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 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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the A-View® device, which is a diagnostic ultrasonic transducer. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets acceptance criteria through clinical performance testing. Therefore, much of the requested information regarding clinical studies, ground truth, expert adjudication, and comparative effectiveness studies is not included in this type of submission.

However, based on the non-clinical performance testing conducted, I can extract information related to acceptance criteria and performance for certain device characteristics.

Here's the breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document details bench tests conducted and states that the A-View® met all performance requirements and specifications, supporting substantial equivalence to the predicate device. Specific acceptance criteria are not explicitly quantifiable values in the provided text (e.g., "leakage less than X ml/hr"), but rather a general statement of meeting requirements.

Acceptance Criteria (Implied)	Reported Device Performance (A-View®)
Functional Performance:	Met all performance requirements and specifications (equivalent to predicate)
Leakage	Met requirements
Balloon inflation	Met requirements
Bond strength	Met requirements
Flexibility of tubing	Met requirements
Kink test	Met requirements
Torque	Met requirements
Tensile strength	Met requirements
Drop test	Met requirements
Real-time aged device	Met requirements
Biocompatibility:	Compliant with ISO 10993 standards (equivalent to predicate)
Cytotoxicity	Met requirements
Sensitization	Met requirements
Intracutaneous reactivity	Met requirements
Acute Systemic Toxicity	Met requirements (even though not required for this classification)

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data. It discusses bench tests for device performance. Sample sizes for these non-clinical tests (e.g., number of devices tested for leakage) are not provided. There is no mention of country of origin for any clinical data because none was presented. The testing described is non-clinical/bench testing, not retrospective or prospective clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. No clinical "test set" with ground truth established by experts is mentioned or described in this 510(k) summary. The device performance was assessed via bench testing, not expert interpretation of clinical data.

4. Adjudication method for the test set

This information is not applicable as there was no clinical "test set" requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The A-View® device is a physical diagnostic ultrasonic transducer, not an AI-powered diagnostic tool. No MRMC study was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the A-View® device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance testing (bench tests), the "ground truth" would be established by the engineering and quality standards set for each test (e.g., a specific pressure maintained for a leak test, a measured force for a tensile test). These are objective physical measurements rather than clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable. The A-View® is a physical medical device, not an AI or machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above (not an AI/ML algorithm).

Summary

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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 (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

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120
Indications for Use	Expiration Date: January 31, 2017See 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
-------------------------------------	----------------------------------------

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Official Contact:	Maarten NibbelkeStroke2Prevent B.V.Dokter Stolteweg 708025 AZ ZwolleThe NetherlandsTel: +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:

Indications for Use:

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	PredicateCordatec A-View®	Proposed DeviceA-View®
Indications for Use	A-View Catheter is intended for use in conjunctionwith TEE investigation of the upper mediastinumin anesthetized patients. They allow visibility ofthe distal ascending aorta by TEE and permit thecondition of the ascending aorta to be evaluatedbefore surgery. A-View Catheters are limited foruse in adult patients.	A-View® is intended for use in conjunction withTEE investigation of the upper mediastinum inanesthetized patients. They allow visibility of thedistal ascending aorta by TEE and permit thecondition of the ascending aorta to be evaluatedbefore surgery. A-View® is limited for use inadult patients.
	Patient Population	Adults	Adults
	Environment of use	Hospitals and outpatient surgery facility whereTEE is performed	Hospitals and outpatient surgery facility whereTEE is performed

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

Feature	PredicateCordatec A-View®	Proposed DeviceA-View®
Contraindications	May not be used in case of severe respiratoryfailure, tracheomalacia or contraindications for theuse of TEE (e.g. systemic tissue disease affectingthe esophagus and/or trachea tissue to a degree notcompatible with any aspect of TEE).	May not be used in case of severe respiratoryfailure, tracheomalacia or contraindications forthe use of TEE (e.g. systemic tissue diseaseaffecting the esophagus and/or trachea tissue to adegree 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 Balloondiameter	29 mm	29 mm
Pilot Balloon	Provides visual indicator of inflation of mainballoon	Provides visual indicator of inflation of mainballoonMade 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 / TissueAndSurface Contact / Mucosal MembraneLimited duration (<24 hours)	Externally Communicating /TissueAndSurface Contact / Mucosal MembraneLimited duration (<24 hours)CytotoxicitySensitizationIntracutaneous reactivityAcute Systemic Toxicity
Performance Testing		LeakageBalloon inflationBond strengthFlexibility of tubingKink testTorqueTensile strengthDrop 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.

Regulation Number and Section

N/A