(182 days)
The Resection Pump 2228 with Resectoscope 8659.xxx is used for endoscopically controlled tissue chip resection and removal of intrauterine polyps, intrauterine myomas or prostate adenomas via suction channel under continuous flow conditions following resection using a high-frequency electrode with a resectoscope.
The Resection Pump 2228 is used in combination with a large diameter resectoscope to suction off tissue chips by a short pulse vacuum after the removal with a high-frequency electrode. The complete procedure is done under endoscopic view and continuous flow conditions. The airflow of the control tube is interrupted when the grip of the working element is in the end position and the tissue is cut. This results in a change in pressure which triggers the resection pump to open the tube clamp valve for a short period of time. This generates a brief vacuum pressure via the secretion trap and the tissue chip is sucked off and collected in the chip fluid trap. The resection pump 2228 is software controlled. Key functions and components are automatically monitored to ensure safe operation. If there is a fault, a message is shown on the LCD display in conjunction with an acoustic signal.
The provided documents describe the Resection Pump 2228, a medical device for tissue chip resection and removal. However, the information regarding "acceptance criteria" and the "study that proves the device meets the acceptance criteria" is limited from the perspective of an AI-based device's performance metrics and clinical studies.
Based on the provided text, the device's performance is primarily established through design to standards and lack of clinical tests. The submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials to establish efficacy unique to this device.
Here's an analysis based on your requested categories, acknowledging the limitations of the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety and Effectiveness: Meets general requirements for medical devices. | "These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." (General statement, no specific metrics provided.) |
| Compliance with Standards: Designed to meet recognized medical device safety standards. | "The resection pump 2228 is designed to meet the standards IEC601-1/ UL2601-1." (Compliance with specific electrical safety standards.) |
| Functional Performance (Suction Mechanism): Ability to effectively suction tissue chips. | "The airflow of the control tube is interrupted when the grip of the working element is in the end position and the tissue is cut. This results in a change in pressure which triggers the resection pump to open the tube clamp valve for a short period of time. This generates a brief vacuum pressure via the secretion trap and the tissue chip is sucked off and collected in the chip fluid trap." (Detailed description of the mechanism, implying it functions as intended by design. No quantitative performance metrics like suction pressure, efficiency of chip removal, or percentage of successful aspirations are provided.) |
| Automated Monitoring and Safety Features: Key functions and components are monitored for safe operation. | "Key functions and components are automatically monitored to ensure safe operation. If there is a fault, a message is shown on the LCD display in conjunction with an acoustic signal." (Confirms the presence of automated monitoring and fault indication. No specific metrics on fault detection rates or response times are given.) |
| Substantial Equivalence: Device is as safe and effective as existing legally marketed predicate devices. | "The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k)-devices sold by Richard Wolf and FemRx." (Conclusion of the 510(k) review, indicating regulatory acceptance based on comparison to predicate devices, not on de novo clinical performance studies.) |
Study Proving Acceptance Criteria:
The document explicitly states: "No clinical tests performed."
The "study" proving the device meets its acceptance criteria is primarily based on technical design, adherence to recognized safety standards, and a demonstration of substantial equivalence to already legally marketed predicate devices. This is typical for a 510(k) premarket notification. The FDA's acceptance is based on the review of the submitted documentation, including product specifications, design principles, and comparison to predicates, rather than new clinical trials.
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable, as no clinical tests or specific "test sets" for performance evaluation (in the AI/clinical study sense) were performed.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical tests were performed, and thus no "ground truth" was established through expert review for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This device is not an AI-assisted diagnostic or interpretive tool, but a mechanical pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm; it's a physical pump that operates with human interaction (endoscopic view, high-frequency electrode).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of clinical performance data for this submission. The "ground truth" for the 510(k) submission is the functional and safety specifications of the device, proven by engineering design, internal testing (not detailed), and compliance with standards, establishing substantial equivalence to predicates.
8. The sample size for the training set:
- Not applicable for this type of device. There is no "training set" in the context of an AI/machine learning model.
9. How the ground truth for the training set was established:
- Not applicable for this type of 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.