NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT

K033328 · Novosci Corp. · DTL · Jan 16, 2004 · Cardiovascular

Device Facts

• Record ID: K033328
• Device Name: NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
• Applicant: Novosci Corp.
• Product Code: DTL · Cardiovascular
• Decision Date: Jan 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NovoSci™ tubing and connectors with NovoCoat™ treatment are indicated for use in cardiopulmonary surgical procedures requiring extracorporeal support for periods up to 6 hours.

Device Story

NovoSci™ tubing and connectors are sterile, single-use, disposable components for extracorporeal circuits during cardiopulmonary bypass surgery. Tubing consists of polyvinyl chloride (PVC); connectors are polycarbonate. Surfaces are treated with NovoCoat™ to improve blood compatibility. Devices connect bypass components to facilitate extracorporeal support. Used in clinical settings by surgical teams. Benefit includes improved hemocompatibility of non-biological surfaces during bypass procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility, in-vitro performance, blood damage, bond strength, hardness, leak testing, and pump life to demonstrate equivalence to the predicate.

Technological Characteristics

Materials: Polyvinyl chloride (PVC) tubing, polycarbonate connectors. Surface treatment: NovoCoat™ for blood compatibility. Form factor: Various sizes and configurations (straight, reducing, Y, luer ports). Sterilization: Sterile, single-use. Connectivity: None (mechanical components).

Indications for Use

Indicated for patients undergoing cardiopulmonary surgical procedures requiring extracorporeal support for up to 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• NovoSci™ Duraflo treated tubing and connectors

Submission Summary (Full Text)

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## JAN 1 6 2004

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR part 807.92.

| Submitter: | NovoSci™ Corp<br>2828 N. Crescent Ridge Dr.<br>The Woodlands, Texas 77381 |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | LeAnn Latham<br>Regulatory Affairs Manager<br>Phone: [phone] |
| Device trade name: | NovoSci™ Tubing and Connectors with NovoCoat™ |
| Common name: | Cardiopulmonary bypass tubing and connectors |
| Classification name: | Catheter, Cannula and Tubing, Vascular,<br>Cardiopulmonary Bypass<br>Adaptor, Stopcock, Manifold, Fitting, Cardiopumonary<br>Bypass |
| Classification:<br>Panel:<br>Product code:<br>Regulation Number: | Class II<br>Cardiovascular (CV)<br>DWF, DTL<br>870.4210, 870.4290 |
| Predicate Device: | NovoSci™ Duraflo treated tubing and connectors |

Device Description:

The NovoSci ™ tubing and connectors treated with NovoCoat™ are sterile, single use only, disposable devices. They are used to connect cardiopulmonary bypass components used during surgery procedures requiring extracorporeal support. When used on devices for cardiopulmonary surgery, the NovoCoat™ treatment improves blood compatibility of non-biological surfaces in the extracorporeal circuit.

NovoSci™ tubing is polyvinyl chloride (PVC) tubing available in various sizes. The NovoSci™ connectors are polycarbonate in various configurations such as straight, reducing, "Y", with or without luer ports.

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Indications for Use:

The NovoSci™ tubing and connectors with NovoCoat™ treatment are indicated for use in cardiopulmonary surgical procedures requiring extracorporeal support for periods up to 6 hours.

Statement of Technological Characteristics Comparison:

The NovoSci™ NovoCoat™ treated tubing and connectors are substantially equivalent to the currently marketed NovoSci™ tubing and connectors with Durafio treatment.

Non-clinical testing

Biocompatibility, in-vitro and performance testing were performed to demonstrate equivalence. These tests include: blood damage, bond strength, hardness, leak test, pump life.

Conclusions:

This data supports that the NovoSci™ NovoCoat™ treated tubing and connectors are substantially equivalent in safety and efficacy to the currently marketed NovoSci 100 Duraflo treated tubing and connectors.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2004

NovoSci™ Corp. c/o Ms. LeAnn Latham 2828 N. Crescent Ridge Drive The Woodlands, TX 77381

Re: K033328

NovoSci™ Tubing and Connectors with NovoCoat™ Regulation Number: 21 CFR 870.4290 and 4210 Regulation Name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTL and DWF Dated: October 15, 2003 Received: October 16, 2003

Dear Ms. Latham:

We have reviewed your Scction 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 adultcration.

If your device is classificd (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 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.

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Page 2 - Ms. LeAnn Latham

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 [phone]. 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 [phone] or [phone] or at its Internet address.

Sincerely Murs,

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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K033328

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## Indications for Use

510(k) Number (if known) K033328

NovoSci™ tubing and connectors with NovoCoat™ Device Names: treatment

Indications for Use:

The NovoSci™ NovoCoat™ treated tubing and connectors are indicated for use in cardiopulmonary surgical procedures requiring extracorporeal support for periods up to 6 hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) N

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