(25 days)
Unknown
The summary mentions "automatically determine bladder volume" but does not explicitly state the method used for this automation, which could potentially involve AI/ML but is not confirmed.
No
The device is described as a "diagnostic ultrasound system," and its intended use is for "non-invasive imaging" and to "automatically determine bladder volume." These functions are for diagnosis and imaging, not for treating or preventing disease.
Yes
The device description explicitly states, "The Uscan is a hand-held, diagnostic ultrasound system..."
No
The device description explicitly states it is a "hand-held, diagnostic ultrasound system" and mentions acquiring "ultrasound echo data," which indicates it includes hardware components (the transducer and processing unit) in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Uscan Function: The Uscan is an ultrasound system that performs non-invasive imaging of the human body. It acquires echo data from within the body and displays it as an image. It does not analyze samples taken from the body.
The description clearly states its purpose is "non-invasive imaging of the human body" and describes its function as acquiring "ultrasound echo data and display it in B-Mode". This is the core function of an ultrasound machine, which is not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
IYO, ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human body, Abdominal, Musculoskeletal, Pediatric, Small Organ (prostate), Peripheral Vessel, Bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Users must have ultrasound training for abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
510(k) Number (if known)
K181574
Device Name Uscan
Indications for Use (Describe)
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.
| 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.
3
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 | Color | |||
| Doppler | 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) | ||||||||
| Peripheral | ||||||||
| Vessel | 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.
4
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 | Color | |||
| Doppler | 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) | ||||||||
| Peripheral | ||||||||
| Vessel | 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.
5
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 | Color | |||
| Doppler | 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) | ||||||||
| Peripheral | ||||||||
| Vessel | 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.
6
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
-
- 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.
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.
7
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 Ultrasound
System
(K162045) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound imaging
of the human body | Diagnostic ultrasound imaging
of the human body | Diagnostic ultrasound imaging
or fluid flow analysis of the
human body |
| Indications for
Use | Abdominal
Pediatric
Small Organ (prostate) | Abdominal
Pediatric
Small Organ (prostate) | Opthalmic
Fetal - OB/GYN
Abdominal
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-Rectal
Trans-Vaginal |
| | Musculo-skeletal
(Conventional) | Musculo-skeletal
(Conventional) | Musculo-skeletal
(Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Peripheral Vessel
Needle guidance |
| | Peripheral Vessel
Needle guidance | | |
| Transducer
Types | Linear Array | Annular Array | Linear Array
Curved Linear Array
Intracavitary
Phased Array |
| Transducer
Frequency | 3.0 - 14.0 MHz | 3.0 - 7.0 MHz | 1.0 - 15.0 MHz |
| Modes of
Operation | 2D / B-mode | 2D / B-mode | 2D / B-mode
Tissue Harmonic Imaging
M-mode
Color M-mode
Color Power Doppler
Combination Modes
Velocity 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 Ultrasound
System
(K162045) |
| Patient
Contact
Materials | Transducers:
ABS+PC (acrylonitrile
butadiene styrene +
polycarbonate) | Transducers: | Transducers:
Acrylonitrile-butadiene-
styrene (ABS) |
| | Cycoloy | Cycoloy | Cycoloy
Polycarbonate (PC) |
| | Polymethyl Pentene based
Olefin Copolymer | Polymethyl Pentene based
Olefin Copolymer | Polymethyl Pentene based
Olefin Copolymer |
| | Silicone Rubber RTV
Thermoplastic polyurethane | Thermoplastic polyurethane | Polysulfone
Poly-Vinyl-Chloride (PVC)
Silicone Rubber
Silicone Rubber RTV |
| | | | Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene
(ABS) |
| System
Characteristics | 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 control
12.1" Liquid Crystal Display
(LCD)
Operating system: Windows
CE |
| | Uscan ultrasound software
running as an "app" on tablet | Uscan ultrasound software
running as an "app" on tablet | |
| | 1 Micro USB port | 1 Micro USB port | 3 USB ports |
| | Dimensions: 9.34"(H) x
6.65"(W) x 0.24"(L)
Weight: 0.39 lbs | Dimensions: 8.15"(H) x
5.39"(W) x 0.31"(L)
Weight: 0.77 lbs | Dimensions: 4.8"(H) x
11.5"(W) x 17.6"(L)
Weight: 12.6 lbs |
| | System operates via battery | System operates via battery | System operates via battery or
AC power |
| | Input: 100-240 VAC, 50/60
Hz
Output: 5VDC, 2 A max | Input: 100 - 240 VAC, 50/60
Hz
Output: 12VDC, 1.5 A max | Input: 100 - 240V options,
50/60 Hz
Output: 15VDC |
| | Distance calculations | Distance, volume calculations | Various obstetrical, cardiac,
volume, and M-mode
measurement and calculation
packages |
| | Wireless networking | Wireless networking | Wireless networking |
| 510(k) Track | Track 3 | Track 3 | Track 3 |
8
9
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 of |
| medical devices – Part 1: Evaluation and testing within a risk management | |
| process | |
| IEC 60601-1 | AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 |
| and 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 - Part |
| 1-2: General requirements for basic safety and essential performance - | |
| Collateral standard: Electromagnetic compatibility - Requirements and | |
| tests | |
| IEC 60601-1-6 | 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 | IEC 60601-2-37:2015 Edition 2.1, Medical electrical equipment – Part 2- |
| 37: Particular requirements for the basic safety and essential performance | |
| of ultrasonic medical diagnostic and monitoring equipment | |
| IEC 62304 | AAMI / ANSI / IEC 62304:2006, Medical device software - Software life |
| cycle processes | |
| IEC 62366 | AAMI / ANSI / IEC 62366-1:2015, Medical devices – Part 1: Application |
| of usability engineering to medical devices | |
| ISO 14971 | ISO 14971:2007, Medical devices - Application of risk management to |
| medical devices | |
| NEMA UD 2-2004 | NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for |
| Diagnostic 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.