(161 days)
No
The document describes image processing for temperature monitoring using PRF shift analysis and image subtraction, but does not mention the use of AI or ML algorithms for this or any other function.
Yes
The device is clearly indicated for "surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue," which directly treats a medical condition.
No
The device is described as a "thermal laser ablation system that causes coagulation necrosis of soft tissue" and is "indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue". This indicates a primary therapeutic function rather than a diagnostic one. While it monitors temperature during treatment, this is for treatment control, not for diagnosing a condition.
No
The device description explicitly states that the system consists of a Workstation containing core system hardware and software, a single-use Laser Applicator Kit (including a Laser Catheter and Thermal-Optical Probe), and off-the-shelf accessories like a Tubing Set and optional Multi-Channel Needle Guide. These are physical components, not solely software.
Based on the provided information, the Avenda Health Treatment System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the living body (in vitro).
- Avenda Health Treatment System Function: The Avenda Health Treatment System is a thermal laser ablation system used for surgical procedures. It directly interacts with and treats soft tissue within the patient's body (in vivo). Its purpose is to ablate, vaporize, excise, incise, and coagulate tissue, not to analyze specimens for diagnostic purposes.
- Intended Use: The intended use clearly describes surgical applications requiring the manipulation of soft tissue, not the analysis of biological samples.
- Device Description: The description details a system for delivering laser energy and monitoring temperature during a surgical procedure, not a system for analyzing biological specimens.
- Input Imaging Modality: While it uses imaging (MRI and ultrasound) for guidance during the procedure, this is for visualizing the target tissue and monitoring the treatment, not for analyzing biological samples.
Therefore, the Avenda Health Treatment System falls under the category of a surgical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Avenda Health Treatment System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, orthopedics, pulmonology, radiology, adiology, and urology, at a wavelength of 980nm.
Product codes
GEX
Device Description
The Avenda Health Treatment System ("Treatment System") is a thermal laser ablation system that causes coagulation necrosis of soft tissue. The Treatment System consists of the capital system Workstation and the single use Laser Applicator Kit. The Workstation contains core system hardware and software, provides the System's touchscreen user interface (UI), and serves as a "hub" to facilitate the connectivity of other System components. The Laser Applicator Kit consists of two patient-contacting disposable components, the Laser Catheter, and the Thermal-Optical Probe ("TOP"), which facilitate delivery of laser energy and monitoring of temperature, respectively. The Treatment Monitoring Software, which operates on the Workstation, provides the UI for controlling the device, displays previously generated patient and treatment plan information for the procedure, and actively monitors the treatment progress during a procedure by displaying output from the TOP.
The Treatment System is additionally used with an off-the-shelf accessory, the Tubing Set, which transports saline in a closed-loop system between the Workstation and Laser Catheter to provide cooling of the Laser Catheter. The Treatment System further includes an optional patient-contacting disposable accessory, the Multi-Channel Needle Guide ("MCG"), which may be used to attach an ultrasound probe to the Laser Catheter and TOP for enhanced visualization tracking, if desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, orthopedics, pulmonology, radiology, adiology, and urology.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical testing included:
- Sterilization Validation in accordance with ISO 11135:2014.
- Packaging and shelf life testing in accordance with ISO 11607-1:2019.
- Biocompatibility evaluation in accordance with ISO 10993-1:2018.
- Software documentation in accordance to FDA's guidance document titled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005.
- Software verification and validation testing in accordance to FDA's guidance document titled, "General Principles of Software Validation," issued January 11, 2002.
- Electrical safety and electromagnetic compatibility testing in accordance with the requirements of IEC 60601-1:2012 and IEC 60601-1-2:2014.
- Non-clinical design verification and validation testing.
The results demonstrate that the device meets established specifications for consistent performance and does not raise different questions of safety or effectiveness compared to predicate devices for laser-based coagulation of soft tissue. No clinical testing was conducted.
Key Metrics
Not Found
Predicate Device(s)
Clinical Laserthermia Systems AB Tranbergels Thermal Therapy System (K142216)
Reference Device(s)
Medtronic Navigation Inc. Visualase Thermal Therapy System (K181859)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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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.
