The Uscan is for non-invasive imaging of the human body and is intended for the following applications: Abdominal. Musculoskeletal, Pediatric, Small Organ, and Peripheral Vessel. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging.

The Uscan can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.

Device Description

The Uscan is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode on an off-the-shelf display. Automated bladder volume measurements are supported.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the supporting study for the Uscan device.

Note: The provided FDA 510(k) summary focuses primarily on establishing substantial equivalence based on technological characteristics and adherence to recognized standards. It does not present a detailed clinical study demonstrating the device "meets acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard in a human population) against specific acceptance thresholds. Instead, it emphasizes bench testing for imaging performance and measurement accuracy, and conformance to regulatory standards.

Therefore, "acceptance criteria" here largely refer to the requirements for safe and effective operation based on engineering and regulatory standards, rather than clinical performance metrics. The "study" refers to the non-clinical testing performed.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from testing described)	Reported Device Performance and Compliance
Safety and Essential Performance (Electrical)	Complies with IEC 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) for basic safety and essential performance.
Electromagnetic Compatibility (EMC)	Complies with AAMI / ANSI / IEC 60601-1-2:2014 for electromagnetic compatibility.
Usability	Complies with IEC 60601-1-6 Edition 3.1 2013-10 (Usability) and AAMI / ANSI / IEC 62366-1:2015 (Application of usability engineering to medical devices).
Particular Requirements for Ultrasonic Medical Diagnostic Equipment	Complies with IEC 60601-2-37:2015 Edition 2.1.
Software Life Cycle Processes	Complies with AAMI / ANSI / IEC 62304:2006.
Risk Management	Complies with ISO 14971:2007. Risks mitigated have been verified.
Biological Evaluation of Medical Devices	Complies with AAMI / ANSI / ISO 10993-1:2009/(R)2013. Biosafety equivalence with predicate devices.
Acoustic Output Measurement	Complies with NEMA UD 2-2004 (R2009).
Imaging Performance	Bench tested; Uscan imaging performance shown to be substantially equivalent to predicate devices.
Measurement Accuracy (e.g., Bladder Volume)	Bench tested; Uscan measurement accuracy shown to be substantially equivalent to predicate devices. (The document specifically mentions "Automated bladder volume measurements are supported" and that measurement accuracy was bench tested. It does not provide specific accuracy metrics or thresholds, only substantial equivalence to predicates.)
Device Operates as Intended (Verification & Validation)	Verification and validation reports.
Safe and Effective for Intended Use	Conclusion from testing is that the device is safe and effective for its intended use, and performs as well or better than the predicate devices.
Substantial Equivalence (overall to predicate devices for Track 3)	Uscan system and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and conform to applicable electromedical device safety standards. EchoNous, Inc. believes the Uscan is substantially equivalent with regard to safety and effectiveness to the predicate devices.

Study Details (Based on the provided text)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of clinical cases or patient data. The document refers to "bench testing" of imaging and measurement accuracy. This implies a test set of physical phantoms, simulated data, or lab-based scenarios, not a human patient cohort.
- Data Provenance: Not applicable for a clinical test set from human subjects since the testing described is non-clinical/bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the testing described is non-clinical bench testing, not a clinical study involving human expert interpretation. Ground truth for bench testing would be established by the physical properties of the phantoms or known parameters of the simulated data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as this refers to a clinical study interpretation process, which is not detailed here.
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:
- No MRMC comparative effectiveness study is described in this document. The focus is on the device itself and its equivalence to predicate devices, not on human-AI augmented performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "bench testing for imaging performance and measurement accuracy" represents a form of standalone testing, as it evaluates the device's technical capabilities (image quality, automated measurements like bladder volume) without human interpretation in a clinical setting mentioned. However, specific metrics (e.g., accuracy, precision) are not provided beyond stating substantial equivalence to predicate devices.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench testing, the ground truth would likely be physical measurements from phantoms or known parameters of simulated datasets used to evaluate imaging performance and measurement accuracy. No clinical ground truth (like pathology or expert consensus on patient data) is mentioned for the testing described.
The sample size for the training set:
- Not applicable. This document does not describe the development or training of any AI/ML components in the Uscan, but rather its regulatory clearance as a diagnostic ultrasound system. While automated bladder volume determination might imply some underlying algorithm, the training data and its size are not disclosed here.
How the ground truth for the training set was established:
- Not applicable, as the training set details are not provided.

