(31 days)
Yes
The summary explicitly mentions "AI-assisted EF Workflow and Trio tool".
No.
Explanation: The "Intended Use / Indications for Use" section states that Kosmos is a "general purpose diagnostic ultrasound system," indicating its primary function is for diagnosis rather than therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Kosmos is a general purpose diagnostic ultrasound system." It also mentions "acquiring, processing, displaying, measuring, and storing ultrasound images" for clinical assessment.
No
The device description explicitly states that Kosmos consists of a tablet and a probe, which are hardware components. It also mentions additional hardware like an ECG Patient Cable and Binaural Headset.
Based on the provided information, the Kosmos device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The intended use and device description clearly state that Kosmos is a diagnostic ultrasound system that acquires images, ECG rhythms, and digital auscultation sounds directly from the patient's body. It does not analyze blood, urine, tissue, or any other specimen removed from the patient.
- The device's function is based on imaging and physiological signal acquisition. Ultrasound, ECG, and digital auscultation are all methods of obtaining information in vivo (within the living body), not in vitro (in glass or outside the body).
Therefore, while Kosmos is a medical device used for diagnosis, it falls under the category of in vivo diagnostic imaging and physiological monitoring systems, not In Vitro Diagnostics.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The specific language for PCCP authorization is "Not Found" in the provided text.
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 capabilities, 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 needle/catheter placement, fluid drainage, and nerve block)
Modes of Operation: B-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.
The device is non-invasive, reusable, and intended to be used on one patient at a time.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, DQD, DPS
Device Description
Kosmos consists of a tablet (i.e., Kosmos Bridge or supported Off-The-Shelf Android tablet provided by the user) and probe (i.e., Kosmos Torso, Torso-One, or Lexsa), which connects to the tablet via a cable. Additional components include the ECG Patient Cable and Binaural Headset for use with Kosmos Torso only. Kosmos can operate on battery or while connected to mains, when used as either handheld device or mounted to the mobile stand (i.e., AI Station 2).
The probe face houses an ultrasound transducer and sealed microphones for auscultation (Kosmos Torso only).
The tablet (i.e., Kosmos Bridge or supported Off-The-Shelf Android tablet provided by the customer) displays clinical and patient data information including the display of ultrasound images, auscultation and ECG waveforms (when connected to Kosmos Torso), and patient data/reports. The tablet also includes speakers for sounds associated with system control and feedback. Additionally, the tablet offers a means of user control with its touchscreen display and buttons.
Although its intended operation is not dependent on Wi-Fi, Kosmos supports Wi-Fi connectivity for:
- patient data archival,
- updating the embedded Kosmos Software (Kosmos Bridge configurations only), or
- downloading or updating the Kosmos Software Application from the Google Play Store (Kosmos On Android configuration only)
Kosmos' ECG capability provides a timing reference with respect to the cardiac cycle as compared with both ultrasound imaging and digital auscultation. Ultrasound imaging, ECG, and DA are all integrated into Kosmos Torso in a time-synchronized manner.
Kosmos' 3-lead single-channel ECG allows for the acquisition and display of a single ECG waveform (lead), which can be any one of the Lead I, or Lead III waveforms. One end of Kosmos' ECG cable connects to the probe via a custom-designed magnetic connector. The other end has three (3) RA/LA/LL leadwires to be connected to user-supplied clip-style electrodes affixed to the patient using the standard RA/LA/LL configuration.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Kosmos is an FDA-cleared medical device: however, the new AI-assisted EF Workflow and Trio tool are not yet cleared by the FDA. Instead, EchoNous is following the Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, April 2020 for this new feature.
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Thoracic/Lung, Abdominal, Vascular/Peripheral Vascular, Musculoskeletal, and interventional guidance (includes needle/catheter placement, fluid drainage, and nerve block)
Indicated Patient Age Range
adult and pediatric patient populations
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)
An assessment of clinical performance data for Kosmos was not required to support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Kosmos (K193518)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Vscan Air (K202035)
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 6, 2021
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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
EchoNous, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114
Re: K212100
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 Dated: July 3, 2021 Received: July 6, 2021
Dear Prithul Bom:
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for 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 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.
