K Number

Device Name

IRIS Thermocoagulator and Digital Colposcope

Manufacturer

Liger Medical, LLC

Date Cleared

2021-04-23

(206 days)

Product Code

HGI HEX PTZ

Regulation Number

884.4120

Intended 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 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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K152843, K161871

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML-powered devices. The performance studies focus on electrical/thermal safety, EMC, and basic device functionality.

Therapeutic

Yes
The device is described as a "thermocoagulator" and is intended for "destruction of human tissue with high temperatures by tissue contact with an electrically heated probe," which is a therapeutic action.

Diagnostic

Yes

The device provides "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," explicitly stating its role in aiding diagnosis.

SaMD (Software as a Medical Device)

The device description clearly states it is a "portable thermal coagulator with integral colposcope" and includes physical components like a heated probe, LCD display, optical camera, and battery. It also mentions hardware checks and testing of physical performance.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro).
Device Function: The IRIS Thermocoagulator and Digital Colposcope performs two main functions:
- Thermocoagulation: This is a therapeutic procedure that involves the destruction of tissue using heat. This is an in vivo (within the body) procedure.
- Digital Colposcopy: This provides magnified visualization of tissues in vivo to aid in selecting areas for biopsy and diagnosis. While it aids in diagnosis, it does not involve testing samples taken from the body.

The device's intended use and description clearly indicate that its primary functions are performed directly on or within the patient's body, not on samples taken from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

HGI, PTZ

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Vagina, cervix and external genitalia (human tissue)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Professional healthcare locations (hospital and non-hospital)

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)

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 IRIS Thermocoagulator & 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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K152843, K161871

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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.

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

Indications for Use

510(k) Number (if known) K202915

Device Name

IRIS Thermocoagulator and Digital Colposcope

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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
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

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

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

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.

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 IRIS
Thermocoagulator and Digital
Colposcope
(K202915) | Secondary Predicate Device:
MobileODT EVA
(K161871) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | Intended for the destruction of
human tissue with high
temperatures by tissue contact
with an electrically heated
probe | 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 | The EVA (Enhanced Visual
Assessment) System is intended to
provide magnified viewing of the
vagina, cervix and external
genitalia in order to aid in
diagnosing abnormalities and
selecting areas for biopsy. The
device is intended for use in
hospitals, doctor's offices, and
remote and rural clinics. |

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
accessories (21 CFR 884-4120)
Product code: HGI
Class II	Gynecologic electrocautery and
accessories (21 CFR 884.4120)
Product Code: HGI
Colposcope, Exempt (21 CFR
884.1630)
Product Code: PTZ
Class II	Colposcope (21 CFR 884.1630)
Product Code: HEX
Class II
Where Used:	Professional Healthcare
Environment	Same	Professional Healthcare
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
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
Observation with Unaided Eye	LED Illumination with Direct
Observation with Unaided Eye	LED Illumination with Direct
Observation with Unaided Eye

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
visualization with Display | and/or Camera Assisted
visualization with Display |
|----------------------------|----------------|-----------------------------------------------------------|---------------------------------------------------------------|
| Working Distance | Not Applicable | 100-400mm | 225-425mm |
| Focusing Mechanism | Not Applicable | Manual | Manual |
| Magnification | Not Applicable | 18x | 225: 16x
425: 15x |
| Digital Magnification | Not Applicable | 1x-4x | 1x-4x |
| Optical magnification | Not Applicable | 3x | 225: 4.0x
425: 3.8x |
| Depth of Field | Not Applicable | 15mm (at 200mm) - 35mm (at
450mm) | 17mm (at 225mm) - 34mm (At
425mm) |
| Field of View | Not Applicable | 55mm (at 200mm) - 123mm (at
450mm) | 45mm (at 225mm) - 100mm (at
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 | 1000lux at 425mm |

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.

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).