ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "ZONARE" in a bold, sans-serif font. Above the word is a stylized graphic that resembles a bird in flight or a stylized eye. The graphic is composed of several curved lines that create a sense of movement. K141641 Page 1 of 4 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92 510(k). # General Information | Applicant: | ZONARE Medical Systems, Inc.<br>420 N. Bernardo Avenue<br>Mountain View, CA 94043 | | | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-------------------------------------| | Contact Person: | Dan Bradford<br>Vice President, Operations<br>Phone: (650) 316-3113<br>Facsimile: (650) 967-9056<br>E-mail: dbradford@zonare.com | | | | Date Prepared: | April 24, 2014 | | | | Trade Name(s): | ZS3 Ultrasound System<br>z.onepro Ultrasound System | | | | Common Name: | Diagnostic Ultrasound System with Accessories | | | | Classification: | II | | | | Classification<br>Name(s): | Ultrasonic Pulsed<br>Doppler Imaging<br>System | Ultrasonic Pulsed<br>Echo Imaging System | Diagnostic Ultrasound<br>Transducer | | Regulation<br>Number: | 21 CFR 892.1550 | 892.1560 | 892.1570 | | Product Code: | IYN | IYO | ITX | | Classification<br>Panel: | Radiology | | | | Predicate Devices: | ZONARE's ZS3 Ultrasound System K120703<br>ZONARE's z.one ultra Ultrasound System K101091 | | | ### Device Description The ZS3 and z.one, Ultrasound Systems (hereafter referred to as "ZS3 Ultrasound Platform" or "ZS3" for simplicity) are full-featured, general purpose, software controlled, diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The platform utilizes ZONARE's patented zone technology which allows the system to collect more data at one time, thereby optimizing image quality. The exam dependent default settings for the ZS3 allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control enables the advanced user to set the system 420 N. Bernardo Avenue Mountain View, CA 94043 Corporate 877-966-2731 Service 877-913-9663 Fax 650-230-2828 www.zonare.com {1}------------------------------------------------ based on image appearance preference. The architecture of the ZS3 Ultrasound Platform supports system integration to a variety of upgradable options and features. Up to three ZONARE transducers can be connected to the multi-transducer port permitting easy transducer transition. The ZS3 Ultrasound Platform can be operated on either battery or AC power. ### Intended Use The device is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological: Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric: small organ (thyroid, breast. testes, etc), Adult & Neonatal Cephalic: Trans-rectal, Trans-cranial, Trans-cranial, Trans-esophageal (non-cardiac and cardiac); Musculosketal (conventional & superficial); 3D/4D; Cardiac - Adult/ Pediatric/ Fetal; Echo, Intra-Cardiac; Pelvic; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity, | Item | ZS3 Ultrasound Platform<br>ZS3 and z.onepro Ultrasound Systems<br>(ZONARE Medical Systems) | ZS3<br>(ZONARE Medical Systems) | z.one ultra and z.one ultra SP<br>(ZONARE Medical Systems) | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------------------------------------------------| | 510(k) Number | Current Submission | K120703 | K101091 | | Intended Use | Diagnostic ultrasound imaging or fluid flow<br>analysis of the human body. | Same | Same | | Indications for<br>Use | The z.onepro is intended for use by a qualified<br>physician for ultrasound evaluation of Ophthalmic;<br>Fetal/obstetric, gynecological; Abdominal (renal,<br>GYN/Pelvic: Intra-operative (abdominal, thoracic,<br>and vascular). Intra-operative neurological;<br>Pediatric: small organ (thyroid, breast, testes, etc.),<br>Adult & Neonatal Cephalic; Trans-rectal, Trans-<br>vaginal, Trans-cranial, Trans-esophageal (non-<br>cardiac and cardiac); Musculoskeletal<br>(conventional & superficial); 3D/4D: Cardiac -<br>Adult/ Pediatric/ Fetal: Echo, Intra-Cardiac: Pelvic;<br>Peripheral vascular; harmonic tissue and contrast<br>imaging and Tissue elasticity. | Same | Same | | Design | Diagnostic zone technology ultrasound based<br>platform | Same | Same | | Safety Standards | IEC 60601-1<br>IEC 60601-2-37<br>IEC 60601-1-2<br>ISO 10993-1, -5, 10, -12<br>AIUM, NEMA UD 2, NEMA UD3 | Same | Same | | Patient Contact<br>Materials | Complies with ISO 10993 | Same | Same | | Mode of<br>Operations | B-Mode, M-Mode, PWD Mode, CWD, CD Mode.