IRIS Thermocoagulator and Digital Colposcope
Device Facts
| Record ID | K202915 |
|---|---|
| Device Name | IRIS Thermocoagulator and Digital Colposcope |
| Applicant | Liger Medical, LLC |
| Product Code | HGI · Obstetrics/Gynecology |
| Decision Date | Apr 23, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.4120 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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.
Device Story
Portable, battery-operated handheld device combining thermal coagulator and digital colposcope; used in professional healthcare settings. Thermal ablation: electrically heated probe tip (100-120°C) destroys tissue; controlled via touchscreen. Colposcopy: LED-illuminated optical camera provides magnified visualization (up to 18x) of cervix/vagina/genitalia; images displayed on LCD; supports image capture and cloud export. Clinician operates device; camera remains outside vaginal cavity. Output aids biopsy site selection and diagnosis. Benefits: portable, integrated diagnostic and treatment tool for resource-limited settings.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical/thermal safety (ANSI AAMI ES60601-1), EMC (IEC 60601-1-2), probe fault/heat-up performance, and endoscope requirements (ISO 8600-1, ISO 8600-3).
Technological Characteristics
Handheld, battery-operated (12V Li-ion). Materials: Polycarbonate (ISO 10993-1 compliant). Thermal: 100-120°C set point, 20-60s duty cycle. Visualization: 2W 5000K LED, 18x magnification, 15.75 lp/mm spatial resolution. Connectivity: Cloud image export. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 8600-1, ISO 8600-3.
Indications for Use
Indicated for destruction of human tissue via high-temperature electrically heated probe and magnified visualization of vagina, cervix, and external genitalia to aid in biopsy selection and diagnosis during colposcopy exams.
Regulatory Classification
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.
Predicate Devices
- Liger Medical Thermocoagulator HTU-110 (K152843)
- MobileODT Ltd. EVA (Enhanced Visual Assessment) System (K161871)
Related Devices
- K132423 — THE GYNOCULAR · Gynius AB · Apr 8, 2014
- K161871 — EVA (Enhanced Visual Assessment) System · Mobileodt , Ltd. · Dec 19, 2016
- K160380 — LT-300 HD · Lutech Industries, Inc. · May 13, 2016
- K181034 — Pocket Colposcope System · Hadleigh Health Technologies, LLC · Sep 21, 2018
- K072691 — CERVICAL MD, MODEL C10 · Sti Medical Systems · Jan 31, 2008
Submission Summary (Full Text)
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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) | <table><tr><td><div style="display:inline-block; vertical-align:middle;"> <img alt="Checked" src="checkbox_checked.png" style="width:16px; height:16px; vertical-align:middle;"/> </div> Depreciable (Part 21 CFR 601 Subpart D) </td></tr><tr><td><div style="display:inline-block; vertical-align:middle;"> <img alt="Unchecked" src="checkbox_unchecked.png" style="width:16px; height:16px; vertical-align:middle;"/> </div> One-Time Standard (21 CFR 601 Subpart C) </td></tr></table> | <div style="display:inline-block; vertical-align:middle;"> <img alt="Checked" src="checkbox_checked.png" style="width:16px; height:16px; vertical-align:middle;"/> </div> Depreciable (Part 21 CFR 601 Subpart D) | <div style="display:inline-block; vertical-align:middle;"> <img alt="Unchecked" src="checkbox_unchecked.png" style="width:16px; height:16px; vertical-align:middle;"/> </div> One-Time Standard (21 CFR 601 Subpart C) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block; vertical-align:middle;"> <img alt="Checked" src="checkbox_checked.png" style="width:16px; height:16px; vertical-align:middle;"/> </div> Depreciable (Part 21 CFR 601 Subpart D) | | | |
| <div style="display:inline-block; vertical-align:middle;"> <img alt="Unchecked" src="checkbox_unchecked.png" style="width:16px; height:16px; vertical-align:middle;"/> </div> 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 Electrocautery<br>and 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.
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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:<br>Liger Medical HTU-110<br>(K152843) | Subject Device:<br>Liger Medical IRIS<br>Thermocoagulator and Digital<br>Colposcope<br>(K202915) | Secondary Predicate Device:<br>MobileODT EVA<br>(K161871) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | Intended for the destruction of<br>human tissue with high<br>temperatures by tissue contact<br>with an electrically heated<br>probe | The IRIS Thermocoagulator and<br>Digital Colposcope is intended<br>for the destruction of human<br>tissue with high temperatures<br>by tissue contact with an<br>electrically heated probe, and<br>to provide magnified<br>visualization of the tissues of<br>the vagina, cervix and external<br>genitalia in order to aid in<br>selecting areas for biopsy and | The EVA (Enhanced Visual<br>Assessment) System is intended to<br>provide magnified viewing of the<br>vagina, cervix and external<br>genitalia in order to aid in<br>diagnosing abnormalities and<br>selecting areas for biopsy. The<br>device is intended for use in<br>hospitals, doctor's offices, and<br>remote 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 and<br>accessories (21 CFR 884-4120)<br>Product code: HGI<br>Class II | Gynecologic electrocautery and<br>accessories (21 CFR 884.4120)<br>Product Code: HGI<br>Colposcope, Exempt (21 CFR<br>884.1630)<br>Product Code: PTZ<br>Class II | Colposcope (21 CFR 884.1630)<br>Product Code: HEX<br>Class II |
| Where Used: | Professional Healthcare<br>Environment | Same | Professional Healthcare<br>Environment |
| 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 Temperature<br>Set 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 Direct<br>Observation with Unaided Eye | LED Illumination with Direct<br>Observation with Unaided Eye | LED Illumination with Direct<br>Observation 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 Assisted<br>visualization with Display | and/or Camera Assisted<br>visualization with Display |
|----------------------------|----------------|-----------------------------------------------------------|---------------------------------------------------------------|
| Working Distance | Not Applicable | 100-400mm | 225-425mm |
| Focusing Mechanism | Not Applicable | Manual | Manual |
| Magnification | Not Applicable | 18x | 225: 16x<br>425: 15x |
| Digital Magnification | Not Applicable | 1x-4x | 1x-4x |
| Optical magnification | Not Applicable | 3x | 225: 4.0x<br>425: 3.8x |
| Depth of Field | Not Applicable | 15mm (at 200mm) - 35mm (at<br>450mm) | 17mm (at 225mm) - 34mm (At<br>425mm) |
| Field of View | Not Applicable | 55mm (at 200mm) - 123mm (at<br>450mm) | 45mm (at 225mm) - 100mm (at<br>425mm) |
| 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,<br>polarizing/glare reducing filter | Digital green filter,<br>polarizing/glare reducing filter |
| Image Output | Not Applicable | Image capture, cloud image<br>exporting | Image capture, cloud patient<br>recording 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.
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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.
