Lumify Ultrasound System

• K Number: K162549
• Device Name: Lumify Ultrasound System
• Manufacturer: Philips Healthcare
• Date Cleared: 2016-10-03 ( 20 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

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.

Predicate Devices

K152899

Reference Devices

K153480

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a "software controlled, diagnostic ultrasound system" without mentioning any AI/ML capabilities.

Therapeutic

No
The device is explicitly stated to be for "diagnostic ultrasound imaging" and "fluid flow analysis," without any mention of therapeutic functions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "Philips Lumify Ultrasound System is intended for diagnostic ultrasound imaging." The "Device Description" also refers to it as a "diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes USB transducers (hardware components) in addition to the software and the COTS device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
• Device Function: The Philips Lumify Ultrasound System is used for diagnostic ultrasound imaging. This involves using sound waves to create images of internal body structures. It does not analyze samples taken from the body.
• Intended Use: The intended use clearly states "diagnostic ultrasound imaging" and "fluid flow analysis" of various anatomical sites within the body.
• Device Description: The description focuses on acquiring and displaying ultrasound data, not on analyzing biological samples.

Therefore, based on the provided information, the Philips Lumify Ultrasound System is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals / home and transport

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 of ultrasonic medical diagnostic and monitoring equipment
• ISO 10993: Biological evaluation of medical devices
• IEC 60601-1-11:2015: Medical Electrical Equipment Part 1-11: General 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 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.

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

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.

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

Not Found

Predicate Device(s)

K152899

Reference Device(s)

K153480

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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Indications for Use

510(k) Number (if known) K162549

Device Name Lumify Ultrasound System

Indications for Use (Describe)

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.

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)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	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
Fetal
Imaging
& 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
Peripheral
Vessel	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

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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	Color
Doppler	Combined
(Specify)
See below	Other*
(Specify)
(Track I
Only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P			P	P
	Abdominal	P	P			P	P
	Intraoperative
(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
Fetal
Imaging
& 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
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: K152899, K153480

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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	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)
Peripheral
Vessel	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

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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 | | | | | | Other*
(Specify) |
|------------------------------|-----------------------------------------------------|-------------------|---|-----|-----|------------------|------------------------------------|---------------------|
| General
(Track I
Only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)
See below | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetric | P | P | | | P | P | |
| | Abdominal | P | P | | | P | P | |
| | Intraoperative
(vascular/epicardial) | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal
Imaging
& 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) | | | | | | | |
| 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: (predicate K153480)

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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

1. Submitter's name, address, telephone number, contact person

Penny Greco Philips Healthcare, Inc. Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810-6302 Tel: [phone] Fax [phone]

Date prepared: September 7, 2016

2. 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 Devices
Primary Predicate Device
Lumify Ultrasound System	K152899	10/30/2015

4) Device Description

Reference Device

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.

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

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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.

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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