(89 days)
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No
The summary describes a mechanical device (polypectomy snare) used with electrosurgical energy and argon beam/plasma for cutting and coagulation. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.
Yes
The device is described as a polypectomy snare used for cutting, resection, and coagulation of polyps, which are therapeutic interventions in the digestive tract.
No
The device is described as a polypectomy snare for cutting, resection, and coagulation of polyps, which are therapeutic procedures, not diagnostic ones.
No
The intended use describes a physical device (flexible polypectomy snares) used with other physical devices (argon beam and argon plasma coagulators, endoscope) for a physical procedure (cutting, resection, coagulation). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a flexible polypectomy snare used for cutting, resection, and non-contact coagulation of polyps within the digestive tract. It uses electrosurgical energy and argon beam/plasma for these procedures.
- Direct Interaction with the Body: The device directly interacts with the patient's body during an endoscopic procedure to remove or treat polyps. It does not analyze a sample taken from the body.
Therefore, based on the provided information, this device is a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These devices are intended for use with argon beam and argon plasma coagulators as flexible polypectomy snares for the cutting, resection and non-contact coagulation of polyps in the digestive tract of the human body by use of high-frequency electrosurgical energy. The argon beam provides contact-free coagulation of bleeding sites that can arise after excision of polyps and ablation of remnants of polyps. The application takes place exclusively with an endoscope.
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
digestive tract
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus with three figures in profile, representing health and human services. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2002
Conmed Corporation Charles M. Hart Director, RA/QA/Safety 14603 Fremont Avenue Centennial, Colorado 80112
Re: K021079
Trade Name: ABCSnare Electrosurgical Probe for Flexible Endoscopes Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Regulatory Class: II Product Code: GEI Dated: March 28, 2002 Received: April 3, 2002
Dear Mr. Hart:
We have reviewed your Section 510(k) premarket 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) 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, 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 (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 (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Charles Hart
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (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,
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): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
These devices are intended for use with argon beam and argon plasma coagulators as flexible polypectomy snares for the cutting, resection and non-contact coagulation of polyps in the digestive tract of the human body by use of high-frequency electrosurgical energy. The argon beam provides contact-free coagulation of bleeding sites that can arise after excision of polyps and ablation of remnants of polyps. The application takes place exclusively with an endoscope.
(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
and Neurological Devices
510(k) Number K021079
Prescription Use _
(Per 21 CFR 801.109)
OR
Over-The-Counter _