(48 days)
No
The document describes a standard intravascular ultrasound imaging system with features like color flow mapping and digital display options. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance study summaries.
No
Explanation: The device is used for diagnostic imaging and evaluation of vascular morphology and blood flow, not for therapeutic intervention or treatment.
Yes
The device "gathers and displays high-resolution intraluminal images that can be analyzed both qualitatively and quantitatively" and provides "diagnostic information" for the "evaluation of vascular morphology." This indicates its use in the diagnosis of conditions related to vascular structure.
No
The device description explicitly states that the system consists of an imaging catheter, a patient interface module, and a system console, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the evaluation of vascular morphology and blood flow within the body (in vivo). IVDs are designed to examine specimens taken from the body (in vitro), such as blood, urine, or tissue samples.
- Device Description: The device description details an imaging system that uses an imaging catheter inserted into vessels. This is a direct imaging method performed on the patient, not a laboratory test on a sample.
- Input Imaging Modality: The input is an "Ultrasonic pulsed echo imaging system," which is an in-vivo imaging technique.
- Anatomical Site: The anatomical site is "coronary arteries and vessels of the peripheral vasculature," which are locations within the living body.
All the characteristics point to an in-vivo imaging device used for diagnostic purposes, but not an IVD.
N/A
Intended Use / Indications for Use
In-Vision™ Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo feature is indicated for qualitative blood flow information from peripheral and coronary vaculature; flov; information can be an adjunct to other methods of estimating blood flow and blood perfusion.
Product codes
DXK
Device Description
The JOMED Inc. In-Vision™ Imaging System consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays high-resolution intra'uminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the In-Vision™ Imaging Systems can be adjunct to interventional therapies, such as balloon angioplasty. With ChromoFloTM, a two-dimensional color map of relative blood flow is overlaid on the grayscale image, providing a ditional information for vessel analysis. The In-Line Digital™ option displays a two-dimensional, 360° rotations, and longitudinal view of the vessel. -
The imaging catheters are all marketed under separate 510(k)'s; Visions catheters K982329, Avanar catheters K000820, and Eagle Eye F/X 2.9F pending future submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed echo imaging system
Anatomical Site
vascular morphology in the coronary arteries and vessels of the peripheral vasculature
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)
Applicable testing was performed to evaluate the modifications to the In-Vision™ Imaging System. The test results were found to be acceptable as required by the respective test plans and protocols.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2330 Echocardiograph.
(a)
Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.(b)
Classification. Class II (performance standards).
0
Jomed Inc.
MAY 28 2003
March 17, 2003
p.113 In-Vision™ Imaging System Special 510(k)
510 (K) Summary In-Vision™ Imaging System
| Date Prepared: | January 2, 2003 |
|---|---|
| Submitted by: | JOMED Inc. |
| 2870 Kilgore Rd. | |
| Rancho Cordova, CA 95670 | |
| Contact person: | Lorry W. Huffman |
| Regulatory Affairs Manager | |
| Phone number: | |
| Facsimile number: | (916) 638-9404 or (800) 228-4728 ext. 404 |
| (916) 638-8112 | |
| Device Name: | In-Vis on™ Imaging System |
Classification name:
892.1560 Ultrasonic pulsed echo imaging system
Class II
Predicate Device:
Cathscanner III Imaging System cleared under K944004 on May 4, 1995; ColorFlo Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K963290 on August 6, 1997; and the Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223 on June 29, 1998.
JOMED Inc. purchased Endesonics Corporation under which K944004, K963290 and K965223 were filed.
Device Description:
The JOMED Inc. In-Vision™ Imaging System consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays high-resolution intra'uminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the In-Vision™ Imaging Systems can be adjunct to interventional therapies, such as balloon angioplasty. With ChromoFloTM, a two-dimensional color map of relative blood flow is overlaid on the grayscale image, providing a ditional information for vessel analysis. The In-Line
1
Jomed Inc. March 17, 2003 In-Vision™ Imaging System Special 510(k) · 213
Digital™ option displays a two-dimensional, 360° rotations, and longitudinal view of the vessel. -
The imaging catheters are all marketed under separate 510(k)'s; Visions catheters K982329, Avanar catheters K000820, and Eagle Eye F/X 2.9F pending future submission.
Intended Use:
In-Vision™ Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo feature is indicated for qualitative blood flow information from peripheral and coronary vaculature; flov; information can be an adjunct to other methods of estimating blood flow and blood perfusion.
Device Technological Characteristics and Comparison to Predicate Device:
The In-Vision™ Imaging System uses the same fundamental scientific technology and has the same intended use and clinical applications as that of the predicate device. This is a software modification version upgrade to V4.1.
Performance Data:
Applicable testing was performed to evaluate the modifications to the In-Vision™ Imaging System. The test results were found to be acceptable as required by the respective test plans and protocols.
Conclusion:
The In-Vision™ Imaging System has the same Intended Use and utilizes the same fundamental scientific technology as that of the predicate devices. The performance data along with the Declaration of Conformity with Design Controls support a determination of substantial equivalence of the modified device, In-Vision™ Imaging System to the
2
(03/148 p:3 (3
predicate devices. This software modification version upgrade to V4.1 raises no new questions about safety and efficacy.
3
Image /page/3/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 symbol of a human figure with three heads, representing health and well-being. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 28 2003
JOMED Inc. c/o Ms. Lorraine W. Huffman Regulatory Affairs Manager 2870 Kilgore Rd. Rancho Cordova, CA 95670
Re: K031148
Trade Name: In-Vision™ Imaging System Regulation Number: 21 CFR 870.2330 Regulation Name: Echocardiograph Regulatory Class: Class II (two) Product Code: DXK Dated: April 8, 2003 Received: April 10, 2003
Dear Ms. Huffman:
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 Federa! 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.
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
4
Page 2 - Ms. Lorraine W. Huffman
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 (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. 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 (301) 594-4646. 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 may be obtained 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.
h.
Bram D. Zuckerman, M.D.
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KO31148 510(k) Number (if known):
Device Name: In-Vision™ Imaging System
Indications for Use:
In-Vision™ Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also incicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vaculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription
Use
(Per 21 CFR 801.19)
OR
Over-the-Counter Use
ﻠﺴﻠ
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Nt