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510(k) Data Aggregation
(41 days)
EverLift Submucosal Lifting Agent
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.
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(338 days)
EverLift Submucosal Lifting Agent
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 is a prefilled plastic syringe with attached plunger rod containing 5mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available, endoscopic injection needle.
The EverLift™ Submucosal Lifting Agent is an injectable liquid 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 laver, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD or polypectomy).
The provided document is a 510(k) premarket notification for the EverLift Submucosal Lifting Agent, describing its substantial equivalence to a predicate device. It details non-clinical performance testing but does not include information about AI/ML device performance or clinical studies involving human readers or AI assistance. Therefore, I cannot fulfill all parts of your request related to AI/ML device acceptance criteria and studies.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document speaks to "functional and performance requirements" and various "functional performance tests" but does not explicitly list quantified acceptance criteria with corresponding performance metrics in a clear table format that would be typical for an AI/ML device. Instead, it states that tests were conducted to "demonstrate substantial equivalence."
Acceptance Criteria and Reported Device Performance (as inferred and specified in the document):
| Acceptance Criteria Category | Specific Criterion (Inferred from testing mention) | Reported Device Performance (Summary from text) |
|---|---|---|
| Functional Performance | Container Closure Integrity | Testing performed. Conclusion: "device meets its functional and performance requirements." |
| Syringe Tip Cap Removal Force | Testing performed. Conclusion: "device meets its functional and performance requirements." | |
| Tube Cap Removal Force | Testing performed. Conclusion: "device meets its functional and performance requirements." | |
| pH Testing | Testing performed. Conclusion: "device meets its functional and performance requirements." | |
| Product Color Evaluation | Testing performed. Conclusion: "device meets its functional and performance requirements." | |
| Lift Duration Testing | Testing performed. Conclusion: "device meets its functional and performance requirements." | |
| Flow Rate Testing | Testing performed. Conclusion: "device meets its functional and performance requirements." | |
| Comparative Bench Testing | Viscosity (vs. predicate) | Comparative bench testing conducted against predicate (Eleview® K150852). Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." Implicitly, viscosity was within acceptable comparative range. |
| Osmolality (vs. predicate) | Comparative bench testing conducted against predicate (Eleview® K150852). Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." Implicitly, osmolality was within acceptable comparative range. | |
| Density (vs. predicate) | Comparative bench testing conducted against predicate (Eleview® K150852). Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." Implicitly, density was within acceptable comparative range. | |
| Preclinical (Animal) Study | Performance in Porcine Model (vs. predicate) | Preclinical testing in a porcine model conducted against predicate (Eleview® K150852). Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." Implicitly, performance in the porcine model was comparable. |
| Biocompatibility | Meets ISO 10993-1 requirements | Biocompatibility testing conducted in accordance with ISO 10993-1. Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." This indicates successful biocompatibility. |
| Sterility & Endotoxin | Bacterial Endotoxin and Pyrogen Testing | Testing performed. Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." This indicates satisfactory results. |
| Chemical Characterization Testing | Testing performed. Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." This indicates satisfactory results. | |
| Shelf Life | Maintain physical/functional requirements for 2 years | An accelerated aging study was performed to confirm that the device meets "all physical and functional requirements throughout a 2-Year Shelf Life." |
| Risk Management | Risks adequately mitigated | Developed under GI Supply's risk management process in accordance with ISO 14971:2007. "The identified risks were adequately mitigated and verified by means of non-clinical performance testing." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "a series of functional performance tests, animal studies, biocompatibility tests, and sterility tests" but does not provide specific sample sizes (e.g., number of devices tested, number of animals in the preclinical study).
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's a non-AI/ML device based on physical/chemical properties and animal studies, "retrospective/prospective" in the context of clinical data isn't directly applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not provided as this is a medical device for submucosal lifting, not an AI/ML diagnostic or image analysis device requiring expert ground truth for image interpretation. The ground truth for this device's performance is based on physical/chemical measurements and in-vivo effects in animal models.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided as this relates to expert review and consensus for imaging or diagnostic studies, which is not relevant to this device's 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
This information is not applicable and not provided. The device is not an AI/ML algorithm that assists human readers. It is a physical agent used in endoscopic procedures.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established through:
- Direct physical and chemical measurements (e.g., pH, viscosity, osmolality, density, flow rate).
- Direct observation of physical effects and safety in an in vitro (container integrity) and ex vivo / in vivo (porcine model for lift duration and performance) setting.
- Results from standardized biocompatibility, sterility, and aging tests.
This is not based on expert consensus, pathology, or outcomes data in the typical sense of AI/ML diagnostic evaluation.
8. The sample size for the training set
This information is not applicable and not provided as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided as this is not an AI/ML device that requires a training set.
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