Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ultrasound functionalities and image processing, not AI/ML-driven features.

Therapeutic

No
Explanation: The device is described as a "Diagnostic Ultrasound system" and its intended use is for "diagnostic ultrasound imaging" and "fluid flow analysis," indicating its purpose is for diagnosis, not therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Philips VISIQ Diagnostic Ultrasound system is intended for diagnostic ultrasound imaging" and "The system is indicated for diagnostic ultrasound imaging and fluid flow analysis". Additionally, the "Device Description" mentions its function is to acquire ultrasound data and display it in various modes of operation.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes an off-the-shelf tablet enclosed within a Philips Ultrasound enclosure and can be used with a USB transducer. These are hardware components, not just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Philips VISIQ Diagnostic Ultrasound system is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the system is for diagnostic ultrasound imaging and fluid flow analysis. This involves using ultrasound waves to create images of internal body structures and assess blood flow.
Device Description: The description focuses on the hardware (tablet, enclosure, transducer) and software used to acquire and display ultrasound data.
Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis. The VISIQ system operates in vivo (within the body) by applying ultrasound to the patient.
Anatomical Sites: The listed anatomical sites are all internal body parts that are imaged directly.
Performance Studies: The summary of performance studies mentions the clinical safety and effectiveness of ultrasound systems, which is consistent with imaging devices, not IVDs.

In summary, the Philips VISIQ Diagnostic Ultrasound system is a medical imaging device that uses ultrasound technology to visualize internal structures and fluid flow within the body. This is distinct from the function of an IVD device, which analyzes specimens outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The VISIQ Ultrasound system is a general purpose, extremely portable, light weight ultrasound system that utilize Pioneer technology in USB probes, intended for use by customers in various clinical settings (private offices, clinics, small hospitals, large hospitals, primary and community healthcare centers) by different users (General Practitioners, Paraprofessionals, physician specialists including OBG's, Ultrasound Lab physicians, and nurse practitioners, etc., The System is intended for diagnostic ultrasound imaging in the following modes: 2D Auto Scan, M-mode, Pulse Wave Doppler, Color Doppler, Tissue Harmonics & iSCAN.

The system is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications, as listed in FDA's Diagnostic Ultrasound Indications for Use Form section 1.3 which includes Fetal/Obstetric, Abdominal, Small Organ (prostate) and Gynecological.

Philips VISIQ Diagnostic Ultrasound system is intended for diagnostic ultrasound imaging in 2D Auto Scan, Mmode, Pulse Wave Doppler, Color Doppler, Tissue Harmonics & iSCAN.

The system is indicated for diagnostic ultrasound imaging and fluid flow analysis and supports the following Indications for Use: Abdominal, Cardiac other (Fetal), Fetal/Obstetric, Gynecological, and Small Organ (Prostate).

The clinical environments where the VISIQ Diagnostic Ultrasound system can be used include large/small hospitals, clinical and medical office settings, and primary and community healthcare centers for the diagnosis of patients.

Product codes (comma separated list FDA assigned to the subject device)

90 IYN, 90 IYO, 90 ITX

Device Description

VISIO is a new general imaging ultrasound system from Philips Ultrasound. VISIO provides ultrasound capabilities in a portable, lightweight, affordable system. Its function is to acquire ultrasound data and to display the data in various modes of operation. VISIQ supports wireless network connectivity to allow the user to export ultrasound images.

The VISIQ system includes an off-the shelf tablet enclosed within a Philips Ultrasound enclosure. The system contains Philips software featuring a closed Operating System. The system can be used with the C5-2 Curved Linear Array USB Transducer.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

Anatomical Site

Fetal/Obstetric, Abdominal, Small Organ (prostate), Gynecological, Cardiac (Fetal)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Customers in various clinical settings (private offices, clinics, small hospitals, large hospitals, primary and community healthcare centers) by different users (General Practitioners, Paraprofessionals, physician specialists including OBG's, Ultrasound Lab physicians, and nurse practitioners, etc.

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 tests relied on in the premarket notification submission for a determination of substantial equivalence includes testing showing compliance with the following standards:

IEC60601-1: Medical electrical equipment. General requirements for . basic safety and essential performance
IEC60601-1-2: Medical electrical equipment - Part 1-2: General . requirements for Safety - Collateral standard: Electromagnetic Compatibility Requirements and Tests
IEC60601-2-37: Medical electrical equipment. Particular requirements . for the safety of ultrasound medical diagnostic and monitoring equipment.
ISO 10993: Biological evaluation of medical devices. .

Quality assurance measure applied to the system design and development include, but were not limited to:

Risk Analysis .
Product Specifications .
Design Reviews .
Verification and Validation .