November 30, 2020
Avenda Health, Inc. % Michael Billig Co-Founder and Chief Executive Officer Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose. California 95110
Re: K201687
Trade/Device Name: Avenda Health Treatment System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: June 19, 2020 Received: June 22, 2020
Dear Michael Billig:
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.
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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 and Part 809); 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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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,
Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K201687
Device Name Avenda Health Treatment System
Indications for Use (Describe)
The Avenda Health Treatment System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, orthopedics, pulmonology, radiology, adiology, and urology, at a wavelength of 980nm.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Notification K201687
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Avenda Health, Inc. 929 Colorado Avenue Santa Monica, CA 90401 USA Phone: 310-957-5202
Contact Person:
Brittany Berry-Pusey, PhD Co-Founder and COO, Avenda Health, Inc. Phone: 310-957-5860 Email: brit@avendahealth.com
Application Correspondent:
Michael J. Billig Regulatory and Clinical Consultant to Avenda Health, Inc. Co-Founder and Chief Executive Officer, Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Office: 408-400-0856 Email: mjb@experiengroup.com
Date Prepared: November 23, 2020
DEVICE INFORMATION [807.92(a)(2)]
Trade Name: Avenda Health Treatment System
Generic Name: Powered Laser Surgical Instrument
Common Name: Focal Laser Therapy System
Classification: 21 CFR$878.4810, Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology
Product Code: GEX
Regulatory Class: II
4
PREDICATE DEVICE [807.92(a)(3)]
Predicate Device: Clinical Laserthermia Systems AB Tranbergels Thermal Therapy System (K142216)
Reference Predicate Device: Medtronic Navigation Inc. Visualase Thermal Therapy System (K181859)
DEVICE DESCRIPTION [807.92(a)(4)]
The Avenda Health Treatment System ("Treatment System") is a thermal laser ablation system that causes coagulation necrosis of soft tissue. The Treatment System consists of the capital system Workstation and the single use Laser Applicator Kit. The Workstation contains core system hardware and software, provides the System's touchscreen user interface (UI), and serves as a "hub" to facilitate the connectivity of other System components. The Laser Applicator Kit consists of two patient-contacting disposable components, the Laser Catheter, and the Thermal-Optical Probe ("TOP"), which facilitate delivery of laser energy and monitoring of temperature, respectively. The Treatment Monitoring Software, which operates on the Workstation, provides the UI for controlling the device, displays previously generated patient and treatment plan information for the procedure, and actively monitors the treatment progress during a procedure by displaying output from the TOP.
The Treatment System is additionally used with an off-the-shelf accessory, the Tubing Set, which transports saline in a closed-loop system between the Workstation and Laser Catheter to provide cooling of the Laser Catheter. The Treatment System further includes an optional patient-contacting disposable accessory, the Multi-Channel Needle Guide ("MCG"), which may be used to attach an ultrasound probe to the Laser Catheter and TOP for enhanced visualization tracking, if desired.
INDICATIONS FOR USE [807.92(a)(5)]
The Avenda Health Treatment System is indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in areas of surgery including: cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, and urology, at a wavelength of 980nm.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [807.92(a)(6)]
The proposed device has the same intended use as the predicate device and reference predicate device. All three devices are powered surgical laser systems, used in a similar range of surgical applications, which perform coagulation of soft tissue at comparable power and wavelengths that can be conducted under image visualization and guidance. The devices are furthermore similar in technological characteristics with respect to providing a similar range of tissue damage and thermal monitoring capabilities. While there are minor technological differences between the
5
proposed and predicate device, particularly with respect to specific laser parameters, these differences do not raise any different questions of safety and effectiveness, as confirmed through the results of performance testing.
The following table (Table 1) presents a tabular comparison of technological characteristics between the proposed device, predicate device, and reference predicate device.
| Feature | Predicate Device | Reference Predicate
Device | Proposed Device |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Clinical Laserthermia
Systems AB.
TranbergCLS Thermal
Therapy System
(K142216) | Medtronic Navigation
Inc.
Visualase Thermal
Therapy System
(K181859) | Avenda Health Inc.
