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.

Device Description

InnoSight diagnostic ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface is touch screen with 11.6" display. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

The major features of the InnoSight diagnostic ultrasound:

64 Channel all digital beam former
Progressive dynamic receive focusing
Wide band all digital demodulation
Native frequency digital scan converter
. InnoSight diagnostic ultrasound can be hand carried for portable use
. Full patient database solutions: DICOM3.0, MP4 /PNG, USB, SSD, PDF report
Supports B (2-D), M, CFM, DPI, PW, Tissue Harmonic Image and combine . mode

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the InnoSight Diagnostic Ultrasound System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) Premarket Notification, primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria and performance metrics for the InnoSight system itself from an independent study.

Instead, the "acceptance criteria" are implied by compliance with various international and FDA-recognized consensus standards for medical electrical equipment, including safety, electromagnetic compatibility, and acoustic output. The "reported device performance" is essentially the statement of compliance with these standards and the demonstration of equivalent functionality to the predicate device.

Category	Acceptance Criteria (Implied by Standards & Equivalence)	Reported Device Performance
Safety	Compliance with IEC 60601-1 (medical electrical equipment - general requirements for basic safety and essential performance) and IEC 60601-2-37 (particular requirements for ultrasonic medical diagnostic and monitoring equipment).	"InnoSight diagnostic ultrasound has been designed to meet the following voluntary and measurement standards: AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text)" and "IEC 60601-2-37 Edition 2.1 2015". Non-clinical performance testing demonstrates compliance. Asserts that the device is "designed and manufactured to the same electrical and physical safety standards" as the predicate.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 (general requirements for basic safety and essential performance – collateral standard: electromagnetic compatibility).	"AAMI / ANSI / IEC IEC 60601-1-2, Ed. 4.0". Non-clinical performance testing demonstrates compliance.
Acoustic Output	Compliance with NEMA UD 2-2004 (R2009) (acoustic output measurement standard for diagnostic ultrasound equipment) and IEC 60601-2-37. Acoustic output levels within Track 3 FDA limits.	"NEMA UD 2-2004 (R2009)" and "IEC 60601-2-37 Edition 2.1 2015". "Acoustic Output: Conform to IEC60601-2-37 and AIUM UD2 requirements for all modes of all probes." "The predicate device and InnoSight Diagnostic Ultrasound Systems have acoustic output levels within the Track 3 FDA limits."
Biocompatibility	Compliance with ISO 10993-1 (biological evaluation of medical devices).	"ISO 10993-1 Fourth Edition 2009-10-15". "The predicate device and the InnoSight Diagnostic Ultrasound Systems are manufactured by bio safety materials." Specifies that for transducer C83B, Cytotoxicity, Irritation and Sensitization tests reference the acceptable results for predicate transducer L154BH.
Software Life Cycle	Compliance with IEC 62304 (medical device software – software life cycle processes).	"IEC 62304:2015".
Image Quality & Functionality	"Ability to collect clinically acceptable images and ultrasound data for clinical applications" (stated as mechanism of action for predicate, implied for submission device). Equivalence to predicate in imaging functions (B, M, PWD, Color Doppler, THI, CPA, iScan, X-Res, SonoCT, Biopsy guide) and post-processing functions. Clinical verification expected, but not explicitly detailed numerically as performance metrics in this document.	The comparison table (pages 14-16) generally states "Same" or "No new imaging function" / "No new post processing function" when comparing features with the predicate CX50 and Sparq. Minor differences in probe types/bandwidth, display size, and number of channels are acknowledged but deemed "tested to prove that they [are] effective" or "safe and effective". Non-clinical verification testing covered system level requirements and risk control measures. Non-clinical validation testing covered intended use, commercial claims, and usability with representative intended users.
Intended Use	The system should be suitable for diagnostic ultrasound imaging and fluid flow analysis in various specified applications (Fetal, Abdominal, Pediatric, Small Organ etc.) and clinical environments.	The "Indications for Use" section (pages 2-8) details the specific applications and modes of operation for the InnoSight system and its various transducers. The comparison with the predicate device states, "No new indications" meaning the InnoSight performs for the same indications as the predicate.