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
Indications for Use
510(k) Number (if known) K212100
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 capabilities, 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 needle/catheter placement, fluid drainage, and nerve block) · Modes of Operation: B-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.
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) | |
|---|---|
| ☑ 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
As required by 21, CFR Section 807.92
1. Submitter
EchoNous, Inc. 8310 154th Ave NE Building B, Suite 200 Redmond, WA 98052 USA
2. Contact Person
Carly Hom Manager, RA/QA Telephone: (602)315-5728 E-mail: carly.hom@echonous.com
3. Date Prepared
August 4, 2021
4. Device / Marketing Trade Name
Kosmos
5. Common / Usual Name
Diagnostic ultrasound system with integrated electronic stethoscope and electrocardiograph
6. Classification
Regulatory Device Class: II Classification Panel: Radiology, Cardiovascular
4
| Classification Name | 21 CFR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
| Electronic Stethoscope | 870.1875 | DQD |
| Electrocardiograph | 870.2340 | DPS |
7. Predicate Devices
Predicate device: Kosmos (K193518); Product Code: IYN, IYO, ITX, DOD, DPS Reference device: Vscan Air (K202035); Product Code: IYN, IYO, ITX
8. Device Description
Kosmos consists of a tablet (i.e., Kosmos Bridge or supported Off-The-Shelf Android tablet provided by the user) and probe (i.e., Kosmos Torso, Torso-One, or Lexsa), which connects to the tablet via a cable. Additional components include the ECG Patient Cable and Binaural Headset for use with Kosmos Torso only. Kosmos can operate on battery or while connected to mains, when used as either handheld device or mounted to the mobile stand (i.e., AI Station 2).
The probe face houses an ultrasound transducer and sealed microphones for auscultation (Kosmos Torso only).
The tablet (i.e., Kosmos Bridge or supported Off-The-Shelf Android tablet provided by the customer) displays clinical and patient data information including the display of ultrasound images, auscultation and ECG waveforms (when connected to Kosmos Torso), and patient data/reports. The tablet also includes speakers for sounds associated with system control and feedback. Additionally, the tablet offers a means of user control with its touchscreen display and buttons.
Although its intended operation is not dependent on Wi-Fi, Kosmos supports Wi-Fi connectivity for:
- patient data archival,
- updating the embedded Kosmos Software (Kosmos Bridge configurations only), or ●
- downloading or updating the Kosmos Software Application from the Google Play Store ● (Kosmos On Android configuration only)
Kosmos' ECG capability provides a timing reference with respect to the cardiac cycle as compared with both ultrasound imaging and digital auscultation. Ultrasound imaging, ECG, and DA are all integrated into Kosmos Torso in a time-synchronized manner.
5
Kosmos' 3-lead single-channel ECG allows for the acquisition and display of a single ECG waveform (lead), which can be any one of the Lead I, or Lead III waveforms. One end of Kosmos' ECG cable connects to the probe via a custom-designed magnetic connector. The other end has three (3) RA/LA/LL leadwires to be connected to user-supplied clip-style electrodes affixed to the patient using the standard RA/LA/LL configuration.
Kosmos is an FDA-cleared medical device: however, the new AI-assisted EF Workflow and Trio tool are not yet cleared by the FDA. Instead, EchoNous is following the Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, April 2020 for this new feature.
9. 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 capabilities, 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/Peripheral Vascular, Musculoskeletal, and interventional guidance (includes 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 pediatric patient populations.
The device is non-invasive, reusable, and intended to be used on one patient at a time.
