The EMBOL-X Aortic Occlusion and Cardioplegia Cannula is intended for use during cardiopulmonary bypass (CPB) procedures to: (1) occlude the ascending aorta, (2) deliver cardioplegia solution, and (3) vent the aortic root.

Device Description

The EMBOL-X Aortic Occlusion and Cardioplegia Cannula consists of a twolumen cannula with three lines and an elastomeric balloon mounted on a 14 French tip. The first cannula lumen is used to inflate the balloon. The inflated balloon occludes the ascending aorta, partitioning the aortic root from the remainder of the arterial circulation. The balloon is expandable to occlude a range of aortic diameters. A two-way stopcock maintains the inflation and deflation of the balloon. The second cannula lumen is attached to two separate lines. The first line is used to deliver antegrade cardioplegia solution, and the second line is used for venting the aortic root. A sliding flange, located at the base of the cannula hub, adjusts to accommodate for varying aortic diameters and assists in anchoring the device during use.

AI/ML Overview

The provided text describes the EMBOL-X Aortic Occlusion and Cardioplegia Cannula, its intended use, and the studies conducted to demonstrate substantial equivalence to predicate devices, rather than a study against a pre-defined set of acceptance criteria with quantified performance metrics.

However, I can extract the information related to the device's performance demonstration and present it in a structured way to answer your request as closely as possible, interpreting "acceptance criteria" as the performance requirements that need to be met for clinical use and "reported device performance" as the outcomes of the performance studies.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria were not provided in the document, I will infer them from the stated "performance requirements for the intended clinical use" and the results from the studies.

Acceptance Criteria (Inferred from intended use)	Reported Device Performance
I. Functional Performance: The device must effectively occlude the ascending aorta.	"Animal testing results demonstrated that the device occludes the ascending aorta." "Proper balloon occlusion is confirmed, then balloon volume is maintained by re-turning the stopcock to the 'closed' position." "If excessive bleedback is observed, the balloon volume is increased 1 cc at a time up to, but not exceeding, the maximum recommended balloon volume until complete occlusion is achieved."
The device must effectively deliver cardioplegia solution.	"Animal testing results demonstrated that the device... delivers cardioplegia to arrest the heart." "After occlusion is achieved, cardioplegia solution delivery is initiated."
The device must effectively vent the aortic root.	"The second cannula lumen is attached to two separate lines... the second line is used for venting the aortic root."
The device must maintain balloon inflation/occlusion.	"A two-way stopcock maintains the inflation and deflation of the balloon."
The device must be able to adjust to varying aortic diameters.	"The balloon is expandable to occlude a range of aortic diameters." "A sliding flange, located at the base of the cannula hub, adjusts to accommodate for varying aortic diameters."
II. Biocompatibility: The materials used must be biocompatible.	"Biocompatibility testing demonstrated that the materials used to fabricate the EMBOL-X Device are biocompatible and meet the requirements of FDA's guidance document, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995)."
III. Safety: The device must not be thrombogenic.	"Animal testing results demonstrated that the device... is not thrombogenic."
The device must not result in depletion of cellular components.	"Animal testing results demonstrated that the device... does not result in depletion of cellular components."
The device must not damage the vessel wall.	"Animal testing results demonstrated that the device... does not damage the vessel wall."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a numerical sample size. The document mentions "Animal testing results," implying a cohort of animals but no specific number is given.
Data Provenance: Prospective (animal testing). The country of origin is not specified, but the submission is to the US FDA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the given text. The evaluations seem to be based on direct physiological observation and laboratory analysis within the animal study rather than expert interpretation of images or other subjective data.

4. Adjudication Method for the Test Set

This information is not provided as the nature of the "test set" is an animal study with direct measurements and observations, not a study requiring adjudication of expert opinions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes performance, biocompatibility, and animal testing to demonstrate substantial equivalence, not a study comparing human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a cardioplegia cannula, not an AI algorithm. Its performance is entirely mechanical/physiological in interaction with the human body.

7. Type of Ground Truth Used

The "ground truth" for the animal study appears to be direct physiological observations and measurements during surgery, such as:
- Visual confirmation of aortic occlusion.
- Arrest of the heart due to cardioplegia delivery.
- Laboratory analysis for thrombogenicity and cellular component depletion.
- Histological examination for vessel wall damage.

8. Sample Size for the Training Set

This question is not applicable as the device is a medical device, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is a medical device, not an AI algorithm requiring a training set.

