(101 days)
No
The description mentions "image processing" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe a process that inherently requires these technologies for speckle contrast analysis.
No
Explanation: The device is intended for blood flow measurements and clinical research use, which are diagnostic and research purposes, not therapeutic.
No
The device is intended for clinical research use to measure blood flow in the microcirculation and generate images of tissue blood perfusion, but it does not state that it is used to diagnose a medical condition.
No
The device description explicitly states it includes hardware components such as a laser beam and a CCD camera for imaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "blood flow measurements in the microcirculation" and "clinical research use." This describes a device that measures a physiological parameter directly on the patient's tissue (in vivo), not a device that analyzes samples taken from the body (in vitro).
- Device Description: The description details a non-contact imaging technique using a laser and camera to measure blood perfusion in tissue. This is an in vivo measurement.
- Anatomical Site: The anatomical site is "tissue blood perfusion in the microcirculation, for example skin." This further confirms it's measuring something directly on the body.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The moorFLPI-2 Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.
Product codes
DPT
Device Description
The moorFLPI-2 is a device to perform non-contact imaging of tissue blood perfusion in the microcirculation, for example skin, using speckle contrast analysis. The tissue surface is illuminated with a diverging infra-red laser beam resulting in a laser speckle pattern. The pattern is imaged by a CCD camera and image processing of the speckle contrast is used to generate colour coded images of the tissue blood perfusion in the microcirculation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue blood perfusion in the microcirculation, for example skin
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)
The moorFLPI-2 was tested in direct comparison to the predicate device using laboratory models and skin blood flow measurements on volunteers. The moorFLPI-2 demonstrated performance, safety and effectiveness equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
moorFLPI Full-Field Laser Perfusion Imager, 510(k) number K063586
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for Moor Instruments. The logo consists of a circular graphic with radiating lines on the left, followed by the text "moor instruments" in a bold, sans-serif font. Below the company name, there is a tagline that reads "innovation in microvascular assessment" in a smaller, lighter font.
510(k) Summary 5
JAN 0 3 2013
Submitter information
| Submitter: | Moor Instruments Ltd |
|---|---|
| Address: | Millwey rise |
| 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 |
| Establishment Reg No: | 8043564 |
| Date of preparation: | September 18th 2012 |
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/0/Picture/7 description: The image contains two logos. The logo on the left has a checkmark inside of a circle with the letters "SGS" to the right of the circle. The text "ISO 17065:2012" is on the left side of the circle. The logo on the right has a crown above a checkmark with the text "UKAS QUALITY MANAGEMENT 005" below the checkmark.
1
Device information
| Trade name: | moorFLPI-2 Full-Field Laser Perfusion Imager |
|---|---|
| Common name: | Full-Field Laser Perfusion Imager |
| Classification name: | Extravascular blood flow probe (21 CFR 870.2120, Product code DPT) |
| Predicate device: | moorFLPI Full-Field Laser Perfusion Imager, 510(k) number K063586 |
The moorFLPI-2 is a device to perform non-contact imaging of tissue blood perfusion in the microcirculation, for example skin, using speckle contrast analysis. The tissue surface is illuminated with a diverging infra-red laser beam resulting in a laser speckle pattern. The pattern is imaged by a CCD camera and image processing of the speckle contrast is used to generate colour coded images of the tissue blood perfusion in the microcirculation.
5.1 Intended Use
The moorFLPI-2 Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.
5.2 Technological comparison to predicate device
The moorFLPI-2 Full-Field Laser Perfusion Imager uses the same technology and principle of operation as the predicate device whilst adding secondary features to improve ease of use. The intended use of both devices is the same.
5.3 Performance comparison to predicate device
The moorFLPI-2 was tested in direct comparison to the predicate device using laboratory models and skin blood flow measurements on volunteers.
5.4 Conclusions from testing
The moorFLPI-2 demonstrated performance, safety and effectiveness equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Moor Instruments, Limited % Mr. Stewart Lillington Product Development Manager Mill Wey Axminster, Devon United Kingdom EX 135HU
January 3, 2013
Re: K122943
Trade/Device Name: moorFLPI-2 Full-Field Laser Perfusion Imager Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular blood flow probe Regulatory Class: Class II Product Code: DPT Dated: November 07, 2012 Received: November 13, 2012
Dear Mr. 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 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 (reporting of medical
3
Page 2 - Mr. Stewart Lillington
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K122943 510(k) Number:
Device name: moorFLPI-2 Full-Field Laser Perfusion Imager
Indications for use:
. - ------
17
The moorFLPI-2 Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.
Prescription Use: Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: No (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden 2012.12.28 15:53:16 -05'00'
(Division Sign-Off) Division of Surgical Devices
510(k) Number K122943