The moorLDLS-BI laser Doppler burns imager assesses the blood flow in burn wounds of the skin, when cleaned of surface debris, to aid in the clinician's assessment of burn wound healing potential. It is intended to be used as an aid to burn wound management for patients with Total Body Surface Area burn of up to 30%.

The device is intended to be used as an aid to burn wound assessment, and not as a stand-alone prediction device.

Device Description

The moor DLS-BI laser Doppler burns imager is an imaging device to aid the clinician to judge the healing potential of bums and the need for surgery.

It uses the laser Doppler imaging technique to quantify the blood flow in an area of skin damaged by a burn. The device uses a line of laser light projected onto the tissue and a linear detector arrav that sample from the line as it is swept across the tissue to rapidly build up a colour coded image of blood flow in the burn area and the surrounding normal skin for healing potential prediction. In addition, a CCD camera is integrated into the scanner unit for recording a colour photograph at the time of scanning, corresponding closely with the blood flow image in size and aspect.

AI/ML Overview

The moorLDLS-BI laser Doppler burns imager is a substantial equivalent to the predicate device moorLDI2-B1 and assesses burn wound healing potential.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the clinical investigation's objectives and the comparative analysis against the predicate device. The primary performance metrics are accuracy in predicting healing potential and agreement with the predicate device.

Acceptance Criteria / Performance Metric	Reported Device Performance (moorLDLS-BI)	Notes
Overall accuracy in predicting burn wound healing potential (compared to healing records)	94.2%	This is a standalone performance metric for the moorLDLS-BI.
Agreement with predicate device (moorLDI2-BI) for HP14 (healing in <14 days)	95.4%	Demonstrates close correlation and substantial equivalence for predicting short healing times.
Agreement with predicate device (moorLDI2-BI) for HP14-21 (healing in 14-21 days)	94.2%	Demonstrates close correlation and substantial equivalence for predicting medium healing times.
Agreement with predicate device (moorLDI2-BI) for HP>21 (healing in >21 days)	98.5%	Demonstrates close correlation and substantial equivalence for predicting long healing times.
Non-inferiority to the predicate device (moorLDI2-BI)	Unlikely to perform more than 1.7% worse. (In fact, performed slightly better)	This indicates that the moorLDLS-BI is at least as effective as the predicate device, fulfilling a key aspect of substantial equivalence.
Electrical safety, laser radiation safety, electromagnetic compatibility, and programmable medical device standards conformity	Designed and tested for compliance with standards	Although specific compliance percentages or detailed results aren't provided, this statement confirms that regulatory safety criteria were met.
Good correlation for tissue blood flow measurement (bench testing)	Good correlation between moorLDLS-BI and predicate device in flow model and normal skin tissue scan results	This bench testing supports the foundational equivalence of the physiological measurement principle between the two devices before clinical application.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 596 burn cases for 204 burn patients.
Data Provenance: Multi-center clinical investigation conducted in five burns centers across various countries: 2 in the UK, 1 in the USA, 1 in Belgium, and 1 in Australia. The study was prospective in nature, as it was a "Clinical Investigation" designed to assess the performance of a new device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with X years of experience).

However, given the nature of "healing records" being the ground truth and the device's intended use as an aid to "clinician's assessment of burn wound healing potential" by "burn surgeons," it is highly probable that the ground truth was established by burn care clinicians/surgeons responsible for patient management and outcome tracking.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for establishing the ground truth from "healing records."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a MRMC comparative effectiveness study was not explicitly done for human readers. The study focused on comparing the performance of the device (moorLDLS-BI) against the predicate device (moorLDI2-BI) and against healing records, not on comparing human reader performance with and without AI assistance.
Effect size of human reader improvement: Not applicable, as this type of study was not conducted as described. The device is intended as an "aid to burn wound management," implying human oversight, but the study directly compares device performance, not human-AI synergy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment was done. The "overall accuracy of 94.2% was found for moorLDLS-Bl when compared with healing records" represents the device's standalone performance in predicting healing potential.
It's important to note that while the device has standalone accuracy, its intended use statement explicitly says, "It is intended to be used as an aid to burn wound assessment, and not as a stand-alone prediction device," indicating that clinical interpretation by a human is still required.

