(139 days)
The ERBELIFT Hand Pump in conjunction with an ERBELIFT Flexible Probe is indicated for the induction of sterile normal saline into the submucosa to lift polyps or other mucosal lesions using direct visualization through a flexible endoscope.
The ERBELIFT™ Hand Pump and Flexible Probe are used for the delivery of pressurized sterile normal saline to the submucosa to lift polyps or other mucosal lesions. A control syringe is filled with sterile normal saline. The filled syringe is attached to the Flexible Probe via a hub with a standard luer lock and loaded into the Hand Pump. The Flexible Probe is primed with the saline and then the distal end of the Probe is placed down the working channel of the endoscope. Under direct visualization, the Probe's tip is placed against the target tissue without puncturing the mucosa. Then, the trigger of the Hand Pump is squeezed to produce the pressurized saline from the control syringe and through the Probe into the bed of the polyp or lesion to achieve a desired tissue lift.
The Hand Pump is made of nylon and stainless steel. It is 8-3/4" (22 cm) long, 6" (15 cm) wide, and having a thickness of 2-1/2" (6 cm). The Pump per squeeze of the handle delivers approximately 0.75 ml of normal saline. The Flexible Probe is made of Polyetheretherketone (PEEK) and nylon (Note: Medical grade inks and reducer are used to imprint logos on the device.). It has a 1.3 mm Outer Diameter and length of 260 cm. The distal tip is tapered to approximately 0.005" and delivers a jet stream of 120 um. The Hand Pump with the Flexible Probe can generate pressures in the approximate range of 145 to 650 psi which correlates to flow rates of 17 to 38 ml/minute.
The Hand Pump is reusable with the Flexible Probe being provided as sterile and single use.
The provided 510(k) summary for the Byrne Medical Incorporated ERBELIFT™ Hand Pump and Flexible Probe does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance with quantitative metrics. The document focuses on demonstrating substantial equivalence to predicate devices through similarities in intended use, materials, and form, and briefly mentions functional bench and animal lab testing. However, it does not provide specific acceptance criteria or performance metrics from these tests.
Therefore, the following sections will indicate where the information is not available in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document states that "Functional bench and animal lab testing has demonstrated that the ERBELIFT Hand Pump and Flexible Probe lifts the submucosa safely and effectively," but it does not provide specific acceptance criteria or quantitative performance results for these tests. Therefore, this table cannot be fully completed from the given text.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Pressure Range (Hand Pump) | Not explicitly stated as acceptance criteria, but described as a characteristic | Approximately 145 to 650 psi |
| Flow Rate (Hand Pump) | Not explicitly stated as acceptance criteria, but described as a characteristic | 17 to 38 ml/minute |
| Volume per squeeze (Hand Pump) | Not explicitly stated as acceptance criteria, but described as a characteristic | Approximately 0.75 ml |
| Delivery method to submucosa | Safe and effective lifting of submucosa | Demonstrated in functional bench and animal lab testing |
| Tissue trauma | Demonstrate less penetration tissue damage compared to predicates | Smaller diameter and fluid stream with no mechanical needle injection causes less penetration tissue damage. Easier to find tissue plane and create a lift. |
| Biocompatibility | ||
| Probe materials biocompatibility | Demonstrate biocompatibility of specific materials | Demonstrated for the specific materials of the Flexible Probe (due to slight differences from predicates) |
| Sterilization | ||
| Sterility (Flexible Probe) | Sterile | Provided as sterile (Ethylene Oxide) |
| Material/Design Characteristics | ||
| Outer Diameter (Flexible Probe) | Not explicitly stated as acceptance criteria, but described as a characteristic | 1.3 mm |
| Length (Flexible Probe) | Not explicitly stated as acceptance criteria, but described as a characteristic | 260 cm |
| Distal tip taper (Flexible Probe) | Not explicitly stated as acceptance criteria, but described as a characteristic | Approximately 0.005" |
| Jet stream size (Flexible Probe) | Not explicitly stated as acceptance criteria, but described as a characteristic | 120 um |
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 for Test Set: Not specified in the provided document. The document mentions "Functional bench and animal lab testing" but does not give details on the number of samples, animals, or tests conducted.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.
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 available in the provided 510(k) summary. The document mentions "Functional bench and animal lab testing" but does not detail how ground truth or performance assessment was established, nor does it refer to human expert involvement in establishing ground truth for the device's functional performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not available in the provided 510(k) summary. Given that the testing mentioned is "functional bench and animal lab testing" for a medical device's physical performance, an adjudication method for human interpretation is unlikely to be applicable or described here.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The ERBELIFT™ Hand Pump and Flexible Probe is a physical medical device for injecting saline, not an AI-powered diagnostic or interpretive tool. Therefore, a study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, standalone algorithm performance testing is not applicable as this device is a physical medical instrument, not a software algorithm. The device's operation involves a human user (endoscopist) directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The term "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For this physical device, the "truth" would be objective measurements and observations from the "Functional bench and animal lab testing." This would likely involve:
- Bench Testing: Direct physical measurements (e.g., pressure, flow rate, volume delivered, jet stream characteristics) and visual inspection of fluid delivery.
- Animal Lab Testing: Direct visualization of submucosal lift, potentially histological analysis of tissue for damage, and observation of overall safety and effectiveness in an in-vivo model.
- The document implies that the "truth" for safety and effectiveness was derived from these direct experimental observations rather than expert consensus on interpretation of data.
8. The sample size for the training set
- Not applicable / Not available. The ERBELIFT™ Hand Pump and Flexible Probe is a physical medical device, not a machine learning model, so there is no "training set" in the context of data used for algorithm development. The development process would have involved design, prototyping, and testing, but not training data for an algorithm.
9. How the ground truth for the training set was established
- Not applicable / Not available. As explained in item 8, there is no "training set" for this physical medical device.
§ 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.