Specific Numerical Performance Targets (Acceptance Criteria) are not provided in detail in this document. The submission hinges on substantial equivalence to a predicate device, supported by compliance with recognized standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient cases or images for evaluating clinical performance. The non-clinical testing involved various engineering tests (e.g., electrical safety, EMC, acoustic output, biocompatibility) conducted on the device itself.
Data Provenance: The data described is primarily from non-clinical performance testing conducted on the device. There is no mention of clinical data (patient data) provenance (e.g., country of origin, retrospective or prospective) because the document explicitly states: "The InnoSight did not require clinical data since substantial equivalence to the primary currently marketed predicate CX50 Diagnostic Ultrasound System demonstrated with indication for use, technological characteristics, Non-clinical performance testing; and Safety and effectiveness."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as there was no clinical test set requiring expert ground truth establishment for a diagnostic performance study. The evaluation focused on engineering performance and substantial equivalence.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The submission explicitly states that clinical data was not required.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not conducted or described in this document. The InnoSight system is a diagnostic ultrasound device designed to be operated by a trained medical professional, not an AI algorithm performing diagnostic tasks without human interaction.

7. Type of Ground Truth Used

Not directly applicable in the context of a clinical diagnostic performance study. For the non-clinical tests, the "ground truth" would be established by the specifications of the standards (e.g., a device must operate within specific acoustic output limits as defined by NEMA UD 2).

8. Sample Size for the Training Set

This information is not applicable. The InnoSight Diagnostic Ultrasound System is a hardware-based imaging system, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its "training" involves engineering design, calibration, and adherence to established physical and electrical principles of ultrasound.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reason stated in point 8.

Summary

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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

{1}------------------------------------------------

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)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	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(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	2D	M	PWDoppler	CWDoppler	Color	CPA	Other*Combined	TissueHarmonicImaging
Ophthalmic	Ophthalmic
FetalImaging &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,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(Conventional)	P	P	P		P	P	Note 1	P
	Musculo-skeletal(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)
PeripheralVessel	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(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	2D	M	PWDoppler	ColorDoppler	CPA	Other*Combined	TissueHarmonicImaging
Ophthalmic	Ophthalmic	P	P	P	P	P	Note1	P
FetalImaging &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(Conventional)
	Musculo-skeletal(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)
PeripheralVessel	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(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	2D	M	PWDoppler	Color	CPA	Other*Combined	TissueHarmonicImaging
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging &Other	Abdominal	P	P	P	P	P	Note1	P
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,testes)	P	P	P	P	P	Note1	P
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	P	P	P	P	P	Note1	P
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note1	P
	Other (specify)

