Lumify Diagnostic Ultrasound System

K242519 · Philips Ultrasound · IYN · May 15, 2025 · Radiology

Device Facts

• Record ID: K242519
• Device Name: Lumify Diagnostic Ultrasound System
• Applicant: Philips Ultrasound
• Product Code: IYN · Radiology
• Decision Date: May 15, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B(2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler, 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, Lung, Trans-vaginal. The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by appropriately trained healthcare professionals. The intended use of the product is to collect ultrasound image data that may be used by clinicians for diagnostic and procedural purposes. The product shall provide the ability for gathering clinically acceptable images and ultrasound data for the clinical presets and anatomies listed under the indications for use. This product is intended to be installed, used, and operated only in accordance with safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgement and best clinical procedure.

Device Story

Mobile, software-controlled ultrasound system; acquires high-resolution ultrasound data via USB-connected transducers (C9-4ec, C5-2, L12-4, S4-1). Operates on COTS iOS/Android mobile devices. Transforms acoustic signals into B-mode, Color Doppler, Pulsed Wave Doppler, and M-mode images. Includes Fertility Package for gynecological assessment; calculates endometrial thickness and mean follicle diameter (up to 15 follicles per ovary). Used by physicians/sonographers in clinical settings for diagnostic/procedural purposes. Output displayed on mobile screen; assists clinicians in evaluating fertility status, uterine/ovarian pathology, and follicular growth. Benefits include portable, high-resolution imaging for point-of-care diagnostics.

Clinical Evidence

Bench testing only. No clinical data required for substantial equivalence. Performance verified through requirements review, risk analysis, and design reviews against established standards (IEC 62304, IEC 60601-1, ISO 14971, ISO 10993-1).

Technological Characteristics

Mobile ultrasound system; COTS iOS/Android platform. Transducers: C9-4ec (endocavitary curved linear), C5-2, L12-4, S4-1. Modes: B, Color Doppler, PWD, M-mode. Connectivity: USB-C. Software: Lumify application. Standards: IEC 60601-1 (safety), IEC 60601-2-37 (ultrasound), IEC 62359 (field characterization), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung, and Trans-vaginal applications. Intended for use by appropriately trained healthcare professionals in clinical environments.

Regulatory Classification

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.

Predicate Devices

• Lumify Diagnostic Ultrasound System (K192226)

Reference Devices

• C9-4v Transducer with ClearVue Ultrasound System (K120321)
• C9-4v Transducer with Philips Affiniti Series Diagnostic Ultrasound System (K240850)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 15, 2025

Philips Ultrasound
Sudipta Chakrabarti
Principal Regulatory Affairs Specialist
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431

Re: K242519
Trade/Device Name: Lumify Diagnostic Ultrasound System
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: August 23, 2024
Received: April 16, 2025

Dear Sudipta Chakrabarti:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K242519 - Sudipta Chakrabarti
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K242519 - Sudipta Chakrabarti
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

**YANNA S. KANG -S**

Yanna Kang, Ph.D.
Assistant Director
Mammography and Ultrasound Team
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K242519 | |
| Device Name Lumify Diagnostic Ultrasound System | |
| Indications for Use (Describe) The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler (PWD), 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, Lung, Trans-vaginal. The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by appropriately trained healthcare professionals. | |
| 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 [e-mail] | |
| "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." | |

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TRADITIONAL 510(k) Summary
Philips Ultrasound
Lumify Diagnostic Ultrasound System with C9-4ec

510(k) Number: K242519

This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.

