(44 days)
The ConMed AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke.
It is indicated for use in abdominal, thoracic, and pediatric (≥ 20kg) procedures where insufflation is desired to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis, and treatment. The trocar of the AirSeal®iFS System is indicated for use with or without visualization.
The ConMed AirSeal iFS System consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a microprocessor-controlled insufflation, recirculation and filtration unit. The cannula, trocar and tube sets are sterile, single-use products. The AirSeal iFS System is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity. The AirSeal iFS System is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode (Adult and Pediatric); or (c) Smoke Evacuation Mode.
The provided text describes the 510(k) summary for the ConMed AirSeal iFS System, which is a medical device intended for insufflation during endoscopic procedures. While it details performance testing, it does not explicitly state acceptance criteria in the form of thresholds or goals. Instead, the performance testing section focuses on demonstrating substantial equivalence to predicate devices through comparisons of measured parameters.
Therefore, I cannot provide a table of acceptance criteria and reported device performance as requested, because specific acceptance criteria values are not present in the document. The document describes what was measured and how it was compared to predicate devices, but not the quantitative criteria for acceptance.
However, I can extract the available information regarding the study that demonstrates the device meets its performance goals, based on the provided text:
Study Details for ConMed AirSeal iFS System (K190303)
The study described is a benchtop performance testing comparison study, demonstrating substantial equivalence to predicate devices. It involved utilizing an abdominal and thoracic pediatric (≥ 20kg) test model.
This section does not contain information about the following:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set (as this is a benchtop study, not an AI/ML algorithm that typically uses a training set).
- How the ground truth for the training set was established.
Benchtop Performance Testing Conducted:
| Performance Area | Measurement | Comparison Method |
|---|---|---|
| Set Pressure | Obtain pressure readings using an insufflation gas flow of 2LPM and 5LPM at set pressure points from 5 – 12mmHg. | Average pressure deviation from set pressure (compared to predicate devices). |
| Initial Insufflation | Obtain pressure readings at an insufflation gas flow of 20LPM with set pressure points at 5, 10, and 15mmHg. | Average of maximum pressures and deviation of average maximum pressure from set pressure (compared to predicate devices). |
| Obturator Removal | Obtain pressure readings at an insufflation gas flow of 10LPM and a set pressure of 12mmHg after removal of a 5mm and 12mm obturator. | Average pressure drop at removal and average pressure overshoot (system compensation) (compared to predicate devices). |
| Instrument Insertion | Obtain pressure readings at an insufflation gas flow of 10LPM and a set pressure of 12mmHg after insertion, manipulation, and removal of a test rod representing 5mm and 12mm instruments. | Average pressure drop at removal and average pressure overshoot (system compensation) (compared to predicate devices). |
| Leak Compensation | Obtain pressure readings at an insufflation gas flow of 20LPM and set pressures of 5mmHg and 12mmHg with introduced leak rates from 0-10LPM. | Average pressure deviation from set pressure (compared to predicate devices). |
In addition to the above, Design verification testing was performed to demonstrate compliance with applicable sections of AAM/ANSI ES60601-1 and IEC 60601-1-2. Software and system verification test results were evaluated for:
- Pressure and flow settings, display, increments.
- System response at various insufflation conditions.
- GUI settings and responses for various insufflation modes.
- System recognition and interaction with accessories.
Ground Truth (for Benchtop Testing):
The "ground truth" in this context refers to the expected physical measurements and operational parameters based on standard engineering principles and the performance of established predicate devices. For instance, "set pressure" is the defined target pressure, and "pressure deviation" is measured against this target.
Standalone Performance (Algorithm Only):
Yes, a form of standalone performance was done for the device itself. The entire performance testing outlined above aims to characterize the device's intrinsic mechanical and software-controlled performance without explicit human intervention (beyond setting initial parameters in the benchtop environment). The device operates based on its internal algorithms and controls to maintain specified pressure, compensate for leaks, and manage flow.
Conclusion stated by ConMed:
Analyses of these activities conclude the benefits associated with the use of the AirSeal iFS System outweigh the residual risks. The subject AirSeal iFS System is safe and effective for its intended use and is substantially equivalent in design, intended use, principles of operation, and technical characteristics to the Stryker PneumoSure and predicate AirSeal iFS System.
§ 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.