(30 days)
Insuflow Synergy™ Port (5 mm) and Insylow® Synergy™ XL Port (8 mm, 10mm and 12mm) have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.
The Insuflow® Synergy™ and Insuflow® Synergy™ XL Port devices are gas conditioning devices that attach to the outlet port of an insufflator or other regulated CO2 source and are design and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow® Synergy™ XL Port consist of a sterile, disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the system.
The Insuflow® Synergy™ and Synergy™ XL Port devices and their modifications involve design changes to existing gas conditioning and path of entry devices used in minimally invasive surgery.
Here's an analysis of the acceptance criteria and study information provided:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with specific performance metrics. Instead, the "acceptance criteria" are implied by demonstrating that the modified devices perform in accordance with specifications and applicable standards, and are "substantially equivalent" to predicate devices. The performance testing focuses on ensuring that the changes do not negatively impact the established functionalities of the original devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Gas Conditioning Functionality (Temperature and Humidity) | The document states: "All of the modified devices utilize the same exact design/parts as the predicates for gas conditioning and sealing. As a result, the existing testing for gas temperature and humidity characterization and seal leak integrity testing previously submitted applies directly to these devices." This implies the modified devices meet the same performance as the predicate devices for gas temperature and humidity. No specific quantifiable metrics are provided in this summary, but it's asserted that prior testing for the predicates covers these aspects. |
| Seal Leak Integrity | Similar to gas conditioning, the document states: "All of the modified devices utilize the same exact design/parts as the predicates for gas conditioning and sealing. As a result, the existing testing for gas temperature and humidity characterization and seal leak integrity testing previously submitted applies directly to these devices." This indicates the modified devices maintain the same seal leak integrity as the predicate devices. No specific quantifiable metrics are provided here. |
| Flow/Pressure Performance | The document states: "Since the lumen designs were changing, flow/pressure performance and insertion/removal testing were repeated and successfully completed for the modified Insuflow® Synergy™ (5 mm) and Synergy™ XL (8 mm,10 mm and 12 mm) Port dual lumen models." While no specific pass/fail criteria or measurements are provided, the claim is that they were "successfully completed," implying they met the required performance for the new lumen designs. |
| Insertion/Removal Performance | The document states: "Since the lumen designs were changing, flow/pressure performance and insertion/removal testing were repeated and successfully completed for the modified Insuflow® Synergy™ (5 mm) and Synergy™ XL (8 mm,10 mm and 12 mm) Port dual lumen models." Similar to flow/pressure, no specific metrics are given, but the successful completion implies the devices perform adequately during insertion and removal, despite the thinner inner lumen wall and smaller overall outer lumen diameter in the dual lumen configuration. |
| Overall Safety and Effectiveness | The ultimate conclusion: "Based on a comparison to the predicate devices and information provided, it is the conclusion of LEXION Medical that the modified Insuflow Synergy™ Port (5 mm) and the Insuflow Synergy™ XL Port (8 mm, 10 mm and 12 mm) devices are substantially equivalent to devices already on the market being used for these applications... and present no new concerns about safety and effectiveness." This broad criterion is met by demonstrating equivalence through the aforementioned performance tests and comparison to predicates. No specific metrics are provided for "safety and effectiveness" beyond the functional performance. |
Study Details
The provided text describes a submission for a Special 510(k), which is typically used for modifications to a legally marketed device that do not significantly affect its safety or effectiveness. As such, the "study" is primarily a performance testing regimen to validate the design changes rather than a large-scale clinical trial or comparative effectiveness study.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of units. The testing was conducted for "the modified Insuflow® Synergy™ (5 mm) and Synergy™ XL (8 mm, 10 mm and 12 mm) Port dual lumen models." This implies that representative samples of each modified size/configuration were tested.
- Data Provenance: The testing was conducted by the manufacturer, LEXION Medical, LLC, as part of their risk analysis and product development. This would be retrospective in the sense that it's laboratory/bench testing performed after the design changes were implemented, but before market introduction of the modified device. The country of origin for the data is not specified, but the submitter is based in St. Paul, MN, USA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of device modification and performance testing (bench testing for flow, pressure, and mechanical integrity) does not typically involve human expert "ground truth" establishment in the way an imaging AI algorithm would. The "ground truth" is defined by engineering specifications and physical measurements.
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Adjudication method for the test set:
- None. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in subjective assessments, such as interpreting medical images. For physical device performance testing, objective measurements against engineering specifications are used, removing the need for expert adjudication in this context.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study is not applicable as this device is a surgical instrument (gas conditioner and port) and not an AI-powered diagnostic or assistive tool for image interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially Yes (in a different context). The device itself is a standalone medical device that performs its function without a human "in the loop" for its primary operation (gas conditioning, port access). It's not an AI algorithm. The performance tests described (flow/pressure, insertion/removal) are standalone tests of the device's physical and functional properties.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the performance testing is based on engineering specifications and measurable physical properties. For example, the "ground truth" for flow/pressure performance would be the required flow rates and pressure tolerances as defined by the device design and relevant industry standards. For insertion/removal, it would relate to acceptable forces, ease of use, and lack of damage.
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The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device, so there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth established for it in this context.
§ 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.