AUTOCON II 400 ELECTROSURGICAL GENERATOR by KARL STORZ ENDOSCOPY-AMERICA, INC.

The Autocon II 400 Electrosurgical Generator is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during open and endoscopic surgeries, including general, plastic, urological, neurological, and gynecologic procedures.

Device Description

The Autocon II 400 consists of a generator, a dual pedal foot switch. and a power cord. The footswitch activates the power for cutting and coagulation. The Autocon II 400 is able to provide either monopolar or bipolar modes for cutting and coagulation. It can be linked to Karl Storz SCB.

AI/ML Overview

This document is a 510(k) summary for the KSEA Autocon II 400 Electrosurgical Generator, indicating its substantial equivalence to predicate devices. It does not contain information on acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics, such as accuracy, sensitivity, or specificity, which would typically be found in an evaluation of AI/ML or diagnostic devices.

The document pertains to the regulatory submission for an electrosurgical generator, which is a medical device used for cutting and coagulating tissue. The assessment is focused on showing its substantial equivalence to existing devices rather than a performance study as described in your request. Therefore, most of the information requested in your prompt is not applicable to this document.

Here's a breakdown of why the requested information is absent based on the provided text:

No AI/ML or Diagnostic Device: The KSEA Autocon II 400 Electrosurgical Generator is an electrosurgical generator. This type of device does not typically involve AI/ML algorithms or require performance metrics like sensitivity, specificity, or accuracy compared to a ground truth, as would be the case for a diagnostic or image analysis device. Its "performance" is generally assessed by electrical safety, power output consistency, and functional equivalence to predicate devices.

Specific answers to your questions, based on the provided text:

A table of acceptance criteria and the reported device performance:
- Not applicable. The document focuses on demonstrating "substantial equivalence" to predicate devices. It states: "The KSEA Autocon II 400 Electrosurgical Generator is substantially equivalent to the predicate devices since the basic design, dimensions, safety features, and intended uses are similar. The minor differences between the KSEA Autocon II 400 Electrosurgical Generator 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." This is the core "acceptance" criteria for this type of 510(k) submission, rather than specific performance metrics.
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 information is not relevant for the type of device and submission presented. There is no "test set" of data in the context of evaluating an algorithm's performance against ground truth.
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 sense of expert review of images or diagnostic outcomes. The "ground truth" for an electrosurgical generator is its adherence to safety standards and functional specifications compared to established predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication method as described is present.
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 not an AI-assisted diagnostic device, so an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic or AI-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of diagnostic performance. For this device, "ground truth" more closely relates to engineering specifications, electrical safety standards, and functional equivalence to predicate devices, which are assessed through engineering tests and regulatory comparisons, not medical ground truth methods.
The sample size for the training set:
- Not applicable. There is no AI model or training set involved.
How the ground truth for the training set was established:
- Not applicable. There is no AI model or training set involved.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for an electrosurgical generator, focusing on its design, safety features, and intended use as compared to existing devices. It does not involve the types of performance studies or acceptance criteria that would be relevant for AI/ML or diagnostic image analysis devices.

Summary

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021.467 o

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) 338-8100	NOV	4 2012
Contact:	James A. LeeRegulatory Affairs Specialist
Device Identification:	Common Name:Electrosurgical Generator
	Trade Name: (optional)The KSEA Autocon II 400 Electrosurgical Generator

Indication: The Autocon II 400 Electrosurgical Generator is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during open and endoscopic surgeries, including general, plastic, urological, neurological, and gynecologic procedures.

Device Description: The Autocon II 400 consists of a generator, a dual pedal foot switch. and a power cord. The footswitch activates the power for cutting and coagulation. The Autocon II 400 is able to provide either monopolar or bipolar modes for cutting and coagulation. It can be linked to Karl Storz SCB.

Substantial Equivalence: The KSEA Autocon II 400 Electrosurgical Generator is substantially equivalent to the predicate devices since the basic design, dimensions, safety features, and intended uses are similar. The minor differences between the KSEA Autocon II 400 Electrosurgical Generator 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:

Aullke

James A. Lee, Ph.D. Senior Regulatory Affairs Specialist

200

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2002 NOV

Karl Storz Endoscopy-America, Inc James A. Lee Senior Regulatory Affairs Specialist 600 Corporate Pointe Culver City, California 90230-7600

Re: K021467

Trade/Device Name: Autocon II 400 Electrosurgical Generator Regulation Number: 878.4400 Regulation Name: Electrosurgical probe Regulatory Class: Class II Product Code: GEI Dated: September 11, 2002 Received: September 12, 2002

Dear Mr. Lee:

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.

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,

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Page 2 -- Mr. James A. Lec

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K021467

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

のです。このため、そのためになるとなるとなると、そのため、そのため、

510(k) Number (if known): Not yet assigned.

BATTAL PARACT AND THE

Specifical Comments of the Comments of the Children

Device Name: Autocon II 400 Electrosurgical Generator

Indications for Use: The Autocon II 400 Electrosurgical Generator is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during open and endoscopic surgeries, including general, plastic, urological, neurological, and gynecologic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:
OR Over-The-Counter Use:
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K021467

(103

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.