1. Submitter’s name, address, telephone number, contact person(s)

Manufacturer: Philips Ultrasound
22100 Bothell Everett Hwy
Bothell, WA 98021-8431

Contact Person: Sudipta Chakrabarti
Principal Regulatory Affairs Specialist
[e-mail]
Phone: [phone]

Secondary Contact: Amy Yang
Director Regulatory Affairs
[e-mail]

Date Prepared: May 13, 2025

2. Name of the device, including the trade of proprietary name if applicable, the common or usual name, and the classification name, if known:

Proprietary Name: Lumify Diagnostic Ultrasound System
Common Name: Diagnostic ultrasound system and transducers

Regulation Description:

| Classification Name | 21 CFR § | Product Code |
| --- | --- | --- |
| Primary | | |
| Ultrasonic pulsed doppler imaging system | 892.1550 | IYN |
| Secondary | | |
| Ultrasonic pulsed echo imaging system | 892.1560 | IYO |
| Diagnostic ultrasonic transducer | 892.1570 | ITX |

Device Class: Class II
Classification Panel: Radiology

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TRADITIONAL 510(k)

Philips Ultrasound

Lumify Diagnostic Ultrasound System with C9-4ec

# 3. Device Description Summary

The Philips Lumify Diagnostic Ultrasound System (Lumify) is a mobile, durable, and reusable, software-controlled medical device, which is intended to acquire high-resolution ultrasound data and to display the data in B mode (2D), Pulsed Wave Doppler, Color Doppler, Combined $(\mathrm{B} + \mathrm{Color})$ , and M modes. The Lumify system is compatible with iOS and Android operating systems.

The Lumify Diagnostic Ultrasound System (iOS) utilizes:

1. A commercial off-the-shelf (COTS) iOS mobile item (smart phone or tablet)
2. The Philips Ultrasound Lumify software running as a medical device application on the COTS device
3. The Philips C5-2 Curved array USB transducer
4. The Philips L12-4 Linear array USB transducer
5. The Philips S4-1 Sector array USB transducer
6. The Philips C9-4ec Curved linear array USB Transducer (subject of this submission)
7. Lumify Micro B Transducer Cable
8. Lumify Micro C Transducer Cable
9. Lumify USB-C to USB-C Transducer Cable
10. Lumify Power Module (LPM)
11. Lumify USB-C to Lightning LPM Cable

Figure 4-1: Hardware components of Lumify Diagnostic Ultrasound System.

The purpose of this traditional 510(k) submission is addition of C9-4ec Transducer and Fertility Package to Lumify Diagnostic Ultrasound System.

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# TRADITIONAL 510(k)

## Philips Ultrasound

## Lumify Diagnostic Ultrasound System with C9-4ec

The C9-4ec transducer is an Endo-cavitary (intravaginal) curved linear probe designed for obstetrical, gynecological and fertility application. C9-4ec transducer is indicated for the following clinical applications: Gynecological (previously cleared), Fetal/Obstetric (previously cleared), and Transvaginal (newly added as part of this 510(k) submission). The C9-4ec transducer is compatible with the Lumify iOS 5.1 version and will be added to Lumify Android 5.1 in the future.

The Fertility Package will allow a user to perform the required labeled measurements for the endometrial thickness and a two-distance measurement as well as the Mean/Average Diameter derived calculation of up to 15 follicles within each ovary. In addition, it will provide users a Summary Page that provides detailed measurements of each follicle as well as measurements of the endometrial thickness.

## 4. Indications for Use and Intended Use

There is no change to the intended use of the subject device due to this change. Trans-vaginal is a newly added clinical indication as part of this change, due to addition of C9-4ec transducer.

## 4.1 Indications for Use

The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B(2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler, 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, Lung, Trans-vaginal.

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

## 4.2 Intended Use

The intended use of the product is to collect ultrasound image data that may be used by clinicians for diagnostic and procedural purposes. The product shall provide the ability for gathering clinically acceptable images and ultrasound data for the clinical presets and anatomies listed under the indications for use.

This product is intended to be installed, used, and operated only in accordance with safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgement and best clinical procedure.

