The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable softwarecontrolled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications.

The specific clinical applications and exam types for the linear transducer include vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body.

The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric).

The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures.

The system is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

Device Description

The EdgeLife Ultrasound Scanner receives instructions from and transmits images to the EdgeLife Ultrasound App running on a paired mobile device that utilizes the iOS operating system via wireless Wi-Fi communication.

The system is a transportable ultrasound system intended for use in environments where healthcare is provided.

The EdgeLife Handheld Wireless Ultrasound System consists of:

EdgeLife Handheld Ultrasound Scanner:
- o Model E8200 with convex and linear transducers
- o Model E8220 with convex and endocavitary transducers
EdgeLife Ultrasound App .
Standard off-the-shelf Wireless Qi charger (not a medical device) ●

AI/ML Overview

The provided text is a 510(k) summary for the EdgeLife Handheld Wireless Ultrasound System (models E8200 and E8220). This document describes the device, its intended use, and a comparison to a predicate device, along with non-clinical performance testing. It does not contain information about a study proving the device meets acceptance criteria related to its human-in-the-loop performance or algorithm-only performance for diagnostic tasks, as would be expected for a device incorporating AI for clinical decision support. Instead, the document focuses on the hardware and basic functional safety and effectiveness of the ultrasound system itself.

Therefore, many of the requested items (e.g., expert ground truth, adjudication, MRMC studies, effect size of AI assistance, standalone algorithm performance, training set details) are not present in the provided text. The document primarily describes the device's technical specifications and compliance with general medical device standards.

Here's a breakdown of what information is available based on the provided text, and what is missing:

Acceptance Criteria and Reported Device Performance

The document describes non-clinical performance testing to support the substantial equivalence of the device to its predicate. These are predominantly engineering and safety acceptance criteria, not diagnostic performance criteria for an AI or imaging algorithm.

Table of Acceptance Criteria (from Non-Clinical Performance Testing):

Test Category	Specific Test / Title/Test Method Summary	Acceptance Criteria (Implied by "Pass")	Reported Device Performance
Biocompatibility	Cytotoxicity (ISO 10993-5)	Non-cytotoxic	Non-cytotoxic
	Irritation (ISO 10993-23 Skin)	Non-irritating	Non-irritating
	Irritation (ISO 10993-23 Vaginal)	Non-irritating	Non-irritating
	Sensitization (ISO 10993-10)	Non-sensitizing	Non-sensitizing
Thermal, Electrical, and Mechanical Safety	Electrical Safety (ANSI AAMI ES 60601-1)	Pass	Pass
	Battery Safety (IEC 62133-2, UN38.3)	Pass	Pass
	Electromagnetic Compatibility (IEC 60601-1-2)	Pass	Pass
	Wireless Coexistence (ANSI C63.27, AAMI TIR69)	Pass	Pass
	FCC Certification (FCC 15, FCC 18)	Certified	Certified
	Acoustic Output (IEC 60601-2-37, IEC 62359)	Pass, Track 3	Pass, Track 3
Cleaning and Disinfection	Model E8200 (AAMI TIR30, AAMI TIR12)	Pass	Pass
	Model E8220 (AAMI TIR30, AAMI TIR12)	Pass	Pass
Non-Clinical Verification Testing	Measurement Accuracy (Internal test methods)	Pass	Pass
Software Verification and Validation	Software verification and validation	Pass	Pass

Study Details (based on available information):

Sample sizes used for the test set and the data provenance:
- The document mentions "internal test methods" for measurement accuracy but does not provide specific sample sizes (e.g., number of measurements, phantoms, or clinical cases) or data provenance (country of origin, retrospective/prospective).
- No clinical study with a "test set" in the context of diagnostic accuracy for an AI component is described. The "performance data" mentioned refers to non-clinical verification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no diagnostic performance study involving expert ground truth is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 MRMC study or any study involving human readers with AI assistance is mentioned. The device is described as an "ultrasonic diagnostic system" to acquire and display data, not one with AI-driven diagnostic assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study is mentioned. The device is an ultrasound system, not an AI diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable, as no diagnostic performance validation is described. The "ground truth" for the non-clinical tests would be defined by the standards and phantoms used (e.g., known dimensions for measurement accuracy).
The sample size for the training set:
- Not applicable, as no AI model requiring a training set is described within the scope of this FDA submission summary. The software validation is generic.
How the ground truth for the training set was established:
- Not applicable.

Conclusion based on the provided text:

The provided 510(k) summary focuses on demonstrating the substantial equivalence of the EdgeLife Handheld Wireless Ultrasound System to a predicate device based on its technical specifications, intended use, and compliance with general medical device safety and performance standards (biocompatibility, electrical safety, EMC, acoustic output, cleaning/disinfection, and basic software/measurement validation). It does not describe any AI-related diagnostic function or a clinical study that evaluates the improvement of human readers with AI assistance, or the performance of an AI algorithm in a standalone capacity. Therefore, the specific criteria and study details requested for AI-driven devices are not present in this document.

