(206 days)
The IRIS Thermocoagulator and Digital Colposcope is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe, and to provide magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in selecting areas for biopsy and diagnosing as needed for a colposcopy exam.
The Liger Medical IRIS Thermocoagulator and Digital Colposcope is a portable thermal coagulator with integral colposcope that provides assistance for clinician examination of the cervix as well as utilizes a heated probe to ablate human tissue. It is specifically designed for use in resource-limited settings. The colposcope and thermal ablation modes can be used separately from each other. The device is a handheld, portable, battery-operated, ablator with an LCD display and optical camera to assist diagnosis and treatment, in a safe, effective, easy to use package with sufficient battery life to sustain work for 4 hours. Thermal coagulation can be used in hospital and non-hospital professional healthcare locations.
The IRIS colposcope/thermal ablation device is not intended on into the vaginal canal during colposcopic examination. The camera remains outside the vaginal cavity and functions comparably to a standard non-invasive colposcope in terms of providing magnified visual assistance to the clinician. There is no patient contact during the colposcopic examination. Contact between the clinician and the device is mitigated through good clinical practice of wearing protective gloves, limiting contact to intact skin protected by operating gloves.
The thermal ablation probe, which is reusable and provided non-sterile, is designed to perform low-power destruction of human tissue with high temperatures by tissue contact with an electrically heated probe tip. The biocompatibility of the probe materials conforms to all recommended endpoints per FDA's guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for limited duration mucosal membrane contact.
The provided text is a 510(k) Summary for the Liger Medical IRIS Thermocoagulator and Digital Colposcope. It details the device's intended use, comparison to predicate devices, and non-clinical performance testing. However, it explicitly states "Not Applicable" under "9. Clinical Performance Data."
Therefore, based solely on the provided text, a detailed response to points 1-7, 8, and 9 for a study proving the device meets acceptance criteria cannot be fully constructed, as the document states no clinical performance data was used for this submission. The device's substantial equivalence was demonstrated through non-clinical performance testing and comparison to predicate devices.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document describes various non-clinical tests performed, implying these tests have acceptance criteria, but the specific numerical acceptance criteria and the precise quantified performance results are not detailed in a comparative table format. We only get a list of tests performed.
Table of Acceptance Criteria (Implied) and Reported Device Performance (General):
| Acceptance Criteria (Implied from tests) | Reported Device Performance (General Statement) |
|---|---|
| Electrical/Thermal Safety | Met ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 |
| Electromagnetic Compatibility (EMC) | Met IEC 60601-1-2:2014 (4th Ed) |
| Probe Fault Detection | Tested; Implied to have met design input requirements |
| Battery Fault Detection | Tested; Implied to have met design input requirements |
| Probe Heat-up time and Temperature Stability at Set-Point | Tested; Implied to have met design input requirements |
| Heater Circuit Hardware Checks | Tested; Implied to have met design input requirements |
| Heater Performance on Tissue | Tested; Implied to have met design input requirements |
| Software Application Testing | Tested; Implied to have met design input requirements |
| Use-Life Testing | Tested; Implied to have met design input requirements |
| Interoperability and Connectivity Testing | Tested; Implied to have met design input requirements |
| Endoscope General Requirements | Met ISO 8600-1:2015 |
| Field of View and Direction of View | Met ISO 8600-3:2019 |
| Limiting Spatial Resolution | Tested; Implied to have met design input requirements |
| Biocompatibility | Conforms to all recommended endpoints per FDA's guidance document "Use of International Standard ISO 10993-1" for limited duration mucosal membrane contact. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified as no clinical performance data was provided. The non-clinical tests would have involved specific test units, but the "sample size" in terms of patient data is not applicable here.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical performance data/test set with human expert ground truth was mentioned.
