(139 days)
Not Found
No
The summary describes standard ultrasound imaging modes and functionalities without mentioning any AI/ML-specific features, algorithms, or performance metrics related to AI/ML.
No
The device is described as a diagnostic ultrasound imaging system, used for visualization and measurement, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The Enovare system's ultrasound scanner connected with a probe enables real time diagnostic ultrasound imaging..." This directly indicates its diagnostic purpose.
No
The device description explicitly lists hardware components such as a system cart, keyboard, ultrasound probe(s), and LCD monitor, indicating it is a hardware-based ultrasound system with associated software, not a software-only medical device.
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, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Enovare System Function: The description clearly states that the Enovare system is an ultrasound scanner used for real-time diagnostic imaging of the body. It uses ultrasound waves to create images of internal structures. This is an in vivo (within the living body) diagnostic method.
The information provided about the Enovare system's intended use, device description, and anatomical sites all point to it being a medical imaging device used directly on patients, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The Enovare system's ultrasound scanner connected with a probe enables real time diagnostic ultrasound imaging for Bmode, Tissue and Contrast Harmonic Imaging, PWD, Power Doppler and combined mode imaging. Signal Analysis and display. Guidance of biopsy and therapy needles, geometrical measurements and calculation of parameters. The system offers optional probes each type optimized to image structure and orientation of tissues during specific clinical applications. These include general Abdominal, Intraoperative, Cardiac, Neurosurgery, Transrectal, Small organs, Urological, Transvaginal, Musculoskeletal.
Product codes (comma separated list FDA assigned to the subject device)
IYO, IYN, IYX
Device Description
The Enovare supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), PWD mode, CFM mode, Amplitude (Power) Doppler mode.
The system consists of:
- system cart
- keyboard
- ultrasound probe(s)
- LCD monitor
The system can perform simple geometric measurements and perform calculations in the vascular and urology areas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
General Abdominal, Intraoperative, Cardiac, Neurosurgery, Transrectal, Small organs, Urological, Transvaginal, Musculoskeletal.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): 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.
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.
Not Found
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
§ 892.1560 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2016
Oreon Technologies Inc. % Mr. Howard Fidel President 520 White Plains Road TARRYTOWN NY 10591
Re: K153620
Trade/Device Name: Enovare Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, IYX Dated: December 18, 2015 Received: February 22, 2016
Dear Mr. Fidel:
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, 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); medical device reporting (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ochs
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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Indications for Use
510(k) Number (if known) K153620
Device Name Enovare Ultrasound System
Indications for Use (Describe)
The Enovare system's ultrasound scanner connected with a probe enables real time diagnostic ultrasound imaging for Bmode, Tissue and Contrast Harmonic Imaging, PWD, Power Doppler and combined mode imaging. Signal Analysis and display. Guidance of biopsy and therapy needles, geometrical measurements and calculation of parameters. The system offers optional probes each type optimized to image structure and orientation of tissues during specific clinical applications. These include general Abdominal, Intraoperative, Cardiac, Neurosurgery, Transrectal, Small organs, Urological, Transvaginal, Musculoskeletal.
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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System: Enovare
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of Operation | ||||
|---|---|---|---|---|---|
| Track 3 | B | PWD | Color Doppler + B | Color + PWD+B | Harmonic |
| Abdominal | p | n | n | n | n |
| Intra-operative (abdominal) | n | n | n | n | n |
| Laparoscopic | n | n | n | n | n |
| Trans-rectal | p | n | n | n | n |
| Trans-vaginal (not fetal) | p | n | n | n | n |
| Small Parts | p | n | n | n | n |
n= new indication, p = previously cleared by FDA
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH
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Transducer: Intraoperative 2001114 System: Enovare Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application Modes of Operation | |||||
|---|---|---|---|---|---|
| Track 3 | B | PWD | Color Doppler + B | Color + PWD+B | Harmonic |
| Abdominal | |||||
| Intra-operative (abdominal) | n | n | n | n | n |
| Laparoscopic | n | n | n | n | n |
| Trans-rectal | |||||
| Trans-vaginal (not fetal) | |||||
| Small Parts |
n= new indication, p = previously cleared by FDA
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH
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System: Enovare _____________________________________________________________________________________________________________________________________________________________ follows: follows.
Clinical Applicatio Modes of Operatio
| Clinical Application | Modes of Operation | ||||
|---|---|---|---|---|---|
| Track 3 | B | PWD | Color Doppler + B | Color + PWD+B | Harmonic |
| Abdominal | |||||
| Intra-operative (abdominal) | |||||
| Laparoscopic | |||||
| Trans-rectal | p | n | n | n | n |
| Trans-vaginal (not fetal) | p | n | n | n | n |
| Small Parts |
n= new indication, p = previously cleared by FDA
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH
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Transducer: Linear 2001021 System: _Enovare Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: lonows.
