(89 days)
The moorVMS-LDF1 and moorVMSLDF2 laser Doppler perfusion and temperature monitors are intended for simultaneous measurement of tissue temperature and blood flow in the microcirculation. The devices are intended for clinical research use.
moorVMS-LDF1 Laser Doppler perfusion and temperature monitor
moorVMS-LDF2 Laser Doppler perfusion and temperature monitor
The provided text is a 510(k) summary for the moorVMS-LDF1 and moorVMS-LDF2 Laser Doppler perfusion and temperature monitors. It outlines the device, its classification, and the substantial equivalence determination by the FDA. However, it does not contain information regarding detailed acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical study report.
The document states that the FDA has determined the device is substantially equivalent to a legally marketed predicate device (DRT4 Laser Doppler perfusion and temperature monitor, K011070). This means the FDA believes the new device is as safe and effective as the predicate, but it does not detail specific performance metrics and their validation studies.
Therefore, I cannot provide the requested information in the structured format you asked for.
Here's why each point cannot be addressed with the provided text:
- Table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory approval based on substantial equivalence, not detailed performance criteria.
- Sample size used for the test set and the data provenance: No test set information is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method for the test set: No test set or adjudication method is mentioned.
- 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: This device is a Laser Doppler perfusion and temperature monitor, not an AI-based diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a monitor, not an algorithm, so this is not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no specific performance study with ground truth is detailed.
- The sample size for the training set: Not applicable as this is not an AI-based device that would require a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains a logo and text. The logo is on the left and features a black and white sun-like design. To the right of the logo is the text "הווקשוווגרונג וועטווו laser Doppler blood flow assessment".
K083082_
510(k) Summary 7
| Submitter: | Moor Instruments Ltd | |
|---|---|---|
| Address: | MillweyAxminster, DevonEX13 5HU, United Kingdom | JAN 13 2009 |
| Telephone: | (+44) 1297 35715 | |
| Fax: | (+44) 1297 35716 | |
| Contact: | Xiabing Huang | |
| Contact title: | Technical Manager | |
| E-mail: | xhuang@moor.co.uk | |
| Date: | October 8th, 2008 | |
| Model Name: | moorVMS-LDF1 Laser Doppler perfusion and temperaturemonitormoorVMS-LDF2 Laser Doppler perfusion and temperaturemonitor | |
| Model Number: | moorVMS-LDF1moorVMS-LDF2 | |
| Common Name: | Laser Doppler perfusion and temperature monitor | |
| Classification Name: | Laser surgical instrument for use in general and plastic surgeryand in dermatology, GEX, 21 CFR 878.4810 | |
| Regulatory Status: | Class II | |
| Establishment Reg No: | 8043564 | |
| Type of 510(k): | Traditional | |
| Reason for submission: | New devices | |
| Predicate Device: | DRT4 Laser Doppler perfusion and temperature monitor510(k) Number K011070 |
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/5 description: The image contains two logos. The logo on the left is the SGS logo, which features a checkmark inside a circle. The logo on the right is the UKAS (United Kingdom Accreditation Service) logo, which features a crown above a checkmark. The UKAS logo also includes the text "UKAS QUALITY MANAGEMENT 005".
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Moor Instruments Ltd. % Xiabing Huang Millwey Axminster, Devon EX13 5HU, United Kingdom
Re: K083082
Trade/Device Name: moorVMS-LDF1 Laser Doppler perfusion and temperature monitor moorVMS-LDF2 Laser Doppler perfusion and temperature monitor Regulation Number: 21 CFR 878.4810
JAN 1 8 2009
Regulation Name: Laser surgical instrument for use in general and plastic surgery and
in dermatology
Regulatory Class: II Product Code: GEX Dated: October 8, 2008 Received: October 16, 2008
Dear Xiabing 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.
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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Page 2 - Xiabing Huang
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark M. Millerson
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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5 Indications for Use Statement
510(k) Number: _ K 083082
moorVMS-LDF1 Laser Doppler perfusion and temperature monitor Device name: moorVMS-LDF2 Laser Doppler perfusion and temperature monitor
Indications for use:
The moorVMS-LDF1 and moorVMSLDF2 laser Doppler perfusion and temperature monitors are intended for simultaneous measurement of tissue temperature and blood flow in the microcirculation. The devices are intended for clinical research use.
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)
David Krone for MKM
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number K083082
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.