Exo Iris is indicated for use by qualified and trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Small Organ (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial). Modes of operation include: B-mode, B-mode + Color Doppler.

Device Description

Exo Iris is a hand-held, general purpose diagnostic imaging system used to enable visualization of anatomical structures and fluid of adult and pediatric patients. The system is intended to be used by trained healthcare professionals.

The system generates 2D images using a single ultrasound transducer with broad imaging capabilities. The images are displayed on a commercial off-the-shelf mobile device (iPhone) by means of a proprietary mobile application (Exo Iris app) provided by Exo Imaging. Images can be displayed in the following modes: B-Mode, B-Mode + Color Doppler.

The mobile application's user interface includes touchscreen menus, buttons, controls, indicators, and navigation icons that allow the operator to control the system and to view ultrasound images.

AI/ML Overview

This document is an FDA 510(k) clearance letter for the Exo Iris Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report on acceptance criteria for an AI/ML-driven device.

Based on the provided text, the Exo Iris is a general diagnostic ultrasound system, not explicitly described as having integrated AI/ML functionality that would necessitate specific performance studies for AI/ML algorithms. The letter states "Clinical data were not required for this type of device." and "Software testing, consisted of verification and validation testing including test cases related to off the shelf software, as well as cybersecurity features." This suggests the software component is more for device control and data display rather than for diagnostic AI/ML algorithms.

Therefore, many of the requested details regarding AI/ML study components (such as expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not present in this document because the device, as described for this 510(k), does not appear to involve a diagnostic AI/ML algorithm requiring such evaluations.

However, I will extract and present the information available regarding acceptance criteria and performance data for the device itself, acknowledging that it's from a device safety/performance perspective rather than an AI/ML algorithm's diagnostic performance.

Acceptance Criteria and Device Performance (as per general device clearance):

Acceptance Criteria Category	Reported Device Performance
Electrical Safety	Yes, compliant with applicable electrical safety standards (IEC 60601-1, IEC 60601-1-2)
Mechanical Safety	Meets mechanical safety standards for a Class II medical device
Biocompatibility	Yes, compliant with ISO 10993
Acoustic Output	Compliant with NEMA UD-2 and applicable FDA Guidance
Software Functionality	Verification and validation testing, including test cases related to off-the-shelf software and cybersecurity features, demonstrated meeting predetermined acceptance criteria.
Risk Management	Potential risks identified per ISO 14971, analyzed, mitigations implemented and tested. All risk mitigations satisfactorily verified and validated.
Design Control	All specifications verified and validated per company's Design Control Process (in compliance with 21 CFR Part 820.30); results demonstrated predetermined acceptance criteria were met.
Substantial Equivalence	Demonstrated substantial equivalence to the predicate device (Butterfly iQ Ultrasound System, K202406) based on indications for use and technological characteristics.

Information NOT Available in the Document (due to the nature of the device and submission):

As the document indicates, clinical data were not required for this type of device, and the focus is on device safety and operational performance compared to a predicate, not AI/ML diagnostic performance. Therefore, the following are not applicable or not provided:

Sample size used for the test set and the data provenance: Not applicable for a standalone AI/ML performance study as this device is a general diagnostic ultrasound system. Device testing involved bench testing and software verification, not a clinical test set of images for an AI.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no AI/ML specific diagnostic test set requiring expert ground truth.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of what is present:

The document describes the regulatory clearance for a diagnostic ultrasound system (Exo Iris). The performance data presented are primarily technical and safety verifications required for medical devices (electrical safety, mechanical safety, biocompatibility, acoustic output, software functionality, and risk management) to demonstrate substantial equivalence to a predicate device, rather than the performance of a diagnostic AI/ML algorithm.

Summary

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August 20, 2021

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Exo Imaging, Inc. % Antoanela Gomard Senior Director of Quality and Regulatory Affairs 3600 Bridge Parkway, Suite 102 REDWOOD CITY CA 94065

Re: K211527

Trade/Device Name: Exo Iris Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 22, 2021 Received: July 27, 2021

Dear Antoanela Gomard:

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/cfpmp/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

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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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K211527

Device Name Exo Iris

Indications for Use (Describe)

Expiration Date: 06/30/2023 See PRA Statement below.

Form Approved: OMB No. 0910-0120

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) Summary Prepared May 13th, 2021

K211527

Sponsor:	Exo Imaging Inc.3600 Bridge ParkwayRedwood City, CA, 94065
Contact Person:	Antoanela GomardSenior Director of Quality and Regulatory Affairs
Telephone:	650 283 0458
Email:	antoanela@exo.inc
Submission Date:	May 13th, 2021
Device Name:	Exo Iris
Common Name:	Diagnostic Ultrasound System
Trade Name:	Exo Iris
Classification:
Regulatory Class:	II
Review Category:	21CFR 892.155021 CFR 892.156021 CFR 892.1570
Classification Panel:	Radiology

Classification Name and Regulation Number Product Code:

	Regulation Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90 - IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90 - IYO
Diagnostic Ultrasound Transducer	892.1570	90 - ITX

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A. Legally Marketed Predicate Devices

The predicate device is the Butterfly iQ Ultrasound System, manufactured by Butterfly Network, Inc. (K202406).

B. Device Description:

The mobile application's user interface includes touchscreen menus, buttons, controls, indicators, and navigation icons that allow the operator to control the system and to view ultrasound images.

C. Intended Use / Indications for Use

Exo Iris is indicated for use by qualified and trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric for the following clinical applications: Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Small Organ (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial).

Modes of operation include: B-mode, B-mode + Color Doppler.

