(199 days)
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No
The summary describes disposable electrodes used in electrosurgical procedures and makes no mention of AI or ML technology.
Yes.
The device is used for LEEP/LLETZ procedures to remove abnormal cells and lesions from the cervix, which is a therapeutic intervention.
No
The device is described as an electrosurgical tool (loop and ball electrodes) used for cutting and sealing tissue, specifically for removing abnormal cells and stopping bleeding. While it's used in procedures that might follow a diagnosis (like LLETZ for CIN and dysplasias), its function is therapeutic (removal of tissue) rather than diagnostic (identifying a condition). The "Diagnosis" mentioned in "LLETZ in the Diagnosis and Treatment" refers to the LLETZ procedure itself providing a tissue sample for subsequent pathological diagnosis, not the electrode performing the diagnosis.
No
The device description explicitly states "Disposable Ball and Loop Electrodes," which are physical hardware components used in a surgical procedure. The intended use also describes the physical action of cutting and sealing tissue using these electrodes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure (LEEP/LLETZ) to remove tissue from the cervix and surrounding areas. This is a therapeutic and diagnostic procedure performed directly on the patient's body.
- Device Description: The device is described as disposable ball and loop electrodes, which are surgical instruments used for cutting and sealing tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is used to perform a procedure directly on the body.
N/A
Intended Use / Indications for Use
The loop electrodes are designed for the LEEP or LLETZ procedure, which is performed to remove a lesion of abnormal cells from the cervix. The loop electrode is attached to an electrosurgical generator that emits an electrical current used to cut away the affected tissues; following the removal of the cells in the affected area the ball electrode is used to seal the area and stop any bleeding that may have occurred.
Some indications for use are:
a. Cervical conizations
b. Large Loop Excision of the Transformation Zone (LLETZ) in the Diagnosis and Treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
c. External Anogenital Lesions
d. Large Vaginal Intraepithelial Neoplasic (VAIN) Lesions.
Product codes
85 HGI
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
cervix, Anogenital, Vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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
§ 884.4120 Gynecologic electrocautery and accessories.
(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2000
Ms. Kerry Anne Kahn Regulatory Affairs Coordinator R-Group International, Inc. 2321 N.W. 66th Ct., Suite W-4 Gainesville, FL 32653
Re: K993777 Disposable Ball and Loop Electrodes Dated: February 25, 2000 Received: February 25, 2000 Requiatory Class: II 21 CFR §884.4120/Procode: 85 HGI
Dear Ms. Kahn:
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 legally marketed predicate 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 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 (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 requlation may result in requlatory 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 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) 594-4591. Additionally, for question 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 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/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
1
Statement of Intended Use
K993777 510(k) Number (if known): Disposable Ball and Loop Electrode Device Name: Indications for Use:
The loop electrodes are designed for the LEEP or LLETZ procedure, which is performed to remove a lesion of abnormal cells from the cervix. The loop electrode is attached to an electrosurgical generator that mits an electrical current used to cut away the affected tiscues following the removal of the cells in the affected area the ball electrode is used to seal the area and stop any bleeding that may have occurred.
Some indications for use are:
- a. Cervical conizations
- b. Large Loop Excision of the Transformation Zone (LLETZ) in the Diagnosis and Treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
- c. External Anogenital Lesions
- d. Large Vaginal Intraepithelial Neoplasic (VAIN) Lesions.
(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)
OR
Over-the-Counter Use: (Optional Format 1-2)
David A. Seyson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number