(53 days)
VivoSight is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.
Multi-Beam Optical Coherence Tomography (OCT) tissue imaging system
The provided text does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary and an FDA clearance letter for the "VivoSight Topical OCT System".
It primarily discusses:
- Device Identification: Trade Name, Common Name, Classification, Predicate Device.
- Intended Use: "Intended to be used as an imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization."
- FDA Clearance: Confirmation of substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide the requested table and study details based on the input.
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Michelson Diagnostics Ltd
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Executive Summary
JAN - 5 2010
This executive summary has been prepared in accordance with 21 CFR 807.87(h) and the 510(k) has been prepared in accordance with 21 CFR 807.92
| Submitter | Michelson Diagnostics Ltd11A Grays Farm Production VillageGrays Farm RoadOrpingtonKentBR5 3BD | |
|---|---|---|
| Contact Person | Name: | Martin Johns |
| Job Title: | Operations Director | |
| Address: | 11A Grays Farm Production VillageGrays Farm RoadOrpingtonKentBR5 3BDUnited Kingdom | |
| Date Summary Prepared | November 11, 2009 | |
| Device Trade Name | VivoSight Topical OCT System | |
| Device Common Name | Multi-Beam Optical Coherence Tomography (OCT) scanner | |
| Device Classification | II | |
| Legally Marketeddevices to which thedevice is substantiallyequivalent | Imalux OCT Imaging System | |
| Description of theDevice | Multi-Beam Optical Coherence Tomography (OCT) tissueimaging system | |
| Intended Use of theDevice | The intended use of the Michelson Diagnostics VivoSightTopical OCT System:Intended to be used as an imaging tool in the evaluation ofexternal human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualizationThis is the same as the predicate device with the addition thatit is for external tissue only | |
| Telephone number: | 00 1 44 208 308 1695 | |
| Fax number: | 00 1 44 121 275 6237 |
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN - 5 2010
Michelson Diagnostics Ltd. % Mr. Martin Johns Operations Director 11A Grays Farm Production Village Grays Farm Road, Orpington Kent BR5 3BD, United Kingdom
Re: K093520
Trade/Device Name: VivoSight Topical OCT System Regulation Number: 21 CFR 892-1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: NOQ Dated: December 16, 2009 Received: December 22, 2009
Dear Mr. Johns:
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. Iisting 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 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 Y 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
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Page 2 - Mr. Martin Johns
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ucm115809.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/cdrl/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
for- ShVrm V.L.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K093520 Device Name:
VivoSight Topical OCT System (A Multi-Beam Optical Coherence Tomography (OCT) scanner)
Indications for Use:
VivoSight is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.
Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use NO (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Version 2.0
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.