CHISON, MODEL 8300
Device Facts
| Record ID | K072210 |
|---|---|
| Device Name | CHISON, MODEL 8300 |
| Applicant | Chison Medical Imaging Co., Ltd. |
| Product Code | IYO · Radiology |
| Decision Date | Aug 24, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
CHISON 8300 is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdomen, obstetric, gynecology, cardiology and small parts etc. This device is intended to adult, pregnant woman, pediatrics.
Device Story
CHISON 8300 is a portable digital ultrasonic diagnostic B/W imaging system. Device utilizes ultrasonic transducers (convex, linear, micro-convex) to acquire acoustic signals from human tissue; system processes signals to generate real-time B-mode or M-mode images. Operated by clinicians in clinical settings for diagnostic examinations of abdomen, obstetrics, gynecology, cardiology, and small parts. System includes cine-memory for storing 128 frames of real-time images. Output displayed on monitor for physician interpretation to support clinical decision-making. Device includes accessories like video printers and trolleys. Benefits include non-invasive diagnostic visualization of internal structures and physiological states.
Clinical Evidence
Bench testing only. Accuracy testing performed for axial distance, lateral distance, circumference, area, and heart rate measurements across three transducer models (C60613S, L40617S, C12616S). Results showed measurement accuracy within ±5% for distances and heart rate, and within ±10% for area measurements. Electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) testing confirmed compliance. Biocompatibility testing (cytotoxicity, sensitization, irritation/intracutaneous reactivity) per ISO 10993-1:2003(E) confirmed safety for skin-contact components.
Technological Characteristics
Portable digital ultrasonic diagnostic B/W system. Transducers: Convex (3.5 MHz), Linear (7.5 MHz), Micro-convex (6.0 MHz). Imaging modes: B, B/B, 4B, B/M, M. Connectivity: Video output for printer. Electrical safety: IEC 60601-1. EMC: IEC 60601-1-2. Biocompatibility: ISO 10993. Surface heating limits provided for transvaginal probe.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in adults, pregnant women, and pediatric patients. Clinical applications include fetal, abdominal, pediatric, small organ (thyroid, parathyroid, parotid, submaxillary gland, breast), cardiac, transvaginal, and peripheral vascular examinations. Modes include B, B/B, 4B, B/M, and M.
Regulatory Classification
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.
Special Controls
*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.
Submission Summary (Full Text)
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# 510(k) Summary
AUG 2 4 2007
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.
The Assigned 510{k} Number is:
K072210
### 1. Applicant Device Information
Device Trade/Proprietary Name: CHISON 8300 Digital Ultrasonic Diagnostic Imaging System Device Common Name: Ultrasonic Imaging System and Transducers Device Classification Name: Ultrasonic Pulsed echo Imaging System
& Diagnostic Ultrasonic Transducer
Review Category: Tier II Product Code: IYO and ITX Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Device Class: II Prescription Status: Prescription Device
Establishment Registration Number: 3004753388
Owner/operator Number: 9066279
Intended Use:
CHISON 8300 is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdomen, obstetric, gynecology, cardiology and small parts etc. This device is intended to adult, pregnant woman, pediatrics.
### Submitter Information
Manufacturer Name:
CHISON MEDICAL IMAGING CO., LTD. No.8 Xiangnan Road, Shuofang, New District, Wuxi, China 214142 Establishment Registration Number: 3004753388 Owner/operator Number: 9066279
Contact Person of the Submission: Ms. Ruoli Mo; Ms. Karen Xie
COMPANY CONFIDENTIAL
X-1
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Image /page/1/Picture/1 description: The image shows handwritten text that appears to be a page number or document identifier. The text includes "K072210" on the first line, followed by "pg 2 of 4" on the second line. The handwriting is somewhat rough, but the characters are generally legible.
Display mode: B, B/B, 4B, B/M, M. In the B or M mode, 128 frames of real-time image can be stored in Cine-memory.
