CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS

K984055 · Sims Deltec, Inc. · FOZ · Jan 29, 1999 · General Hospital

Device Facts

• Record ID: K984055
• Device Name: CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS
• Applicant: Sims Deltec, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jan 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Indications for Use

The CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheter is used when therapy requires repeated venous access for intravenous injection or infusion and/or venous blood sampling.

Device Story

CliniCath® PolyFlow® is a peripherally inserted venous catheter; provides repeated venous access for IV injection, infusion, or blood sampling. Device consists of single- or dual-lumen radiopaque polyurethane catheter; includes preinserted stylet, clamps, and stylet/flushing assembly. Optional accessories include introducer needle, injection cap, and procedural tray. Used in clinical settings by healthcare professionals for peripheral vein insertion with tip placement in peripheral or central vasculature. Functions as a conduit for fluid delivery or blood withdrawal. Benefits patient by facilitating venous access for therapy. Substantially equivalent to existing silicone and polyurethane catheters.

Clinical Evidence

No clinical data. Bench testing only, conducted in accordance with FDA 'Guidance on Premarket Notification [510(k)] Submissions for Short- and Long-term Intravascular Catheters' (March 1995). Biocompatibility testing performed.

Technological Characteristics

Radiopaque polyurethane catheter; single- and dual-lumen configurations; sizes 2F to 5F; lengths 20cm to 65cm. Includes preinserted stylet, clamps, and flushing assembly. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for patients requiring repeated peripheral venous access for IV therapy, infusion, or blood sampling.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• CliniCath® Peripherally Inserted Catheters (SIMS Deltec, Inc.)
• BIOVUE Peripherally Inserted Catheters (Johnson & Johnson Medical Inc.)

Submission Summary (Full Text)

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K984055

# 510(k) SUMMARY OF SAFETY AND EFFECTIVEN

# CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters

November 12, 1998

#### I. GENERAL INFORMATION

| Applicant's Name and Address: | SIMS Deltec, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa Stone<br>Manager, Regulatory Affairs<br>Tel. [phone] |
| Common/Usual Name: | Peripherally Inserted Venous Catheters |
| Proprietary Name: | CliniCath® PolyFlow® Polyurethane Peripherally<br>Inserted Catheters |
| Equivalence Device Comparison: | CliniCath® Peripherally Inserted Catheters<br>(manufactured by SIMS Deltec, Inc.)<br><br>BIOVUE Peripherally Inserted Catheters<br>(manufactured by Johnson & Johnson Medical Inc.) |

#### II. DEVICE DESCRIPTION

The modified CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters are similar in design and function to the current commercially available CliniCath® Peripherally Inserted Catheters.

The catheters are designed to permit repeated venous access for intravenous injection or infusion and/or venous blood sampling

The product consists of single- and dual-lumen, radiopaque polyurethane catheters with preinserted stylets, clamps, and attached stylet/flushing assemblies. Catheters will be made available with and without the following accessories: introducer needle, injection cap and procedural tray. Catheters will be provided in single- and multi-unit package configurations.

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# INTENDED USE OF DEVICE III.

The CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheter is used when therapy requires repeated venous access for intravenous injection or infusion and/or venous blood sampling.