Summary

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September 18, 2024

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EdgeLife Technologies LLC % Quinn Place Chief Operating Officer 485 Brickell Avenue Suite 4802 Miami, Florida 33031

Re: K234153

Trade/Device Name: EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 13, 2023 Received: August 23, 2024

Dear Quinn Place:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health 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) K234153

Device Name

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)

Indications for Use (Describe)

The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures.

The system is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE . TECHNOLOGIES", with the word "LIFE" in blue, a red dot in the middle, and the word "TECHNOLOGIES" in blue.

K234153

EdgeLife Handheld Wireless Ultrasound System - 510(k) Summary

The following 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.

Subject Device Trade Name:	EdgeLife Handheld Wireless Ultrasound System
Subject Device Model Numbers:	E8200, E8220
Common Name:	Diagnostic Ultrasound System and Accessories

Regulation Number	Regulation Name	Product Code
21 CFR § 892.1550	Ultrasonic Pulsed Doppler ImagingSystem	IYN
21 CFR § 892.1560	Ultrasonic Pulsed Doppler ImagingSystem	IYO
21 CFR § 892.1570	Diagnostic Ultrasonic Transducer	ITX

Regulation Number, Name and Product Codes 1.1

FDA 510(k) Review Panel:	Radiology
Classification:	Class II
Manufacturer:	Edge Life Technologies485 Brickell Avenue, Suite 4802Miami, Florida 33031 U.S.A.
Contact Name:	Quinn Place, Chief Operating Officerqplace@edgelifetech.com
Date 510(k) Summary Prepared:	December 20, 2023
Predicate Device:	Vscan Air K202035
Reference Device:	Clarius Ultrasound Scanner K192107

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Image /page/5/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is written in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE • TECHNOLOGIES", with the word "LIFE" in black, a red dot in the middle, and the word "TECHNOLOGIES" in black. The logo is simple and modern.

1.2 Device Description

The EdgeLife Handheld Wireless Ultrasound System, including Scanners, follows Track 3.

The system is a transportable ultrasound system intended for use in environments where healthcare is provided.

The EdgeLife Handheld Wireless Ultrasound System consists of:

EdgeLife Handheld Ultrasound Scanner:
- o Model E8200 with convex and linear transducers
- o Model E8220 with convex and endocavitary transducers
EdgeLife Ultrasound App .
Standard off-the-shelf Wireless Qi charger (not a medical device) ●

Indications for Use 1.2.1

The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications.

The specific clinical applications and exam types for the linear transducer include vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system,

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Image /page/6/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is written in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE • TECHNOLOGIES" in smaller, gray letters. The bullet point between the words "LIFE" and "TECHNOLOGIES" is red.

non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body.

The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, gynecology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric).

The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures.

The system is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.

1.2.2 Comparison of Subject Device and Predicate Device

Comparison of intended use and technological characteristics between EdgeLife Handheld Wireless Ultrasound Scanner and the predicate device, Vscan Air, is presented in the following table.

