(174 days)
No
The summary describes a catheter that provides ultrasound imaging and facilitates catheter placement. There is no mention of AI, ML, image processing beyond basic display, or any data analysis that would suggest the use of these technologies. The performance studies focus on safety and effectiveness for catheter placement, not on the performance of any analytical or interpretive software.
No.
The device facilitates the placement of other catheters and provides imaging, but it does not directly treat a condition or disease. Its function is primarily assistive and diagnostic rather than therapeutic.
Yes
Explanation: The device provides an intraluminal, cross-sectional ultrasound image, which is used to view the area of interest. This imaging capability is a diagnostic function, as it allows medical professionals to visualize and assess internal structures.
No
The device description explicitly states it is a "Catheter," which is a physical hardware component used within the body. It also provides an "intraluminal, cross-sectional ultrasound image," indicating it includes ultrasound hardware.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The CrossPoint TransAccess Catheter is a medical device used within the body (intraluminal) to facilitate the placement of other catheters and provide ultrasound imaging of the peripheral vasculature. It is an interventional device used during a medical procedure.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with and images the internal anatomy.
Therefore, the function and intended use of the CrossPoint TransAccess Catheter clearly fall outside the definition of an In Vitro Diagnostic device.
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
ITX, DQY
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
Ultrasound
Anatomical Site
Peripheral Vascular
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
Results of in-vitro testing and animal studies demonstrate that the CrossPoint TransAccess Catheter is safe and effective to allow the positioning and placement of catheters within the peripheral vasculature.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Endosonics' devices, Visions 2.9F Ultrasonic Imaging Catheter and Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter.
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
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.
Date Prepared: August 1, 2001
510(k) Number: 9 Be Determined
Applicant Information:
Contact Person:
TransVascular, Incorporated 1505-D Adams Drive Menlo Park, CA 94025
Steve Jwanouskos Vice President, Clinical & Regulatory Affairs
Phone: (650) 473-4500 x105 Fax: (650) 473-4545
Device Information:
Classification: Class II
Trade Name: CrossPoint™ TransAccess® Catheter
(013365
Classification Name: Percutaneous Catheter (21 CFR 870.1250)
Equivalent Device:
The subject device (CrossPoint TransAccess Catheter) is substantially equivalent in intended use and/or method of operation to the Perclose Outback Catheter (K001577) and Endosonics' devices, Visions 2.9F Ultrasonic Imaging Catheter and Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter.
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:
Performance
Results of in-vitro testing and animal studies demonstrate that the CrossPoint TransAccess Catheter is safe and effective to allow the positioning and placement of catheters within the peripheral vasculature.
Biocompatibility
The materials used in the manufacture of the CrossPoint TransAccesss Catheter have been shown to be biocompatible when tested in accordance with ISO 10993-1 requirements.
Summary:
Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.
CONFIDENTIAL
54
1
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
(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)
Prescription Use
(Per 21 CFR 801.109)
F-3
Division of Cardiovascular & Respiratory Devices
510(k) Number K013365
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Trans Vascular Incorporated C/o Mr. Mark Job TUV Product Service, Inc. 1775 Old Highway 8 New Brighton, MN 55112
APR 0 2 2002
Re: K013363
Trade Name: Crosspoint Transaccess Catheter Regulation Number: 21 CFR 892.1570 and 21 CFR 870.1250 Regulation Name: Diagnostic Ultrasonic Transducer and Percutaneous Catheter Regulatory Class: II (two) Product Code: ITX and DQY Dated: February 28, 2002 Received: March 1, 2002
Dear Mr. Job:
We have reviewed your Section 510(k) premarket 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.
This determination of substantial equivalence applies to the following transducer intended for use with the Crosspoint Transaccess Catheter, as described in your premarket notification:
Transducer Model Number 0.014" Guidewire Compatible; 6.2 French
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.
3
Page 2 - Mr. Mark Job
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 (08) 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information. including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your 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 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) 594-4591. 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" (21 CFR Part 807.97). 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
4
Page 3 - Mr. Mark Job
If you have any questions regarding the content of this letter, please contact Elisa Harvey at (301) 443-8262 extension 167.
Sincerely yours,
for
Bram D. Zuckerman, M.D.
Acting Director
Division of Cardiovascular
and Respiratory Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
Center for Devices and Radiological Health Premarket Notification [510(k)] Indications for Use Statement
0133663
K
Date Prepared: August 1, 2001
Device Trade Name:
CrossPoint TransAccess Catheter
Indications for Use:
The CrossPoint TransAccess Catheter is latended to facilitate the placement and positioning of catheters within the periphers wascellature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the ares of interest. The CrossPoint TrausAccess Catheter is not indicated for use in the coronary or cerchral vasculature.
TransVascular, Inc.
CONFIDENTIAL
Prescription Use
(21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K013363