Summary of what the document implies about "meeting acceptance criteria":

The provided 510(k) summary primarily demonstrates that the Uscan device meets regulatory acceptance criteria by:

Conforming to a comprehensive list of FDA-recognized international and national standards for medical electrical equipment, software, usability, risk management, biological evaluation, and acoustic output.
Undergoing bench testing that showed its imaging performance and measurement accuracy to be "substantially equivalent" to predicate devices.
Having verified risk mitigation and functioning as intended per verification and validation reports.

It does not provide details about specific clinical performance acceptance criteria (e.g., diagnostic accuracy thresholds like sensitivity/specificity for detecting certain conditions) or a clinical study demonstrating the device's ability to meet such criteria in a human population. The approval is based on substantial equivalence and compliance with engineering and safety standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 10th, 2018

EchoNous, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

Re: K181574

Trade/Device Name: Uscan Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: June 14, 2018 Received: June 15, 2018

Dear Mr. Job:

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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Rodges

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K181574

Device Name Uscan

Indications for Use (Describe)

The Uscan can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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510(k) Number (if known)

Device Name Uscan

System:

TABLE 1.3-1: USCAN INDICATIONS FOR USE FORM

Uscan

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P
	Small Organ (Specify)	P						1
Fetal Imaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	N						2
	Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

1: Small organ imaging is prostate.

2: Includes imaging to assist in the placement of needles and catheters in vascular structures.

All items marked "P" were previously cleared in 510(k) K160420.

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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510(k) Number (if known)

Device Name Uscan

TABLE 1.3-2: USCAN INDICATIONS FOR USE FORM

System:	Uscan
Transducer:	Uscan Sector Probe (B3-5)
Intended Use:	Diagnostic ultrasound imaging of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P
	Small Organ (Specify)	P						1
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

1: Small organ imaging is prostate.

2: Includes imaging to assist in the placement of needles and catheters in vascular structures.

All items marked "P" were previously cleared in 510(k) K160420.

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Number (if known)

Device Name Uscan

TABLE 1.3-3: USCAN INDICATIONS FOR USE FORM

System:	Uscan
Transducer:	Uscan Linear Probe (L14-6)
Intended Use:	Diagnostic ultrasound imaging of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	N						2
	Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

X Prescription Use (Part 21 CFR 801 Subpart D)

Additional Comments:

1: Small organ imaging is prostate.

2: Includes imaging to assist in the placement of needles and catheters in vascular structures.

Type of Use (Select one or both, as applicable)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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510(k) Summary

1. Submitter:

EchoNous, Inc. 8310 154th Ave NE Bldg B. Ste 200 Redmond, WA 98052 USA

2. Contact Person:

Trish Liau Regulatory Affairs Manager Telephone: (425) 402-4044 E-mail: patricia.liau@echonous.com

3. Date Prepared:

March 30, 2018

1. Proprietary/Marketed Names: Uscan (subject to change)

ട. Common/Usual Name: Diagnostic ultrasound system with accessories

Classification: 6.

Regulatory Class: II Review Category: Tier II Classification Panel: Radiology

Name	21 CFR Number	Product Code
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

7. Predicate Devices:

Primary predicate: Uscan Ultrasound System (K160420) Reference predicate: SonoSite SII Ultrasound System (K162045)

Device Description: 8.

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9. Intended Use:

The Uscan is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, Small Organ, and Peripheral Vessel. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging.

The Uscan can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.

10. Technological Characteristics:

The Uscan and SII ultrasound systems are Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.

