(101 days)
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.
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.
The provided text describes the moorFLPI-2 Full-Field Laser Perfusion Imager, a device intended for non-contact imaging of tissue blood perfusion in the microcirculation for clinical research use. It focuses on demonstrating substantial equivalence to a predicate device (moorFLPI Full-Field Laser Perfusion Imager, K063586).
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on a qualitative comparison to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalent technology and principle of operation to predicate | Uses the same technology and principle of operation as the predicate device |
| Performance equivalent to predicate device | Demonstrated performance equivalent to the predicate device |
| Safety equivalent to predicate device | Demonstrated safety equivalent to the predicate device |
| Effectiveness equivalent to predicate device | Demonstrated effectiveness equivalent to the predicate device |
| Same intended use as predicate device | Intended use is the same as the predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the "test set." It mentions "laboratory models and skin blood flow measurements on volunteers." The number of volunteers or specific lab models used is not provided.
- Data Provenance: The study was conducted by Moor Instruments Ltd, located in the United Kingdom. It appears to be a prospective comparison study as it describes testing the moorFLPI-2 directly against the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study focuses on direct device comparison rather than relying on expert-established ground truth for a diagnostic outcome.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a direct device comparison (measuring blood flow), a traditional expert adjudication method for a test set of cases is unlikely to be applicable in the same way as for diagnostic imaging.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a measurement instrument for blood flow, not an AI-powered diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The moorFLPI-2 is a standalone device ("Full-Field Laser Perfusion Imager") that performs measurements. The study described compares its performance to another standalone device (the predicate). Therefore, the study, by its nature of comparing two instruments, can be considered evaluating its standalone performance in relation to the predicate. However, it's not an "algorithm only" in the sense of a software-based AI system; it's a hardware device with integrated signal processing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" in the diagnostic sense (e.g., pathology for a tumor) is not directly applicable here. The study established "ground truth" through direct comparison to the predicate device's measurements on the same laboratory models and volunteers. The predicate device (moorFLPI) itself implicitly serves as the "reference standard" or "ground truth" for the new device's performance, as the goal was to demonstrate equivalence.
8. The Sample Size for the Training Set
This information is not applicable or not provided. The moorFLPI-2 is a measurement device that uses speckle contrast analysis, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its underlying physics and signal processing are based on established principles, rather than learning from a large dataset.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" for an AI algorithm.
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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 riseAxminsterDevonEX13 5HUUnited 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.
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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.
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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
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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
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Indications for Use Statement
K122943 510(k) Number:
Device name: moorFLPI-2 Full-Field Laser Perfusion Imager
Indications for use:
. - ------
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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
§ 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).