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510(k) Data Aggregation
(227 days)
The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic 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 EVA15 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 25 mmHg 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 appears to be a 510(k) premarket notification summary for a medical device, the EVA15 insufflator with an AutoEvac accessory. The document describes the device, its intended use, technological characteristics, and a comparison to a predicate device, as well as non-clinical testing performed.
However, the provided text does not contain information related to an AI/ML driven device study, nor does it detail acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.
The EVA15 insufflator is a physical medical device (a laparoscopic insufflator) with a new accessory (AutoEvac) that automatically activates/deactivates smoke evacuation based on sensing surgical energy. The core technology involves gas insufflation and venturi-based smoke evacuation, not AI/ML algorithms that require complex efficacy studies based on ground truth, expert readers, or MRMC studies.
Therefore, I cannot extract the information requested in your prompt because it is not present in the provided document. The questions you've asked (e.g., sample size for test/training set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth) are typically relevant for AI/ML medical devices, especially those for diagnostic or prognostic purposes, which this device is not.
The "Non-clinical Testing" section mentions:
- "Performance testing of the insufflator has demonstrated the ability to activate and de-activate smoke evacuation when electrosurgical energy is switched on and off."
- "including testing to IEC 60601-1:2005/AMD1:2012 / AMD 2:2020 (Edition 3.2) - Medical Electrical Equipment - Part 1: General Requirements For Safety"
- "and IEC 60601-1-2:2014 / A1:2020 (Edition 4.1) – Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests."
These are standard electrical safety and EMC (Electromagnetic Compatibility) tests for medical devices, which are functional performance tests, not AI/ML model validation studies.
In summary, the provided text describes a traditional medical device modification for which the acceptance criteria and study described in your prompt are not applicable.
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(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.
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(28 days)
The EVA15 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 15 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.
There are 3 operating modes:
- (a) Continuous Flow (similar to a traditional endoscopic insufflator) delivers a fixed flow between 0 and 15 standard liters per minute (SLPM)
- (b) Intermittent Pressure Insufflation (similar to traditional laparoscopic insufflation) a pressure is targeted, but the flow delivered in targeting that pressure is limited to 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
- (c) Continuous Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is limited to 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).
The 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 15mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supplies to supply the pneumatic circuitry for insufflation and smoke evacuation respectively.
The provided text is a 510(k) summary for the EVA15 Insufflator. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria, especially in an AI/software context.
This document is for a medical device (insufflator), not an AI/software device. The regulatory filings for traditional medical devices like this typically focus on demonstrating substantial equivalence to a predicate device through engineering specifications, performance testing (often physical and bench testing), and adherence to recognized standards, rather than clinical studies with human readers or AI performance metrics.
Therefore, I cannot extract the requested information in the format provided because it is not present in the document. The document explicitly states:
- "As the subject device is identical in design to the predicate, performance data from the predicate device were leveraged to support the performance of the subject device." This indicates that no new performance study was conducted for this specific 510(k) submission, as the design is unchanged from the predicate.
- The comparison table focuses on physical characteristics, operating modes, and basic performance parameters (flow, pressure range), not on metrics like sensitivity, specificity, or reader improvement with AI.
In summary, the provided text does not contain any information relevant to acceptance criteria and studies for an AI/software device. This type of document would not typically include the details requested in your prompt.
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