(262 days)
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Not Found
No
The provided text describes a medical procedure (LLETZ) and its indications, but contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The text describes "LLETZ", which is a procedure (Loop Electrosurgical Excision Procedure) used to remove abnormal cells from the cervix. It does not describe a device that treats or diagnoses a condition.
No
The provided text describes the indications for a medical procedure (LLETZ) based on diagnostic findings (cytological and colposcopic suspicion of CIN, abnormal pap smear report). It does not describe a device that performs diagnostic functions itself. It outlines when a procedure is indicated based on findings, not a device that creates findings.
Unknown
The provided text does not contain a device description, which is essential to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The provided information describes a device used for the LLETZ procedure, which is a surgical procedure performed in vivo (inside the body) on the cervix.
- The indications for use relate to the clinical assessment of the cervix (cytological and colposcopic suspicion of CIN, abnormal pap smear reports, colposcopic examination findings) and the physician's decision to perform a surgical procedure.
Therefore, the device is a surgical instrument used for a therapeutic procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
Indication for the LLETZ procedure include: A cytological and coposcopic suspicion of CIN; A transformation zone which is fully visible and fully confined to the cervix; LLETZ in indicated for those patients who have had abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix unsatisfactory finding and who, in the physician's opinion are suitable candidates for the procedure.
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
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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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 2000
Mr. Mark J. Kahn Palm Medical USA, Inc. 6322 N.W. 18th Drive Suite 170 Gainesville, FL 32653
Re: K993527 Ball and Loop Electrodes for LOOP and LLETZ procedures Dated: April 4, 2000 Received: April 7, 2000 Regulatory Class: II 21 CFR §884.4120/Procode: 85 HGI
Dear Mr. Kahn:
We have reviewed your Section 510(k) notification of intent to market the device 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 practice, labeling, 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 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 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 questions 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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
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
Page 1 of 1
510(k) Number (if known): K993527
Device Name: Loop ELECTRODE/BALL ELECTREDE
Indications For Use:
Indication for the LLETZ procedure include:
A cytological and coposcopic suspicion of CIN;
A transformation zone which is fully visible and fully confined to the cervix;
LLETZ in indicated for those patients who have had abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix unsatisfactory finding and who, in the physician's opinion are suitable candidates for the procedure.
(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 Reproductive, Abdominal, ENT, and Radiological Devices510(k) NumberK993527 | (Division Sign-Off) | Division of Reproductive, Abdominal, ENT, and Radiological Devices | 510(k) Number | K993527 | |
|---|---|---|---|---|---|
| (Division Sign-Off) | |||||
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |||||
| 510(k) Number | K993527 | ||||
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
(Optional Format 1-2-96)