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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Avenda Health Treatment System, a laser ablation system for soft tissue coagulation. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets acceptance criteria" in the context of an AI/Machine Learning (ML) device is not directly applicable or available in this document.

The document states: "[807.92(b)(2)] Clinical Testing Summary: No clinical testing was conducted to support this 510(k) Premarket Notification." This means there was no human-in-the-loop study (MRMC) or standalone algorithm performance study performed for this submission to evaluate its effectiveness in a traditional clinical setting against a ground truth.

Instead, the submission relies on non-clinical bench testing to demonstrate that the device is as safe and effective as its predicate devices, focusing on the system's physical and technical performance.

Here's a breakdown of the requested information, highlighting what is available and what is not:

1. Table of acceptance criteria and the reported device performance:

Since no clinical efficacy acceptance criteria for an AI/ML component are presented, the "acceptance criteria" here refers to the performance of the physical device as demonstrated through non-clinical testing.

Acceptance Criteria (Implied from Non-Clinical Testing)	Reported Device Performance (Summary)
Sterilization validated to ISO 11135:2014	Meets requirements (results not detailed)
Packaging and shelf life validated to ISO 11607-1:2019	Meets requirements (results not detailed)
Biocompatibility evaluated to ISO 10993-1:2018	Meets requirements (results not detailed)
Software documentation in accordance with FDA guidance (May 2005)	Meets requirements (documentation submitted)
Software verification and validation to FDA guidance (January 2002)	Meets requirements (testing performed)
Electrical safety to IEC 60601-1:2012	Meets requirements (testing performed)
Electromagnetic compatibility to IEC 60601-1-2:2014	Meets requirements (testing performed)
Non-clinical design verification and validation	Meets established specifications; confirms no different questions of safety/effectiveness compared to predicates.

2. Sample size used for the test set and the data provenance:

Test set sample size: Not applicable/not specified for clinical testing, as no clinical testing was performed. For non-clinical bench testing, the sample sizes would refer to the number of physical devices or components tested, but these details are not provided in the summary.
Data provenance: Not applicable for clinical data. For non-clinical testing, the data would originate from the manufacturer's internal testing facilities.

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 ground truth was established due to the absence of clinical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical testing requiring expert adjudication was performed.

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, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical testing was conducted to support this 510(k) Premarket Notification." The device is a laser ablation system, not an AI/ML diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone performance study was not done in the context of an AI/ML algorithm. The device is a physical laser system, and its performance was evaluated through non-clinical bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

No clinical ground truth (expert consensus, pathology, outcomes data) was used or established, as no clinical testing was conducted. The "ground truth" for this submission are the established engineering and safety standards for medical devices and the performance characteristics of the predicate devices, against which the proposed device's physical and electrical performance was compared.

8. The sample size for the training set:

Not applicable, as there is no mention of an AI/ML component or a "training set" for such a component in the context of this 510(k) submission.

9. How the ground truth for the training set was established:

Not applicable, as there is no mention of an AI/ML component or a "training set" in the context of this 510(k) submission.

In summary, the provided document outlines a 510(k) submission for a physical medical device (a laser ablation system) that achieved clearance based on demonstrating substantial equivalence through non-clinical bench testing. It does not involve AI/ML components, clinical trials, or the establishment of ground truth for diagnostic or assistive accuracy.

Summary

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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)

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

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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)]

