(126 days)
Not Found
No
The summary mentions image processing but does not explicitly mention AI, ML, or related terms like deep learning or neural networks in the device description or performance studies. The focus is on the imaging system and standard software control and processing.
No.
The device is described as an "imaging tool" that provides "visualization for assessment by physicians to support in forming a clinical judgment." There is no indication that it treats, diagnoses, or mitigates any disease or condition.
Yes
The device is described as an "imaging tool in the evaluation of external human tissue microstructure" that provides "real-time depth visualization for assessment by physicians to support in forming a clinical judgment." This indicates its use in assessing a patient's condition, which is a diagnostic purpose.
No
The device description explicitly lists multiple hardware components including a mobile cart, touchscreen, hand-held probe with an LC-OCT imaging system, and a central power unit (CPU) that integrates various imaging and electronic peripherals. The software runs on a computer embedded within the CPU and controls these hardware components.
Based on the provided information, deepLive is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- deepLive's Intended Use: deepLive is described as a "non-invasive imaging tool in the evaluation of external human tissue microstructure." It directly images the patient's skin in real-time.
- No Specimen Analysis: The device description and intended use do not mention the analysis of any biological specimens taken from the patient.
Therefore, deepLive falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
deepLive is intended to be used as a non-invasive imaging tool in the evaluation of external human tissue microstructure by providing three-dimensional, cross-sectional and en-face real-time depth visualization for assessment by physicians to support in forming a clinical judgment.
Product codes
NOO
Device Description
deepLive was designed for an easy integration into clinical practices. The device is composed of:
- A. A mobile cart, allowing the user to move the whole device and including a cart tablet for accessories.
- B. A touchscreen, fixed on the cart mast, displaying the software interfaces to the user.
- C. A hand-held probe, integrating the LC-OCT imaging system (interferometric microscope, OCT camera). The probe is connected to the CPU front panel by a sheathed cable bundle, and stored in a dedicated probe-holder fixed on the cart tablet. The probe is the interface between the device, the doctor and the patient: its measuring head (tip) must be positioned in contact with the patient's skin.
- D. A central power unit (CPU), mounted on the cart, integrating various imaging and electronic peripherals (laser, computer, electronic cards, drivers, power supplies, etc.), driving and powering the imaging probe.
- E. A software running on the device's computer, which controls the components of the system, acquires and processes images, and provides user interfaces for performing examinations and managing data.
deepLive hardware interfaces are located on the front-panel of the CPU. Input/output connections include:
- 1 Display port to connect the screen
- · 3 USB ports to connect external drives (Wifi key, hard drive disk, etc.)
deepLive software runs on a computer embedded in the CPU of the device. The computer uses Windows Enterprise LTSC operating system. The software executable and all dynamic libraries needed for program execution are deployed at a specific location in the file system.
The secured access to the computer operating system, deepLive software and data folders are managed by Windows sessions authentication system. The computer hosting deepLive is also likely to have applications installed by DAMAE Medical:
- · Synology Drive: used to retrieve device data for maintenance and software improvement purposes.
- TeamViewer: remote control software used for software manual update and software issues solving.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography
Anatomical Site
external human tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in clinical practices.
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)
Safety and performance of the deepLive device have been evaluated and verified in accordance with product and software specifications and applicable performance standards through verification, validation, nonclinical performance, and safety testing. Product requirements testing was performed to test the device requirements at the product level. Test cases covered general product functionality, hardware functionality, accuracy of measurement methods, labeling, manufacturability, maintenance, and packaging & environmental conditions.
Software integration testing was performed to test requirements defined in the software specifications documents. These tests covered both the integration of unitary software bricks, as well as the verification of the functional requirements and non-functional constraints of the complete software system. This also includes cybersecurity test that cybersecurity risk control measures are correctly implemented at the product level.
Validation testing was performed to validate the finished product and leveraged several validation tests including user requirements testing, usability testing, biological evaluation testing, and nonclinical evaluation. Safety testing was performed in accordance with the following standards:
- IEC 60601-1:2005 Medical Electrical Equipment Part 1: General requirements for basic . safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral Standard: Electromagnetic disturbances Requirements and tests
- EN 60825-1 :2014 Safety of laser products Part 1: Equipment classification and ● requirements
- EN 62471:2008 Photobiological Safety of lamps and lamp systems ●
- ASTM D4169-22 Distribution cycle 12 (road and air modes) Assurance level II ●
- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process
Verification, validation, nonclinical performance, and safety test results established that the device meets its design requirements and indications for use, that it is as safe and as effective as the predicate device, and that no new questions of safety and effectiveness have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
July 9, 2024
DAMAE Medical % Rory Carrillo Regulatory Consultant Cosm 45 Bartlett St. San Francisco, California 94110
Re: K240610
Trade/Device Name: deepLive Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NOO Dated: May 28, 2024 Received: May 28, 2024
Dear Rory Carrillo:
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.
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"
1
(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 OS 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 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-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 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.
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-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,
Jessica Carr -S
Jessica Carr, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
deepLive
Indications for Use (Describe)
deepLive is intended to be used as a non-invasive imaging tool in the evaluation of external human tissue microstructure by providing three-dimensional, cross-sectional and en-face real-time depth visualization for assessment by physicians to support in forming a clinical judgment.
