(110 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound imaging modes and a mobile application interface. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is described as a "diagnostic imaging system" used to "enable visualization of anatomical structures and fluid," indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to enable diagnostic ultrasound imaging." The "Device Description" also refers to it as a "general purpose diagnostic imaging system."
No
The device description explicitly states it is a "hand-held, general purpose diagnostic imaging system" that uses a "single ultrasound transducer." This indicates the device includes hardware components (the transducer and the system generating the images) in addition to the software application.
Based on the provided information, the Exo Iris device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Exo Iris Function: The description clearly states that the 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." It uses ultrasound to create images of internal body structures.
- No Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. Its function is entirely based on generating and displaying images from within the body using ultrasound waves.
Therefore, the Exo Iris falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
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 patients for the following clinical applications: Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Procedural Guidance, Small Organ (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include: B-Mode + Color Doppler, B-Mode + M-Mode.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The subject device, 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 imaqing capabilities. The imaqes 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, B-Mode+ M-Mode.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
anatomical structures and fluids
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified and trained healthcare professionals in environments where healthcare is provided
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The verification and validation testing included testing to the following applicable standards:
- . ANSI/AAMI ES60601-1: 2005 / (R)2012 – Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance
- . IEC 60601-1-2 (Edition 4.0): 2014+AMD1:2020, FCC Part 15, Subpart B Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- IEC 60601-2-37:2007 + A1:2015, Edition 2.1 Medical electrical equipment Part . 2: 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 (R2009) Rev 3, Acoustic Output Measurement Standard for . Diagnostic Ultrasound Equipment.
- . IEC 62304 Edition 1.1 2015-06 Consolidated Version, Medical Device Software -Software Life Cycle Processes
Successful results for the following tests were included in the submission as performance data supporting substantial equivalence:
-
- Bench testing for electrical and mechanical safety in compliance with the standards cited above.
-
- Bench testing for ultrasound in compliance with the standards cited above and applicable Guidance published by FDA.
-
- Software testing, consisted of verification and validation testing including test cases related to off the shelf software, as well as cybersecurity features.
No human clinical data is provided to support substantial equivalence. The Exo Iris introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
November 9, 2022
Image /page/0/Picture/1 description: The image shows 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 consists of a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Exo Imaging, Inc. % Antoanela Gomard Vice President of Quality and Regulatory Affairs 4201 Burton Drive SANTA CLARA CA 95054
Re: K222198
Trade/Device Name: Exo Iris (El2001) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 13, 2022 Received: October 14, 2022
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/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
Yanna S. Kang -S
Yanna Kang, Ph. D. Assistant Director Mammography and Ultrasound Team DHT 8C: 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
2
Indications for Use
Submission Number (if known)
Device Name
Exo Iris (El2001)
Indications for Use (Describe)
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), Procedural Guidance, Small Organ (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include: B-Mode + Color Doppler, B-Mode + M-Mode.
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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3
510(k) Summary Prepared July 21st, 2022
| Sponsor | Exo Imaging Inc. |
|---|---|
| 4201 Burton Drive | |
| Santa Clara, CA, 95054 | |
| Contact Person | Antoanela Gomard |
| Vice President of Quality and Regulatory Affairs | |
| Telephone | 650-283-0458 |
| antoanela@exo.inc | |
| Submission Date | July 21st, 2022 |
| Device Name | Exo Iris |
| Common Name | Diagnostic Ultrasound System |
| Trade Name | Exo Iris |
| Regulatory Class | II |
| Review Category | 21CFR 892.1550 |
| 21 CFR 892.1560 | |
| 21 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 |
A. Legally Marketed Predicate Devices
The predicate device is the Exo Iris, manufactured by Exo Imaging Inc. (K211527) cleared on 20th August 2021.
B. Reference Device
The reference device is the Butterfly iQ Ultrasound System, manufactured by Butterfly Network, Inc. (K202406).
4
C. Device Description:
The subject device, 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 imaqing capabilities. The imaqes 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, B-Mode+ M-Mode.
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.
D. Intended Use / Indications for Use
The subject device, 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), Procedural Guidance, Small Organ (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic.
Modes of operation include: B-mode + Color Doppler, B-Mode+ M-Mode.
E. Substantial Equivalence
The subject device is substantially equivalent to the predicate, Exo Iris 1.0 (Exo lmaging, Redwood City, CA) cleared through 510(k) premarket notification on 08/20/2021 (K211527).
