(257 days)
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Not Found
No
The summary describes a standard electrosurgical electrode and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
Yes.
The device is intended to cut and coagulate tissue during minimally invasive surgical procedures, which is a therapeutic function.
No
The provided information describes the device as intended for cutting and coagulating tissue during surgical procedures, which are therapeutic actions, not diagnostic ones. Diagnostic devices are used to identify or determine the nature of a disease or condition.
No
The device description explicitly states "MIS Electrosurgical Electrode," which is a hardware component used in electrosurgery. The intended use also describes cutting and coagulating tissue, which is a physical action performed by a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut and coagulate tissue during minimally invasive surgical procedures." This describes a device used on the patient's body during surgery, not a device used to test samples from the body in a lab setting.
- Device Description: The device is an "MIS Electrosurgical Electrode," which is a surgical tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting markers, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The MIS Electrosurgical Electrodes when used with an electrosurgical generator are intended to cut and coagulate tissue during minimally invasive surgical procedures. General surgery.
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.
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).
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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 shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three wavy lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 1998
Mr. Daniel S. Brown President E-TEK. Incorporated 16 Pennsylvania Street Denver, Colorado 80203-4115
Re: K971829
Trade Name: MIS Electrosurgical Electrode Regulatory Class: II Product Code: GEI Dated: October 29, 1997 Received: October 31, 1997
Dear Mr. Brown:
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 requirements , 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
1
Page 2 - Mr. Brown
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) 594-4595. 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,
A. ळ20/2
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices ...... Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
11971829 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MIS Electrosurgical Electrode
Indications For Use:
General surgery.
The MIS Electrosurgical Electrodes when used with an electrosurgical generator are intended to cut and coagulate tissue during minimally invasive surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
tiosell
(Division Sign-Off)
Division of General Restorative Devices, K971829..
510(k) Number
Prescription Use .... (Per 21 CFR 801.109)
OR
Over-The-Counter-Use .........................................................................................................................................................
(Optional Format 1-2-96)