(90 days)
Not Found
No
The summary describes a device using established laser Doppler technology and compares its performance to a predicate device using the same technique. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is intended for blood flow measurements, which is diagnostic, not therapeutic.
Yes
Explanation: The device is intended for "blood flow measurements in the microcirculation," which is a diagnostic function to assess a physiological condition.
No
The device description explicitly states it is a "device for imaging blood flow" and uses a "low power infrared laser beam combined with a visible target beam to scan...". This indicates the presence of hardware components (laser, scanning mechanism) beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "for blood flow measurements in the microcirculation." This describes a measurement taken directly from the living body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description confirms it "quantify movement of blood cells beneath the skin surface," which is an in vivo measurement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly on the patient's skin to measure blood flow in real-time.
N/A
Intended Use / Indications for Use
The moorLDI2-IR infrared Laser Doppler Imager is intended for blood flow measurements in the microcirculation.
Product codes (comma separated list FDA assigned to the subject device)
DPT, GEX
Device Description
The moorLD12-IR infrared laser Doppler imager 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 existing MK1 moorLDI laser Doppler imager, which use a low power visible red HeNe laser, the moorLDI2-IR has a low power infrared laser beam combined with a visible target beam to scan in a raster pattern over the skin surface to build up a colour coded image of blood flow.
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
Not Found
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)
In order to evaluate the performance of the moorLD2-IR infrared laser Doppler perfusion imager, and determine its substantial equivalence to the predicate device moorLDI, a set of comparison tests has been carried out. These include flow model, single point measurement and image scan using both devices. The results suggest that moorl DI2-IR has achieved the same performance as the predicate device moorLDl laser Doppler imager.
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
Moor Instruments Ltd
DEC 1 0 2003
EDICAL AND OPTO-ELECTRONIC INSTRUMENTATION
Millwey, Axminster Devon EX13 5HU England
Image /page/0/Picture/4 description: The image is a black and white drawing of a sun-like figure. The figure has a dark, circular center with many lines radiating outwards from the center. The lines vary in length and thickness, and they are arranged in a radial pattern around the center.
TEL: +44 (0) 1297 35715 FAX: +44 (0) 1297 35716 E-MAIL: mail @moor.co.uk WEBSITE: http://www.moor.co.uk
Image /page/0/Picture/6 description: The image contains a handwritten string of alphanumeric characters. The string reads 'K032841'. The characters are written in a cursive style, with some connections between the numbers.
Premarket Notification 510(k) Summary
Company Name:
Address:
Telephone No:
Fax No:
Contact Name:
Contact Title:
Date:
MOOR INSTRUMENTS LIMITED
MILLWEY AXMINSTER, DEVON U.K. EXI3 SHU
+44 (0)1297 35715
+44 (0)1297 35716
DAVE BOGGETT
Managing Director
02/12/2003
Image /page/0/Picture/22 description: The image shows a circular seal with the text "ASSURED FIRM" around the top half of the circle. Inside the circle is the number 5485. Below the number is a check mark and the letters "SGS".
Image /page/0/Picture/23 description: The image contains two logos. The logo on the left is the ISO 9001 quality standard logo, which is a circular seal with the text "QUALITY ASSURED FIRM" around the perimeter and "ISO 9001" in the center. The logo on the right is the UKAS Quality Management logo, which features a crown above a checkmark and the text "UKAS QUALITY MANAGEMENT" below. The number 605 is at the bottom of the UKAS logo.
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K03284|
510(k) Summary
Classification Name:
Blood Flow, Cardiovascular Product Code: DPT
Common/Usual Name:
Trade/Proprietary Name:
Establishment Registration No:
Classification:
Performance Standard:
CFR Section: 870.2120
Laser Doppler Perfusion Imager
moorLDI2-IR Infrared Laser Doppler Imager
8043564
Regulatory Class II
The equipment conforms to IEC 825:1:1993 + A1:1997 + A2:2001 Class 3R Medical Laser Product as per IEC 825:1:1993 + A1:1997 + A2:2001
The equipment complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50. Dated July 26, 2001
Reason for Submission:
Predicate Devices:
New Device
moorLDI Laser Doppler Perfusion Imager 510(k) Number - K980383
Description of the Device
The moorLD12-IR infrared laser Doppler imager 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 existing MK1 moorLDI laser Doppler imager, which use a low power visible red HeNe laser, the moorLDI2-IR has a low power infrared laser beam combined with a visible target beam to scan in a raster pattern over the skin surface to build up a colour coded image of blood flow.
Intended Use
The moorLDI2-IR infrared Laser Doppler Imager is intended for blood flow measurements in the microcirculation.
2
Technological Characteristics
. moorLDI2-IR Compared with moorLDI Laser Doppler Imager
The operation and design of the moor DI2-IR infrared laser Doppler image is based on the predicate device moorLDI. They both have the same intended use. Both devices rely on the same physical principle, i.e. the laser Doppler principle, to measure the tissue blood perfusion. Both instruments scan a low power laser beam over the tissue surface in a raster pattern to produce a two dimensional colour coded blood perfusion image. The main differences between two devices are the laser sources and inclusion of colour video camera in the moorLDI2-IR.
However, the potential hazards due to use of a near infrared lascr source is not considered to compromise the safety of the instrument since the moorLD12-IR has been designed to comply with all related safety standards and has implemented the extra safety precautions such as beam attenuator, visible aiming beam and infrared emission indicator to reduce the risks to an acceptable level.
Performance Data
In order to evaluate the performance of the moorLD2-IR infrared laser Doppler perfusion imager, and determine its substantial equivalence to the predicate device moorLDI, a set of comparison tests has been carried out. These include flow model, single point measurement and image scan using both devices. The results suggest that moorl DI2-IR has achieved the same performance as the predicate device moorLD1 laser Doppler imager.
Conclusions
From the description of the technological characteristics and the performance data, it can be concluded that the moorLDI2-IR infrared laser Doppler imager is substantial cquivalence to the predicate device moorLDI in terms of effectiveness and safety.
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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 features a stylized eagle with three wavy lines representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
DEC 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. David Boggett Managing Director Moor Instrument Ltd Millwey Axminster Devon, EX 13 5HU United Kingdom
Re: K032841
Trade/Device Name: moorLD12-IR Infrared Laser Doppler Imager Regulation Number: 21 CFR 870.2120, 21 CFR 878.4810 Regulation Name: Extravascular blood flow probe; Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: DPT, GEX Dated: September 5, 2003 Received: September 11, 2003
Dear Dr. 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 (Spccial 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencics. 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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Page 2 - Dr. David Boggett
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K 032841
Device Name: moorLD12-1R Infrared Laser Doppler Imager
Indications For Use:
The moorLDI2-IR infrared laser Doppler Imager is intended for blood flow measurements in the microcirculation.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K632841