KSEA CO2 ENDOFLATOR by KARL STORZ ENDOSCOPY

These instruments are intended for use by qualified surgeons and provide gas insufflation designed for diagnostic laparoscopic procedures, and laparoscopic sterilization procedures.

Device Description

The Karl Storz CO2 Endoflator is a gas insufflator designed to deliver CO2 gas to the abdominal cavity to facilitate the use of endoscope and accessories.

AI/ML Overview

The provided text describes a 510(k) summary for the Karl Storz CO2 Endoflator, a gas insufflator for Ob/Gyn laparoscopic surgical and diagnostic procedures. This document is a regulatory submission for medical device clearance, not a study evaluating device performance against specific acceptance criteria. Therefore, most of the requested information about acceptance criteria, study design, and performance metrics is not available in the provided text.

Here's what can be extracted and what cannot:

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

Not Available: The document does not provide specific acceptance criteria or quantitative performance data. The clearance is based on substantial equivalence to predicate devices, meaning it is deemed as safe and effective as existing, legally marketed devices, rather than meeting new, specific performance thresholds.

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

Not Available: No test set or associated data provenance is mentioned as this is a regulatory submission for device clearance via substantial equivalence, not a clinical study report.

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 Available: No test set or ground truth establishment process is described.

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

Not Available: No test set or adjudication method is described.

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 device is a CO2 insufflator, not an AI-powered diagnostic or imaging device used by human readers, so MRMC studies or AI-assistance metrics are irrelevant.

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

Not Applicable: This device is a CO2 insufflator, not an algorithm, so standalone algorithm performance is irrelevant.

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

Not Available: No ground truth is mentioned, as this is a regulatory submission document for substantial equivalence, not a clinical performance study. The "ground truth" for 510(k) clearance is typically the performance and safety of legally marketed predicate devices.

8. The sample size for the training set

Not Applicable: There is no mention of a training set as this is not an algorithm being developed. The device's design and manufacturing are based on established engineering principles and comparison to existing devices.

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

Not Applicable: As above, no training set is mentioned.

Summary of what is available from the SENS document:

The device, Karl Storz CO2 Endoflator, was cleared for marketing based on its substantial equivalence to predicate devices. This means the FDA determined that the device is as safe and effective as other similar devices already on the market, and raises no new issues of safety or effectiveness. The minor differences noted have no effect on performance, function, or intended use.

Intended Use: For Ob/Gyn laparoscopic surgical and diagnostic procedures to deliver CO2 gas to the abdominal cavity to facilitate the use of an endoscope and accessories.
Predicate Devices: The submission states the device is "substantially equivalent to the predicate devices" but does not name them or provide their specific performance metrics.
Regulatory Class: Class II (Product code: 85 HIF, per 21 CFR §884.1730 for a Laparoscopic Insufflator).

In conclusion, the provided document is a regulatory notice of 510(k) clearance based on substantial equivalence, not a detailed study report with specific acceptance criteria and performance data.

Summary

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MAY 27 1997 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 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

Applicant:	Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 558-1500
Contact:	Kevin KennanRegulatory Affairs Specialist
Device Identification:	Common Name:Gas Insufflator

Trade Name: (optional) Karl Storz CO2 Endoflator

The Karl Storz CO2 Endoflator is designed for Ob/Gyn laparoscopic surgical and Indication: diagnostic procedures.

Device Description: The Karl Storz CO2 Endoflator is a gas insufflator designed to deliver CO2 gas to the abdominal cavity to facilitate the use of endoscope and accessories.

The Karl Storz CO2 Endoflator is substantially equivalent to the Substantial Equivalence: predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz CO2 Endoflator and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signed:

Kevin Kennan Regulatory Affairs Specialist

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 1997

Mr. Kevin A. Kennan Regulatory Affairs Specialist -Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Re: K963423

KSEA CO2 Endoflator ... Dated: April 22, 1997 Received: April 23, 1997 Regulatory class: II 21 CFR §884.1730/Product code: 85 HIF

Dear Mr. Kennan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 53 1 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Vin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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210(k) Number (if known): 963423

Device Name: KSEA CO2 Endoflator

Indications for Use: These instruments are intended for use by qualified surgeons and provide gas insufflation designed for

diagnostic laparoscopic procedures, and 印
laparoscopic sterilization procedures. 程

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Rathbun, Jr.

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_1963423

Prescription Use:

OR Over-The-Counter Use:

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.