InnoSight Diagnostic Ultrasound System

K172056 · Qisda Corporation · IYO · Dec 13, 2017 · Radiology

Device Facts

• Record ID: K172056
• Device Name: InnoSight Diagnostic Ultrasound System
• Applicant: Qisda Corporation
• Product Code: IYO · Radiology
• Decision Date: Dec 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), M-Mode, PW Doppler, CPA, Tissue Harmonic imaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Small Organ (Breast, Thyroid, testes), trans-rectal, trans-vaginal, Other (OB/GYN, Urology, Nerve), Cardiac Adult and Peripheral Vessel. The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed. The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.

Device Story

InnoSight is a compact, portable diagnostic ultrasound system. It uses piezoelectric transducers to emit high-voltage bursts and detect reflected sound echoes. The system features a 64-channel all-digital beam former, progressive dynamic receive focusing, and wide-band digital demodulation. It supports B-mode, M-mode, Color Flow (CFM), Power Doppler (CPA), Pulse Wave (PW) Doppler, and Tissue Harmonic imaging. Operated via an 11.6-inch touch screen, the device is used by trained clinicians in hospitals, clinics, and point-of-care environments. It provides real-time imaging and fluid flow analysis; clinicians interpret these images to assist in diagnosis. The system includes remote access image management via LAN and supports USB-based file archiving. It benefits patients by providing portable, high-detail diagnostic imaging for various anatomical applications.

Clinical Evidence

Bench testing only. No clinical data provided. The device was evaluated for safety and performance through compliance with recognized standards including IEC 60601-1 (electrical safety), IEC 60601-2-37 (ultrasonic safety), ISO 10993 (biocompatibility), and NEMA UD-2/UD-3 (acoustic output measurement).

Technological Characteristics

64-channel all-digital beam former; piezoelectric transducers (2-15 MHz); 11.6" LCD touch screen interface. Connectivity: LAN, USB, HDMI. Materials: P1700, Valox420, RTV 664, RTV560, KE45 (ISO 10993 compliant). Software: Digital scan converter, progressive dynamic receive focusing. Power: 115/230V AC. Sterilization: Not applicable (device is non-sterile).

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, small organ (breast, thyroid, testes), trans-rectal, trans-vaginal, OB/GYN, urology, nerve, cardiac adult, and peripheral vessel applications. For use by trained medical professionals in clinics, hospitals, and point-of-care settings.

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.

Predicate Devices

• BenQ Medical Technology UP600 (K132690)
• Philips CX50 and Sparq Diagnostic Ultrasound Systems (K162329)

Submission Summary (Full Text)

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December 13, 2017

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

Qisda Corporation % Mr. Bob Leiker Owner/manager Leiker Regulatory & Quality Consulting 4157 North Del Rav Circle CLOVIS CA 93619

Re: K172056

Trade/Device Name: InnoSight Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: November 7, 2017 Received: November 14, 2017

Dear Mr. Leiker:

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 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.

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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'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

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# PREMARKET NOTIFICATION [510(k)] Summary

| Company Name: | Qisda Corporation<br>No.157,Shanying Rd.,Gueishan Dist.,Taoyuan City, Taiwan | |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Bob Leiker<br>Leiker Regulatory & Quality Consulting<br>4157 North Del Rey Circle in Clovis, CA 93619<br>Telephone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Device Name: | InnoSight Diagnostic Ultrasound System | |
| Common Name: | Diagnostic Ultrasound Imaging System | |
| Classification Name: | Regulatory Class: II<br>Review Category: Tier II<br>Classification Panel: Radiology | |
| | Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN<br>Diagnostic Ultrasound Transducer 21 CFR 892.1570, Product Code 90-ITX | |
| Registration Number: 3010220244 | | |
| Factory Location: | Qisda Corporation<br>No.159,Shanying Rd.,Gueishan Dist.,Taoyuan City Taiwan | |

## Predicate Device Comparison:

The BenQ UP600 (K132690) and Philips CX50 and Sparq (K162329) are of a comparable and substantially equivalent type. It has the same technological characteristics, key safety and effectiveness features, physical design, and has the same intended uses and basic operating modes as the predicate device.

