(30 days)
Not Found
No
The summary describes a catheter for facilitating placement and providing ultrasound images, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is intended to facilitate catheter placement and provide imaging, not to treat a specific medical condition or disease.
Yes
The device provides an "intra-luminal, cross-sectional ultrasound image of the area of interest," which is used to visualize and assess the anatomical site, thereby serving a diagnostic function.
No
The device description explicitly states it is a "CrossPoint TransAccess Catheter," which is a physical medical device used for catheter placement and ultrasound imaging. It is not described as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health.
- The description of the CrossPoint TransAccess Catheter clearly states its intended use is to facilitate the placement and positioning of catheters within the peripheral vasculature and to provide an intra-luminal ultrasound image of the area of interest.
This device is used inside the body for imaging and procedural assistance, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest. The CrossPoint TransAccess Catheter is not indicated for use in the coronary or cerebral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
ITX, DQY
Device Description
Trade Name: CrossPoint® TransAccess® Catheter
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
Results of in-vitro testing demonstrate that the modified design of the CrossPoint TransAccess Catheter is safe and effective to allow the positioning and placement of catheters within the peripheral vasculature.
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): 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.
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.
Not Found
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
§ 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
JUL 2 8 2003
510(k) Safety and Effectiveness Information Summary
This summary of 510(k) Safety and Effectiveness Information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
June 20, 2003. Date Prepared:
510(k) Number:
Contact Person: Applicant Information:
TransVascular, Incorporated 1505-D Adams Drive Menlo Park, CA 94025-1439
Richard E. Anderson Phone: (650) 473-4500 X124 Fax: (650) 473-4545 Email: randerson@transvascular.com
Classification: Class II
Device Information:
Trade Name: CrossPoint® TransAccess® Catheter
Classification Name: Percutaneous Catheter (21 CFR 870.1250) and Diagnostic Ultrasound Transducer (21 CFR 892.1570)
Equivalent Device:
The subject device (CrossPoint TransAccess Catheter) is substantially equivalent in intended use and/or method of operation to the original CrossPoint TransAccess Catheter (K013363).
Intended Use:
The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest. The CrossPoint TransAccess Catheter is not indicated for use in the coronary or cerebral vasculature.
Test Results:
Results of in-vitro testing demonstrate that the modified design of the CrossPoint TransAccess Catheter is safe and effective to allow the positioning and placement of catheters within the peripheral vasculature.
Summary:
Based on the product performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2003
TransVascular, Inc. c/o Mr. Richard E. Anderson 1505-D Adams Drive Menlo Park, CA 94025-1439
Re: K031920
CrossPoint® TransAccess® Catheter Regulation Number: 21 CFR 870.1250, 892.1570 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II Product Code: ITX, DQY Dated: June 20, 2003 Received: June 23, 2003
Dear Mr. Anderson:
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. Iisting 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 - Mr. Richard E. Anderson
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 (301) 594-4692. 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 vours.
J. Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
TransVascular, Inc.
Special 510(k)
This application
Indications for Use
510(k) Number (if known):
Device Name:
CrossPoint TransAccess Catheter
Indications for Use: The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intra-luminal, cross-sectional ultrasound image of the area of interest. The CrossPoint TransAccess Catheter is not indicated for use in the coronary or cerebral vasculature.
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 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
N. Qatun
OR
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K03192