(217 days)
Not Found
Not Found
No
The summary describes electrosurgical electrodes for cutting, coagulation, and vaporization of tissue, which are standard electrosurgical functions. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis that would indicate the presence of AI/ML. The device description focuses on the physical electrodes and their connection to a generator.
Yes
The device is indicated for the treatment of benign prostatic hyperplasia (BPH) and bladder cancer, which are therapeutic applications.
No
The device description indicates it is used for "cutting, coagulation, and vaporization of soft tissue," which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is an electrosurgical electrode, which is a hardware component used in conjunction with a resectoscope and electrosurgical generator. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is used in vivo (within the body) for cutting, coagulation, and vaporization of soft tissue.
- IVDs are used to provide information about a physiological state, health, or disease. This device is a surgical tool used for treatment (cutting, vaporization, resection) of tissue, not for diagnostic purposes.
The device is an electrosurgical electrode used in a resectoscope for surgical procedures in urology.
N/A
Intended Use / Indications for Use
CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome Resection Electrodes are indicated for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.
Product codes (comma separated list FDA assigned to the subject device)
78FAS
Device Description
CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome™ Resection Electrodes are electrosurgical electrodes used in CIRCON ACMI's resectoscopes utilizing a direct connection between the electrode and the active cord of the electrosurgical generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
prostatic and bladder tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
8.4/5
973820
PG-1 UF Z
MAY 1 2 1998
510(k) Summary
#K973820
- Circon Corporation Submitter: 1) 6500 Hollister Avenue Santa Barbara, CA 93117
Dr. Ronald J. Ehmsen Contact: (805) 961-3290
Date Prepared: May 7, 1998
- Name of Device: CIRCON ACMI USA Elite System™ Vapor Trode™ Vaporization 2) Electrode and VaporTomena Resection Electrode
Proprietary/Trade Name: CIRCON ACMI VaporTrode™ Vaporization Electrode and VaporTome™ Resection Electrode
Common/Usual Name: Electrode, Electrosurgical, Active, Urological
Classification: Class II (21 CFR §876.4300)
Classification Name: Endoscopic Electrosurgical Unit and Accessories (78FAS)
3) Names of Predicate or Legally Marketed Devices:
CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes are substantially equivalent to the Grooved Roller Electrodes marketed by American Cystoscope Makers, Inc. (ACMI, a predecessor of CIRCON ACMI Division of Circon Corporation). These devices were confirmed to be preamendments devices in a letter dated August 31, 1995, from Mr. T. Wells of FDA's Office of Compliance. The VaporTome™ Resection Electrodes are substantially equivalent to the Resectoscope Cutting Loops marketed by American Cystoscope Makers, Inc., which are also preamendments devices.
4) Description of Device:
CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome™ Resection Electrodes are electrosurgical electrodes used in CIRCON ACMI's resectoscopes utilizing a direct connection between the electrode and the active cord of the electrosurgical generator.
'The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents.
1
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PG. 2 OF 2
510(k) Summary #K973820 Circon Corporation Circon ACMI USA Elite System™ Vaporization Electrode and Vapor Tome Resection Electrode May 7, 1998 Page 2
Intended Use of Device: ર)
CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome Resection Electrodes are indicated for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.
() Comparison of Technological Characteristics:
CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTomeTM Resection Electrodes are substantially equivalent2 to the American Cystoscope Makers, Inc. Grooved Roller Electrodes and Resectoscope Cutting Loops. respectively. Those preamendments devices employed similar design considerations and operating principles. Any differences between these devices do not raise new questions regarding safety or effectiveness.
"The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K973820
Circon ACMI USA Elite System™ Vaporization Electrode and VaporTome™ Resection Electrode Dated: March 16, 1998 Received: March 20, 1998 Regulatory Class: II 21 CFR 876.4300/Procode: 78 FAS
Dear Dr. Ehmsen:
MAY 1 2 1998
Ronald J. Ehmsen, Sc.D.
CIRCON Corporation
6500 Hollister Avenue
Vice President, Regulatory Affairs
Santa Barbara, CA 93117-3019
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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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) 594-4613. 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/dsmaldsmamain.html".
Sincerely yours.
Lillian Yin, 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
ਸ
3
510(k) Number: K973820
Device Name: Circon ACMI USA Elite System™ Vaporization Electrode and VaporTomeTM Resection Electrode
Indications for Use:
Circon ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome™ Resection Electrodes are indicated for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Poler R Sathing
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973820
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)