4. Adjudication method for the test set:
- Not applicable as no clinical performance data/test set requiring adjudication was mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a MRMC comparative effectiveness study was not done according to this document. The device includes a digital colposcope for magnified visualization to aid in selecting areas for biopsy and diagnosis, but the submission explicitly states "Not Applicable" for clinical performance data, meaning no study assessing human reader improvement with or without AI assistance was presented here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical instrument (thermocoagulator and digital colposcope), not an AI algorithm in isolation. While it has a "Digital Colposcope" component capable of camera-assisted visualization, the document does not describe any standalone algorithm performance.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" would be the established engineering and safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 8600-1, ISO 8600-3, ISO 10993-1) against which the device's technical performance was measured. No clinical ground truth (e.g., pathology, outcomes data) was used or presented in this 510(k) summary.
8. The sample size for the training set:
- Not applicable. This document is for a physical medical device, not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 23, 2021
Liger Medical, LLC Wm. Dean Wallace, MD, Ph.D. President 3300 North Running Creek Way, Building G, Suite G20 Lehi, UT 84043
Re: K202915
Trade/Device Name: IRIS Thermocoagulator and Digital Colposcope Regulation Number: 21 CFR§ 884.4120 Regulation Name: Gynecologic Electrocautery and Accessories Regulatory Class: II Product Code: HGI, PTZ Dated: March 24, 2021 Received: March 26, 2021
Dear Wm. Dean Wallace:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202915
Device Name
IRIS Thermocoagulator and Digital Colposcope
Indications for Use (Describe)
The IRIS Thermocoagulator and Digital Colposcope is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe, and to provide magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in selecting areas for biopsy and diagnosing as needed for a colposcopy exam.
| Type of Use (Select one or both, as applicable) | Depreciable (Part 21 CFR 601 Subpart D) One-Time Standard (21 CFR 601 Subpart C) | Depreciable (Part 21 CFR 601 Subpart D) | One-Time Standard (21 CFR 601 Subpart C) |
|---|---|---|---|
| Depreciable (Part 21 CFR 601 Subpart D) | |||
| One-Time Standard (21 CFR 601 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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K202915 Page 1 of 8
Liger Medical LLC
LIGER MEDICAL
Innovation for Better Women's Health
3300 North Running Creek Way Building G, Basement Suite G20 Lehi, Utah 84043, USA 801-256-6576 www.ligermedical.com
510(k) Summary: K202915
1. Submitter Information
Manufacturer Name and Address
Liger Medical LLC 3300 North Running Creek Way Building G, Basement Suite G20 Lehi, Utah 84043 USA Phone: 801-256-6576
Official Correspondent
Wm. Dean Wallace MD, PhD Liger Medical LLC 3300 North Running Creek Way Building G, Basement Suite G20 Lehi, Utah 84043
- Date Prepared: April 20, 2021 2.
- Device Information: 3.
Proprietary Name: IRIS Thermocoagulator and Digital Colposcope
Common Name: Thermocoagulator and Colposcope
FDA Classification:
| Thermocoagulator | Colposcope | |
|---|---|---|
| Product Code: | HGI | PTZ |
| Regulation Name: | Gynecologic Electrocauteryand Accessories | Colposcope, Exempt |
| Regulation Number: | 21 CFR 884.4120 | 21 CFR 884.1630 |
| Regulatory Class: | Class II | Class II |
4. Predicate Device(s):
The IRISThermocoagulator & Digital Colposcope is substantially equivalent to the following device(s):
| Manufacturer | Device | 510(k) | Date Cleared |
|---|---|---|---|
| Liger Medical LLC | Liger Medical Thermocoagulator HTU-110 | K152843 | 06/24/2016 |
Copyright © Liger Medical LLC. All rights reserved. The content are proprietary to Liger Medical LLC, Unauthorized use, disclosure and reproduction are strictly prohibited.