| Qisda<br>Product Name<br>510(k) Number | Predicate Device<br>BenQ Medical Technology UP600 | Submission Device<br>InnoSight Diagnostic Doppler Ultrasound | Predicate Device<br>CX50 and Sparq Diagnostic Ultrasound Systems |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K132690 | Pending | K162329 |
| Qisda | Predicate Device | Submission Device | Predicate Device |
| Indications for Use | This device is a general-purpose ultrasonic imaging<br>instrument intended for use by a qualified physician<br>for evaluation of Abdomen; Pediatric; Small Organ<br>(breast, testes, thyroid); heart soft tissue; Peripheral<br>Vascular; Musculo-skeletal; Ob/Gyn and Urology. | InnoSight Diagnostic Ultrasound System is intended Philips CX50 and Sparq Diagnostic Ultrasound<br>for diagnostic ultrasound imaging in B (2D),<br>M-Mode, PW Doppler, CPA, Tissue Harmonic<br>imaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Small Organ (Breast, Thyroid, testes), trans-rectal,<br>trans-vaginal, Other (OB/GYN, Urology, Nerve),<br>Cardiac Adult and Peripheral Vessel. The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. | Systems are intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:<br>Ophthalmic, Intraoperative, Laparoscopic, Fetal,<br>Abdominal, Pediatric, Small Organ, Adult Cephalic,<br>Neonatal Cephalic, Trans-vaginal, Musculo-skeletal,<br>Gynecological, Cardiac Adult, Cardiac Pediatric,<br>Trans-Esoph. (Cardiac), Intracardiac echo,<br>Peripheral Vessel, Other (Carotid) |
| Design | Based on 128 channel full digital beam former. | Based on 64 channel full digital beam former. | Based on 128 channel full digital beam former. |
| Operating Controls | • Autocorrelation for color processing and FFT for<br>pulse and CW Doppler processing.<br>• Supporting both Linear, Curve linear and Phase<br>array probes from 1.5 to 10 MHz. | Autocorrelation for color processing and FFT for<br>pulse and CW Doppler processing.<br>Supporting both Linear, Curve linear and Phase array probes from 2 to 15 MHz. Cine play back capability and Image file archive Software upgrade with USB flash drive. Digital Scan Converter 1366x768 | Autocorrelation for color processing and FFT for pulse and CW Doppler processing.<br>It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: |
| | Cine play back capability and Image file archive | § TGC 8 slider, +/- 22.5 dB | * TGC 8 slider |
| | Software upgrade with USB flash drive. | § Depth Range: 1 to 28 cm | * Depth Range: 1 to 30 cm |
| | Digital Scan Converter 1024x768 | § Image sector size: 46 lines to full B (256 lines) | * Digital Scan Converter 1024x768 |
| | TGC 8 slider, +/- 24dB | § Image Sector position: Steering within full maximum | * B orientation flip: L/R invert key |
| | § Depth Range: 3 to 24 cm | § B orientation flip: L/R key with marking on the screen | * B Dynamic range control: Up to 170 dB |
| | § Image sector size: 32 lines to full B (256 lines) | § B Dynamic range control: preset 100 levels | * Image Processing: Smoothing, edge enhancement |
| | § Image Sector position: Steering within full maximum | § Gray Scale Control: 5 levels | * PW/B update: with UPDATE key |
| | § B orientation flip: L/R key with marking on the screen | § Focal Number: 10 focal zone setting | * PW cursor steering: Steer key |
| | § B Dynamic range control: preset 5 curves over 50-90 dB | § B persistence: 10 levels | * Spectrum baseline shift and invert |
| | § Gray Scale Control: 7 Settings | § Image Processing: Smoothing, edge enhancement | * Color ROI setting: trackball and set key to control size and position |
| | § Focal Number: 12 focal zone setting | § PW sweeping speed 1,2,4,8 sec over display. | * Freeze control: Touch freeze key |
| | § B persistence: 30-90% recursive | § PW Wall filter setting: 20 levels | * PW Wall filter setting |
| | § Image Processing: Smoothing, edge enhancement | § PW sample volume: 0.23 to 20 mm | * PW sample volume: 0.8 to 24.6mm |