	EdgeLife HandheldWireless UltrasoundSystem	Vscan Air(K202035)	Substantial EquivalenceComparison
Scanner Type	Dual-Headed	Dual-Headed	Same
Transducer	Convex and Linear(E8200)Convex and Endocavitary(E8220)	Convex andLinear	Similar
			The subject and predicatehave the same convex andlinear transducers. Thesubject device alsoincludes an endocavitarytransducer on one of thedual headed probes.Endocavitary transducersare commonly found incurrent ultrasound systemsincluding the predicatedevice. Performance testresults support that this
	EdgeLife HandheldWireless UltrasoundSystem	Vscan Air(K202035)	Substantial EquivalenceComparison
			difference does not raisenew questions of safetyand effectiveness.
Classification	Class II	Class II	Same
Product Codes	IYN, IYO, ITX	ITX, IYN,IYO	Same
Clinical Settings	Hospitals, clinics and otherprofessional healthcarefacility settings	Hospitals,clinics andmedical officesettings, home,emergencyenvironments	Similar. The onlydifference is that thesubject device is notintended for use in homehealth or road/airambulance environments.This difference does notraise new questions ofsafety and effectiveness.
Users	Trained Healthcareprofessionals	TrainedHealthcareprofessionals	Same
PatientPopulation	adult and pediatric	adult andpediatric	Same
Intended Use	Diagnostic ultrasoundimaging and fluid flowanalysis.	Diagnosticultrasoundimaging andfluid flowanalysis	Same
Indications forUse	The EdgeLife HandheldWireless UltrasoundSystem is ageneral-purpose, handheld,wireless, portablesoftware-controlledultrasonic diagnosticsystem that usespulsed-echo technology toacquire and displayultrasound data in B-Mode,M-Mode, Color Doppler,and Pulse-Wave Doppler(PW) modes. TheEdgeLife HandheldWireless UltrasoundSystem is intended for	Refer toK202035510(k)Summary.	Similar. Both subject andpredicate devices areintended for diagnosticultrasound echo imaging,measurement and analysisof the human body for thesame applications.The subject device alsoincludes an endocavitarytransducer that allows forclinical applicationsincluding gynecology,obstetrics, urology,transvaginal, transrectal,and interventionalprocedures. These
EdgeLife HandheldWireless UltrasoundSystem	Vscan Air(K202035)	Substantial EquivalenceComparison
imaging, measurement,and fluid flow analysis ofthe human body for thefollowing clinicalapplications.The specific clinicalapplications and examtypes for the lineartransducer includevascular/peripheralvascular, musculoskeletal(conventional andsuperficial), small organs,thoracic/lung, abdominal,intraoperative (excludingneurological, centralnervous system,non-central cardiovascularsystem), urology,gynecology, pediatric,fetal, peripheral vessel,carotid, interventional andprocedure guidance ofneedles into the body.The specific clinicalapplications and examtypes for the convextransducer include:abdominal, pulmonary,thoracic, intra-operative(abdominal organs &vascular), pediatric, smallorgan, urology,gynecology, obstetrics,musculoskeletal(conventional andsuperficial), vascular,carotid, and cardiac (adultand pediatric).		application types arefound in other legallymarketed ultrasoundsystems including theReference Device and arenot novel. Performancedata support theindications for use.Therefore, thesedifferences do not raisenew questions of safetyand effectiveness.
	EdgeLife HandheldWireless UltrasoundSystem	Vscan Air(K202035)	Substantial EquivalenceComparison
	The specific clinicalapplications and examtypes for the Endocavitarytransducer includegynecology, obstetrics,urology, transvaginal,transrectal, andinterventional procedures.The system is a portableultrasound system intendedfor use in environmentswhere healthcare isprovided by trainedhealthcare professionals.
Portability	Handheld portable	Handheldportable	Same
SystemComponents	Dual-headed probesMobile appCharger	Dual-headedprobeMobile appCharger	Same.
Frequency	Convex:2-5 MHz withcenter frequency of 3.2MHzLinear 4-12 MHz, withcenter frequency of 7.5MHzEndocavitary: 4-9 MHzwith the center frequencyof 6.5 MHz	Convex: from2 - 5 MHz withcenterfrequency of3.3 MHzLinear: From 3- 12 MHz withcenterfrequency of7.7 MHz	Similar. The differencesdon't raise any issuesabout safety andeffectiveness of thedevice.
Elements	All transducers have 128elements	GE: Linear192, convex:192	Similar. The differencesdon't raise any issuesabout safety andeffectiveness of thedevice.
Display	iOS device	iOS or Androiddevice	Similar. This differencedoes not raise newquestions of safety oreffectiveness.
	EdgeLife HandheldWireless UltrasoundSystem	Vscan Air(K202035)	Substantial EquivalenceComparison
Software	Mobile app downloads oniOS viewing device	Mobile appdownloads oniOS andAndroidviewing device	Similar. This differencedoes not raise newquestions of safety oreffectiveness.
Image Format	JPG and DICOM, DICOMtransfer to PACS orimaging archive systems	JPG andDICOM,DICOMtransfer toPACS orimagingarchivesystems	Same
Penetration depth	Convex up to 30 cmLinear < 8 cmEndocavity < 12 cm	Convex up to24 cm andlinear up to 8cm	Similar.The linear end has thesame maximumpenetration depth.Performance data supportthat the penetration depthsof the Subject devicesdon't raise any issuesabout safety andeffectiveness of thedevice.
Principle ofOperation	Piezoelectric transducerelements.	Piezoelectrictransducerelements	Same.
Power Source	Built in lithium-ionBattery	Built inlithium-ionBattery	Same
Charging Plate	Anker and other off-theshelf charging plates.	Anker	Similar. The performancedoesn't raise any issuesabout safety andeffectiveness of thedevice.
Battery AndCharging	Rechargeable internalbattery	Rechargeableinternalbattery	Same
WirelessCapability	Wi-Fi directlycommunicates between theprobe and mobile device	Wi-Fi directlycommunicatesbetween theprobe and mobile device	Same
	EdgeLife HandheldWireless UltrasoundSystem	Vscan Air(K202035)	Substantial EquivalenceComparison
		probe andmobile device
ConnectivityRequirements	IEEE 802.11n/5GHz	IEEE 802.11nPeer-to-peerconnectivity(Android only)Bluetooth BLE4.0	Similar. Differences donot raise questions ofsafety and effectiveness.
SecurityProtocols	The scanner's Wi-Fi usesWPA2 security andrequires a password whenfirst connecting to theMobile Device.	Enterprise-grade wirelessencryptionstandardsincluding EAPand WPA2(PSK).	Similar. Differences donot raise questions ofsafety and effectiveness.
Modes ofOperation	B-ModeM-ModeColor DopplerPulsed Wave Doppler(PW)	B-modeColor DopplerB+ColorDopplerHarmonicimaging	Similar. Both devicesincorporatewell-establishedultrasound modes and thesubject device does notintroduce novel modes ofoperation. Therefore, thisdifference does not raisequestions of safety andeffectiveness.
Acoustic Output	Track 3	Track 3	Same
Electrical Safetyand EMC,Acoustic Output	Track 3ANSI/AAMI ES60601-1IEC 60601-1-2IEC 62359IEC 60601-2-37	Track 3ANSI/AAMIES60601-1IEC 60601-1-2IEC60601-2-37IEC60601-1-11IEC 62359	Similar. The onlyexception is the subjectdevice has not undergoneEMC testing for the homeuse environment.
Biocompatibility	ISO 10993-1	ISO 10993-1	Same

