(32 days)
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No
The 510(k) summary describes standard monopolar electrosurgical electrodes and accessories for tissue manipulation and coagulation, with no mention of AI or ML capabilities in the intended use, device description, or any other section.
Yes
The device is used to coagulate and manipulate tissue, which are therapeutic actions.
No
The device is described as being used to "coagulate tissue," "Dissection," "manipulation," "cut," and "ablation," which are all therapeutic or surgical actions, not diagnostic ones.
No
The device description clearly states "Monopolar Electrodes and Accessories," which are physical hardware components used in electrosurgery. The intended use also describes physical actions like "coagulate tissue," "Dissection," and "manipulation of tissue" using these electrodes. There is no mention of software as the primary or sole component of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states the device is used for coagulating, dissecting, manipulating, and cutting tissue during endoscopy. This is a direct surgical intervention performed on the patient's body, not a test performed on a sample.
- Intended Use: The intended use is for surgical procedures (endoscopy) to modify tissue, not to analyze a sample for diagnostic purposes.
Therefore, the Monopolar Electrodes and Accessories described are surgical instruments, not IVDs.
N/A
Intended Use / Indications for Use
The Monopolar Electrodes and Accessories are indicated when Endoscopy is indicated, used primarily to coagulate tissue, for use with HF Electrosurgical Units. Targeted Anatomical sites include primarily, the Abdominal (suprapubic) region. The device is reusable, non-sterile, for use as follows: 1. Spatula tip-Dissection-Coagulation & manipulation of tissue. 2. L-Hook tip-Dissection & manipulation 3. J-Hook tip-Core out with a knife-cutting effect (ablation) 4. Knife-tip-Coagulate with scalpel-like cutting 5. Button/Needle-tip-Spot 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
Abdominal (suprapubic) region
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)
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Reference Device(s)
Not Found
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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, wave-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Ms. Jonel Manciu President US Endo, Inc. 826 Eagle Drive Bensenville, Illinois 60106
Re: K992485
Trade Name: Monopolar Electrodes and Cables Regulatory Class: II Product Code: GEI Dated: June 26, 1999 Received: July 26, 1999
Dear Ms. Manciu:
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.
1
Page 2 - Ms. Jonel Manciu
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 vour 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 vours.
Mark N Millhussen
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section D - Statement of Indications for Use
Prepare a Susament of Indications for Use as a separate page. The Indications for Use form may be used. The satement should include specific indical settings, define the target population, anatomical sites, etc. This statement must be consistent with your labeling, advertising and instructions for use. Once the review is complete, FDA will include the Indications for Use Statement with the Subclanial Equivalence (SE) letter to the applieant and make it available to the public on the Interner.
Indications for Use Statement
Ver/3-4/24/96
Applicant: US ENDO INC.
510(k) Number (if known): K992485
Device Name: Monopolar Electrodes and Accessories
Indications For Use:
The Monopolar Electrodes and Accessories are indicated when Endoscopy is indicated, used primarily to coagulate
tissue, for use with HF Electrosurgical Units
Targeted Anatomical sites include primarily, the Abdominal (suprapubic) region.
The device is reusable, non-sterile, for use as follows:
- Spatula tip-Dissection-Coagulation & manipulation of tissue.
- L-Hook tip-Dissection & manipulation
- J-Hook tip-Core out with a knife-cutting effect (ablation)
- Knife-tip-Coagulate with scalpel-like cutting
- Button/Needle-tip-Spot coagulation
for
Mark n. Melkeiser
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992485
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109) (Optional Formal 1-2-96) P. 003