The first release of VISIQ introduces no new indications for use, modes, features, or technologies relative to the predicate devices that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K133833, K120321

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

K141369
Page 1 of 4

JUL 0 2 2014

Summary of Safety and Effectiveness

Submitter's name, address, telephone number, contact person: Saraswathi Deora Senior Manager, Quality and Regulatory Saraswathi.Deora@philips.com On Behalf of: Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA 98021-8431

This summary was prepared on 1st April, 2014.

Name of the device including the trade or proprietary name if applicable the common or usual name, and the classification name, if knows:

Diagnostic ultrasound system and transducers Common/Usual Name:

Proprietary Name:

VISIQ Diagnostic Ultrasound System

Classification:

Class II

| 21 CFR Section | Classification Name | Product
Code |
|----------------|------------------------------------------------|-----------------|
| 892.1550 | System, Imaging, Pulsed Doppler,
Ultrasonic | 90 IYN |
| 892.1560 | System, Imaging, Pulsed Echo,
Ultrasonic | 90 IYO |
| 892.1570 | Transducer, Ultrasonic, Diagnostic | 90 ITX |

Substantially Equivalent Devices:

Device Name	510(k)
Philips Nuvis Diagnostic Ultrasound System	K133833
Philips ClearVue Diagnostic Ultrasound System	K120321

1. Device Description:
  VISIO is a new general imaging ultrasound system from Philips Ultrasound. VISIO provides ultrasound capabilities in a portable, lightweight, affordable system. Its function is to acquire ultrasound data and to display the data in various modes of operation. VISIQ supports wireless network connectivity to allow the user to export ultrasound images.

1

The VISIQ system includes an off-the shelf tablet enclosed within a Philips Ultrasound enclosure. The system contains Philips software featuring a closed Operating System. The system can be used with the C5-2 Curved Linear Array USB Transducer.

1. Intended Use:
  The VISIQ Ultrasound system is a general purpose, extremely portable, light weight ultrasound system that utilize Pioneer technology in USB probes, intended for use by customers in various clinical settings (private offices, clinics, small hospitals, large hospitals, primary and community healthcare centers) by different users (General Practitioners, Paraprofessionals, physician specialists including OBG's, Ultrasound Lab physicians, and nurse practitioners, etc., The System is intended for diagnostic ultrasound imaging in the following modes: 2D Auto Scan, M-mode, Pulse Wave Doppler, Color Doppler, Tissue Harmonics & iSCAN.

The system is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications, as listed in FDA's Diagnostic Ultrasound Indications for Use Form section 1.3 which includes Fetal/Obstetric, Abdominal, Small Organ (prostate) and Gynecological.

6) Technological comparison to predicate devices

| Feature | VISQ | ClearVue350/550
(K120321) | Nuvis (K133833) |
|-----------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Intended
Use | Diagnostic
ultrasound imaging
or fluid flow analysis
of the human body as
follows | Diagnostic ultrasound
imaging or fluid flow
analysis of the human body
as follows | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body as follows |
| Indication
for Use | - | - | - |
| | Fetal/Obstetric | Fetal/Obstetric | Fetal/Obstetric |
| | Abdominal | Abdominal | Abdominal |
| | - | Pediatric | - |
| | Small Organ
(prostate) | Small Organ (prostate) | - |
| | - | Neonatal Cephalic | - |
| | - | Adult Cephalic | - |
| | - | Trans-rectal | - |
| | - | Trans-vaginal | - |
| | - | Musculo-skel
(conventional) | - |
| | - | Musculo-skel (superficial) | - |
| | Other | Other (Gynecological) | Other (Gynecological) |

Technological Characteristics

2

	(Gynecological)
		Cardiac Adult
		Cardiac Pediatric
		Trans-esoph. (Cardiac)
	Other (Fetal)	Other (Fetal)	Other (Fetal)
		Peripheral vessel
		Other (Carotid)
			Other(Urology)
Transducer
Types	The C5-2 Curved
linear array USB
transducer	S4-1 Sector Array
C5-2 Curved Array
C9-4v Curved Array
L12-4 Broadband Sector
Linear Array	The C5-2 Curved linear
array USB transducer
Transducer
Frequency	1-6Mhz	1-12Mhz	1-6Mhz
Modes of
Operation	2D Auto Scan, M-
mode, Pulse Wave
Doppler, Color
Doppler, Tissue
Harmonics &
iSCAN.	B (or 2-D), M-mode
(including Anatomical M-
mode), Pulse Wave
Doppler, Continuous Wave
Doppler, Color Doppler,
Tissue Harmonics, iSCAN,
X-Res, angio, 3D
(freehand), and SonoCT.	B (or 2-D(, Color
Doppler, and the
Combined Mode
(B+Color)
PW
Doppler	Available	Available	Available
CW
Doppler	Available	Available	Available
Patient
contact
materials	Acrylonitrile
butadiene styrene
Silicone Rubber
PVC - Flexible	Acrylonitrile butadiene
styrene
Silicone Rubber
PVC - Flexible	Acrylonitrile
butadiene styrene
Silicone Rubber
PVC - Flexible
510(k)
Track	Track 3	Track 3	Track 3
Regulatory
Class	Class II	Class II	Class II