7. The Type of Ground Truth Used

Outcomes Data (Healing Records): The primary ground truth for the overall accuracy of the moorLDLS-BI was based on "healing records." This refers to the actual observed healing time of the burn wounds, which is a direct patient outcome.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. The description mentions a "clinical investigation" and performance data, but does not distinguish between a training set and a testing set in the context of machine learning model development. This suggests the moorLDLS-BI, while a new device, might not be heavily reliant on a trainable "algorithm" in the modern AI sense, but rather on a refined physical measurement principle and associated processing algorithms for which the mentioned clinical investigation serves as a validation/test set.

9. How the Ground Truth for the Training Set Was Established

Since a distinct "training set" is not mentioned or detailed, the method for establishing its ground truth is also not described. If any internal development process involved a training phase, that information is not part of this 510(k) summary.

Summary

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struments laser Doppler blood flow assessment

moorLDLS-Bl 510(k) Summary ર

K132163 : Page 1 of 3

Submitter:	Moor Instruments Ltd
Address:	MillweyAxminster, DevonEX13 5HU, United Kingdom	JAN 29 2014
Telephone:	(+44) 1297 35715
Fax:	(+44) 1297 35716
Contact:	Xiabing Huang
Contact title:	Managing Director
E-mail:	xhuang@moor.co.uk
Date:	July 1, 2013
Model Name:	moorLDLS-BI Laser Doppler Burns Imager
Model Number:	moorLDLS-BI
Common Name:	Laser Doppler Burns Imager
Classification Name:	Extravascular blood flow probe, DPT, 21 CFR 870.2120Laser surgical instrument for use in general and plastic surgeryand in dermatology, GEX, 21 CFR 878.4810
Regulatory Status:	Class II
Establishment Reg No:	8043564
Type of 510(k):	Traditional
Reason for submission:	New Device
Predicate Device:	moorLDI2-BI Laser Doppler Burns Imager

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510(k) Number K060976

Moor Instruments Ltd Millwey Axminster Devon EX13 5HU UK tel +14 (0)1297 35715 fax +44 (0)1297 35716 · amail sales@moor.co.uk website www.moor.co.uk Company Registered in England No. 2200367 VAT Ringisualion No. 08490987008

ﺑ

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Image /page/0/Picture/8 description: The image shows two semi-circular shapes, one above the other. Both shapes have a similar pattern of lines radiating outwards from a central point. The lines appear to be slightly curved and unevenly spaced, giving the impression of a natural or organic structure.

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K132163 Description of the Device

Page 2 of 3

The moor DLS-BI laser Doppler burns imager is an imaging device to aid the clinician to judge the healing potential of bums and the need for surgery.

Intended Use

The device is intended to be used as an aid to burn wound assessment, and not as a stand-alone prediction device.

Substantial Equivalence

Technological Characteristics

The operation and design of the moorLDLS-BI laser Doppler burns imager and the predicate device moorLDI2-B1 are very similar. Both devices rely on the same physical principle, i.e. the laser Doppler imaging technology, to measure the tissue blood perfusion for healing potential prediction of burn wounds. The moorLDLS-Bl uses the same dedicate colour palette as the predicate device to predict three types of burn wound healing potentials, i.e. HP14: healing in <14 days, HP14-21: healing in 14-21 days and HP>21: healing in > 21 days.

The main difference between two devices is the scanning method. The predicate device moorLDI2-BI scans a low power laser beam (single laser spot) over the tissue surface in a raster pattern to produce a two dimensional colour coded blood perfusion image, while the moorLDLS-BI laser Doppler burns imager uses a low power laser line to sweep across the tissue for rapid scanning which could be important in clinical environment to minimize scan time and patient discomfort.