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 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(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	2D	M	PWDoppler	CWDoppler	Color	CPA	Other*Combined	TissueHarmonicImaging
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging &Other	Abdominal	N	N	N	N	N	N	Note 1	N
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (breast,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(Conventional)
	Musculo-skeletal(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)
PeripheralVessel	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(TRACK 1ONLY)	Clinical ApplicationSpecific(TRACKS 1 & 3)	2D	M	PWDoppler	Color	CPA	Others*Combined	TissueHarmonicImaging
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal	P	P	P	P	P	Note1	P
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (breast,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(Conventional)
	Musculo-skeletal(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)
PeripheralVessel	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(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	2D	M	PWDoppler	Color	CPA	Others*Combined	TissueHarmonicImaging
Ophthalmic	Ophthalmic
	Fetal
FetalImaging &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,thyroid, testes)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(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)
PeripheralVessel	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 CorporationNo.157, Shanying Rd., Shan-Ting Li, Gueishan Dist.,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 DeviceCX50 and Sparq DiagnosticUltrasound SystemsK162329	Submission DeviceInnoSight Diagnostic DopplerUltrasoundPending	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 DeviceCX50 and Sparq DiagnosticUltrasound SystemsK162329	Submission DeviceInnoSight Diagnostic DopplerUltrasoundPending	Difference
working principle	The user typically uses adetector (called a probe) toplace it directly on thepatient's body and move it,then reads the image on thescreen. Creating anultrasound image is generallydivided into three steps:generating ultrasound,receiving echoes andinterpreting. These echoesas they appear on thescreen.	Same	None
Mechanism of action	The intended use of thisproduct is to collectultrasound image data thatcan be used by clinicians fordisease screening,diagnosis, and surgery. Thisproduct should have theability to collect clinicallyacceptable images andultrasound data for clinicalapplications.	Same	None
Product composition	Color ultrasound diagnosticsystems and probes includemainframes (includingdisplays, control panels andcarts), probes and optionalcomponents (barcodescanners, printers, foot	The InnoSight color ultrasoundsystem consists of a cart, atouch system, and a probe.Optional accessories include aprinter.	Comparison ofdeclaredproducts withpredicateproduct.Differentstructure of thecart and less
Comparison item	Predicate DeviceCX50 and Sparq DiagnosticUltrasound SystemsK162329	Submission DeviceInnoSight Diagnostic DopplerUltrasoundPending	Difference
	pedals, ECG leads).		optionalaccessories.But these havebeen tested toprove that theyeffective.
Core components	Display: 43cm (17-in) LDCdisplay.	11.6 - in touch panel	Compared withthe predicateproduct, thescreens aredifferent, butthey are usedby doctors inclinicallyeffective use toprove that theyeffective.
	Host signal input:Physiological ECG andbreathingThree probe socket	Host signal input:Single probe socketThree probe socket by MTM	The signal inputof the declaredproduct host isa single probesocket, which issimpler than thecomparisonproduct. Hasbeen tested toprove that it issafe andeffective.
	The signal output of the host:	The signal output of the host:	The video
Comparison item	Predicate DeviceCX50 and Sparq DiagnosticUltrasound SystemsK162329	Submission DeviceInnoSight Diagnostic DopplerUltrasoundPending	Difference
	External printerUSB serial dataVideo: S-Video, VGA	USB serial dataVideo: HDMI	output of thedeclaredproduct isHDMI. Unlikethe comparisonproduct, it hasbeen tested forHDMI andproved to besafe andeffective.
	Number of physicalchannels:Transmitting channel -128Receiving channel -128	Number of physical channels:Transmitting channel -64Receiving channel -64	There are fewertransmitting andreceivingchannels for thedeclaredproducts, andrelevant testshave beencarried out toprove that theyare safe andeffective.

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Comparison item	Predicate DeviceCX50 and Sparq DiagnosticUltrasound SystemsK162329		Submission DeviceInnoSight Diagnostic DopplerUltrasoundPending		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	Predicatedevice.
	C9-4v	Broadband		L12-4	Broadband
		Curved Array			linear array
		probe			probe
	L12-4	Broadband		C83B	Broadband
		linear array			Curved Array
		probe			probe
	X7-2t	TEE probe
Imaging function	B		B			No New
	M		M			imagingfunction
	PWD		PWD
	Color DopplerB+PWDB+Color Doppler		Color DopplerB+PWDB+ Color Doppler