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Image /page/7/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is written in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE ● TECHNOLOGIES", with the word "LIFE" and "TECHNOLOGIES" in smaller font and a red circle in between the two words.

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Image /page/8/Picture/0 description: The image shows the logo for "EDGE LIFE ● TECHNOLOGIES". The word "EDGE" is written in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE ● TECHNOLOGIES", with the word "LIFE" in black, a red circle, and the word "TECHNOLOGIES" in black.

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Image /page/9/Picture/0 description: The image shows the logo for "EDGE LIFE ● TECHNOLOGIES". The word "EDGE" is written in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE ● TECHNOLOGIES", with the word "LIFE" in black, a red circle, and the word "TECHNOLOGIES" in black.

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Image /page/10/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is written in large, blue, block letters. Below the word "EDGE" is the phrase "LIFE ● TECHNOLOGIES" written in a smaller, gray font. There is a red circle between the words "LIFE" and "TECHNOLOGIES".

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Image /page/11/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is in large, bold, blue font. Below the word "EDGE" is the phrase "LIFE . TECHNOLOGIES", with the word "LIFE" in black, a red dot in the middle, and the word "TECHNOLOGIES" in gray.

The subject device shares the same intended use, principle of operation and similar technological characteristics as the predicate device. Similarities include portability, wireless handheld

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Image /page/12/Picture/0 description: The image is a logo for "EDGE LIFE TECHNOLOGIES". The word "EDGE" is in large, bold, blue letters. Below "EDGE" are the words "LIFE" and "TECHNOLOGIES" in smaller, thinner, gray letters. There is a red dot between the words "LIFE" and "TECHNOLOGIES".

dual-headed transducer probes, mobile app, convex and linear transducers. The main differences from the predicate are the endocavitary transducer head and inclusion of Pulsed Wave Doppler (PW) mode. The PW mode is a well-established mode of operation. The endocavitary transducer also does not represent novel technology and has been cleared in several legally marketed ultrasound systems including the Reference Device, Clarius Ultrasound System K192017. Performance testing including IEC 60601-2-37 demonstrate that these differences do not raise new questions of safety and effectiveness.

Non-Clinical Performance Testing 1.2.3

The following performance data are provided in support of the substantial equivalence determination between the subject device and predicate device.

Test	Title/Test Method Summary	Results
Biocompatibility
Cytotoxicity	ISO 10993-5	Non-cytotoxic
Irritation	ISO 10993-23 Skin Irritation	Non-irritating
	ISO 10993-23 Vaginal Irritation	Non-irritating
Sensitization	ISO 10993-10	Non-sensitizing
Thermal, Electrical, and Mechanical Safety
Electrical Safety	ANSI AAMI ES 60601-1	Pass
Battery Safety	IEC 62133-2UN38.3	Pass
ElectromagneticCompatibility	IEC 60601-1-2	Pass
WirelessCoexistence	ANSI C63.27AAMI TIR69	Pass
FCC Certification	FCC 15, FCC 18	Certified
Acoustic Output	IEC 60601-2-37IEC 62359	Pass, Track 3
Cleaning and Disinfection
Model E8200	AAMI TIR30, AAMI TIR12	Pass
Model E8220	AAMI TIR30, AAMI TIR12	Pass
Non-Clinical Verification Testing
MeasurementAccuracy	Internal test methods	Pass
Software Verification and Validation
Software verification and validation		Pass

	Table 4: Summary of Non-Clinical Performance Testing
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Regulation Number and Section

N/A