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.

Summary

{0}------------------------------------------------

K08085z

mar 3 0 2009

Image /page/0/Picture/2 description: The image shows the logo for Karl Storz Endoscopy. The word "STORZ" is in large, bold, sans-serif font, with the "O" represented by a circle with a smaller circle inside. Below this, the words "KARL STORZ ENDOSCOPY" are printed in a smaller, sans-serif font. The logo is simple and professional, likely representing a medical or technological company.

510(k) SUMMARY

Sponsor/Submitter:	Karl Storz Endoscopy-America, Inc.600 Corporate PointeCulver City, CA 90230-7600Phone: (310) 338-8100Fax: (310) 410-5519
Contact Person:	Crystal DizolRegulatory Affairs SpecialistEmail: cdizol@ksea.com
Date of Submission:	March 25, 2008
Device Trade Name:	KSEA Electronic CO2 ENDOFLATOR LC
Common Name:	Laparoscopic insufflator
Classification Name:	Laparoscopic insufflator
Regulation Number:	21 CFR 884.1730
Product Code:	HIF
Predicate Device(s):	KSEA CO2 ENDOFLATOR (K963423)Karl Storz Model 264305-20 Electronic ENDOFLATOR (K962863)
Device Description:	The KSEA Electronic CO2 ENDOFLATOR LC is an insufflation device foruniversal application in laparoscopic examinations and operations.
Indications for Use:	The KSEA Electronic CO2 ENDOFLATOR LC provides CO2 gasdistention of the abdomen for the diagnostic and/or operativelaparoscopy. See the instruction manual for your laparoscope for specialindications for use.
TechnologicalCharacteristics:	The KSEA Electronic CO2 ENDOFLATOR LC is an electronic CO2 gasinsufflator. The device is intended to be used with a central gas supplyline to achieve pressures from 0-30 mmHg and flow rates of 0-30 L/min.
Summary ofSubstantialEquivalence:	The KSEA Electronic CO2 ENDOFLATOR LC is substantially equivalentto the predicate devices since the basic features, design, and intendeduses are similar. The minor differences between the KSEA ElectronicCO2 ENDOFLATOR LC and the predicate devices raise no new issues ofsafety and effectiveness, as these design differences have no affect onthe performance, function, or intended use of the devices. For acomparison between the KSEA Electronic CO2 ENDOFLATOR LC andthe predicate devices, refer to the attached substantial equivalencechart

{1}------------------------------------------------

STORE STORZENDOSCOPY

SUBSTANTIAL EQUIVALENCE TABLE FOR KSEA ELECTRONIC CO₂ ENDOFLATOR LC

080852

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2009

Ms. Crystal K. Dizol Regulatory Affairs Specialist KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue EL SEGUNDO CA 90245

Re: K080852

Trade/Device Name: KSEA Electronic CO2 ENDOFLATOR LC Regulation Number: 21 CFR §884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: March 6, 2009 Received: March 9, 2009

Dear Ms. Dizol:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,

{3}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.

Sincerely yours,

Laura B. Morris

anine M. M. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known): K080852

Device Name:

KSEA Electronic CO2 ENDOFLATOR LC

Indications for Use:

Prescription Use: (21 CFR 801 Subpart D) AND/OR Over-The-Counter Use:

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.

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.