Clinical Applicatio Mode s of Operatio
| Clinical Application | Modes of Operation | ||||
|---|---|---|---|---|---|
| Track 3 | B | PWD | Color Doppler + B | Color + PWD+B | Harmonic |
| Abdominal | p | n | n | n | n |
| Intra-operative (abdominal) | |||||
| Laparoscopic | |||||
| Trans-rectal | |||||
| Trans-vaginal (not fetal) | |||||
| Small Parts | p | n | n | n | n |
n= new indication, p = previously cleared by FDA
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH
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510(k) Summary
I. SUBMITTER
Oreon Technologies Inc. Suite 500 520 White Plains Road Tarrytown, NY 10591
Phone: 914 413 0087 Email: howard@oreonetch.com
Contact Person: Howard Fidel Date Prepared: October 25, 2015
II. DEVICE
Name of Device: Enovare Common or Usual Name: Diagnostic Ultrasound System Classification Names: Ultrasonic Pulsed Echo Imaging System (90 IYO CFR 892.1560) Ultrasonic Pulsed Doppler Imaging System (90 IYN, CFR 892.1560) Diagnostic Ultrasound Transducer (90 ITX, CFR 892.1570) Regulatory Class: II
III. PREDICATE DEVICES
B & K Medical Flex Focus 1202, K123254
3G Ultrasound Sonalis K043189
IV. DEVICE DESCRIPTION
The Enovare supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), PWD mode, CFM mode, Amplitude (Power) Doppler mode.
The system consists of:
- system cart
- keyboard ●
- ultrasound probe(s) ●
- LCD monitor ●
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The system can perform simple geometric measurements and perform calculations in the vascular and urology areas.
V. INDICATIONS FOR USE
The Enovare system's ultrasound scanner connected with a probe enables real time diagnostic ultrasound imaging for B-mode, Tissue and Contrast Harmonic Imaging, PWD. Power Doppler. Color Doppler and combined mode imaging. Signal Analysis and display. Guidance of biopsy and therapy needles, geometrical measurements and calculation of parameters. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
The system offers optional probes each type optimized to image structure and orientation of tissues during specific clinical applications. These include general Abdominal, Intraoperative, Cardiac, Neurosurgery, Transrectal, Small organs, Urological, Transvaginal, Musculoskeletal.
VI. COMPARISON OF TECHNICAL CHARACTERISTICS
This device operates identically to the predicate devices in that the piezoelectric material in the transducer used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images.
VII SAFETY AND EFFECTIVENESS
The Enovare is compliant to IEC 60601-1 Edition 3.1, International Electrotechnical Commission, Safety of Medical Electrical Equipment, Class II, Type B. Transducer is Type BF.
VIII BIOCOMATIBILITY
Enovare was tested in accordance with the testing requirements of the ISO 10993 recognized standards and found to be safe for its intended use.
IX CONCULUSION
The Enovare Ultrasound System is the same device as the predicate Sonalis system with additional added features found in the B&K Medical Flex Focus predicate. Otherwise the Enovare system also has updated components from the Sonalis that do not affect safety and efficacy. The Enovare has the same intended uses as found in the predicate devices and uses the same technological characteristics.
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| Indications for use | Enovare | Sonalis
K043189 | B & K Medical Flex Focus 1202
K123254 | | Thermal, Mechanical,
and Electrical Safety | 7. Patient Contact
Materials | 8. Cleaning,
Disinfection,
Sterilization |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | General purpose ultrasound device for obtaining diagnostic medical images. Optional probes are available for general abdominal, small organ, gynecological, intraoperative, peripheral vascular muskulo skeletal and urological anatomy. | General purpose ultrasound device for obtaining diagnostic medical images. Optional probes are available for general abdominal, small organ, gynecological and urological anatomy. | Abdominal, Cardiac, Fetal, Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts, Transvaginal, Peripheral Vascular, Muskulo-skeletal | Enovare | Designed to comply with IEC 60601-1 Edition
3.1, and/or prior editions. | The materials of construction of the patient
contact portions of probes, components or
accessories are identical to those used in
similar probes, components or accessories of
the Sonalis System and other predicate
ultrasound systems. | Cleaning and disinfection are the same as with
the predicate Sonalis, and is described on page
40 of the user's manual. Sterilization is by
Steris, the same as the B&K predicate and is
described on page 41 of the user's manual. |
| Scan Modes | B, PWD, CFM and combinations, Tissue Harmonic Imaging | Full Screen 2-D, Four Quadrant B-mode, B-mode, B-mode. | B, M, PWD, CFM and combinations, Tissue Harmonic Imaging | Sonalis
K043189 | IEC 60601-1-2 | The materials of construction of the patient
contact portions of 5 probes, components or
accessories are identical to those used in similar
probes, components or accessories of the
Sonada predicate ultrasound system. | Cleaning and disinfection is by industry
standard methods described the user's manual. |
| Transducers | Peripheral Vascular
Endo-Rectal
Intraoperative | Peripheral Vascular
Endo-Rectal | Peripheral Vascular
Endo-Rectal
Intraoperative | B & K Medical Flex Focus 1202
K123254 | IEC 60601-1-2 | | Sterilization by Steris. |
| Acoustic Output | All transducers are within Track III requirements. | All transducers are within Track I requirements. | 1. All transducers are within Track III requirements. | | | | |
| Biometric
Measurements | Same as Sonalis predicate. See page 12 of the system's User's Manual included in Section 4 of this submission. | Distance 6% - 14%
Area 10%
Ellipse 6%-23% | | | | | |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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omparison of Oreon Technologies Enovare to the Predicate Device