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510(k) Data Aggregation
(61 days)
The device PNEUMOCLEAR™ is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimal invasive surgery.
The PNEUMOCLEAR™ is a microprocessor controlled CO2 insufflator that consists of the following major components and features: (1) a casing, (2) a world power supply, (3) pressure reducers, (4) pressure sensors, (4) venting systems, (5) various safety valves. (6) a suction pump. (7) a fluid sensor and (8) a software controlled graphical user interface (GUI) touch screen with various setting keys and display elements. The proposed device offers six operating modes (i.e. Standard, High Flow/Bariatric, Pediatric, Advanced Flow, Vessel Harvest, and TAMIS. The PNEUMOCLEAR™is not intended to enter the sterile field, and cannot be sterilized. It is to be used with specially designed single-use insufflation tube sets that are delivered sterile. Specifically, five different tube sets may be used with the proposed device: (1) insufflation tube set with integrated filter, (2) insufflation tube set with integrated filter and heating wire; (3) insufflation tube set with integrated filter, heating wire and humidification media; (4) insufflation and smoke evacuation tube set with integrated filter, heating wire, and humidification media; and insufflation and smoke evacuation tube set with integrated filter. When used with a smoke evacuation tube set the PNEUMOCLEAR™ allows for removal and filtration of CO2 and surgical smoke from the abdomen, rectum or colon during laparoscopic and transanal minimally invasive procedures and at the end of a procedure.
The PNEUMOCLEAR™ device is a CO2 insufflator for endoscopic procedures. The information provided outlines several performance tests but does not present a formal table of acceptance criteria with reported device performance or extensive details on study design as typically found in clinical trials for AI/ML devices.
However, based on the provided text, we can infer some "acceptance criteria" through the comparisons made against predicate devices and adherence to relevant standards. The "study" refers to a series of bench tests, electrical safety and electromagnetic compatibility testing, software verification and validation, biocompatibility testing, and sterilization and package testing.
Here's an attempt to structure the information as requested, with caveats regarding the absence of explicit acceptance criteria and detailed study parameters for each test:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Electrical Safety & EMC | Conformance to IEC 60601-1 and IEC 60601-1-2 standards. | "Test results demonstrate that the proposed device conforms to the below standards: IEC 60601-1 2005/(R)2012 and A1:2012. C1:2009/(R)2012 andA2:2010/(R)2012 (consolidated text); and IEC 60601-1-2 Third Edition: 2007-03." |
| Software | Device performs as intended, developed, tested, and verified according to FDA guidance and IEC 62304. | "Software verification and validation testing of the PNEUMOCLEAR™ demonstrates that the device performs as intended. It was developed, tested and verified in accordance with the above FDA guidance document and in accordance with the following standard: IEC 62304 First Edition 2006-05." |
| Biocompatibility | Conformance to AAMI/ANSI/ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 standards for insufflation tube sets. | "Biocompatibility testing was performed on the insufflation tube sets of the proposed device PNEOMOCLEAR™ in accordance with: AAMI/ANSI/ISO 10993-1 Fourth Edition 2009-10-15; ISO 10993-5: 2009 (R) 2014; ISO 10993-10 Third Edition 2010-08-01; and ISO 10993-11 Second Edition 2006-08-15." |
| Sterilization & Packaging | ETO sterilization validation per ISO 11135-1, ISO 14937, ISO 10993-7, AAMI TIR 28. Residual EO < 4mg, ECH < 5mg (4 days aeration). Sterility Assurance Level (SAL) < 10^-6. Package and product integrity per ISO 11607-1, ASTM-F-1980. | "ETO sterilization validation for the sterile single use tube sets was performed in accordance with the below standards: ISO 11135-1 Second Edition 2014; ISO 14937 Second Edition 2009-10-15; ISO 10993-7 Second Edition 2008-10-15; and AAMI TIR 28 2009/(R)2013. Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO < 4 mg and ECH < 5 mg after 4 days of aeration (gas release) that remains on the tube set will not be exceeded. A sterility assurance level (SAL) < 10^-6 is achieved. Package and product integrity of the tube sets were tested in accordance with the following standards: ISO 11607-1 First Edition 2006-04-15; and ASTM-F-1980: 2002." |
| Bench Testing - Pressure Regulation (High Flow/Bariatric vs. Predicate Standard) | Substantially equivalent pressure regulation to predicate device (Insufflator 50L FM134) in Standard Operating Mode. | Comparative bench testing performed to demonstrate substantial equivalence. |
| Bench Testing - Pressure Regulation (High Flow/Bariatric vs. Predicate Bariatric) | Substantially equivalent pressure regulation to predicate device (Insufflator 50L FM134) in Bariatric Operating Mode. | Comparative bench testing performed to demonstrate substantial equivalence. |
| Bench Testing - Advanced Flow vs. Predicate Bariatric | Substantially equivalent performance to predicate device (Insufflator 50L FM134) in Bariatric Operating Mode. | Comparative bench testing performed to demonstrate substantial equivalence. |