The Standard configuration of the applicant device includes Main unit, probes, relative accessories, please see the Figure IV-1 ~ Figure IV-6 in Chapter IV Device Description for the pictures of the device.
There's no unique feature or technological characteristics for the applicant device.
### The accessories are listed as following tables:
| Part Name | Model | Application |
|---------------|-------------------------------------|--------------------------------|
| Video Printer | SONY or Mitsubishi video<br>printer | Print video image |
| Trolley | TR-8000 | Carry 8300 and its accessories |
### The Applicant Probe type:
| Probe Model | Type | Frequency | Application | Track |
|-------------|--------------|-----------|--------------------|-------|
| C60613S | Convex | 3.5 MHz | Abdomen Probe | 1 |
| L40617S | Liner Probe | 7.5 MHz | Superficial Probe | 1 |
| C12616S | Micro-convex | 6.0 MHz | Transvaginal Probe | 1 |
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## 5. Effectiveness and Safety Considerations
### Effectiveness:
### · Accuracy Test was conducted for the effectiveness:
The following Table 1, Table 2 and Table 3 display the measurement accuracy of different type transducers using with CHISON 8300.
| Measurement | Unit | Range of availability | Accuracy |
|----------------------------------------------------|------|------------------------|----------|
| Axial Distance | mm | Full Screen (30~240mm) | <±5% |
| Lateral Distance | mm | Full Screen (0~240mm) | <±5% |
| Circumference:<br>tracing method elliptical method | mm | Full Screen (0~240mm) | <±5% |
| Area:<br>tracing method elliptical method | cm² | Full Screen (0~240mm) | <±10% |
| Heart Rate | bpm | 15~999 | <±5% |
Table 1 Measurement accuracy of CHISON-C60613S at 3.5MHz
| Measurement | Unit | Range of availability | Accuracy |
|----------------------------------------------------|------|------------------------|-------------|
| Axial Distance | mm | Full Screen (40~150mm) | $<\pm 5\%$ |
| Lateral Distance | mm | Full Screen (0~150mm) | $<\pm 5\%$ |
| Circumference:<br>tracing method elliptical method | mm | Full Screen (0~150mm) | $<\pm 5\%$ |
| Area:<br>tracing method elliptical method | cm2 | Full Screen (0~150mm) | $<\pm 10\%$ |
Table 3 Measurement accuracy of CHISON-L40617S at 7.5 MHz
| Measurement | Unit | Range of availability | Accuracy |
|----------------------------------------------------|------|-----------------------|------------|
| Axial Distance | mm | Full Screen (3~100mm) | $$\pm$5%$ |
| Lateral Distance | mm | Full Screen (0~100mm) | $$\pm$5%$ |
| Circumference:<br>tracing method elliptical method | mm | Full Screen (0~100mm) | $$\pm$5%$ |
| Area:<br>tracing method elliptical method | cm2 | Full Screen (0~100mm) | $$\pm$10%$ |
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K072210
- pg 4 of 4
### Safety Considerations:
The Electrical Safety Testing following IEC 60601-1 and Electromagnetic Compatibility Testing following IEC 60601-1-2 was conducted as the Test Report No. 48889604302. Please see the Appendix II for the test report.
For invasive probe, the means to limit the surface heating of the transvaginal probe is provided.
Conclusion: The applicant device is safe with regards to electrical safety and electromagnetic compatibility.
Per 1987 Tripartite Biocompatibility Guidance to Medical Device, FDA Guideline "INFORMATION FOR MANUFACTURERS SEEKING MARKETING CLEARANCE OF DIAGNOSTIC ULTRASOUND SYSTEMS AND TRANSDUERS" dated May 1, 1997 and with regard to Table 1 Initial Evaluation Tests for Consideration and Table 2 Supplementary Evaluation Tests for Consideration in ISO 10993-1:2003(E), Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, the necessary tests for Biocompatibility Testing includes: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity.
