(239 days)
The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
The subject device consists of an insufflator, a high pressure tube and a pneumoperitoneum tube. The insufflator is a microprocessor-controlled CO2 insufflator that consists of the following major components and features: housing, power supply, pressure reducers, venting system, fluid sensor, gas heater, various setting keys and display elements. The insufflator is not intended to enter the field and cannot be sterilized. The pneumoperitoneum tube shall be cleaned, disinfected, and sterilized prior to subsequent use.
The provided document is a 510(k) summary for an Insufflator (K222812), intended to facilitate the use of a laparoscope by distending the peritoneal cavity with gas. It primarily focuses on demonstrating substantial equivalence to a predicate device (K030837) and a reference device (K153513) through non-clinical performance testing.
Based on the provided information, here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of "acceptance criteria" for specific performance metrics in a pass/fail format alongside the device's reported performance. Instead, it lists the standards and the types of comparative non-clinical performance testing performed, implying that meeting these standards and showing comparable performance to the predicate device would be the acceptance criteria.
However, we can infer some criteria from the "General Comparison" table (Table 2) and the "Performance Specifications" in Table 3 (which is incomplete in the provided text).
| Aspect / Category | Acceptance Criteria (Implied / Inferred) | Reported Device Performance (Subject Device K222812) | Comments / Comparison to Predicate |
|---|---|---|---|
| Set Pressure Range | Pediatric mode: 1-10mmHg; Adult/Bariatric: 1-30mmHg (matching reference device) | Pediatric mode: 1-10mmHg; Adult and bariatric mode: 1-30mmHg | Different from predicate (1-30mmHg) but aligns with capabilities of the reference device. |
| Accuracy of Pressure | ≤ ± 2mmHg (comparable to predicate's ±1mmHg or within acceptable limits) | ± 2mmHg | Different from predicate (±1mmHg). This difference is not stated to raise safety concerns. |
| Set Gas Flow Range | 1-50L/min (matching reference device) | 1-50L/min | Different from predicate (1-40L/min) but matches reference device. |
| Overpressure Warning | Warning initiated when actual pressure is >3mmHg above nominal pressure | When actual pressure is >3mmHg above nominal pressure, the overpressure warning is initiated | Different from predicate (>4mmHg). Subject device has a tighter warning threshold. |
| Gas Supply Warning | Warning when cylinder 41°C | When the gas temperature is greater than 41°C, the gas injection will be interrupted, device warning initiated. | Different from predicate (>42°C). Subject device has a slightly lower warning threshold. |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same as predicate and reference device. |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same as predicate and reference device. |
| Software V&V | In accordance with relevant FDA guidance | Test results demonstrated software function met requirements | Performed for Major Level of Concern software. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "non clinical tests were conducted" and "comparative performance testing was also conducted on the subject and predicate devices." However, it does not specify the sample sizes used for these tests. The tests are non-clinical, meaning they involve lab testing of the devices themselves, not patient data. Therefore, questions of country of origin of data or retrospective/prospective are not applicable for this non-clinical submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the studies are entirely non-clinical performance and safety tests of a medical device (insufflator). There is no "ground truth" to be established by clinical experts for a test set in the context of this 510(k) submission.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as above. Non-clinical engineering tests do not involve expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (insufflator) and relies on non-clinical performance and safety testing. There are no human readers or cases involved in the presented studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable in the traditional sense for this device. The device is hardware with embedded software, not an AI algorithm performing diagnostic or therapeutic functions needing standalone performance evaluation in the context of AI/ML. The software verification and validation were performed as an integral part of the device's functionality.
7. The Type of Ground Truth Used:
As the studies are non-clinical performance tests, the "ground truth" would be established by:
- Engineering specifications and standards: Adherence to standards like IEC 60601-1, IEC 60601-1-2, ASTM D4169, AAMI TIR 30, AAMI TIR 12, ISO 15883-2, ISO 17665-1, ISO 14971, and IEC 60601-2-18.
- Expected physical and functional performance: Measured parameters like flow rate, pressure accuracy, temperature, and warning thresholds are compared against design specifications and the performance of the predicate device.
8. The Sample Size for the Training Set:
This information is not applicable. The device is an insufflator, not a machine learning or AI model that requires a training set of data. The software within the device is likely deterministic control software, subject to standard software verification and validation, not machine learning model training.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set mentioned or implied for this device.
§ 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.