Type of Use: Prescription Use (Part 21 CFR 801 Subpart D)
10. Basis for Substantial Equivalence
Kosmos is substantially equivalent to its predicate device with regards to intended use. technological characteristics, and safety and effectiveness. A comparison between the subject device, predicate device, and reference device are provided in the table below.
6
| Feature | Subject Device:
Kosmos (This 510(k)
Submission) | Predicate Device:
Kosmos (K193518) | Reference Device:
Vscan Air (K202035) | Comparison |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
capabilities, 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/Peripheral
Vascular,
Musculoskeletal, and
interventional
guidance (includes
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 by qualified and
trained healthcare
professionals in the clinical
assessment of the cardiac
and pulmonary systems and
the abdomen by acquiring,
processing, displaying,
measuring, and storing
synchronized ultrasound
images, electrocardiogram
(ECG) rhythms, and digital
auscultation (DA) sounds
and waveforms.
With respect to its
ultrasound imaging
capabilities, Kosmos is a
general purpose diagnostic
ultrasound system used in
the following clinical
applications and modes of
operation:
Clinical Applications:
Cardiac,
Thoracic/Lung,
Abdominal, Peripheral
Vascular, and Image
Guidance for
Needle/Catheter
Placement Modes of Operation:
B-mode, M-mode,
Color Doppler,
Combined Modes of
B+M and B+CD, and
Harmonic Imaging | Vscan Air is a battery-
operated software-based
general-purpose
ultrasound imaging
system for use by
qualified and trained
healthcare professionals
or practitioners that are
legally authorized or
licensed by law in the
country, state or other
local municipality in
which he or she practices.
The users may or may not
be working under
supervision or authority
of a physician. Users may
also include medical
students working under
the supervision or
authority of a physician
during their education /
training. The device is
enabling visualization and
measurement of
anatomical structures and
fluid including blood
flow.
Vscan Air's pocket-sized
portability and simplified
user interface enables
integration into training
sessions and examinations
in professional healthcare
facilities (ex. Hospital,
clinic, medical office),
home environment,
road/air ambulance and
other environments as
described in the user
manual. The information
can be used for
basic/focused assessments
and adjunctively with
other medical data for
clinical diagnosis
purposes during routine,
periodic follow-up, and
triage.
Vscan Air supports Black/
white (B-mode), Color
flow (Color doppler),
Combined (B + Color
Doppler) and Harmonic
imaging modes with both
the curved and linear | Addition of the following
Clinical Applications:
Vascular Musculoskeletal Fluid Drainage Nerve Block Addition of the following
modes of operation:
Pulsed-Wave (PW) Doppler Continuous-Wave
(CW) Doppler Combined Modes of
B+PW and B+CW |
| | Kosmos is intended to be
used in clinical care and
medical education
settings on adult and
pediatric patient
populations. | Kosmos is intended to be
used in clinical care and
medical education settings
on adult and pediatric
patient populations. The
device is non-invasive,
reusable, and intended to
be used on one patient at a
time.
Type of Use: Prescription
Use (Part 21 CFR 801
Subpart D) | | |
| Feature | Subject Device:
Kosmos (This 510(k) Submission) | Predicate Device:
Kosmos (K193518) | Reference Device:
Vscan Air (K202035) | Comparison |
| | The device is non-invasive, reusable, and intended to be used on one patient at a time.
Type of Use:
Prescription Use (Part 21 CFR 801 Subpart D) | | array transducers.
With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatric, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional), pediatrics, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, ophthalmic, pediatrics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).