## 5. Substantially Equivalent Devices

**Predicate Device:** K192226, Philips Ultrasound – Lumify Diagnostic Ultrasound System

**Primary Reference Device:** K120321, C9-4v Transducer with ClearVue Ultrasound System

**Secondary Reference Device:** K240850, C9-4v Transducer with Philips Affiniti Series Diagnostic Ultrasound System (system)

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# TRADITIONAL 510(k)

## Philips Ultrasound

## Lumify Diagnostic Ultrasound System with C9-4ec

### 6. Technological Comparison to Predicate Devices

The following Table 6.1 provides an overview of the comparison between the subject device, predicate (Lumify Diagnostic Ultrasound System, K192226), primary reference device (C9-4v with ClearVue Ultrasound System, K120321), and secondary reference device (C9-4v with Affiniti Series Diagnostic Ultrasound System, K240850) devices.

| Feature /Characteristic | Lumify Diagnostic Ultrasound System K242519 (Subject Device) | Lumify Diagnostic Ultrasound System K192226 (Predicate Device) | C9-4v with ClearVue Ultrasound System K120321 (Primary Reference Device) | C9-4v with Affiniti Series Diagnostic Ultrasound System K240850 (Secondary Reference Device) | Comparison/Discussion/Comments |
| --- | --- | --- | --- | --- | --- |
| Regulation Number | 892.1550 | 892.1550 | 892.1550 | 892.1550 | Identical |
| Device Classification Name | Ultrasound pulsed doppler imaging system, Ultrasonic pulsed echo imaging system, Diagnostic ultrasonic transducer | Ultrasound pulsed doppler imaging system, Ultrasonic pulsed echo imaging system, Diagnostic ultrasonic transducer | Ultrasound pulsed doppler imaging system, Ultrasonic pulsed echo imaging system, Diagnostic ultrasonic transducer | Ultrasound pulsed doppler imaging system, Ultrasonic pulsed echo imaging system, Diagnostic ultrasonic transducer | Identical |
| Device Classification | II | II | II | II | Identical |
| Primary Product Code | IYN | IYN | IYN | IYN | Identical to predicate device |
| Secondary Product Codes | IYO, ITX | IYO, ITX | IYO, ITX | IYO, ITX | Identical to predicate device |
| Feature Trade Name | Fertility Package | Not applicable
This feature was not available with this version | Fertility calculation package | Fertility calculation package | Fertility count feature has been added under the Fertility preset for subject device with the newly added C9-4ec transducer. The Fertility Package is currently available with Affiniti Series Ultrasound System and ClearVue Ultrasound System. The version of |

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# TRADITIONAL 510(k)

# Philips Ultrasound

Lumify Diagnostic Ultrasound System with C9-4ec

| Feature /Characteristic | Lumify Diagnostic Ultrasound System K242519 (Subject Device) | Lumify Diagnostic Ultrasound System K192226 (Predicate Device) | C9-4v with ClearVue Ultrasound System K120321 (Primary Reference Device) | C9-4v with Affiniti Series Diagnostic Ultrasound System K240850 (Secondary Reference Device) | Comparison/Discussion/Comments |
| --- | --- | --- | --- | --- | --- |
| | | | | | this features will be available with the subject device is an expansion and enhancement of this Fertility measurement feature.
Main differences include:
The Lumify allows for a two distance diameter measurement vs a single distance diameter measurement offered on Affiniti and ClearVue
The Lumify offers a mean diameter based on two distance diameter performed for each follicle vs follicle volume calculated from one diameter distance for each follicle in on Affiniti and ClearVue.
The Lumify allows a maximum of up to 15 READILY LABELED follicles to be measured on each side of the ovary while the Affiniti only allows for a maximum of 10 READILY LABELED follicles on each side of the ovary and ClearVue allows 8 READILY LABELED follicles on each side of the ovary. |

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# TRADITIONAL 510(k)