D. Substantial Equivalence

The Exo Iris Ultrasound System is substantially equivalent to the Butterfly iQ Ultrasound System, manufactured by Butterfly Network, Inc. (K202406). They are both portable ultrasound systems for diagnostic use. The indications for use and the core technology of the devices are similar as illustrated in the tables below.

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Device	Subject Device	Predicate Device
Name	Exo Iris Ultrasound System(this submission)	Butterfly iQ Ultrasound System510(k): K202406
Indicationsfor Use	Exo Iris is indicated for use by qualifiedand trained healthcare professionals inenvironments where healthcare is providedto enable diagnostic ultrasound imagingand measurement of anatomical structuresand fluids of adult and pediatric patients forthe following clinical applications:Peripheral Vessel (including carotid, deepvein thrombosis and arterial studies), SmallOrgan (including thyroid, scrotum andbreast), Cardiac, Abdominal, Urology,Fetal/Obstetric, Gynecological,Musculoskeletal (conventional),Musculoskeletal (superficial).Modes of operation include: B-mode, B-mode + Color Doppler.	The Butterfly iQ Ultrasound System is indicatedfor use by trained healthcare professionals inenvironments where healthcare is provided toenable diagnostic ultrasound imaging andmeasurement of anatomical structures andfluids of adult and pediatric patients for thefollowing clinical applications: PeripheralVessel (including carotid, deep vein thrombosisand arterial studies), Procedural Guidance,Small Organs (including thyroid, scrotum andbreast), Cardiac, Abdominal, Urology,Fetal/Obstetric, Gynecological,Musculoskeletal (conventional),Musculoskeletal (superficial) and Ophthalmic.Modes of operation include B-mode, B-mode +M-mode, B-mode + Color Doppler, B-mode +Power Doppler.
Manufacturer	Exo Imaging Inc.	Butterfly Network, Inc.
510(k)number	TBD	K202406
Regulationmedicalspecialty	Radiology	Radiology
Product code	IYN, IYO. ITX	IYN, IYO. ITX
Regulationnumber	21CFR 892.155021 CFR 892.156021 CFR 892.1570	21CFR 892.155021 CFR 892.156021 CFR 892.1570
Regulationdescription	Diagnostic Ultrasound System	Diagnostic Ultrasound System
Classification	II	II
IntendedUsers	Trained healthcare professionals	Trained healthcare professionals
510(k) Track	Track 3	Track 3
ImagingModes	B-mode (Anatomy) / B-mode +ColorDoppler (Flow)	B-mode, B-mode + M-mode, B-mode + ColorDoppler, B-mode + Power Doppler.

Table 1 Comparison of Indications for Use

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Parameters	Subject Device	Predicate Device (K202406)
Trade Name	Exo Iris	Butterfly iQ Ultrasound System
Manufacturer	Exo Imaging, Inc.	Butterfly Network, Inc.
General Device Description
Device type	Handheld portable diagnosticultrasound system	Handheld portable diagnosticultrasound system
Transducer Characteristics
Array Type	Single probe 2D phased array	Single probe 2D phased array
Other Relevant Similarities
Source of Energy	Battery-operated	Battery-operated
Electrical Safety	Yes, compliant with applicableelectrical safety standards	Yes, compliant with applicable electricalsafety standards
Mechanical Safety	Meets mechanical safety standards fora class II medical device	Meets mechanical safety standards fora class II medical device
Biocompatibility	Yes, compliant with ISO 10993	Yes, compliant with ISO 10993
Sterility	Non-sterile	Non-sterile
Display	COTS Device Display (iPhone)	COTS device display

Table 2. Substantial Equivalence Comparison for Technological Characteristics

Based on the comparison of indications for use and technological characteristics, the subject device is substantially equivalent to the predicate device.

E. Performance Data

All specifications for Exo Iris have been verified and validated as required by the risk analysis. All design verification and validation activities were performed by the designated individual(s) according to the company's Design Control Process and the results demonstrated that the predetermined acceptance criteria were met.

The verification and validation testing included testing to the following applicable standards:

IEC 60601-1: Edition 3.0 2005 (3.0 2005 + CORR. 1:2006 + CORR. 2:2007 + -
A1:2012). Medical Electrical Equipment - Part 1: General Requirements for Safety.
IEC 60601-1-2: Edition 4.0 2014, Medical Electrical Equipment Part 1-2: -General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

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IEC 60601-2-37: Edition 2.0 Am 1 2015, Medical Electrical Equipment Part 2--37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment.
-ISO 10993:2009 Biological Evaluation of Medical Devices. Part 1
-NEMA UD-2: 2004 Rev 3, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.

Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30. Exo Imaging certifies that all verification and validation activities provided in this submission were performed by designated individuals and results demonstrate that predetermined acceptance criteria were met. Successful results for the following tests were included in the submission as performance data supporting substantial equivalence:

1. Bench testing for electrical and mechanical safety in compliance with the standards cited above
1. Bench testing for ultrasound in compliance with the standards cited above and applicable Guidance published by FDA.
1. Software testing, consisted of verification and validation testing including test cases related to off the shelf software, as well as cybersecurity features.

Clinical data were not required for this type of device.

F. Conclusion

Potential risks were identified according to the ISO 14971. The risks were analyzed with regard to risk/benefit category and mitigations were implemented and tested as part of the performance testing described above. All risk mitigations were satisfactorily verified and validated. Where there were technological differences from the predicate, these were shown not to result in any new issues of safety or efficacy according to the performance data submitted.

Therefore, the Exo Iris Ultrasound System is substantially equivalent to the predicate device with regards to intended use and technological characteristics. Results of performance testing demonstrated that the device met the design requirements.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.