(72 days)
The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures. The IR Viewer is indicated for use in procedures for inserting a needle or catheter in superficial, peripheral vessels.
The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures.
The provided document does not contain acceptance criteria or a study that proves the device meets acceptance criteria.
The document is a 510(k) premarket notification summary for the IR Viewer, a device for visualizing patient vasculature. It outlines the device description, intended use, predicate devices, and the FDA's substantial equivalence determination.
Here's a breakdown of what is and isn't in the document regarding your request:
What is present:
- Device Description: The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing for procedures involving needle or catheter insertion in superficial, peripheral vessels.
- Intended Use Statement: Clearly defined.
- Predicate Devices: ESP7 (Ironmaster) and Venoscope (Trinity Partners) are mentioned.
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.
What is explicitly stated but lacks detail:
- "Performance Data: Performance data were submitted to characterize the device." This line is present, indicating that performance data exists and was submitted to the FDA, but the document does not elaborate on what that data entails, what the acceptance criteria were, or the results of any specific study.
Therefore, I cannot provide the requested information because it is not contained within the provided text. To answer your questions, details from the actual performance data submission would be required.
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InfraRed Imaging Systems 510(k) Application
| Liquid crystal vein locatorTransilluminator | 880.6970886.1945 | l | General HospitalOphthalmic | KZAHJN | |
|---|---|---|---|---|---|
| Classification Name | ClassificationSection | Class | Panel | ProductCode | |
| Classification : | |||||
| Proposed ProprietaryTrade Name: | IR Viewer | ||||
| Date: | September 28, 2004 | ||||
| Company Contact: | Dale Siegel1275 Kinnear RoadColumbus, Ohio 43212614-675-3729dsiegel@irimagesys.com | ||||
| Company: | InfraRed Imaging Systems, Inc.1275 Kinnear RoadColumbus, OH 43212-1155Telephone: 614/675-3729Fax: 614/487-3704 | ||||
| DEC 1 0 2004 | PREMARKET NOTIFICATION 510(K) SUMMARY |
The IR Viewer is a non-invasive, electronic medical device Device Description: that provides visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures. The IR Viewer is indicated for use in procedures for
inserting a needle or catheter in superficial, peripheral vessels.
ESP7 (Ironmaster) Predicate Devices: Venoscope (Trinity Partners) Performance Data:
Intended Use:
Performance data were submitted to characterize the device.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2004
Dr. Dale Siegel President InfraRed Imaging Systems, Incorporated 1275 Kinnear Road Columbus, Ohio 43212
Re: K042679
Trade/Device Name: IR Viewer Regulation Number: 880.6970 Regulation Name: Liquid Crystal Vein Locator Regulatory Class: I Product Code: KZA Dated: September 28, 2004 Received: September 29, 2004
Dear Dr. Siegel:
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.
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Page 2 - Dr. Siegel
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.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susakume
$\frac{+}{/}$
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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InfraRed Imaging Systems 510(k) Application
Indications for Use Statement
510(k) Number (if known): ڀَلَ جَ لَوْرَ کَ 7°C
Device Name: IR Viewer
Indications for Use:
The IR Viewer is a non-invasive, electronic device for visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures. It is indicated for use in procedures for inserting a needle or catheter in superficial, peripheral vessels.
Prescription Use or (21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antony 20, 1955
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042679
§ 880.6970 Liquid crystal vein locator.
(a)
Identification. A liquid crystal vein locator is a device used to indicate the location of a vein by revealing variations in the surface temperature of the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.