(184 days)
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.
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 provided document is a 510(k) summary for a medical device called the "TBD Irrigation Aspiration Coagulation Electrode" (ICE). This summary describes the device and its substantial equivalence to previously cleared devices. However, it does not include a detailed study proving the device meets specific acceptance criteria in the format requested.
The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and functional comparisons with predicate devices, rather than presenting a performance study with defined acceptance criteria.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and what is missing:
Information that can be extracted/inferred:
- Device Performance Reported: The document reports that:
- "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."
Information that is missing or not explicitly detailed in the provided text:
- A table of acceptance criteria: Specific, quantifiable acceptance criteria are not explicitly defined in the document as "acceptance criteria." Instead, the performance metrics mentioned above (e.g., <4% difference in irrigation flow, <8% difference in aspiration capability) act as implicit performance targets based on comparison to predicate devices.
- Sample size used for the test set and the data provenance: The document mentions "Laboratory tests" but does not specify the sample size (e.g., number of devices tested, number of measurements taken) or the provenance of the data (country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these tests would be the measured performance of the predicate device. Expert consensus is not a factor for these types of engineering/laboratory tests.
- Adjudication method: Not applicable, as expert adjudication is not relevant for these types of laboratory tests comparing physical attributes.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No, this type of study is not mentioned or described. The device is a surgical tool, and the focus is on its physical performance rather than diagnostic accuracy or human interpretation of images.
- Standalone (i.e., algorithm only without human-in-the-loop performance) study: No, this is not applicable as the device is a physical electrosurgical tool, not an AI algorithm.
- Type of ground truth used:
- For irrigation flow and aspiration capability: The "ground truth" was the measured performance of the predicate device (MMP #0055).
- For coagulation capabilities: The "ground truth" was the performance of the UMP ACE electrodes, as the ICE electrodes use the "same UMP DBL electrodes."
- Sample size for the training set: Not applicable, as this is a physical medical device, not an AI model that requires a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
Attempt to present the information in the requested format, acknowledging missing details:
Acceptance Criteria and Device Performance Study for Utah Medical Products Inc.'s ICE electrodes
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Irrigation Fluid Flow | Difference of less than 4% compared to predicate (MMP #0055) | Differed by less than 4% compared to predicate (MMP #0055) |
| Aspiration Capability | Difference of less than 8% compared to predicate (MMP #0055) | Differed by less than 8% compared to predicate (MMP #0055) |
| Coagulation Capabilities | Equivalent to predicate devices (UMP ACE, based on UMP DBL electrodes) | Equivalent to UMP ACE electrodes (as they use the same UMP DBL electrodes) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. The text only refers to "Laboratory tests."
- Data Provenance: Not specified. It can be inferred that these were internal laboratory tests conducted by Utah Medical Products, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The ground truth for these engineering tests was based on direct measurement of physical properties of the predicate devices.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Expert adjudication is not relevant for objective laboratory measurements of device performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument, not a diagnostic imaging or AI-driven system that would typically undergo such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm-only) performance study was not done. The device is a physical electrosurgical tool, not an AI algorithm.
7. The type of ground truth used
- Ground Truth Type: For irrigation fluid flow and aspiration capability, the ground truth was the measured performance of the identified predicate device (MegaDyne Medical Products, Inc.'s All-In-One Hand Control #0055). For coagulation capabilities, the ground truth was the performance of Utah Medical Products, Inc.'s ACE-311 and ACE-511 Aspiration/Coagulation Electrodes, as the ICE electrodes use the same core coagulating components (UMP DBL electrodes).
8. The sample size for the training set
- Sample Size: Not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable.
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Image /page/0/Picture/1 description: The image is a black and white logo for Utah Medical Products Inc. The logo features the company's name in bold, uppercase letters at the top, with a horizontal line underneath. Below the line is a stylized symbol that appears to be a combination of the letters 'U' and 'M', forming a unique shape. The symbol is solid black and has a rounded, modern design.
510(k) Summary
December 27, 1996
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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
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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
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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)
§ 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).