The Sarns Standard Venous Return Catheters with Duraflo Treatment and the Sarns Right Angle Venous Return Catheters with Duraflo Treatment are indicated for use in dual cannulation of the superior and inferior vena cava for venous drainage during cardiopulmonary bypass surgery.

The Sarns Two Stage Venous Return Catheters with Duraflo Treatment, Venoatrial Catheters with Duraflo Treatment, and the Dual Stage Venous Return Catheters with Duraflo Treatment are indicated for use in single tube drainage of the right atrium and vena cava during cardio pulmonary bypass surgery.

Device Description

The only difference between the Sarns Venous Return Catheters with Duraflo® Treatment and the Sarns Venous Return Catheters is the addition of the Duraflo® Treatment. As a result of this process, a layer of heparin is deposited on the inside and outside of the catheter tip, tube, and connector.

As with their predicate devices, all of the Sarns Venous Return Catheters with Duraflo® Treatment are sterile, single-use medical devices. The Sarns Venous Return Catheters with Duraflo® Treatment are available in sizes ranging from 8 French to 51 French. (The French size is the outer diameter of the catheter in millimeters multiplied by three.). The Sarns Standard and Right Angle Venous Return Catheters with Duraflo® Treatment are available as a single tube. The Sarns Two Stage, Venoatrial, and Dual Stage Venous Return Catheters with Duraflo® Treatment consist of two differently-sized tubes. Many different models of the Sarns Venous Return Catheters with Duraflo® Treatment are available with wire-reinforced tubing. Some models of the multi-stage versions of the Sarns Venous Return Catheters with Duraflo® Treatment have an integral connector. Additionally, the Sarns Venous Return Catheters with Duraffo® Treatment have been coated with heparin via the Duraflo® Treatment process.

AI/ML Overview

This document describes a 510(k) submission for Sarns Venous Return Catheters with Duraflo® Treatment, which are substantially equivalent to existing Sarns Venous Return Catheters. The only difference is the addition of a Duraflo® Treatment, which deposits a layer of heparin on the catheters. Therefore, the acceptance criteria and supporting study are focused on demonstrating that the addition of the Duraflo® Treatment does not negatively affect the performance or safety of the device, and that the new treated catheters perform as intended and are equivalent to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Specifications)	Reported Device Performance
The Sarns Venous Return Catheters with Duraflo® Treatment must perform as intended according to their established performance specifications.	"The Sarns Venous Return Catheters with Duraflo® Treatment perform as intended according to their performance specifications." (Conclusion from Nonclinical Tests)
The performance characteristics of the Sarns Venous Return Catheters with Duraflo® Treatment must be comparable to the currently marketed Sarns Venous Return Catheters (predicate devices).	"The performance characteristics of selected models were chosen as being representative of the technological attributes of all models of Sarns Venous Return Catheters) of the Sarns Venous Return Catheters with Duraflo® Treatment were tested and compared with the performance characteristics of the currently marketed Sarns Venous Return Catheters." "All new and existing performance characteristics of the Sarns Venous Return Catheters with Duraflo® Treatment have been validated."
No dimensional changes to the catheters should occur due to the addition of the Duraflo® Treatment.	"There will be no dimensional changes to the catheters due to the addition of the Duraflo® Treatment." (Technological Characteristics section)
The device must remain sterile.	"All of the Sarns Venous Return Catheters with Duraflo® Treatment are sterile, single-use medical devices." (Device Description)

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

Test Set Sample Size: "selected models were chosen as being representative of the technological attributes of all models of Sarns Venous Return Catheters with Duraflo® Treatment." The exact number of models tested is not specified in the provided text.
Data Provenance: The study was a non-clinical performance study conducted by the device manufacturer, 3M Health Care, in the USA. It is a prospective study in the sense that the new Duraflo® treated catheters were tested for the purpose of demonstrating substantial equivalence.

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

This information is not provided in the given text. The study described is a non-clinical performance study, likely involving engineering and material science evaluations, rather than studies requiring expert medical interpretation of diagnostic data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is a non-clinical performance assessment, not one requiring adjudication of expert opinions on diagnostic interpretations.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission pertains to a medical device (catheter) with a change in coating, and not an AI-powered diagnostic product.

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

A standalone performance study, as typically understood for AI algorithms, was not done. This submission is for a physical medical device.

7. The Type of Ground Truth Used

For the non-clinical performance studies, the "ground truth" would be established by:

Performance Specifications: Pre-defined engineering and functional specifications for the catheters (e.g., flow rates, material strength, coating integrity, biocompatibility, sterility).
Predicate Device Performance: The established and validated performance characteristics of the currently marketed Sarns Venous Return Catheters. The new device's performance was compared against these established benchmarks.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device, not an AI model that requires a training set.

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

This information is not applicable as there is no training set for an AI model.