{4}------------------------------------------------
LIGER MEDICAL
Innovation for Better Women's Health
3300 North Running Creek Way Building G, Basement Suite G20 Lehi, Utah 84043, USA 801-256-6576 www.ligermedical.com
510(k) Summary: K202915
| MobileODT Ltd. | EVA (Enhanced Visual Assessment) System | K161871 | 12/19/2016 |
|---|---|---|---|
| ---------------- | ----------------------------------------- | --------- | ------------ |
The predicate devices have not been subject to a design-related recall.
5. Device Description
The Liger Medical IRIS Thermocoagulator and Digital Colposcope is a portable thermal coagulator with integral colposcope that provides assistance for clinician examination of the cervix as well as utilizes a heated probe to ablate human tissue. It is specifically designed for use in resource-limited settings. The colposcope and thermal ablation modes can be usedseparately from each other. The device is a handheld, portable, battery-operated, ablator with an LCD display and optical camera to assist diagnosis and treatment, in a safe, effective, easy to use package with sufficient battery life to sustain work for 4 hours. Thermal coagulation can be used in hospital and non-hospital professional healthcare locations.
The IRIS colposcope/thermal ablation device is not intended on into the vaginal canal during colposcopic examination. The camera remains outside the vaginal cavity and functions comparably to a standard non-invasive colposcope in terms of providing magnified visual assistance to the clinician. There is no patient contact during the colposcopic examination. Contact between the clinician and the device is mitigated through good clinical practice of wearing protective gloves, limiting contact to intact skin protected by operating gloves.
The thermal ablation probe, which is reusable and provided non-sterile, is designed to perform low-power destruction of human tissue with high temperatures by tissue contact with an electrically heated probe tip. The biocompatibility of the probe materials conforms to all recommended endpoints per FDA's guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for limited duration mucosal membrane contact.
ACCESSORIES
The IRIS is compatible with the following accessories:
- · Liger Medical HTU-110 Thermocoagulator 19mm Flat Probe
- · Liger Medical HTU-110 Thermocoagulator 19mm Nipple Probe
- · Liger Medical HTU-110 Thermocoagulator 16mm Flat Probe
Copyright © Liger Medical LLC. All rights reserved. The content are proprietary to Liger Medical LLC, Unauthorized use, disclosure and reproduction are strictly prohibited.
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K202915 Page 3 of 8
Liger Medical LLC
Image /page/5/Picture/2 description: The image shows the logo for Liger Medical. The logo features a purple cross with a light blue abstract figure of a woman in the center. To the right of the cross, the words "LIGER MEDICAL" are written in light blue, with the tagline "Innovation for Better Women's Health" written in a smaller font below.
3300 North Running Creek Way Building G, Basement Suite G20 Lehi, Utah 84043, USA 801-256-6576 www.ligermedical.com
510(k) Summary: K202915
6. Indications for Use
The IRISThermocoagulator and Digital Colposcope is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe, and to provide magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in selecting areas for biopsy and diagnosing abnormalities as needed for a colposcopy exam.
Copyright © Liger Medical LLC. All rights reserved. The content are proprietary to Liger Medical LLC, Unauthorized use, disclosure and reproduction are strictly prohibited.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image is a logo for Liger Medical. The logo features a purple cross with a teal figure of a woman in the center. To the right of the cross is the text "LIGER MEDICAL" in teal, with the tagline "Innovation for Better Women's Health" in a smaller font below.
