These cannulae are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Device Description

The Three Stage Venous Return Cannula consists of a single tube body with a 3/8" flared end to allow for connection to the bypass circuit. These cannulae have three open areas for venous drainage. An obturator is included. Its purpose is to decrease blood loss during insertion depth markers are printed on each cannula and aid in positioning the cannula.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "Three Stage Venous Return Cannula." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the information you're requesting regarding acceptance criteria, study details, and specific metrics like AI improvement effect size or standalone algorithm performance, is largely not applicable to this document.

However, I can extract the information that is present regarding performance evaluation and how the device meets "acceptance criteria" in the context of a 510(k).

Here's a breakdown based on your request, with clarifications on why certain sections are not applicable:

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

The document does not provide a formal table of specific, quantified acceptance criteria with corresponding numerical performance results. Instead, it lists types of performance evaluations conducted to demonstrate substantial equivalence to a predicate device. The "performance" is implicitly that the device performs "as intended" and is "substantially equivalent."

Acceptance Criteria Category (Implicit)	Reported Device Performance
Functional & Mechanical Performance
Connector attachment	Performed as intended, substantially equivalent to predicate.
Clamp test	Performed as intended, substantially equivalent to predicate.
Obturator Seal Test	Performed as intended, substantially equivalent to predicate.
Kink test	Performed as intended, substantially equivalent to predicate.
Collapse test	Performed as intended, substantially equivalent to predicate.
Tensile test	Performed as intended, substantially equivalent to predicate.
Hemodynamic Performance
Flow Testing	Modified device includes a third basket to maintain comparable flow characteristics to the dual stage venous return cannulae. Performed as intended, substantially equivalent to predicate.
Simulated Use
Simulated use test	Performed as intended, substantially equivalent to predicate.
Overall Equivalence
Intent (Use, Principles, Technology, Design, Materials, and Performance)	Substantially equivalent to predicate. Differences do not raise new safety/effectiveness issues.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided document. The performance evaluations are listed, but the number of units tested for each evaluation is not detailed.
Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) for a device like this, these would typically be in-house engineering and bench tests, not clinical studies with patients.

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

Not applicable. For a 510(k) submission of this type, which involves bench and simulated use testing of a physical medical device, "ground truth" is established through engineering specifications, validated test methods, and comparison to the predicate device's known performance characteristics. There is no mention of "experts" in the context of establishing ground truth in the way one would for diagnostic imaging or AI algorithms.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert consensus panels, often for image interpretation or diagnosis. This document pertains to performance evaluations of a physical medical device.

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

Not applicable. This is a conventional medical device (venous cannula) and does not involve AI or human readers. Therefore, an MRMC study or AI assistance effect size is irrelevant.

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

Not applicable. This is a physical medical device, not a software algorithm.

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

The "ground truth" for the performance evaluations listed would be based on:

Engineering specifications and standards: For characteristics like connector attachment strength, kink resistance, tensile strength, and collapse pressure.
Predicate device performance: The performance of the predicate Dual Stage Venous Return Cannula served as the benchmark for "substantially equivalent" performance.
Biocompatibility principles: While not explicitly detailed as "ground truth," the materials used (implicitly similar to the predicate) would be expected to meet biocompatibility standards.

8. The sample size for the training set

Not applicable. This document describes a physical medical device undergoing performance evaluation for a 510(k) submission, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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Koso034

SECTION 03: 510(k) SUMMARY (807.92c)

	510(k) Summary	JUN 17 2008
	Submitter Information	2
	Device Name	2
	Identification of Predicate Device	2
	Device Description	2
	Intended Use	2
	Technological Characteristics	2 - 3
	Performance Evaluations	3
Conclusion for 510(K) Summary		3

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Three Stage Venous Return Cannula

Submitter Information

This Premarket Notification is submitted by:

Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, Michigan 48103

Contact:	Andrea N. Wallen
Telephone:	1-800-262-3304, Ext. 6395
Fax:	734-741-6030
Date:	January 3, 2008

Device Name

Trade Name: Three Stage Venous Return Cannula Common Name: Venous Cannula Classification Name: CPB vascular catheters, cannulae, or tubing are classified as Class II devices per 21 CFR § 870.4210.

Predicate Device

The unmodified predicate device is identified as Terumo's current line of Dual Stage Venous Return Cannulae, which fall under 510(k) # K810415.

Device Description

Intended Use

These cannulae are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Technological Characteristics

The Three Stage Venous Return Cannula is used in open heart surgery. During open heart surgery, blood is drained into a venous cannula upstream of the heart at the superior/ inferior vena cava and right atrium. The cannula is connected to tubing that routes the blood to a heart/ lung machine where the blood is pumped and oxygenated. The blood then continues through this perfusion circuit back to

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the outlet side of the heart (the patient's aorta), where the blood re-enters the patient's circulatory system via an arterial cannulae.

There are three major differences between the modified and unmodified devices.

. The distal portion of the three stage spring reinforced body maintains a single outside diameter to allow for a smaller incision site, whereas the dual stage cannula has a step-up in the outer diameter.
. The (unmodified) dual stage device has a 1/2" connection site. whereas the (modified) three stage device has a 3/8" connection site which allows for a smaller blood volume to prime the bypass circuit.
. The modified device includes a third basket which has been added to allow the smaller diameter to maintain comparable flow characteristics to the dual stage venous return cannulae.

Performance Evaluation

Comparison studies of the performance specifications of the Three Stage Venous Return Cannula and the unmodified predicate Dual Stage Venous Return Cannula have been conducted and have shown to be substantially equivalent to the predicate (unmodified) Dual Stage Venous Return Cannula. These tests include:

. Connector attachment
Clamp test .
Obturator Seal Test �
Kink test .
Collapse test .
Tensile test .
Flow Testing .
. Simulated use test

Conclusion

In summary, the Three Stage Venous Return Cannula performed as intended and is substantially equivalent in intended use, principles of operation, technology, design, materials, and performance to the predicate (unmodified) Dual Stage Venous Return Cannula. Any noted differences between the devices do not raise new issues of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2008

Terumo Cardiovascular Systems Corporation c/o Ms. Andrea Wallen Specialist, Regulatory Management 6200 Jackson Road Ann Arbor, MI 48103

Re: K080034

Three Stage Venous Return Cannula, Model 816460 Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheters, cannula, or tubing Regulatory Class: Class II (two) Product Code: DWF Dated: April 7, 2008 Received: April 8, 2008

Dear Ms. Wallen:

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 it may of receiver to one of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Andrea Wallen

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 (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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Duna R. Vachner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Three Stage Venous Return Cannula

Indications For Use:

These cannulae are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Andres N. Wallen
Andres N. Wallen

Andrea N. Wallen Regulatory Affairs Specialist Terumo Cardiovascular Systems

Prescription Use X OR

Over-The-Counter Use

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Holmes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K080034

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).