(109 days)
No reference devices were used in this submission.
No
The document describes image acquisition, processing, display, and recording, but there is no mention of AI, ML, or any advanced analytical techniques that would typically fall under those categories. The processing described appears to be standard image handling and display.
No
The device is an imaging system designed to visually assess circulation and tissue perfusion, not to provide therapy or treatment.
Yes
The device is used for fluorescence imaging to assess blood flow and tissue perfusion, allowing clinicians to visually assess circulation, which falls under diagnostic capabilities for medical conditions.
No
The device description explicitly details hardware components including an imager, articulated arm, mobile cart, cameras, and processing hardware. While software is mentioned for secondary functions, the core device is a physical imaging system.
Based on the provided information, the Asimov-MKS Imaging System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Asimov-MKS Imaging System is used for in vivo imaging of blood flow and tissue perfusion within the patient's body during surgery. It does not analyze samples taken from the patient.
- The device description focuses on imaging technology and its application during surgical procedures. It describes cameras, illumination, processing hardware, and how it's used in a surgical setting.
- The intended use is for fluorescence imaging of blood flow and tissue perfusion. This is a direct assessment of physiological processes within the living patient.
- The use of indocyanine green (ICG) is as an imaging agent injected into the patient's bloodstream, not as a reagent used to test a sample in vitro.
Therefore, the Asimov-MKS Imaging System falls under the category of an in vivo imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Asimov-MKS Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, reconstructive, and micro surgeries.
Product codes (comma separated list FDA assigned to the subject device)
IZI
Device Description
The Asimov-MKS Imaging System is a fluorescence angiography imaging system. It is a prescription device intended to be used in hospital surgical suites, ambulatory surgery centers, and similarly equipped healthcare facilities. The Asimov-MKS Imaging System consists of an imager mounted to the distal end of an articulated arm that is affixed to a mobile cart.
Under the supervision of the surgeon, the imager illuminates a region of interested with near infrared and/or white light. Cameras, integral to the imager, acquire fluorescence and/or white light color images and direct the acquired images to processing hardware within the cart.
The articulated arm allows the imager to be directed at the region of interest. The arm affords unencumbered access to the patient and permits the cart to be positioned outside of the sterile field.
The cart allows the Asimov-MKS Imaging System to be positioned as needed for a surgical procedure and to be relocated within a facility for additional procedures or storage. The cart houses the processing hardware that display and record the acquired images. Software executed on the processing hardware provides secondary functions such as patient biographical data entry, image review, and data archive.
To maintain the sterile surgical field, a sterile drape covers the imager and portions of the arm during clinical use. The single use drape streamlines device cleaning after use.
The fluorescent imaging agent utilized is indocyanine green (ICG). ICG is injected into the patient's blood stream, rapidly binds to the blood plasma, and is transported on the blood from the injection point to the region of interest. The ICG fluoresces when illuminated with the near infrared light emitted by the imager. Images of the fluorescence allow the clinician to visually assess circulation and related tissue perfusion.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence imaging, White-light color imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use, in hospital surgical suites, ambulatory surgery centers, and similarly equipped healthcare facilities. Users work under the supervision of the surgeon.
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)
Results of verification and validation testing performed by OnLume Inc. confirm the Asimov-MKS Imaging System conforms to design specifications and meets the needs of the intended users. Additionally, testing performed by an independent certified testing laboratory demonstrates the device complies with the requirements of applicable FDA recognized consensus safety standards for medical devices. In aggregate the test results and associated performance data demonstrate that the Asimov-MKS Imaging System is equivalent and performs at least as well as the predicate device.
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.
SPY Elite® Intraoperative Perfusion Assessment System - K182907
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.
No reference devices were used in this submission.
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
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
OnLume Inc. Mr. Greg Bange Senior Manager - Regulatory Affairs and Quality Assurance 3300 Commercial Ave Madison, Wisconsin 53714
January 17, 2020
Re: K192761
Trade/Device Name: Asimov-MKS Imaging System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: IZI Dated: December 18, 2019 Received: December 20, 2019
Dear Greg Bange:
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.
Neil R.P. Ogden Assistant Director, THT4A4 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
Enclosure
2
Indications for Use
510(k) Number (if known) K192761
Device Name Asimov-MKS Imaging System
Indications for Use (Describe)
The Asimov-MKS Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, reconstructive, and micro surgeries.
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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Image /page/3/Picture/0 description: The image shows the logo and contact information for Onlume. The logo features the word "Onlume" in a blue sans-serif font, with a stylized lightbulb above the "l". Below the logo is the address "3300 Commercial Ave, Madison, WI 53714" and the website "www.onlume.com".
