(53 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses solely on the imaging technology itself.
No
The device is indicated for imaging external tissues, which is a diagnostic function, not a therapeutic one. It provides cross-sectional, real-time images for assessment, not treatment.
Yes
Explanation: The device is an imaging system indicated for "real-time imaging of external tissues of the human body," which is a diagnostic function. The predicate device listed is also an "OCT Imaging System."
No
The device description explicitly states it is a "Multi-Beam Optical Coherence Tomography (OCT) tissue imaging system," which is a hardware system.
Based on the provided information, the VivoSight device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "imaging of external tissues of the human body." This describes a device used for in vivo imaging (imaging within a living organism), not in vitro testing (testing outside of the body, typically on biological samples like blood, urine, or tissue biopsies).
- Device Description: The description "tissue imaging system" further supports its use for direct imaging of the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis, which are hallmarks of IVD devices.
Therefore, the VivoSight is an in vivo imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the Michelson Diagnostics VivoSight Topical OCT System: 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 This is the same as the predicate device with the addition that it is for external tissue only
Product codes
NOQ
Device Description
Multi-Beam Optical Coherence Tomography (OCT) tissue imaging system
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
external tissues of the human body
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Imalux OCT Imaging System
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.
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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).
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§ 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.
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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 Ltd
11A Grays Farm Production Village
Grays Farm Road
Orpington
Kent
BR5 3BD | |
|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Contact Person | Name: | Martin Johns |
| | Job Title: | Operations Director |
| | Address: | 11A Grays Farm Production Village
Grays Farm Road
Orpington
Kent
BR5 3BD
United 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 Marketed
devices to which the
device is substantially
equivalent | Imalux OCT Imaging System | |
| Description of the
Device | Multi-Beam Optical Coherence Tomography (OCT) tissue
imaging system | |
| Intended Use of the
Device | The intended use of the Michelson Diagnostics VivoSight
Topical OCT System:
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
This is the same as the predicate device with the addition that
it is for external tissue only | |
| | Telephone number: | 00 1 44 208 308 1695 |
| | Fax number: | 00 1 44 121 275 6237 |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff entwined with snakes.
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