KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1

• K Number: K080852
• Device Name: KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
• Manufacturer: KARL STORZ ENDOSCOPY-AMERICA, INC.
• Date Cleared: 2009-03-30 ( 369 days)
• Product Code: HIF
• Regulation Number: 884.1730
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: K963423 , K962863
• Predicate For: N/A

Intended Use

The KSEA Electronic CO2 ENDOFLATOR LC provides CO2 gas distention of the abdomen (pneumoperitoneum) for diagnostic or operative laparoscopy. See the instruction manual for your laparoscope for special indications for use.

Device Description

The KSEA Electronic CO2 ENDOFLATOR LC is an insufflation device for universal application in laparoscopic examinations and operations.

AI/ML Overview

The provided text is a 510(k) summary for the KSEA Electronic CO2 ENDOFLATOR LC. This document focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not present in this type of submission. The KSEA Electronic CO2 ENDOFLATOR LC is a medical device (a laparoscopic insufflator) that relies on demonstrating that its technological characteristics and intended use are similar to previously cleared devices, and that any differences do not raise new issues of safety or effectiveness.

Here’s a breakdown based on the provided text, indicating where information is present and where it is not applicable or not detailed in this type of submission:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) with thresholds. For this type of device, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices, meaning it performs similarly in its intended function.
• Reported Device Performance: The document states: "The KSEA Electronic CO2 ENDOFLATOR LC is an electronic CO2 gas insufflator. The device is intended to be used with a central gas supply line to achieve pressures from 0-30 mmHg and flow rates of 0-30 L/min." This describes the designed capabilities rather than reported performance from a study.
  • Table:

    Acceptance Criteria (Implicit)	Reported Device Performance (Capabilities)
    Substantially equivalent to predicate devices in terms of basic features, design, and intended uses, raising no new issues of safety and effectiveness.	"The KSEA Electronic CO2 ENDOFLATOR LC is substantially equivalent to the predicate devices since the basic features, design, and intended uses are similar."
    Achieve pressures within the physiological and surgical range for laparoscopic insufflation.	Capable of achieving pressures from 0-30 mmHg.
    Deliver flow rates suitable for laparoscopic procedures.	Capable of delivering flow rates of 0-30 L/min.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided: This 510(k) summary does not describe a clinical study with a "test set" in the context of diagnostic accuracy or AI performance. The determination of substantial equivalence is based on comparing the new device's design and technological characteristics to those of predicate devices, often through engineering bench tests and design verification rather than human subject trials for performance endpoints.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable / Not Provided: No "test set" requiring expert ground truth establishment for performance evaluation is mentioned in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided: No "test set" and thus no adjudication method is referenced.

5. 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

• Not Applicable / Not Provided: The device is a laparoscopic insufflator, not an AI-assisted diagnostic or decision-support tool. Therefore, an MRMC study related to human reader performance with AI assistance is not relevant or included.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable / Not Provided: The device is a hardware insufflation device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided: No clinical ground truth is established for device performance in this type of submission. Substantial equivalence relies on comparing technical specifications and intended use against predicate devices, and likely includes verification/validation testing for pressure/flow accuracy, safety features, etc., which are usually assessed against engineering standards and specifications rather than clinical ground truth from human patients.

8. The sample size for the training set

• Not Applicable / Not Provided: This device is not an AI model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

• Not Applicable / Not Provided: As there is no training set, this information is not relevant.

In summary: The provided K080852 510(k) summary is for a traditional medical device (a laparoscopic insufflator), not a software or AI-driven diagnostic device. Therefore, the submission focuses on demonstrating substantial equivalence to predicate devices based on design, technological characteristics, and intended use, rather than presenting a detailed clinical study with performance metrics, ground truth, and expert evaluation typically seen for AI/diagnostic devices.

Regulation Number and Section

§ 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.