The biocompatibility test results of all kinds of material of finished products are provided in Chapter IV, Section 4.3 Biological Specifications and Appendix I.
Conclusion: The all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of all the possible skin-contact component material in the finished product meets the requirement of Biocompatibility
The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Chison Medical Imaging Co., Ltd. c/o Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
AUG 2 4 2007
K072210 Re:
Trade/Device Name: CHISON 8300 Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: June 23, 2007 Received: August 9, 2007
Dear Mr. Borsai:
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 CHISON 8300, as described in your premarket notification:
### Transducer Model Number
CHISON L40617S
CHISON C60613S
CHISON C12616S
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 898. In addition, FDA may
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Page 2 - Mr. Tamas Borsai
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 that 1 D.I has matutes 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 our); laborning (21 S) 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 I notification. The FDA finding of substantial equivalence of your device to a legally marketed nontioution: ice 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 If you desire spocent acrievier 3 at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (240) 276-3666.
Sincerely vours,
forni M. Thaz. GNCS
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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# 2210
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
### Device Name: CHISON 8300
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B/M) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | |
| Abdominal | | N | N | | | | | | N | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurologica | | | | | | | | | | |
| Pediatric | | N | N | | | | | | N | |
| Small Organ (specify) | | N | N | | | | | | N | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | N | N | | | | | | N | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletalConventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Comments:
Small organs include: thyroid, parathyroid, parotid, submaxillary gland, and Breast
Pediatric Intended Uses include: Cardiology, Abdomen, Peripheral Vasa
________________________________________________________________________________________________________
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANQTHER PAGE IF
NEEDED) (Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Reproductive, Abdominal, and
Prescription Use (Per 21 CFR 801.109)
Radiological Devices 6772 510(k) Number
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# Diagnostic Ultrasound System Indications for Use Form Device Name: CHISON L40617S
| | Mode of Operation | | | | | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B/M) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative(specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric(specify) | | N | N | | | | | | N | | |
| Small Organ(specify) | | N | N | | | | | | N | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethra | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other(specify) | | | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E<br>Comments:<br>Small organs include: thyroid, parathyroid, parotid, submaxillary gland, and Breast<br>Pediatric Intended Uses include: Cardiology, Abdomen, Peripheral Vasa | | | | | | | | | | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thham
Prescription Use (Per 21 CFR 801.109
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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Premarket Notification 510(k) Submission Report No .: A20071027
----:
....
### K072210 Diagnostic Ultrasound System Indications for Use Form Device Name: CHISON C60613S
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B/M) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | |
| Abdominal | | N | N | | | | | | N | |
| Intraoperative(specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric(specify) | | | | | | | | | | |
| Small Organ(specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethra | | | | | | | | | | |
| 'ravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | . . | | | | | | |
| Other(specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Comments:
Small organs include: thyroid, parathyroid, parotid, submaxillary gland, and Breast
Pediatric Intended Uses include: Cardiology, Abdomen, Peripheral Vasa
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Phlam
V Prescription Use (Per 21 CFR 801.109
(Division Sign-Off) 4 Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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Premarket Notification 510(k) Submission Indications for Use Report No.: A20071027
### 072210 Diagnostic Ultrasound System Indications for Use Form Device Name: CHISON C12616S
| | Mode of Operation | | | | | | | | | |
|----------------------------------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B/M) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative(specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric(specify) | | | | | | | | | | |
| Small Organ(specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | N | N | | | | | | N | |
| Transurethra | | | | | | | | | | |
| 'ravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other(specify) | | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | | | |
Comments:
:
i
Small organs include: thyroid, parathyroid, parotid, submaxillary gland, and Breast
Pediatric Intended Uses include: Cardiology, Abdomen, Peripheral Vasa
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON+ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DWhm
Division Sign Off
Prescription Use (Per 21 CFR 801.10
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