Feature	Uscan Ultrasound System(This submission)	Uscan Ultrasound System(K160420)	SonoSite SII UltrasoundSystem(K162045)
Intended Use	Diagnostic ultrasound imagingof the human body	Diagnostic ultrasound imagingof the human body	Diagnostic ultrasound imagingor fluid flow analysis of thehuman body
Indications forUse	AbdominalPediatricSmall Organ (prostate)	AbdominalPediatricSmall Organ (prostate)	OpthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-RectalTrans-Vaginal
	Musculo-skeletal(Conventional)	Musculo-skeletal(Conventional)	Musculo-skeletal(Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricPeripheral VesselNeedle guidance
	Peripheral VesselNeedle guidance
TransducerTypes	Linear Array	Annular Array	Linear ArrayCurved Linear ArrayIntracavitaryPhased Array
TransducerFrequency	3.0 - 14.0 MHz	3.0 - 7.0 MHz	1.0 - 15.0 MHz
Modes ofOperation	2D / B-mode	2D / B-mode	2D / B-modeTissue Harmonic ImagingM-modeColor M-modeColor Power DopplerCombination ModesVelocity Color Doppler
PW Doppler	Not available	Not available	Not available
CW Doppler	Not available	Not available	Not available
Feature	Uscan Ultrasound System(This submission)	Uscan Ultrasound System(K160420)	SonoSite SII UltrasoundSystem(K162045)
PatientContactMaterials	Transducers:ABS+PC (acrylonitrilebutadiene styrene +polycarbonate)	Transducers:	Transducers:Acrylonitrile-butadiene-styrene (ABS)
	Cycoloy	Cycoloy	CycoloyPolycarbonate (PC)
	Polymethyl Pentene basedOlefin Copolymer	Polymethyl Pentene basedOlefin Copolymer	Polymethyl Pentene basedOlefin Copolymer
	Silicone Rubber RTVThermoplastic polyurethane	Thermoplastic polyurethane	PolysulfonePoly-Vinyl-Chloride (PVC)Silicone RubberSilicone Rubber RTV
			UrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene(ABS)
SystemCharacteristics	Uscan:Handheld tablet (off-the-shelf)9.7" Liquid Crystal Display(LCD)Operating system: Android	Uscan:Handheld tablet (off-the-shelf)7.86" Liquid Crystal Display(LCD)Operating system: Android	SII:Handheld display and control12.1" Liquid Crystal Display(LCD)Operating system: WindowsCE
	Uscan ultrasound softwarerunning as an "app" on tablet	Uscan ultrasound softwarerunning as an "app" on tablet
	1 Micro USB port	1 Micro USB port	3 USB ports
	Dimensions: 9.34"(H) x6.65"(W) x 0.24"(L)Weight: 0.39 lbs	Dimensions: 8.15"(H) x5.39"(W) x 0.31"(L)Weight: 0.77 lbs	Dimensions: 4.8"(H) x11.5"(W) x 17.6"(L)Weight: 12.6 lbs
	System operates via battery	System operates via battery	System operates via battery orAC power
	Input: 100-240 VAC, 50/60HzOutput: 5VDC, 2 A max	Input: 100 - 240 VAC, 50/60HzOutput: 12VDC, 1.5 A max	Input: 100 - 240V options,50/60 HzOutput: 15VDC
	Distance calculations	Distance, volume calculations	Various obstetrical, cardiac,volume, and M-modemeasurement and calculationpackages
	Wireless networking	Wireless networking	Wireless networking
510(k) Track	Track 3	Track 3	Track 3

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11. Basis for Substantial Equivalence:

Summary of Non-Clinical Tests

The Uscan has been designed and evaluated to comply with the following FDA recognized standards.

Reference No.	Title
ISO 10993-1	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation ofmedical devices – Part 1: Evaluation and testing within a risk managementprocess
IEC 60601-1	AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance(IEC 60601-1:2005, MOD)
IEC 60601-1-2	AAMI / ANSI / IEC 60601-1-2:2014, Medical electrical equipment - Part1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements andtests
IEC 60601-1-6	IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
IEC 60601-2-37	IEC 60601-2-37:2015 Edition 2.1, Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performanceof ultrasonic medical diagnostic and monitoring equipment
IEC 62304	AAMI / ANSI / IEC 62304:2006, Medical device software - Software lifecycle processes
IEC 62366	AAMI / ANSI / IEC 62366-1:2015, Medical devices – Part 1: Applicationof usability engineering to medical devices
ISO 14971	ISO 14971:2007, Medical devices - Application of risk management tomedical devices
NEMA UD 2-2004	NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard forDiagnostic Ultrasound Equipment

The Uscan has been bench tested for imaging performance and measurement accuracy, with tests showing the Uscan imaging performance and measurement accuracy to be substantially equivalent to the predicate devices.

Verification and validation reports, traceability, and risk analysis demonstrate the Uscan operates as intended and risks mitigated have been verified.

The conclusion from the testing is the device is safe and effective for its intended use, and performs as well or better than the predicate devices.

The Uscan system and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and conform to applicable electromedical device safety standards. EchoNous, Inc. believes the Uscan is substantially equivalent with regard to safety and effectiveness to the predicate devices.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.