(158 days)
Not Found
No
The device description and performance studies focus on the physical components and basic functionalities of a catheter and associated accessories, with no mention of AI or ML. The predicate devices are also standard medical devices without AI/ML capabilities.
No
The device is solely for investigatory purposes, providing visibility for evaluation but not directly treating a condition.
Yes
The A-View® catheters are intended for use in conjunction with TEE investigation to evaluate the condition of the ascending aorta before surgery, which is a diagnostic purpose.
No
The device description explicitly states it consists of a catheter and potentially a syringe and connectors, which are physical hardware components, not 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The A-View catheters are used in conjunction with TEE (Transesophageal Echocardiography) to improve visibility of the distal ascending aorta during a medical procedure (TEE investigation). They are a physical device used within the body to facilitate imaging, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "use in conjunction with TEE investigation" and allows "visibility of the distal ascending aorta by TEE." This describes a procedural aid, not a diagnostic test performed on a biological sample.
The device is a medical device used in vivo (within the body) to assist with an imaging procedure. It does not perform a diagnostic test on a sample in vitro (outside the body).
N/A
Intended Use / Indications for Use
A-View® catheters are intended for use in conjunction with TEE investigation of the upper mediastinum in anaesthetised patients. They allow visibility of the distal ascending aorta by TEE and permit the condition of the ascending aorta to be evaluated before surgery. A-View Catheters are limited for use in adult patients.
Product codes
MUI, ITX
Device Description
A-View Basic consists of only the catheter itself. The A-View catheter has three tubes connected by a Y-connector of which one holds a distal, large balloon, one holds a small, pilot balloon and the third holds a stop cock with two standard female luer connections. Both balloons are clear and colorless. On the main shaft a distance mark indicating 24 cm from the closest balloon shoulder is pointed out. A-View Plus consists of the catheter plus a standard 50 ml syringe with luer connector and a swivel Y-connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper mediastinum, distal ascending aorta
Indicated Patient Age Range
adult patients
Intended User / Care Setting
anaesthetised patients
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)
Data is contained within this 510(k) demonstrating A-View catheters meet the requirements of ISO 14971 (Risk Management), ISO 10993 (Biocompatibility), EN 550 (Sterilization), and EN 868 (Packaging).
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
§ 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
cordateכ
JUL 30 2007 K070515
Section 4: 510(k) Summary
The assigned 510(k) number is: K070515
| Company: | Cordatec n.v.
Kwikaard 104
B-2980 Zoersel
Belgium
Telephone: 32 3 380 15 81
Fax: 32 3 380 15 90 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Barbara DeBiase |
| Date Prepared: | June 25, 2007 |
| Proprietary Names: | A-View® Basic and A-View Plus |
| Classification Name: | Accessory to a Diagnostic Ultrasound Transducer |
| Common Name: | Tracheal Balloon Catheter |
| Classification: | 21 CFR 892.1570, Class II, Product Code MUI |
| Predicate Device: | • Saline based upon its pre-amendment status in
conjunction with ultrasonic water baths;
• K052021 V5Ms Transesophageal Transducer and MPT7
Multiplane Transesophageal Transducer by Siemens
Medical Solutions USA Inc.;
• K994373 HDI 1500/SA 8800 Ultrasound System with
Multiplane by Advanced Technology Laboratories Inc.; and
• K052517 Site-Rite 5 Ultrasound System by C.R. Bard Inc. |
| Device Description: | A-View Basic consists of only the catheter itself. The A-
View catheter has three tubes connected by a Y-connector
of which one holds a distal, large balloon, one holds a
small, pilot balloon and the third holds a stop cock with
two standard female luer connections. Both balloons are
clear and colorless. On the main shaft a distance mark
indicating 24 cm from the closest balloon shoulder is
pointed out. A-View Plus consists of the catheter plus a
standard 50 ml syringe with luer connector and a swivel Y-
connector. |
| Intended Use: | A-View® catheters are intended for use in conjunction
with TEE investigation of the upper mediastinum in
anaesthetised patients. They allow visibility of the distal
ascending aorta by TEE and permit the condition of the
ascending aorta to be evaluated before surgery. A-View
Catheters are limited for use in adult patients. |
| Performance Data | Data is contained within this 510(k) demonstrating A-View
catheters meet the requirements of ISO 14971 (Risk
Management), ISO 10993 (Biocompatibility), EN 550
(Sterilization), and EN 868 (Packaging). |
| Conclusion: | A-View catheters are substantially equivalent in function,
materials and intended use to the above referenced |
1
cordateכ
predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2007
Cordatec N.V. C/O Ms. Barbara DeBiase Regulatory Consultant 1467 Vigilante Avenue Bailey, Colorado 80421
Re: K070515
Trade/Device Name: A-View® Basic and Plus Catheters Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: II Product Code: ITX Dated: July 23, 2007 Received: July 24, 2007
Dear Ms. DeBiase:
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.
3
Page 2 -Ms. DeBiase
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 (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 (240) 276-0120. 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/industry/support/index.html.
Sincerely vours.
Chres
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
4
Indications for Use
510(k) Number (if known): K070515
Device Name: A-View® Basic and Plus Catheters
Indications for Use:
A-View Catheters are intended for use in conjunction with TEE investigation of the upper mediastinum in anaesthetised patients. They allow visibility of the distal ascending aorta by TEE and permit the condition of the ascending aorta to be evaluated before surgery. A-View Catheters are limited for use in adult patients.
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ita Ch (actrybc)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page ___ of __________________________________________________________________________________________________________________________________________________________________
510(k) Number: K070515