(272 days)
Not Found
Not Found
Yes
The document explicitly mentions "AI-assisted automated ejection fraction software (Auto EF)" and "Auto Anatomical Structure Labeling and View Identification software (AI FAST)".
No.
The device is described as a "general-purpose diagnostic ultrasound system" intended for "clinical assessment" by acquiring, processing, displaying, measuring, and storing various types of medical data, including ultrasound images. Its indicated uses are for diagnosis and assessment, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Kosmos is a general-purpose diagnostic ultrasound system."
No
The device description explicitly states that Kosmos is a "general-purpose diagnostic ultrasound system," which implies the inclusion of hardware components necessary for ultrasound image acquisition, processing, and display, in addition to the software features mentioned.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The description clearly states that Kosmos is a general-purpose diagnostic ultrasound system. It acquires, processes, displays, measures, and stores ultrasound images, ECG rhythms, and digital auscultation sounds and waveforms. It also includes AI-assisted software for image processing and analysis.
- Method of Use: The device is used non-invasively on the patient's body to generate images and collect physiological data. It does not involve the examination of specimens taken from the body.
Therefore, because the device operates by interacting with the patient's body directly and does not analyze specimens in vitro, it falls outside the definition of an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms.
With respect to its ultrasound imaging capability, Kosmos is a general-purpose diagnostic ultrasound system used in the following clinical applications and modes of operation:
Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular, Musculoskeletal, and interventional guidance (includes free hand needle / catheter placement fluid drainage, and nerve block) Modes of Operation: B-mode, M-mode, Color Doppler, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Combined Modes of B+M, and B+CD, B+PW, B+CW, and Harmonic Imaging
Kosmos is intended to be used in clinical care and medical education settings on adult and pediations. Kosmos includes the Al-assisted automated ejection fraction software, known as Auto EF, which is used to process previously acquired transthoracic cardiac ultrages, to store images, and to manipulate and make measurements on images using the Kosmos. Auto EF provides automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. Auto EF is indicated for use on adult patients only in healthcare facilities.
The Kosmos includes the Auto Anatomical Structure Labeling and View Identification, also referred to as AI FAST, software, which is intended for use only by qualified and trained medical professionals for automatic real-lime detection and labeling of anatomical structures during image acquisition during cardiac, thoracic/lung, or abdominal ultrasound imaging. This feature is only indicated for use on adult patients in healthcare facilities.
The device is non-invasive, reusable, and intended to be used on one patient at a time.
Product codes
IYN, IYO, ITX, DQD, DPS, QIH
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Thoracic/Lung, Abdominal, Vascular, Musculoskeletal
Indicated Patient Age Range
Adult and pediatric patients. Auto EF: adult patients only. AI FAST: adult patients only.
Intended User / Care Setting
Qualified and trained healthcare professionals in clinical care and medical education settings.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
August 29, 2024
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is an emblem representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, and the words "U.S. FOOD & DRUG" are stacked above the word "ADMINISTRATION".
EchoNous, Inc. Joshua Kim Sr. Manager, Regulatory Affairs 8310 154th Ave NE, Bldg B, Ste 200 Redmond, Washington 98052
Re: K233826
Trade/Device Name: Kosmos Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, DQD, DPS, QIH Dated: July 31, 2024 Received: July 31, 2024
Dear Joshua Kim:
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.
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).
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Your device is also subject to, among other requirements, the Quality System (QS) 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.
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.
For comprehensive regulatory information about mediation-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,
Marjan Nabili -S for
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
2
Indications for Use
510(k) Number (if known) K233826
Device Name Kosmos
Indications for Use (Describe)
Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms.
With respect to its ultrasound imaging capability, Kosmos is a general-purpose diagnostic ultrasound system used in the following clinical applications and modes of operation:
Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular, Musculoskeletal, and interventional guidance (includes free hand needle / catheter placement fluid drainage, and nerve block) Modes of Operation: B-mode, M-mode, Color Doppler, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Combined Modes of B+M, and B+CD, B+PW, B+CW, and Harmonic Imaging
Kosmos is intended to be used in clinical care and medical education settings on adult and pediations. Kosmos includes the Al-assisted automated ejection fraction software, known as Auto EF, which is used to process previously acquired transthoracic cardiac ultrages, to store images, and to manipulate and make measurements on images using the Kosmos. Auto EF provides automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. Auto EF is indicated for use on adult patients only in healthcare facilities.
The Kosmos includes the Auto Anatomical Structure Labeling and View Identification, also referred to as AI FAST, software, which is intended for use only by qualified and trained medical professionals for automatic real-lime detection and labeling of anatomical structures during image acquisition during cardiac, thoracic/lung, or abdominal ultrasound imaging. This feature is only indicated for use on adult patients in healthcare facilities.
The device is non-invasive, reusable, and intended to be used on one patient at a time.
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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