(88 days)
The device Insufflator 50L FM134 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, Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.
The Insufflator 50L FM134 is a microprocessor controlled CO2 insufflator that consists of the following major components and features: a casing, a world power supply, pressure reducers, a venting system, redundant pressure measurement, a fluid sensor, a gas heater, a software controlled graphical user interface (GUI) touch screen and various setting keys and display elements. The Insufflator 50L FM134 is not intended to enter the sterile field, and cannot be sterilized. The device is to be used with specially designed single-use tube sets that are delivered sterile. Specifically, the proposed device is to be used with a single-use tube set with heating wire and integrated filter or with a single-use tube set with integrated filter but without heating wire.
The provided text describes the 510(k) premarket notification for the Insufflator 50L FM134. However, it does not detail specific acceptance criteria or an overarching study proving the device meets acceptance criteria in the way one might expect for a diagnostic or prognostic AI/ML device (e.g., sensitivity, specificity, AUC thresholds).
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "acceptance criteria" can be inferred from the standards and comparisons performed.
Here's a breakdown based on the provided text, addressing the points where information is available and noting where it is not:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a medical device (CO2 insufflator) and not an AI/ML diagnostic, the acceptance criteria are not in terms of traditional metrics like sensitivity/specificity but rather compliance with safety, performance, and biocompatibility standards, and comparability to predicate devices.
| Acceptance Criterion (Inferred from tests performed) | Reported Device Performance (Summary from study) |
|---|---|
| Electrical Safety (IEC 60601-1:2005) | - Conforms to the standard. |
| Electromagnetic Compatibility (IEC 60601-1-2:2007) | - Conforms to the standard. |
| Software Development & Verification | - Developed, tested, and verified in accordance with "Software Contained in Medical Devices" guidance and IEC 62304:2006. - Design verification demonstrates the device performs as intended and does not raise new questions of safety and effectiveness. |
| Comparative Bench Testing (vs. 45L Core Insufflator F114) | - Reaching set pressure: Comparable to predicate. - Compensation of small and large leakages: Comparable to predicate. - Overpressure scenarios: Comparable to predicate. - Maximum flow rate (50 l/min vs. 45 l/min): Leads on average to a slightly better insufflation performance compared to the predicate device 45L Core Insufflator. Also substantially equivalent to Nebulae™ I 50 LPM Insufflator for this characteristic. |
| Biocompatibility (ISO 10993 series) | - Cytotoxicity: Conforms to ISO 10993-5:2009. - Irritation and Skin Sensitization: Conforms to ISO 10993-10:2010. - Systemic Toxicity: Conforms to ISO 10993-11:2006. - Chemical Characterization (for heated tube set): Conforms to ISO 10993 - 18:2005. |
| ETO Sterilization Validation (Tube Sets) | - EO & ECH Residuals: Limit of EO |
§ 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.