(23 days)
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 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.
The provided document is a 510(k) premarket notification for the Hi-Light Diagnostic Ultrasound System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data to prove the device meets specific acceptance criteria in the same way a novel device might.
Based on the document, here's what can be extracted and inferred regarding the acceptance criteria and supporting studies:
-
A table of acceptance criteria and the reported device performance:
Acceptance Criteria Type Criteria/Standard Reported Device Performance Clinical Performance (Imaging) Not explicitly defined in quantitative metrics for this type of submission. The overarching criterion is "substantially equivalent" to predicate for intended clinical use (evaluating differences in echogenicity of soft tissue of small parts in adult patients (thyroid, breast, and testicles) and superficial musculoskeletal diagnosis). "applies the latest technologies to produce optimal images." "configured to provide clear and stable images." "same fundamental scientific technologies as the predicate device." "supports the same operating mode (B) and the same measurement functions for anatomic structures." Safety Standards IEC 60601-1 (Safety Requirements for Medical Equipment, 2012) In conformance IEC 60601-1-2 (EMC Requirements for Medical Equipment, 2007) In conformance IEC 60601-2-37 (Diagnostic Ultrasound Safety Standards, 2007) In conformance Acoustic Output FDA guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", dated September 9, 2008 Testing conducted as per guidance Biocompatibility ISO 10993-1 (Evaluation and testing, 2003) Acceptable for specified usage of the system ISO 10993-5 (Tests for in vitro cytotoxicity, 1999) (Implied acceptable through conformance to ISO 10993) ISO 10993-10 (Tests for irritation and delayed-type hypersensitivity, 2002) (Implied acceptable through conformance to ISO 10993) ISO 10993-11 (Tests for systemic toxicity, 2006) (Implied acceptable through conformance to ISO 10993) Technological Equivalence Same intended use and operational characteristics as predicate OR same intended use and different operational characteristics where substantial equivalency can be demonstrated without raising new questions of safety and effectiveness. "same fundamental scientific technologies as the predicate device" "narrowed, but still in the scope of the predicate device" "does not raise any questions regarding its safety and effectiveness" -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No clinical test set or data provenance is mentioned because the submission explicitly states: "Clinical Test: Clinical testing not required" for this device. The assessment is based on non-clinical testing and comparison to a predicate device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable, as no clinical testing was performed and therefore no ground truth was established by experts for a test set.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical testing was performed.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a diagnostic ultrasound system, not an AI-powered diagnostic algorithm. No MRMC study was mentioned or performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware diagnostic ultrasound system, not a standalone algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for clinical performance. The "ground truth" for the submission is the established safety and effectiveness of the predicate device (Siemens Acuson S2000, K081148) and adherence to recognized non-clinical safety standards.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
Summary of the Study:
The "study" referenced in this 510(k) submission is primarily a non-clinical comparative study demonstrating compliance with recognized safety and performance standards for medical devices and establishing substantial equivalence to a previously cleared predicate device.
- Objective: To demonstrate that the Hi-Light Diagnostic Ultrasound System is substantially equivalent to the Siemens Acuson S2000 Ultrasound System (K081148).
- Methodology:
- Non-clinical Testing: The device underwent testing to established international and FDA-recognized safety standards, including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, acoustic output testing per FDA guidance, and biocompatibility testing per ISO 10993 series.
- Comparative Analysis: A detailed comparison was made between the Hi-Light system and the predicate device (Siemens Acuson S2000) regarding:
- Indications for Use
- Intended Use
- Principles of Operation
- Device characteristics (e.g., size, weight, transducer specifications like type, frequency, applications, number of elements, modes of operation, array footprint).
- Basis for Equivalence: The submission argues that the Hi-Light uses the "same fundamental scientific technologies" and has "narrowed, but still in the scope" clinical applications compared to the predicate. The differences (primarily size and some modes of operation) do not raise new questions of safety or effectiveness.
- Outcome: The FDA determined that the device is substantially equivalent to the predicate device based on the non-clinical testing and comparative analysis, and thus did not require clinical testing.
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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.
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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.
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) | |||||
| PeripheralVessel | Peripheral vessel | ||||
| Other (specify) |
System: Hi-Light Diagnostic Ultrasound System N = new indication; P= previously cleared by FDA
Page | 2of 3
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| Clinical Application | Specific (Tracks 1 & 3) | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 only) | B | M | PWD | CWD | ColorDoppler | 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) | ||||||||
| PeripheralVessel | 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 MedicalEquipment Co., Ltd. | Siemens |
|---|---|---|
| Trade Name | Hi-Light | Acuson S2000 |
| 510(k) Number | - | K081148 |
| Product Code | IYO, ITX | IYN, IYO, ITX |
| Regulation Number | 892.1560892.1570 | 892.1550892.1560892.1570 |
| Regulation Name | Ultrasonic pulsed echo | Ultrasonic pulsed Doppler imaging |
| imaging | system | |
| Indications for Use | This diagnostic ultrasoundsystem (Hi-Light) and itstransducers are intended foruse in clinical examinationsto evaluate differences in theechogenicity of soft tissue ofsmall parts in adultpatients ,(thyroid, breast, andtesticles) and for superficialmuscular skeletal diagnosis.The system is forprescription use only by atrained sonographer underthe direction of a qualifiedphysician or directly by aqualified physician. | The Modified S2000, the S2000ABVS Ultrasound system, is intendedfor the following applications:General Radiology, Abdominal, Fetal,Small Parts, Transcranial, OB/GYN,Cardiac, Pelvic, Neonatal/AdultCephalic, Pediatric, Urology,Vascular, Musculoskeletal,Superficial Musculoskeletal, andPeripheral Vascular applications. Thesystem supports the transducers listedin the Ultrasound Indications for Usetables, including the 14L5BV forB-mode imaging of a patient's breastusing an optional automatic scanningfunction. The device is not intended tobe used as a replacement forscreening mammography.The system also provides for themeasurement of anatomical structuresand analysis as provided in theoriginal S2000 Ultrasound System,which provides information that isused by medical health careprofessionals for clinical diagnosispurposes. |
| Significant Differences | The main difference is thesizeDimensions: 364 mm (W) x63.5 mm(H) x 375mm (D)Weight: 5 kg | Dimensions: 623 mm (W) x 1300mm (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
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equivalent 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.