(31 days)
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.
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.
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.
The provided document is a 510(k) Premarket Notification for the EchoNous Kosmos device. It specifically states that "An assessment of clinical performance data for Kosmos was not required to support a determination of substantial equivalence."
Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria from a clinical perspective. It only reports compliance with non-clinical performance standards.
As requested, I will provide the information that is available in the document, acknowledging the absence of clinical performance data.
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical performance criteria are provided, this table will reflect compliance with non-clinical performance standards.
| Acceptance Criteria Category | Standard Designation Number and Date | Title of Standard | Reported Device Performance |
|---|---|---|---|
| Non-Clinical Performance Standards | |||
| Electromagnetic Compatibility | CISPR 11:2015+AMD1:2016+AMD2:2019 CSV Consolidated version | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Basic Safety and Essential Performance | 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) | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Electromagnetic Disturbances | 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 | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Usability | 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 | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Diagnostic Ultrasound Equipment | 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 | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Biological Evaluation | ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management proce (Note: Document lists "proce", likely "process") | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Risk Management | ISO 14971:2019 | Medical devices - Application of risk management to medical devices | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Software Life Cycle | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | Medical device software - Software life cycle processes | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Usability Engineering | IEC 62366-1 Edition 1.0 2015-02 (Including CORRIGENDUM 1 (2016)) | Medical devices - Part 1: Application of usability engineering to medical devices | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Symbols for Medical Devices | 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 | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Ultrasonics Field Characterization | IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION and 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 | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Acoustic Output Measurement | NEMA UD 2-2004 (R2009) | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| ECG Trunk Cables & Leadwires | ANSI AAMI EC53:2013 | ECG trunk cables and patient leadwires | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Medical Device Security | AAMI TIR57:2016 | Principles for medical device security - Risk management. | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
| Cleaning Reusable Medical Devices | AAMI TIR 30:2011 | A Compendium Of Processes, Materials, Test Methods, And Acceptance Criteria For Cleaning Reusable Medical Devices | "Kosmos has been designed and evaluated to comply with the FDA-recognized consensus standards... All verification and validation testing for Kosmos confirms that product specifications are met..." (Implies compliance with this standard) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for clinical data. The document focuses on compliance with non-clinical performance standards. For these standards, "All verification and validation testing" was conducted, implying that the device itself underwent testing to confirm its specifications were met, rather than using a separate "test set" of clinical data.
- Data Provenance: Not applicable for clinical data. The focus is on the device's adherence to engineering and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set with ground truth established by experts is described for this submission. The "ground truth" for the non-clinical tests would be the specifications outlined in the various standards.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document explicitly states: "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."
Therefore, no MRMC comparative effectiveness study was done for AI-assisted features for this 510(k) submission, as these features were not part of the current clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document does not describe standalone algorithm performance studies for The Kosmos device. The mention of "AI-assisted EF Workflow and Trio tool" indicates potential future AI capabilities, but these are specifically noted as "not yet cleared by the FDA" in this submission.
7. The type of ground truth used
For the non-clinical performance data, the "ground truth" is implied to be the requirements and specifications within the listed FDA-recognized consensus standards (e.g., IEC 60601 series, ISO 10993, NEMA UD 2). The device's performance was evaluated against these established benchmarks.
8. The sample size for the training set
Not applicable. This document is a 510(k) for a diagnostic ultrasound system and its integrated components, focusing on substantial equivalence to predicate devices and compliance with non-clinical performance standards. It does not describe the development or training of AI algorithms.
9. How the ground truth for the training set was established
Not applicable, as no AI training set is described in this submission.
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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
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- 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
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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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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
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| 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.
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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.