Type of Use: Prescription Use (Part 21 CFR 801 Subpart D) | |
| Ultrasound Substantial Equivalence (Technological Characteristics) | | | | |
| Transducer Types | Phased Array Linear Array | Phased Array | Curved Array Linear Array | Addition of Linear Array Transducer |
| Feature | Subject Device:
Kosmos (This 510(k)
Submission) | Predicate Device:
Kosmos (K193518) | Reference Device:
Vscan Air (K202035) | Comparison |
| Clinical
Applications | Phased Array
Transducer:
Anatomy/ Region of
Interest:
AbdominalPediatricCardiac AdultCardiac PediatricPeripheral VascularThoracic/Lung
Interventional Guidance:
Nonvascular
Linear Array
Transducer:
Anatomy/ Region of
Interest:
Vascular/Peripheral
VascularMusculoskeletal
Interventional guidance
Needle/catheter
placementFluid drainageNerve block | Phased Array
Transducer:
Anatomy/ Region of
Interest:
AbdominalPediatricCardiac AdultCardiac PediatricPeripheral VascularThoracic/Lung
Interventional Guidance:
Nonvascular | Linear Array
Transducer:
Anatomy/ Region of
Interest:
Vascular/peripheral
vascularMusculoskeletal
(conventional and
superficial)Small organsThoracic/lungOphthalmicPediatricsNeonatal cephalic
Interventional guidance
Free hand
needle/catheter
placementFluid drainageNerve blockVascular access and
biopsy | Remains unchanged
Addition of Linear Array
Transducer Clinical
Applications |
| Transducer
Frequency | Phased Array
Transducer:
1.5 - 4.5 MHz with center
frequency 3Hz
Linear Array
Transducer:
4-11 MHz with center
frequency 7.5 MHz | Phased Array
Transducer:
1.5 - 4.5 MHz with center
frequency 3Hz | Linear Array
Transducer :
3-12 MHz with center
frequency of 7.7 MHz | Remains unchanged
Addition of technological
characteristics for Linear
Array Transducer |
| Modes of
Operation | Phased Array
Transducer:
B-modeM-modeColor Doppler | Phased Array
Transducer:
B-modeM-modeColor Doppler | | Addition of the following
modes of operation:
Pulsed-Wave (PW)
DopplerContinuous-Wave |
| Feature | Subject Device:
Kosmos (This 510(k)
Submission) | Predicate Device:
Kosmos (K193518) | Reference Device:
Vscan Air (K202035) | Comparison |
| | Pulsed-Wave (PW) Doppler Continuous-Wave (CW) Doppler Combined Modes:
B+M, B+CD,
B+PW, and B+CW Harmonic Imaging | Combination Modes:
B+M, B+CD Harmonic Imaging | | (CW) Doppler
Combined Modes:
B+PW and B+CW |
| | Linear Array
Transducer:
B-mode | | Linear Array
Transducer:
B-mode Color Doppler Combined Modes of
B + CD Harmonic Imaging | Addition of Linear Array
Transducer B-mode |
| 510(k) Track | Phased Array
Transducer:
Track 3 | Phased Array
Transducer:
Track 3 | | Remains unchanged |
| | Linear Array
Transducer:
Track 3 | | Linear Array
Transducer:
Track 3 | Remains unchanged |
| | DA (Digital Auscultation) and ECG Substantial Equivalence (Technological Characteristics) | | | |
| DA Pickup
Sensor and
Processing | Audio microphone +
digital signal processing
Sampling Rate: 12.7 kHz | Audio microphone + digital
signal processing
Sampling Rate: 12.7 kHz | | Remains unchanged |
| DA Filter
Modes | Heart/Midrange (50 - 600
Hz) | Heart/Midrange (50 - 600
Hz) | | Remains unchanged |
| DA Sound
Amplification | Analog gain: 20 dB
Digital gain: user
adjustable up to 25 dB | Analog gain: 20 dB
Digital gain: user
adjustable up to 25 dB | | Remains unchanged |
| DA Volume
Control | Yes; 15 volume steps
available | Yes; 15 volume steps
available | | Remains unchanged |
| DA Ambient
Noise
Reduction | Yes | Yes | | Remains unchanged |
| DA Direct
Listening | Sounds can be listened to
in real time using a
digital-to-analog binaural
headset | Sounds can be listened to
in real time using a
digital-to-analog
binaural headset | | Remains unchanged |
| ECG Non-
Continuous
Monitoring
Leads | 3-lead, single-channel,
user-supplied commercial
electrodes | 3-lead, single-channel,
user-supplied
commercial electrodes | | Remains unchanged |
| ECG
Anatomical
Sites | Chest (torso) and Leg | Chest (torso) and Leg | | Remains unchanged |
| Feature | Subject Device:
Kosmos (This 510(k) Submission) | Predicate Device:
