(139 days)
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.
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.
The provided document is a 510(k) summary for the Enovare Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving the device meets those criteria.
However, based on the information provided, we can extract some relevant details concerning safety and effectiveness.
Here's an analysis of the provided information, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as performance metrics with thresholds for the Enovare system in a typical table format you might expect for a new performance study. Instead, it demonstrates equivalence to predicate devices by claiming:
- Identical Operation: "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." (Page 8)
- Safety Compliance: "The Enovare is compliant to IEC 60601-1 Edition 3.1, International Electrotechnical Commission, Safety of Medical Electrical Equipment, Class II, Type BF." (Page 8)
- Biocompatibility: "Enovare was tested in accordance with the testing requirements of the ISO 10993 recognized standards and found to be safe for its intended use." (Page 8)
- Acoustic Output: "All transducers are within Track III requirements." (Page 9) This is a key safety parameter.
- Biometric Measurements (listed for predicate Sonalis, implied for Enovare due to "Same as Sonalis predicate"):
- Distance: 6% - 14%
- Area: 10%
- Ellipse: 6% - 23%
Therefore, the "acceptance criteria" here are largely met by demonstrating adherence to safety standards and analogous performance to predicate devices for specific functionalities. A direct table of acceptance criteria for the Enovare's performance is not presented.
2. Sample Size Used for the Test Set and Data Provenance
The document does not report a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance study using the Enovare system.
The "study" or rather, the evidence presented, is a technical comparison and compliance assessment against established safety standards and predicate devices. No new clinical performance study is detailed with specific patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. As there's no detailed clinical performance study with a test set of images or cases described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method
This information is not provided. Again, without a clinical performance study involving a test set and expert review, an adjudication method is not applicable or mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No. The document does not mention an MRMC comparative effectiveness study where human readers improve with or without AI assistance. The Enovare is an ultrasound system for diagnostic imaging, not an AI-powered diagnostic tool. The submission focuses on device equivalence and safety.
6. If a Standalone (algorithm only without human-in-the-loop performance) study was done
No. The Enovare is a diagnostic ultrasound system, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable or mentioned.
7. The type of ground truth used
For the safety and equivalence assessment:
- Engineering Standards: Ground truth for safety (e.g., electrical safety, biocompatibility, acoustic output) is established by adherence to recognized international standards like IEC 60601-1 and ISO 10993.
- Predicate Device Specifications: Ground truth for functional performance (e.g., scan modes, types of transducers, biomechanical measurements) is established by comparing to the specifications and cleared indications for use of the predicate devices (Sonalis K043189 and B & K Medical Flex Focus 1202).
8. The Sample Size for the Training Set
Not applicable. This document describes a traditional medical imaging device submission, not an AI/Machine Learning device. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, there is no training set for this type of device.
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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 | SonalisK043189 | B & K Medical Flex Focus 1202K123254 | Thermal, Mechanical,and Electrical Safety | 7. Patient ContactMaterials | 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 Edition3.1, and/or prior editions. | The materials of construction of the patientcontact portions of probes, components oraccessories are identical to those used insimilar probes, components or accessories ofthe Sonalis System and other predicateultrasound systems. | Cleaning and disinfection are the same as withthe predicate Sonalis, and is described on page40 of the user's manual. Sterilization is bySteris, the same as the B&K predicate and isdescribed 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 | SonalisK043189 | IEC 60601-1-2 | The materials of construction of the patientcontact portions of 5 probes, components oraccessories are identical to those used in similarprobes, components or accessories of theSonada predicate ultrasound system. | Cleaning and disinfection is by industrystandard methods described the user's manual. |
| Transducers | Peripheral VascularEndo-RectalIntraoperative | Peripheral VascularEndo-Rectal | Peripheral VascularEndo-RectalIntraoperative | B & K Medical Flex Focus 1202K123254 | 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. | ||||
| BiometricMeasurements | 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
§ 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.