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

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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 PredicateDevice	Proposed Device
	Clinical LaserthermiaSystems AB.TranbergCLS ThermalTherapy System(K142216)	Medtronic NavigationInc.Visualase ThermalTherapy System(K181859)	Avenda Health Inc.Avenda HealthTreatment System(K________)
Classification	21 CFR§878.4810, LaserSurgical Instrument forUse in General and PlasticSurgery and inDermatology	21 CFR§878.4810, LaserSurgical Instrument forUse in General and PlasticSurgery and inDermatology	Same
Product Code	GEX	GEX, FRN, LLZ	GEX
IntendedUse/Indications for Use	The TranbergCLS ThermalTherapy System isindicated for use insurgical applicationsrequiring the ablation,vaporization, excision,incision, and coagulationof soft tissue in areas ofsurgery including:gastroenterology, generalsurgery, plastic surgery,genitourinary (urology),gynecology (GYN),neurosurgery,otolaryngology (ENT)head and neck,orthopedics,ophthalmology,pulmonology, and thoracicsurgery.	The Visualase™ ThermalTherapy System isindicated for use tonecrotize or coagulate softtissue through interstitialirradiation or thermaltherapy under magneticresonance imaging (MRI)guidance in medicine andsurgery in cardiovascularthoracic surgery(excluding the heart andthe vessels in thepericardial sac),dermatology,ear-nose-throat surgery,gastroenterology, generalsurgery, gynecology, headand neck surgery,neurosurgery, plasticsurgery, orthopedics,pulmonology, radiology,and urology, forwavelengths 800nmthrough 1064nm.When therapy isperformed under MRIguidance, and when datafrom compatible MRI	The Avenda HealthTreatment System isindicated for use insurgical applicationsrequiring the ablation,vaporization, excision,incision, and coagulationof soft tissue in areas ofsurgery including:cardiovascular thoracicsurgery (excluding theheart and the vessels inthe pericardial sac),dermatology,ear-nose-throat surgery,gastroenterology, generalsurgery, gynecology, headand neck surgery,neurosurgery, plasticsurgery, orthopedics,pulmonology, radiology,and urology, at awavelength of 980nm.
Feature	Predicate Device	Reference PredicateDevice	Proposed Device
	Clinical LaserthermiaSystems AB.TranbergCLS ThermalTherapy System(K142216)	Medtronic NavigationInc.Visualase ThermalTherapy System(K181859)	Avenda Health Inc.Avenda HealthTreatment System(K____)
		sequences is available, theVisualase™ system canprocess images usingprotonresonance-frequency(PRF) shift analysis andimage subtraction to relatechanges in complex phaseangle back to relativechanges in tissuetemperature duringtherapy. The image datamay be manipulated andviewed in a number ofdifferent ways, and thevalues of data at certainselected points may bemonitored and/ordisplayed over time.The Visualase™ ThermalTherapy System iscompatible with GeneralElectric Medical SystemsSigna model MR scannersand with Siemens MedicalSolutions MagnetomEspree systems. Wheninterpreted by a trainedphysician, this deviceprovides information thatmay be useful in thedetermination orassessment of thermaltherapy. Patientmanagement decisionsshould not be made solelyon the basis ofVisualase™ analysis.
Wavelength (Diodelaser 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 PredicateDevice	Proposed Device
	Clinical LaserthermiaSystems AB.TranbergCLS ThermalTherapy System(K142216)	Medtronic NavigationInc.Visualase ThermalTherapy System(K181859)	Avenda Health Inc.Avenda HealthTreatment System(K)
Mode of operation	Continuous wave (CW) orcontrolled by tissuetemperature monitored bya temperature sensor	Continuous wave (CW),pulsed, or externalmodulation modes.	Continuous Wave (CW)
Output powerincrements	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 IEC60825-1)	Class 4	Class 4	Same
Laser SafetyClassification FDA	Class 2	Class 2	Same
Power source (General)	100-240V AC / 50-60Hz	100-240V AC / 50-60Hz	120V AC / 60Hz
Operating temperaturerange	15°C - 28°C	18°C - 35°C	10°C - 33°C
Emergency switch	Yes	Yes	Same
Key activation of laseroutput	Yes	Yes	Same
Remote Interlock	Yes	Yes	Same
Power ON/OFF visualindicator	Yes	Yes	Same
Laser emissionIndicator	Yes	Yes	Same
Internal laser powermonitor	Yes	Yes	Same
Manual reset	Yes	Yes	Same
Fiber insertion interlock	Yes	Yes	Same
Audio warning signallevel	Fixed at HIGH	HIGH, MEDIUM, LOW,and OFF	Same as Predicate Device
Pump-driven applicatorcooling	Yes	Yes	Same
Feature	Predicate Device	Reference PredicateDevice	Proposed Device
	Clinical LaserthermiaSystems AB.TranbergCLS ThermalTherapy System(K142216)	Medtronic NavigationInc.Visualase ThermalTherapy System(K181859)	Avenda Health Inc.Avenda HealthTreatment System(K________)
Applicator KitIncluded?	No	Yes	Same as ReferencePredicate Device
PC interface	Yes	Yes	Same
Thermal feedbackmechanism	Direct, Thermocouple	Indirect, MRThermometry	Same as Predicate Device
Usage of software	Yes	Yes	Same
Collection of thermaldata	Yes	Yes	Same

Table 1: Substantial Equivalence Table

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510(k) SUMMARY

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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).

Regulation Number and Section

§ 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.