(176 days)
Not Found
Not Found
No
The summary describes a standard electrosurgical generator with basic functions (cutting, coagulation, monopolar/bipolar modes) and does not mention any AI or ML capabilities.
Yes
The device is described as an electrosurgical generator used by surgeons to cut and coagulate tissue, which are direct therapeutic actions.
No
The device description states its intended use is for "cutting and coagulating tissue" using electrical current, not for identifying or analyzing disease.
No
The device description explicitly states it consists of a generator, a foot switch, and a power cord, which are hardware components.
Based on the provided information, the Autocon II 400 Electrosurgical Generator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide a high frequency electrical current for cutting and coagulating tissue within the body during surgery. This is an in vivo procedure, meaning it's performed on living tissue inside the patient.
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside the body to obtain information about a patient's health.
The Autocon II 400 is a surgical device used directly on the patient's tissue, not for testing samples in a lab.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Autocon II 400 consists of a generator, a 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Ko6 2464
FEB 6 2007
Page 111
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 Drive
Culver City, CA 90230
(310) 338-8100 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | James A. Lee
Senior Regulatory 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) clectrical current for cutting and coagulating tissue.
Device Description: The Autocon II 400 consists of a generator, a 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.
gned:
James A. Lee, Ph.D.
Signed:
James A. Lee, Ph.D.
1
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wings and tail. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Karl Storz Endoscopy-America, Inc. % Mr. James A. Lec Senior Regulatory Affairs Specialist 600 Corporate Points 5th Floor Culver City, California 90230-7600
FEB 1 6 2007
Re: K062464
K002404
Trade/Device Name: Modified AUTOCON II 400 Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 25, 2007 Received: January 29, 2007
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your Section 910(tr) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure, to regars actment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food. Drug, devices mail have been recadssiriou in accession of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applic and Cosment Act (Act) that to hot require of the general controls provisions of the Act. The Y ou may, merelore, market the device, soojeer es use as annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see above) this existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FD may be subject to such additional controlio. "Entroling component" be found in the Oods of concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated of a sevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other matt that TDA has made a decommances and regulations administered by other Federal agencies. You must of ally if cuchal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Mr. James A. Lee
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and will you to ough finding of substantial equivalence of your device to a legally prematice notification. "The started 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 11 you a some office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/cdrh/industry/support/index.html.
Sincerely yours,
mluh N. Mlleken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Kobz464
510(k) Number (if known): K62464
Device Name: Modified AUTOCON II 400 Electrosurgical Generator
Indications for Use:
The Autocon II 400 Electrosurgical Generator is intended for use by qualified surgeous to provide a high frequency (HF) electrical current for cutting and coagulating tissue.
Prescription Use: _____ OR Over-The-Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRK, Office of Device Evaluation (ODE)
V.O.
(Division Sign-C
Division of Gene al, Restorative,
and Neurological Devices
510(k) Nur
COG