Summary

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JUN 18 58

15964374

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is _____________________________________________________________________________________________________________________________________________________________

Submitter's Name: 3M Health Care 6200 Jackson Road, Ann Arbor, Michigan 48103 Submitter's Address: Jason Smith Contact Person: (313) 663-4145 Phone Number: 663-5062 FAX Number: (313) Summary Date:

Device Trade Names:

Sarns Venous Return Catheters with Duraflo® Treatment, Sarns Right Angle Venous Return Catheters with Duraflo® Treatment, Sarns Two Stage Venous Return Catheters with Duraflo® Treatment, Sarns Venoatrial Catheters with Duraflo® Treatment, Sarns Dual Stage Venous Return Catheters with Duraflo® Treatment.

Device Classification Name:

"Cardiopulmonary Bypass Vascular Catheter, Cannuia, or Tubing" (21 CFR 870.4210)

Predicate Devices:

The Sarns Venous Return Catheters with Duraflo® Treatment are substantially equivalent to the existing Sarns Venous Return Catheters [510(k) clearance numbers listed in the table below].

Catheter Type	510(k) Number	Clearance Date
20, 24, 28, and 32 French Size (Fr.)non-wire Venous Return Catheter sizes;8, 10, 12, 14, 16, 18, 20, 22, 24, 28,30, and 34 Fr. wire-reinforced VenousReturn Catheter sizes, Right Angle VenousReturn Catheters	K905224	2/5/91
Venoatrial Catheters	K875048	2/18/88
Two Stage Venous Return Catheters(wire-reinforced), Dual Stage VenousReturn Catheters	K810415	3/17/81
32, 36, and 40 Fr. wire-reinforcedVenous Return Catheters	K790246	3/2/79
Two Stage Venous Return Catheters (non-wire-reinforced)	K770431	3/16/77
32, 26, 40 and 51 Fr. Venous ReturnCatheters	Preamendment

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Device Description:

As with their predicate devices, all of the Sarns Venous Return Catheters with Duraflo® Treatment are sterile, single-use medical devices. The Sarns Venous Return Catheters with Duraflo® Treatment are available in sizes ranging from 8 French to 51 French. (The French size is the outer diameter of the catheter in millimeters multiplied by three.). The Sarns Standard and Right Angle Venous Return Catheters with Duraflo® Treatment are available as a single tube. The Sarns Two Stage, Venoatrial, and Dual Stage Venous Return Catheters with Duraflo® Treatment consist of two differently-sized tubes. Many different models of the Sarns Venous Return Catheters with Duraflo® Treatment are available with wire-reinforced tubing. Some models of the multi-stage . versions of the Sarns Venous Return Catheters with Duraflo® Treatment have an integral connector. Additionally, the Sarns Venous Return Catheters with Duraffo® Treatment have been coated with heparin via the Duraflo® Treatment process.

Indications for Use:

The Sarns Standard and Right Angle Venous Return Catheters with Duraflo® Treatment are indicated for use in dual cannulation of the superior and inferior vena cava for venous drainage during cardiopulmonary bypass surgery. The Sarns Two Stage Venous Return, Dual Stage Venous Return, and Venoatrial Catheters with Duraflo® Treatment are indicated for use in single tube drainage of the right atrium and vena cava during cardiopulmonary bypass surgery.

Technological Characteristics:

Nonclinical Performance:

The performance characteristics of selected models were chosen as being representative of the technological attributes of all models of Sarns Venous Return Catheters) of the Sarns Venous Return Catheters with Duraflo® Treatment were tested and compared with the performance characteristics of the currently marketed Sarns Venous Return Catheters. All new and existing performance characteristics of the Sarns Venous Return Catheters with Duraflo® Treatment have been validated.

Clinical Performance:

Clinical testing was not performed on these devices.

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Conclusions from Nonclinical Tests:

The Sarns Venous Return Catheters with Duraflo® Treatment perform as intended according to their performance specifications. The Sarns Venous Return Catheters with Duraflo® Treatment are substantially equivalent to their predicate devices.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure, with three faces in profile, representing the department's mission to protect the health of all Americans.

JUN 18 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jason Smith Requlatory Affairs Coordinator 3M Health Care Cardiovascular Systems Sarns and CDI Products ............ 6200 Jackson Road Ann Arbor, Michigan 48103-9300

Re: * K964374 Sarns Venous Return Catheters with Duraflo® Treatment Requlatory Class: II (Two) Product Code: 74 DWF Dated: April 9, 1997 Received: April 10, 1997

Dear Mr. Smith:

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 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). 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 reqistration, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 - Mr. Jason Smith

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"dsmo@fdadr.cdrh.fda.gov."

Sincerely yours,

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): K 944/3 74

Device Name: Sarns Venous Return Catheters with Duraflo Treatment

Indications For Use:

The Sarns Standard Venous Return Catheters with Duraflo Treatment and the Sarns Right Angle Venous Return Catheters with Duraflo Treatment ~ are indicated for use in dual cannulation of the superior and inferior vena cava for venous drainage during cardiopulmonary bypass surgery.

Page 1 of 178

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
(1.e., 510(k) Number)	K964374
Division of Cardiovascular and Respiratory Devices
510(k) Number

Prescription Use ✓(Per 21 CFR 801.109)	OR	Over-The-Counter Use ______
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Signature
(Optional Format 1-2-96)

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).