(95 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ultrasound imaging technology 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 a diagnostic imaging system used to visualize anatomical structures and fluids; it is not indicated for treating conditions.
Yes
The device description explicitly states, "Exo Iris is a hand-held, general purpose diagnostic imaging system." The intended use also mentions it is "to enable diagnostic ultrasound imaging."
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:
- Definition of IVD: 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.
- Exo Iris Function: The description clearly states that Exo Iris is a diagnostic imaging system that uses ultrasound to visualize anatomical structures and fluids within the body. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes imaging and measurement of internal structures and fluids, which is consistent with an in-vivo imaging device, not an in-vitro diagnostic device.
Therefore, the Exo Iris is a medical imaging device, specifically an ultrasound system, and not an IVD.
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), 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.
Product codes
IYN, IYO, ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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).
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
August 20, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary Prepared May 13th, 2021
K211527
| Sponsor: | Exo Imaging Inc.
3600 Bridge Parkway
Redwood City, CA, 94065 |
|-----------------------|-----------------------------------------------------------------------|
| Contact Person: | Antoanela Gomard
Senior 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 892.1550
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 |
4
A. Legally Marketed Predicate Devices
The predicate device is the Butterfly iQ Ultrasound System, manufactured by Butterfly Network, Inc. (K202406).
B. 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.
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.
5
| Device | Subject Device | Predicate Device |
|---|---|---|
| Name | Exo Iris Ultrasound System | |
| (this submission) | 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), 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 patients 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. | Butterfly Network, Inc. |
| 510(k) | ||
| number | TBD | K202406 |
| Regulation | ||
| medical | ||
| specialty | Radiology | Radiology |
| Product code | 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 | ||
| Regulation | ||
| description | Diagnostic Ultrasound System | Diagnostic Ultrasound System |
| Classification | II | II |
| Intended | ||
| Users | Trained healthcare professionals | Trained healthcare professionals |
| 510(k) Track | Track 3 | Track 3 |
| Imaging | ||
| Modes | B-mode (Anatomy) / B-mode +Color | |
| Doppler (Flow) | B-mode, B-mode + M-mode, B-mode + Color | |
| Doppler, B-mode + Power Doppler. |
Table 1 Comparison of Indications for Use
6
| 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 diagnostic | |
| ultrasound system | Handheld portable diagnostic | |
| ultrasound 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 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 | ||
| 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.
7
- 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:
-
- 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.
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.