(126 days)
The EVA 15 Insufflator is intended for use in diagnostic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA 15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.
The laparoscopic tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 25mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supply the pneumatic circuitry for insufflation and smoke evacuation respectively.
This document describes the 510(k) submission for the EVA15 Insufflator, emphasizing the modifications and the non-clinical testing performed to demonstrate substantial equivalence to its predicate device (K202799 - Palliare EVA15).
Here’s a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that the device met its acceptance criteria, which were the "same acceptance criteria as applied to the predicate" (K202799). However, specific numerical acceptance criteria are not detailed for all tests. The performance reported indicates successful completion of these tests.
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Pressure Range | Maximum Pressure Delivery | Up to 25 mmHg (New Indications for Use) | Device successfully delivers up to 25 mmHg pressure. |
| Non-clinical Testing | Static condition - Pressure accuracy | (Not explicitly detailed, but implied to be within acceptable limits for the predicate device) | Demonstrated that the subject device met its acceptance criteria. This performance is considered sufficient to demonstrate substantial equivalence and does not present different questions of safety or effectiveness. |
| Dynamic condition - Simulated leak | (Not explicitly detailed, but implied to be within acceptable limits for the predicate device) | Demonstrated that the subject device met its acceptance criteria. This performance is considered sufficient to demonstrate substantial equivalence and does not present different questions of safety or effectiveness. | |
| Dynamic condition - Smoke evacuation | (Not explicitly detailed, but implied to maintain cavity pressure during evacuation for the predicate device) | Demonstrated that the subject device met its acceptance criteria, including evacuating surgical smoke without loss of cavity pressure. This performance is considered sufficient to demonstrate substantial equivalence and does not present different questions of safety or effectiveness. | |
| ID Chipset Functionality | Reading chip for correct tubeset and use time | Correctly read chip to determine presence of chipset and identity of tubeset; enforce 48-hour use limit. | Software verification and validation confirmed the EVA 15 insufflator could read the connector chip correctly to determine the presence of the chipset and the identity of the tubeset, and implicitly enforce the 48-hour use limitation. |
| Safety Valve | Spring pressure relief valve performance | (Not explicitly detailed, but implied to function correctly as a safety measure) | Verification of the spring pressure relief valve performance was performed and the device met its acceptance criteria. This performance is considered sufficient to demonstrate substantial equivalence and does not present different questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of subject data (e.g., patient data for an AI algorithm). The testing described is non-clinical performance testing of the device itself (hardware and software). Therefore, specific sample sizes for a data-driven test set are not applicable here. The provenance of any data used for testing (e.g., country of origin, retrospective/prospective) is not mentioned as the testing focuses on device function.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as the document describes non-clinical performance testing of a medical device (an insufflator), not an AI algorithm that requires expert-established ground truth from images or patient data.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or mentioned. This type of study focuses on human reader performance with and without AI assistance, which is not relevant for an insufflator device.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study of the device was performed in the form of non-clinical testing (static and dynamic conditions). This is not an "algorithm only" study in the typical AI context; rather, it refers to the performance of the integrated device system. The document states: "Performance testing of the insufflator in the revised pressure range demonstrated that the subject device met its acceptance criteria... Testing included: Static condition (Pressure accuracy), Dynamic condition (Simulated leak, Smoke evacuation)."
7. Type of Ground Truth Used
The "ground truth" for this device's performance testing would be the engineering specifications and established functional requirements for insufflators. For example, pressure accuracy would be compared against a calibrated standard, and smoke evacuation effectiveness against predefined thresholds. It's not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
This information is not applicable as the device is a hardware/software system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.