(508 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description focuses on standard ultrasound technology.
No
The device is described as a diagnostic ultrasound imaging system, acquiring and displaying real-time ultrasound data for diagnostic investigations, with no mention of treating or preventing diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The system is intended for use by a qualified physician for diagnostic ultrasound imaging of the human body..." and "The UNEXEF38G ultrasound instrument is intended to perform the following diagnostic ultrasound investigations." This directly indicates its diagnostic purpose.
No
The device description explicitly states it is a "software controlled ultrasound system" and mentions an "ultrasound probe consisting of ultrasonic transducers," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging of the human body in Peripheral Vascular vessels." This describes an in-vivo (within the living body) diagnostic procedure, not an in-vitro (outside the living body) diagnostic test.
- Device Description: The description details an ultrasound system that acquires and displays real-time ultrasound data from within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) or performing tests on biological specimens outside of the body, which are hallmarks of IVD devices.
Therefore, the UNEXEF-38G Ultrasound System is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The system is intended for use by a qualified physician for diagnostic ultrasound imaging of the human body in Peripheral Vascular vessels.
The UNEXEF38G ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (A/B-Mode), Color Flow Doppler (CFD), and provides calculations of Flow mediated dilation measurements during reactive hyperemia.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The UNEXEF-38G Ultrasound System is a portable, software controlled ultrasound system used to acquire and display high resolution, real-time ultrasound data in a variety of modes and clinical settings. This system is s Track 3 device that employs an ultrasound probe consisting of ultrasonic transducers arranged in a comb, whereby ultrasound can be generated by supplying electric pulse signals to a group of transducers consisting of multiple adjacent transducers in the single probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Peripheral Vascular vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician
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 UNEXEF-38G Ultrasound system has been tested as a Track 3 device per the FDA Guidance document "Information for the Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The device conforms and has been tested to applicable acoustic output standards as well as medical device safety standards.
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.
Fukuda Denshi UF-760AG (K110920), Fukuda Denshi UF-870AG (K081919)
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
§ 892.1550 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.
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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2014
Toyota Tsusho Corporation % Mr. Doug Blakely Regulatory Affairs 504 Rittiman Road SAN ANTONIO TX 78209
Re: K131973
Trade/Device Name: UNEXEF-38G Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 14, 2014 Received: October 22, 2014
Dear Mr. Blakely:
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.
1
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 A Ochs
for
Janine M. Morris 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) K131973
Device Name UNEXEF-38G Ultrasound System
Indications for Use (Describe)
The system is intended for use by a qualified physician for diagnostic ultrasound imaging of the human body in Peripheral Vascular vessels.
The UNEXEF38G ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (A/B-Mode), Color Flow Doppler (CFD), and provides calculations of Flow mediated dilation measurements during reactive hyperemia.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Diagnostic Ultrasound Indications For Use
System: UNEXEF-38G Ultrasound System (K131973)
Transducer: TO-1431
Indications For Use:
The system is intended for use by a qualified physician for diagnostic ultrasound imaging or fluid flow analysis of the human body in Peripheral Vascular vessels.
The UNEXEF38G ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (A/B-Mode), Color Flow Doppler (CFD), and provides calculations of Flow mediated dilation measurements during reactive hyperemia.
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B/A | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral vessel | YES | YES | YES | |||||
| Peripheral | ||||||||
| Vessel | Other (Specify) |
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UNEX CORPORATION
2-6-1, Sakae, Naka-ku, Nagoya, Aichi 460-0008, Japan
Image /page/4/Picture/2 description: The image shows the logo for UNEX corporation. The logo consists of a grid of diamonds on the left, with some of the diamonds filled in with black. To the right of the grid is the word "UNEX" in a stylized font, with the word "corporation" underneath in a smaller, sans-serif font.
510(K) Summary
The summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Subpart E, Section 807.92.
The assigned 510(K) number is
Date Prepared: June 24, 2013
1. Submitters Name, address, telephone number, contact person:
Toyota Tsusho Corporation 2-3-13 Konan, Minato-Ku Tokyo Tokyo 108-8202 Japan
Manufacturer:
UNEX Corporation 2-6-1, Sakae, Naka-ku Nagoya Aichi 460-0008 Japan
Corresponding Official/Contact Person:
Doug Blakely 504 Rittiman Road San Antonio, TX 78209
Email: DBlakely1@satx.rr.com Phone: 210-240-4521 Fax: 408-547-4521
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Device Name:
UNEXEF-38G Ultrasound System Common Name: Diagnostic Ultrasound system with accessories Classification: Regulatory Class II Review Category: Tier II
UNEXEF-38G:510(K) Submission
5
UNEX CORPORATION
2-6-1, Sakae, Naka-ku, Nagoya, Aichi 460-0008, Japan
21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
3. Identification of the predicate or legally marketed device:
Toyota Tsusho Corporation believes the UNEXEF-38G Ultrasound System described in this submission is substantially equivalent to the following devices:
Fukuda Denshi UF-760AG (K110920) Fukuda Denshi UF-870AG (K081919)
4. Device Description
The UNEXEF-38G Ultrasound System is a portable, software controlled ultrasound system used to acquire and display high resolution, real-time ultrasound data in a variety of modes and clinical settings. This system is s Track 3 device that employs an ultrasound probe consisting of ultrasonic transducers arranged in a comb, whereby ultrasound can be generated by supplying electric pulse signals to a group of transducers consisting of multiple adjacent transducers in the single probe.
5. Intended Use:
The system is intended for use by a qualified physician for diagnostic ultrasound imaging or fluid flow analysis of the human body in Peripheral Vascular vessels.
The UNEXEF38G ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (A/B-Mode), Color Flow Doppler (CFD), and provides calculations of Flow mediated dilation measurements during reactive hyperemia.
6. Safety Consideration:
The UNEXEF-38G Ultrasound system has been tested as a Track 3 device per the FDA Guidance document "Information for the Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The device conforms and has been tested to applicable acoustic output standards as well as medical device safety standards.
Conclusion:
Intended uses and other key features of the UNEXEF-38G are consistent with traditional clinical practice and FDA guidance. The product development process conforms with 21 CFR 820, and ISO 13485 quality systems. The device conforms to applicable electro-medical device safety standards with compliance verified through independent evaluation and on-going internal audits. It is the opinion of Toyota Tsusho Corporation and UNEX that the UNEXEF-38G Ultrasound System is substantially equivalent and is as safe and effective as the legally marketed predicate devices.