(232 days)
The moorLDI2 Laser Doppler Imager is intended for blood flow measurements in the microcirculation. It is intended to be used for clinical research applications and pre-clinical research applications.
The moorLDI2 is a device to perform non-invasive blood flow measurements in the microcirculation, for example skin, using the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. The system scans a very low power laser beam across the tissue. Moving blood in the microvasculature causes a Doppler frequency shift of the laser light, which is photo detected and processed to generate a colour coded blood flow map, line by line. An in built CCD camera records a colour photograph to aid visualisation of the scan site.
The Moor Instruments Ltd moorLDI2 Laser Doppler Imager is a device intended for blood flow measurements in the microcirculation for clinical and pre-clinical research applications. The 510(k) summary provides information regarding its performance and comparison to a predicate device (moorLDI2-IR laser Doppler imager, K032841).
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a pass/fail sense for a clinical study comparing the new device against specific benchmarks. Instead, it focuses on demonstrating substantial equivalence to the predicate device. The performance characteristics of the device itself are given.
| Parameter | Acceptance Criteria (Equivalent to Predicate) | Reported Device Performance (moorLDI2) |
|---|---|---|
| Flux (Tissue perfusion) | Range: 0-5000 PU | Range: 0-5000 PU |
| Accuracy: ±10% relative to Moor Instruments 'standard' moorLDI; ±3% of measurement from temperature controlled (22 ±1°C) motility standard | Accuracy: ±10% relative to Moor Instruments 'standard' moorLDI; ±3% of measurement from temperature controlled (22 ±1°C) motility standard | |
| Conc (Concentration of blood flow) | Range: 0-5000 AU | Range: 0-5000 AU |
| Accuracy: ±10%; ±3% of measurement value | Accuracy: ±10%; ±3% of measurement value | |
| DC (Intensity) | Range: 0-5000 AU | Range: 0-5000 AU |
| Accuracy: ±10%; ±3% of measurement value | Accuracy: ±10%; ±3% of measurement value | |
| Maximum image resolution | 256 x 256 pixels | 256 x 256 pixels |
| Scan speed | 4ms/pixel, 10ms/pixel, 50ms/pixel | 4ms/pixel, 10ms/pixel, 50ms/pixel |
| Operating principle | Same as predicate device | Same as predicate device |
| Image resolution options | Same as predicate device | Same as predicate device |
| Laser classification | Same as predicate device (Class 3R) | Class 3R (per IEC 60825-1:2007) |
| Scan head external dimensions | Same as predicate device | Same as predicate device |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "The moorLDI2 laser Doppler imager was tested in direct comparison to the predicate device using laboratory models and skin blood flow measurements on volunteers."
- Sample Size: Not explicitly provided. The number of laboratory models or volunteers used is not specified.
- Data Provenance: The study involved "laboratory models" and "skin blood flow measurements on volunteers." The country of origin for the data is implicitly the United Kingdom, where Moor Instruments Ltd is based. The data would be considered prospective as it involves new testing for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The type of testing performed (laboratory models, skin blood flow measurements) suggests objective measurements rather than subjective expert consensus for ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable as the document describes direct comparison testing using objective measurements of performance characteristics rather than an expert-adjudicated test set in the traditional sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted or described. The device is a measurement instrument, and the study focused on technical performance comparison rather than human reader interpretation with and without AI assistance.
6. Standalone Performance:
Yes, a standalone performance evaluation was done. The document provides detailed specifications and performance parameters like "Accuracy" for Flux, Concentration, and DC (Intensity), stating these accuracies relative to a standard. The study also concludes that the device performs "as well as or better than the predicate device," which implies standalone performance evaluation of the new device and its comparison to the predicate.
7. Type of Ground Truth Used:
The ground truth appears to be based on objective physical measurements from "laboratory models" and "skin blood flow measurements on volunteers." For parameters like Flux, Conc, and DC, accuracy is given relative to "Moor Instruments 'standard' moorLDI" and a "temperature controlled (22 ±1°C) motility standard." This suggests a reliance on established measurement standards and controlled experimental conditions to define the true values.
8. Sample Size for the Training Set:
This information is not provided and is likely not applicable. The device is not described as an AI/ML algorithm that requires a training set in the conventional sense. It's a measurement instrument, and its development would involve engineering design and calibration rather than AI model training.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is not applicable, as there is no mention of an AI/ML component requiring a training set with established ground truth.