Section 8 510(k) Summary
Submitter
OnLume Incorporated 3300 Commercial Avenue Madison, WI 53714 Phone: 888-751-5131 Contact: Greg Bange Date Prepared: December 18, 2019
Device Identification
| Device Name: | Asimov-MKS Imaging System |
|---|---|
| Trade Name: | Asimov-MKS Imaging System |
| Common Name: | Fluorescence Angiography System |
| Regulation Number: | 21 CFR 892.1600 |
| Regulation Description: | Angiographic x-ray system |
| Regulation Name: | System, X-Ray, Angiographic |
| Regulatory Class: | Class II |
| Product Code: | IZI |
Predicate Device
SPY Elite® Intraoperative Perfusion Assessment System - K182907
Reference Devices
No reference devices were used in this submission.
Device Description
The Asimov-MKS Imaging System is a fluorescence angiography imaging system. It is a prescription device intended to be used in hospital surgical suites, ambulatory surgery centers, and similarly equipped healthcare facilities. The Asimov-MKS Imaging System consists of an imager mounted to the distal end of an articulated arm that is affixed to a mobile cart.
Under the supervision of the surgeon, the imager illuminates a region of interested with near infrared and/or white light. Cameras, integral to the imager, acquire fluorescence and/or white light color images and direct the acquired images to processing hardware within the cart.
The articulated arm allows the imager to be directed at the region of interest. The arm affords unencumbered access to the patient and permits the cart to be positioned outside of the sterile field.
The cart allows the Asimov-MKS Imaging System to be positioned as needed for a surgical procedure and to be relocated within a facility for additional procedures or storage. The cart houses the processing hardware that display and record the acquired images. Software executed on the
4
processing hardware provides secondary functions such as patient biographical data entry, image review, and data archive.
To maintain the sterile surgical field, a sterile drape covers the imager and portions of the arm during clinical use. The single use drape streamlines device cleaning after use.
The fluorescent imaging agent utilized is indocyanine green (ICG). ICG is injected into the patient's blood stream, rapidly binds to the blood plasma, and is transported on the blood from the injection point to the region of interest. The ICG fluoresces when illuminated with the near infrared light emitted by the imager. Images of the fluorescence allow the clinician to visually assess circulation and related tissue perfusion.
Indications for Use / Intended Use
The Asimov-MKS Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, reconstructive, and micro surgeries.
Technological Characteristics
The subject and predicate devices employ the same fundamental scientific principles and have substantially equivalent technological characteristics. The predicate and subject devices have functionally equivalent subsystems for the imager, articulated arm, and mobile cart. The subject device illuminates the surgical field with infrared light of the same wavelength as that of the predicate device. The predicate device uses ambient room light when capturing a color image, whereas, the subject device utilizes both ambient light and the integral white LEDs during color imaging. Both the subject and predicate devices are draped during surgical use and utilize ICG as the fluorescent agent. Neither device is intended to contact the patient during use.
Two operational differences between the predicate and the Asimov-MKS Imaging System are:
- . The Asimov-MKS Imaging System supports the real-time display of combined white-light color and fluorescence images (i.e. fluorescence overlaid on color images). Thus, the user may assess blood flow and tissue perfusion as indicated in the fluorescence images referenced directly to the anatomy as indicated in the white-light color images during the surgical procedure. The predicate device does not support the real-time display of overlaid images.
- The Asimov-MKS Imaging System is able to acquire fluorescence images with no changes in the ambient lighting of a typical suite. The predict device requires that the surgical suite be darkened during fluorescence image acquisition.
The following table compares key attributes of the Asimov-MKS Imaging System to those of the predicate device.
