Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging technology and features like image processing (smoothing, edge enhancement) which are not inherently AI/ML. There is no mention of AI, ML, deep learning, or any related terms in the summary.

Therapeutic

No.
The device is described as a "diagnostic ultrasound system" intended for "diagnostic ultrasound imaging" and "fluid flow analysis." It explicitly states that the system "in no way interprets these images or provides a medical diagnosis," indicating its role is purely for imaging and not for therapy.

Diagnostic

Yes
The product is explicitly named "InnoSight Diagnostic Ultrasound System" and its intended use is stated as "diagnostic ultrasound imaging."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "compact and portable diagnostic ultrasound device" with integrated hardware components like a touch screen display, beam former, and digital scan converter. It also mentions compliance with hardware-related standards like IEC 60601-1 and IEC 60601-2-37.

IVD (In Vitro Diagnostic)

Based on the provided text, the InnoSight Diagnostic Ultrasound System is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
InnoSight's Function: The InnoSight system uses ultrasound technology to create images of internal structures within the body. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states it is for "diagnostic ultrasound imaging" and "fluid flow analysis" within the body, not for analyzing samples.
Device Description: The description focuses on the ultrasound technology, beam forming, and image processing, all of which are related to generating images from within the body.
Lack of IVD-Specific Information: The text does not mention any components or processes related to handling or analyzing biological specimens.

Therefore, the InnoSight Diagnostic Ultrasound System is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (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, 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.

Product codes

IYN, IYO, ITX

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

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

B (2D), M-Mode, PW and CW Spectral Doppler, CPA, Tissue Harmonic imaging and Color Doppler modes.

Anatomical Site

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 Pediatric, Peripheral Vessel and Carotid.

Indicated Patient Age Range

Adult, pediatric

Intended User / Care Setting

Qualified medical professional. Physician offices, clinics, hospitals, and clinical point-of-care.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 complies 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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K162329, K181313

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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

2

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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3

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 1
ONLY)	Specific
(TRACKS 1 & 3)	2D	M	PW
Doppler	CW
Doppler	Color	CPA	Other*
Combined	Tissue
Harmonic
Imaging
Ophthalmic	Ophthalmic
Fetal
Imaging &
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)
Peripheral
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)

4

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 1
ONLY)	Specific
(TRACKS 1 & 3)	2D	M	PW
Doppler	Color
Doppler	CPA	Other*
Combined	Tissue
Harmonic
Imaging
Ophthalmic	Ophthalmic	P	P	P	P	P	Note1	P
Fetal
Imaging &
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)
Peripheral
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

5

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 1
ONLY)	Specific
(TRACKS 1 & 3)	2D	M	PW
Doppler	Color	CPA	Other*
Combined	Tissue
Harmonic
Imaging
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)
Peripheral
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)

6

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 1
ONLY)	Specific
(TRACKS 1 & 3)	2D	M	PW
Doppler	CW
Doppler	Color	CPA	Other*
Combined	Tissue
Harmonic
Imaging
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)
Peripheral
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

7

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 1
ONLY) | Clinical Application
Specific
(TRACKS 1 & 3) | 2D | M | PW
Doppler | Color | CPA | Others*
Combined | Tissue
Harmonic
Imaging |
|------------------------------|--------------- | Ophthalmic | Ophthalmic | Fetal
Imaging &
Other | Fetal | | Abdominal | | Intra-operative Specify | | Intra-operative Neuro | | Laparoscopic | | Pediatric | | Small thyroid, testes) | | | | | Neonatal Cephalic | | Adult Cephalic | | Trans-rectal | | Trans-vaginal | | Trans-urethral | | Trans-esoph.(non-Card) | | Musculo-skelet (Conventional) | | | | | Musculo-skelet (Superficial) | | | | | Intravascular | Cardiac | Other (Ob/GYN) | | Cardiac Adult | | Cardiac Pediatric | | Intravascular(Cardiac) | | Trans-esoph.(Cardiac) | | Intra-cardiac | | Other (specify) | Peripheral
Vessel | Peripheral vessel | | Other (specify) -------------------------------------|----|---|---------------|-------|-----|---------------------|-------------------------------|
| | | | | | | |
| P | P | P | P | P | Note1 | P |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Organ (breast,
| | | | |
| | | | | | | |
| | | | | | | |
| P | P | P | P | P | Note 1 | P |
| P | P | P | P | P | Note 1 | P |
| | | | | | | |
| | | | | | | |
al
| | | | |
al
| | | | |
| | | | | | | |
| P | P | P | P | P | Note 1 | P |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |

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)

8

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 1
ONLY)	Specific
(TRACKS 1 & 3)	2D	M	PW
Doppler	Color	CPA	Others*
Combined	Tissue
Harmonic
Imaging
Ophthalmic	Ophthalmic
	Fetal
Fetal
Imaging &
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)
Peripheral
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)

9

K192254

PREMARKET NOTIFICATION [510(k)] Summary

| Company Name: | Qisda Corporation
No.157, Shanying Rd., Shan-Ting Li, Gueishan Dist.,
Taoyuan City, Taiwan |

---------------	--------------------------------------------------------------------------------------------------

Johnson Sheu 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

10

design, and has the same intended uses and basic operating modes as the predicate device.

| Comparison item | Predicate Device
CX50 and Sparq Diagnostic
Ultrasound Systems
K162329 | Submission Device
InnoSight Diagnostic Doppler
Ultrasound
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
CX50 and Sparq Diagnostic
Ultrasound Systems
K162329 | Submission Device
InnoSight Diagnostic Doppler
Ultrasound
Pending | Difference |
| working principle | The user typically uses a
detector (called a probe) to
place it directly on the
patient's body and move it,
then reads the image on the
screen. Creating an
ultrasound image is generally
divided into three steps:
generating ultrasound,
receiving echoes and
interpreting. These echoes
as they appear on the
screen. | Same | None |
| Mechanism of action | The intended use of this
product is to collect
ultrasound image data that
can be used by clinicians for
disease screening,
diagnosis, and surgery. This
product should have the
ability to collect clinically
acceptable images and
ultrasound data for clinical
applications. | Same | None |
| Product composition | Color ultrasound diagnostic
systems and probes include
mainframes (including
displays, control panels and
carts), probes and optional
components (barcode
scanners, printers, foot | The InnoSight color ultrasound
system consists of a cart, a
touch system, and a probe.
Optional accessories include a
printer. | Comparison of
declared
products with
predicate
product.
Different
structure of the
cart and less |
| Comparison item | Predicate Device
CX50 and Sparq Diagnostic
Ultrasound Systems
K162329 | Submission Device
InnoSight Diagnostic Doppler
Ultrasound
Pending | Difference |
| | pedals, ECG leads). | | optional
accessories.
But these have
been tested to
prove that theyeffective. |
| Core components | Display: 43cm (17-in) LDC
display. | 11.6 - in touch panel | Compared with
the predicate
product, the
screens are
different, but
they are used
by doctors in
clinically
effective use to
prove that theyeffective. |
| | Host signal input:
Physiological ECG and
breathing
Three probe socket | Host signal input:
Single probe socket
Three probe socket by MTM | The signal input
of the declared
product host is
a single probe
socket, which is
simpler than the
comparison
product. Has
been tested to
prove that it is
safe and
effective. |
| | The signal output of the host: | The signal output of the host: | The video |
| Comparison item | Predicate Device
CX50 and Sparq Diagnostic
Ultrasound Systems
K162329 | Submission Device
InnoSight Diagnostic Doppler
Ultrasound
Pending | Difference |
| | External printer
USB serial data
Video: S-Video, VGA | USB serial data
Video: HDMI | output of the
declared
product is
HDMI. Unlike
the comparison
product, it has
been tested for
HDMI and
proved to be
safe and
effective. |
| | Number of physical
channels:
Transmitting channel -128
Receiving channel -128 | Number of physical channels:
Transmitting channel -64
Receiving channel -64 | There are fewer
transmitting and
receiving
channels for the
declared
products, and
relevant tests
have been
carried out to
prove that they
are safe and
effective. |