Avenda Health
Treatment System
(K________) |
| Classification | 21 CFR§878.4810, Laser
Surgical Instrument for
Use in General and Plastic
Surgery and in
Dermatology | 21 CFR§878.4810, Laser
Surgical Instrument for
Use in General and Plastic
Surgery and in
Dermatology | Same |
| Product Code | GEX | GEX, FRN, LLZ | GEX |
| Intended
Use/Indications for Use | The TranbergCLS Thermal
Therapy System is
indicated for use in
surgical applications
requiring the ablation,
vaporization, excision,
incision, and coagulation
of soft tissue in areas of
surgery including:
gastroenterology, general
surgery, plastic surgery,
genitourinary (urology),
gynecology (GYN),
neurosurgery,
otolaryngology (ENT)
head and neck,
orthopedics,
ophthalmology,
pulmonology, and thoracic
surgery. | The Visualase™ Thermal
Therapy System is
indicated for use to
necrotize or coagulate soft
tissue through interstitial
irradiation or thermal
therapy under magnetic
resonance imaging (MRI)
guidance in medicine and
surgery in cardiovascular
thoracic surgery
(excluding the heart and
the vessels in the
pericardial sac),
dermatology,
ear-nose-throat surgery,
gastroenterology, general
surgery, gynecology, head
and neck surgery,
neurosurgery, plastic
surgery, orthopedics,
pulmonology, radiology,
and urology, for
wavelengths 800nm
through 1064nm.
When therapy is
performed under MRI
guidance, and when data
from compatible MRI | The Avenda Health
Treatment System is
indicated for use in
surgical applications
requiring the ablation,
vaporization, excision,
incision, and coagulation
of soft tissue in areas of
surgery including:
cardiovascular thoracic
surgery (excluding the
heart and the vessels in
the pericardial sac),
dermatology,
ear-nose-throat surgery,
gastroenterology, general
surgery, gynecology, head
and neck surgery,
neurosurgery, plastic
surgery, orthopedics,
pulmonology, radiology,
and urology, at a
wavelength of 980nm. |
| Feature | Predicate Device | Reference Predicate
Device | Proposed Device |
| | Clinical Laserthermia
Systems AB.
TranbergCLS Thermal
Therapy System
(K142216) | Medtronic Navigation
Inc.
Visualase Thermal
Therapy System
(K181859) | Avenda Health Inc.
Avenda Health
Treatment System
(K____) |
| | | sequences is available, the
Visualase™ system can
process images using
proton
resonance-frequency
(PRF) shift analysis and
image subtraction to relate
changes in complex phase
angle back to relative
changes in tissue
temperature during
therapy. The image data
may be manipulated and
viewed in a number of
different ways, and the
values of data at certain
selected points may be
monitored and/or
displayed over time.
The Visualase™ Thermal
Therapy System is
compatible with General
Electric Medical Systems
Signa model MR scanners
and with Siemens Medical
Solutions Magnetom
Espree systems. When
interpreted by a trained
physician, this device
provides information that
may be useful in the
determination or
assessment of thermal
therapy. Patient
management decisions
should not be made solely
on the basis of
Visualase™ analysis. | |
| Wavelength (Diode
laser generator) | 1064nm | 800nm – 1064nm | 980nm |
| Output power | 1W - 25W at output port | 3W – 15W at output port | Up to 14W at output port |
| Output power accuracy | ±10% of selected value | ±20% of selected value | ±20% of selected value |
| Feature | Predicate Device | Reference Predicate
Device | Proposed Device |
| | Clinical Laserthermia
Systems AB.
TranbergCLS Thermal
Therapy System
(K142216) | Medtronic Navigation
Inc.
Visualase Thermal
Therapy System
(K181859) | Avenda Health Inc.