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| Attribute | Subject Device | Predicate Device |
|---|---|---|
| Trade Name | Asimov-MKS Imaging System | |
| (subject to change when placed | ||
| on the market) | SPY Elite® Intraoperative | |
| Perfusion Assessment System - | ||
| K182907 | ||
| Common Name | fluorescence angiography | |
| imaging system | fluorescence angiography | |
| imaging system | ||
| Product Code | IZI (21 CFR 892.1600) | IZI (21 CFR 892.1600) |
| Regulation Device Name | System, X-Ray, Angiographic | System, X-Ray, Angiographic |
| Combination Product | No (used with equivalent third- | |
| party items) | Yes | |
| Fluorescence agent | indocyanine green (ICG) | indocyanine green (ICG) |
| Fluorescence Excitation | ||
| Source | Infrared laser diode | |
| 805 nm | ||
| 55mW (at laser aperture) | Infrared laser diode | |
| 805 nm | ||
| 119mW (at laser aperture) | ||
| Fluorescence Detector | CMOS | CCD |
| Fluorescence Detector | ||
| Output | 12 bits/pixel | |
| 1024 x 768 (pixels/frame) | 8 bits/pixel | |
| 1024 x 768 (pixels/frame) | ||
| Fluorescence Frame rates | Display rate: | |
| 30 fps | ||
| Capture/Record rate: | ||
| 30 fps | Display rate: | |
| 30 fps | ||
| Capture/Record rate: | ||
| 30, 15, 7.5, or 3.75 fps (user | ||
| selected) | ||
| Fluorescence record | ||
| capacity (continuous real- | ||
| time image record | Up to 160,000 frames | Up to 1024 frames |
| White Light Excitation | ||
| Source (for color images) | Integral LED and Ambient | Ambient |
| White Light Detector | CMOS | CCD |
| White Light Detector | ||
| Output | 8 bits/pixel | |
| 1024 x 768 (pixels/frame) | 8 bits/pixel | |
| 1024 x 768 (pixels/frame) | ||
| White Light Frame rates | Display: | |
| 30 fps | ||
| Record: | ||
| 30 fps and single snapshot | ||
| image | Display: | |
| 30 fps | ||
| Record: | ||
| Single snapshot image | ||
| White Light record capacity | ||
| (continuous real-time image | ||
| record) | Up to 160,000 frames | 1 frame per snapshot |
| Working distance (cm) | 30 | 30 |
| Field of View (cm2) | 266 (19 x 14) | 266 (19 x 14) |
| Output dimensions (in | ||
| pixels) | 1024 x 768 | 1024 x 768 |
| Attribute | Subject Device | Predicate Device |
| Display Bit Depth | 8 | 8 |
| Real-time | ||
| Color image with | ||
| Fluorescence Overlay | Yes | No |
| Ambient Light Level | High (room lights on) | Low (room lights off) |
| Mobile | Yes | Yes |
| Power Source | Wall | Wall1 |
| Patient contact | ||
| (w/ imaging device) | None | None |
| Consumables | ||
| (single use) | Sterile Drape, ICG | Sterile Drape, ICG |
| Operating System | Linux | Windows |
| Report Generation | Various formats and data | Various formats and data |
| Data Archive | WiFi export | USB export |
6
1 The predicate device has battery support for completion of image data record in the event of a wall power failure. Battery support is unnecessary in the subject device as images are recorded in real-time.
Performance Data
Results of verification and validation testing performed by OnLume Inc. confirm the Asimov-MKS Imaging System conforms to design specifications and meets the needs of the intended users. Additionally, testing performed by an independent certified testing laboratory demonstrates the device complies with the requirements of applicable FDA recognized consensus safety standards for medical devices as listed in the following table.
| Applicable Standards | ||
|---|---|---|
| Standard Number | ||
| (Edition and Publication | ||
| Date) | Title | FDA |
| Recognition | ||
| number | ||
| IEC 60601-1:2005 + | ||
| A1:2012 |
(ed 3.1 2012-08) | Medical electrical equipment Part 1:
General requirements for basic safety and essential
performance | 19-4 |
| IEC 60601-1-2:2014
(ed 4.0 2014-02) | Medical electrical equipment Part 1-2:
General requirements for basic safety and essential
performance – Collateral Standard:
Electromagnetic disturbances – Requirements and
test | 19-8 |
| IEC 60601-1-6:2010 +
A1:2013
(ed 3.1 2013-10) | Medical electrical equipment Part 1-6:
General requirements for basic safety and essential
performance - Collateral Standard: Usability | 5-89 |
7
| Applicable Standards | ||
|---|---|---|
| IEC 60825-1:2007 | ||
| (ed 2.0, 2007-03) | Safety of laser products –Part 1: | |
| Equipment classification and requirements | 12-273 | |
| IEC 62471 | ||
| (ed. 1.0, 2006-07) | Photobiological safety of lamps and lamp systems | 12-249 |
In aggregate the test results and associated performance data demonstrate that the Asimov-MKS Imaging System is equivalent and performs at least as well as the predicate device.
Conclusion
The Asimov-MKS Imaging System is substantially equivalent to the predicate device. The devices have the same intended use and the same technological characteristics. The technological differences that exist do not raise new types of safety or effectiveness questions. Further, results of performance testing demonstrate the Asimov-MKS Imaging System is equivalent to the predicate.