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| 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 beused by qualified andtrained healthcareprofessionals in theclinical assessment forthe following clinicalapplications by acquiring,processing, displaying,measuring, and storingultrasound images, orsynchronized ultrasoundimages,electrocardiogram (ECG)rhythms, and digitalauscultation (DA) soundsand waveforms.With respect to itsultrasound imagingcapabilities, Kosmos is ageneral purposediagnostic ultrasoundsystem used in thefollowing clinicalapplications and modesof operation:Clinical Applications:Cardiac,Thoracic/Lung,Abdominal,Vascular/PeripheralVascular,Musculoskeletal, andinterventionalguidance (includesneedle/catheterplacement, fluiddrainage, and nerveblock) Modes of Operation:B-mode, M-mode,Color Doppler,Pulsed-Wave (PW)Doppler,Continuous-Wave(CW) Doppler,Combined Modes ofB+M, and B+CD,B+PW, B+CW, andHarmonic Imaging | Kosmos is intended to beused by qualified andtrained healthcareprofessionals in the clinicalassessment of the cardiacand pulmonary systems andthe abdomen by acquiring,processing, displaying,measuring, and storingsynchronized ultrasoundimages, electrocardiogram(ECG) rhythms, and digitalauscultation (DA) soundsand waveforms.With respect to itsultrasound imagingcapabilities, Kosmos is ageneral purpose diagnosticultrasound system used inthe following clinicalapplications and modes ofoperation:Clinical Applications:Cardiac,Thoracic/Lung,Abdominal, PeripheralVascular, and ImageGuidance forNeedle/CatheterPlacement Modes of Operation:B-mode, M-mode,Color Doppler,Combined Modes ofB+M and B+CD, andHarmonic Imaging | Vscan Air is a battery-operated software-basedgeneral-purposeultrasound imagingsystem for use byqualified and trainedhealthcare professionalsor practitioners that arelegally authorized orlicensed by law in thecountry, state or otherlocal municipality inwhich he or she practices.The users may or may notbe working undersupervision or authorityof a physician. Users mayalso include medicalstudents working underthe supervision orauthority of a physicianduring their education /training. The device isenabling visualization andmeasurement ofanatomical structures andfluid including bloodflow.Vscan Air's pocket-sizedportability and simplifieduser interface enablesintegration into trainingsessions and examinationsin professional healthcarefacilities (ex. Hospital,clinic, medical office),home environment,road/air ambulance andother environments asdescribed in the usermanual. The informationcan be used forbasic/focused assessmentsand adjunctively withother medical data forclinical diagnosispurposes during routine,periodic follow-up, andtriage.Vscan Air supports Black/white (B-mode), Colorflow (Color doppler),Combined (B + ColorDoppler) and Harmonicimaging modes with boththe curved and linear | Addition of the followingClinical Applications:Vascular Musculoskeletal Fluid Drainage Nerve Block Addition of the followingmodes of operation:Pulsed-Wave (PW) Doppler Continuous-Wave(CW) Doppler Combined Modes ofB+PW and B+CW |
| Kosmos is intended to beused in clinical care andmedical educationsettings on adult andpediatric patientpopulations. | Kosmos is intended to beused in clinical care andmedical education settingson adult and pediatricpatient populations. Thedevice is non-invasive,reusable, and intended tobe used on one patient at atime.Type of Use: PrescriptionUse (Part 21 CFR 801Subpart 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 |
| ClinicalApplications | Phased ArrayTransducer:Anatomy/ Region ofInterest:AbdominalPediatricCardiac AdultCardiac PediatricPeripheral VascularThoracic/LungInterventional Guidance:NonvascularLinear ArrayTransducer:Anatomy/ Region ofInterest:Vascular/PeripheralVascularMusculoskeletalInterventional guidanceNeedle/catheterplacementFluid drainageNerve block | Phased ArrayTransducer:Anatomy/ Region ofInterest:AbdominalPediatricCardiac AdultCardiac PediatricPeripheral VascularThoracic/LungInterventional Guidance:Nonvascular | Linear ArrayTransducer:Anatomy/ Region ofInterest:Vascular/peripheralvascularMusculoskeletal(conventional andsuperficial)Small organsThoracic/lungOphthalmicPediatricsNeonatal cephalicInterventional guidanceFree handneedle/catheterplacementFluid drainageNerve blockVascular access andbiopsy | Remains unchangedAddition of Linear ArrayTransducer ClinicalApplications |