Kosmos (K193518) | Reference Device:
Vscan Air (K202035) | Comparison |
| ECG
Leadwires
and Trunk
Assembly | Combines trunk cable and
three leadwires into a
single, non-sterile,
reusable assembly that
forms a conduction
channel for transmitting
signals from user-supplied
clip-style electrodes
affixed to patient skin to
the Thor probe | Combines trunk cable and
three leadwires into a
single, non-sterile, reusable
assembly that forms a
conduction channel for
transmitting signals from
user-supplied clip-style
electrodes affixed to patient
skin to the Thor probe | | Remains unchanged |
| DA and ECG
Visualization | Sounds and ECG
waveforms can be
visualized and recorded
on the Thor tablet with or
without an internet
connection | Sounds and ECG
waveforms can be
visualized and recorded on
the Thor tablet with or
without an internet
connection | | Remains unchanged |
| System Characteristics | | | | |
| Dimensions
and Weight | Handheld tablet display
unit (proprietary) –
Kosmos Bridge
Height: 146 mm Width: 216mm Depth: 59mm Weight: 657g
Kosmos Torso Probe
(Phased Array – ECG,
DA, and Ultrasound)
Height: 150mm
(excluding cable (the
hard plastic housing
length)) Width: 56mm Depth: 35mm Weight: 290 grams
(with ferrite-
equipped cable) Cable dimensions:
1.8 meters
Kosmos Torso-One Probe
(Phased Array -
Ultrasound Only)
Height: 150 mm
(excluding cable (the
hard plastic housing
length)) Width: 56 mm Depth: 35 mm Weight: 275 grams
(with ferrite-
equipped cable) | Handheld tablet display
unit (proprietary) -
Kosmos Bridge
Height: 146 mm Width: 216mm Depth: 59mm Weight: 657g
Kosmos Torso Probe
Height: 150mm
(excluding cable (the
hard plastic housing
length)) Width: 56mm Depth: 35mm Weight: 290 grams
(with ferrite-equipped
cable) Cable dimensions: 1.8
meters | Dimension and weight
(maximum)
Length: 131 Width: 64 Height: 31 Weight: 205 +/- 3g
Linear Array Transducer
Footprint: 40 mm x 7
mm (lens) | Addition of the following
transducers:
Kosmos Torso-One
(Ultrasound-Only
Probe) Kosmos Torso-One
- USB (Ultrasound-
Only Probe) Kosmos Lexsa
(Linear Probe) |
| Feature | Subject Device:
Kosmos (This 510(k) Submission) | Predicate Device:
Kosmos (K193518) | Reference Device:
Vscan Air (K202035) | Comparison |
| | 1.8 meters | | | |
| | Kosmos Torso-One Probe USB (Phased Array – Ultrasound Only)
Height: 150 mm (excluding cable (the hard plastic housing length)) Width: 56 mm Depth: 35 mm Weight: 267 grams (with ferrite-equipped cable) Cable dimensions: 1.5 meters Kosmos Lexsa Probe (Linear Array) Height: 150 mm (excluding cable (the hard plastic housing length)) Width: 56 mm Depth: 35 mm Weight: 275 grams (with ferrite-equipped cable) Cable dimensions: 1.8 meters | | | |
| Power Source | Mains and battery operated (rechargeable lithium ion battery) | Mains and battery operated (rechargeable lithium ion battery) | | Remains unchanged |
| Patient Contact Materials | Probe and ECG Leadwires materials are biocompatible | Probe and ECG Leadwires are biocompatible | | Remains unchanged |
| Ingress Protection (IP) Rating | Kosmos Bridge: IP22 All Probes: IPX7 | Kosmos Bridge: IP22 Torso Probe: IPX7 | | Remains unchanged |
| DICOM | Yes | Yes | | Remains unchanged |
| Wireless Networking | IEEE 802.11 a/b/g/n/ac Bluetooth 4.2 or later | IEEE 802.11 a/b/g/n/ac Bluetooth 4.2 or later | | Remains unchanged |
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Traditional 510(k) Premarket Notification – Kosmos
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9
10
Traditional 510(k) Premarket Notification – Kosmos
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Traditional 510(k) Premarket Notification – Kosmos
11. Non-Clinical Performance Data
Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards in the table below. All verification and validation testing for Kosmos confirms that
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product specifications are met and are equivalent in design and technological and performance characteristics as the predicate devices.