# DEVICE COMPARISON IV.

| | CliniCath® PolyFlow®<br>Polyurethane Peripherally<br>Inserted Catheters | CliniCath® Peripherally<br>Inserted Catheters | BIOVUE Peripherally<br>Inserted Catheters |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Johnson & Johnson Medical<br>Inc. |
| INDICATION FOR USE | The CliniCath® PolyFlow®<br>Polyurethane Peripherally<br>Inserted Catheter is used<br>when therapy requires<br>repeated venous access for<br>intravenous injection or<br>infusion and/or venous blood<br>sampling. | The CliniCath® Peripherally<br>Inserted Catheter is used<br>when therapy requires<br>repeated venous access for<br>intravenous injection or<br>infusion and/or venous blood<br>sampling. | BIOVUE Peripherally<br>Inserted Catheters are<br>designed for prolonged<br>peripheral venous access for<br>the infusion of IV therapy<br>solutions and blood sampling. |
| CATHETER INSERTION | Peripheral vein | Peripheral vein | Peripheral vein |
| CATHETER TIP<br>PLACEMENT | Peripheral/Central | Peripheral/Central | Peripheral/Central |
| CATHETER MATERIAL | Radiopaque Polyurethane | Radiopaque Silicone | Radiopaque Polyurethane |
| AVAILABLE CATHETER<br>SIZES | Single-Lumen<br>2 French (24 Gauge)<br>3 French (20 Gauge)<br>4 French (18 Gauge)<br>5 French (16 Gauge)<br><br>Dual-Lumen<br>4 French (18 Gauge)<br>5 French (16 Gauge) | Single-Lumen<br>---<br>3 French (20 Gauge)<br>4 French (18 Gauge)<br>5 French (16 Gauge)<br><br>--- | Single-Lumen<br>2 French (24 Gauge)<br>3 French (20 Gauge)<br>4 French (18 Gauge)<br>---<br><br>Dual-Lumen<br>4 French (18 Gauge)<br>5 French (16 Gauge) |
| | CliniCath® PolyFlow®<br>Polyurethane Peripherally<br>Inserted Catheters | CliniCath® Peripherally<br>Inserted Catheters | BIOVUE Peripherally<br>Inserted Catheters |
| CATHETER O.D. AND I.D.<br>(Nominal) | | | |
| Single-Lumen | | | |
| 2 French | 0.7 mm O.D. x 0.4 mm I.D. | - | 0.7 mm O.D. x 0.4 mm I.D. |
| 3 French | 1.0 mm O.D. x 0.5 mm I.D. | 0.9 mm O.D. x 0.5 mm I.D. | 1.0 mm O.D. x 0.6 mm I.D. |
| 4 French | 1.4 mm O.D. x 0.8 mm I.D. | 1.3 mm O.D. x 0.8 mm I.D. | 1.2 mm O.D. x 0.8 mm I.D. |
| 5 French | 1.7 mm O.D. x 1.0 mm I.D. | 1.7 mm O.D. x 1.0 mm I.D. | - |
| Dual-Lumen | | | |
| 4 French | 1.4 mm O.D. x 0.8/0.6 mm I.D. | - | 1.3 mm O.D. x <i>I.D. not noted</i> |
| 5 French | 1.7 mm O.D. x 0.9/0.8 mm I.D. | - | 1.7 mm O.D. x <i>I.D. not noted</i> |
| CATHETER LENGTH<br>(Nominal) | 20 cm, 30 cm, 50 cm, and 65 cm | 20 cm and 65 cm | 20 cm, 30 cm, and 60 cm |
| FLOW RATE (Nominal) | DELTEC FLOW RATES:<br>GRAVITY FLOW AT 1<br>METER | DELTEC FLOW RATES:<br>GRAVITY FLOW AT 1<br>METER | J&J FLOW RATES:<br>GRAVITY FLOW AT 48<br>INCHES |
| Single-Lumen | | | |
| 2 French, 50 cm | 37 ml/hr | - | - |
| 2 French, 30 cm | 62 ml/hr | - | 66 ml/hr |
| 2 French, 20 cm | 89 ml/hr | - | - |
| 3 French, 65 cm | 123 ml/hr | 68 ml/hr | - |
| 3 French, 60 cm | - | - | 150 ml/hr |
| 3 French, 20 cm | 362 ml/hr | 227 ml/hr | 270 ml/hr |
| 4 French, 65 cm | 659 ml/hr | 479 ml/hr | - |
| 4 French, 60 cm | - | - | 570 ml/hr |
| 4 French, 20 cm | 1505 ml/hr | >999 ml/hr | 960 ml/hr |
| 5 French, 65 cm | 1444 ml/hr | >999 ml/hr | - |
| 5 French, 20 cm | 3020 ml/hr | >999 ml/hr | - |
| Dual-Lumen | | | |
| 4 French, 60 cm | - | - | 150 ml/hr (each lumen) |
| 4 French, 65 cm | 224 ml/hr (lg lumen)<br>123 ml/hr (sm lumen) | - | - |
| 4 French, 20 cm | 611 ml/hr (lg lumen)<br>322 ml/hr (sm lumen) | - | 240 ml/hr (each lumen) |
| 5 French, 60 cm | 660 ml/hr (lg lumen)<br>424 ml/hr (sm lumen) | - | 540 ml/hr (each lumen) |
| 5 French, 65 cm | - | - | - |
| 5 French, 20 cm | 1606 ml/hr (lg lumen)<br>1096 ml/hr (sm lumen) | - | - |

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# 510(k) Summary of Safety and Effectiveness Page 3 of 4

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# 510(k) Summary of Safety and Effectiveness Page 4 of 4

## SUMMARY OF STUDIES V.

### Functional Testing A.

In-vitro testing was conducted in accordance with the FDA "Guidance on Premarket Notification [510(k)] Submissions for Short- and Long-term Intravascular Catheters," dated March 1995.

Biocompatibility testing was conducted on the device.

### B. Clinical Studies

Clinical studies were not deemed necessary regarding the CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheter due to its similarity in design and function to current commercially available peripherally inserted catheters.

### C. Conclusion Drawn from the Studies

The results of the testing indicated that the CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters function according to specification and the materials used in the device are biocompatible. Therefore, the device is considered acceptable for human use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 29 1999

Ms. Lisa J. Stone Manager, Requlatory Affairs SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

K984055 Re : Trade Name: CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters Regulatory Class: II Product Code: FOZ Dated: November 12, 1998 November 13, 1998 Received:

Dear Ms. Stone:

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 The general controls provisions of the Act 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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. 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. Stone

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA acinding 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 the regulation chercica) hisbidian's by Solorigeneral 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 "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters

Indications for Use:

"The CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheter is used when therapy requires repeated venous access for intravenous injection or infusion and/or venous blood sampling."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | Brenk Bolster |
|---------------------------------------------------------------------|---------------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K984055 |

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The Counter Use ___________