KSEA THERMOFLATOR (MODEL 26 4320 20) by KARL STORZ ENDOSCOPY-AMERICA, INC.

This device is designed to carefully deliver large flow rates for rapid insufflation, and monitor the amounts of CO2 gas needed to establish and maintain proper distention of the peritoneal cavity during Ob/Gyn laparoscopic surgical and diagnostic procedures

Device Description

The KSEA Thermoflator (model 26 4320 20) is a microprocessor-based system, with gas output that is user adjustable from 0-30 liters/minute, and pressure that is user adjustable from 0-30 mmHg. The unit uses contemporary technology in pressure and flow-sensing, and incorporates a wide variety of safety features.

AI/ML Overview

The provided document is a 510(k) summary for the Karl Storz Endoscopy-America, Inc. KSEA Thermoflator (model 26 4320 20), a laparoscopic insufflator. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI/ML device would.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-driven medical devices, are not applicable to this 510(k) submission.

Here's a breakdown of what can be extracted from the provided text according to your request:

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

This information is not provided in the context of specific quantitative acceptance criteria or a performance study where the device's output is measured against such criteria. The document states: "The KSEA Thermoflator (model 26 4320 20) is substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the KSEA Thermoflator (model 26 4320 20) and the predicate device raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices."

This implies that the "acceptance criteria" are met by demonstrating that the device's design, intended use, and fundamental functionality are consistent with existing legally marketed devices, and any differences do not negatively impact safety or effectiveness. There are no performance metrics or numerical targets given.

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. This submission is based on a comparison to predicate devices, not on a clinical trial with a test set of patient data.

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. There is no "ground truth" establishment in the context of a clinical performance study described here.

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

Not applicable. No test set or adjudication process is mentioned.

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. This is a device for insufflation, not an AI-driven diagnostic tool that would involve human readers.

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

Not applicable. This is a hardware device; the concept of "standalone algorithm performance" does not apply.

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

Not applicable. No ground truth in the sense of a clinical or diagnostic reference standard is used or required for this type of submission. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This submission does not involve machine learning algorithms that require a training set.

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

Not applicable. (See #8)

Summary

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Image /page/0/Picture/0 description: The image shows a grainy, black and white photograph of what appears to be a label or a piece of paper. The number 455073 is visible in the center of the image. There is a circular shape on the right side of the image. The image is heavily textured and has a worn appearance.

Karl Storz Endoscopy-America, Inc 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500

Toll Free 800 421 0837 Fax 310 410 5527

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CRF 807.92. All data included in this documents are accurate and complete to the best of KSEA's knowledge.

Applicant:

Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City. CA 90230 (310) 558-1500

DEC - 6 1996

Contact:

Betty M. Johnson Manager, Regulatory Affairs

Device Identification:

Common Name Laparoscopic Insufflator

Trade Name (optional) KSEA Thermoflator (model 26 4320 20)

Indication:

Device Description:

Substantial Equivalence:

The KSEA Thermoflator (model 26 4320 20) is substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the KSEA Thermoflator (model 26 4320 20) and the predicate device raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices.

Signed: Beth M.C. Johnson

Betty M. Johnson Manager, Regulatory Affairs

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.