	B+M		B+M
	B+M+ Color Doppler		B+M+ Color Doppler

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	Predicate Device	Submission Device	Difference
Comparison item	CX50 and Sparq DiagnosticUltrasound SystemsK162329	InnoSight Diagnostic DopplerUltrasoundPending
	B+ Color Doppler +PWD	B+ Color Doppler +PWD
	Tissue Harmonic Imaging(THI)	Tissue Harmonic Imaging (THI)
	Tissue Doppler Imaging	Color Power Angio (CPA)
	Color Power Angio (CPA)	iScan
	iScan	X-Res
	X-Res	SonoCT Imaging
	Contrast imaging	Biopsy guide
	SonoCT Imaging	Enhanced Needle Visualization
	Biopsy guide
	Biopsy needle visualization
Post processingfunction	2D depth ;Continuous tracing ;Distance ;Ellipse ;Heart Rate ;High Q Automatic Doppler2-Points Measurement ;Time/ Slope ;Volume ;Angle ;Area ;Circumference ;Simpson method	2D depth ;Continuous tracing ;Distance ;Ellipse ;Heart Rate ;High Q Automatic Doppler2-Points MeasurementTime/ Slope ;Volume ;Angle ;Area ;Circumference ;	No new postprocessingfunction
Other features	DICOM networkingDICOM structured report( SR )	Same	None
Applicable power	Rated voltage in the range of	Same	None
Comparison Item	Predicate DeviceCX50 and Sparq DiagnosticUltrasound SystemsK162329	Submission DeviceInnoSight Diagnostic DopplerUltrasoundPending	Difference
supply voltage range	± 10%, the device can worknormally
Continuous run time	>8h	Same	None
Electromagneticcompatibility	Meet the requirements of IEC60601-1-2	Same	None
Sound outputparameter	Meet the requirements ofIEC60601-2-37	Same	None
Biocompatibility	Meet the appropriaterequirements of the followingstandards:ISO 10993-1ISO 10993-5ISO 10993-10	Same	None
Electrical safety	Meet the appropriaterequirements of the followingstandards:IEC 60601-1IEC 60601-2-37IEC 60601-1-1IEC 60601-1-2	Same	None
Radiation safety	Comply with IEC 60601-2-37	Same	None
Software corefunction	By coordinating the buttons,soft keys and trackball of thecontrol panel: Acousticoutput power, focus, depth,THI, probe operatingfrequency (soft-frequency)	Through the touch panel:Acoustic output power, focus,depth, THI, probe operatingfrequency, color ROI size, colorROI position, sample packetsize, line density, color sampling	No new function
Comparison item	Predicate DeviceCX50 and Sparq Diagnostic	Submission DeviceInnoSight Diagnostic Doppler	Difference
	Ultrasound Systems	Ultrasound
	K162329	Pending
	color ROI size, color ROIsetting, sample package size(soft-pack), line density(soft-density), color samplingScale, pulse repetitionfrequency, spectral ROI size(soft-gate), spectral ROIposition (trackball), spectralsampling size, the systemcan change the aboveimaging parameters. Byadjusting these parameters,the user can change thesound field devices.	size, pulse repetition frequency,spectral ROI size, spectral ROIposition, spectral sampling sizeThe system can change theabove imaging parameters. Byadjusting these parameters, theuser can change the sound fielddevices.
Applicable people	Adult, pediatric	Adult, pediatric	No difference
Applicable part	Fetus, Abdomen, Smallorgans (Thyroid, Scrotum,Thyroid, Prostate andBreast), Other (Gynecology),Adult heart, Peripheral bloodvessels, Pediatrics,Musculoskeletal(Conventional),Musculoskeletal(Superficial), Other(Gynecology), Rectum ,Transvaginal, Esophagealheart	Fetus, Abdomen, Small Organs(Thyroid, Scrotum, Thyroid,Prostate and Breast), Other(Gynecology), Adult heart,Peripheral blood vessels,Musculoskeletal (Conventional),Other (Gynecological), Rectal,Transvaginal, Adult cephalicvein	No new preset
Contact with thehuman body	Contacting the body surface,transthoracic	Contacting the body surface,intraluminal	Less contactparts
Comparison item	Predicate DeviceCX50 and Sparq DiagnosticUltrasound SystemsK162329	Submission DeviceInnoSight Diagnostic DopplerUltrasoundPending	Difference
	intraluminal
Indication	Fetal imaging and other,heart, peripheral vascular	Same	No difference
Applicable diseasestage and exten	Suitable for any stage anddegree of disease	Same	No difference
Use environment	All departments of thehospital. Imaging Center,Professional Clinic, Primaryand Secondary CareCenters.	Same	No difference
Instructions	Philips color ultrasounddiagnostic system usingconventional methods	Same	No difference
Precautions andwarnings	Please refer to the usermanual	Same	No difference
Contraindications	No known contraindications	Not for ophthalmology
Sterilization/disinfectionon method	Non-sterile, routinedisinfection	Same	No difference

