(40 days)
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.
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.
The provided document is a 510(k) summary for the Philips VISIQ Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness criteria.
Therefore, the document does not contain specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for a new clinical study. The submission instead relies on a comparison of technological characteristics and the established safety and effectiveness of the predicate devices.
Here's how to address each point based on the provided text:
Acceptance Criteria and Study for Philips VISIQ Diagnostic Ultrasound System
1. Table of Acceptance Criteria and Reported Device Performance:
No specific, quantified acceptance criteria for performance are stated in the provided 510(k) summary for the VISIQ device. The submission asserts substantial equivalence based on technological characteristics and regulatory compliance, rather than new performance-based criteria.
| Acceptance Criteria Category | Reported Device Performance (as implied by substantial equivalence) |
|---|---|
| Safety | The device meets: - IEC60601-1 (Medical electrical equipment. General requirements for basic safety and essential performance) - IEC60601-1-2 (Electromagnetic Compatibility Requirements and Tests) - IEC60601-2-37 (Particular requirements for the safety of ultrasound medical diagnostic and monitoring equipment) - ISO 10993 (Biological evaluation of medical devices) - Acoustic output levels are below Track 3 FDA limits. - Materials have equivalent biosafety as predicates and are safe for application. - Designed and manufactured to the same electrical and physical safety standards as predicates. |
| Effectiveness | The device is considered substantially equivalent to predicate devices (Philips Nuvis K133833, Philips ClearVue K120321) in terms of its diagnostic ultrasound imaging and fluid flow analysis capabilities for the specified indications for use (Fetal/Obstetric, Abdominal, Small Organ (prostate), Gynecological). This is based on sharing similar gray-scale and Doppler capabilities, and essentially the same technologies for imaging, Doppler functions, and signal processing as the predicates. |
| Intended Use & Indications | The device's intended use and indications for use align with the predicate devices, specifying diagnostic ultrasound imaging and fluid flow analysis for Fetal/Obstetric, Abdominal, Small Organ (prostate) and Gynecological applications, across various clinical settings and users. |
| Technological Characteristics | The device's technological characteristics (transducer type, frequency, modes of operation, patient contact materials) are presented as comparable to, or within the range of, the predicate devices for the claimed indications. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This 510(k) submission does not describe a new clinical performance study requiring a test set of data samples. The determination of substantial equivalence relies on non-clinical testing for safety and technological comparison to predicate devices, which are already marketed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no new clinical study (test set) is described, there is no mention of experts establishing ground truth for such a set.
4. Adjudication method for the test set:
- Not applicable. No test set or clinical study requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document does not describe an MRMC study or any study involving AI assistance for human readers. This device is a general diagnostic ultrasound system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware and software system for image acquisition and display, not a standalone algorithm for diagnosis. Performance is evaluated through comparison to predicate devices and adherence to safety standards.
7. The type of ground truth used:
- Not applicable. Since no specific clinical performance study for the VISIQ device's diagnostic capabilities is detailed, the concept of "ground truth" for a new study is not relevant here. The "truth" for this submission is that the device features and performance are equivalent to predicate devices, which are already considered safe and effective for their intended uses. Clinical safety and effectiveness are "well accepted" for ultrasound systems with these characteristics.
8. The sample size for the training set:
- Not applicable. No machine learning or AI algorithm development and training is described for this device.
9. How the ground truth for the training set was established:
- Not applicable. No machine learning or AI algorithm development and training is described for this device, so no training set with associated ground truth was established by the submitter for this 510(k).
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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 | ProductCode |
|---|---|---|
| 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 |
-
- 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.
- Device Description:
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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.
-
- 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.
- Intended Use:
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) |
|---|---|---|---|
| IntendedUse | Diagnosticultrasound imagingor fluid flow analysisof the human body asfollows | Diagnostic ultrasoundimaging or fluid flowanalysis of the human bodyas follows | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody as follows |
| Indicationfor 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
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| (Gynecological) | |||
|---|---|---|---|
| Cardiac Adult | |||
| Cardiac Pediatric | |||
| Trans-esoph. (Cardiac) | |||
| Other (Fetal) | Other (Fetal) | Other (Fetal) | |
| Peripheral vessel | |||
| Other (Carotid) | |||
| Other(Urology) | |||
| TransducerTypes | The C5-2 Curvedlinear array USBtransducer | S4-1 Sector ArrayC5-2 Curved ArrayC9-4v Curved ArrayL12-4 Broadband SectorLinear Array | The C5-2 Curved lineararray USB transducer |
| TransducerFrequency | 1-6Mhz | 1-12Mhz | 1-6Mhz |
| Modes ofOperation | 2D Auto Scan, M-mode, Pulse WaveDoppler, ColorDoppler, TissueHarmonics &iSCAN. | B (or 2-D), M-mode(including Anatomical M-mode), Pulse WaveDoppler, Continuous WaveDoppler, Color Doppler,Tissue Harmonics, iSCAN,X-Res, angio, 3D(freehand), and SonoCT. | B (or 2-D(, ColorDoppler, and theCombined Mode(B+Color) |
| PWDoppler | Available | Available | Available |
| CWDoppler | Available | Available | Available |
| Patientcontactmaterials | Acrylonitrilebutadiene styreneSilicone RubberPVC - Flexible | Acrylonitrile butadienestyreneSilicone RubberPVC - Flexible | Acrylonitrilebutadiene styreneSilicone RubberPVC - Flexible |
| 510(k)Track | Track 3 | Track 3 | Track 3 |
| RegulatoryClass | 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
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K141369
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- 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
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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
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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
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| 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)
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
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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 IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | 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)
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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 IOnly) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | 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) | ||||||||
| FetalImaging& 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) | ||
| PeripheralVessel | 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
§ 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.