(351 days)
The moorLDI2-BI laser Doppler burns imager assesses the blood flow in debrided burn wounds of the skin. 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 moorLDI2-BI laser Doppler imager is a measurement device to aid the clinician judge the healing potential of burns and the need for surgery. It uses the laser Doppler technique to quantify the blood flow in an area of skin damaged by a burn. The device has the means to scan a low power visible red laser beam or low power near infrared laser beam combined with a visible red target beam, across the skin surface enabling a colour coded image of the blood flow in the burn area and the surrounding normal skin to be recorded, together with a monochrome photo image. In addition, a colour video image of the scanned area is recorded using a CCD camera which is an integral part of the device. Regions of interest (e.g. a burn area) can be selected and the statistics of the blood flow values, within the region, calculated and displayed.
Here's an analysis of the provided text regarding the acceptance criteria and study for the moorLDI2-BI Laser Doppler Burns Imager:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Prediction Accuracy for Healing Potential) | Reported Device Performance |
|---|---|
| Better than 90% accuracy | Better than 90% accuracy |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of cases or patients. The study was conducted "over a 3 year period, from 2001 to 2004."
- Data Provenance: The study was conducted by a group of experienced burns surgeons working in 5 hospital burns centers. The country of origin is not explicitly stated, but the company is based in the UK and the initial predicate device was cleared by the FDA, suggesting international relevance. The study appears to be prospective in nature, as it investigated the use of the devices over a 3-year period to identify and quantify blood flow ranges for prediction.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: A "group of experienced burns surgeons" from 5 hospital burns centers. The exact number is not specified, but it implies multiple experts.
- Qualifications of Experts: "Experienced burns surgeons." No further details on years of experience are provided.
4. Adjudication Method for the Test Set
The text mentions that the experts "identified and quantified three laser Doppler blood flow ranges (high, medium and low) which allow an experienced burns surgeon to predict the healing potential." This suggests a consensus-based approach among the group of surgeons, but a specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not explicitly mentioned. The study described focused on the device's ability to aid surgeons in prediction, not on comparing surgeon performance with and without AI assistance or the device.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not explicitly mentioned. The device is described as an "aid to burn wound management" and for use "by a trained operator (a burns surgeon or under the direction of a burns surgeon)," indicating a human-in-the-loop system rather than a fully autonomous algorithm. The "PC software uses a colour palette for blood flow images based on the results of this clinical investigate which can be used by a trained operator... as an aid to predicting healing potential."
7. Type of Ground Truth Used
The ground truth was based on the healing potential of the burn, categorized as "healing in <14 days, 14-21 days and > 21 days." This is a form of outcomes data or clinical endpoint as assessed by experienced burns surgeons.
8. Sample Size for the Training Set
The document does not explicitly mention a separate training set or its sample size. The description of the performance study sounds more like a validation of pre-established "laser Doppler blood flow ranges (high, medium and low)" rather than a development or training study for a new algorithm within the moorLDI2-BI. The "PC software for the moorLDI2-BI is designed specifically for the recording and measurement of blood flow in skin burns... uses a colour palette for blood flow images based on the results of this clinical investigate." This implies the "clinical investigate" informed the color palette and predictive ranges used in the software, rather than explicitly training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As no separate training set is explicitly described in the context of a machine learning algorithm, the establishment of ground truth for a training set is not applicable in the conventional sense of AI/ML development. Instead, the "laser Doppler blood flow ranges (high, medium and low)" (which could be considered analogous to predictive categories) were "identified and quantified" by the "group of experienced burns surgeons" over the 3-year study period based on observed healing outcomes.
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Image /page/0/Picture/0 description: The image shows the logo for Moor Instruments. The logo consists of a stylized sun-like graphic on the left, followed by the text "moor instruments" in a combination of bold and regular font weights. Below this, the text "laser Doppler blood flow assessment" is printed in a smaller, lighter font.
510(k) Summary
Page
| Company Name: | MOOR INSTRUMENTS LIMITED |
|---|---|
| Address: | Millwey, Axminster, Devon EX13 5HU UK |
| Telephone No: | +44 (0) 1297 35715 |
| Fax No: | +44 (0) 1297 35716 |
| Contact Name: | DAVID BOGGETT |
| Contact Title: | Managing Director |
| Date: | 9 th August 2006 |
| Classification Name: | Blood Flow, CardiovascularProduct Code: DPT, GEXRegulation Number: 21 CFR 870.2120 /21 CFR 878.4210 |
| Common/Usual Name: | moorLDI Burns Imager |
| Trade/Proprietary Name: | moorLDI2-BI Laser Doppler Burns Imager |
| Establishment Registration No: | 8043564 |
| Classification: | Regulatory Class II |
| Performance Standards: | The equipment conforms to:- |
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Medical Electrical Equipment as per BS EN 60601-1:1990
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Class 3R Medical Laser Product as per IEC 825:1:1993 + A1:1997 + A2:2001
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21 CFR 1040:10 and 1040:11 Except for deviations pursuant to Laser Notice No. 50 Dated July 26, 2001
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Electromagnetic Compatibility Requirements and Tests as per BS EN 60601-1-2:1993 including AMD10002 1998
MAR 27 20076060976
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- General Requirements for Programmable Electrical Medical Systems as per BS EN 60601-1-4:1997
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- Medical Electrical Equipment Part 1: General Requirements for Safety as per UL 2601-1:2003
Additional or expanded indications
moorLDI Laser Doppler Blood Flow Imager 510(k) K980383 moorLDI2-IR Infrared laser Doppler Imager 510(k)
Moor Instruments Ltd Millwey Axminster Devon EX13 SHU 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
Reason for Submission:
Predicate Devices:
Image /page/0/Picture/10 description: The image contains two logos. The logo on the left is the SGS logo, which features a checkmark inside a circle with the letters "SGS" below it. The logo on the right is the UKAS Quality Management logo, which features a crown above a checkmark with the letters "UKAS" below it. The number 005 is at the bottom of the UKAS logo.