Summary

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1980631

2 1999 FEB

Attachment 9
510(k) Summary

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EMBOL-X. Inc. EMBOL-X Cardioplegia Cannula/ Occluder Device 510(k) Premarket Notification

510(k) SUMMARY

I. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

EMBOL-X, Inc. 3110 Coronado Drive Santa Clara, California 95054 Telephone: (408) 986-8301 Facsimile: (408) 986-8302

Contact Person: Donald Johnson Vice President, Regulatory Affairs and Quality Assurance

Date Prepared: February 11, 1997

II. Name of Device and Name/Address of Sponsor

Trade name: EMBOL-X Aortic Occlusion and Cardioplegia Cannula

EMBOL-X, Inc. 3110 Coronado Drive Santa Clara, California 95054

III. Classification Name

Cardiopulmonary Bypass Vascular Cannula. 21 C.F.R. § 870.4210; Vascular Clamp, 21 C.F.R. § 870.4450

IV. Predicate Devices

(1) Heartport's Endoaortic Clamp (K962510)
(2) Datascope's Precluder DL Occluding Balloon (K832356)
(3) Medtronic's DLP Aortic Root Cannula (K790565)
(4) RMI's Anteplegia Cannula (K896636)

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v. Intended Use/Indications

VI. Device Description

VII. Principles of Operation

Prior to use, the aortic diameter is estimated in order to determine the recommended balloon inflation volume from the device labels and Instructions for Use. To prepare the device for insertion, sterile solution (saline or water) is injected into the balloon through the two-way stopcock to displace the air in the device. The air is aspirated, and the balloon is inspected for visual competency. After the air is completely aspirated, the vacuum on the balloon is maintained by closing the two-way stopcock. The clamp on the vent line is closed prior to insertion.

To insert the device, the tip is moistened and inserted in an incision in the aorta. The device is positioned in the mid-ascending aorta with the tip of the cannula directed away from the aortic root. The device is secured in position with sutures which are tied through the flange slots around the base of the cannula. The sliding flange rests against the exterior of the aorta to assist in anchoring the device. After the device has been inserted, the vent line is unclamped to allow the tubing to fill by bleedback.

Once the patient is stable on CPB and the heart is decompressed, the arterial flow is decreased, and the balloon is inflated to the recommended inflation volume to create an occlusive seal. To verify that the aorta is completely occluded, the vent line clamp is opened. If excessive bleedback is observed, the balloon volume is increased 1 cc at a time up to, but not exceeding, the maximum recommended balloon volume until complete occlusion is achieved.

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Proper balloon occlusion is confirmed, then balloon volume is maintained by re turning the stopcock to the "closed" position.

After occlusion is achieved, cardioplegia solution delivery is initiated. After the CPB procedure is complete, the device is removed by reducing the arterial flow rate, deflating the balloon, loosening the sutures, withdrawing the device from the aorta, and tightening the sutures to achieve hemostasis. The arterial flow rate can then be returned to normal.

VIII. Comparison to Predicate Devices

The EMBOL-X Aortic Occlusion and Cardioplegia Cannula is substantially similar to currently available CPB vascular cannulae which are used to administer cardioplegia solution during CPB procedures. The EMBOL-X Device is designed with a curved tip that is surrounded by an elastomeric balloon. The balloon is deployed to partition the aortic root from the remainder of the arterial circulation and thereby prevent blood from flowing back into the surgical field. Several currently marketed devices also serve this purpose, including endoaortic clamps and other balloon-type cardioplegia catheters.

Data Demonstrating Substantial Equivalence IX.

Performance testing on the EMBOL-X Aortic Occlusion and Cardioplegia Cannula demonstrated that the device meets EMBOL-X, Inc. performance requirements for the intended clinical use of the device. Biocompatibility testing demonstrated that the materials used to fabricate the EMBOL-X Device are biocompatible and meet the requirements of FDA's guidance document, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995). Animal testing results demonstrated that the device occludes the ascending aorta and delivers cardioplegia to arrest the heart. In addition, the device is not thrombogenic, does not result in depletion of cellular components and does not damage the vessel wall.

X. Conclusion

Performance, biocompatibility and animal testing demonstrated that the EMBOL-X Aortic Occlusion and Cardioplegia Cannula is safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1999

Ms. Alexis Ball EMBOL-X, Inc. 645 Clyde Avenue Mountain View, CA 94043-2208

Re: K980631 EMBOL-X Aortic Occlusion and Cardioplegia Cannulae (AOCC) Requlatory Class: II (two) Product Code: DXC November 23, 1998 Dated: Received: November 24, 1998

Dear Ms. Ball:

We have reviewed your Section 510(k) 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, Druq, 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Alexis Ball

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: EMBOL-X Aortic Occlusion and Cardioplegia Cannula Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bera L. Campbell

ardiovascular, Respiratory, and Neurological Devices K99063 510(k) Number_

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).