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BenQ T3300 Diagnostic Ultrasound System (K181313) is an additional predicate device for comparing form the biocompatibility point of view.

BenQ T3300 (K181313) is the Diagnostic Ultrasound System which equipped with three transducers L154BH, C62B and P42B6.

Since the materials used and the manufacturing process of C83B that has direct contact with the patients are equivalent to the transducer L154BH, therefore, Cytotoxicity, Irritation and Sensitization tests for C83B can reference the testing performed for transducer L154BH and the result is acceptable.

Premarket Notification 510(k) Summary

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General Device Description:

The major features of the InnoSight diagnostic ultrasound:

64 Channel all digital beam former
Progressive dynamic receive focusing
Wide band all digital demodulation
Native frequency digital scan converter
. InnoSight diagnostic ultrasound can be hand carried for portable use
. Full patient database solutions: DICOM3.0, MP4 /PNG, USB, SSD, PDF report
Supports B (2-D), M, CFM, DPI, PW, Tissue Harmonic Image and combine . mode

Intended Use:

The InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in 2D, M-Mode, PW and CW Spectral 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, Pediatric, Small Organ (breast, thyroid, testes), Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Other (OB/GYN, Urology, Nerve),

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Cardiac Adult, Cardiac Pediatric, Peripheral Vessel and Carotid. The clinical environments where the system can be 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.

Technological Characteristics:

Display Modes	Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler andTriplex 2-D/CD/Pulsed Doppler image formats; Dual B and Color in real time
Description ofTransducers	InnoSight Diagnostic Ultrasound System withC6-2 Curved Linear Array 2-6MHzL12-4 Linear Array 4-12MHzS4-2 Phase Array 2-4MHzC9-4v Micro Curved Linear Array 4-9MHzC83B Micro Curved Linear Array 3-8MHz
Measurements	Distance; area; Volume; circumference; Heart Rate; calipers; velocity; PI, RICardiac, OB/GYN and Vascular package.
Principle ofOperation	Applying high voltage burst to the Piezoelectric material in the transducerand detect the reflected echo to construct the 2-D B-mode, Doppler color,and Doppler spectrum image for diagnostic purpose.
OperatingControls	TGC 8 slider, +/- 22.5 dB Depth Range: 1 to 30 cm Image sector size: 32 lines to full B (256 lines) Image Sector position: Steering within full maximum B orientation flip: L/R key with marking on the screen B Dynamic range control: preset 100 levels over 20-100 dB Gray Scale Control: 4 Settings Focal Number: 10 focal zone setting B persistence: 30-90% recursive Image Processing: Smoothing, edge enhancement PW sweeping speed 2,4,8 sec over display. PW Wall filter setting: 20 settings, 1% to 20% of PRF PW sample volume: 0.5 to 10mm with 0.5mm step size. PW/B update: with UPDATE key PW cursor steering: Steer key PW angle correction: +/- 72 degree user control PW trace: Peak, Mean PW spectrum dynamic range: 8 preset curve over 15-96 dB Spectrum baseline shift and invert Color ROI setting: Touch and drag to control size and position Color steering on flat probe: +/- 20 Color Wall Filter: Color wall filter with 20 settings, 1% to 20% of PRF Color & B priority: C-B priority soft menu Color Packet size: preset per Exam range from 8 to 12 Color spatial filter: preset per Exam, horizontal, vertical, off Zoom factor: Up to 10x Freeze control: Touch freeze key Cine control: step, play backward, play continuously
AcousticOutput	Conform to IEC60601-2-37 and AIUM UD2 requirements for all modes of all probes