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)
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3
K240610
510(k) Summary
General Information
| 510(k) Sponsor | DAMAE Medical |
|---|---|
| Address | 14 Rue Sthrau |
| Paris, France | |
| 75013 | |
| Correspondence Person | Rory A. Carrillo |
| Regulatory Consultant | |
| Contact Information | Email: rory@cosmhq.com |
| Phone: 415-580-0916 | |
| Date Prepared | February 29, 2024 |
Proposed Device
| Proprietary Name | deepLive OSP12 |
|---|---|
| Common Name | deepLive |
| Classification Name | System, Imaging, Optical Coherence Tomography (Oct) |
| Regulation Number | 21 CFR 892.1560 |
| Regulation Name | Ultrasonic pulsed echo imaging system |
| Product Code | NQQ |
| Regulatory Class | II |
Predicate Device
| Proprietary Name | VivoSight Dx Topical OCT System |
|---|---|
| Premarket Notification | K153283 |
| Classification Name | System, Imaging, Optical Coherence Tomography (Oct) |
| Regulation Number | 21 CFR 892.1560 |
| Regulation Name | Ultrasonic pulsed echo imaging system |
| Product Code | NQQ |
| Regulatory Class | II |
4
Device Description
deepLive was designed for an easy integration into clinical practices. The device is composed of:
- A. A mobile cart, allowing the user to move the whole device and including a cart tablet for accessories.
- B. A touchscreen, fixed on the cart mast, displaying the software interfaces to the user.
- C. A hand-held probe, integrating the LC-OCT imaging system (interferometric microscope, OCT camera). The probe is connected to the CPU front panel by a sheathed cable bundle, and stored in a dedicated probe-holder fixed on the cart tablet. The probe is the interface between the device, the doctor and the patient: its measuring head (tip) must be positioned in contact with the patient's skin.
- D. A central power unit (CPU), mounted on the cart, integrating various imaging and electronic peripherals (laser, computer, electronic cards, drivers, power supplies, etc.), driving and powering the imaging probe.
- E. A software running on the device's computer, which controls the components of the system, acquires and processes images, and provides user interfaces for performing examinations and managing data.
deepLive hardware interfaces are located on the front-panel of the CPU. Input/output connections include:
- 1 Display port to connect the screen
- · 3 USB ports to connect external drives (Wifi key, hard drive disk, etc.)
deepLive software runs on a computer embedded in the CPU of the device. The computer uses Windows Enterprise LTSC operating system. The software executable and all dynamic libraries needed for program execution are deployed at a specific location in the file system.
The secured access to the computer operating system, deepLive software and data folders are managed by Windows sessions authentication system. The computer hosting deepLive is also likely to have applications installed by DAMAE Medical:
- · Synology Drive: used to retrieve device data for maintenance and software improvement purposes.
- TeamViewer: remote control software used for software manual update and software issues solving.
5
Indications for Use
deepLive is intended to be used as a non-invasive imaging tool in the evaluation of external human tissue microstructure by providing three-dimensional, cross-sectional and en-face real-time depth visualization for assessment by physicians to support in forming a clinical judgment.
| Feature/
Function | Proposed Device
deepLive | Predicate Device:
VivoSight Dx (K153283) | Substantially
Equivalent |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indications
for
Use | deepLive is intended to be
used as a non-invasive
imaging tool in the evaluation
of external human tissue
microstructure by providing
three-dimensional,
cross-sectional and en-face
real-time depth visualization
for assessment by physicians
to support in forming a clinical
judgment. | VivoSight Dx is a Multi-Beam
Optical Coherence Tomography
(OCT) system indicated for use
in the two-dimensional,
cross-sectional, real-time
imaging of external tissues of
the human body. | Yes |
| Measurement
Technology | Optical Coherence Tomography | Optical Coherence Tomography | Yes |
| Near Infrared
Wavelength
(700-1400mm) | Yes | Yes | Yes |
| Lite Source
Wavelength | 800 nm | 1305 nm | Yes |
| Frame rate (fps) | B-scan: 8 fps
A-scan : 8 fps | 5fps | Yes |
| Lateral resolution | 1.3μm | 7.5 μm | Yes |
| Axial resolution | 1.1μm | 10 μm | Yes |
| Lateral Scanning
Range | 1.2 mm | 6 mm | Yes |
| Axial Scanning
Range | 0.5mm | 1 mm | Yes |
| Optical Safety | Class 1 | Class 1 | Yes |
Substantial Equivalence
6
Performance Testing
Safety and performance of the deepLive device have been evaluated and verified in accordance with product and software specifications and applicable performance standards through verification, validation, nonclinical performance, and safety testing. Product requirements testing was performed to test the device requirements at the product level. Test cases covered general product functionality, hardware functionality, accuracy of measurement methods, labeling, manufacturability, maintenance, and packaging & environmental conditions.
Software integration testing was performed to test requirements defined in the software specifications documents. These tests covered both the integration of unitary software bricks, as well as the verification of the functional requirements and non-functional constraints of the complete software system. This also includes cybersecurity test that cybersecurity risk control measures are correctly implemented at the product level.
Validation testing was performed to validate the finished product and leveraged several validation tests including user requirements testing, usability testing, biological evaluation testing, and nonclinical evaluation. Safety testing was performed in accordance with the following standards:
- IEC 60601-1:2005 Medical Electrical Equipment Part 1: General requirements for basic . safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral Standard: Electromagnetic disturbances Requirements and tests
- EN 60825-1 :2014 Safety of laser products Part 1: Equipment classification and ● requirements
- EN 62471:2008 Photobiological Safety of lamps and lamp systems ●
- ASTM D4169-22 Distribution cycle 12 (road and air modes) Assurance level II ●
- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process
Verification, validation, nonclinical performance, and safety test results established that the device meets its design requirements and indications for use, that it is as safe and as effective as the predicate device, and that no new questions of safety and effectiveness have been raised.
7
Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, the deepLive device raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy, and performance.