(21 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound technology and software.
No
The device is described as a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging and fluid flow analysis." This indicates its purpose is to diagnose conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the Philips Lumify Diagnostic Ultrasound System is "intended for diagnostic ultrasound imaging" and is a "diagnostic ultrasound system."
No
The device description explicitly lists hardware components beyond the software, including USB transducers and a power module.
Based on the provided information, the Philips Lumify Diagnostic Ultrasound System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it is for "diagnostic ultrasound imaging" and "fluid flow analysis." This involves imaging structures and processes within the body, not analyzing samples taken from the body (which is the core of IVD).
- Device Description: The description details a system for acquiring and displaying ultrasound data. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-related terms: The document does not use any terminology typically associated with IVD devices, such as "sample," "reagent," "assay," "analyte," etc.
In summary, the Lumify system is a medical imaging device used for non-invasive diagnostic purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Lumify Diagnostic Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Lumify is a portable system facilitating point of care ultrasound applications.
The Lumify Diagnostic Ultrasound System includes:
- A commercial off-the-shelf (COTS) Android or iOS mobile device ●
- Philips Ultrasound software running as an app (Android or iOS) on the COTS device ●
- The C5-2 Curved array USB transducer
- The L12-4 Linear array USB transducer
- The S4-1 Sector array USB transducer
- The Lumify Power Module (LPM) to convert the USB interface used on the family of Lumify transducers to Apple's iAP2 Lightning interface standard used on iPhones and iPads, and to provide battery power to the transducers when using an iOS mobile device
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
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)
The Lumify Diagnostic Ultrasound System did not require clinical studies because substantial equivalence to the currently marketed predicate Lumify Ultrasound System (K162549) has been established.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
September 6, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Philips Healthcare % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114
Re: K192226
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 15, 2019 Received: August 16, 2019
Dear Prithul Bom:
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. 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 located 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.
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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192226
Device Name Lumify Diagnostic Ultrasound System
Indications for Use (Describe)
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.
Lumify is a transportable ultrasound system intended for use in environments where healthcare professionals.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of Safety and Effectiveness
Lumify Diagnostic Ultrasound System
This summary of safety and effectiveness information is submitted in accordance with 21CFR §807.92
-
- Submitter's name, address, telephone number, contact person. Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431
| Contact person: | Paul Elias, Regulatory Affairs Specialist |
|---|---|
| Email: | Paul.Elias@philips.com |
| Tel: | 425-482-8396 |
| Fax: | 425-487-8666 |
| Secondary Contact: | Hebe Sun, Senior Regulatory Affairs Manager |
| Email: | Hebe.Sun@philips.com |
July 15, 2019 Date prepared:
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common name: Diagnostic ultrasound system and transducers Proprietary name: Lumify Diagnostic Ultrasound System
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
These devices are classified as follows:
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
As stated in 21 CFR, parts 892.1550, 892.1560, and 892.1570, each of these generic types of devices has been classified as Class II.
3. Substantially Equivalent Devices
Philips Ultrasound believes the proposed Lumify Diagnostic Ultrasound System is substantially equivalent to the following currently marketed predicate device:
| Predicate Device | 510(k) |
|---|---|
| Lumify Ultrasound System | K162549 |
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4. Device Description
The Lumify Diagnostic Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Lumify is a portable system facilitating point of care ultrasound applications.
The Lumify Diagnostic Ultrasound System includes:
- A commercial off-the-shelf (COTS) Android or iOS mobile device ●
- Philips Ultrasound software running as an app (Android or iOS) on the COTS device ●
- The C5-2 Curved array USB transducer
- The L12-4 Linear array USB transducer
- The S4-1 Sector array USB transducer
- The Lumify Power Module (LPM) to convert the USB interface used on the family of Lumify transducers to Apple's iAP2 Lightning interface standard used on iPhones and iPads, and to provide battery power to the transducers when using an iOS mobile device
5. Indications for Use
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.
Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
6. Technological Comparison to Predicate Devices
The Lumify Diagnostic Ultrasound System employs the same fundamental scientific technology as the currently marketed predicate Lumify Ultrasound System (K162549). The transducers, scanning modes, and indications for use are identical. The primary differences are the implementation of the Lumify software application for iOS and the addition of the Lumify Power Module (LPM). The LPM converts the USB interface used on the family of Lumify transducers to Apple's iAP2 Lightning interface, and powers transducers when using an iOS mobile device.
7. Safety Considerations and Nonclinical Performance Testing
As a Track 3 ultrasound device, the Philips Lumify Diagnostic Ultrasound System is designed to comply with the acoustic output display requirements of IEC 60601-2-37 Ed 2.1 (Particular requirements for the basic safety and essential performance of ultrasonic medical and monitoring equipment). The Lumify Diagnostic Ultrasound System complies with the referenced standard as well as the FDA ultrasound guidance document,
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"Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," issued on June 27, 2019.
System acoustic output limits are identical to the currently marketed predicate Lumify Ultrasound System (K162549):
- Ispta.3 ≤ 720 MW/cm2 트
- 트 MI