(265 days)
Based on the overview provided, I cannot definitively say whether the device contains an AI model.
Here's why:
- The overview describes the general function and features of the device. It mentions things like "a small embedded device," "connects to a sensor," "transmits data wirelessly," and "processes the data locally."
- These actions can be performed by various types of embedded systems, not necessarily those utilizing AI. Simple microcontrollers can perform these functions with traditional programming.
- To confirm if it contains an AI model, the overview would need to specifically mention:
- Machine learning: Terms like "machine learning," "trained model," "inference engine," or "neural network."
- Specific AI tasks: Such as "object recognition," "anomaly detection," "predictive analytics," "natural language processing," etc., which are performed locally on the device.
- AI acceleration hardware: Mentions of GPUs, NPUs (Neural Processing Units), or other hardware designed for AI computation.
In conclusion, based solely on the provided overview, it's not possible to verify the presence of an AI modelDentro deste dispositivo."
Could you provide more details from the overview or the device's specifications? That might help clarify if it uses AI.
No.
The device is clearly stated as a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging," which means it is used for identifying conditions, not 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..." and "It is indicated for diagnostic ultrasound imaging and fluid flow analysis..." The device description also consistently refers to it as a "Diagnostic Ultrasound System."
Yes
The 510(k) summary describes a "software platform" used with existing off-the-shelf hardware (smartphones and tablets) and explicitly states "The Device is an app that performs...". It also notes that the software does not perform direct patient treatment or diagnosis, but rather acts as a "Class II mobile medical app" under the FDA's guidance for regulating mobile applications. All indications point to a software-only offering.
To definitively say if {{overview}} is an In Vitro Diagnostic (IVD), I need more information about the device and its intended use. However, I can explain what generally constitutes an IVD and how to evaluate if a device falls under that category based on the information you provide in {{overview}}:
What is an In Vitro Diagnostic (IVD)?
Generally, an IVD is a medical device that is intended for use in vitro (outside the body) for the examination of specimens derived from the human body (such as blood, urine, tissue, or other body fluids) in order to provide information for diagnostic, monitoring, or screening purposes.
Key characteristics often associated with IVDs include:
- Purpose: To provide information about a physiological or pathological state, or congenital abnormality; to determine compatibility with potential recipients; or to monitor therapeutic measures.
- Method: Examination of specimens outside the human body.
- Specimen Source: Human body specimens (blood, urine, tissue, etc.).
- Intended User: Typically healthcare professionals or individuals for self-testing.
- Examples: Blood glucose meters, pregnancy tests, COVID-19 test kits, laboratory analyzers and reagents, blood typing kits.
How to Determine if {{overview}} is an IVD based on the information you provide:
Analyze the information in {{overview}} looking for answers to these questions:
- What is the intended use of the device? Does it state it is used to diagnose, monitor, or screen for a specific condition or physiological state?
- What type of specimens does it interact with? Does it analyze human body specimens like blood, urine, saliva, tissue, etc.?
- Where and how is the analysis performed? Is the analysis done in vitro (outside the body)?
- What type of information does the device provide? Does it yield diagnostic information, monitoring information, or screening information?
- Are there specific claims about its use in diagnosis or screening? Look for phrases like "for diagnosis," "to determine," "to monitor," "screening test," etc.
Based on the information in {{overview}}, here are possible scenarios and how they relate to whether it's an IVD:
- If {{overview}} describes a device that analyzes human body specimens (like blood, urine, etc.) outside the body to diagnose a condition, monitor a disease, or screen for something: It is highly likely to be an IVD.
- If {{overview}} describes a device that analyzes substances not derived from the human body (e.g., environmental samples, food samples): It is likely not an IVD.
- If {{overview}} describes a device that interacts with the human body in vivo (inside the body) to provide information (e.g., an imaging device, a monitoring wearable): It is likely not an IVD. (These would be general medical devices, but typically not IVDs).
- If {{overview}} describes a device used in vitro but not for the purpose of examining human body specimens for diagnostic or monitoring purposes (e.g., a laboratory instrument used for research purposes not relating to human diagnosis): It may not be strictly regulated as an IVD, although it could still be a lab device.
- If {{overview}} is ambiguous or lacks details about the intended use or specimen type: It is difficult to say definitively. More information would be needed.
Conclusion:
To give you a more confident answer, please provide the full text of {{overview}}. With that information, I can analyze the details and tell you whether it aligns with the characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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 (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.
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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
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 (B+ Color), and M modes. The Lumify system is compatible with iOS and Android operating systems.
The Lumify Diagnostic Ultrasound System (iOS) utilizes:
- A commercial off-the-shelf (COTS) iOS mobile item (smart phone or tablet)
- The Philips Ultrasound Lumify software running as a medical device application on the COTS device
- The Philips C5-2 Curved array USB transducer
- The Philips L12-4 Linear array USB transducer
- The Philips S4-1 Sector array USB transducer
- The Philips C9-4ec Curved linear array USB Transducer (subject of this submission)
- Lumify Micro B Transducer Cable
- Lumify Micro C Transducer Cable
- Lumify USB-C to USB-C Transducer Cable
- Lumify Power Module (LPM)
- Lumify USB-C to Lightning LPM Cable
The purpose of this traditional 510(k) submission is addition of C9-4ec Transducer and Fertility Package to Lumify Diagnostic Ultrasound System.
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 Trans-vaginal (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.
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, Lung, Trans-vaginal.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by healthcare professionals in environments where healthcare is provided.
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 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
All pre-determined acceptance criteria were met.
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.
FDA 510(k) Clearance Letter for Lumify Diagnostic Ultrasound System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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.
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K242519 - Sudipta Chakrabarti Page 2
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 Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 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)
[X] 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
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."
Page 5
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)
[X] 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
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."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 6
Page 1 of 12
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
sudipta.chakrabarti@philips.com
Phone: 615-243-8084
Secondary Contact: Amy Yang
Director Regulatory Affairs
amy.yang@philips.com
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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Page 2 of 12
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 (B+ Color), and M modes. The Lumify system is compatible with iOS and Android operating systems.
The Lumify Diagnostic Ultrasound System (iOS) utilizes:
- A commercial off-the-shelf (COTS) iOS mobile item (smart phone or tablet)
- The Philips Ultrasound Lumify software running as a medical device application on the COTS device
- The Philips C5-2 Curved array USB transducer
- The Philips L12-4 Linear array USB transducer
- The Philips S4-1 Sector array USB transducer
- The Philips C9-4ec Curved linear array USB Transducer (subject of this submission)
- Lumify Micro B Transducer Cable
- Lumify Micro C Transducer Cable
- Lumify USB-C to USB-C Transducer Cable
- Lumify Power Module (LPM)
- 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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Page 3 of 12
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 Trans-vaginal (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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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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| 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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| 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, Trans-vaginal | |||||
| 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, Carotid, Cardiac | |||||
| The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals. | Fetal/Obstetric, Abdominal, Pediatric, Small Organ (thyroid, scrotum, prostate, breast), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, 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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| 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. | 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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| 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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| 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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| 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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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
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- 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.