UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM

{0}------------------------------------------------ 08/919 Fukuda Denshi Co, Ltd 39-4 Hongo 3-chome, Bunkyo-ku, Tokyo, Japan 1. Submitter Information Image /page/0/Picture/2 description: The image contains a logo or emblem with the text "FLORIDA BEACH". The text is arranged in two lines, with "FLORIDA" on the top line and "BEACH" on the bottom line. The logo also includes a triangular shape above the text, which may represent a mountain or a wave. ## Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c) **SEP - 9 2008** | a. Submitter: | Fukuda Denshi Co. Ltd.<br>39-4 Hingo 3-chome, Bunkyo-ku<br>Tokyo 113-8420<br>Japan | |--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | A. Contact Person: | Mr. Loran Van Noy<br>Fukuda Denshi USA INC.<br>17725 N.E. 65th Street Bldg. C<br>Redmond, WA 98052-4911<br>Phone: 425-881-7737<br>Fax: 425-869-2018 | | B. Date Prepared: | 23 June 2008 | #### 2. Name of device - a. Trade name: UF-870AG - Common name:Medical Diagnostic Ultrasound Imaging System and transducers C. - Classification name:Ultrasonic Pulsed Doppler Imaging System 21 CFR 892.1550 D. 90-IYN Ultrasonic Pulsed Echo Imaging System 21 CFR 892.1560 90-110 Diagnostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX - 3. Equivalent Legally-Marketed Devices: Kontron Medical Sigma 5000 Series Imagic, K050099, K053084, K061437 The technological characteristics of the predicate device are the same as those of the new device. - 4. Description The UF-870AG is an ultrasound instrument intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes the transducers necessary for these procedures. The system is a mobile console approximately 19" wide, 31" deep and 53-57" high equipped with a keyboard control panal, a large TFT screen, assorted transducers and image storage or hard-copy devices. {1}------------------------------------------------ Fukuda Denshi Co, Ltd 39-4 Hongo 3-chome, Bunkyo-ku, Tokyo, Japan Image /page/1/Picture/1 description: The image contains a collection of text elements arranged in a visually complex manner. The text appears to be rendered in a pixelated or low-resolution style, making it difficult to discern individual characters or words. The overall composition suggests a collage or arrangement of textual fragments, possibly forming a larger design or pattern. #### 5. Intended use Diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). - 6. Performance Data - a. Non-clinical tests: The device has been evaluated for acoustic output and thermal, and has been found conform with applicable medical device safety standards. Cleared patient contact materials, electrical and mechanical safety are unchanged. - Clinical tests: Since the UF-870AG uses the same technology and principles as existing E. devices, clinical tests are not required. - Conclusion: Intended uses and other key features are consistent with traditional clinical F. practice, FDA guidelines and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Fukuda Denshi that the UF-870AG is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized manner. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 9 2008 Fukuda Denshi % Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298 Re: K081919 Trade/Device Name: UF-870AG Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, ITX, and IYN Dated: August 22, 2008 Received: August 25, 2008 Dear Mr. Mosenkis: 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 UF-870AG Diagnostic Ultrasound System, as described in your premarket notification: Transducer Model Number FUT-SA162-5A FUT-1-5PA FUT-CA602-5A FUT-3-8 PA FUT-3-8TEM {3}------------------------------------------------ ## Pagera Reme Me Reger HEALTH & HUMAN SERVICES Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three wing-like extensions, positioned to the right of the department's seal. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. FUT-TV A114-7A FUT-4-9-MC FUT-LA385-12A FUT-5-12L50 FUT-PEN2 FUT-PEN4 FUT-PEN8 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 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 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded. The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to: > Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, {4}------------------------------------------------ "Misbranding by reference to premarket notification" (21CFR Part 807.97). Ұдығаа юралық (21) other general information on your responsibilities under the Division@fpmall Boulevard Manufacturers, International and Consumer Assistance at its toll-free number (800)1838209968 (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 Paul Hardy at (240) 276-3666. Sincerely yours, Herbert Lewin Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the words "FLORIDA DEPTH". The text is arranged vertically, with "FLORIDA" on top of "DEPTH". The image is low resolution, making the text appear pixelated. The background is white. #### System: UF-870AG Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PW D | CW D | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |-----------------------------------|---|---|---|------|------|---------------|-------------------|------------------------|--------------------|-----------------| | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | N | N | | N | | | Abdominal | | N | N | N | | N | N | | N | | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neuro-<br>logical | | | | | | | | | | | | Pediatric | | N | N | N | | N | N | | N | | | Small organs (specify) | | N | N | N | | N | N | | N | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | N | N | N | N | N | N | | N | | | Cardiac | | N | N | N | N | N | N | | N | | | Transesophageal | | N | N | N | N | N | N | | N | | | Transrectal | | | | | | | | | | | | Transvaginal | | N | N | N | | N | N | | N | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | N | N | N | N | N | N | | N | | | Laparascopic | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | N | N | N | | N | N | | N | | | Musculo-skeletal Super-<br>ficial | | N | N | N | | N | N | | N | | | Other (specify) | | | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: · Small organs: Thyroid, Breast, Testicle · Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD - …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… ����������������������������������������������������������������������������������������������������������������������������������������������������������������������������� Concurrence of CDRH, Office of Device Evaluation (ODE) | | Prescription Use (Per 21 CFR 801.109) | | |----------------------------------------|-----------------------------------------|--------------| | UF-870AG, V01-01 : 510(k<br>Edition 1B | July 2008 | Page 3 of 15 | | | (Division Sign-Off) | | | | Division of Reproductive, Abdominal and | | | | Radiological Devices<br>510/k) Numher | | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the text "FUKUDA DENSHI". The text is displayed in a stylized font, with a textured or patterned effect. The overall impression is of a logo or brand name. #### Diagnostic Ultrasound Indications for Use Form Transducer: FUT-SA162-5A System: UF-870AG Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |-----------------------------------|-------------------|---|---|------|------|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PW D | CW D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neuro-<br>logical | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small organs (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | N | N | N | N | N | N | N | | N | | | Cardiac | N | N | N | N | N | N | N | | N | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | N | N | N | N | N | N | N | | N | | | Laparascopic | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | | Musculo-skeletal Super-<br>ficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: · Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD 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