(31 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the technology as essentially the same as predicate devices without mentioning AI/ML.
No
The device is explicitly stated to be a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging" and "fluid flow analysis" for the "diagnosis of patients." It collects and displays ultrasound data but does not provide any therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Nuvis Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging..." and "The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications...".
No
The device description explicitly states that the Nuvis system includes a commercial off-the-shelf Android tablet and a USB transducer, which are hardware components. While the software is a key part of the system, it is not the sole component.
Based on the provided information, the Nuvis Diagnostic Ultrasound System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Nuvis system is used for diagnostic ultrasound imaging directly on the patient's body (Fetal/Obstetric, Abdominal, Urology, Gynecology, Cardiac Fetal). It acquires ultrasound data and displays it, it does not analyze samples like blood, urine, or tissue.
- The intended use clearly states "diagnostic ultrasound imaging" and "fluid flow analysis" within the patient's body.
- The device description focuses on acquiring and displaying ultrasound data from the patient.
- The clinical environments are where patients are diagnosed directly.
Therefore, the Nuvis Diagnostic Ultrasound System falls under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / Indications for Use
The Nuvis Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, and the Combined Mode (B+Color). The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Other-Urology, Other-Gynecology, and Other-Cardiac Fetal.
The clinical environments where Nuvis can be used include hospital, clinic, and medical office settings for the diagnosis of patients.
Product codes (comma separated list FDA assigned to the subject device)
90 IYN, 90 IYO, 90 ITX
Device Description
The Nuvis Diagnostic Ultrasound systems is a mobile, general purpose, software The Navis Diagnostic Ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Nuvis supports wireless network connectivity to allow the user to export (non-DICOM) ultrasound images.
The Nuvis system includes:
- A commercial off-the-shelf Android tablet (COTS). O
- Nuvis software running as an app on the off-the-shelf tablet 0
- The C5-2 Curved linear array USB transducer ಂ
The Nuvis mobile system provides customers with a smaller, lower cost, and more easily leveraged ultrasound system.
Mentions image processing
Nuvis uses essentially the same technologies for imaging, Doppler functions and signal processing as the predicates Clear Vue and EPIQ.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound imaging
Anatomical Site
Fetal/Obstetric, Abdominal, Other-Urology, Other-Gynecology, Other-Cardiac Fetal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The clinical environments where Nuvis can be used include hospital, clinic, and medical office settings for the diagnosis of patients.
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 this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:
- IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
- ISO 10993: Biological evaluation of medical devices.
Quality assurance measures applied to the system design and development include, but were not limited to:
- Rick Analysis .
- Product Specifications .
- Design Reviews .
- . Verification and Validation
The first release of Nuvis 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.
K120321, K132304, K070907, K102153
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
§ 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.
0
This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E, Section 807.92
1 ) Submitter's name, address, telephone number, contact person
JAN 1 7 2014
Penny Greco Philips Healthcare, Inc. Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810-6302 Tel: (978) 659-4615 Fax (978) 975-7324
Date prepared: December 10, 2012
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/Usual Name: Diagnostic ultrasound system and transducers
Proprietary Name: Classification:
Nuvis Diagnostic Ultrasound System 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 |
3) Substantially Equivalent Devices
| Philips Healthcare ClearVue Diagnostic Ultrasound System | K120321 |
|---|---|
| Philips EPIQ C5-1 Transducer | K132304 |
| Interson USB Ultrasound Probe System | K070907 |
| Mobisante MobiUS | K102153 |
4) Device Description
The Nuvis Diagnostic Ultrasound systems is a mobile, general purpose, software The Navis Diagnostic Ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Nuvis supports wireless network connectivity to allow the user to export (non-DICOM) ultrasound images.
The Nuvis system includes:
- A commercial off-the-shelf Android tablet (COTS) . O
- Nuvis software running as an app on the off-the-shelf tablet 0
- The C5-2 Curved linear array USB transducer ಂ
1 of 4
1
The Nuvis mobile system provides customers with a smaller, lower cost, and more easily leveraged ultrasound system.
5) Intended Use
The Nuvis Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, and the Combined Mode (B+Color). The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Other-Urology, Other-Gynecology, and Other-Cardiac Fetal.
The clinical environments where Nuvis can be used include hospital, clinic, and medical office settings for the diagnosis of patients.
6) Technological comparison to predicate devices
Philips ClearVue (K120321) and Nuvis are Track 3 systems that employ the same fundamental scientific technology. Nuvis leverages the common software platform used with other Philips ultrasound systems, including ClearVue.
The Nuvis C5-2 transducer is the same as the ClearVue C5-2 transducer, but with minor modifications including USB connectivity, which is similar to the Interson USB ultrasound transducers. The Nuvis C5-2 transducer has equivalent indications to the ClearVue C5-2 and EPIQ C5-1 transducers.
While the predicate, ClearVue, is a standard ultrasound system, Nuvis is a mobile system that runs on a commercial off the shelf tablet (COTS), similar to Interson USB and Mobisante MobiUS that run on commercially available devices.
Philips Nuvis is substantially equivalent to a the Mobisante MobiUS (K102153). Similar to the Mobisante MobiUS, the first release of Nuvis was tested for connection to a host computer. In the case of Nuvis the connection is to an Android tablet.
