(196 days)
84700, 302, DC-101
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms, and the description focuses on basic imaging and measurement capabilities.
No.
The device is described as a "diagnostic device intended for use in diagnostic ultrasound imaging" and "designed for use in the evaluation of vascular morphology," indicating it is for diagnosis, not treatment.
Yes
The 'Device Description' section explicitly states, "The Visions 8.2F PV catheter is a diagnostic device intended for use in diagnostic ultrasound imaging of the peripheral vasculature."
No
The device description explicitly states it is a catheter, which is a physical hardware component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Visions catheters are used within the body (intravascularly) to image blood vessels using ultrasound. They are a diagnostic imaging tool, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states "evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels." This describes an imaging procedure performed directly on the patient.
- Device Description: The description confirms it's a "diagnostic device intended for use in diagnostic ultrasound imaging of the peripheral vasculature."
Therefore, the Visions catheters fall under the category of in vivo diagnostic devices (used within the living body), not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The EndoSonics Visions 8.2F PV catheter is a diagnostic device intended for use in diagnostic ultrasound imaging of the peripheral vasculature.
The Visions catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels.
The Visions ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide:
- An image of the vessel lumen and wall structures. (1)
- (2) Dimensional measurements from the image.
Product codes
ITX
Device Description
The Visions 8.2F PV is available in an over-the-wire design. The catheter has a 7.0F shaft with a maximum distal diameter of 8.2F.
All catheters are manufactured from similar biocompatible materials. Biocompatability testing has been performed.
Testing of the EndoSonics Visions catheters include radiopacity, tensile strength of the catheter shaft, catheter distal end tensile strength, profile measurements, and biocompatibility. These tests demonstrated the devices meet or exceed specification as well as catheter tip profiles were within specification tolerances. Tensile strength of the catheter shaft and catheter tip show that the catheter tip met design specifications.
The acoustic outputs for the Visions 8.2F PV catheter were found to be:
= 0.0158 mW/cm-= 0.044 W/cm2 = 0.012 MI
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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
radiopacity, tensile strength of the catheter shaft, catheter distal end tensile strength, profile measurements, and biocompatibility. These tests demonstrated the devices meet or exceed specification as well as catheter tip profiles were within specification tolerances. Tensile strength of the catheter shaft and catheter tip show that the catheter tip met design specifications.
Key Metrics
Not Found
Predicate Device(s)
EndoSonics Visions 3.5F model 84700 Intravascular Imaging Catheter, EndoSonics Cathscanner Model 302 Intravascular Imaging Catheter, Millar Mikro-Tip Doppler Catheter Model DC-101, Small Vessel Balloon Angioplasty Catheter, ATL Ultramark 8 Ultrasound Imaging System, CVIS Insight System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
JAN 1 4 1999
EndoSonics Corporation
Visions 8.2F PV Models 88900
510(k) Premarket Notification
June 30, 1998
510(k) Summary
| Submitted By: | EndoSonics Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670
916-638-8008
Contact: Adam Savakus |
|-----------------------|------------------------------------------------------------------------------------------------------------------|
| Summary Preparation: | June 30, 1998 |
| Device: | EndoSonics Visions 8.2F PV Intravascular Imaging Catheter |
| Common or Usual Name: | Ultrasonic Imaging Catheter |
| Predicate Devices: | EndoSonics Visions 3.5F model 84700 Intravascular Imaging Catheter |
| | EndoSonics Cathscanner Model 302 Intravascular Imaging Catheter |
| | Millar Mikro-Tip Doppler Catheter Model DC-101
Millar Instruments Incorporated
Houston, TX |
| | Small Vessel Balloon Angioplasty Catheter
Cook Incorporated
Bloomington, IN 47402 |
| | ATL Ultramark 8 Ultrasound Imaging System
Adva...l Techno'ogy Labs
Bothell WA |
| | CVIS Insight System
Cardiovascular Imaging Systems
Sunnyvale, CA |
1
510(k) Summary
The EndoSonics Visions 8.2F PV catheter is a diagnostic device intended for use in diagnostic ultrasound imaging of the peripheral vasculature.
The Visions 8.2F PV is available in an over-the-wire design. The catheter has a 7.0F shaft with a maximum distal diameter of 8.2F.
The EndoSonics Visions 8.2F PV catheter is substantially equivalent to existing devices such as the EndoSonics Cathscanner Model 302 and Visions Model 84700 catheters with the Oracle (Cathscanner III) Imaging System, the Cook Small Vessel Balloon Angioplasty catheter, the ATL Ultramark 8 imaging system, the Millar Mikro Tip Doppler catheter, and the CVIS Insight imaging system and catheters
All catheters are manufactured from similar biocompatible materials. Biocompatability testing has been performed.
Testing of the EndoSonics Visions catheters include radiopacity, tensile strength of the catheter shaft, catheter distal end tensile strength, profile measurements, and biocompatibility. These tests demonstrated the devices meet or exceed specification as well as catheter tip profiles were within specification tolerances. Tensile strength of the catheter shaft and catheter tip show that the catheter tip met design specifications.
The acoustic outputs for the Visions 8.2F PV catheter were found to be:
= 0.0158 mW/cm-= 0.044 W/cm2 = 0.012 MI
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Image /page/2/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 symbol that resembles three overlapping, curved lines, possibly representing a stylized human form or a symbol of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Mr. Adam Savakus Vice President, Clinical and Regulatory Affairs EndoSonics Corporation 2870 Kigore Road Rancho Cordova, CA 95670
Re: K982329 Trade Name: Visions 8.2F PV Ultrasoinic Imaging Catheter (Model 88900) Regulatory Class: II Product Code: ITX Dated: October 16, 1998 Received: October 19, 1998
Dear Mr. Savakus:
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 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Reqister. Please note: this
3
Page 2 - Mr. Adam Savakus
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.
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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4586. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number:
K98 2329
Visions 8.2F PV Ultrasoinic Imaing Catheter (Model 88900) Device Name:
Indications for Use:
The Visions catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels.
The Visions ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide:
- An image of the vessel lumen and wall structures. (1)
- (2) Dimensional measurements from the image.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chrityl-mytten
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological De 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)