3300 North Running Creek Way Building G, Basement Suite G20 Lehi, Utah 84043, USA 801-256-6576 www.ligermedical.com
510(k) Summary: K202915
7. Predicate Comparison
The following table compares the IRISThermocoagulator & Digital Colposcope to indications for use, technological characteristics, and materials:
| Product Attribute | Primary Predicate Device:Liger Medical HTU-110(K152843) | Subject Device:Liger Medical IRISThermocoagulator and DigitalColposcope(K202915) | Secondary Predicate Device:MobileODT EVA(K161871) |
|---|---|---|---|
| Indications for Use: | Intended for the destruction ofhuman tissue with hightemperatures by tissue contactwith an electrically heatedprobe | The IRIS Thermocoagulator andDigital Colposcope is intendedfor the destruction of humantissue with high temperaturesby tissue contact with anelectrically heated probe, andto provide magnifiedvisualization of the tissues ofthe vagina, cervix and externalgenitalia in order to aid inselecting areas for biopsy and | The EVA (Enhanced VisualAssessment) System is intended toprovide magnified viewing of thevagina, cervix and externalgenitalia in order to aid indiagnosing abnormalities andselecting areas for biopsy. Thedevice is intended for use inhospitals, doctor's offices, andremote and rural clinics. |
Copyright © Liger Medical LLC. All rights reserved. The contents of this document are proprietary to Liger Medical LLC, Unauthorized use, disclosure and reproduction are strictly prohibited.
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Image /page/7/Picture/1 description: The image shows the logo for Liger Medical. The logo consists of a purple cross with a teal figure of a woman inside. To the right of the cross is the text "LIGER MEDICAL" in teal, with the tagline "Innovation for Better Women's Health" in a smaller font below.
3300 North Running Creek Way Building G, Basement Suite G20 Lehi, Utah 84043, USA 801-256-6576 www.ligermedical.com
510(k) Summary: K202915
| diagnosing abnormalities as | |||
|---|---|---|---|
| needed for a colposcopy exam. | |||
| Product Classification: | Gynecologic electrocautery andaccessories (21 CFR 884-4120)Product code: HGIClass II | Gynecologic electrocautery andaccessories (21 CFR 884.4120)Product Code: HGIColposcope, Exempt (21 CFR884.1630)Product Code: PTZClass II | Colposcope (21 CFR 884.1630)Product Code: HEXClass II |
| Where Used: | Professional HealthcareEnvironment | Same | Professional HealthcareEnvironment |
| Energy Used: | 12V Lithium-ion battery | Same | Unknown |
| Maximum Output Power: | 49W | Same | Not Applicable |
| Method of Activation: | On/Off Switch | Same | On/Off Switch |
| Thermal Ablation TemperatureSet Point | 100°C | 100 - 120°C | Not Applicable |
| Thermal Ablation Duty Cycle | 45 seconds | 20 - 60 seconds | Not Applicable |
| Method of Operation: | Single-button with Status LEDs | Touchscreen with Status LEDs | Touchscreen with Status LEDs |
| Materials: | Polycarbonate | Same | Unknown |
| Biocompatibility: | ISO 10993-1:2009 Validated | Same | Not Applicable |
| Method of Visualization | LED Illumination with DirectObservation with Unaided Eye | LED Illumination with DirectObservation with Unaided Eye | LED Illumination with DirectObservation with Unaided Eye |
Copyright © Liger Medical LLC. All rights reserved. The contents of this document are proprietary to Liger Medical LLC, Unauthorized use, disclosure and reproduction are strictly prohibited.
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image is a logo for Liger Medical. The logo features a purple cross with a teal figure of a woman in the center. To the right of the cross is the text "LIGER MEDICAL" in teal, with the tagline "Innovation for Better Women's Health" in a smaller font below.