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SAFETY CONSIDERATIONS:

InnoSight diagnostic ultrasound has been designed to meet the following voluntary and measurement standards:

RecognitionNumber	Regulations No./ Version	Recognition Standard
12-105	NEMA UD 2-2004 (R2009)	Acoustic Output Measurement Standard forDiagnostic Ultrasound Equipment Revision3 (Radiology)
12-293	IEC 60601-2-37 Edition 2.1 2015	Medical electrical equipment - Part 2-37:Particular requirements for the basic safetyand essential performance of ultrasonicmedical diagnostic and monitoringequipment
19-4	AAMI / ANSIES60601-1:2005/(R)2012 AndA1:2012,, C1:2009/(R)2012 AndA2:2010/(R)2012 (ConsolidatedText)	Medical Electrical Equipment - Part 1:General Requirements For Basic SafetyAnd Essential Performance (lec60601-1:2005, Mod). (General II (ES/EMC))
19-8	AAMI / ANSI / IECIEC 60601-1-2, Ed. 4.0	Medical Electrical Equipment - Part 1-2:General Requirements For Basic SafetyAnd Essential Performance – CollateralStandard: Electromagnetic Compatibility -Requirements And Tests (Edition 4).(General II (ES/EMC))
2-220	ISO 10993-1 Fourth Edition2009-10-15	Biological Evaluation Of Medical Devices -Part 1: Evaluation And Testing Within ARisk Management Process [Including:Technical Corrigendum 1 (2010)].(Biocompatibility)
13-79	IEC 62304:2015	Medical device software – Software lifecycle processes

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510(k) Submission InnoSight Diagnostic Ultrasound System

Summary of Non-Clinical Performance Data

Non-clinical performance testing has been performed on the InnoSight Diagnostic Ultrasound Systems and demonstrates compliance with the following FDA recognized consensus standards:

IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
IEC 60601-1-2 Medical Electrical Equipment – Part 1-2, General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic Compatibility, 2007 * IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2007 * ISO 10993: Biological evaluation of medical devices

The device also comply with the FDA ultrasound specific guidance for Industry and FDA Staff - Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008).

Non-Clinical verification testing has been performed to cover system level requirements and the risk control measures. Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users.All these tests were used to support substantial equivalence of the subject device and demonstrate that the InnoSight Diagnostic Ultrasound Systems complies with the aforementioned international and FDA-recognized consensus standards and FDA ultrasound guidance document, and meets the acceptance criteria and is adequate for its intended use.

Therefore, InnoSight is substantially equivalent to the predicate CX50 Diagnostic Ultrasound System in terms of safety and effectiveness

Summary of Clinical Performance Data

The InnoSight did not require clinical data since substantial equivalence to the primary currently

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marketed predicate CX50 Diagnostic Ultrasound System demonstrated with indication for use, technological characteristics, Non-clinical performance testing; and Safety and effectiveness.

Substantial Equivalence Conclusion

The InnoSight Diagnostic Ultrasound Systems are substantially equivalent to the currently marketed predicate device

The predicate device and the InnoSight Diagnostic Ultrasound Systems are indicated for the diaqnostic ultrasonic imaging and fluid flow analysis.
The predicate device and the InnoSight Diagnostic Ultrasound Systems have the same gray-scale and Doppler capabilities.
The predicate device and InnoSight Diagnostic Ultrasound Systems use essentially the same technologies for imaging, Doppler functions and signal processing.
The predicate device and InnoSight Diagnostic Ultrasound Systems have acoustic output levels within the Track 3 FDA limits.
The predicate device and the InnoSight Diagnostic Ultrasound Systems are manufactured by bio safety materials.
The predicate device and InnoSight Diagnostic Ultrasound Systems are designed and manufactured to the same electrical and physical safety standards.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.