SUNRAY FETAL MONITOR

{0}------------------------------------------------ Sunray Medical Apparatus Co., Ltd. Sponsor: Fetal Monitor, model: SRF618B5 Subject Device: 510(k) submission report (V1.0), Chapter 4 File No.: # MAR 2 1 2013 ### Chapter 4. 510(k) Summary # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92. ### 1. Submitter Information Sponsor Name: Sunray Medical Apparatus Co., Ltd. Address: 4/F No. 242 Tianhe Dong Road, Guangzhou, PR China Contact Person: Rong Jingbo (R&D Director) Tel: +86-20-87570362 / 87502927 Fax: +86-20-87583004 / 87514127 Email: rongjb@sunray.cn ## Application Correspondent Information: MEDLAB (Shenzhen) Information Service Co., Ltd. Address: Rm. 2706-Building A, Zhongfang Jingyuan, Futian District, Shenzhen, PR China, 518034 Contact Person: Ms. Sabrina Wei (Manager) Tel: +86-755-83089699 Fax: +86-755-83089760 Email: sabrinawei@hotmail.com #### 2. Subject Device Information | Type of 510(k) submission: | Traditional | |----------------------------|---------------------------------------------| | Common Name: | Fetal Monitor | | Trade Name: | Fetal Monitor, model: SRF618B5 | | Classification Name: | Perinatal monitoring system and accessories | | Review Panel: | Obstetrical and Gynecological | | Product Code: | HGM, HGL | | Regulation Number: | 884.2740 | | Regulation Class: | 2 | ## 3. Predicate Device Information Report by Sunray Medical Apparatus Co., Ltd. {1}------------------------------------------------ | Sponsor: | Sunray Medical Apparatus Co., Ltd. | | |--------------------|--------------------------------------------|------------------| | Subject Device: | Fetal Monitor, model: SRF618B5 | | | File No.: | 510(k) submission report (V1.0), Chapter 4 | | | Sponsor: | Bionet Co., Ltd. | Bionet Co., Ltd. | | Device Name: | FC-700 | FC-1400 | | 510(k) Number: | K043597 | K043598 | | Product Code: | HGM | HGM | | Regulation Number: | 884.2740 | 884.2740 | | Regulation Class: | 2 | 2 | ## 4. Device Description SRF618B5 is a fetal monitor, providing continuous monitoring, displaying, printing and recording of single or twin (optional) Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) for antepartum testing and monitoring. SRF618B5 irradiates the ultrasound wave to maternal abdomen, and detects the Doppler effect signal reflected from the heart of the fetus. SRF618B5 extracts FHR and FM from this signal and provides the fetal heart beat sound with internal speaker. SRF618B5 measures the UA of a pregnant woman using TOCO sensor. SRF618B5 displays FHR, UA and FM with waveforms and numbers on the color LCD screen, saves them in internal flash memory and prints parts of them to review in details. #### 5. Intended Use SRF618B5 Fetal Monitor detects and displays single or twin (optional) Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) in a real time on the color LCD viewer, and also provides the fetal heart beat sound with internal speaker. Ten hours of tracing may be stored and later retrieved for printing. It is intended for antepartum use by trained healthcare personnel. It is not intend for home use. #### 6. Test Summary SRF618B5 Fetal Monitor has been evaluated the safety and performance by lab bench testing according to the following standards: - IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, + 1988+A1:1991+A2:1995 - IEC 60601-2-37, Medical electrical equipment Part 2-37: Particular requirements for the � basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2001+A1:2004+A2:2005 - IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety � Report by Sunray Medical Apparatus Co., Ltd. Page 4-2 {2}------------------------------------------------ Sponsor: Sunray Medical Apparatus Co., Ltd. Fetal Monitor, model: SRF618B5 Subject Device: 510(k) submission report (V1.0), Chapter 4 File No.: and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 2001+A1:2004 - 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, . 2009 - ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and . delaved-type hypersensitivity, 2002+A1:2006 #### 7. Comparison to Predicate Device Compare with predicate devices, the subject device is very similar in design principle, intended use, indication for use, functions, material and the applicable standards. The following differences between subject device and predicate devices do not raise and new questions of safety or effectiveness. (1) Although the Power Supply, Working and Storage Environment, Dimensions and Weight, and some Safety Degree of subject device are a little different from predicate devices, they are both compliance with IEC 60601-1 requirements. (2) Although some specifications of FHR (Fetal Heart Rate) and UC (Uterine Contraction Pressure) measurement for subject device are a little different from predicate devices, they can conduct their function normally. (3) Although some specifications of Printer & Recorder, Display & Sound for subject device are a little different from predicate devices, these are only assistant functions. (4) Although some Ultrasound Transducer Specification of subject device is a little different from predicate devices, they are both compliance with Track 1 requirement of "Guidance for Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers". Conclusions: The subject device has all features of the predicate devices. The differences do not affect the safety and effectiveness of the subject device. #### 8. Conclusion The subject device has all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate devices. #### 9. Summary Prepared Date: 17 January 2013 Report by Sunray Medical Apparatus Co., Ltd. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 21, 2013 Sunray Medical Apparatus Co., Ltd. % Ms. Sabrina Wei Project Manager MEDLAB (Shenzhen) Information Service Co., Ltd. B102, Nanshan Medical Devices Industrial Park No.1019 of Nanhai Ave. SHENZHEN GUANGDONG 518067 P.R. CHINA Re: K123335 Trade/Device Name: Fetal Monitor, model: SRF618B5 Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM, HGL Dated: January 17, 2013 Received: March 4, 2013 Dear Ms. Wei: 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. {4}------------------------------------------------ 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Herbert Lerner -S for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Chapter 3. Indications for Use # Indications for Use 510(k) Number (if known): K123335 Device Name: Fetal Monitor, model: SRF618B5 Indications for Use: SRF618B5 Fetal Monitor detects and displays single or twin (optional) Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) in a real time on the color LCD viewer, and also provides the fetal heart beat sound with internal speaker. Ten hours of tracing may be stored and later retrieved for printing. It is intended for antepartum use by trained healthcare personnel. It is not intended for home use. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Herbert - S (Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123335 510(k) Number 510(k) Number {6}------------------------------------------------ ## Diagnostic Ultrasound Indications for Use Form ## System: Fetal Monitor, model: SRF618B5 Transducer: 2MHz PW Probe Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body for antepartum use as follows: | | Mode of Operation | | | | | | | | |---------------------------------|-------------------|---|---|-----|-----|---------------|-----------------------|---------------------| | Clinical Application | | B | M | PWD | CWD | Color Doppler | Combined<br>(Specify) | Other*<br>(Specify) | | Ophthalmic | | | | | | | | | | Fetal / Obstetrics | | | | N | | | | | | Abdominal | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neurological) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Transrectal | | | | | | | | | | Transvaginal | | | | | | | | | | Transurethral | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Cardiac | | | | | | | | | | Intravascular | | | | | | | | | | Peripheral vascular | | | | | | | | | | Other (Urology) | | | | | | | | | N = new indication; P = previously cleared by FDA; E = added under this appendix Additional Comment: The above probe is a 2 MHz PW transducer for the fetal heart rate (FHR) detection. There are two FHR transducers in this device. These two transducers are the same. Use one for single fetus, use two for twins. Image /page/6/Picture/7 description: The image shows the text "Herbert P Lerner-S 2013.03.21 15:41:47". The text is in a simple, sans-serif font and is printed in black ink. The background of the image is white. The text appears to be a timestamp or a record of some kind. Page 2 of 2 Report by Sunray Medical Apparatus Co.