(38 days)
The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.
The SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor controlled insufflation, recirculation and filtration unit (the "DPIS 2000 Unit"). The cannula, trocar and tube sets are sterile, single-use products. The DPIS 2000 Unit is non-sterile and reusable. The subject device of this filing is a modification to the original filing. The modification is to allow the operation of two trocars simultaneously, one AirSeal trocar and one conventional trocar. The predicate filing was a modification to allow the simultaneous operation of two AirSeal* trocars.
Here's a summary of the acceptance criteria and study information for K132169, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes general functionalities that the device's testing aimed to demonstrate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to create and maintain a port of entry. | The device was tested to show its ability to create and maintain a port of entry during simulated laparoscopic surgery. |
| Ability to maintain adequate pneumoperitoneum. | The device was tested to show its ability to maintain adequate pneumoperitoneum during the course of laparoscopic surgery. |
| Ability to aid in the evacuation of smoke. | The device was tested to show its ability to aid in the evacuation of smoke. |
| Sterility of reusable devices. | Sterility validation was done in accordance with ISO 11137:2006 and AAMI TIR 27:2001, achieving a Sterility Assurance Level (SAL) of 10⁻⁶. |
| Operation of two trocars simultaneously (one AirSeal, one conventional). | The subject device is a modification to allow simultaneous operation of one AirSeal trocar and one conventional trocar (the predicate filing allowed two AirSeal trocars). Testing would have validated this. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text refers to "Engineering Test summaries" but does not provide details on the number of units or test runs.
- Data Provenance: The tests are described as "Engineering Tests." It's highly probable these were conducted internally by SurgiQuest, Inc. in the US (Milford, CT is their location). The data is prospective in nature, as it involves active testing of the device's performance.
3. Number of Experts and Qualifications for Ground Truth of Test Set
Not applicable. The tests described are engineering performance tests, not clinical studies requiring expert interpretation of medical data.
4. Adjudication Method for Test Set
Not applicable, as this was an engineering performance study, not a clinical study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This submission concerns an insufflator and trocar system, and the studies mentioned are engineering performance tests, not studies analyzing human reader performance with medical images.
6. Standalone Performance Study
Yes, the studies described ("Engineering Test 0627131045 01" and "Engineering Test 0627131059 01") are standalone performance studies. They assess the device's technical capabilities (e.g., smoke evacuation, CO2 consumption) directly.
7. Type of Ground Truth Used
The ground truth for these engineering tests would be derived from:
- Measured physical parameters: Data obtained from sensors and instruments measuring aspects like gas flow, pressure, CO2 consumption, and smoke evacuation rates during simulated procedures.
- Engineering specifications and standards: Adherence to established performance parameters as defined by internal design specifications and relevant industry standards (e.g., ISO for sterility).
8. Sample Size for Training Set
Not applicable. This is an engineering device, not an AI/machine learning algorithm that requires a training set of data.
9. How Ground Truth for Training Set Was Established
Not applicable.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.