InnoSight Diagnostic Ultrasound System
Device Facts
| Record ID | K192254 |
|---|---|
| Device Name | InnoSight Diagnostic Ultrasound System |
| Applicant | Qisda Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Sep 18, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), M-Mode, PW and CW Spectral Doppler, CPA, Tissue Harnonic imaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Other (Ob/GYN, Urology, Nerve), Cardiac Adult, Cardiac Pediatic, Peripheral Vessel and Carotid. The clinical environments where the used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where the intensity of electromagnetic disturbances is high.
Device Story
Compact, portable diagnostic ultrasound system; uses piezoelectric transducers to emit high-voltage pulses and detect reflected echoes. System processes signals via 64-channel digital beamformer; performs progressive dynamic receive focusing and wide-band digital demodulation. Supports B-mode, M-mode, PW/CW Doppler, Color Doppler, CPA, and Tissue Harmonic Imaging. Operated by trained clinicians in hospitals, clinics, and point-of-care settings via 11.6-inch touch screen. Provides real-time imaging and automated measurements (e.g., heart rate, volume, velocity) to assist clinicians in diagnosis. Data output includes DICOM, MP4, PNG, and PDF reports. Benefits include high-resolution imaging for disease screening and surgical guidance; exam-dependent defaults minimize user adjustment.
Clinical Evidence
No clinical data required; substantial equivalence demonstrated via non-clinical performance testing, including system-level verification, risk control validation, and usability testing. Compliance with IEC 60601-1, IEC 60601-2-37, and ISO 10993 standards confirmed.
Technological Characteristics
All-digital architecture; 64-channel beamformer; 11.6-inch touch display. Transducers: C6-2, L12-4, S4-2, C9-4v, C83B. Piezoelectric sensing. Connectivity: DICOM 3.0, USB, SSD. Biocompatible materials per ISO 10993. Standards: IEC 60601-1, IEC 60601-2-37, NEMA UD 2.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional), urology, nerve, cardiac (adult/pediatric), peripheral vessel, and carotid applications. Not for ophthalmology.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Philips CX50 and Sparq (K162329)
- BenQ T3300 (K181313)
Related Devices
- K172056 — InnoSight Diagnostic Ultrasound System · Qisda Corporation · Dec 13, 2017
- K102390 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM · Sonosite,Inc. · Nov 19, 2010
- K130659 — SPEQRT ULTRASOUND SYSTEM · Signostics Pty, Ltd. · Apr 3, 2013
- K171579 — M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 18, 2017
- K132768 — S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM · Sonoscape Company Limited · Oct 4, 2013
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
September 18, 2019
Qisda Corporation % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k SAINT PAUL, MN 55114
Re: K192254
Trade/Device Name: InnoSight Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 19, 2019 Received: August 20, 2019
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K192254
### Device Name InnoSight Diagnostic Ultrasound System
## Indications for Use (Describe)
InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), M-Mode, PW and CW Spectral Doppler, CPA, Tissue Harnonic imaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Adult Cephalic, Trans-rectal, Musculo-skel. (Conventional), Other (Ob/GYN, Urology, Nerve), Cardiac Adult, Cardiac Pediatic, Peripheral Vessel and Carotid. The clinical environments where the used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where the intensity of electromagnetic disturbances is high.
