SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT

K964374 · 3M Healthcare · DWF · Jun 18, 1997 · Cardiovascular

Device Facts

• Record ID: K964374
• Device Name: SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT
• Applicant: 3M Healthcare
• Product Code: DWF · Cardiovascular
• Decision Date: Jun 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. 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 cardiopulmonary bypass surgery.

Device Story

Venous return catheters used during cardiopulmonary bypass surgery; facilitate venous drainage from right atrium and vena cava. Subject devices feature Duraflo® treatment, a heparin coating applied to internal and external surfaces of catheter tip, tube, and connector. Available in various configurations including standard, right angle, two-stage, and dual-stage; some models wire-reinforced. Sterile, single-use devices. Heparin coating intended to improve hemocompatibility. No dimensional changes compared to predicate devices. Used by surgical teams in clinical settings.

Clinical Evidence

No clinical data. Bench testing only; performance characteristics of representative models compared to predicate devices to validate safety and effectiveness.

Technological Characteristics

Sterile, single-use venous return catheters (8-51 French). Materials identical to predicates with addition of Duraflo® heparin coating on internal/external surfaces. Available as single or multi-stage tubes; some wire-reinforced. No dimensional changes.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring venous drainage via dual cannulation of superior/inferior vena cava or single tube drainage of right atrium and vena cava.

Regulatory Classification

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.

Predicate Devices

• Sarns Venous Return Catheters (K905224)
• Venoatrial Catheters (K875048)
• Two Stage Venous Return Catheters (K810415)
• 32, 36, and 40 Fr. wire-reinforced Venous Return Catheters (K790246)
• Two Stage Venous Return Catheters (K770431)
• 32, 26, 40 and 51 Fr. Venous Return Catheters (Preamendment)

Submission Summary (Full Text)

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JUN 18

1964374

# 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

Submitter's Address: 6200 Jackson Road, Ann Arbor, Michigan 48103

Contact Person: Jason Smith

Phone Number: [phone]

FAX Number: [phone]

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, Cannula, 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 Venous Return Catheter sizes, Right Angle Venous Return Catheters | K905224 | 2/5/91 |
| Venoatrial Catheters | K875048 | 2/18/88 |
| Two Stage Venous Return Catheters (wire-reinforced), Dual Stage Venous Return Catheters | K810415 | 3/17/81 |
| 32, 36, and 40 Fr. wire-reinforced Venous 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 Return Catheters | Preamendment | |

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## 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 Duraflo® 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:

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. There will be no dimensional changes to the catheters due to the addition of the Duraflo® Treatment.

## Nonclinical Performance:

The performance characteristics of selected models (these 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 Sams Venous Return Catheters with Duraflo® Treatment perform as intended according to their performance specifications. The Sams Venous Return Catheters with Duraflo® Treatment are substantially equivalent to their predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 18 1997

Mr. Jason Smith
Regulatory 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
Regulatory 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 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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "[e-mail]."

Sincerely yours,

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

Enclosure

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02/21/96 16:59:59 CDRH Facts-On-Demand-> 313 663 5062 Fax ?s: 301.443.0010 Page 20

510(k) Number (if known): K964374

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.

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 cardiopulmonary bypass surgery.

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Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)