| Standards
Developing
Organization | Standard Designation
Number and Date | Title of Standard |
|-----------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CISPR/CIS/B | CISPR 11:2015+
AMD1:2016+AMD2:2019
CSV Consolidated version | Industrial, scientific and medical equipment -
Radio-frequency disturbance characteristics -
Limits and methods of measurement |
| ANSI AAMI
IEC | ES60601-1:2005/(R)2012
and A1:2012,
C1:2009/(R)2012 and
A2:2010/(R)2012 | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance (IEC 60601-1:2005, MOD) |
| ANSI AAMI
IEC | 60601-1-2:2014 | Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements
and tests |
| IEC | 60601-1-6 Edition 3.1
2013-10 | Medical electrical equipment - Part 1-6:
General requirements for basic safety and
essential performance - Collateral standard:
Usability |
| IEC | 60601-2-37 Edition 2.1
2015 | Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety and
essential performance of ultrasonic medical
diagnostic and monitoring equipment |
| ISO | 10993-1:2018 | Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk
management proce |
| ISO | 14971:2019 | Medical devices - Application of risk
management to medical devices |
| IEC | 62304 Edition 1.1 2015-06
CONSOLIDATED
VERSION | Medical device software - Software life cycle
processes |
| IEC | 62366-1 Edition 1.0 2015-
02 | Medical devices - Part 1: Application of
usability engineering to medical devices
[Including CORRIGENDUM 1 (2016)] |
| ISO | 15223-1 Third Edition
2016-11-01 | Medical devices - Symbols to be used with
medical device labels, labelling, and
information to be supplied - Part 1: General
requirements |
| Standards
Developing
Organization | Standard Designation
Number and Date | Title of Standard |
| IEC | 62359 Edition 2.1 2017-09
CONSOLIDATED
VERSION | Ultrasonics - Field characterization - Test
methods for the determination of thermal and
mechanical indices related to medical
diagnostic ultrasonic fields |
| NEMA | UD 2-2004 (R2009) | Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment Revision 3 |
| AIM | Standard 7351731 Rev.
2.00 2017-02-23 | Ultrasonics - Field characterization - Test
methods for the determination of thermal and
mechanical indices related to medical
diagnostic ultrasonic fields |
| ANSI AAMI | EC53:2013 | ECG trunk cables and patient leadwires |
| AAMI | TIR57:2016 | Principles for medical device security - Risk
management. |
| AAMI | TIR 30:2011 | A Compendium Of Processes, Materials, Test
Methods, And Acceptance Criteria For
Cleaning Reusable Medical Devices |
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12. Clinical Performance Data
An assessment of clinical performance data for Kosmos was not required to support a determination of substantial equivalence.
13. Conclusion
The conclusions drawn from the nonclinical tests, laboratory reports and internal testing demonstrate that the Kosmos device is as safe, as effective, and performs as well as or better than the predicate device (K193518).