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.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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## System: InnoSight Diagnostic Doppler Ultrasound System InnoSight Diagnostic Ultrasound Pulsed Echo System InnoSight Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | |
|------------------------------|------------------------------------------|----|-------------------|---------------|---------------|-------|-----|--------------------|-------------------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | 2D | M | PW<br>Doppler | CW<br>Doppler | Color | CPA | Other*<br>Combined | Tissue<br>Harmonic<br>Imaging |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | P | P | P | | P | P | Note 1 | P |
| | Abdominal | P | P | P | | P | P | Note 1 | P |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | N |
| | Small Organ (breast,<br>thyroid, testes) | P | P | P | | P | P | Note 1 | P |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | N | N | N | N | N | N | Note 1 | N |
| | Trans-rectal | P | P | P | | P | P | Note 1 | P |
| | Trans-vaginal | P | P | P | | P | P | Note 1 | P |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | Note 1 | P |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | P | P | P | | P | P | Note 1 | P |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1 | P |
| | Cardiac Pediatric | N | N | N | | N | N | Note 1 | N |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | Note 1 | P |
| | Other (specify) | | | | | | | | |
N = new indication;
P = previously cleared by FDA
E = added under
## this appendix
Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/Color; 2D/Color /PW Doppler and 2D/CPA/PW Doppler
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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### C6-2 Curved Linear Array 2-6MHz Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|----|---|---------------|------------------|-----|--------------------|-------------------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | 2D | M | PW<br>Doppler | Color<br>Doppler | CPA | Other*<br>Combined | Tissue<br>Harmonic<br>Imaging |
| Ophthalmic | Ophthalmic | P | P | P | P | P | Note1 | P |
| Fetal<br>Imaging &<br>Other | Fetal | P | P | P | P | P | Note1 | P |
| | Abdominal | P | P | P | P | P | Note1 | P |
| | Intra-operative Specify | | | | | | | |
| | Intra-operative Neuro | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Note1 | N |
| | Small Organ (specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Ob/GYN) | P | P | P | P | P | Note1 | P |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/Color, 2D/Color /PW Doppler and 2D/CPA/PW Doppler
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Indications For Use
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L12-4 Linear Array 4-12MHz Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | | Mode of Operation | | | | | |
|------------------------------|------------------------------------------|----|-------------------|---------------|-------|-----|--------------------|-------------------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | 2D | M | PW<br>Doppler | Color | CPA | Other*<br>Combined | Tissue<br>Harmonic<br>Imaging |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal | Fetal | | | | | | | |
| Imaging &<br>Other | Abdominal | P | P | P | P | P | Note1 | P |
| | Intra-operative Specify | | | | | | | |
| | Intra-operative Neuro | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast, thyroid,<br>testes) | P | P | P | P | P | Note1 | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | P | P | Note1 | P |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Ob/GYN) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | Note1 | P |
| | Other (specify) | | | | | | | |
N = new indication;
E=
E = added under this appendix
Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/Color /PW Doppler and 2D/CPA/PW Doppler
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
P = previously cleared by FDA;
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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### S4-2 Phase Array 2-4MHz Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | | | | Mode of Operation | | | | |
|------------------------------|------------------------------------------|----|---|---------------|-------------------|-------|-----|--------------------|-------------------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | 2D | M | PW<br>Doppler | CW<br>Doppler | Color | CPA | Other*<br>Combined | Tissue<br>Harmonic<br>Imaging |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal | Fetal | | | | | | | | |
| Imaging &<br>Other | Abdominal | N | N | N | N | N | N | Note 1 | N |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (breast,<br>thyroid, testes) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | N | N | N | N | N | N | Note 1 | N |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1 | P |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA;