11

12

13

14

| Comparison item | Predicate Device
CX50 and Sparq Diagnostic
Ultrasound Systems
K162329 | | Submission Device
InnoSight Diagnostic Doppler
Ultrasound
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
device. |
| | 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 | | | imaging
function |
| | PWD | | PWD | | | |
| | Color Doppler
B+PWD
B+Color Doppler | | Color Doppler
B+PWD
B+ 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 Diagnostic
Ultrasound Systems
K162329	InnoSight Diagnostic Doppler
Ultrasound
Pending
	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 processing
function	2D depth ;
Continuous tracing ;
Distance ;
Ellipse ;
Heart Rate ;
High Q Automatic Doppler
2-Points Measurement ;
Time/ Slope ;
Volume ;
Angle ;
Area ;
Circumference ;
Simpson method	2D depth ;
Continuous tracing ;
Distance ;
Ellipse ;
Heart Rate ;
High Q Automatic Doppler
2-Points Measurement
Time/ Slope ;
Volume ;
Angle ;
Area ;
Circumference ;	No new post
processing
function
Other features	DICOM networking
DICOM structured report
( SR )	Same	None
Applicable power	Rated voltage in the range of	Same	None
Comparison Item	Predicate Device
CX50 and Sparq Diagnostic
Ultrasound Systems
K162329	Submission Device
InnoSight Diagnostic Doppler
Ultrasound
Pending	Difference
supply voltage range	± 10%, the device can work
normally
Continuous run time	>8h	Same	None
Electromagnetic
compatibility	Meet the requirements of IEC
60601-1-2	Same	None
Sound output
parameter	Meet the requirements of
IEC60601-2-37	Same	None
Biocompatibility	Meet the appropriate
requirements of the following
standards:
ISO 10993-1
ISO 10993-5
ISO 10993-10	Same	None
Electrical safety	Meet the appropriate
requirements of the following
standards:
IEC 60601-1
IEC 60601-2-37
IEC 60601-1-1
IEC 60601-1-2	Same	None
Radiation safety	Comply with IEC 60601-2-37	Same	None
Software core
function	By coordinating the buttons,
soft keys and trackball of the
control panel: Acoustic
output power, focus, depth,
THI, probe operating
frequency (soft-frequency)	Through the touch panel:
Acoustic output power, focus,
depth, THI, probe operating
frequency, color ROI size, color
ROI position, sample packet
size, line density, color sampling	No new function
Comparison item	Predicate Device
CX50 and Sparq Diagnostic	Submission Device
InnoSight Diagnostic Doppler	Difference
	Ultrasound Systems	Ultrasound
	K162329	Pending
	color ROI size, color ROI
setting, sample package size
(soft-pack), line density
(soft-density), color sampling
Scale, pulse repetition
frequency, spectral ROI size
(soft-gate), spectral ROI
position (trackball), spectral
sampling size, the system
can change the above
imaging parameters. By
adjusting these parameters,
the user can change the
sound field devices.	size, pulse repetition frequency,
spectral ROI size, spectral ROI
position, spectral sampling size
The system can change the
above imaging parameters. By
adjusting these parameters, the
user can change the sound field
devices.
Applicable people	Adult, pediatric	Adult, pediatric	No difference
Applicable part	Fetus, Abdomen, Small
organs (Thyroid, Scrotum,
Thyroid, Prostate and
Breast), Other (Gynecology),
Adult heart, Peripheral blood
vessels, Pediatrics,
Musculoskeletal
(Conventional),
Musculoskeletal
(Superficial), Other
(Gynecology), Rectum ,
Transvaginal, Esophageal
heart	Fetus, Abdomen, Small Organs
(Thyroid, Scrotum, Thyroid,
Prostate and Breast), Other
(Gynecology), Adult heart,
Peripheral blood vessels,
Musculoskeletal (Conventional),
Other (Gynecological), Rectal,
Transvaginal, Adult cephalic
vein	No new preset
Contact with the
human body	Contacting the body surface,
transthoracic	Contacting the body surface,
intraluminal	Less contact
parts
Comparison item	Predicate Device
CX50 and Sparq Diagnostic
Ultrasound Systems
K162329	Submission Device
InnoSight Diagnostic Doppler
Ultrasound
Pending	Difference
	intraluminal
Indication	Fetal imaging and other,
heart, peripheral vascular	Same	No difference
Applicable disease
stage and exten	Suitable for any stage and
degree of disease	Same	No difference
Use environment	All departments of the
hospital. Imaging Center,
Professional Clinic, Primary
and Secondary Care
Centers.	Same	No difference
Instructions	Philips color ultrasound
diagnostic system using
conventional methods	Same	No difference
Precautions and
warnings	Please refer to the user
manual	Same	No difference
Contraindications	No known contraindications	Not for ophthalmology
Sterilization/disinfection
on method	Non-sterile, routine
disinfection	Same	No difference

