Philips Lumify Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B + Color), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:

Fetal/Obstetric. Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac.

Lumify is a transportable ultrasound system intended for use in environments where is provided by healthcare professionals.

Device Description

The Lumify Ultrasound System with the S4-1 transducer and new intended use environments 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 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 array USB transducer
The L12-4 Linear array USB transducer
The S4-1 Sector array USB transducer

The Lumify Ultrasound System provides customers with a smaller, lower cost, and more easily leveraged ultrasound system.

AI/ML Overview

The provided text focuses on regulatory approval (510(k) clearance) for a medical device, the Philips Lumify Ultrasound System. It primarily outlines the device's intended use, technological comparison to predicate devices, and compliance with various safety and performance standards. However, it does not contain information about specific acceptance criteria for a study, reported device performance metrics against those criteria, or details of a study designed to prove the device meets such criteria.

The document explicitly states: "The Lumify Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Lumify/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." This indicates that a de novo study with specific acceptance criteria and detailed performance metrics to prove device effectiveness was not conducted for the 510(k) clearance. Instead, the clearance relies on demonstrating substantial equivalence to already cleared predicate devices.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The information that can be extracted relates to the device's intended use and the regulatory process:

1. A table of acceptance criteria and the reported device performance:
* Not provided in the document. The document states that clinical testing was not required as the device introduces no new indications, modes, features, or technologies that haven't been accepted with predicate devices.

2. Sample size used for the test set and the data provenance:
* Not provided in the document. As clinical testing was not deemed necessary for this 510(k) submission, there is no mention of a test set sample size or data provenance from such a study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not provided in the document. No information about experts or ground truth establishment for a test set is included.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not provided in the document.

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:
* Not provided in the document. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and no MRMC studies are mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable/Not provided in the document. The device is a diagnostic ultrasound system that is operated by healthcare professionals, not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not provided in the document.

8. The sample size for the training set:
* Not applicable/Not provided in the document. The documentation indicates that clinical testing was not required. The device's substantial equivalence relies on established medical device technologies and predicates, rather than a new algorithm requiring a training set in the context of this submission.

9. How the ground truth for the training set was established:
* Not applicable/Not provided in the document. As above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a symbol of three stylized human profiles. The profiles are stacked on top of each other, creating a sense of unity and collaboration. The seal is black and white.

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

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

October 5, 2016

Re: K162549

Trade/Device Name: Lumify Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 10, 2016 Received: September 13, 2016

Dear Mr. Job:

This letter corrects our substantially equivalent letter of 10/3/2016.

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

{1}------------------------------------------------

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/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 vours.

Jeff Bollyea
FDA

for 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}------------------------------------------------

Indications for Use

510(k) Number (if known) K162549

Device Name Lumify Ultrasound System

Indications for Use (Describe)

Fetal/Obstetric. Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac.

Lumify is a transportable ultrasound system intended for use in environments where is provided by healthcare professionals.

Type of Use (Select one or both, as applicable)

2 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)

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 PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

510(k) Number:

Device name: Lumify 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	P	N			P	P
	Abdominal	P	N			P	P
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	N	N			N	N
	Small Organ (thyroid,scrotum, prostate, breast)	P	N			P	P
	Neonatal Cephalic	N	N			N	N
	Adult Cephalic	N	N			N	N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel(conventional)	P	N			P	P
	Musculo-skel (superficial)	P	N			P	P
	Other (Urology)	P	N			P	P
	Other (Gynecology	P	N			P	P
Cardiac	Cardiac Adult	N	N
	Cardiac Pediatric	N	N
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal Echo)	P	N			P	P
PeripheralVessel	Peripheral vessel	P	N			P	P
	Other (Carotid)	P	N			P	P

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Combined mode: B+Color
Previous submission: K152899, K153480

(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

{4}------------------------------------------------

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	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
(Track IOnly)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P			P	P
	Abdominal	P	P			P	P
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P			P	P
	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	P
	Other (Gynecology)	P	P			P	P
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal Echo)	P	P			P	P
PeripheralVessel	Peripheral vessel
	Other (Carotid)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Combined mode: B+Color
Previous submission: K152899, K153480

(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

{5}------------------------------------------------

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 IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal/Obstetric
	Abdominal	P	P			P	P
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P			P	P
	Small Organ (thyroid,scrotum, prostate, breast)	P	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	P
	Musculo-skel (superficial)	P	P			P	P
	Other (Urology)
	Other (Gynecology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	P			P	P
	Other (Carotid)	P	P			P	P

Device name: L12-4

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Combined mode: B+Color
Previous submission: K152899, K153480

(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

{6}------------------------------------------------

510(k) Number:

Device name: S4-1

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
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P			P	P
	Abdominal	P	P			P	P
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P			P	P
	Small Organ (thyroid,scrotum, prostate, breast)
	Neonatal Cephalic	P	P			P	P
	Adult Cephalic	P	P			P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel(conventional)
	Musculo-skel (superficial)
	Other (Urology)
	Other (Gynecology)	P	P			P	P
Cardiac	Cardiac Adult	P	P			P	P
	Cardiac Pediatric	P	P			P	P
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel
	Other (Carotid)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Combined mode: B+Color
Previous submission: (predicate K153480)

(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

{7}------------------------------------------------

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 7, 2016

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 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
3) Substantially Equivalent DevicesPrimary Predicate DeviceLumify Ultrasound System	K152899	10/30/2015

4) Device Description

Reference Device

12/16/2015

The Lumify Ultrasound System includes:

ClearVue Ultrasound System

A commercial off-the-shelf Android device (COTS) o
Philips ultrasound software running as an app on the off-the-shelf device O

K153480

The C5-2 Curved array USB transducer O
The L12-4 Linear array USB transducer O
The S4-1 Sector array USB transducer O

{8}------------------------------------------------

The Lumify Ultrasound System provides customers with a smaller, lower cost, and more easily leveraged ultrasound system.

5) Intended Use

The Lumify Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, the Combined Mode (B+Color) and M-Mode. The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, and Cardiac.

The Lumify Ultrasound System is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

5) Technological comparison to predicate devices

The Lumify Ultrasound System is a Track 3 system that employs the same fundamental scientific technology as that cleared with K152899. The primary difference between Lumify submitted in K152899 is the addition of the S4-1 (K153480) transducer for the cardiac indication, the additional M mode, pediatric indication, and the new use environments: home and transport for use by healthcare professionals. The additional Lumify indications for use and mode of operation were cleared with the Philips ClearVue S4-1 (K153480).

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 o and essential performance
IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for o Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-2-37: Medical electrical equipment. Particular requirements for the safety O of ultrasonic medical diagnostic and monitoring equipment
ISO 10993: Biological evaluation of medical devices o
IEC 60601-1-11:2015: Medical Electrical Equipment Part 1-11: General o Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
IEC 60601-1-12:2015: Medical Electrical Equipment Part 1-12: General o Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.

{9}------------------------------------------------

Quality assurance measures 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 Lumify Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Lumify/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

The Lumify Ultrasound System is substantially equivalent to the predicates identified above.

The Lumify Ultrasound System is essentially the same as the Lumify Ultrasound System (K152899) but with the S4-1 transducer (K153480), additional indications, mode of operation, and new intended use environments.

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

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.