SAFE-CATH

K960764 · Scientific Device Manufacturer, LLC · FOZ · Apr 24, 1997 · General Hospital

Device Facts

• Record ID: K960764
• Device Name: SAFE-CATH
• Applicant: Scientific Device Manufacturer, LLC
• Product Code: FOZ · General Hospital
• Decision Date: Apr 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

These devices are intended for various non-permanent intravascular applications including pressure monitoring, fluid administration, and blood sampling.

Device Story

Polyurethane intravascular catheters; single- or multi-lumen configurations; include flexible distal tip (except smallest sizes); proximal end features fixed female locking luers; extension tubes with clamps; centimeter markings for depth. Provided in kits with guidewire, dilator, syringe, scalpel, suture wing, and introducer needle. Used by clinicians in clinical settings for vascular access. Facilitates fluid delivery, hemodynamic monitoring, and blood collection. Sterilized via ethylene oxide.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Polyurethane catheter body and extension tubes; flexible polyurethane distal tip; molded-on female locking luers; centimeter depth markings. Sterilization via ethylene oxide. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring non-permanent intravascular access for pressure monitoring, fluid administration, 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

• Central Venous Multi-Lumen Catheter with flexible tip (Arrow International)
• Temporary Dual and Triple Lumen Catheters (Vas-Cath Incorporated)

Submission Summary (Full Text)

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scientific device manufacturer, L.L.C.

K960764

999 Andersen Drive, Suite 120

San Rafael, California 94901

Phone [phone] Fax [phone]

APR 24 1997

# Summary of Safety and Effectiveness

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: K960764

## Applicant Information:

Date Prepared: January 20, 1997

Name: Scientific Device Manufacturer, LLC.

Address: 999 Andersen Drive, Suite 120
San Rafael, California 94901

Contact Person: Richard C. Ball

Phone Number: 415-454-9370

Fax Number: 415-454-9380

## Device Information:

Trade Name: Safe-Cath

Common Name: Single- and Multi-Lumen Intravascular Catheter

Classification Name: Intravascular Catheter

## Equivalent Device:

Central Venous Multi-Lumen Catheter with flexible tip (Arrow International).

Temporary Dual and Triple Lumen Catheters (Vas-Cath Incorporated).

## Device Description:

The various SDM Central Venous Catheters consist of polyurethane bodies with zero to five polyurethane extension tubes. Except for the smallest French sizes of the single lumen devices, the catheters all contain an additional flexible polyurethane distal tip. The proximal end(s) of each catheter terminate in molded-on, fixed, female locking luers. Where present, the extension tubes are joined to the catheter body by insert-molded polyurethane and contain clamps for occluding the tubes. Many configurations are marked with centimeter markings to indicate insertion depth.

Catheters will be offered in "kits" which will include some or all of the following depending on configuration: Catheter, guidewire in dispenser, dilator, syringe, scalpel, suture wing, and introducer needle. The makeup of specific sets can be seen in the Appendix D of this 510(k) submission. These kits will be packaged in semi-rigid vacuum formed trays containing a heat-sealed, ethylene oxide permeable lids, or in standard Tyvek/Poly pouches, depending on the product configuration.

{1}

sdm

scientific device manufacturer, L.L.C.

999 Andersen Drive, Suite 120

San Rafael, California 94901

Phone [phone] Fax [phone]

SDM,LLC

510(k) Submittal

Central Venous Catheters, Standard

## Intended Use:

These devices are intended for various non-permanent intravascular applications including pressure monitoring, fluid administration, and blood sampling.

## Comparison To Predicate Device:

Scientific Device Manufacturer's Vascular Access Catheters are substantially equivalent to currently marketed vascular access catheters will regard to intended use, materials, dimensions and mechanical properties. Predicate devices include those made by Arrow International and Vas-Cath Incorporated. No significant changes or modifications were made from those predicate devices other than the addition of two 8.5FR 5-Lumen versions. With the exception of slightly smaller lumen sizes, the 5-Lumen catheters are constructed in the same manner as the other SDM devices. SDM, L.L.C., therefore posits that its devices are equivalent in safety, effectiveness and intended use to those devices.

Signed: Q. Ball

Name: Richard C. Ball

Position: VP Regulatory Affairs and Quality Assurance

Date: January 20, 1997