(201 days)
Not Found
No
The summary describes a laser Doppler imaging device that quantifies blood flow to aid clinician assessment. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The device appears to rely on direct measurement and visualization of blood flow for clinician interpretation, not automated analysis or prediction using AI/ML algorithms.
No
The device is an imaging tool used to aid in the assessment of burn wounds and judge healing potential; it does not directly treat or provide therapy.
Yes
The device assesses blood flow in burn wounds to aid in the clinician's assessment of burn wound healing potential, which is a diagnostic purpose.
No
The device description explicitly details hardware components, including a laser line projector, a linear detector array, and a CCD camera, which are integral to its function of acquiring laser Doppler and photographic images.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The device description clearly states that the moorLDLS-BI "assesses the blood flow in burn wounds of the skin" and "quantifies the blood flow in an area of skin damaged by a burn." This involves direct interaction with the patient's skin, not the analysis of a biological sample (like blood, urine, tissue biopsy, etc.) that has been removed from the body.
- The input modality is Laser Doppler imaging. This is an imaging technique applied externally to the body, not a method for analyzing a biological sample in a laboratory setting.
Therefore, the moorLDLS-BI is a medical device used for in vivo assessment (assessment within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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%.
Product codes (comma separated list FDA assigned to the subject device)
DPT, GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Laser Doppler Imaging, CCD camera for color photograph
Anatomical Site
Skin (burn wounds)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended to be used within the hospital environments by burns surgeons.
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall accuracy: 94.2% when compared with healing records.
Agreement with predicate device: 95.4% for HP14, 94.2% for HP14-21 and 98.5% for HP>21.
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
struments laser Doppler blood flow assessment
moorLDLS-Bl 510(k) Summary ર
K132163 : Page 1 of 3
| Submitter: | Moor Instruments Ltd | |
|---|---|---|
| Address: | Millwey | |
| Axminster, Devon | ||
| EX13 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 870.2120 | |
| Laser surgical instrument for use in general and plastic surgery | ||
| and 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 |
5-1
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
Image /page/0/Picture/7 description: The image contains two logos. The logo on the left has a check mark inside of a circle with the text "ISO 9001:2000 SGS" underneath. The logo on the right has a check mark with a crown above it and the text "UKAS Management Systems 005" underneath. Both logos appear to be quality assurance or certification marks.
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.
.
1
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.
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.
Intended Use
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.
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 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.
5-2
2
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;
-
- 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.
- To compare the performance of the moorLDLS-Bl with the predicate device moorLDI2-BI burns imager.
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.
5-3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
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
4
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
5
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