Similar to the Mobisante MobiUS (SP1), the Nuvis was verified with a commercial offshelf computer/tablet. The Nuvis Android display is 7 inches, which is similar to, but larger than the Mobisante MobiUS SP1 display of 4.1 inches. Both the Mobisante system and Nuvis are battery operated, have WiFi technology and utilize USB connectivity for the ultrasound transducers. Both the MobiUS SP1 and Nuvis have up to 32 GB of internal storage. Nuvis has a display 1280 x 800 compared to the smaller MobiUS SP1 which is 800 x 480.
2
7) Determination of Substantial Equivalence
Non-clinical performance data
Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:
-
IEC 60601-1: Medical electrical equipment. General requirements for basic o safety
and essential performance -
IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General o
-
Requirements for Safety Collateral standard: Electromagnetic Compatibility - Requirements and Tests
-
IEC 60601-2-37: Medical electrical equipment. Particular requirements for the o safety of ultrasonic medical diagnostic and monitoring equipment
-
ISO 10993: Biological evaluation of medical devices. o
Quality assurance measures applied to the system design and development include, but were not limited to:
- Rick Analysis .
- Product Specifications .
- Design Reviews .
- . Verification and Validation
Summary of Clinical Tests
The first release of Nuvis 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
Nuvis is substantially equivalent to the predicates identified above.
- Nuvis uses commercial off-the-shelf devices (COTS) similar to the predicates o Interson USB and Mobisante MobiUS.
- 0 Nuvis is indicated for the diagnostic ultrasonic imaging and fluid flow analysis similar to the predicates.
- Nuvis has the same gray-scale and Doppler capabilities as the predicates o ClearVue and EPIQ.
- o Nuvis uses essentially the same technologies for imaging, Doppler functions and signal processing as the predicates Clear Vue and EPIQ.
- Nuvis has acoustic output levels below the Track 3 FDA limits the same as the ্ত predicates, ClearVue and EPIQ.
- Nuvis is manufactured under the same quality system as the predicates o Clear Vue and EPIQ.
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3
K133833
Page 4 of 4
- Both the predicate, ClearVue, and Nuvis are manufactured of materials with O equivalent biosafety. The materials have been evaluated and found to be safe for this application.
- Nuvis is designed and manufactured to the same electrical and physical safety o standards as the predicates, ClearVue and EPIQ.
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(s)
Not applicable. No components supplied sterile.
Track
This is a Track 3 system
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2014
Philips Ultrasound, Inc. % Mr. Mark Job Third Party Official Regulatory Technology Services, LLC 1394 25TH Street NW BUFFALO MN 55313
Re: K133833
Trade/Device Name: Nuvis 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: November 11, 2013 Received: December 17, 2013
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 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. 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 Acuson Sc2000 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
CS-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.
5
Page 2-Mr. Job
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 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); 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/Reportal/roblem/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 Small Manufacturers, International and Consumer Assistance 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,
Sm.m.7)
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
Indications for Use
510(k) Number (if known) K133833
Device Name
Philips Nuvis Diagnostic Ultrasound System
Indications for Use (Describe)
Philips Nuvis Diagnostic Ultrasound system is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, and Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Fetal/Obstetric Abdominal Other (Urology) Other (Gynecology) Other Cardiac (Fetal Echo)
The clinical environments where the Nuvis Diagnostic Ultrasound system can be used include hospital, clinical and medical office settings 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)
Form Approved: OMB No 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
7
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
510(k) Number:
Device name: Nuvis Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | Other* |
| (Track I | (Tracks 1 & III) | D | D | Doppler | (Specify) | (Specify) | ||
| Only) | See below | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | N | N | N | |||||
| Abdominal | N | N | N | |||||
| Intraoperative | ||||||||
| (vascular/epicardial) | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | Pediatric | |||||||
| Imaging | Small Organ (thyroid, | |||||||
| & Other | scrotum, prostate, breast) | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Musculo-skel | ||||||||
| (conventional) | ||||||||
| Musculo-skel (superficial) | ||||||||
| Other (Urology) | N | N | N | |||||
| Other (Gynecology | א | N - | N | |||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Intracardiac) | ||||||||
| Other (Fetal Echo) | Z | N | N | |||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (Carotid) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
| Acres March All and States
4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-8-8-8-8-8-8-8-8-8-8-8-8-8-8-8-8-8-8-8-8-8-2- | 4 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1 | COMMON |
|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Acres of | | |
. |
|
.
1.6 ---------
- Bronne Battle Land
1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1
1
| -------- | |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
Prescription Use (Per 21 CFR 801.109)
8
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
| 510(k) Number: | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Device name: | C5-2 | ||||||||
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | Specific | B | M | PW | CW | Color | Combined | Other* | |
| (Track I | (Tracks I & III) | D | D | Doppler | (Specify) | (Specify) | |||
| Only) | See below | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetric | N | N | |||||||
| Abdominal | N | N | N | ||||||
| Intraoperative | |||||||||
| (vascular/epicardial) | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | ||||||||
| Imaging | Small Organ (thyroid, | ||||||||
| & Other | scrotum, prostate, breast) | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Intra-luminal | |||||||||
| Musculo-skel | |||||||||
| (conventional) | |||||||||
| Musculo-skel (superficial) | |||||||||
| Other (Urology) | N | N | N | ||||||
| Other (Gynecology) | N | N | N | ||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Other (Intracardiac) | |||||||||
| Other (Fetal Echo) | N | N | N | ||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Carotid) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
| -------
Combined mode: B+Color
. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
. | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Previous submission: | .
1 | |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
Prescription Use (Per 21 CFR 801.109)
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