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Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of a caduceus, which is a symbol of medicine.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2016
Moor Instruments Ltd Stewart Lillington Product Development Manager Millwey Rise Axminster, EX13 5HU GB
Re: K152749
Trade/Device Name: moorLDI2-IR Infrared Laser Doppler Imager, moorLDI2-HIR High Resolution Infrared Laser Doppler Imager, moorLDI2-VR Visible Red Laser Doppler Imager Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular Blood Flow Probe Regulatory Class: Class II Product Code: DPT, GEX Dated: April 6, 2016 Received: April 13, 2016
Dear Stewart Lillington:
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 comply
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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 4
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K152749
Device Name moorLDI2 Laser Doppler Imager
Indications for Use (Describe)
The moorLDI2 Laser Doppler Imager is intended for blood flow measurements in the microcirculation. It is intended to be used for clinical research applications and pre-clinical research applications.
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/1 description: The image shows the logo for Moor Instruments. The logo consists of a blue circle with white lines radiating from the center on the left. To the right of the circle is the text "moor instruments" in blue, with the words "innovation in microvascular assessment" in a smaller font below.
5 510(k) Summary
5.1 Submitter Information:
| Type of 510(k): | Traditional | ||
|---|---|---|---|
| Submitter: | Moor Instruments Ltd | ||
| Establishment Reg No: | 8043564 | ||
| Address: | Millwey, Axminster, Devon, EX13 5HU, United Kingdom | ||
| Telephone: | (+44) 1297 35715 | ||
| Fax: | (+44) 1297 35716 | ||
| Contact: | Stewart Lillington | ||
| Contact title: | Product Development Manager | ||
| E-mail: | lillington@moor.co.uk | ||
| Date: | September 17th, 2015 | ||
| Device Information: | |||
| Trade Names: | moorLDI2-IRmoorLDI2-HIRmoorLDI2-VR | (moorLDI2 Infrared laser Doppler imager)(moorLDI2 High resolution infrared laserDoppler imager)(moorLDI2 Visible red laser Doppler imager) | |
| Common Name: | moorLDI2 laser Doppler imager | ||
| Classification Name: | Extravascular blood flow probe(21 CFR 870.2120, Product code DPT)Powered laser surgical instrument(21 CFR 878.4810, Product Code GEX) | ||
| Predicate Device: | moorLDI2-IR laser Doppler imager510(k) Number - K032841Product codes DPT & GEX |
Moor Instruments Ltd Millwey Axminster Devon EX13 5HU UK tel +44 (0)1297 35715 fax +44 (0)1297 35716 email sales@moor.co.uk website www.moor.co.uk Company Registered in England No. 2209367 VAT Registration No. GB490667906
Image /page/3/Picture/6 description: The image contains two certification logos. The first logo on the left is for ISO 13485 system certification, featuring a blue checkmark enclosed within a stylized "S" shape, accompanied by the text "SGS". The second logo on the right is a UKAS Management Systems accreditation mark, which includes a crown above a checkmark, with the text "UKAS MANAGEMENT SYSTEMS" and the number "0005" below.
Image /page/3/Picture/7 description: The image shows a partial view of a circular diagram with a light blue and white color scheme. The diagram is divided into sections by white lines radiating from the center. The text "5-1" is visible near the center of the diagram. The overall impression is that of a stylized sun or a pie chart with a limited data set.
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5.2 Device information
| Trade names: | moorLDI2-IR | (moorLDI2 Infrared laser Doppler imager) |
|---|---|---|
| moorLDI2-HIR | (moorLDI2 High resolution infrared laserDoppler imager) | |
| moorLDI2-VR | (moorLDI2 Visible red laser Doppler imager) | |
| Common Name: | moorLDI2 laser Doppler imager | |
| Classification Name: | Extravascular blood flow probe(21 CFR 870.2120, Product code DPT) | |
| Powered laser surgical instrument(21 CFR 878.4810, Product Code GEX) | ||
| Predicate Device: | moorLDI2-IR laser Doppler imager510(k) Number - K032841 |
5.3 Description of the device
The moorLDI2 is a device to perform non-invasive blood flow measurements in the microcirculation, for example skin, using the established laser Doppler technique to quantify movement of blood cells beneath the skin surface.
Laser Doppler Imaging (LDI) is a technique first established commercially in the early 1990's and as such published studies now cover numerous pre-clinical research and clinical applications.
The system scans a very low power laser beam across the tissue. Moving blood in the microvasculature causes a Doppler frequency shift of the laser light, which is photo detected and processed to generate a colour coded blood flow map, line by line. An in built CCD camera records a colour photograph to aid visualisation of the scan site.