| | § PW sweeping speed 2,4,8 sec over display. | § PW/B update: with UPDATE key | * Continuously variable steering in 2D, color Doppler, and Doppler modes |
| | § PW Wall filter setting: 15 settings, 0.25 to 20% of | § PW cursor steering: Steer key | * Color Wall Filter setting |
| | PRF | § PW angle correction: - 72,0,72 degree user control | * PW selectable sweep speeds |
| | § PW sample volume: 0.5 to 10mm with 0.5mm step size. | § PW spectrum dynamic range: 8 preset curve over 10-80 dB | * Spectrum normal/invert display around baseline |
| | § PW/B update: with UPDATE key | § Spectrum baseline shift and invert | * High definition zoom |
| | § PW cursor steering: Steer key | § M Process: Peak, Mean | * Cine control: step, play backward, play continuously |
| | § PW angle correction: 0 to 72 degree user control | § Color ROI setting: Touch and drag to control size | Color & B (echo) priority: controls for echo write priority |
| | § PW spectrum dynamic range: 5 preset curve over 15-48 dB | and position<br>§ Color steering on flat probe: +/- 15 | |
| | § Spectrum baseline shift and invert | § Color Wall Filter: Color wall filter with 20 settings | |
| | § M Process: Peak, Mean | § Color & B priority: C-B priority Key | |
| | § Color ROI setting: trackball and set key to control size and position | § Color Packet size: preset per Exam range from 8 to 11 | |
| | § Color steering on flat probe: +/- 15 | § Zoom factor: Up to 5x | |
| | § Color Wall Filter: Color wall filter with 15 selection, 0.25-20% of PRF | § Freeze control: Touch freeze key | |
| | § Color & B priority: C-B priority soft menu | § Cine control: step, play backward, play continuously | |
| | § Color Packet size: preset per Exam range from 8 to 12<br>§ Color spatial filter: preset per Exam, horizontal, vertical, off<br>§ Zoom factor: 1.2, 1.5, 2, 2.5, 3, 4 | | |
| | § Freeze control: Toggling freeze key | | |
| | § Cine control: step, play backward, play continuously | | |
| Qisda | Predicate Device | Submission Device | Predicate Device |
| Safety Compliance | IEC 60601-1 International Electrotechnical<br>Comission; Medical Electrical Equipment - Part 1<br>IEC60601-2 International Electrotechnical<br>Comission; Electromagnetic Compatibility<br>IEC 60601-2-37 International Electrotechnical<br>Comission; Medical Electrical Equipment - Part | IEC 60601-1 International Electrotechnical<br>Comission; Medical Electrical Equipment - Part 1<br>IEC60601-2 International Electrotechnical<br>Comission; Electromagnetic Compatibility<br>IEC 60601-2-37 International Electrotechnical<br>Comission; Medical Electrical Equipment - Part | IEC 60601-1 International Electrotechnical<br>Comission; Medical Electrical Equipment - Part 1<br>IEC60601-2 International Electrotechnical<br>Comission; Electromagnetic Compatibility<br>IEC 60601-2-37 International Electrotechnical<br>Comission; Medical Electrical Equipment - Part |
| Patient Contact Materials | 2-37<br>RTV664+Ultrason S2010 silicon rubber complies<br>with ISO10993-5 and ISO10993-10 | 2-37<br>Housing: P1700 and Valox420/ Lens: RTV 664 and<br>RTV560/ Glue:KE45 are compliance with ISO | 2-37<br>All patient contact materials of the CX50 Ultrasound<br>System and transducers are detailed in K123754. |
| Operation Mode | B (2-D), M, CFM,CPA, PW, CW, Tissue Harmonic<br>Image and combine mode | 10993-5 and ISO 10993-10<br>B (2-D), M, CFM, CPA, PW,CW, Tissue Harmonic<br>Image and combine mode | 2D Echo, M-mode, PW, CW, 2D Color, Tissue<br>Tissue Doppler and Harmonics (Tissue and<br>Contrast) and Combination modes |
| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode;<br>2-D/Pulsed Doppler and Triplex 2-D/CD/Pulsed<br>Doppler image formats; Dual B and Color in real time | Single and dual 2-D; Display of Duplex 2-D/M-mode;<br>2-D/Pulsed Doppler and Triplex 2-D/CD/Pulsed<br>Doppler image formats; Dual B and Color in real time…