(29 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound technology and software.
No
The device is described as a "diagnostic ultrasound system" and its intended use is for "diagnostic ultrasound imaging," which involves identifying medical conditions rather than treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging." Additionally, the "Device Description" characterizes it as a "diagnostic ultrasound system."
No
The device description explicitly states that the system includes transducers (C5-2 and L12-4), which are hardware components essential for acquiring ultrasound data. While it uses software on a COTS device, it is not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Philips Lumify Diagnostic Ultrasound System is used for diagnostic ultrasound imaging. This involves using sound waves to create images of internal structures within the body.
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging" and lists various anatomical sites within the body.
- Device Description: The description details the components of an ultrasound system, including transducers that are applied to the body.
The information provided consistently describes a device used for imaging inside the body, which is the opposite of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Philips Lumify 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 Urology Gynecological Cardiac Fetal Echo Small Organ Musculo-skeletal Peripheral Vessel Carotid
Lumify is intended for use in environments where bealthcare is provided by healthcare professionals, with the exception of home, ambulance, or air.
The Lumify 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, Urology, Gynecological, Cardiac Fetal, Small Organ, Muskulosketel (Conventional & Superficial), Peripheral Vessel, Carotid.
Lumify is intended for use in environments where healthcare is provided by healthcare professionals for the diagnosis of patients, with the exception of home, ambulance and air.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
Lumify with the L12-4 transducer is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Lumify supports wireless network connectivity to allow the user to export ultrasound images.
The Lumify Diagnostic Ultrasound System includes:
- A commercial off-the-shelf Android device (COTS)
- Philips ultrasound software running as an app on the off-the-shelf device
- The C5-2 Curved linear array USB transducer
- The L12-4 Linear array USB transducer
Lumify provides customers with a smaller, lower cost, and more easily leveraged ultrasound system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetric, Abdominal, Urology, Gynecological, Cardiac Fetal, Small Organ, Musculo-skeletal, Peripheral Vessel, Carotid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals for the diagnosis of patients, with the exception of home, ambulance and air.
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 tests which show 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 0 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 o
- Product Specifications 0
- Design Reviews O
- Verification and Validation 0
Summary of Clinical Tests:
Lumify introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Nuvis/ClearVue) 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.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
Philips Healthcare, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K152899
Trade/Device Name: Philips Lumify 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: October 21, 2015 Received: October 22, 2015
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.
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 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.
1
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/Resourcesfor You/Industry/default.htm. 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
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,
Robert Ochs
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K152899 Device Name
Philips Lumify Diagnostic Ultrasound System
Indications for Use (Describe)
Philips Lumify 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 Urology Gynecological Cardiac Fetal Echo Small Organ Musculo-skeletal Peripheral Vessel Carotid
Lumify is intended for use in environments where bealthcare is provided by healthcare professionals, with the exception of home, ambulance, or air.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Survices (201) 443-6740 E.F
3
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
510(k) Number:
Device name: Lumify 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 | P | P | P | |||||
| Abdominal | P | P | P | |||||
| Intraoperative | ||||||||
| (vascular/epicardial) | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (thyroid, | ||||||||
| scrotum, prostate, breast) | N | N | N | |||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Musculo-skel | ||||||||
| (conventional) | N | N | N | |||||
| Musculo-skel (superficial) | N | N | N | |||||
| Other (Urology) | P | P | P | |||||
| Other (Gynecology) | P | P | P | |||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Intracardiac) | ||||||||
| Other (Fetal Echo) | P | P | P | |||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | ||||
| Other (Carotid) | N | N | N |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
| Combined mode: B+Color |
|---|
| Previous submission: K133833 |
(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)
4
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 | ||||||||
| (Track I | ||||||||
| Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | ||||||||
| See below | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | P | P | P | |||||
| Abdominal | P | P | P | |||||
| Intraoperative | ||||||||
| (vascular/epicardial) | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (thyroid, | ||||||||