Image /page/4/Figure/7 description: The image shows a schematic diagram of a laser Doppler vibrometer system. The system includes a laser, shutter, photodiode, lenses, camera, scanning mirror, Doppler signal processor, and computer. The laser beam is directed through the shutter and lenses, then reflected off the scanning mirror onto the scanned area. The reflected light is collected by the lenses and photodiode, and the Doppler signal processor analyzes the signal to determine the vibration characteristics of the scanned area, which is then displayed on the computer.
Figure 1. Principle of operation
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The moorLDI2 laser Doppler imager scan head case consists of two injection moulded parts. Additionally a detachable injection moulded connector covers the external connectors in normal use. All injection moulded components are manufactured using Sika Biresin RG53 FR resin which is flame retardant to UL 94-V0. The enclosure has a cream coloured painted finish.
Image /page/5/Picture/2 description: The image shows a piece of medical equipment that is white and blue. The equipment has a white rectangular top with a blue handle. The equipment is attached to a blue stand that has a vertical pole and a horizontal base. The equipment is likely used for medical imaging or treatment.
Figure 2. moorLDI2 fitted to Desktop Stand (DS2)
There are 3 moorLD12 variants based upon the same design, moorLD12-VR, moorLD12-IR and moorLDI2-HIR. The key differences are shown in Table 1. In all other respects the three instruments are essentially identical in terms of their design and construction. Where differences between the instruments are not significant, they are collectively referred to using the generic term "moorLDI2".
| Model | moorLDI2-VR | moorLDI2-IR | moorLDI2-HIR | |
|---|---|---|---|---|
| Laser type | Helium Neongas laser | Infra-red laserdiodeVisible red laserdiode | Infra-red laserdiode | Visible red laserdiode |
| Wavelength | 633nm | 785nm658nm | 785nm | 658nm |
| Maximumoutput power | 2.5mW | 2.35mW130 $\mu$ W | 1.5mW | 130 $\mu$ W |
| Beam diameter(1/e² points) | 1.2mm | 1.2mm | 0.7mm minimum (25cm from scan head) | |
| Beamdivergence | 1.4milliradians | 2.6milliradians | ||
| Scan Area(20cm Distance) | (Normal area): 6.6cm x 6.6cm(Large area): 13cm x 13cm | (Normal area): 2.5cm x 2.5cm(Large area): 5cm x 5cm | ||
| Scan Area(100cm Distance) | (Normal area): 25cm x 25cm(Large area): 50cm x 50cm | (Normal area): 9.4cm x 9.4cm(Large area): 18.8cm x 18.8cm |
Table 1
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The physical and performance characteristics of the moorLDI2 laser Doppler imager are summarised in Table 1 and Table 2:
| MeasuredParameters | Flux (Tissue perfusion) | |
|---|---|---|
| Range: | 0-5000 PU | |
| Accuracy: | ±10% relative to Moor Instruments 'standard' moorLDI±3% of measurement from temperature controlled (22 ±1°C) motility standard | |
| Conc (Concentration of blood flow) | ||
| Range: | 0-5000 AU | |
| Accuracy: | ±10%±3% of measurement value | |
| DC (Intensity) | ||
| Range: | 0-5000 AU | |
| Accuracy: | ±10%±3% of measurement value | |
| Maximum imageresolution | 256 x 256 pixels | |
| Scan speed | 4ms/pixel, 10ms/pixel, 50ms/pixel | |
| Standard system | High resolution system (moorLDI2-HIR) | |
| 20cm distance(Normal area): 6.6cm x 6.6cm(Large area): 13cm x 13cm100cm distance(Normal area): 25cm x 25cm(Large area): 50cm x 50cm | 20cm distance(Normal area): 2.5cm x 2.5cm(Large area): 5cm x 5cm100cm distance(Normal area): 9.4cm x 9.4cm(Large area): 18.8cm x 18.8cm | |
| Scan area | ||
| Bandwidth | Lower cut-off frequency (3dB): 20/100/250Hz (Scan rate dependant)Upper cut-off frequency (0.1dB): 3/15/22.5kHz (Selectable) | |
| CMOS Camera | Colour, Auto Focus, 2592 x 1944 pixel resolution, 1296 x 972 (2 x binned) pixel resolution | |
| Indoor: e.g. hospital or laboratory use | ||
| Operatingenvironment | Temperature range: | 15-30°C |
| Humidity:Atmospheric pressure:Lighting conditions: | 20-80% RH (excluding condensation)within 86.0kPa to 106.0kPa (645mmHg to 795mmHg)Normal, ambient room lighting | |
| Storage andtransportationenvironment | Temperature range:Humidity:Atmospheric pressure:Humidity: | 5-50°C20-80% RH (excluding condensation)50.0-106.0kPa (375-795mmHg)0-80%, non-condensing |
| Dimensions | Scan Head:PSU: | 426x244x300mm (WxHxD) max107x56x171mm (WxHxD) max |
| Weight | Scan Head:PSU: | 9.0kg0.5kg |
| Power source | AC mains, Universal switched mode, 100-230V, 50-60Hz, 50VA power consumption |