| TransducerFrequency | Phased ArrayTransducer:1.5 - 4.5 MHz with centerfrequency 3HzLinear ArrayTransducer:4-11 MHz with centerfrequency 7.5 MHz | Phased ArrayTransducer:1.5 - 4.5 MHz with centerfrequency 3Hz | Linear ArrayTransducer :3-12 MHz with centerfrequency of 7.7 MHz | Remains unchangedAddition of technologicalcharacteristics for LinearArray Transducer |
| Modes ofOperation | Phased ArrayTransducer:B-modeM-modeColor Doppler | Phased ArrayTransducer:B-modeM-modeColor Doppler | Addition of the followingmodes 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) DopplerCombined Modes:B+PW and B+CW | ||
| Linear ArrayTransducer:B-mode | Linear ArrayTransducer:B-mode Color Doppler Combined Modes ofB + CD Harmonic Imaging | Addition of Linear ArrayTransducer B-mode | ||
| 510(k) Track | Phased ArrayTransducer:Track 3 | Phased ArrayTransducer:Track 3 | Remains unchanged | |
| Linear ArrayTransducer:Track 3 | Linear ArrayTransducer:Track 3 | Remains unchanged | ||
| DA (Digital Auscultation) and ECG Substantial Equivalence (Technological Characteristics) | ||||
| DA PickupSensor andProcessing | Audio microphone +digital signal processingSampling Rate: 12.7 kHz | Audio microphone + digitalsignal processingSampling Rate: 12.7 kHz | Remains unchanged | |
| DA FilterModes | Heart/Midrange (50 - 600Hz) | Heart/Midrange (50 - 600Hz) | Remains unchanged | |
| DA SoundAmplification | Analog gain: 20 dBDigital gain: useradjustable up to 25 dB | Analog gain: 20 dBDigital gain: useradjustable up to 25 dB | Remains unchanged | |
| DA VolumeControl | Yes; 15 volume stepsavailable | Yes; 15 volume stepsavailable | Remains unchanged | |
| DA AmbientNoiseReduction | Yes | Yes | Remains unchanged | |
| DA DirectListening | Sounds can be listened toin real time using adigital-to-analog binauralheadset | Sounds can be listened toin real time using adigital-to-analogbinaural headset | Remains unchanged | |
| ECG Non-ContinuousMonitoringLeads | 3-lead, single-channel,user-supplied commercialelectrodes | 3-lead, single-channel,user-suppliedcommercial electrodes | Remains unchanged | |
| ECGAnatomicalSites | 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 |
| ECGLeadwiresand TrunkAssembly | Combines trunk cable andthree leadwires into asingle, non-sterile,reusable assembly thatforms a conductionchannel for transmittingsignals from user-suppliedclip-style electrodesaffixed to patient skin tothe Thor probe | Combines trunk cable andthree leadwires into asingle, non-sterile, reusableassembly that forms aconduction channel fortransmitting signals fromuser-supplied clip-styleelectrodes affixed to patientskin to the Thor probe | Remains unchanged | |
| DA and ECGVisualization | Sounds and ECGwaveforms can bevisualized and recordedon the Thor tablet with orwithout an internetconnection | Sounds and ECGwaveforms can bevisualized and recorded onthe Thor tablet with orwithout an internetconnection | Remains unchanged | |
| System Characteristics | ||||
| Dimensionsand Weight | Handheld tablet displayunit (proprietary) –Kosmos BridgeHeight: 146 mm Width: 216mm Depth: 59mm Weight: 657gKosmos Torso Probe(Phased Array – ECG,DA, and Ultrasound)Height: 150mm(excluding cable (thehard plastic housinglength)) Width: 56mm Depth: 35mm Weight: 290 grams(with ferrite-equipped cable) Cable dimensions:1.8 metersKosmos Torso-One Probe(Phased Array -Ultrasound Only)Height: 150 mm(excluding cable (thehard plastic housinglength)) Width: 56 mm Depth: 35 mm Weight: 275 grams(with ferrite-equipped cable) | Handheld tablet displayunit (proprietary) -Kosmos BridgeHeight: 146 mm Width: 216mm Depth: 59mm Weight: 657gKosmos Torso ProbeHeight: 150mm(excluding cable (thehard plastic housinglength)) Width: 56mm Depth: 35mm Weight: 290 grams(with ferrite-equippedcable) Cable dimensions: 1.8meters | Dimension and weight(maximum)Length: 131 Width: 64 Height: 31 Weight: 205 +/- 3gLinear Array TransducerFootprint: 40 mm x 7mm (lens) | Addition of the followingtransducers:Kosmos Torso-One(Ultrasound-OnlyProbe) 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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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.