Avenda Health
Treatment System
(K) |
| Mode of operation | Continuous wave (CW) or
controlled by tissue
temperature monitored by
a temperature sensor | Continuous wave (CW),
pulsed, or external
modulation modes. | Continuous Wave (CW) |
| Output power
increments | 1W | 0.5W | 0.1W |
| Cooling | TEC | TEC | Same |
| Channel(s) | 1 | 1 | Same |
| Output port | SMA 905 | SMA 905 | Proprietary |
| Aiming wavelength | 635nm | 650nm | 635 or 650nm |
| Laser Type (per IEC
60825-1) | Class 4 | Class 4 | Same |
| Laser Safety
Classification FDA | Class 2 | Class 2 | Same |
| Power source (General) | 100-240V AC / 50-60Hz | 100-240V AC / 50-60Hz | 120V AC / 60Hz |
| Operating temperature
range | 15°C - 28°C | 18°C - 35°C | 10°C - 33°C |
| Emergency switch | Yes | Yes | Same |
| Key activation of laser
output | Yes | Yes | Same |
| Remote Interlock | Yes | Yes | Same |
| Power ON/OFF visual
indicator | Yes | Yes | Same |
| Laser emission
Indicator | Yes | Yes | Same |
| Internal laser power
monitor | Yes | Yes | Same |
| Manual reset | Yes | Yes | Same |
| Fiber insertion interlock | Yes | Yes | Same |
| Audio warning signal
level | Fixed at HIGH | HIGH, MEDIUM, LOW,
and OFF | Same as Predicate Device |
| Pump-driven applicator
cooling | Yes | Yes | Same |
| Feature | Predicate Device | Reference Predicate
Device | Proposed Device |
| | Clinical Laserthermia
Systems AB.
TranbergCLS Thermal
Therapy System
(K142216) | Medtronic Navigation
Inc.
Visualase Thermal
Therapy System
(K181859) | Avenda Health Inc.
Avenda Health
Treatment System
(K________) |
| Applicator Kit
Included? | No | Yes | Same as Reference
Predicate Device |
| PC interface | Yes | Yes | Same |
| Thermal feedback
mechanism | Direct, Thermocouple | Indirect, MR
Thermometry | Same as Predicate Device |
| Usage of software | Yes | Yes | Same |
| Collection of thermal
data | Yes | Yes | Same |
Table 1: Substantial Equivalence Table
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7
8
510(k) SUMMARY
9
PERFORMANCE DATA [807.92(b)]
All necessary performance testing was conducted on the Avenda Health Treatment System to support a determination of substantial equivalence to the predicate device.
[807.92(b)(1)] Non-clinical Testing Summary:
The non-clinical, bench testing included:
- Sterilization Validation in accordance with ISO 11135:2014, Sterilization of health-care . products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
- Packaging and shelf life testing in accordance with ISO 11607-1:2019. Packaging for . terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
- . Biocompatibility evaluation in accordance with ISO 10993-1:2018, Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process and FDA Guidance Document titled, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,'" issued June 16, 2016.
- Software documentation in accordance to FDA's guidance document titled, "Guidance . for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005.
- Software verification and validation testing in accordance to FDA's guidance document . titled, "General Principles of Software Validation," issued January 11, 2002.
- Electrical safety and electromagnetic compatibility testing in accordance with the . requirements of IEC 60601-1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests, respectively.
- . Non-clinical design verification and validation testing.
The collective results of the non-clinical testing demonstrate that the Avenda Health Treatment System meets the established specifications necessary for consistent performance during its intended use. The collective bench testing furthermore confirm that the Avenda Health Treatment System does not raise different questions of safety or effectiveness for achieving the same intended use of providing laser-based coagulation of soft tissue when compared to the predicate devices.
[807.92(b)(2)] Clinical Testing Summarv:
No clinical testing was conducted to support this 510(k) Premarket Notification.
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CONCLUSIONS [807.92(b)(3)]
The Avenda Health Treatment System (proposed device), the predicate device, Tranberg CLS Thermal Therapy System (K142216), and the reference predicate device. Visualase Thermal Therapy System (K181859) are all designed to coagulate soft tissue using a laser under image guidance with the aid of thermal feedback. The devices have the same Intended Use and similar Indications for Use. The devices also have similar technological characteristics, and any differences in technological differences do not raise different questions of safety and effectiveness. The results of non-clinical performance testing demonstrated that the device meets the established specifications necessary for consistent performance to achieve its intended use as safely and as effectively as the predicate device and reference predicate device and confirmed that the technological differences between the proposed device, predicate device and reference predicate device do not raise different questions of safety or effectiveness. As such, the Avenda Health Treatment System is as safe, as effective, and performs as well as the legally marketed predicate device, Tranberg CLS Thermal Therapy System (K142216), and reference predicate device, Visualase Thermal Therapy System (K181859).