(105 days)
Not Found
No
The document describes a standard ultrasound system with various imaging modes and digital processing capabilities. There is no mention of AI, ML, or any features that would typically indicate the use of such technologies for image analysis, interpretation, or other functions. The description focuses on the hardware, operating system, and basic imaging modalities.
No
The device is described as an "ultrasonic instrument" and "ultrasound system" intended for "evaluation" and "diagnostic" purposes, which are indicative of an imaging device used for diagnosis rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" states it's for "evaluation," and the "Summary of Performance Studies" directly refers to it as a "Diagnostic Ultrasound System." Additionally, the predicate device is a "Diagnostic Ultrasound System."
No
The device description explicitly states it is a "compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart" and utilizes "interchangeable electronic-array transducers," indicating it includes significant 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 that the device is an "ultrasonic instrument intended for use by a qualified clinician for evaluation of Fetal/OB, Abdominal...". This describes a device used for imaging and diagnosis based on the physical properties of the body, not for examining specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body.
- Device Description: The description details an ultrasound system that uses transducers to generate and receive sound waves for imaging. This is consistent with an in-vivo diagnostic device, not an in-vitro one.
- Input Imaging Modality: The input modality is "Ultrasonic," which is an in-vivo imaging technique.
- Anatomical Site: The listed anatomical sites are all parts of the human body being imaged directly.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
The device is a general-purpose ultrasonic imstrument intended for use by a qualified clinician for evaluation of Fetal/OB, Abdominal (GYN & Urology), Pediatric, Small Organ (breast, testes, thyroid), Cardiac (Adult & Pediatric), Peripheral Vascular, Vascular Access, Musculo-skeletal Conventional & Superficial.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Site -Rite Halcyon device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart.The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, or a combination of these modes. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery in the docking station , the Site~Rite Halcyon is used primarily where portability, size and convenience are essential.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/OB, Abdominal (GYN & Urology), Pediatric, Small Organ (breast, testes, thyroid), Cardiac (Adult & Pediatric), Peripheral Vascular, Musculo-skeletal Conventional & Superficial.
Indicated Patient Age Range
Adult & Pediatric (for Cardiac), Fetal, Pediatric, Neonatal (Cephalic transducer-specific), Adult (Cephalic transducer-specific)
Intended User / Care Setting
qualified clinician
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)
Non-Clinical Tests:
The Site~Rite Halcyon Diagnostic Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.
The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility.
IEC 60601-1: 2005 Medical Electrical Equipment - Part 1: General Requirements for Safetv
IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
IEC 60601-2-37: 2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3.
NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
Clinical Test:
No clinical testing was 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
§ 892.1550 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.
0
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 depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, interconnected design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2017 CHISON MEDICAL IMAGING CO., LTD. Mr. OIFEI LIU REGULATORY AFFAIRS MANAGER NO.228. CHANGJIANG EAST ROAD, BLOCK 51 AND 53. PHASE 5 INDUSTRIAL PARK, SHUOFANG, New District, WUXI 214142 CHINA
Re: K170870
Trade/Device Name: Site~rite Halcyon Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 25, 2017 Received: May 30, 2017
Dear Qifei Liu:
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. O'Hara
For
Robert Ochs Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K1708070
Device Name
Site~Rite Halcyon Diagnostic Ultrasound System
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The device is a general-purpose ultrasonic imstrument intended for use by a qualified clinician for evaluation of Fetal/OB, Abdominal (GYN & Urology), Pediatric, Small Organ (breast, testes, thyroid), Cardiac (Adult & Pediatric), Peripheral Vascular, Vascular Access, Musculo-skeletal Conventional & Superficial.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- |
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3
Diagnostic Ultrasound Indications For Use
System: Site~Rite Halcyon Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | N | N | N | N | N | N | N | 3,4 |
| Abdominal | N | N | N | N | N | N | N | 3,4 | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | 3,4 | |
| Small Organ[1] (Specify) | N | N | N | N | N | N | N | 3,4 | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | N | N | 3,4 | |
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | N | N | 3,4 | |
| Other (Urology) | N | N | N | N | N | N | N | 3,4 | |
| Other (OB/GYN) | N | N | N | N | N | N | N | 3,4 | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | 3,4 |
| Cardiac Pediatric | N | N | N | N | N | N | N | 3,4 | |
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | N | 3,4 |
| Other | Vascular Access | N | N | N | N | N | N | N | 3,4 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note : 1. Combined modes are B/M, B/CFM , B/PW ,B/CFM/PW
-
Small Organ: thyroid, testes, breast
-
Includes guidance of biopsy (2D)
-
Tissue Harmonic Imaging
× Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
4
System: Site~Rite Halcyon Diagnostic Ultrasound System Transducer: C3
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | N | N | N | N | N | N | 3,4 | |
| Abdominal | N | N | N | N | N | N | 3,4 | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ[1] (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Other (Urology) | N | N | N | N | N | N | 3,4 | ||
| Other (OB/GYN) | N | N | N | N | N | N | 3,4 | ||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Peripheral Vessel | Peripheral vessel |
N = new indication; P = previously cleared by FDA; Note : 1. Combined modes are B/M, B/CFM , B/PW, B/CFM/PW E = added under this appendix
-
Small Organ: thyroid, testes, breast
-
Includes guidance of biopsy (2D)
-
Tissue Harmonic Imaging
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
5
System: Site~Rite Halcyon Diagnostic Ultrasound System Transducer: L7SVA
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||
|---|---|---|---|
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | 3,4 | |
| Small Organ [1] (Specify) | N | N | N | N | N | N | N | 3,4 | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | N | N | 3,4 | |
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | N | N | 3,4 | |
| Other (Urology) | |||||||||
| Other (OB/GYN) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | N | 3,4 |
| Other | Vascular Access | N | N | N | N | N | N | N | 3,4 |
P = previously cleared by FDA; N = new indication; Note : 1. Combined modes are B/M, B/CFM , B/PW ,B/CFM/PW
-
Small Organ: thyroid, testes, breast
-
Includes guidance of biopsy (2D)
-
Tissue Harmonic Imaging
Prescription Use _ Over-The-Counter Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health
6
System: Site~Rite Halcyon Diagnostic Ultrasound System Transducer: P3
510(k)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | Fetal | ||||||||
| Other | Abdominal | N | N | N | N | N | N | 3,4 | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ[1] (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Other (Urology) | |||||||||
| Other (OB/GYN) | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | 3,4 | |
| Cardiac Pediatric | N | N | N | N | N | N | 3,4 | ||
| Peripheral Vessel | Peripheral vessel |
N = new indication; P = previously cleared by FDA;
Note : 1. Combined modes are B/M, B/CFM , B/PW ,B/CFM/PW
-
Small Organ: thyroid, testes, breast 3. Includes guidance of biopsy (2D)
-
Tissue Harmonic Imaging
E = added under this appendix
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
7
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. Submitter:
| Submitter: | Chison Medical Imaging Co., Ltd. |
|---|---|
| Address: | No.228, ChangJiang East Road,Block 51 and 53, |
| Phase 5 Industrial Park, ShuoFang, New District, | |
| Wuxi 214142, China | |
| No.9 Xin Hui Huan Road, New District ,WuXi P.R.China | |
| Contact: | Mr. Liu Qifei |
| Tel: | +86-510-85310019 |
| Fax: | +86-510-85310021 |
| Date Prepared: | June 15, 2016 |
2. Device :
Trade Name: Site~Rite Halcyon Diagnostic Ultrasound System
Common Name: Diagnostic Ultrasound System with Accessories
Classification: Regulatory Class: II
Review Category: Tier II
| Classfication Name | 21 CFR Section | Product Code |
|---|---|---|
| Ultrasonic pulsed doppler imaging system | 892.1550 | 90-IYN |
| Ultrasonic pulsed echo imaging system | 892.1560 | 90-IYO |
| Diagnostic ultrasonic transducer | 892.1570 | 90-ITX |
3. Predicate Device(s):
SonoTouch Series Diagnostic Ultrasound Systems 510(k) Number: K121867
4. Device Description:
The Site -Rite Halcyon device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart.The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, or a combination of these modes. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery in the docking station , the Site~Rite Halcyon is used primarily where portability, size and convenience are essential.
8
5. Indications for Use:
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified clinician for evaluation of Fetal/OB, Abdominal (GYN & Urology), Pediatric, Small Organ (breast, testes, thyroid), Cardiac (Adult & Pediatric), Peripheral Vascular, Vascular Access, Musculo-skeletal Conventional & Superficial
6. Summary of Non-Clinical Tests:
The Site~Rite Halcyon Diagnostic Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.
The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility.
IEC 60601-1: 2005 Medical Electrical Equipment - Part 1: General Requirements for Safetv
IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
IEC 60601-2-37: 2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3.
NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
7. Clinical Test:
No clinical testing was required.
8. Comparison to Predicate Device:
Table 1 Substantial Equivalence Comparison
| Predicate Device | Submission Device | ||
|---|---|---|---|
| Product | |||
| Name | SonoTouch Series | ||
| Diagnostic Ultrasound | |||
| Systems | Site~Rite Halcyon Diagnostic | ||
| Ultrasound System | Remark | ||
| Indications | |||
| for Use | Fetal/OB; | ||
| Abdominal (GYN & Urology); | |||
| Pediatric; | Fetal/OB; | ||
| Abdominal (GYN & Urology); | |||
| Pediatric; | SE | ||
| Analysis | |||
| 1 | |||
| Small Omgan(breast, testes, | |||
| thyroid); | Small Omgan(breast, testes, | ||
| thyroid); | |||
| Cardiac (adult & pediatric); | Cardiac (adult & pediatric); | ||
| Peripheral Vascular; | Peripheral Vascular; | ||
| Vascular Access; | |||
| Musculo-skeletal Conventional & | |||
| Superficial; | Musculo-skeletal Conventional & | ||
| Superficial. | |||
| Transrectal; | |||
| Transvaginal. | |||
| Design | Based on an embedded Linux | ||
| operating system. | Based on an embedded Linux | ||
| operating system. | |||
| Autocorrelation for color | |||
| processing and FFT for pulse | Autocorrelation for color processing | ||
| and FFT for pulse | Same | ||
| Supporting Linear, Curve , and | |||
| Phase array probes . | Supporting Linear, Curve , and | ||
| Phase array probes . | |||
| Cine play back capability | |||
| Image file archive | Cine play back capability | ||
| Image file archive | |||
| Operation | |||
| Controls | B-Mode | B-Mode | Same |
| B/M Acoustic Output: 0-10, 1 step | B/M Acoustic Output: 0-10, 1 step | ||
| Focus Number: 4 steps | Focus Number: 4 steps | Same | |
| High Density: 0, 1 | High Density: 0, 1 | Same | |
| Frame Average: 0-7 steps | Frame Average: 0-7 steps | Same | |
| Edge Enhance: 0-7steps | Edge Enhance: 0-7steps | Same | |
| B Color Map: 0-31steps | B Color Map: 0-31steps | Same | |
| Gain: 0 - 255 steps | Gain: 0 - 255 steps | Same | |
| Dynamic Range: 30 - 90dB | Dynamic Range: 30 - 90dB | Same | |
| THI: on/off | THI: on/off | Same | |
| Depth: 1.5 - 24.6 cm | Depth: 1.5 - 24.6 cm | Same | |
| Color Flow Mode | Color Flow Mode | Same | |
| CF/PDI Focus Depth | CF/PDI Focus Depth | ||
| Frame Average: 0-7 steps | Frame Average: 0-7 steps | Same | |
| PRF: 0-15 steps | PRF: 0-15 steps | Same | |
| Gain: 0 - 255 steps | Gain: 0 - 255 steps | Same | |
| Wall Filter: 0-3 steps | Wall Filter: 0-3 steps | Same | |
| Angle:20,0,-20 | Angle:20,0,-20 | Same | |
| CF/PDI Focal Number: 1 | CF/PDI Focal Number: 1 | Same | |
| Color Map: 0-8 steps | Color Map: 0-8 steps | Same | |
| Color Threshold: 0-15 steps | Color Threshold: 0-15 steps | Same | |
| M-Mode | M-Mode | Same | |
| Sweep Speed: 4 steps | Sweep Speed: 4 steps | ||
| M Color: 4 types | M Color: 4 types | Same | |
| M Gain: 0 - 255 steps | M Gain: 0 - 255 steps | Same | |
| PW-Mode | PW-Mode | Same | |
| Doppler Gain:0~255 | Doppler Gain:0~255 | ||
| PRF:0~15 | PRF:0~15 | Same | |
| Wall Filter:0~3 | Wall Filter:0~3 | Same | |
| Volume:0~15 | Volume:0~15 | Same | |
| Pixel Ratio(0~7) | Pixel Ratio(0~7) | Same | |
| Doppler Dynamic(0~7) | Doppler Dynamic(0~7) | Same | |
| Enhance(0~3) | Enhance(0~3) | Same | |
| Angle(-70~+70 degrees) | Angle(-70~+70 degrees) | Same | |
| Color Map(0~8) | Color Map(0~8) | Same | |
| Sweep Speed: 4 steps | Sweep Speed: 4 steps | Same | |
| PW Angle Steer: -20°–20° | PW Angle Steer: -20°–20° | Same | |
| Safety | |||
| Standards | |||
| Compliance | IEC60601-1 | ||
| IEC60601-1-2 | |||
| IEC60601-2-37 | |||
| ISO 10993-1 | |||
| ISO 10993-5 | |||
| ISO 10993-10 | |||
| AIUM/ NEMA UD2 | |||
| AIUM/ NEMA UD3 | IEC60601-1 | ||
| IEC60601-1-2 | |||
| IEC60601-2-37 | |||
| ISO 10993-1 | |||
| ISO 10993-5 | |||
| ISO 10993-10 | |||
| AIUM/ NEMA UD2 | |||