Indication for Use

Both devices have the same intended use, i.e. assessing the blood flow in debrided burn wounds of the skin and to be used as an aid to burn wound management for patients with burn wounds.

Both devices are intended to be used within the hospital environments by burns surgeons for the same patient population, i.e. patients with burn wounds at 48 hours to 5 days post-burn.

Performance Data

The moorLDLS-BI burns imager has been designed and tested for compliance with the standards for electrical safety, laser radiation safety, electromagnetic compatibility and programmable medical device.

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K132163

Page 3 of 3

To establish the substantial equivalent between the predicate device for the effectiveness of burns assessment, two types of performance bench testing and a clinical investigation have been carried out. The bench testing includes a flow model experiment and image scan of normal skin tissue using both devices. The results show that the moorLDLS-Bl and the predicate device have a good correlation for tissue blood flow measurement.

A multi-centre clinical investigation entitled 'Clinical Investigation of the moorLDLS-Bl for Burn Healing Potential Assessment' was conducted in five burns centres (2 in the UK, 1 in the USA, 1 in the Belgium, 1 in the Australia).

The objectives of this clinical investigation were

To assess the performance and accuracy of a new moorLDLS-BI line scan burns 1. imager for prediction of burn wound healing potential;

1. To compare the performance of the moorLDLS-Bl with the predicate device moorLDI2-BI burns imager.
  The clinical investigation of the performance and accuracy for burns assessment using both devices has been performed on 596 burns cases for 204 burns patients. An overall accuracy of 94.2% was found for moorLDLS-Bl when compared with healing records. The agreement between the moorLDLS-Bl and moorLDI2-Bl as the non-reference stand was 95.4% for HP14, 94.2% for HP14-21 and 98.5% for HP>21.

A specific analysis of non-inferiority was performed and found that the moorLDLS-Bl is unlikely to perform more than 1.7% worse than the predicate device moorLDI2-Bl. In fact, the moorLDLS-Bl performed slightly better than the moorLD12-Bl for these data, so there may well be no drop in accuracy at all.

The laser Doppler blood flow images of burns and/or their interpretation can be adversely influenced by a number of factors: these must be considered during image interpretation. These are referred to as patient and technical related confounding factors such as un-debrided skin, infection, medication/sickness, Tattoos, edge effect, high reflection, and movement artefact;

Conclusions

Based on the indications for use, design, technology, performance and functional testing, and clinical evaluation, it can be concluded that the moorLDLS-Bl laser Doppler burns imager is substantial equivalent to the predicate device moorLD12-B1 as an aid to assessing healing potential in burn damaged skin in terms of effectiveness and safety.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Moor Instruments Ltd. Xiabing Huang Managing Director Millwey, Axminster Devon, EX13 5HU UNITED KINGDOM

January 29, 2014

Re: K132163

Trade/Device Name: MoorLDLS-BI laser-doppler burns imager Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular blood flow probe Regulatory Class: Class II Product Code: DPT, GEX Dated: December 12, 2013 Received: December 26, 2013

Dear Dr. Huang:

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 with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 – Xiabing Huang

CFR Part 807); labeling (21 CFR Part 801); medical device 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

For

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4 Indications for Use Statement

510(k) Number:_K132163

Device Name: moorLDLS-81 Laser Doppler Burns Imager

Indications For Use:

The moorl.DLS-81 laser Doppler burns imager assesses the blood flow in burn wounds of the skin, when cleaned of surface debris, to aid in the clinician's assessment of burn wound healing potential. It is intended to be used as an aid to burn wound management for patients with Total Body Surface Area burn of up to 30%.

Prescription Use: Yes
(Part 21 CFR 601 SubpartD)

AND/OR

Over-The-Counter User No (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden: Neil R Ogden - System - 05'00'

(Division Slgn-off) for BSA

Division of Surgical Devices

510(k) Number_K132163

Regulation Number and Section

§ 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).