(281 days)
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Not Found
No
The description focuses on the electrohydraulic mechanism for stone fragmentation and does not mention any AI or ML components or functionalities.
Yes
The device is described as an "Electrohydraulic Lithotripter" intended to "fragment stones (calculi) in the urinary and biliary tracts." This function directly treats a medical condition (calculi) to restore proper bodily function, which falls under the definition of a therapeutic device.
No
The device is described as an electrohydraulic lithotripter used to fragment stones, which is a therapeutic function, not a diagnostic one. It is used to break up existing calculi, not to diagnose their presence or characteristics.
No
The device description clearly states it is a "bipolar electronic device" and a "generator" that produces sparks and hydraulic shock waves, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The CIRCON ACMI AEH-3 Electrohydraulic Lithotripter is used to fragment stones within the body (in vivo). It directly interacts with the stones inside the urinary and biliary tracts.
The description clearly states its purpose is to fragment stones in the urinary and biliary tracts, which is an internal procedure, not an external diagnostic test on a specimen.
N/A
Intended Use / Indications for Use
CIRCON ACMI's AEH-3 Electrohydraulic Lithotripter and Probes are intended to be used to fragment stones (calculi) in the urinary and biliary tracts, including the kidney, ureter, bladder, urethra, and common bile duct.
Product codes
78 FFK
Device Description
The CIRCON ACMI AEH-3 Electrohydraulic Lithotripter is a bipolar electronic device. When used with its flexible probes, the system is capable of fragmenting calculi so that fragments can be removed without requiring major surgery. In the presence of recommended irrigant solutions, sparks produced by activating the AEH-3 generator produce a series of high amplitude hydraulic shock waves that initiate fragmentation. These shock waves have no adverse effect on tissue because of tissue flexibility, as long as the probe does not come in contact with the tissue surface.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
urinary and biliary tracts, including the kidney, ureter, bladder, urethra, and common bile duct
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4480 Electrohydraulic lithotriptor.
(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”
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510(k) Summary: #K980492
Circon Corporation Applicant: 6500 Hollister Avenue Santa Barbara, CA 93117 (805) 685-5100
Ronald J. Ehmsen, Sc.D., Vice President, Regulatory Affairs Contact:
Device Identification:
Proprietary Name: CIRCON ACMI AEH-3TM Electrohydraulic Lithotripter and Probes Common/Usual Name: Electrohydraulic Lithotripter (Intracorporeal) and Accessories Classification Name: Electrohydraulic Lithotriptor
Device Classification: Class III (Currently undergoing review of reclassification petition to reclassify to Class II).
Substantial Equivalence:
CIRCON ACMI's AEH-3 Electrohydraulic Lithotripter and Probes are substantially equivalent' in design, materials and intended use to other devices that are legally marketed for the same intended uses. Such devices are currently manufactured by Northgate Technologies, Inc., Karl Storz Endoscopy-America, Inc. and Richard Wolf Medical Instruments Corporation.
Intended Use:
CIRCON ACMI's AEH-3 Electrohydraulic Lithotripter and Probes are intended to be used to fragment stones (calculi) in the urinary and biliary tracts, including the kidney, ureter, bladder, urethra, and common bile duct.
Device Description:
The CIRCON ACMI AEH-3 Electrohydraulic Lithotripter is a bipolar electronic device. When used with its flexible probes, the system is capable of fragmenting calculi so that fragments can be removed without requiring major surgery. In the presence of recommended irrigant solutions, sparks produced by activating the AEH-3 generator produce a series of high amplitude hydraulic shock waves that initiate fragmentation. These shock waves have no adverse effect on tissue because of tissue flexibility, as long as the probe does not come in contact with the tissue surface.
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
Image /page/1/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH &" are arranged in a semi-circle above the eagle, and the words "HUMAN SERVICES" are arranged in a semi-circle below the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 1998
Ronald J. Ehmsen, Sc. D. Vice President, Regulatory Affairs Circon Corporation 6500 Hollister Avenue Santa Barbara, California 93117-3019 Re: K980492
AEH-3 Electrohydraulic Lithotripter and Probes Dated: September 10, 1998 Received: September 11, 1998 Regulatory Class: III 21 CFR 876.4480/Procode: 78 FFK
Dear Dr. Ehmsen:
We have reviewed your Section 510%) 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 531 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) 594-4613. 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/cdr/dsmaldsmamain.html".
Sincerely your
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
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510(k) Number: K980492
Device Name: AEH-3 Electrohydraulic Lithotripter and Probes
Indications for Use:
CIRCON ACMI's AEH-3 Electrohydraulic Lithotripter and Probes are intended to be used to fragment stones (calculi) in the urinary and biliary tracts, including the kidney, ureter, bladder, urethra, and common bile duct.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
William Yin
(Division Sign-Off)
OR
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.
Over-The-Counter Use (Optional Format 1-2-96)