16

17

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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:

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

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),

20

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.

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.

Technological Characteristics:

| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler and
Triplex 2-D/CD/Pulsed Doppler image formats; Dual B and Color in real time |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of
Transducers | InnoSight Diagnostic Ultrasound System with
C6-2 Curved Linear Array 2-6MHz
L12-4 Linear Array 4-12MHz
S4-2 Phase Array 2-4MHz
C9-4v Micro Curved Linear Array 4-9MHz
C83B Micro Curved Linear Array 3-8MHz |
| Measurements | Distance; area; Volume; circumference; Heart Rate; calipers; velocity; PI, RI
Cardiac, OB/GYN and Vascular package. |
| Principle of
Operation | Applying high voltage burst to the Piezoelectric material in the transducer
and detect the reflected echo to construct the 2-D B-mode, Doppler color,
and Doppler spectrum image for diagnostic purpose. |
| Operating
Controls | 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 |
| Acoustic
Output | Conform to IEC60601-2-37 and AIUM UD2 requirements for all modes of all probes |

21

22

SAFETY CONSIDERATIONS:

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

| Recognition

Number	Regulations No./ Version	Recognition Standard
12-105	NEMA UD 2-2004 (R2009)	Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment Revision
3 (Radiology)
12-293	IEC 60601-2-37 Edition 2.1 2015	Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety
and essential performance of ultrasonic
medical diagnostic and monitoring
equipment
19-4	AAMI / ANSI
ES60601-1:2005/(R)2012 And
A1:2012,, C1:2009/(R)2012 And
A2:2010/(R)2012 (Consolidated
Text)	Medical Electrical Equipment - Part 1:
General Requirements For Basic Safety
And Essential Performance (lec
60601-1:2005, Mod). (General II (ES/EMC))
19-8	AAMI / ANSI / IEC
IEC 60601-1-2, Ed. 4.0	Medical Electrical Equipment - Part 1-2:
General Requirements For Basic Safety
And Essential Performance – Collateral
Standard: Electromagnetic Compatibility -
Requirements And Tests (Edition 4).
(General II (ES/EMC))
2-220	ISO 10993-1 Fourth Edition
2009-10-15	Biological Evaluation Of Medical Devices -
Part 1: Evaluation And Testing Within A
Risk Management Process [Including:
Technical Corrigendum 1 (2010)].
(Biocompatibility)
13-79	IEC 62304:2015	Medical device software – Software life
cycle processes

23

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

24

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.