<br>Elastorgraphy, Contrast Enhanced, 3D/4D, ECG<br>(for cardiac cycle referenced timing only)<br>Combined Modes include B+CD, B+PW. | Same | Same | | Item | ZS3 Ultrasound Platform | ZS3 | z.one ultra and z.one ultra SP | | | ZS3 and z.onepro Ultrasound Systems<br>(ZONARE Medical Systems) | (ZONARE Medical Systems) | (ZONARE Medical Systems) | | | B+CD+PW, B+M, M+CM, B+CD+M+CM, | | | | | B+Elastorgraphy, B+CEUS, and + ECG Trace | | | | | B-Mode (2D): Depth, Distance, Circ/Arca/ Volume | Same | Same | | Measurements | | | | | | M-Mode: Depth, Distance, HR | | | | | PWD (Manual): Velocity. Velocity Pairs, RI, Accl. | | | | | S/D, A/B, PI, HR/ PWD (AutoTrace: RI, PI, Accl, | | | | | S/D, HR, AT, TAMX and TAMN | | | | Principle of | Applying high voltage burst to the Piezoelectric | Same | Same | | Operation | material in the transducer and detect reflected echo | | | | | to construct the diagnostic image | | | | Acoustic Output | Track 3:MI, TIS, TIC, TIB (TI Range 0-6.0) | Same | Same | | | Derated ISPTA: 720mW/cm2 maximum, | | | | | Mechanical Index ≤ 1.9 maximum or Derated ISPPA | | | | | ≤ 190 W/cm2 max | | | | | Ophthalmic use: | | | | | TI = Max (TISas. TIC) ≤ 1; | | | | | ISPTA.3 ≤ 50mW/cm2: and MI ≤ 0.23 | | | | Transducer Types | Linear Array | Same | Same | | | Curved Linear Array | | | | | Phased Array | | | | | Trans-esophageal | | | | | Pencil Probe | | | | | Intracavitary | | | | Transducer | 1.0 - 20.0 MHz | Same | 1.0-14.0 MHz | | Frequency | | | | | | | | | | DICOM | Yes | Same | Same | | Compliant | | | | | Special | Yes | Same | Same | | Procedures User | | | | | Interface | | | | | Display Monitor/ | ZS3: Color 19" Liquid Crystal Display (LCD)/ 2 | Color 19" Liquid Crystal | Cart: Same | | | arm articulation plus tilt and swivel | Display (LCD)/ 2 arm | Scan Engine: 5.8" Liquid | | Monitor Arm | z.onepro: Color 17" Liquid Crystal Display (LCD)/ | articulation plus tilt and | Crystal Display (LCD) | | | | | | | | Tilt and swivel | swivel | | | Scanner | Integrated | Same | Portable | | Transducer | Multi-Transducer Port (Three) | Same | Cart: same | | Port(s) | | | Scanner/ Scan Module: One | | Dimensions/ | Height, max (in operational use) 157.5cm (62in) | Same | Cart: Same | | Weight | Height, min (in operational use) 128cm (50.5in) | | | | | Height min (displayed lower for transport) 104cm | | Scanner/ Scan Module: | | | (41in) | | Height: 7.3cm (2.9in)/ 5.4cm | | | Width: 51cm (21.1in) | | (2.1in) | | | Depth: 72cm (28.2) | | Width: 25.7cm | | | Weight: 65.3kg (144lb) | | (10.1in)/22.0cm (8.7) | | | | | Depth: 25cm (9.8in)/ 25cm | | | | | (9.8in) | | | | | Weight: 2.5kg (5.6lb)/ 1.6kg | | | | | (3.5lb) | | Power | 100-240V options, ~ 50-60Hz, 6A max. | Same | same | | Item | ZS3 Ultrasound Platform | ZS3 | z.one ultra and zone ultra SP | | | ZS3 and z.onepro Ultrasound Systems<br>(ZONARE Medical Systems) | (ZONARE Medical Systems) | (ZONARE Medical Systems) | | Requirements | | | | | Rechargeable<br>Battery | Yes (up to 3.0 hour operation per charge) | Same | same | | Wireless<br>Capability | Yes (IEEE 802.11b/g. Wi-Fi compliant) | Same | Same | ### Comparison of ZONARE ZS3 Ultrasound Platform to the Predicate Devices 420 N. Bernardo Avenue Mountain View, CA 94043 Corporate 877-966-2731 Service 877-913-9663 Fax 