E = added under this appendix Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/CW Doppler; 2D/Color; 2D/Color /PW Doppler; 2D/Color /CW Doppler; 2D/CPA/CW Doppler and 2D/CPA/PW Doppler
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Indications For Use
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### C9-4v Micro Curved Linear Array 4-9MHz Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| General<br>(TRACK 1<br>ONLY) | Clinical Application<br>Specific<br>(TRACKS 1 & 3) | 2D | M | PW<br>Doppler | Color | CPA | Others*<br>Combined | Tissue<br>Harmonic<br>Imaging |
|------------------------------|----------------------------------------------------|----|---|---------------|-------|-----|---------------------|-------------------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | P | P | P | P | P | Note1 | P |
| | Abdominal | | | | | | | |
| | Intra-operative Specify | | | | | | | |
| | Intra-operative Neuro | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast,<br>thyroid, testes) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | P | P | Note 1 | P |
| | Trans-vaginal | P | P | P | P | P | Note 1 | P |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| Cardiac | Other (Ob/GYN) | P | P | P | P | P | Note 1 | P |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (specify) | | | | | | | |
P = previously cleared by FDA; N = new indication;
E = added under this appendix
Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/Color /PW Doppler and 2D/CPA/PW Doppler
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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### C83B Micro Curved Linear Array 3-8MHz Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|------------------------------|------------------------------------------|-------------------|---|---------------|-------|-----|---------------------|-------------------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | 2D | M | PW<br>Doppler | Color | CPA | Others*<br>Combined | Tissue<br>Harmonic<br>Imaging |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal<br>Imaging &<br>Other | Abdominal | N | N | N | N | N | Note 1 | N |
| | Intra-operative Specify | | | | | | | |
| | Intra-operative Neuro | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Note 1 | N |
| | Small Organ (breast,<br>thyroid, testes) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Ob/GYN) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | N | N | N | N | N | Note 1 | N |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/Color /PW Doppler and 2D/CPA/PW Doppler
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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## K192254
# PREMARKET NOTIFICATION [510(k)] Summary
| Company Name: | Qisda Corporation<br>No.157, Shanying Rd., Shan-Ting Li, Gueishan Dist.,<br>Taoyuan City, Taiwan |
|---------------|--------------------------------------------------------------------------------------------------|
|---------------|--------------------------------------------------------------------------------------------------|
- Johnson Sheu <Johnson.Sheu@Qisda.com> Contact:
- Device Name: InnoSight Diagnostic Ultrasound System
- Common Name: Diagnostic Ultrasound Imaging System
- Classification Name: Requlatory Class: II Review Category: Tier II Classification Panel: Radiology
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer 21 CFR 892.1570, Product Code 90-ITX
Registration Number: 3010220244
- Qisda Corporation Factory Location: No.159,Shanying Rd.,Shan-Ting Li, Gueishan Dist., Taoyuan City, Taiwan
# Predicate Device Comparison:
The Philips CX50 and Sparq (K162329) is a comparable and substantially equivalent type. It has the same technological characteristics, key safety and effectiveness features, physical
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design, and has the same intended uses and basic operating modes as the predicate device.
| Comparison item | Predicate Device<br>CX50 and Sparq Diagnostic<br>Ultrasound Systems<br>K162329 | Submission Device<br>InnoSight Diagnostic Doppler<br>Ultrasound<br>Pending | Difference |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The modified CX50 and | The InnoSight Diagnostic | No new |
| | Sparq Diagnostic Ultrasound | Ultrasound System is intended | indications |
| | Systems are intended for | for diagnostic ultrasound | |
| | diagnostic ultrasound | imaging in 2D, M-Mode, PW and | |
| | imaging in B (or 2-D), | CW Spectral Doppler, CPA, | |
| | M-mode (including | Tissue Harmonic imaging and | |
| | Anatomical – mode), Pulse | Color Doppler modes. It is | |
| | Wave Doppler, continuous | indicated for diagnostic | |
| | Wave Doppler, color | ultrasound imaging and fluid flow | |
| | Doppler, tissue Doppler | analysis in the following | |
| | Imaging and Harmonics | applications: Fetal, Abdominal, | |
| | (Tissue and contrast) modes. | Pediatric, Small Organ (breast, | |
