(88 days)
The Autocon II 200 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, ENT, gynecologic, and arthroscopic procedures.
The Autocon II 200 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 200 is able to provide either monopolar or bipolar modes for cutting and coagulation. It can be linked to Karl Storz SCB.
This document pertains to a 510(k) submission for an electrosurgical generator, not an AI or imaging device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and human reader performance is not applicable. The provided text describes the device, its intended use, and its substantial equivalence to predicate devices, but does not include details of performance studies against specific acceptance criteria in the manner applicable to AI-driven diagnostic tools.
However, I can extract the relevant information that is present in the document.
1. A table of acceptance criteria and the reported device performance:
The provided document (K023924 510(k) Summary) for the Autocon II 200 Electrosurgical Generator does not explicitly state quantitative acceptance criteria or a formal performance study with reported device performance in a table format as might be seen for an AI diagnostic device.
For electrosurgical generators, "acceptance criteria" are generally met through substantial equivalence to predicate devices and adherence to relevant electrical and safety standards (e.g., IEC standards for electromedical equipment). The document highlights:
| Acceptance Criteria (Implied by 510(k) process for this device type) | Reported Device Performance |
|---|---|
| Safety and Effectiveness: No new issues of safety and effectiveness compared to predicate devices. | "The minor differences between the KSEA Autocon II 200 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." |
| Intended Use: Device performs its intended functions for cutting and coagulating tissue. | "The Autocon II 200 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..." (Implies the device can perform these functions). |
| Basic Design, Dimensions, and Features: Similar to predicate devices. | "The KSEA Autocon II 200 Electrosurgical Generator is substantially equivalent to the predicate devices since the basic design, dimensions, safety features, and intended uses are similar." |
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. The submission does not describe a "test set" of data or patient cases for evaluating performance in the context of an AI or diagnostic imaging device. The 510(k) relies on substantial equivalence and adherence to manufacturing and safety standards.
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. No ground truth establishment by experts for a test set is mentioned, as this is not an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method for a test set 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 not an AI-driven device, so an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an electrosurgical generator, not an algorithm, so a standalone performance evaluation of an algorithm without human-in-the-loop performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No ground truth for performance evaluation of a diagnostic nature is mentioned or relevant to this device type in this submission.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not an AI device.
9. How the ground truth for the training set was established:
Not applicable. There is no "training set" and therefore no ground truth establishment for such a set.
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K023924 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 |
|---|---|
| Contact: | Susie S. ChenDirector, Regulatory & Product Legal Affairs |
| Device Identification: | Common Name:Electrosurgical Generator |
| Trade Name: (optional)The KSEA Autocon II 200 Electrosurgical Generator |
Indication: The Autocon II 200 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, ENT, gynecologic, and arthroscopic procedures.
Device Description: The Autocon II 200 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 200 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 200 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 200 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:
Susie S. Chen
Director, Regulatory & Product Legal Affairs
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three horizontal lines above it, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2003
Karl Storz Endoscopy Susie S. Chen Director, Regulatory & Product Legal Affairs 600 Corporate Pointe Drive Culver City, California 90230
Re: K023924
Trade/Device Name: Autocon II 200 Electrosurgical Generator Regulation Number: 878.4400 Regulation Name: Electrosurgical Generator Regulatory Class: Class II Product Code: GEI Dated: November 20, 2002 Received: November 25, 2002
Dear Ms. Chen:
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. Iisting 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
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Page 2 - Ms. Susie S. Chen
(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 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
Miriam C. Provost
(0) 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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510(k) Number (if known): Not yet assigned.
Device Name: Autocon II 200 Electrosurgical Generator
Indications for Use: The Autocon II 200 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, ENT, gynecologic and arthroscopic procedures.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
(Per 21 CFR 801.109) said:
OR Over-The-Counter Use:
(Optional Format 1-2-96)
Muriam C. Provost
vision Sign-Off) Division of General, Restorative and Neurological Devices
0003
510(k) Number K023924
§ 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.