# Philips Ultrasound

Lumify Diagnostic Ultrasound System with C9-4ec

| Feature /Characteristic | Lumify Diagnostic Ultrasound System K242519 (Subject Device) | Lumify Diagnostic Ultrasound System K192226 (Predicate Device) | C9-4v with ClearVue Ultrasound System K120321 (Primary Reference Device) | C9-4v with Affiniti Series Diagnostic Ultrasound System K240850 (Secondary Reference Device) | Comparison/Discussion/Comments |
| --- | --- | --- | --- | --- | --- |
| Indications for Use | The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B(2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler, 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, Lung, Transvaginal
The Lumify system is a transportable ultrasound system intended for use in environments where healthcare | The Philips Lumify Diagnostic 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, | Fetal/Obstetric, Abdominal, Pediatric, Small Organ (thyroid, scrotum, prostate, breast), Neonatal Cephalic, Adult Cephalic, Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Gynecological, Cardiac Adult, Cardiac Pediatric, Cardiac Other: Fetal, Peripheral Vessel, Peripheral Vessel Other: Carotid | Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Trans-vaginal, Lung. | Identical to predicate device, except Lung was added through K203406 for Lumify Diagnostic Ultrasound System with B-line Detection and B-line counting feature and Pulsed Wave Doppler (PWD) was added during the Lumify software version 5.0 release through a Letter to File. The letter to file is consistent with FDA guidance document: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers – Guidance for Industry and Food and Drug Administration Staff, February 21, 2023, Section 5.1.2.2, Table 2: Well-established ultrasound modes of operation Trans-vaginal clinical indication is a newly added clinical indication as part of the subject 510(k) submission. “Trans-vaginal” clinical indication is available on reference devices. |

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# TRADITIONAL 510(k)

# Philips Ultrasound

Lumify Diagnostic Ultrasound System with C9-4ec

| Feature /Characteristic | Lumify Diagnostic Ultrasound System K242519 (Subject Device) | Lumify Diagnostic Ultrasound System K192226 (Predicate Device) | C9-4v with ClearVue Ultrasound System K120321 (Primary Reference Device) | C9-4v with Affiniti Series Diagnostic Ultrasound System K240850 (Secondary Reference Device) | Comparison/Discussion/Comments |
| --- | --- | --- | --- | --- | --- |
| | is provided by healthcare professionals. | Carotid, Cardiac
The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals. | | | |
| Modes of Operations | B (2D), Pulse Wave, Color Doppler, Combined (B+Color), and M modes | B (2D), Color Doppler, Combined (B+Color), and M modes | B (2D), M modes, PWD, CWD, Color Doppler, Combined: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD | B (2D), M modes, PWD, CWD, Color Doppler, Combined (B+PWD; B+Color; B+Amplititude; B+M), Combined (B+M+Color), Combined (B+Color+PWD; B+Amplititude+ PWD), Combined (B+CWD; B+Color+CWD; B+Amplititude+ CWD) | Identical to predicate device, except Pulsed Wave Doppler (PWD) was added during the Lumify software version 5.0 released through a Letter to File. The letter to file is consistent with FDA guidance document: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers – Guidance for Industry and Food and Drug Administration Staff, February 21, 2023, Section 5.1.2.2, Table 2: Well-established ultrasound modes of operation. There is no change to the Modes of |

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# TRADITIONAL 510(k)

# Philips Ultrasound

Lumify Diagnostic Ultrasound System with C9-4ec

| Feature /Characteristic | Lumify Diagnostic Ultrasound System K242519 (Subject Device) | Lumify Diagnostic Ultrasound System K192226 (Predicate Device) | C9-4v with ClearVue Ultrasound System K120321 (Primary Reference Device) | C9-4v with Affiniti Series Diagnostic Ultrasound System K240850 (Secondary Reference Device) | Comparison/Discussion/Comments |
| --- | --- | --- | --- | --- | --- |
| | | | | | Operations due to the addition of new transducer, C9-4ec subject to this 510(k) submission. |
| Principles of Operation (subject Fertility Count preset) | The primary use of the Fertility preset is to perform a focused gynecological study using 2D, PW, and Color modes. The preset will be used to assess a patient's fertility status by evaluating the endometrium (appearance, size, and presence of pathology), and uterus, ovaries, and adnexa (uterine and ovarian size and appearance, presence of uterine, ovarian, and adnexal pathology, presence/number of antral follicles, and progressive ovarian follicular and endometrial lining growth post hormonal stimulation) | Not Applicable This preset was not available with this version. | The primary use of the Fertility preset is to perform a focused gynecological study using 2D, PW, and Color modes. The preset will be used to assess a patient's fertility status by evaluating the endometrium (appearance, size, and presence of pathology), and uterus, ovaries, and adnexa (uterine and ovarian size and appearance, presence of uterine, ovarian, and adnexal pathology, presence/number of antral follicles, and progressive ovarian follicular and endometrial lining growth post hormonal stimulation) | The primary use of the Fertility preset is to perform a focused gynecological study using 2D, PW, and Color modes. The preset will be used to assess a patient's fertility status by evaluating the endometrium (appearance, size, and presence of pathology), and uterus, ovaries, and adnexa (uterine and ovarian size and appearance, presence of uterine, ovarian, and adnexal pathology, presence/number of antral follicles, and progressive ovarian follicular and endometrial lining growth | Identical to reference devices |

