(197 days)
The 45L CORE Insufflator F114 is a CO2 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application, the low flow application and the bariatric application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F114 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.
The 45L CORE Insufflator F114 is a microprocessor controlled CO2 insufflator designed with a high flow application, a low flow application, a bariatric application and a vessel harvesting application. The device incorporates the following major components and features: a casing, a world power supply, pressure reducers, a venting system, a fluid sensor, a gas heater and various setting symbols and display elements. The device is equipped with a continuous pressure measurement mode and redundant discontinuos pressure measurement mode that controls the conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. In addition, a software controlled active pressure reduction ensures that the preset nominal pressure value conforms to the actual pressure that is measured in the cavity. Finally, the 45L CORE Insufflator F114 is designed with several alarms to inform the operator in case of an overpressure. The device is to be used with specially designed single-use tubing sets.
The 45L CORE Insufflator F114 is a medical device used for laparoscopic and endoscopic procedures. The information provided outlines its substantial equivalence to predicate devices rather than a detailed study with specific acceptance criteria and performance data in a tabular format. However, based on the text, we can infer the aspects that were evaluated for substantial equivalence.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with numerical performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices (40 L High Flow Insufflator F113, HI-FLO Therme Pneu 45, Stryker Heated Insufflator Tube Set, Surgiflator 20). The "acceptance criteria" are implied to be that the new device does not raise new questions of safety and effectiveness compared to these predicates, and that its performance is equivalent or similar enough not to warrant additional concerns.
From the text, we can glean the following comparisons and performance claims:
| Acceptance Criteria (Implied) | Reported Device Performance (F114) |
|---|---|
| Overall Safety & Effectiveness | Substantially equivalent to predicate devices (F113, HI-FLO, Stryker/Surgiflator tube sets) and does not raise new questions of safety and effectiveness. |
| Functionality as CO2 Insufflator | Intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. Functions for high flow, low flow, bariatric, and vessel harvesting applications. |
| Peritoneal Cavity Distention | Effectively facilitates the use of a laparoscope by filling the peritoneal cavity with gas to distend it. |
| Pediatric Use (Low Flow) | Indicated for pediatric use. |
| Vessel Harvesting Application | Creates a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures. |
| Bariatric Mode Performance | Similar to the existing High Flow Mode of the F113 and identical with regard to the maximum flow performance to the High Flow Mode of the HI-FLO. Performance testing of the bariatric mode demonstrates no new questions of safety or effectiveness. |
| Maximum Gas Supply Pressure | Bariatric Mode: 70 mmHg. High Flow Mode: 65 mmHg. Veress Mode: 60 mmHg. These increases in pressure do not raise new questions of safety and effectiveness. |
| Pressure Measurement and Control | Equipped with continuous pressure measurement mode and redundant discontinuous pressure measurement mode. Software-controlled active pressure reduction ensures preset nominal pressure conforms to actual pressure in the cavity. Continuous pressure measurement in different modes demonstrates no new questions of safety or effectiveness. |
| Alarms | Several alarms to inform the operator in case of overpressure. |
| Tube Set Compatibility & Performance | To be used with specially designed single-use tubing sets. Proposed tube sets are substantially equivalent to Stryker Heated Insufflator Tube Set and Surgiflator 20's heatable tube sets. Major difference (connector design for combined connection of insufflation, pressure measurement, and heating) does not raise new safety/effectiveness questions. Technical characteristics are equivalent. |
| Sterilization (Tube Sets) | Sterilized according to EN 550, Method C (Ethylene Oxide). Residual ethylene oxide limit (250 ppm) not exceeded. Sterility assurance level (SAL) of ≤ 10-6 achieved (in accordance with DIN EN 14698-1 and EN1174, Part 1-3). |
| Biocompatibility (Tube Sets) | Components in short-term indirect contact with patient made of materials identical to predicate devices. Materials are well-characterized chemically and physically in published literature and have a long history of safe use regarding biocompatibility. |
| General Controls Compliance (Implied by FDA review acceptance) | Device subject to general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. (This is a regulatory requirement, not a performance criterion in the same vein as those above, but it's an "acceptance criterion" for market clearance). |
2. Sample size used for the test set and the data provenance
The document states "Bench testing demonstrates the safety and effectiveness of the F114." It does not provide specific details on the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). Typically, "bench testing" would imply laboratory-based tests on manufactured units, rather than human, animal, or clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. Given that the submission focuses on substantial equivalence via bench testing and comparison to predicate devices, there's no mention of a ground truth established by experts in the context of clinical performance or diagnostic accuracy.
4. Adjudication method for the test set
This information is not provided. As above, for bench testing, an adjudication method for ground truth (which is relevant for perceptual or diagnostic tasks) would typically not be 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
There is no mention of an MRMC study. This device is an insufflator, a mechanical device, not an imaging analysis or AI-driven diagnostic tool. Therefore, human reader improvement with or without AI assistance is not relevant to its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to an insufflator device. It is a piece of medical equipment used by a human operator, not an algorithm that performs a task autonomously.
7. The type of ground truth used
For the performance assessment, the "ground truth" implicitly refers to engineering specifications, regulatory standards (e.g., ISO, EN), and the established performance of the predicate devices. For example, for sterilization, the ground truth is a specific sterility assurance level (SAL) and residual gas limits. For pressure output, the ground truth would be the specified pressure ranges and stability. It's based on objective, measurable physical parameters.
8. The sample size for the training set
This information is not provided and is not applicable in the context of a purely hardware device like an insufflator. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons mentioned above.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.