| 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) | P | P | P | |||||
| Other (Gynecology) | P | P | P | |||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Intracardiac) | ||||||||
| Other (Fetal Echo) | P | P | P | |||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Carotid) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
| Combined mode: B+Color |
|---|
| Previous submission: K133833 |
(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)
5
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
| 510(k) Number: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Device name: | L12-4 | |||||||
| 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 | ||||||||
| Imaging | ||||||||
| & Other | Fetal/Obstetric | |||||||
| Abdominal | N | N | N | |||||
| Intraoperative | ||||||||
| (vascular/epicardial) | ||||||||
| Intraoperative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (thyroid, | ||||||||
| scrotum, prostate, breast) | P | P | P | |||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Intra-luminal | ||||||||
| Musculo-skel | ||||||||
| (conventional) | P | P | P | |||||
| Musculo-skel (superficial) | P | P | P | |||||
| Other (Urology) | ||||||||
| Other (Gynecology) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Intracardiac) | ||||||||
| Other (Fetal Echo) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | ||||
| Other (Carotid) | P | P | P |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
| Combined mode: B+Color |
|---|
| Previous submission: (K120321) |
(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)
6
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability
Traditional 510(k) | Doc. ID: | 238367 |
|--------------------------|--------------------------------------------------------------|------------|-------------|
| | Lumify Diagnostic Ultrasound System | Revision: | A |
| | with the
L12-4 Transducer | Doc. date: | 2015 Sep 02 |
| | | Page: | 51 of 121 |
510(k) Summary of Safety and Effectiveness
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
- Submitter's name, address, telephone number, contact person
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: September 2, 2015
- 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: | Lumify | |
| Classification: | Class II | |
| 21 CFR Section | ||
| 892.1550 | ||
| 892.1560 | ||
| 892.1570 | Classification Name | |
| System, Imaging, Pulsed Doppler, Ultrasonic | ||
| System, Imaging, Pulsed Echo, Ultrasonic | ||
| Transducer, Ultrasonic, diagnostic | Product Code | |
| 90 IYN | ||
| 90 IYO | ||
| 90 ITX | ||
| 3) Substantially Equivalent Devices | ||
| Primary Predicate Device | ||
| Nuvis Diagnostic Ultrasound System K133833 01/17/2014 |
Reference Device ClearVue Diagnostic Ultrasound System K120321 02/17/2012
- Device Description
Lumify with the L12-4 transducer is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various
7
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability
Traditional 510(k)
Lumify Diagnostic Ultrasound System
with the
L12-4 Transducer | Doc. ID: | 238367 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------|-------------|
| | | Revision: | A |
| | | Doc. date: | 2015 Sep 02 |
| | | Page: | 52 of 121 |
modes of operation. Lumify supports wireless network connectivity to allow the user to export ultrasound images.
The Lumify Diagnostic Ultrasound System includes:
- o A commercial off-the-shelf Android device (COTS)
- o Philips ultrasound software running as an app on the off-the-shelf device
- o The C5-2 Curved linear array USB transducer
- o The L12-4 Linear array USB transducer
Eumify provides customers with a smaller, lower cost, and more easily leveraged ultrasound system.
5) Intended Use
The Lumify 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, Urology, Gynecological, Cardiac Fetal, Small Organ, Muskulosketel (Conventional & Superficial), Peripheral Vessel, Carotid.
Lumify is intended for use in environments where healthcare is provided by healthcare professionals for the diagnosis of patients, with the exception of home, ambulance and air.
5) Technological comparison to predicate devices
Lumify is a Track 3 system that employs the same fundamental scientific technology as that cleared with K133833. The primary difference between Lumify submitted as Nuvis (K133833) and Lumify submitted with this 510(k) is the addition of the L12-4 transducer (K120321). The additional Lumify indications for use were cleared with the Clear Vue L12-4 (K12032). The L12-4 is the same as the ClearVue L12-4 with equivalent indications for use, but with minor modifications including USB connectivity (same as the C5-2 K133833).
6) 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 tests which show compliance with the following standards:
- · IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance
8
| Philips Ultrasound, Inc. | Quality, Regulatory and Sustainability
Traditional 510(k)
Lumify Diagnostic Ultrasound System
with the
L12-4 Transducer | Doc. ID: | 238367 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------|-------------|
| | | Revision: | A |
| | | Doc. date: | 2015 Sep 02 |
| | | Page: | 53 of 121 |
- o 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 0 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 o
- Product Specifications 0
- Design Reviews O
- Verification and Validation 0
Summary of Clinical Tests
Lumify introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Nuvis/ClearVue) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.
7) Conclusions
Lumify is substantially equivalent to the predicates identified above.
Lumify is essentially the same as Nuvis (K133833) but with the L12-4 transducer (K120321) and additional indications.
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