| Bench Testing - Steady Control Feature (Advanced Flow) | Safety and effectiveness of the Steady Control Feature demonstrated, preventing abdominal pressure rise above set value. | Bench testing performed demonstrating safety and effectiveness, including plausibility checks for flow and pressure. |
| Bench Testing - Advanced Flow Leakage Compensation | Substantial equivalence in large leakage compensation and abdominal pressure maintenance with Steady Control Feature active, compared to predicate Bariatric mode. | Comparative bench testing performed. |
| Bench Testing - TAMIS Mode Pressure Regulation | Substantially equivalent pressure regulation to predicate device (SurgiQuest AirSeal iFS System) with and without smoke evacuation activation. | Comparative bench testing performed. |
| Bench Testing - Stryker SDC3 HD Control | Effectiveness in controlling PNEUMOCLEAR™ and remotely displaying device settings/warnings. | Bench testing performed demonstrating effectiveness. |
| Bench Testing - RFID Tube Set Recognition | Effectiveness of RFID transponder technology for tube set recognition. | Bench testing performed demonstrating effectiveness. |
| Bench Testing - Smoke Evacuation Performance | Comparative performance of smoke evacuation function to reference device (Olympus High Flow Insufflation Unit UHI-4). | Comparative bench testing performed. |
| Bench Testing - Desufflation Function | Safety and effectiveness of the desufflation function. | Bench testing performed demonstrating safety and effectiveness. |
| Bench Testing - Insufflation Tube Set (ST296 vs. Predicate ST260) | Comparative performance of tube set with integrated filter and heating wire (ST296) to predicate tube set (ST260) in terms of safety and effectiveness. | Comparative bench testing performed. |
| Bench Testing - Insufflation Tube Set (ST297 vs. Reference Insuflow) | Comparative performance of tube set with integrated filter, heating wire, and humidification material (ST297) to reference device (Insuflow). | Comparative bench testing performed. |
2. Sample Sizes Used for the Test Set and Data Provenance
- The document does not specify sample sizes for any of the bench tests, electrical safety, software, biocompatibility, or sterilization tests.
- The data provenance is not explicitly stated as country of origin, retrospective or prospective. However, the tests are stated to have been performed by "independent laboratories" implying these are controlled laboratory tests rather than clinical studies. Given the context of a 510(k) submission, these would be prospective testing protocols executed to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable in the context of this device and the provided document. The PNEUMOCLEAR™ is a hardware-based insufflator, not an AI/imaging device requiring expert interpretation for ground truth establishment. The "ground truth" for its performance is determined by objective physical measurements (e.g., pressure, flow, electrical parameters) and adherence to engineering standards.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially for diagnostic devices where subjective interpretation is involved. The performance of this device is assessed through objective, quantifiable measurements against design specifications and predicate device performance.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists interpreting images) to assess the impact of AI assistance on reader performance. The PNEUMOCLEAR™ is a therapeutic/procedural device, not a diagnostic one of this nature. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Beyond the software verification and validation, which assesses the algorithm's functionality, a standalone study in the context of an AI-driven diagnostic device (e.g., measuring algorithm-only performance metrics like AUC, sensitivity, specificity on a dataset) was not performed or described. The device's "algorithms" primarily refer to its control logic (e.g., for pressure regulation, "Intelligent Steady Insufflation" in Advanced Flow mode), which are evaluated through the various bench tests demonstrating the device's functional performance in a simulated environment.
7. The Type of Ground Truth Used
- The "ground truth" for the PNEUMOCLEAR™ device is based on objective physical measurements (e.g., pressure, flow rates, electrical parameters, chemical residuals, sterility levels) and adherence to established international and national standards (IEC, ISO, AAMI, ASTM). For comparative bench testing, the performance of the predicate devices under identical conditions serves as a benchmark for "substantial equivalence."
8. The Sample Size for the Training Set
- This information is not applicable. The PNEUMOCLEAR™ is a deterministic device, not an AI/ML device that typically requires a 'training set' for machine learning models. Its control logic and performance characteristics are based on engineering design and calibration, not learned from data. The software described is for controlling the device, not for making predictions or classifications based on a large dataset.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no "training set" in the context of this device.
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