(41 days)
EverLift™ Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic device.
The GI Supply EverLift™ Submucosal Lifting Agent (10mL) is a prefilled plastic syringe with attached plunger rod containing 10mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available endoscopic injection needle.
EverLift™ Submucosal Lifting Agent is an injectable liguid composition for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD), and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, including the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers, and other pathological lesions by EMR, ESD, or polypectomy.
EverLift™ Submucosal Lifting Agent is injected into the submucosal layer by means of a standard, commercially available endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD, or polypectomy).
This document focuses on the EverLift™ Submucosal Lifting Agent (10mL) and its substantial equivalence to a predicate device, the EverLift™ Submucosal Lifting Agent (5mL). This is a medical device, not an AI/ML algorithm, therefore most of the requested information regarding AI/ML studies (such as MRMC studies, standalone performance, training set details, or ground truth establishment methods for AI) is not applicable.
The acceptance criteria and device performance are established through a series of non-clinical performance tests designed to show that the 10mL device is as safe and effective as the previously cleared 5mL predicate device.
Here's the relevant information extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several non-clinical performance tests. For each test, the conclusion is that the subject device (10mL) performed equivalently or met the acceptance criteria used for the predicate device (5mL). The specific numerical acceptance criteria for each test are not explicitly detailed in quantifiable values, but rather referred to as "the same method and acceptance criteria as the predicate device" or conforming to specific ISO/USP standards.
| Test Description | Conforming Standard(s) / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Syringe Tip Cap Removal Force Testing | Same method and acceptance criteria as the predicate device (not explicitly quantified) | Confirmed that the syringe tip cap removal force is equivalent between the subject and predicate devices. |
| Product Color Testing | Same method and acceptance criteria as the predicate device (not explicitly quantified) | Confirmed that product color is identical between the two devices. |
| Injection Flow Rate Testing | Same method and acceptance criteria as the predicate device (not explicitly quantified) | Confirmed that the injection flow rate is equivalent between the subject and predicate devices. |
| Graduation Marking Tolerance | ISO 7886-1:2017, Sterile hypodermic needles for single use – Part 1: Syringes for manual use (specific criteria from standard not detailed) | Confirmed that the marking tolerance meets the acceptance criteria defined in ISO 7886-1. |
| Container Closure Integrity Testing | Same method and acceptance criteria as the predicate device (not explicitly quantified) | Confirmed that the container closure integrity is identical between the subject and predicate devices. |
| Tray Lid Peel Force Testing | Acceptance criteria were met post-distribution simulation (not explicitly quantified) | Confirmed that the differences in secondary packaging do not raise different questions of safety or effectiveness. |
| Sterility Assurance Level (SAL) | ISO 17665-1, Sterilization of healthcare products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | Validation results confirmed that the Sterility Assurance Level (SAL) is identical for both devices (10-6). |
| LAL Testing | USP , Bacterial Endotoxins; USP , Transfusion and Infusion Assemblies and Similar Medical Devices (specific criteria from standards not detailed) | Confirmed that the LAL level is identical between the subject and predicate devices. LAL testing will also be performed on each lot prior to final product release. |
| Distribution and Post-Distribution Testing | D7386-16, ASTM Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems (acceptance criteria from standard not detailed) | Confirmed that package integrity is identical between the subject and predicate devices. |
| Accelerated and Post-Accelerated Aging Studies | F1980-16, ASTM Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices (acceptance criteria from standard not detailed) | Results of the testing were identical between the subject and predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each individual non-clinical performance test. It refers to "the subject device" and "the predicate device" implying that samples of each were tested.
The data provenance is from non-clinical performance testing conducted by the manufacturer, GI Supply. This is typically laboratory or bench testing. There is no mention of human subject data, retrospective, or prospective studies in a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable as this is a medical device performance study, not a study evaluating an AI/ML algorithm requiring expert ground truth for interpretation of images or other data. The "ground truth" for these tests is defined by the technical specifications of the device and relevant international standards (e.g., ISO, USP, ASTM).
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/ML study requiring adjudication of expert interpretations. The evaluation is based on objective measurements against predefined technical specifications and standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is not mentioned as this is not an AI/ML device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No. This device is a submucosal lifting agent, a physical medical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" (or basis for acceptance) for these non-clinical performance tests consists of:
- Technical specifications of the device (implying equivalence to the predicate device).
- International standards such as ISO 7886-1:2017, ISO 17665-1, USP , USP , ASTM D7386-16, and ASTM F1980-16.
- The performance of the legally marketed predicate device (K191923) as a benchmark for equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or medical "ground truth" established in this context.
§ 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.