(90 days)
To facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
The Surgiflator-30 is a laparoscopic high flow insufflator intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it. The Surgifiator-30 incorporates the same design features as the W.O.M. Surgifiator 20-PIM. The only differences lie in the following: Surgiflator-30 offers an increased flow rate of max. 30 Vmin. The device will also be available as a 25 Vmin version. The Surgifiator-30 does not offer optional simultaneous pressure monitoring.
The provided text is a 510(k) summary for a medical device called the SURGIFLATOR 30, a laparoscopic insufflator. This type of regulatory submission historically focused on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials with detailed acceptance criteria and performance data as might be seen for novel devices today.
Therefore, the document does not contain the typical information requested regarding acceptance criteria, a specific study proving it, sample sizes, expert involvement for ground truth, or an MRMC comparative effectiveness study. The basis for clearance is demonstrating substantial equivalence to existing devices.
Here's an analysis of what can be extracted or inferred based on the document's nature:
Acceptance Criteria and Device Performance
Since this is a 510(k) submission from 1997, the "acceptance criteria" are broad and relate to demonstrating substantial equivalence to predicate devices already on the market. The primary "performance" reported is related to an increased flow rate.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device "Performance" |
|---|---|
| Equivalence in Intended Use: To facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it. | Met: Intended use is identical to predicate devices. |
| Similar Technological Characteristics: Design features similar to predicate. | Met: "incorporates the same design features as the W.O.M. Surgiflator 20-PIM." |
| Performance within established safety and effectiveness parameters for high-flow insufflators. | Achieved: Increased flow rate to max. 30 L/min (from 20 L/min in predicate). Also available as 25 L/min version. No optional simultaneous pressure monitoring (a difference noted, implying it doesn't negatively impact safety/effectiveness relative to predicates). |
| Safety profile consistent with predicate devices. | Achieved: Relies on the established safety and utility of laparoscopic techniques using high-flow insufflators as thoroughly reported in literature. |
Study Information (Based on 510(k) Context)
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Sample size used for the test set and the data provenance:
- Not applicable / Not provided. A formal "test set" in the sense of a clinical study or performance study with a specific sample size is not described. The basis for safety and effectiveness relies on comparison to predicate devices and general medical literature.
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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 / Not provided. Ground truth establishment for a test set is not detailed as there isn't a described performance study with a test set. The "ground truth" for the device's utility and safety is implicitly drawn from established medical literature and the long history of laparoscopic procedures and insufflators.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / None. No formal adjudication method is mentioned as there isn't a described test set needing ground truth adjudication.
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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. This is a medical device for laparoscopic insufflation, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant or described.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical instrument (an insufflator), not an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's safety and effectiveness relies on a combination of historical clinical experience and established medical literature regarding laparoscopic techniques and the use of high-flow insufflators. The document cites several medical textbooks to support the general safety and utility of such devices.
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The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device where a "training set" would be used.
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How the ground truth for the training set was established:
- Not applicable / Not provided. As above, no training set is relevant to this device submission.
§ 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.