(184 days)
Not Found
No
The device description and intended use focus on electrosurgical and fluid management functions, with no mention of AI or ML technologies.
Yes
The device is indicated for "electrosurgical fulguration (coagulation) of the uterine cervix," which is a treatment procedure, signifying a therapeutic purpose.
No.
The device is indicated for electrosurgical fulguration (coagulation) and aspiration/irrigation, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines physical components made of stainless steel, ULTEM®, PVC, and ABS, indicating it is a hardware device with electrosurgical capabilities, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for electrosurgical procedures (fulguration/coagulation) on the uterine cervix. This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device is an electrosurgical electrode with irrigation and aspiration capabilities. It is used in conjunction with an electrosurgical generator and vacuum suction system. These are all tools used for surgical intervention.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis of biological specimens.
The device is a surgical tool used for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Irrigation/Aspiration/Coagulation Electrodes, ICE-311 and ICE-511, are indicated for electrosurgical fulguration (coagulation) of the uterine cervix as part of the procedure called Loop Excision of the Transformation Zone (LETZ®), or other loop electrosurgery procedures where simultaneous electrosurgical fulguration and small-volume fluid irrigation and/or aspiration is needed.
Product codes (comma separated list FDA assigned to the subject device)
78 HGI
Device Description
The device consists of a stainless steel spherical ball electrode attached to an ULTEM® irrigation and aspiration head that has PVC irrigation and aspiration tubes. The posterior end of the electrode shaft fits snugly into a standard electrosurgical pen which is connected to an electrosurgical generator that has been cleared for marketing by the FDA. The irrigation tube has a PVC female Luer fitting for connection to a fluid source and the aspiration tube has an ABS suction adapter for connection to a standard vacuum suction system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine cervix
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)
Laboratory tests of the UMP ICE and the MMP #0055 have demonstrated that the irrigation fluid flow differs by less than 4% and that the aspiration capability differs by less than 8%. The coagulation capabilities of the UMP ICE and the UMP ACE are equivalent since they are based on the same UMP DBL electrodes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
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
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510(k) Summary
December 27, 1996
. || || 7 10007
Trade Name: TBD Irrigation Aspiration Coagulation Electrode Common Name: Electrosurgical Cutting and Coagulation Device and Accessories, 21 CFR 878.4400 Classification:
The Irrieation/Aspiration/Coagulation Electrodes (ICE) are substantially equivalent to Utah Medical Products, Inc.'s ACE-311 and ACE-511 Aspiration/Coagulation Electrodes (K955093) used for fluid aspiration and coagulation, combined with the irrigation feature of the MegaDyne Medical Products, Inc. 's All-In-One Hand Control #0055 (K922002).
The device consists of a stainless steel spherical ball electrode attached to an ULTEM® irrigation and aspiration head that has PVC irrigation and aspiration tubes. The posterior end of the electrode shaft fits snugly into a standard electrosurgical pen which is connected to an electrosurgical generator that has been cleared for marketing by the FDA. The irrigation tube has a PVC female Luer fitting for connection to a fluid source and the aspiration tube has an ABS suction adapter for connection to a standard vacuum suction system.
The ICE-311 and ICE-511, are indicated for electrosurgical fulguration (coagulation) of the uterine cervix as part of the procedure called Loop Excision of the Transformation Zone (LETZ®), or other loop electrosurgery procedures where simultaneous electrosurgical fulguration and small-volume fluid irrigation and/or aspiration is needed. When used according to the instructions for use, in the hands of a trained user, the device provides an effective tool for allaving excessive bleeding by fulgurating and desiccating the surface of wounds produced during surgical procedures. The irrigation and aspiration features allow the user to flush the surface of the wound and aspirate fluids and blood that would interfere with cauterization of the surgical wound. The Aspiration and Coagulation functions of the ICE electrodes are identical to the functions of the UMP ACE electrodes. The irrigation function of the ICE electrodes is substantially equivalent to the function of the MMP #0055, although that device is intended for use in laparoscopic procedures.
The technological characteristics of the ICE electrodes are substantially equivalent to the UMP ACE electrodes and the MMP #0055 hand control. There are differences in the materials used, however, they are all biocompatible materials. The MMP #0055 has flow control valves incorporated into it, whereas, the UMP ICE requires external control of the irrigation fluid and the aspiration vacuum.
Laboratory tests of the UMP ICE and the MMP #0055 have demonstrated that the irrigation fluid flow differs by less than 4% and that the aspiration capability differs by less than 8%. The coagulation capabilities of the UMP ICE and the UMP ACE are equivalent since they are based on the same UMP DBL electrodes.
Kevin L. Cornwall
Kevin L. Cornwell President & CEO
5k-35
36
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John W. Smith Quality Assurance Manager Utah Medical Products, Inc. 7043 South 300 West Midvale, Utah 84047-1048
. II II 3 1997
Re: K965245 Disposable Irrigation/Aspiration/Coagulation Electrode Dated: April 21, 1997 Received: April 23, 1997 Regulatory class: II 21 CFR §884.4120/Product code: 78 HGI
Dear Mr. Smith:
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 intens 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, 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 OS 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 marked 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) 594-4613. 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" (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
h.7liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name: Irrigation/Aspiration/Coagulation Electrode
X965245
Indications For Use:
Indications
The Irrigation/Aspiration/Coagulation Electrodes, ICE-311 and ICE-511, are indicated for electrosurgical fulguration (coagulation) of the uterine cervix as part of the procedure called Loop Excision of the Transformation Zone (LETZ®), or other loop electrosurgery procedures where simultaneous electrosurgical fulguration and small-volume fluid irrigation and/or aspiration is needed.
Contraindications
The ICE-311 and ICE-511 should not be used where loop electrosurgery is contraindicated. Examples of contraindications for LETZ are:
- Pregnancy .
- Acute or active inflammation of the cervix, endometrium, fallopian tube, ovary or . peritoneum (cervicitis, endometritis, tubo-ovarian inflammatory disease or pelvic inflammatory disease)
- Invasive cancer that is visible on examination t
- Known or suspected cervical changes secondary to DES (diethylstilbestrol) uterine . exposure.
Consult the electrosurgery unit (ESU) operation manual for details.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert B. Malling
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K965245
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)