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# TRADITIONAL 510(k)

# Philips Ultrasound

Lumify Diagnostic Ultrasound System with C9-4ec

| Feature /Characteristic | Lumify Diagnostic Ultrasound System K242519 (Subject Device) | Lumify Diagnostic Ultrasound System K192226 (Predicate Device) | C9-4v with ClearVue Ultrasound System K120321 (Primary Reference Device) | C9-4v with Affiniti Series Diagnostic Ultrasound System K240850 (Secondary Reference Device) | Comparison/Discussion/Comments |
| --- | --- | --- | --- | --- | --- |
| | | | | post hormonal stimulation) | |
| Patient Population for Fertility Package | Gynecology patients for follicular assessment | Not applicable. Fertility package is not available in the currently commercialized version of Lumify | Gynecology patients for follicular assessment | Gynecology patients for follicular assessment | Identical to reference devices |
| Users | Lumify Ultrasound System is used by healthcare professionals | Lumify Ultrasound System is used by healthcare professionals | Trained healthcare professionals Intended for sonographers, physicians, and biomedical engineers who operate and maintain your product. | Trained healthcare professionals Intended for sonographers, physicians, and biomedical engineers who operate and maintain your product. | Identical to predicate device |
| Use Environment | The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals. | The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals. | Clinics, hospitals, and clinical point-of-care for diagnosis of patients. | Clinics, hospitals, and clinical point-of-care for diagnosis of patients. | Identical to predicate device |
| Compatible Transducers | L12-4
S4-1
C5-2
C9-4ec | L12-4
S4-1
C5-2 | C9-4v | C9-4v | C9-4ec is a newly added transducer for the subject device in |

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# TRADITIONAL 510(k)

# Philips Ultrasound

Lumify Diagnostic Ultrasound System with C9-4ec

| Feature /Characteristic | Lumify Diagnostic Ultrasound System K242519 (Subject Device) | Lumify Diagnostic Ultrasound System K192226 (Predicate Device) | C9-4v with ClearVue Ultrasound System K120321 (Primary Reference Device) | C9-4v with Affiniti Series Diagnostic Ultrasound System K240850 (Secondary Reference Device) | Comparison/Discussion/Comments |
| --- | --- | --- | --- | --- | --- |
| | | | | | comparison to the predicate device. |
| Transducer Characteristics | | | | | |
| C9-4ec Transducer Model | Endocavitary Curved linear transducer | Not applicable. C9-4ec is not available with this version. | Endocavitary Curved linear transducer | Endocavitary Curved linear transducer | Identical to reference devices. C9-4ec is a newly added transducer as part of this 510(k) submission. |
| New Transducer Indications for Use | Indications for C9-4ec transducer: Gynecological, Fetal/Obstetric, and Trans-vaginal | Not applicable. C9-4ec is not available with this version. | Indications for C9-4v transducer: Fetal/Obstetric, Trans-Rectal, Trans-vaginal, Gynecological | Fetal/OB, Trans-vaginal, GYN, Urology, Fetal Echo | Identical to primary reference device, except proposed C9-4ec does not have trans-rectal clinical indication. |
| Transducer preset | C9-4ec: Fertility, Gyn Pelvis, OB Early | Not applicable. C9-4ec is not available with this version. | OB EV Gyn EV Gyn EV Fertility Urology EC Prostate | Gyn Fertility, Gyn Pelvis, Gyn Penetration, OB Early, OB Fetal Heart, OB General, Urology Bladder | Similar to secondary reference device. Secondary reference device has additional presets that are not available on the proposed C9-4ec |
| C9-4ec Transducer Modes of Operations | Fertility, Gyn Pelvis: B (2D), Color Flow, M-Mode, PW Doppler OB Early: B (2D), Color Flow, M-Mode | Not applicable. C9-4ec is not available with this version | B (2D), M mode, PW Doppler, Color Doppler, Combined: B + PWD; B + Color; B + Amplitude; B + M, Combined: B + M + Color, Combined: B + Color + PWD; B + Amplitude + PWD | B (2D), M mode, PW Doppler, Color Doppler, Combined: B + PWD; B + Color; B + Amplitude; B + M, Combined: B + M + Color, Combined: B + Color + PWD; B + Amplitude + PWD | Similar to reference devices. Reference devices have additional modes available. |
| 510(k) Track | Track 3 | Track 3 | Track 3 | Track 3 | Identical |