| StandardsDevelopingOrganization | Standard DesignationNumber and Date | Title of Standard |
|---|---|---|
| CISPR/CIS/B | CISPR 11:2015+AMD1:2016+AMD2:2019CSV Consolidated version | Industrial, scientific and medical equipment -Radio-frequency disturbance characteristics -Limits and methods of measurement |
| ANSI AAMIIEC | ES60601-1:2005/(R)2012and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance (IEC 60601-1:2005, MOD) |
| ANSI AAMIIEC | 60601-1-2:2014 | Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - Collateral Standard:Electromagnetic disturbances - Requirementsand tests |
| IEC | 60601-1-6 Edition 3.12013-10 | Medical electrical equipment - Part 1-6:General requirements for basic safety andessential performance - Collateral standard:Usability |
| IEC | 60601-2-37 Edition 2.12015 | Medical electrical equipment - Part 2-37:Particular requirements for the basic safety andessential performance of ultrasonic medicaldiagnostic and monitoring equipment |
| ISO | 10993-1:2018 | Biological evaluation of medical devices - Part1: Evaluation and testing within a riskmanagement proce |
| ISO | 14971:2019 | Medical devices - Application of riskmanagement to medical devices |
| IEC | 62304 Edition 1.1 2015-06CONSOLIDATEDVERSION | Medical device software - Software life cycleprocesses |
| IEC | 62366-1 Edition 1.0 2015-02 | Medical devices - Part 1: Application ofusability engineering to medical devices[Including CORRIGENDUM 1 (2016)] |
| ISO | 15223-1 Third Edition2016-11-01 | Medical devices - Symbols to be used withmedical device labels, labelling, andinformation to be supplied - Part 1: Generalrequirements |
| StandardsDevelopingOrganization | Standard DesignationNumber and Date | Title of Standard |
| IEC | 62359 Edition 2.1 2017-09CONSOLIDATEDVERSION | Ultrasonics - Field characterization - Testmethods for the determination of thermal andmechanical indices related to medicaldiagnostic ultrasonic fields |
| NEMA | UD 2-2004 (R2009) | Acoustic Output Measurement Standard forDiagnostic Ultrasound Equipment Revision 3 |
| AIM | Standard 7351731 Rev.2.00 2017-02-23 | Ultrasonics - Field characterization - Testmethods for the determination of thermal andmechanical indices related to medicaldiagnostic ultrasonic fields |
| ANSI AAMI | EC53:2013 | ECG trunk cables and patient leadwires |
| AAMI | TIR57:2016 | Principles for medical device security - Riskmanagement. |
| AAMI | TIR 30:2011 | A Compendium Of Processes, Materials, TestMethods, And Acceptance Criteria ForCleaning 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).
§ 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.