K180363, implies acceptance)

The conclusion explicitly states: "The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device."

Sample size used for the test set and the data provenance:
- Not applicable (N/A) for AI/SaMD test set. This document describes a physical medical device.
- For the non-clinical tests (biocompatibility, performance, sterilization, shelf-life), specific sample sizes for tests on the physical device are not detailed in the provided summary, but standard practices for these types of tests would have been followed. The provenance would be the manufacturing site where the device prototypes were produced for testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A for AI/SaMD. Ground truth as understood in AI (e.g., image annotations by radiologists) is not relevant for this physical device. The "ground truth" for this device's performance would be the physical properties and material characteristics verified by laboratory testing professionals.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A for AI/SaMD. Adjudication methods are typically used for establishing consensus ground truth for complex interpretations (like medical images), which is not relevant here.
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:
- N/A for AI/SaMD. This device is an accessory for an endoscopy procedure, not an AI system. No human reader studies (MRMC) would be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A for AI/SaMD. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this physical device, the "ground truth" is established through objective laboratory measurements and tests against established international standards (e.g., ISO, ASTM) for biocompatibility, sterility, dimensions, material properties, and functional performance. It's not based on expert consensus on diagnostic interpretations or patient outcomes data in an AI sense.
The sample size for the training set:
- N/A for AI/SaMD. There is no training set for a physical medical device.
How the ground truth for the training set was established:
- N/A for AI/SaMD.

In summary, the provided document pertains to the FDA 510(k) clearance of a physical medical device accessory, not an AI or software product. Therefore, most of the requested information regarding AI model validation and performance is not present or applicable. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices through comparability of indications for use, technological characteristics, and successful completion of standard non-clinical safety (biocompatibility, sterility) and performance tests.

Summary

Regulation Number and Section

§ 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.