(83 days)
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No
The summary describes a standard electrosurgical accessory and makes no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is used to perform coagulation, which is a therapeutic intervention to stop bleeding or destroy tissue.
No
The device is described as an "electrosurgical accessory" used for "delivery of argon gas and electrosurgical current... to perform coagulation." This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "Sterile, single-use electrosurgical accessory" and a "ConMed ABC® Probe for Flexible Endoscopes," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "Sterile, single-use electrosurgical accessory used in conjunction with an ABC® generator for delivery of agron gas and electrosurgical current... to perform coagulation." This describes a device used during a surgical procedure on a patient's body for therapeutic purposes (coagulation).
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health.
This device is an electrosurgical accessory used in vivo (within the living body) during a medical procedure.
N/A
Intended Use / Indications for Use
Sterile, single-use electrosurgical accessory used in conjunction with an ABC® generator for delivery of agron gas and electrosurgical current through a flexible endoscope to perform coagulation.
Product codes
GEI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which consists of three stylized human profiles facing right, arranged in a stacked formation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 1999
Mr. Ira D. Duesler, Jr. Quality Engineer ConMed Corporation 310 Broad Street Utica. New York 13501
Re: K990586
Trade Name: ConMed ABC® Probe for Flexible Endoscopes Regulatory Class: II Product Code: GEI Dated: February 22,1999 Received: February 23, 1999
Dear Mr. Duesler:
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 II (Special Controls) or 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 requirement, as set forth in the Quality System Regulation (QS) 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.
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Page 2 - Mr. Ira D. Duesler, Jr.
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) 594-4595. 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/dsmamain.html".
Sincerely yours,
f
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): __ K 990586
ConMED ABC® Probe for Flexible Endoscopes Device Name:
Indications for Use:
Sterile, single-use electrosurgical accessory used in conjunction with an ABC® generator for delivery of agron gas and electrosurgical current through a flexible endoscope to perform coagulation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K990586
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter