(164 days)
The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac and peripheral vascular applications.
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac; peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.
The SIUI CTS-8800 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
The provided text is a 510(k) summary for the SIUI CTS-8800 Digital Ultrasound Imaging System. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326)).
However, this document does not contain information regarding specific acceptance criteria for device performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria. The document focuses on regulatory compliance, safety considerations (acoustic output, electrical safety), and demonstrating substantial equivalence based on intended use, principles of operation, and technological characteristics to a predicate device.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be answered from the text. The document does not specify any quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, image quality metrics) or report specific performance values for the device against such criteria. The "Conclusion" states that the device is "as safe and effective as the legally marketed predicate device," implying performance equivalence, but no specific metrics are given.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from the text. No test set, study, or data provenance is mentioned.
3. 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)
- Cannot be answered from the text. No ground truth establishment or expert involvement for a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered from the text. No adjudication method is mentioned as no test set study is described.
5. 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
- Cannot be answered from the text. The device is an ultrasound imaging system, not an AI-powered diagnostic aide for human readers. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be answered from the text. The device is an imaging system, not a standalone algorithm. Performance claims are for the overall system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be answered from the text. No ground truth is mentioned.
8. The sample size for the training set
- Cannot be answered from the text. No "training set" is relevant or mentioned for this type of device submission. This is not an AI/ML device requiring training data.
9. How the ground truth for the training set was established
- Cannot be answered from the text. Not applicable as there is no training set.
Summary:
The provided 510(k) summary for the SIUI CTS-8800 Digital Ultrasound Imaging System focuses on demonstrating substantial equivalence to a predicate device (Ultrasonix Ergosonix 500 Ultrasound Scanner, K042326) primarily through technical specifications, intended use, and compliance with general safety standards like IEC 60601-1, ISO10993-5, ISO 10993-10, and acoustic output measurements per NEMA UD 2. It does not present any clinical study data or specific performance metrics (like sensitivity, specificity, or accuracy) against predefined acceptance criteria for diagnostic performance. Therefore, almost all specific questions related to acceptance criteria and study data cannot be answered from this document.
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510(k) Summary
MAR - 5 2010
This summary of 510(k) safety and effectiveness information is provided in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).
The assigned 510(k) number is: K092907
- 510(k) Owner:
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road, Shantou, Guangdong 515041, China Tel: 86-754-882501 50 Fax: 86-754-88251499
Contact Person:
Flower Cai
Shantou Institute of Ultrasonic Instruments Co., Ltd. 77 Jinsha Road, Shantou, Guangdong 515041, China
Date Prepared: February 4, 2010
2. Device/Trade Name:
CTS-8800 Digital Ultrasound Imaging System
Classification Name:
Regulatory Class: II
| Ultrasonic Pulsed Doppler Imaging System | 90-IYN (per 21 CFR 892.1550) |
|---|---|
| Ultrasonic Pulsed Echo Imaging System | 90-IYO (per 21 CFR 892.1560) |
| Diagnostic Ultrasound Transducer | 90-ITX (per 21 CFR 892.1570) |
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3. Predicate Device:
The subject device is substantially equivalent to the device currently having FDA 510(k) clearance Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326) with respect to intended use, principles of operation and technological characteristics.
4. Device Description:
The SIUI CTS-8800 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
5. Intended Use:
The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac and peripheral vascular applications.
6. Safety Considerations:
The CTS-8800 Digital Ultrasound Imaging System has been tested per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004. The device conforms to applicable medical device safety standards, such as IEC 60601-1, ISO10993-5 and ISO 10993-10.
7. Conclusion:
The conclusions drawn from testing of the CTS-8800 Digital Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate device.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
APR - 1 2010
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) % Mr. Bob Leiker ORS Representative Quality and Regulatory Services, Inc. 7263 Cronin Circle DUBLIN CA 94568
Re: K092907
Trade/Device Name: CTS-8800 Digital Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: February 4, 2010 Received: February 16, 2010
Dear Mr. Leiker:
This letter corrects our substantially equivalent letter of March 5, 2010.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the CTS-8800 Digital Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
Convex Array C3L60G Linear Array L7L38G Convex Array 4DL40G Phased Array P3F14G
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours
Donald JAB
Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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(
SIUI CTS-8800 Digital Ultrasound Imaging System
Indications for Use Statement
Device Name:
CTS-8800 Digital Ultrasound Imaging System with
Convex Array Transducer C3L60G
Linear Array Transducer L7L38G
Convex Array Transducer 4DL40G
Phased Array Transducer P3F14G
Indications for Use:
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardi ;
peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.
Prescription Use (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K092907
: 让
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Diagnostic Ultrasound Indications for Use Form
3.1 System Indications for Usc Form System: CTS-8800
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | O: er*(S ecify) | |
| Ophthalmic | Ophthalmic | N | |||||||
| FetalImaging& Other | Fetal | N | N | ||||||
| Abdominal | N | N | N | N | N | ||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | |||||
| Small Organ (Specify) | N | N | N | N | |||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeleral(Conventional) | N | N | N | N | |||||
| Musculo-skeletal(Superficial) | N | N | N | N | |||||
| Intravascular | |||||||||
| Other (Specify) | N | N | N | N | N | ||||
| Cardiac | Cardiac Adult | N | N | N | N | ||||
| Cardiac Pediatric | N | N | N | N | |||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | ||||
| Other (Specify) |
N = new indication: P = previously cleared by FDA: E = added under this appendix
- Other modes of oneration include: 3-D Imaging:
· Other modes of Oncranon a lines include: Prosuste, Kidney, Uterus, Ovary Small organs include: Thyroid, Testes, Breast
Prescription Usc (Per 2) CFR 801.109)
Division of Radiolo Offica of In
510K K692907
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Diagnostic Ultrasound Indications for Use Form
3.2 Transducer Indications for Use Form Transducer: Convex Array C3L60G
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Ot er*(S cify) |
| Ophthalmic | Ophthalmic | - | ||||||
| FetalImaging& Other | Fetal | N | N | - | ||||
| Abdominal | N | N | N | . | N | - | ||
| 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) | N | N | N | N | - | |||
| Cardiac | Cardiac Adult | - | ||||||
| Cardiac Pediatric | - | |||||||
| Intravascular (Cardiac) | - | |||||||
| Trans-esoph. (Cardiac) | - | |||||||
| Intra-cardiac | - | |||||||
| Other (Specify) | - | |||||||
| PeripheralVessel | Peripheral vessel | - | ||||||
| Other (Specify) | - |
Other (Specity)
N = new indication; P = previously cleared by FDA: E = addch under this annendix Additional Comments: Other uses include: Prostate, Kidney, Utcrus, Qvary
Prescription Use (Per 21 CFR 801.109)
DAPO
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
S10K. K092907
Indications For Use
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Diagnostic Ultrasound Indications for Use Form
3.3 Transducer Indications for Use Form Transduccr: Lincar Array L7L38G
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging& Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | |||||
| Small Organ (Specify) | N | N | N | N | |||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-csoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | |||||
| Musculo-skeletal(Superficial) | N | N | N | N | |||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | ||||
| Other (Specify) |
N = new indication: P = previously cleared by FDA: E = added under this appeadix N = new indication: P = previously cleared by 12711 = 1211 = 1211 = 161
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safet
S10K 6042461
Indications l'or Use
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Diagnostic Ultrasound Indications for Use Form
3.4 Transducer Indications for Use Form Transducer: Conyex Array 4DL40G
| Clinical Application | Mode of Operation | Ot er*(Specify) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | ||
| Ophthalmic | Ophthalmic | N | |||||||
| FetalImaging& Other | Fetal | N | |||||||
| Abdominal | N | N | |||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Ncuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skelctal(Superficial) | |||||||||
| Intravascular | N | ||||||||
| Other (Specify) | N | ||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication: P = previously cleared by FDA: E = added under this apnendix
· Other modes include: 3-D Imaging;
· Other mouts include: 5-2 millions Prostate. Kidney, Uterus, Ovary
Prescription Use (Per 21 CFR 801.109)
Division of Rediological Office of in Vitro Diagn
610K K692907
Indications For Use
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ടുപ്പു പോട്-8800 Digital Ultrasound Imaging System
Diagnostic Ultrasound Indications for Use Form
3.5 Transducer Indications for Use Form Transducer: Phased Array P3F14G
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Otl * | (Specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatric | ||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-csoph. (non-Card.) | |||||||||
| Musculo-skolctal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | N | N | N | N | |||||
| Cardiac | Cardiac Pediatric | N | N | N | N | ||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
Outer (Specify)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Sefaty
610K. K092907
§ 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.