650-230-2828 www.zonare.com {2}------------------------------------------------ . · 420 N. Bernardo Avenue Mountain View, CA 94043 Corporate 877-966-2731 Service 877-913-9663 Fax 650-230-2828 www.zonare.com : : i : {3}------------------------------------------------ # Summary of Non-Clinical Testing Performed: The ZS3 and z.onewo Ultrasound Systems were tested in accordance with FDA Guidance Document -Manufacturer's Seeking Clearance for Ultrasound Systems and Transducers. The following testing was completed: | Test | Method | Result | |---------------------------------------|-----------------------------------------------------------------------------------------------|--------| | Mechanical Verification | In accordance with device<br>performance specifications | PASS | | Electrical Safety | In accordance with IEC 60601-1 | PASS | | EMC Testing | In accordance with IEC 60601-<br>1-2 | PASS | | Thermal and Acoustic Output | In accordance with IEC 60601-<br>2-37 | PASS | | Biocompatibility | In accordance with ISO 10993 | PASS | | Cleaning & Disinfection | In accordance with FDA<br>Guidance Document | PASS | | Software Validation &<br>Verification | In accordance with 62304 and<br>FDA Guidance Document<br>Principles of Software<br>Validation | PASS | NOTE: ZONARE's ZS3 Ultrasound Platform and transducers do not require clinical studies to support the determination of substantial equivalence. ### Conclusion The ZS3 and z.one, Ultrasound Systems are substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to ZONARE's ZS3 and z.one ultra Ultrasound Systems. There are no new no new issues of safety and/or effectiveness introduced by the modification proposed when used as instructed. 420 N. Bernardo Avenue Mountain View, CA 94043 Corporate 877-966-2731 Service 877-913-9663 Fax 650-230-2828 www.zonare.com {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES ============================================================================================================================================================================== Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 18, 2014 ZONARE Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LI.C. 1394 25th Street NW BUFFALO MN 55313 Rc: K141641 Trade/Device Name: ZS3 and z.onepro Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN. 1Y(), ITX Dated: June 17, 2014 Received: June 19, 2014 Dear Mr. Job: 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 10 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. This determination of substantial equivalence applies to the following transducers intended for use with the ZS3 and 2.0nepro Ultrasound System, as described in your premarket notification: | | Transducer Model Number | | |------------------------------------------------------------------|-------------------------|--------| | C4-1 | C6-2 | C9-3 | | C10-3 | C8-3(3D) | P4-1c | | V11-3BE Transducer (off-the-shelf) (Endo-Cavity Transducer E9-3) | | | | E9-4 | E9-3 (3D) | L10-5 | | L8-3 | L14-5sp | L14-5v | | L20-5 | P8-3TEE | | | VF-PM Part #09-2005 (off the shelf) (P9-3ic) | | | | A2CW | A5CW | | {5}------------------------------------------------ Page 2—Mr. Job 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 statules 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. 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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm. Sincerely yours, Smh.7) for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K141641 # Device Name ZS3 and z.onepro Ultrasound System #### Indications for Use (Describe) The ZS3 and z.onepro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obsteric, gynccological; Abdominal (renal, GYN/Pelvic; Intracter and vascular), Intra-operative neurological; Pediatric: small organ (thyroid, breast, testes, etc.), Adult & Neonatal Cephalic; Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/ Pediatric/ Fetal; Echo, Intra-Cardiac; Peripheral vascular; hamonic tissue and contrast imaging and Tissue elasticity. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Sm.7) 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." {7}------------------------------------------------ | System: | ZS3 and z.onc Ultrasound System | | | | | | | | |---------------------------|-----------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-------------------|-------| | Transducer: | System Union of all Transducer Types | | | | | | | | | Intended Use: | Diagnostic ultrasound imaging or 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 | Combined<br>Modes | Other | | Ophthalmic | Ophthalmic | P | P | P | P | P | P | P | | Fetal Imaging &<br>Other | Fetal | P | P | P | P | P | P | P5 | | | Abdominal | P | P | P | P | P | P | P5 | | | Intra-operative<br>(Specify) | P | P | P | P | P | P | P4 | | | Intra-operative (Neuro) | P | P | P | P | P | P | P4 | | | Laparoscopic | P | P | P | P | P | P | P4 | | | Pediatric | P | P | P | P | P | P | P4 | | | Small Organ (Thyroid,<br>Breast, Testes, etc.) | P | P | P | P | P | P | P5,8 | | | Neonatal Cephalic | P | P | P | P | P | P | P4 | | | Adult Cephalic | P | P | P | P | P | P | P5 | | | Trans-rectal | P | P | P | P | P | P | P5 | | | Trans-vaginal | P | P | P | P | P | P | P4 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-<br>Card.) | P | P | P | P | P | P | P5 | | | Musculo-skel.<br>(Conventional) | P | P | P | P | P | P | P5,8 | | | Musculo-skel.<br>(Superficial) | P | P | P | P | P | P | P5,8 | | | Intravascular | | | | | | | | | | Other<br>(3D/4D and Contrast) | P | P | P | P | P | P | P | | Cardiac | Cardiac Adult | P1 | P | P | P | P | P | P4 | | | Cardiac Pediatric | P1 | P | P | P | P | P | P4 | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph (Cardiac) | P1 | P | P | P | P | P | P4 | | | Intra-cardiac | P1 | P | P | N | P | N | | | | (Other (3D/4D)) | P | P | P | P | P | P | | | Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | P5,8 | | | Other (3D/4D) | P | P | P | P | P | P | | Table 1.3-1: Diagnostic Ultrasound Indications for Use Form - ZONARE's ZS3 and z.onenro Ultrasound System N - new system indication: P - previously cleared by FDA 510(k) K10109) or K120703. (S1 Jude K031066 & K073709) and (Sherzhen Mindray K123185), E=Added under Appendix E ' Includes B-Mode and Humonic (contrast) imaging (HI) 2 Includes PWD-Mode imaging and I ligh Pulse Repetition Rate PWD-Mode (IIPRF) meludes it william in the ringing and Pright and Roponial (DPD), and Power Doppler (PD) 4 Includes B+CD. B-PW. B+CD+PW. B+M, M+CM, B+CD-M+CM, B+Elassorgraphy, B+CEUS, and + ECG Trace ' Color M-Modc (CM) " Abdominal includes renal, G Y N/Pelvic Intra operative include abdominal. Ihoracic (cardiac) and vascular (PV) * Freehand tissue clasticity Prescription Use (Per 21 CFR 80) Subpart 12) Page 2 of 20 {8}------------------------------------------------ | C4-1 | | | | | | | | | |----------------------------|------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|-------------------|--------------------|-----------| | System: | | ZS3 and z.one... Ultrasound System | | | | | | | | Transducer: | | Curvilinear Transducer C4-1 | | | | | | | | Intended Use: | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | Clinical Application | | Mode of Operation | | | | | | | | General<br>(Tracks I Only) | Specific<br>(Track 1 & III) | B | M | PWD | CWD | Color<br>Doppler1 | Combined<br>Modes4 | Other*,** | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | P | P | P | N | P | P | | | | Abdominal2 | P | P | P | N | P | P | | | | Intra-operative<br>(Specify)3 | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | | P | P | | | Fetal Imaging &<br>Other | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | | | | Neonatal Cephalic | | | | | |…