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| Electrical safetyclassification | Type of protection against electric shock – Class 1Degree of protection against electric shock – Non-patient contact, no applied partDegree of protection against ingress of liquid – IPX0 (not protected)Degree of protection against flammable anaesthetics – equipment not suitable for use inthe presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide |
|---|---|
| Medical deviceclassification | Class IIa Active device for diagnosis under EC directive 93\42 EEC 14th June 1993Medical Device Directive. |
| LaserClassification | Class 3R (per IEC 60825-1:2007) |
| MinimumComputerSpecification | Dual core Pentium® 4 processor, 2GHz or higher compatible CPU2GB RAMSuper VGA monitor (1024 x 768 resolution or higher)100GB of available hard drive spaceOperating System: Windows 7 (32/64-bit), Windows 8 (32/64-bit)2 USB ports |
Table 2
5.4 Intended Use
The moorLDI2 Laser Doppler Imager is intended for blood flow measurements in the microcirculation. It is intended to be used for clinical research applications and pre-clinical research applications. The intended use remains the same as for the predicate device.
5.5 Technological comparison to predicate device
The moorLDI2 laser Doppler imager uses the same principle of operation as the predicate device. The overall optical and mechanical design is very similar to the predicate device, but the electronic control system and associated software have been completely redesigned to resolve component obsolescence problems and to reduce the manufacturing costs.
The design of the predicate device consists of a scan head and a separate control box which contains most of the electronic control systems. In the revised design most of the electronic systems are now integrated within the scan head and the only extra component is a small external mains power supply. The external design of the scan head remains unchanged, except for revised graphics on the front panel. The following picture shows the revised design on the left and the predicate device on the right.
Image /page/7/Picture/8 description: The image shows three pieces of equipment from Moor Instruments. The first piece of equipment on the left is a moorLDI2 with a black power supply box next to it. The second piece of equipment is also a moorLDI2. The third piece of equipment on the right is a moorLDI Laser Doppler Imager Control.
Although the revised design involves changes to the electronic hardware and software, it uses the same principles of operation and is intended to provide essentially the same measurement performance as the existing system. All of the major performance specifications remain unchanged.
The similarities between the systems are as follows:
- Has the same intended use. ●
- . Uses the same operating principle.
- . Has the same image resolution options.
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- . Has the same laser classification.
- . The scan head has the same external dimensions.
The main differences between the systems are as follows:
- . The revised design has all electronics, with the exception of the mains power supply, located in the scan head. Therefore it no longer requires the large external control box, just a small external PSU.
- . A visible red (633nm) laser option has been added which restricts measurement depth to superficial surface blood flow.
- . A high resolution option has been introduced which provides increased spatial resolution for smaller measurements sites.
- . A USB camera has replaced the Firewire camera to increase reliability and reduce the build cost of the system.
The model range has been extended to include 3 variants which differ in terms of laser wavelength and image area and resolution. The model variants are related to the predicate device as shown in Table 3.
| Model | Laser (Wavelength) | ImageResolution | Image area | Comparison withpredicate device |
|---|---|---|---|---|
| moorLDI2-IR | Infra-red laser diode (785nm) | Standard | Standard | Same |
| moorLDI2-HIR | Infra-red laser diode (785nm) | High | Small | New |
| noorLDI2-VR | Helium Neon gas laser (633nm) | Standard | Standard | New |
Table 3
The visible red (633nm) laser in the moorLDI2-VR system provides reduced measurement depth compared with the infrared (785nm) laser in the other two systems. The moorLDI2-HIR system is optimised to provide increased resolution for smaller measurement sites.
5.6 Performance comparison to predicate device
The moorLD12 laser Doppler imager was tested in direct comparison to the predicate device using laboratory models and skin blood flow measurements on volunteers.
5.7 Conclusions
The moorLDI2 laser Doppler imager demonstrated that the device is as safe, as effective and performs as well as or better than the predicate device.
§ 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).