(23 days)
Not Found
No
The document describes standard ultrasound technology and image processing, with no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as a "Diagnostic Ultrasound System" intended to "evaluate differences in the echogenicity of soft tissue" and "generate on-screen displays of anatomic structures," which clearly indicates a diagnostic purpose rather than a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "diagnostic ultrasound system".
No
The device description explicitly states it is a "portable Diagnostic Ultrasound System" and mentions "custom probes," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the body (in vitro).
- Device Function: The description clearly states that this device is a "Diagnostic Ultrasound System." It transmits ultrasonic energy into patients and processes the received echoes to generate images of anatomical structures within the body. This is an in vivo (within the living body) diagnostic method.
- Intended Use: The intended use describes evaluating differences in echogenicity of soft tissue in adult patients and for superficial muscular skeletal diagnosis. This is done by imaging the patient directly.
Therefore, based on the provided information, the Hi-Light Diagnostic Ultrasound System is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This diagnostic ultrasound system (Hi-Light) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients (thyroid, breast, and testicles) and for superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The Hi-Light is a portable Diagnostic Ultrasound System, which applies the latest technologies to produce optimal images. The system facilitates a workflow from image acquisition through to archival in a standard DICOM interface to the clinics PACs system. Various image parameter adjustments, a 15 inch high resolution display and custom probes are configured to provide clear and stable images. The modes of operation include B mode.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed echo imaging
Anatomical Site
small parts (thyroid, breast, and testicles), superficial muscular skeletal
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
trained sonographer under the direction of a qualified physician or directly by a qualified physician.
Clinical examinations
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)
Clinical testing not required
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2015
Qingdao Hisense Medical Equipment Co., Ltd. % Mr. Mark Job Responible Third Party Official 1394 25th Street, NW BUFFALO MN 55313
Re: K151709
Trade/Device Name: Hi-Light Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: June 23, 2015 Received: June 24, 2015
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, 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.
Michael D'Hara For
Robert Ochs, Ph.D. Acting 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)
Device Name Hi-Light Diagnostic Ultrasound System
Indications for Use (Describe)
This diagnostic ultrasound system (Hi-Light) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients (thyroid, breast, and testicles) and for superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
| 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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| Fetal Imaging
| & Other | Fetal | ||||
|---|---|---|---|---|---|
| Abdominal | |||||
| Intra-operative (specify) | |||||
| Intra-operative (neuro) | |||||
| Laparoscopic | |||||
| Pediatric | |||||
| Small Organ (specify) Breast, | |||||
| Thyroid, Testes | N | ||||
| Neonatal Cephalic | |||||
| Adult Cephalic | |||||
| Trans-rectal | |||||
| Trans-vaginal | |||||
| Trans-urethral | |||||
| Trans-esoph. (non-cardiac) | |||||
| Musculo-skeletal (conventional) | |||||
| Musculo-skeletal (superficial) | N | ||||
| Intravascular | |||||
| Other (specify) | |||||
| Cardiac | Cardiac Adult | ||||
| Cardiac Pediatric | |||||
| Intravascular (Cardiac) | |||||
| Trans-esoph. (Cardiac) | |||||
| Intra-cardiac | |||||
| Other (specify) | |||||
| Peripheral | |||||
| Vessel | Peripheral vessel | ||||
| Other (specify) |
System: Hi-Light Diagnostic Ultrasound System N = new indication; P= previously cleared by FDA
Page | 2of 3
4
| Clinical Application | Specific (Tracks 1 & 3) | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | B | 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) Breast, | ||||||||
| Thyroid, Testes | N | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-cardiac) | ||||||||
| Musculo-skeletal (conventional) | ||||||||
| Musculo-skeletal (superficial) | N | |||||||
| Intravascular | ||||||||
| Other (specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (specify) |
Transducer: LA06 transducer for use with Hi-Light
N = new indication; P= previously cleared by FDA
Page | 3of 3
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510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. The assigned 510(k) number is: ______
Submitter:
Qingdao Hisense Medical Equipment Co., Ltd. No. 169 Songling Road, Laoshan District Qingdao City, Shandong Province,China Tel: 86- 532-55753841 Fax: 86(0)532-55753841
Official Correspondent:
Wangwei Project Manager of Qingdao Hisense Medical Equipment Co., Ltd. Tel : 86(0) 532-55753841 Fax: 86(0) 532-55753841 Email:wangwei@hisense.com
US Agent:
Guy Scott WinProbe Corporation 11770 US Hwy 1 Suite 405E Palm Beach Gardens, FL 33408 Tel: (561)626 4405 Email:gscott@winprobe.com
Date Prepared:
February 19, 2015
Device Name and Classification:
Common/Usual Name: Diagnostic Ultrasound System Proprietary Name: Hi-Light Diagnostic Ultrasound System
Classification Name:
21 CFR 892.1560 Ultrasonic, Pulsed Echo, Imaging 21 CFR 892.1570 Transducer, Ultrasonic, Diagnostic Product Codes: IYO, ITX Regulatory Class: Class II
Predicate Device:
Siemens Acuson S2000 Ultrasound System, K081148
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Device description:
The Hi-Light is a portable Diagnostic Ultrasound System, which applies the latest technologies to produce optimal images. The system facilitates a workflow from image acquisition through to archival in a standard DICOM interface to the clinics PACs system. Various image parameter adjustments, a 15 inch high resolution display and custom probes are configured to provide clear and stable images. The modes of operation include B mode.
