(72 days)
Not Found
ESP7, Venoscope
No
The summary does not mention AI, ML, or any related concepts like training or test sets for algorithms. The device description focuses on infrared imaging for visualization.
No
The device aids in visualization for medical procedures, but it does not directly treat a condition or restore health, which is the function of a therapeutic device.
No
Explanation: The device is used for visualization during procedures for inserting needles/catheters, which is an interventional/procedural use rather than a diagnostic one. It supplements normal viewing, indicating it aids in the execution of a procedure rather than making a diagnosis.
No
The device description explicitly states it is an "electronic medical device" and provides visualization of vasculature, implying the presence of hardware components for image acquisition and display, not just software processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides visualization of patient vasculature for procedures involving needle or catheter insertion. This is a clinical procedure performed directly on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description reinforces that it's a non-invasive electronic medical device for visualizing vasculature.
- Input Imaging Modality: Infrared imaging is used to visualize structures within the body, not to analyze a biological sample.
- Anatomical Site: The device is used on superficial, peripheral vessels, which are part of the patient's body.
IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. This device does not fit that description. It's a medical device used for visualization during a clinical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KZA, HJN
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 of vascular structures. The IR Viewer is indicated for use in procedures for inserting a needle or catheter in superficial, peripheral vessels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data were submitted to characterize the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
ESP7, Venoscope
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).
Not Found
§ 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.
0
InfraRed Imaging Systems 510(k) Application
| | Liquid crystal vein locator
Transilluminator | 880.6970
886.1945 | l | General Hospital
Ophthalmic | KZA
HJN |
|-------------------------------------|-------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-----------------|
| | Classification Name | Classification
Section | Class | Panel | Product
Code |
| | Classification : | | | | |
| Proposed Proprietary
Trade Name: | | | IR Viewer | | |
| Date: | | | September 28, 2004 | | |
| | Company Contact: | | Dale Siegel
1275 Kinnear Road
Columbus, Ohio 43212
614-675-3729
dsiegel@irimagesys.com | | |
| Company: | | | InfraRed Imaging Systems, Inc.
1275 Kinnear Road
Columbus, OH 43212-1155
Telephone: 614/675-3729
Fax: 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.
1
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.
2
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
3
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