7) Determination of Substantial Equivalence

Non-Clinical Performance Data:

Non-clinical tests relied on in the premarket notification submission for a determination of substantial equivalence includes testing showing compliance with the following standards:

IEC60601-1: Medical electrical equipment. General requirements for . basic safety and essential performance
IEC60601-1-2: Medical electrical equipment - Part 1-2: General . requirements for Safety - Collateral standard: Electromagnetic Compatibility Requirements and Tests

3

K141369
Page 4 of 4

IEC60601-2-37: Medical electrical equipment. Particular requirements . for the safety of ultrasound medical diagnostic and monitoring equipment.
ISO 10993: Biological evaluation of medical devices. .

Quality assurance measure applied to the system design and development include, but were not limited to:

Risk Analysis .
Product Specifications .
Design Reviews .
Verification and Validation .

Summary of Clinical Tests:

The first release of VISIQ introduces no new indications for use, modes, features, or technologies relative to the predicate devices that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.

8) Conclusions

VISIQ is substantially equivalent to the predicates identified above.

VISIQ and Nuvis use commercial off the shelf devices (COTS) .
Both the predicates, ClearVue and Nuvis have the same gray-scale and . Doppler capabilities as VISIQ.
Both the predicates. ClearVue and Nuvis use essentially the same . technologies for imaging, Doppler functions and signal processing as VISIQ.
Both the predicates, ClearVue and Nuvis have acoustic output levels . below the track 3 FDA limits, which is the same for VISIQ.
Both the predicates, ClearVue and Nuvis are manufactured of materials . with equivalent biosafety as VISIO. The materials have been evaluated and found to be safe for this application.
Both the predicates. ClearVue and Nuvis are designed and manufactured . to the same electrical and physical safety standards as VISIQ.

514 Performance Standards

There are no Sec.514 performance standards for this device

Prescription Status

This is a prescription device. The prescription device statement appears in the labeling,

Sterilization Site

Not Applicable. No components supplied sterile.

Track

This is a Track 3 System

4

Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 2, 2014

Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K141369

Trade/Device Name: VISIQ Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN. IYO, ITX Dated: June 10. 2014 Received: June 11, 2014

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the VISIQ Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

C5-2

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

5

Page 2-Mr. Job

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

6

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

Indications for Use

510(k) Number (if known)

K141369

Device Name

VISIQ Diagnostic Ultrasound System Indications for Use (Describe)

Philips VISIQ Diagnostic Ultrasound system is intended for diagnostic ultrasound imaging in 2D Auto Scan, Mmode, Pulse Wave Doppler, Color Doppler, Tissue Harmonics & iSCAN.

The system is indicated for diagnostic ultrasound imaging and fluid flow analysis and supports the following Indications for Use: Abdominal, Cardiac other (Fetal), Fetal/Obstetric, Gynecological, and Small Organ (Prostate).

The clinical environments where the VISIQ Diagnostic Ultrasound system can be used include large/small hospitals, clinical and medical office settings, and primary and community healthcare centers for the diagnosis of patients.

Type of Use (Select one or both, as applicable)	X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

C Publishing Services (301) 441-4740

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

7

510(k) Number:

Device name: VISIQ Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)
See below	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	N	N	N		N	N	N(1-4)
	Abdominal	N	N	N		N	N	N(1-4)
	Intra-operative
(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	Small Organ (prostate)	N	N	N		N	N	N(1-4)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel
(conventional)
	Musculo-skel
(superficial)
	Other (Gynecological)	N	N	N		N	N	N(1-4)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Fetal)	N	N	N		N	N	N(1-4)
Peripheral	Peripheral vessel
Vessel	Other (Carotid)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: 1. Tissue Harmonics, 2. iSCAN, 3. AutoScan, 4. X-Res
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD,
Previous submission:
none

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (1 BE/102 DO NOT THE OF Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

8

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number: Device name: C5-2 transducer used with VISIQ Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or Nuid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)
See below	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	N	N	N		N	N	N(1-4)
	Abdominal	N	N	N		N	N	N(1-4)
	Intra-operative
(vascular/epicardial)
Fetal
Imaging
& Other	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ ( prostate,)	N	N	N		N	N	N(1-4)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-
Card.)
	Intra-luminal
	Musculo-skel
(conventional)
	Musculo-skel
(superficial)
	Other (Gynecological)	N	N	N		N	N	N(1-4)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Fetal)	N	N	N		N	N	N(1-4)
Peripheral
Vessel	Peripheral vessel
	Other (specify)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
*Other modes: 1. Tissue Harmonics, 2. iSCAN, 3. AutoScan, 4. X-Res
Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD
Previous submission:	none

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

FORM FDA 3881 (9/13)

Page 3 of 3

PSC Publishing Scritocs (30) ) 44 1-4 740