3300 North Running Creek Way Building G, Basement Suite G20 Lehi, Utah 84043, USA 801-256-6576 www.ligermedical.com
510(k) Summary: K202915
| and/or Camera Assistedvisualization with Display | and/or Camera Assistedvisualization with Display | ||
|---|---|---|---|
| Working Distance | Not Applicable | 100-400mm | 225-425mm |
| Focusing Mechanism | Not Applicable | Manual | Manual |
| Magnification | Not Applicable | 18x | 225: 16x425: 15x |
| Digital Magnification | Not Applicable | 1x-4x | 1x-4x |
| Optical magnification | Not Applicable | 3x | 225: 4.0x425: 3.8x |
| Depth of Field | Not Applicable | 15mm (at 200mm) - 35mm (at450mm) | 17mm (at 225mm) - 34mm (At425mm) |
| Field of View | Not Applicable | 55mm (at 200mm) - 123mm (at450mm) | 45mm (at 225mm) - 100mm (at425mm) |
| On-axis Spatial Resolution | Not Applicable | 15.75 lp/mm | 11.78 lp/mm |
| On-axis Angular Resolution | Not Applicable | 0.029 deg | 0.022 deg |
| Distortion | Not Applicable | <3.0% | <2.5% |
| Light Source | Not Applicable | 2W 5000K LED | 3W 6500K star LED |
| Color | Not Applicable | Digital green filter,polarizing/glare reducing filter | Digital green filter,polarizing/glare reducing filter |
| Image Output | Not Applicable | Image capture, cloud imageexporting | Image capture, cloud patientrecording and image exporting |
| Image Freeze | Not Applicable | Full image capturing support | Full image capturing support |
| Illuminance | Not Applicable | 7200lux at 300mm | >1000lux at 425mm |
Copyright © Liger Medical LLC. All rights reserved. The contents of this document are proprietary to Liger Medical LLC, Unauthorized use, disclosure and reproduction are strictly prohibited.
{9}------------------------------------------------
K202915 Page 7 of 8
Liger Medical LLC
3300 North Running Creek Way Building G, Basement Suite G20 Lehi, Utah 84043, USA 801-256-6576 www.ligermedical.com
510(k) Summary: K202915
Image /page/9/Figure/5 description: The image contains four panels. The first panel contains the word "Pictures". The second and third panels contain images of a medical device with labels pointing to different parts of the device. The fourth panel contains an image of the side of the medical device.
This medical device product has functions subject to FDA premarket revew as well as functions that are not subject to FDA premarket review. For this application, if the product has functions that are not subject to FDA assessed those functions only to the exter could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the FDA premarket review. The IRIS Thermocogulator & Digital Colposcope has the same intended use but different technological characteristics compared to the predicated in technological characteristics do not rase different questions of safety and effectiveness and can be evaluated through performance testing.
Copyright © Liger Medical LC. All rights reserved. The content are proprietary to Liger Medical LC, Unauthorized use, disclosure and reproduction are strictly prohibited.
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K202915 Page 8 of 8
Liger Medical LLC
Image /page/10/Picture/2 description: The image is a logo for Liger Medical. The logo features a purple cross with a teal figure of a woman in the center. To the right of the cross is the text "LIGER MEDICAL" in teal, with the tagline "Innovation for Better Women's Health" in a smaller font below.
3300 North Running Creek Way Building G, Basement Suite G20 Lehi, Utah 84043, USA 801-256-6576 www.ligermedical.com
510(k) Summary: K202915
Non-Clinical Performance Testing 8.
Non-clinical tests were conducted to verify that the IRIS Thermocoagulator & Digital Colposcope met all design input requirements and is substantially equivalent to the predicate device(s).
The IRISThermocoagulator & Digital Colposcope was tested for electrical/thermal safety and EMC according to the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 ●
- . IEC 60601-1-2:2014 (4th Ed)
The following additional bench testing for performance verification and validation purposes was performed:
- . Probe Fault Detection
- Battery Fault Detection
- . Probe Heat-up time and Temperature Stability at Set-Point
- . Heater Circuit Hardware Checks
- Heater Performance on Tissue
- . Software Application Testing
- . Use-Life Testing
- . Interoperability and Connectivity Testing
- . Endoscope General Requirements per ISO 8600-1:2015
- . Field of View and Direction of View per ISO 8600-3:2019
- . Limiting Spatial Resolution
9. Clinical Performance Data
Not Applicable
10. Conclusion
Based on the comparison and analysis above, the IRIS Thermocoagulator & Digital Colposcope is substantially equivalent to the predicate device(s).
Copyright © Liger Medical LLC. All rights reserved. The content are proprietary to Liger Medical LLC, Unauthorized use, disclosure and reproduction are strictly prohibited.
§ 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).