(68 days)
Not Found
Not Found
No
The summary describes a device for illumination and video recording, with no mention of AI or ML capabilities or related concepts like image processing, training sets, or performance metrics associated with AI/ML.
No
The device provides illumination and video capabilities for medical procedures, but it does not directly treat or diagnose any medical condition.
No
Explanation: The Intended Use section describes the device as a fiber-optic illuminator and a visual aid for recording, with no mention of diagnosing conditions or diseases.
No
The intended use describes a device that provides head lamp illumination and fiber-optic illumination for endoscopes, which are hardware components. It also mentions using video, but the primary functions described are hardware-based illumination.
Based on the provided information, the VES 3001/w is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a light source (head lamp and endoscope illuminator) and a video system for visualization and recording. These are all related to in vivo procedures (examining or treating within the living body), not in vitro procedures (examining samples outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information based on laboratory tests
The VES 3001/w appears to be a medical device used for visualization and illumination during procedures, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The VES 3001/w use is indicated in the following situations:
- Whenever there is a need for head lamp illumination of the fiber-optic type.
- When ever there is a need for a fiber-optic illuminator for an endoscope.
- When ever there is a need to use video either as a visual aid for as a method of recording or both.
- When ever there is a requirement for any or all of the above at the same time.
Product codes
FSS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
Image /page/0/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 a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
. In 2 9 1998
Mr. John D. Plumadore · Director of Engineering AngioLaz Incorporated P.O. Box 556 Bellows Falls, Vermont 05101
Re: K981821 Trade Name: VES 3001/2 Dual Output Video Illuminator Regulatory Class: II Product Code: FSS Dated: May 20, 1998 Received: May 22, 1998
Dear Mr. Plumadore:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. John D. Plumadore
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(K) Number (if known) K- 981821 Device Name VES 3001/2 Dual Output Video Illuminator
Indications For Use:
The VES 3001/w use is indicated in the following situations:
- Whenever there is a need for head lamp illumination of the fiber-optic type .
- When ever there is a need for a fiber-optic illuminator for an endoscope .
- . When ever there is a need to use video either as a visual aid for as a method of recording or both.
- When ever there is a requirement for any or all of the above at the same . time.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
..............................................................................................................................................................................
Concurrence of CDRH, Office of Device Evaluation (ODE) "
Sign-Off
(Division Sign-Off)
Division of General Restorative Devices K981821
510(k) Number
Prescription Use
Use
(Per 21 CFR 801.109)
, ;
or
Over-The-Counter
(Optional Format 1-2-96)