5
| Table 1 Comparison of Indications for Use | |||
|---|---|---|---|
| -- | -- | ------------------------------------------- | -- |
| Device Name | Predicate Device | Predicate Device | Reference Device |
|---|---|---|---|
| Exo Iris Ultrasound System | |||
| (this submission) | Exo Iris Ultrasound System | ||
| 510(k): K211527 | Butterfly iQ Ultrasound System | ||
| 510(k): K202406 | |||
| 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 patients for the following | |||
| clinical applications: Peripheral | |||
| Vessel (including carotid, deep vein | |||
| thrombosis and arterial studies), | |||
| Procedural Guidance, Small Organ | |||
| (including thyroid, scrotum and | |||
| breast), Cardiac, Abdominal, | |||
| Urology, Fetal/Obstetric, | |||
| Gynecological, Musculoskeletal | |||
| (conventional), Musculoskeletal | |||
| (superficial) and ophthalmic. | |||
| Modes of operation include: B- | |||
| mode, B-mode + Color Doppler, B- | |||
| Mode + M-Mode. | 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. | The Butterfly iQ Ultrasound System is | ||
| indicated for use by 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 patient= | |||
| for the following clinical applications: | |||
| Peripheral Vessel (including carotid, | |||
| deep vein thrombosis and arterial | |||
| studies), Procedural Guidance, Small | |||
| Organs (including thyroid, scrotum and | |||
| breast), 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. | Exo Imaging Inc. | Butterfly Network, Inc. |
| Device Name | Predicate Device | Predicate Device | Reference Device |
| Exo Iris Ultrasound System | |||
| (this submission) | Exo Iris Ultrasound System | ||
| 510(k): K211527 | Butterfly iQ Ultrasound System | ||
| 510(k): K202406 | |||
| 510(k) | |||
| number | TBD | K211527 | K202406 |
| Regulation | |||
| medical | |||
| specialty | Radiology | Radiology | Radiology |
| Product code | IYN, IYO. ITX | IYN, IYO. ITX | IYN, IYO. ITX |
| Regulation | |||
| number | 21CFR 892.1550 | ||
| 21 CFR 892.1560 | |||
| 21 CFR 892.1570 | 21CFR 892.1550 | ||
| 21 CFR 892.1560 | |||
| 21 CFR 892.1570 | 21CFR 892.1550 | ||
| 21 CFR 892.1560 | |||
| 21 CFR 892.1570 | |||
| Regulation | |||
| description | Diagnostic Ultrasound System | Diagnostic Ultrasound System | Diagnostic Ultrasound System |
| Classification | II | II | II |
| Intended | |||
| Users | Trained healthcare professionals | Trained healthcare professionals | Trained healthcare professionals |
| 510(k) Track | Track 3 | Track 3 | Track 3 |
| Imaging | |||
| Modes | B-mode, B-mode + Color Doppler, B- | ||
| Mode + M-Mode | B-mode / B-mode + Color Doppler | B-mode, B-mode + M-mode, B-mode + | |
| Color Doppler, B-mode + Power Doppler |
6
7
| Parameters | Subject Device | Predicate Device | Reference Device (K202406) |
|---|---|---|---|
| Trade Name | Exo Iris | Exo Iris | Butterfly iQ Ultrasound System |
| Manufacturer | Exo Imaging, Inc. | Exo Imaging, Inc. | Butterfly Network, Inc. |
| General Device Description | |||
| Device type | Handheld portable diagnostic ultrasound system | Handheld portable diagnostic ultrasound system | Handheld portable diagnostic ultrasound system |
| Transducer Characteristics | |||
| Array Type | Single probe 2D phased array | Single probe 2D phased array | Single probe 2D phased array |
| Other Relevant Similarities | |||
| Source of Energy | Battery-operated | Battery-operated | Battery-operated |
| Electrical Safety | Yes, compliant with applicable electrical safety standards | Yes, compliant with applicable electrical safety standards | Yes, compliant with applicable electrical safety standards |
| Mechanical Safety | Meets mechanical safety standards for a class II medical device | Meets mechanical safety standards for a class II medical device | Meets mechanical safety standards for a class II medical device |
| Biocompatibility | Yes, compliant with ISO 10993 | Yes, compliant with ISO 10993 | Yes, compliant with ISO 10993 |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Display | COTS Device Display (iPhone) | COTS Device Display (iPhone) | COTS device display |
Table 2. Substantial Equivalence Comparison for Technological Characteristics
8
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:
- . ANSI/AAMI ES60601-1: 2005 / (R)2012 – Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance
- . IEC 60601-1-2 (Edition 4.0): 2014+AMD1:2020, FCC Part 15, Subpart B Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- IEC 60601-2-37:2007 + A1:2015, Edition 2.1 Medical electrical equipment Part . 2: 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 (R2009) Rev 3, Acoustic Output Measurement Standard for . Diagnostic Ultrasound Equipment.
- . IEC 62304 Edition 1.1 2015-06 Consolidated Version, Medical Device Software -Software Life Cycle Processes
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:
-
- Bench testing for electrical and mechanical safety in compliance with the standards cited above.
-
- Bench testing for ultrasound in compliance with the standards cited above and applicable Guidance published by FDA.
-
- Software testing, consisted of verification and validation testing including test cases related to off the shelf software, as well as cybersecurity features.
9
No human clinical data is provided to support substantial equivalence. The Exo Iris introduces no new indications for use, modes, features or technologies relative to the predicate devices that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.
F. Conclusion
Potential risks were identified according to the ISO 14971. The risks were analyzed with regards 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.