Interson USB Ultrasound System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a stacked formation. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 13, 2017 Interson Corporation % David Asarnow, Ph.D. Quality/Regulatory Manager 7150 Koll Center Parkway PLEASANTON CA 94566 Re: K163443 Trade/Device Name: Interson USB Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 17, 2017 Received: March 17, 2017 Dear Dr. Asarnow: 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'Hara For Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K163443 Device Name Interson USB Ultrasound System #### Indications for Use (Describe) The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, or Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: - Fetal/Obstetric Abdominal Pediatric Small Organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Peripheral Vessel The system is intended for use by healthcare professionals. Type of Use (Select one or both, as applicable) | <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## SECTION 1.3 - INDICATIONS FOR USE The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, or Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: - Fetal/Obstetric Abdominal Pediatric Small Organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Peripheral Vessel The system is intended for use by healthcare professionals. The Indications for Use statement on Form 3881 is provided in Tab 4, followed by the clinical applications and modes of operation applicable to each application for each transducer and for the system. {4}------------------------------------------------ ## Diagnostic Ultrasound Indications for Use ## Interson USB Ultrasound System Device Name: GP-C01 Transducer Mode: B, color Doppler, B + color Doppler Intended Use: Diagnostic ultrasound imaging and fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |-----------------------------|------------------------------------------------------------------|-------------------|---|-----|-----|--------------------------|--------------------|---------------------| | General<br>(Track 1 only) | Specific<br>(Tracks 1&3) | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(B+CD) | Other*<br>(Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetric | N | | | | N | N | | | | Abdominal | N | | | | N | N | | | | Intra-Operative (Specify) | | | | | | | | | | Intra-Operative Neurological | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric<br>(excluding transcranial<br>& neonatal) | | | | | | | | | | Small Organ (Scrotum, prostate,<br>lymph nodes, thyroid, breast) | N | | | | N | N | | | Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-card.) | | | | | | | | | | Muscular-Skeletal (Conventional) | N | | | | N | N | | | | Muscular-Skeletal (Superficial) | N | | | | N | N | | | | Intravascular | | | | | | | | | | Other (Urology) | N | | | | N | N | | | | Other (Gynecology) | N | | | | N | N | | | | Other (Pelvic Floor) | N | | | | N | N | | | | Other (Neuromuscular) | N | | | | N | N | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | Other (Specify) | | | | | | | | N = New Indication, P=Previously cleared by FDA; E=added under this appendix *Examples of other modes may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler and Color Velocity Imaging {5}------------------------------------------------ ## Diagnostic Ultrasound Indications for Use # Interson USB Ultrasound System ## Device Name: SP-L01 Transducer Modes: B, color Doppler, B + color Doppler Intended Use: Diagnostic ultrasound imaging and fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |-----------------------------|------------------------------------------------------------------|-------------------|---|-----|-----|--------------------------|--------------------|---------------------| | General<br>(Track 1 only) | Specific<br>(Tracks 1&3) | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(B+CD) | Other*<br>(Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetric | | | | | | | | | | Abdominal | N | | | | N | N | | | | Intra-Operative (Specify) | | | | | | | | | | Intra-Operative Neurological | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric<br>(excluding transcranial<br>& neonatal) | N | | | | N | N | | | | Small Organ (Scrotum, prostate,<br>lymph nodes, thyroid, breast) | N | | | | N | N | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | Fetal<br>Imaging<br>& Other | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-card.) | | | | | | | | | | Muscular-Skeletal (Conventional) | N | | | | N | N | | | | Muscular-Skeletal (Superficial) | N | | | | N | N | | | | Intravascular | | | | | | | | | | Other (Urology) | N | | | | N | N | | | | Other (Gynecology) | N | | | | N | N | | | | Other (Pelvic Floor) | N | | | | N | N | | | | Other (Neuromuscular) | N | | | | N | N | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | | | | N | N | | | | Other (Specify) | | | | | | | | N = New Indication, P=Previously cleared by FDA; E=added under this appendix ^*Examples of other modes may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler and Color Velocity Imaging {6}------------------------------------------------ ## Diagnostic Ultrasound Indications for Use ## Device Name: Interson USB Ultrasound System Modes: B, color Doppler, B + color Doppler Intended Use: Diagnostic ultrasound imaging and fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation | | | | | | |---------------------------|------------------------------------------------------------------|---|-------------------|-----|-----|--------------------------|--------------------|---------------------| | General<br>(Track 1 only) | Specific<br>(Tracks 1&3) | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Combined<br>(B+CD) | Other*<br>(Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetric | N | | | | N | N | | | | Abdominal | N | | | | N | N | | | | Intra-Operative (Specify) | | | | | | | | | | Intra-Operative Neurological | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric<br>(excluding transcranial<br>& neonatal) | N | | | | N | N | | | | Small Organ (Scrotum, prostate,<br>lymph nodes, thyroid, breast) | N | | | | N | N | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | Fetal | Trans-rectal | | | | | | | | | Imaging<br>& Other | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-card.) | | | | | | | | | | Muscular-Skeletal (Conventional) | N | | | | N | N | | | | Muscular-Skeletal (Superficial) | N | | | | N | N | | | | Intravascular | | | | | | | | | | Other (Urology) | N | | | | N | N | | | | Other (Gynecology) | N | | | | N | N | | | | Other (Pelvic Floor) | N | | | | N | N | | | | Other (Neuromuscular) | N | | | | N | N | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | | | | N | N | | | | Other (Specify) | | | | | | | | N = New Indication, P=Previously cleared by FDA; E=added under this appendix *Examples of other modes may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler and Color Velocity Imaging {7}------------------------------------------------ ## 510(k) Summary K163443 Provided in accordance with 21CFR 807.92 (c). # Submitter Information- 21 CFR 807.92 (a)(1) | Date of submission: | 11/28/2016 | |--------------------------------|----------------------------------------------------------------------------------------------------------------------| | Submitter information: | Interson Corporation<br>7150 Koll Center Parkway<br>Pleasanton, CA 94566 | | Establishment Registration No: | 2939830 | | Contact person: | David Asarnow<br>Quality/Regulatory Manager<br>(925) 462-4948 (tel)<br>(925) 462-4833 (fax)<br>dasarnow@interson.com | #### Name of Device and Classification - 21 CFR 807.92 (a)(2) | Device trade name: | USB Ultrasound System | |--------------------|----------------------------------------------| | Common name: | Diagnostic ultrasound system and transducers | | Classification: | Class II | | 21 CFR Section | Classification Name | Product Code | |----------------|------------------------------------------|--------------| | 892.1550 | Ultrasonic pulsed doppler imaging system | IYN | | 892.1560 | Ultrasonic pulsed echo imaging system | IYO | | 892.1570 | Diagnostic ultrasonic transducer | ITX | ## Track Track 3 ## Predicate Device - 21 CFR 807.92 (a)(3) | Philips Lumify Diagnostic Ultrasound System | K152899 | 10/30/2015 | |---------------------------------------------|---------|------------| | Interson USB Ultrasound Probe System | K070907 | 4/17/2007 | ## Device Description - 21 CFR 807.92 (a)(4): The Interson USB Ultrasound Imaging System is a self-contained portable, solid-state, multiple-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and {8}------------------------------------------------ software-based controls offering a full complement of conventional operating modes, parameter controls, and recording functions. The selection of transducers offered with the system permit a wide range of clinical applications including Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Musculo-skeletal, Urology, Gynecology, Pelvic Floor, Neuromuscular, and Peripheral Vessel. The initial operational settings for each transducer are preprogrammed in the system. User-customized parameter settings for each transducer may be set by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the Cine function. The Interson USB Ultrasound transducers operate in B-Mode, color Doppler, and combined mode (B + color Doppler), providing high resolution and high penetration performance. The product family uses curved and flat linear array transducers and includes a General Purpose (GP) probe and a Small Parts (SP) probe. The SeeMore software application used in the Interson USB Ultrasound System supports static image acquisition and a cine function capable of storing up to 32 to 1024 sequential images. Management of patient history is enabled by the image or cine-storage function. The SeeMore control software runs on standard Microsoft Windows platforms. ## Intended Use/Indications for Use - 21 CFR 807.92 (a)(5) The Interson Ultrasound Imaging System is intended for diagnostic ultrasound imaging in B, color Doppler, or Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: - Fetal/Obstetric Abdominal Pediatric Small Organ Musculo-skeletal Urology Gynecology Pelvic Floor Neuro-muscular Peripheral Vessel The system is intended for use by healthcare professionals. {9}------------------------------------------------ ## Product Models | Model | Common Applications | |-------------------------|----------------------------------------------------------------------------------------| | Transducer Model GP-C01 | Fetal/Obstetric, Abdominal, Urology, Musculo-<br>skeletal, Small Organs, Neuromuscular | | Transducer Model SP-L01 | Pediatric, Small Organs, Peripheral Vessel | All models are used with SeeMore control software. ## Summary of technological characteristics of the device compared to the predicate device- 21 CFR 807.92 (a)(6) | Device<br>Features | Subject Device:<br>Interson Ultrasound<br>System | Predicate 1:<br>Philips Lumify<br>K152899 | Predicate 2:<br>Interson Ultrasound<br>System K070907 | |-------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Intended Use | Diagnostic ultrasound<br>imaging in B, color<br>Doppler and<br>Combined (B + Color)<br>modes. | Diagnostic ultrasound<br>imaging in B, color<br>Doppler, and<br>Combined (B + Color)<br>modes. | Diagnostic ultrasound<br>imaging in B mode<br>(all transducers), A<br>mode (ophthalmic) | | Indications<br>for Use | Indicated for<br>diagnostic ultrasound<br>imaging and fluid<br>flow analysis in<br>specified applications | Indicated for<br>diagnostic ultrasound<br>imaging and fluid<br>flow analysis in<br>specified applications | Indicated for<br>diagnostic ultrasound<br>imaging in specified<br>applications | | Array<br>Geometry | Curved and linear | Curved and linear | Non-Array | | Mechanics | Solid State | Solid State | Mechanical | | Software<br>platform | Commercial off-the-<br>shelf operating system<br>(Windows) | Commercial off-the-<br>shelf operating system<br>(Android) | Commercial off-the-<br>shelf operating system<br>(Windows) | | Software<br>control | Standalone | Standalone | Standalone | | Measurement<br>function | 2D measurement and<br>area measurement | 2D measurement tool | 2D measurement tool | | Wireless<br>networking | Not supported | Supported | Not supported | | Connector | USB | USB | USB | {10}------------------------------------------------ #### Determination of Substantial Equivalence #### Non-clinical Performance Data Non-clinical testing relied on in this premarket notification submission for a determination of substantial equivalence include tests which show compliance with the following standards: 1. Recognition Number 12-105: NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3. (Radiology) 2. Recognition Number 19-4: AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) 3. Recognition Number 12-293: IEC 60601-2-37 (2015), Amendment 2, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. (Radiology) 4. Recognition Number 19-8: IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests 5. Recognition Number 5-89: IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability 6. Recognition Number 5-40: ISO 14971 Second edition 2007-03-01, Medical devices -Application of risk management to medical devices 7. Recognition Number 2-173: AAMI ANSI ISO 10993-10:2010/(R)2014, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization 8. Recognition Number 2-153: AAMI ANSI ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity #### Summary of Clinical Tests The Interson USB Ultrasound System product family introduces no new modes, features, or technologies relative to the predicate devices (Philips Lumify K152899 and Interson K070907) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices. #### 514 Performance Standards There are no Sec. 514 performance standards for this device. {11}------------------------------------------------ # Prescription Status This is a prescription device. The prescription device statement appears in the labeling. Sterilization Site(s) Not applicable. No components are supplied sterile. ## Conclusions Interson Corporation concludes that the subject device, the Interson Ultrasound USB Imaging System, has been shown to be substantially equivalent to the predicate devices identified above.