A-View

K170338 · Stroke2prevent B.V. · ITX · May 16, 2017 · Radiology

Device Facts

• Record ID: K170338
• Device Name: A-View
• Applicant: Stroke2prevent B.V.
• Product Code: ITX · Radiology
• Decision Date: May 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended 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.

Device Story

A-View® is a catheter with an inflatable balloon inserted through an endotracheal tube in anesthetized patients; balloon is inflated with sterile saline. Device functions as an acoustic window during transesophageal echocardiography (TEE) to improve visualization of the distal ascending aorta. Used in hospitals and outpatient surgery facilities by clinicians performing TEE. Output is an enhanced ultrasound image of the aorta, aiding surgical planning. Benefits include improved diagnostic visibility of the ascending aorta before surgery.

Clinical Evidence

Bench testing only. Performance testing included leakage, balloon inflation, bond strength, tubing flexibility, kink test, torque, tensile strength, and drop testing. Biocompatibility testing performed per ISO 10993-5, 10993-10, and 10993-11 for cytotoxicity, sensitization, intracutaneous reactivity, and acute systemic toxicity.

Technological Characteristics

Catheter with inflatable balloon; saline-filled for acoustic contrast. Dimensions: 2 mm ID / 4 mm OD, 1065 mm length. Depth markings at 24 cm and 28 cm. Sterilized via Ethylene Oxide (EO). Biocompatibility: Externally communicating/tissue/surface contact, limited duration (<24 hours).

Indications for Use

Indicated for adult patients undergoing TEE investigation of the upper mediastinum while anesthetized. Contraindicated in patients with severe respiratory failure, tracheomalacia, or conditions precluding TEE (e.g., systemic tissue disease affecting esophagus/trachea).

Regulatory Classification

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.

Predicate Devices

• Cordatec n.v. - A-View® - K070515

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Expiration Date: January 31, 2017<br>See PRA Statement on last page. |
| 510(k) Number ( <i>if known</i> ) | 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 ( <i>Select one or both, as applicable</i> ) | |
| XX Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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|-------------------------------------|----------------------------------------|
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| Official Contact: | Maarten Nibbelke<br>Stroke2Prevent B.V.<br>Dokter Stolteweg 70<br>8025 AZ Zwolle<br>The Netherlands<br>Tel: [phone] |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| 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<br>Cordatec A-View® | Proposed Device<br>A-View® | |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Indications for Use | A-View Catheter is intended for use in conjunction<br>with TEE investigation of the upper mediastinum<br>in anesthetized patients. They allow visibility of<br>the distal ascending aorta by TEE and permit the<br>condition of the ascending aorta to be evaluated<br>before surgery. A-View Catheters are limited for<br>use in adult patients. | A-View® is intended for use in conjunction with<br>TEE investigation of the upper mediastinum in<br>anesthetized patients. They allow visibility of the<br>distal ascending aorta by TEE and permit the<br>condition of the ascending aorta to be evaluated<br>before surgery. A-View® is limited for use in<br>adult patients. | |
| | Patient Population | Adults | Adults |
| | Environment of use | Hospitals and outpatient surgery facility where<br>TEE is performed | Hospitals and outpatient surgery facility where<br>TEE is performed |

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# 510(k) Summary April 19, 2017 Page 2 of 4

| Feature | Predicate<br>Cordatec A-View® | Proposed Device<br>A-View® |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contraindications | May not be used in case of severe respiratory<br>failure, tracheomalacia or contraindications for the<br>use of TEE (e.g. systemic tissue disease affecting<br>the esophagus and/or trachea tissue to a degree not<br>compatible with any aspect of TEE). | May not be used in case of severe respiratory<br>failure, tracheomalacia or contraindications for<br>the use of TEE (e.g. systemic tissue disease<br>affecting the esophagus and/or trachea tissue to a<br>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<br>diameter | 29 mm | 29 mm |
| Pilot Balloon | Provides visual indicator of inflation of main<br>balloon | Provides visual indicator of inflation of main<br>balloon<br>Made slightly larger than predicate |
| Catheter shaft -<br>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<br>And<br>Surface Contact / Mucosal Membrane<br>Limited duration (<24 hours) | Externally Communicating /Tissue<br>And<br>Surface Contact / Mucosal Membrane<br>Limited duration (<24 hours)<br>Cytotoxicity<br>Sensitization<br>Intracutaneous reactivity<br>Acute Systemic Toxicity |
| Performance Testing | | Leakage<br>Balloon inflation<br>Bond strength<br>Flexibility of tubing<br>Kink test<br>Torque<br>Tensile strength<br>Drop test |

### Substantial Equivalence Discussion

Indications for Use / Patient Population / Environment of Use: A comparison of Indications for Use concludes that they are similar.

Discussion: There is no difference in indications for use, patient population and environment of use.

Prescriptive: Both are prescription devices. Discussion: There are no differences.

Design and Technology: The design and employed technology of both devices is similar, with similar components, methods of construction, and operation. Discussion: There is no difference is in design and technology.

Performance and Specifications: The testing related to performance and specifications demonstrate that both devices perform the same functions using the same technology.

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## 510(k) Summary April 19, 2017 Page 3 of 4

Discussion: There are no differences between both devices, thus they can be found substantially equivalent.

Compliance with Standards: We utilized several recognized standards in the evaluation of the subject device.

- ISO 10993-5, Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity . (2009)
- ISO 10993-10, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin . Sensitization (2010)
- ISO 10993-11, Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity ● (2006)

Discussion: We have evaluated performance to the closest available standards and the results support the determination of substantial equivalence.

## Non-clinical Performance Testing:

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 (<24 hours)
- And
- Externally communicating / Tissue / Dentin / Bone / Limited duration of use (< 24 hours) ●

Test that was performed included:

- Cytotoxicity ●
- . Sensitization
- Intracutaneous reactivity / Irritation
- . Acute Systemic Toxicity even though it is not required

## Differences

There are slight differences between the proposed device. The differences are:

- Pilot balloon was modified in size and shape for easier viewing by the clinician ●
- O This change has no performance change, only that it is larger than the predicate
- . Materials - some materials were changed
- The materials were evaluated via ISO 10993 testing o
- . Device marking
- The proposed device has an additional marking at 28 cm on the main shaft o
- . This assists the user in depth placement

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## 510(k) Summary April 19, 2017 Page 4 of 4

# Substantial Equivalence Conclusion

Based upon the foregoing performance testing and comparison to the legally marketed predicate device for indications for use, technology, and performance we believe we have demonstrated that the A-View® is substantially equivalent to the predicate device.