Table 6.1 Technological Comparison of Proposed Subject Device, Predicate Device & Reference Devices

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TRADITIONAL 510(k)
Philips Ultrasound
Lumify Diagnostic Ultrasound System with C9-4ec

7. Safety Considerations

The proposed Lumify Diagnostic Ultrasound System with C9-4ec transducer, are all Track 3 devices and comply with the reference standards and with FDA ultrasound guidance document, “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Guidance for Industry and Food and Drug Administration Staff, February 21, 2023”.

8. Non-Clinical Performance Data

The proposed modification of the Lumify Diagnostic Ultrasound System was tested in accordance with Philips internal procedures. Philips Ultrasound tested the subject device per the following standards to ensure the continued safe and effective performance:

- IEC 62304 Medical device software - Software life cycle processes, 2006 + A 2015
- IEC62366-1 Medical devices – Part 1: Application of usability engineering to medical devices, 2015
- ISO 14971 Medical devices- Application of risk management to medical devices, 2019
- IEC 60601-1 - Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-37- Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 60601-1-2 4.1 ed - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests; 2020
- IEC 62359, Ultrasonics – Field characterization – Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017-09
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process; 2018

Non-clinical verification testing was conducted to address the system level requirements according to system and design specifications, and risk control measures. The activities to assure the safe and effective performance of the Lumify Diagnostic Ultrasound System with C9-4ec transducer included, but are not limited to, the following:

- Requirements Review
- Risk Analysis and Management Review
- Product Specification Review
- Design Reviews

9. Clinical Performance Data

The proposed Lumify Diagnostic Ultrasound System with C9-4ec transducer did not require clinical data for determination of substantial equivalence since substantial equivalence was demonstrated based on the following attributes:

- Design features

Page 11 of 12

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Page 12 of 12

TRADITIONAL 510(k)
Philips Ultrasound
Lumify Diagnostic Ultrasound System with C9-4ec

- Indications for use
- Fundamental scientific technology
- Non-clinical performance testing
- Safety and Effectiveness

10. Sterilization

Not applicable. The Lumify Diagnostic Ultrasound System’s existing transducers as well as newly added C9-4ec transducer are not supplied sterile.

11. Conclusion

For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed subject device, Lumify Diagnostic Ultrasound System, including C9-4ec transducer meets its intended use.

The proposed Lumify Diagnostic Ultrasound System introduces Trans-vaginal as a new clinical indication compared to predicate Lumify Diagnostic Ultrasound System (K192226). The addition of Trans-vaginal clinical indication is due to the addition of C9-4ec transducer. Trans-vaginal clinical indication is previously cleared with Reference devices, C9-4v transducer for Affiniti Diagnostic Ultrasound System (K240850) and C9-4v transducer for ClearVue Ultrasound System (K120321).

The changes made to the subject device do not affect the use of the device, nor do they introduce any new or significantly modified risks. The results of the relevant performance and compatibility tests support a determination that the proposed subject device does not raise new questions of safety or effectiveness. Therefore, the proposed device is substantially equivalent to the predicate device in terms of indications for use, design, technological characteristics, modes of operations, safety, and effectiveness.