Intended Use:
This diagnostic ultrasound system (Hi-Light) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients ,(thyroid, breast, and testicles) and for superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
Clinical Test: Clinical testing not required
Non-clinical Test:
Testing according to the following safety standards are conducted on the subject device:
-
IEC 60601-1 Safety Requirements for Medical Equipment, 2012
-
IEC 60601-1-2 EMC Requirements for Medical Equipment, 2007
-
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards, 2007
-
Acoustic output testing as per the FDA guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers'', dated September 9, 2008
-
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing,2003, ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity,1999, ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and delayed-type hypersensitivity,2002, ISO 10993-11, Biological Evaluation of Medical Devices - Part 11: Tests for systemic todcity,2006
Comparison to the predicate device:
The Hi-Light diagnostic ultrasound system uses the same fundamental scientific technologies as the predicate device (Siemens Acuson S2000, K081148). Table 1 compares the Hi-Light to the predicate device with respect to indications for use, intended use, and principles of operation for the determination of substantial equivalence.
| Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd. | Siemens |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Hi-Light | Acuson S2000 |
| 510(k) Number | - | K081148 |
| Product Code | IYO, ITX | IYN, IYO, ITX |
| Regulation Number | 892.1560
892.1570 | 892.1550
892.1560
892.1570 |
| Regulation Name | Ultrasonic pulsed echo | Ultrasonic pulsed Doppler imaging |
| | imaging | system |
| Indications for Use | This diagnostic ultrasound
system (Hi-Light) and its
transducers are intended for
use in clinical examinations
to evaluate differences in the
echogenicity of soft tissue of
small parts in adult
patients ,(thyroid, breast, and
testicles) and for superficial
muscular skeletal diagnosis.
The system is for
prescription use only by a
trained sonographer under
the direction of a qualified
physician or directly by a
qualified physician. | The Modified S2000, the S2000
ABVS Ultrasound system, is intended
for the following applications:
General Radiology, Abdominal, Fetal,
Small Parts, Transcranial, OB/GYN,
Cardiac, Pelvic, Neonatal/Adult
Cephalic, Pediatric, Urology,
Vascular, Musculoskeletal,
Superficial Musculoskeletal, and
Peripheral Vascular applications. The
system supports the transducers listed
in the Ultrasound Indications for Use
tables, including the 14L5BV for
B-mode imaging of a patient's breast
using an optional automatic scanning
function. The device is not intended to
be used as a replacement for
screening mammography.
The system also provides for the
measurement of anatomical structures
and analysis as provided in the
original S2000 Ultrasound System,
which provides information that is
used by medical health care
professionals for clinical diagnosis
purposes. |
| Significant Differences | The main difference is the
size
Dimensions: 364 mm (W) x
63.5 mm(H) x 375mm (D)
Weight: 5 kg | Dimensions: 623 mm (W) x 1300
mm (H) x 1103 mm (D)
Weight: 166 kg |
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Table 1. Predicate Device Comparison
Intended Use:
The intended use and clinical applications of the Hi-Light system are narrowed, but still in the scope of the predicate device. Both systems are intended to be used with a conventional extracorporeal transducer. The type of transducer specified for use with the Hi-Light system is linear which is also used with the predicate system. A comparison of the transducers is provided in Table 2:
| | LA06
(Hi-Light) | 14L5
(Acuson S2000 K081148) |
| -- | -------------------- | -------------------------------- |
|---|
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| Type | Linear | Linear |
|---|---|---|
| Frequency Bandwidth | 5 – 12 MHz | 5 – 14 MHz |
| Applications | • Breast | |
| • Testes | ||
| • Thyroid | ||
| • Musculoskeletal | • Breast | |
| • Testes | ||
| • Thyroid | ||
| • Musculoskeletal | ||
| • Peripheral Vessel | ||
| Number of Elements | 128 | 128 |
| Modes of Operation | B | B, C, D, M |
| Array Footprint | 38.1 mm | 39 mm |
Table 2. Probe Comparison
Operating Principle and Design:
Both the Hi-Light and the predicate system transmit ultrasonic energy into patients then perform post processing of received echoes to generate on-screen displays of anatomic structures of the human body. Both systems are designed with an LCD display screen and hand-held transducers. Both systems support the same operating mode (B) and the same measurement functions for anatomic structures. The operation characteristics (installation and use, mode of operation) and the power supply are the same in both systems.
Non-clinical Test and Safety:
The Hi-Light system is in conformance with the standards described above which are the same or equivalent to those of the predicate device.
Biocompatibility:
The patient contact materials of human body surface are evaluated under ISO 10993 and determined acceptable for the specified usage of the system. Both systems have the same acceptance level for biocompatibility.
Conclusion:
Clinical studies are not required to support substantial equivalence for these conventional ultrasound systems. In addition, as discussed in the above technological comparison, the technological characteristics of the Hi-Light system are substantially equivalent to the referenced predicate device that has been previously cleared for USA distribution.
Substantially Equivalent Determination:
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same operational characteristics as the previously cleared predicate device, or the device has the same intended use and different operational characteristics in which substantial equivalency can be demonstrated in the device in comparison to the predicate device. In addition, the new device does not raise new questions regarding its safety and effectiveness as compared to the predicate device. It is shown in this 510(k) submission that the difference between the Hi-Light and the predicate device does not raise any questions regarding its safety and effectiveness. The Hi-Light, as designed and produced, is determined to be substantially
9
equivalent to the predicate device.