(88 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the established laser Doppler technique and 2D scanning, not AI/ML processing.
No
Explanation: The device is described as a "Microcirculation Camera" intended for "blood flow measurements" and "imaging blood flow". There is no mention of it being used for treatment or therapy.
Yes
The device is described as "imaging blood flow in the microcirculation" to "quantify movement of blood cells beneath the skin surface." This is a measurement of a physiological parameter, which is a diagnostic function.
No
The device description explicitly states it is a "microcirculation camera" and uses the "laser Doppler technique," indicating it is a hardware device that performs imaging. The performance studies also mention testing for electrical safety and electromagnetic immunity, which are relevant to hardware devices.
Based on the provided information, the Aimago EasyLDI Microcirculation Camera is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "blood flow measurements in the microcirculation." This is a measurement of a physiological process within the living body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device description confirms it "quantifies movement of blood cells beneath the skin surface." This is an in-vivo measurement.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples, reagents, or any of the typical components or processes associated with in-vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Aimago EasyLDI operates directly on the living tissue to measure blood flow.
N/A
Intended Use / Indications for Use
The Aïmago EasyLDI microcirculation camera is intended for blood flow measurements in the microcirculation. / The Aimago EasyLDI Microcirculation Camera is intended for blood flow measurements in the microcirculation.
Product codes (comma separated list FDA assigned to the subject device)
DPT
Device Description
The Aimago EasyLDI microcirculation camera is a device for imaging blood flow in the microcirculation. It uses the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. Unlike the predicate devices, the EasyLDI performs a 2dimensional Laser Doppler area scan to build up a color coded image of blood flow more rapidly than either predicate device. The moorLDLS laser Doppler line scanner uses a line scanner to sweep a line of laser light across the tissue to build up the image of blood flow and the moorLD12-IR laser Doppler imager uses a single low power infrared laser beam to achieve this goal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Laser Doppler
Anatomical Site
microcirculation / beneath the skin surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Testing has been performed in-house as well as at contract laboratories has demonstrated that the Aïmago EasyLDI fulfills the requirements for Subpart B of Part 15 for Class A digital devices according to the FCC Rules for Digital Devices, the requirements ESD safety and electromagnetic immunity according to standard IEC 60601-1-2 and all electrical safety requirements from IEC 60601-1.
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
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the text "K121429" in a handwritten style. Below this, the words "Traditional 510(k)" are printed in a smaller, sans-serif font. The text appears to be part of a document or label, possibly related to a medical device or regulatory submission.
510(k) Summary 5
In accordance with 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter Information:
| Submitter name: | Aïmago SA
Parc Scientifique EPFL
PSE-D, 4th floor
1015 Lausanne, Switzerland |
|-------------------------------|---------------------------------------------------------------------------------------|
| Contact person during review: | Marc André |
| Contact Title: | Chief Technology Officer |
| Phone: | +41 21 510 55 61 |
| Fax: | +41 21 510 55 56 |
| Mailto: | Marc.Andre@aimago.com |
| Submission Type: | Traditional 510(k) |
| Date prepared: | 08 May 2012 |
Device Name:
| Proprietary name: | Aïmago EasyLDI |
|---|---|
| Common name: | Laser Doppler Imager |
| Class | Class II |
| Classification name: | 21 CFR 870.2120, Extravascular blood flow probe |
| Product code: | DPT |
| Review panel: | Cardiovascular |
Predicate Device:
Substantial Equivalence is claimed with the predicate devices:
moorLDLS Laser Doppler Line Scanner (K063561), and the .
. moorLDI2-IR Infrared Laser Doppler Imager (K032841)
both manufactured by MOOR INSTRUMENTS LTD., Millwey, Axminster, Devon (UK).
Both the new and the predicate devices use the Laser Doppler imaging technology to visualize blood flow in the microcirculation. While the predicate devices perform a single point and a 1dimensilonal line scan, respectively, the Aïmago EasyLDI performs a 2-dimensional area scan.
1
Device Description:
The Aimago EasyLDI microcirculation camera is a device for imaging blood flow in the microcirculation. It uses the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. Unlike the predicate devices, the EasyLDI performs a 2dimensional Laser Doppler area scan to build up a color coded image of blood flow more rapidly than either predicate device. The moorLDLS laser Doppler line scanner uses a line scanner to sweep a line of laser light across the tissue to build up the image of blood flow and the moorLD12-IR laser Doppler imager uses a single low power infrared laser beam to achieve this goal.
Intended Use:
The Aïmago EasyLDI microcirculation camera is intended for blood flow measurements in the microcirculation.
Comparison of Technological Characteristics:
Both the new and the predicate devices use the Laser Doppler imaging technology to visualize blood flow in the microcirculation. While the predicate devices perform a single point and a 1dimensilonal line scan, respectively, the Aïmago EasyLD! performs a 2-dimensional area scan.
Summary of Testing:
Testing has been performed in-house as well as at contract laboratories has demonstrated that the Aïmago EasyLDI fulfills the requirements for Subpart B of Part 15 for Class A digital devices according to the FCC Rules for Digital Devices, the requirements ESD safety and electromagnetic immunity according to standard IEC 60601-1-2 and all electrical safety requirements from IEC 60601-1.
Conclusion:
Based on the above, Aïmago SA concluded that the Aïmago EasyLD! microcirculation camera is substantially equivalent to the legally marketed predicate devices and is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aimago SA % Mr. Marc Andre' Chief Technology Officer Parc Scientifique EPFL PSE-D. 4th Floor Lausanne, Switzerland 1015
AUG 1 0 2012
Re: 121429
Trade/Device Name: EasyLDI Microcirculation Camera Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular blood flow probe Regulatory Class: Class II Product Code: DPT Dated: July 17, 2012 Received: July 19, 2012
Dear Mr. Andre':
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. 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
3
Page 2 - Mr. Marc Andre'
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
y yours,
Pon.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Aïmago EasyLDI
Indications for Use Statement
510(k) Number (if known):
Device Name:
EasyLDI Microcirculation Camera
Indications for Use:
The Aimago EasyLDI Microcirculation Camera is intended for blood flow measurements in the microcirculation.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
E. Keith
(Division Sign-Off) Division of Survical, Orthopedic, and Restorative Devices
510(k) Number K121429