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Description of the Device:
The moorLDI2-BI laser Doppler imager is a measurement device to aid the clinician judge the healing potential of burns and the need for surgery.
It uses the laser Doppler technique to quantify the blood flow in an area of skin damaged by a burn. The device has the means to scan a low power visible red laser beam or low power near infrared laser beam combined with a visible red target beam, across the skin surface enabling a colour coded image of the blood flow in the burn area and the surrounding normal skin to be recorded, together with a monochrome photo image. In addition, a colour video image of the scanned area is recorded using a CCD camera which is an integral part of the device.
Regions of interest (e.g. a burn area) can be selected and the statistics of the blood flow values, within the region, calculated and displayed.
Intended Use
The moorLDI2-Bl laser Doppler burns imager assesses the blood flow in debrided burn wounds of the skin. 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%.
Technological Characteristics
The operation and design of the moorLDI2-Bl laser Doppler burns imager is based on the predicate moorLDI and moorLDI2-IR laser Doppler imagers.
The burns imager laser light source is either .-
a Helium Neon red gas laser as used in the moorLDI or a visible red laser diode as used in the moorLDI2-VR or a near infrared laser diode with visible red target beam as used in the moorLDI2-IR.
(Note that the moorLDI2-VR differs from the moorLDI2-IR in that it has a visible red laser diode rather than a near infrared laser diode).
The burns imager with the near infrared laser has identical hardware to that of the moorLDI2-IR.
The design and construction of the electronics and the basic optics are the same for all three imagers. The instrument case for the burns imager is the same as that of the moorLDI2-IR except for the colour and the labelling of the front panel.
The main difference between the devices is the PC software for image display and processing.
The PC software for the moorLDI2-Bl is designed specifically for the recording and measurement of blood flow in skin burns. The range of instrument settings and image processing operations is limited to those appropriate for aiding the clinician in assessing the healing potential of a burn wound. The PC software for the moorLDI and moorLDI2-IR is designed for research applications where a wide range of instrument settings are needed to investigate blood flow in the microcirculation of skin and other organs. The moorLDI and the
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moorLD12-IR has been used over a number of years for measurement and recording of blood flow in skin burns and reports have been published in international journals.
The moorLDI2-BI and it's predicate devices are calibrated identically and use the same blood perfusion units.
Performance Data
The moorLDI2-Bl is manufactured to the same design as the moorLDI and moorLDI2-IR.
It has the same test and performance specifications.
The use of the moorLDI, the moorLDI2-VR and moorLDI2-IR imagers to assess the healing potential of a burn has been investigate over a 3 year period, from 2001 to 2004, by a group of experienced burns surgeons working in 5 hospital burns centres.
They have identified and quantified three laser Doppler blood flow ranges (high, medium and low) which allow an experienced burns surgeon to predict the healing potential of a burn (healing in <14 days, 14-21 days and > 21 days) to better than 90% accuracy after confounding factors such as wound infection, etc. are taken into account. The moorLDI2-BI PC software uses a colour palette for blood flow images based on the results of this clinical investigate which can be used by a trained operator (a burns surgeon or under the direction of a burns surgeon) as an aid to predicting healing potential and hence the need, or not, for surgery.
The moorLDI2-BI blood flow images of burns and/or their interpretation can be adversely influenced by a number of factors: these must be considered during assessment. These are referred to as confounding factors: un-debrided skin/debris/eye coverings, infection, medication/sickness, edge effect, high reflection, scan too soon after debridement, and scan after day 5.
Conclusions
The moorLDI2-BI is substantially equivalent to the predicate devices in terms of technological characteristics and performance.
All three devices can be used to image burns. The moorLDI2-Bl uses PC software specifically designed for imaging in a clinical environment and assessing blood flow in burn damaged skin in order to predict healing potential.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Moor Instruments Limited % Mr. David Boggett Managing Director Millwey, Axminster Devon EX13 5HU UK
MAR 2 7 2007
Re: K060976
Trade/Device Name: moorLD12-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: March 16, 2007 Received: March 20, 2007
Dear Mr. Boggett:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ke. P.10/2
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ko60976
Indications for Use Statement
510(k) Number: K060976
Device name: moorLDI2-BI Laser Doppler Burns Imager
Indications for use:
· The moorLDI2-BI laser Doppler burns imager assesses the blood flow in debrided burn wounds of the skin. 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 801 SubpartD) AND/OR
Over-The-Counter Use: No (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rohr
(Division Sign-Off) (Division of General, Restorative, and Neurological I 510(k) Number
§ 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).