| AIUM/ NEMA UD3 | Same | ||
| Operation | |||
| Mode | B, THI,B/M, M, CFM, | ||
| PW,PDI,DPD, Trapezoidal | |||
| image,Compound Imaging | B, THI,B/M, M, CFM, PW,PDI,DPD, | ||
| Trapezoidal image,Compound | |||
| Imaging | Same | ||
| Display | |||
| Modes | B, 2B,4B, B/M ,M, B+PW, | ||
| B+CFM, B+PDI/DPD, | |||
| B+CFM+PW,B+ PDI/DPD+PW | B, 2B,4B, B/M ,M, B+PW, | ||
| B+CFM, B+PDI/DPD, | |||
| B+CFM+PW,B+ PDI/DPD+PW | Same | ||
| Display | |||
| Annotations | Logo; Hospital Name; Exam | ||
| date;Exam time; Acoustic | |||
| Power ;Mechanical index;Tissue | |||
| thermal indes; patient name and | |||
| ID; Image Preview ; Gray/Color | |||
| Bar ; Cine Gauge ; Measurement | |||
| Summary Window; Measurement | |||
| results window;Probe | |||
| Type ;Imaging Parameters by | |||
| Mode ; focal position; Body | |||
| Pattern;Image Management | |||
| Menu; Image Palette ; System | |||
| Messages ; Menu | |||
| indication ;Status;Battery status ; | |||
| Biopsy Guide Line and | |||
| Zone ;Heart Rate ;TGC curve | |||
| display; Imaging parameters | |||
| displayed on the screen | Logo; Hospital Name; Exam | ||
| date;Exam time; Acoustic | |||
| Power ;Mechanical index;Tissue | |||
| thermal indes; patient name and ID; | |||
| Image Preview ; Gray/Color Bar ; | |||
| Cine Gauge ; Measurement | |||
| Summary Window; Measurement | |||
| results window;Probe Type ;Imaging | |||
| Parameters by Mode ; focal position; | |||
| Body Pattern;Image Management | |||
| Menu; Image Palette ; System | |||
| Messages ; Menu | |||
| indication ;Status;Battery status ; | |||
| Biopsy Guide Line and Zone ;Heart | |||
| Rate ;TGC curve display; Imaging | |||
| parameters displayed on the screen | Same | ||
| Display | |||
| Monitor | 10"high-resolution color LCD | ||
| monitor | 10"high-resolution color LCD monitor | Same | |
| Measurements | 2D mode: Distance ,Area, | ||
| Volume,Ratio,Strenosis, | |||
| Histogram,Profile, Angle | |||
| M mode: Distance,Time, Slope, | |||
| Heart Rate,Velocity; | |||
| Doppler mode: D | |||
| Velocity ,Time ,Heart | |||
| Rate,Acceleration ,D | |||
| Trace,PS/ED , Volume Flow | 2D mode: Distance ,Area, | ||
| Volume,Ratio,Strenosis, | |||
| Histogram,Profile, Angle | |||
| M mode: Distance,Time, Slope, | |||
| Heart Rate,Velocity; | |||
| Doppler mode: D | |||
| Velocity ,Time ,Heart | |||
| Rate,Acceleration ,D Trace,PS/ED , | |||
| Volume Flow | Same | ||
| Transducer | |||
| Types & | |||
| Connectors | Convex Array, Phased Array, | ||
| Linear Array | |||
| 1 ports | Convex Array, Phased Array, Linear | ||
| Array | |||
| 1 ports | Same | ||
| Acoustic | |||
| Output | Derated IspTA: 720mW/cm² | ||
| maximum. | |||
| TIS/TIB/TIC: 6.0 maximum, | |||
| MI: 1.9 maximum, | |||
| Derated Isppa: 190 | |||
| W/cm²maximum | Derated IspTA: 720mW/cm² | ||
| maximum. | |||
| TIS/TIB/TIC: 6.0 maximum, | |||
| MI: 1.9 maximum, | |||
| Derated Ispea: 190 | |||
| W/cm²maximum | Same | ||
| Power Supply | Voltage: 100-240V~ | ||
| Frequenzy:50-60Hz | |||
| Power Consumption:60VA Max. | Voltage: 100-240V~ | ||
| Frequenzy:50-60Hz | |||
| Power Consumption:60VA Max. | Same |
9
10
11
Comparison Analysis
SE Analysis1:
Compared with the predicate device, the subject device has some differences in Indications for Use Items. But all of them for the subject device include the clinical basic items, and fall within these for the predicate device; all of them meet the clinical use and no new risk is raised.
9. Substantially Equivalent Conclusion:
In accordance with the Act. 21 CFR Part 807 and based on the information provided in this premarket notification, Chison Medical Imaging Co., Ltd. concludes that the Site~Rite Halcyon Diagnostic Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.