(103 days)
Not Found
No
The description focuses on a physical device (catheter with an inflatable balloon) used to improve image quality during a TEE procedure. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device facilitates better imaging for diagnosis and evaluation, but it does not directly treat or mitigate a disease or condition.
No
The A-View® device is an accessory used to improve the quality of imaging during a TEE procedure, but it does not independently diagnose or interpret medical conditions. Its purpose is to facilitate better visibility for the clinician performing the TEE.
No
The device description clearly states that the A-View® is a catheter with an inflatable balloon, which is a physical hardware component.
Based on the provided information, the A-View® 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- A-View® Function: The A-View® is a physical device (a catheter with an inflatable balloon) that is inserted into the body to improve the quality of an imaging procedure (TEE). It does not analyze a sample taken from the body.
- Intended Use: The intended use clearly states it's for use in conjunction with a TEE investigation to improve visibility during the procedure. It's a tool to aid in imaging, not a diagnostic test itself.
Therefore, the A-View® falls under the category of a medical device used in vivo (within the living body) to facilitate a diagnostic procedure, rather than an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
A-View® is intended for use in conjunction with TEE investigation of the upper mediastinum in anesthetized 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® is limited for use in adult patients.
Product codes
ITX
Device Description
The A-View® is a catheter with an inflatable balloon that is inserted through an endotracheal tube of an anesthetized patient. Once inserted the balloon is inflated with saline. This inflated balloon is placed near the aortic arch so that when the clinician is performing a TEE (transesophageal echocardiography) procedure the saline filled balloon provides better contrast for an image.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
TEE (transesophageal echocardiography)
Anatomical Site
upper mediastinum, distal ascending aorta, aortic arch
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Hospitals and outpatient surgery facility where TEE is performed
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)
Bench Tests: We have performed bench tests and found that the A-View® met all performance requirements and specifications and was found to be equivalent in comparison to the predicate. The test included:
- Leakage
- Balloon inflation
- Bond strength
- Flexibility of tubing
- Kink test
- Torque
- Tensile strength
- Drop test
- Tests real-time aged devices.
Biocompatibility: We have performed ISO 10993-1 testing as the materials in patient of the A-View® as:
- Surface Contact / Mucosa membrane / Limited duration of use (
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that they appear to be connected or overlapping.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2017
Stroke2Prevent B.V. % Mr. Paul Dryden Consultant/Manager Promedic, LLC 24301 Woodsage Drive BONITA SPRINGS FL 34134
Re: K170338
Trade/Device Name: A-View® Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: April 19, 2017 Received: April 21, 2017
Dear Mr. Dryden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|---|---|
| Indications for Use | Expiration Date: January 31, 2017 |
| See PRA Statement on last page. | |
| 510(k) Number ( if known ) | K170338 |
| Device Name | A-View® |
| Indications for Use (Describe) | A-View® is intended for use in conjunction with TEE investigation of the upper mediastinum in anesthetized 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® is limited for use in adult patients. |
| Type of Use ( Select one or both, as applicable ) | |
| XX Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS
BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete and
review the collection of information. Send comments regarding this burden estimate or any other aspect of this
information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and
Drug Administration
Office of Chief Information Officer Paperwork
Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (8/14)
| Page 1 of 1 | PSC Publishing Services (301) 443-6740 |
|---|---|
| ------------------------------------- | ---------------------------------------- |
3
| Official Contact: | Maarten Nibbelke
Stroke2Prevent B.V.
Dokter Stolteweg 70
8025 AZ Zwolle
The Netherlands
Tel: +31 (0)38 3032 630 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | A-View® |
| Common/Usual Name: | Diagnostic Ultrasound Transducer |
| Classification: | ITX - Diagnostic Ultrasound Transducer, CFR 892.1570 |
| Predicate Device: | Cordatec n.v. - A-View® - K070515 |
Device Description:
The A-View® is a catheter with an inflatable balloon that is inserted through an endotracheal tube of an anesthetized patient. Once inserted the balloon is inflated with saline. This inflated balloon is placed near the aortic arch so that when the clinician is performing a TEE (transesophageal echocardiography) procedure the saline filled balloon provides better contrast for an image.
Indications for Use:
A-View® is intended for use in conjunction with TEE investigation of the upper mediastinum in anesthetized 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® is limited for use in adult patients.
Contraindications:
May not be used in case of severe respiratory failure, tracheomalacia or contraindications for the use of TEE (e.g. systemic tissue disease affecting the esophagus and/or trachea tissue to a degree not compatible with any aspect of TEE).
Device Comparison
Table 5.1 compares the subject device to the predicate
| Feature | Predicate
Cordatec A-View® | Proposed Device
A-View® | |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Indications for Use | A-View Catheter is intended for use in conjunction
with TEE investigation of the upper mediastinum
in anesthetized 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. | A-View® is intended for use in conjunction with
TEE investigation of the upper mediastinum in
anesthetized 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® is limited for use in
adult patients. | |
| | Patient Population | Adults | Adults |
| | Environment of use | Hospitals and outpatient surgery facility where
TEE is performed | Hospitals and outpatient surgery facility where
TEE is performed |
4
510(k) Summary April 19, 2017 Page 2 of 4
| Feature | Predicate
Cordatec A-View® | Proposed Device
A-View® |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contraindications | May not be used in case of severe respiratory
failure, tracheomalacia or contraindications for the
use of TEE (e.g. systemic tissue disease affecting
the esophagus and/or trachea tissue to a degree not
compatible with any aspect of TEE). | May not be used in case of severe respiratory
failure, tracheomalacia or contraindications for
the use of TEE (e.g. systemic tissue disease
affecting the esophagus and/or trachea tissue to a
degree not compatible with any aspect of TEE). |
| Provided sterile | Yes - EO | Yes - EO |
| Compatibility with | Endotracheal tubes ≥ 7.0 mm ID | Endotracheal tubes ≥ 7.0 mm ID |
| Balloon filled | Sterile saline | Sterile saline |
| Depth Markings | At 24 cm | At 24 cm and 28 cm |
| Main Balloon
diameter | 29 mm | 29 mm |
| Pilot Balloon | Provides visual indicator of inflation of main
balloon | Provides visual indicator of inflation of main
balloon
Made slightly larger than predicate |
| Catheter shaft -
ID/OD | 2 mm / 4 mm | 2 mm / 4 mm |
| Total overall length | 1065 mm | 1065 mm |
| Shelf-Life | 3 years | 4 years |
| Biocompatibility | Externally Communicating / Tissue
And
Surface Contact / Mucosal Membrane
Limited duration (