| | The devices are indicated for | thyroid, testes), Adult Cephalic, | |
| | diagnostic ultrasound | Trans-rectal, Trans-vaginal, | |
| | imaging and fluid flow | Musculo-skel. (Conventional), | |
| | analysis in the following | Other (OB/GYN, Urology, | |
| | applications: Ophthalmic, | Nerve), Cardiac Adult, Cardiac | |
| | Intracardiac echo, | Pediatric, Peripheral Vessel and | |
| | Intraoperative, Laparoscopic, | Carotid. | |
| | Fetal, Abdominal, Pediatric, | | |
| | Small Organ, Adult Cephalic, | | |
| | Neonatal Cephalic, | | |
| | Trans-vaginal, Trans-rectal, | | |
| | Musculoskeletal, | | |
| | Gynecological, Cardiac | | |
| | Adult, Cardiac pediatric, | | |
| | Trans-Esophogeal. | | |
| | (Cardiac), Peripheral Vessel, | | |
| | Other (Carotid). | | |
| Comparison item | Predicate Device<br>CX50 and Sparq Diagnostic<br>Ultrasound Systems<br>K162329 | Submission Device<br>InnoSight Diagnostic Doppler<br>Ultrasound<br>Pending | Difference |
| working principle | The user typically uses a<br>detector (called a probe) to<br>place it directly on the<br>patient's body and move it,<br>then reads the image on the<br>screen. Creating an<br>ultrasound image is generally<br>divided into three steps:<br>generating ultrasound,<br>receiving echoes and<br>interpreting. These echoes<br>as they appear on the<br>screen. | Same | None |
| Mechanism of action | The intended use of this<br>product is to collect<br>ultrasound image data that<br>can be used by clinicians for<br>disease screening,<br>diagnosis, and surgery. This<br>product should have the<br>ability to collect clinically<br>acceptable images and<br>ultrasound data for clinical<br>applications. | Same | None |
| Product composition | Color ultrasound diagnostic<br>systems and probes include<br>mainframes (including<br>displays, control panels and<br>carts), probes and optional<br>components (barcode<br>scanners, printers, foot | The InnoSight color ultrasound<br>system consists of a cart, a<br>touch system, and a probe.<br>Optional accessories include a<br>printer. | Comparison of<br>declared<br>products with<br>predicate<br>product.<br>Different<br>structure of the<br>cart and less |
| Comparison item | Predicate Device<br>CX50 and Sparq Diagnostic<br>Ultrasound Systems<br>K162329 | Submission Device<br>InnoSight Diagnostic Doppler<br>Ultrasound<br>Pending | Difference |
| | pedals, ECG leads). | | optional<br>accessories.<br>But these have<br>been tested to<br>prove that theyeffective. |
| Core components | Display: 43cm (17-in) LDC<br>display. | 11.6 - in touch panel | Compared with<br>the predicate<br>product, the<br>screens are<br>different, but<br>they are used<br>by doctors in<br>clinically<br>effective use to<br>prove that theyeffective. |
| | Host signal input:<br>Physiological ECG and<br>breathing<br>Three probe socket | Host signal input:<br>Single probe socket<br>Three probe socket by MTM | The signal input<br>of the declared<br>product host is<br>a single probe<br>socket, which is<br>simpler than the<br>comparison<br>product. Has<br>been tested to<br>prove that it is<br>safe and<br>effective. |
| | The signal output of the host: | The signal output of the host: | The video |
| Comparison item | Predicate Device<br>CX50 and Sparq Diagnostic<br>Ultrasound Systems<br>K162329 | Submission Device<br>InnoSight Diagnostic Doppler<br>Ultrasound<br>Pending | Difference |
| | External printer<br>USB serial data<br>Video: S-Video, VGA | USB serial data<br>Video: HDMI | output of the<br>declared<br>product is<br>HDMI. Unlike<br>the comparison<br>product, it has<br>been tested for<br>HDMI and<br>proved to be<br>safe and<br>effective. |
| | Number of physical<br>channels:<br>Transmitting channel -128<br>Receiving channel -128 | Number of physical channels:<br>Transmitting channel -64<br>Receiving channel -64 | There are fewer<br>transmitting and<br>receiving<br>channels for the<br>declared<br>products, and<br>relevant tests<br>have been<br>carried out to<br>prove that they<br>are safe and<br>effective. |
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| Comparison item | Predicate Device<br>CX50 and Sparq Diagnostic<br>Ultrasound Systems<br>K162329 | | Submission Device<br>InnoSight Diagnostic Doppler<br>Ultrasound<br>Pending | | Difference | |
|------------------|--------------------------------------------------------------------------------|--------------|----------------------------------------------------------------------------|--------|--------------|----------------------|
| | Probe: | Type | | Probe: | Type | |
| | model | | | model | | |
| | S4-2 | Phased array | | S4-2 | Phased array | |
| | | probe | | | probe | |
| | C6-2 | Broadband | | C6-2 | Broadband | |
| | | Curved Array | | | Curved Array | Probe type and |
| | | probe | | | probe | bandwidth |
| | C8-5 | Broadband | | C9-4v | Broadband | range are |
| | | Curved Array | | | Curved Array | smaller than |
| | | probe | | | probe | Predicate<br>device. |
| | C9-4v | Broadband | | L12-4 | Broadband | |
| | | Curved Array |…
