ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)

K980090 · Luther Medical Products, Inc. · LJS · Mar 24, 1998 · General Hospital

Device Facts

• Record ID: K980090
• Device Name: ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)
• Applicant: Luther Medical Products, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Mar 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ONECATH Catheter System is designed for use when patient therapy requires repeated venous access or prolonged intravenous administration of fluids, medications, and/or nutritional solutions as prescribed. The catheter is designed to be inserted in a peripheral vein. While any vessel suitable for insertion may be used; the basilic vein is the most commonly used vein. Note: This product may be used in pediatric as well as adult patients. Vascular cannulation is an important Procedure in the management of ill infants and children. The indications for use in children are the same as adults; however, insertion techniques are often modified according to the age and size of a child. If the practitioner is inexperienced in utilizing this product in a child, appropriate consultation should be sought.

Device Story

ONECATH is a peripherally inserted central catheter (PICC) system used for long-term venous access. It consists of a radiopaque polyurethane catheter, a stainless steel needle, and a two-part locking needle protection device (SafeSide II) with a flashback chamber. Available in lengths of 5-60 cm and gauges 16-22. The device is inserted by a clinician into a peripheral vein (e.g., antecubital) using an over-the-needle technique. It features a Y-site injection port with a pre-inserted stylet and vent plug. The catheter allows for IV administration, blood therapy, and blood sampling. By providing reliable venous access, it facilitates the management of patients requiring prolonged therapy, reducing the need for repeated venipuncture. The device is latex-free and DEHP-free.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use similarity to the predicate device. Potential complications are well-known and documented in scientific literature for infusion catheters.

Technological Characteristics

Materials: Radiopaque polyurethane catheter, stainless steel needle. Design: Over-the-needle introducer with protected needle, Y-site injection port, 5cm interval markings. Dimensions: 16-22 gauge, 5-60 cm length. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for adult and pediatric patients requiring repeated venous access or prolonged IV administration of fluids, medications, or nutritional solutions. Inserted into peripheral veins (e.g., basilic).

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• ONECATH (K930743)

Submission Summary (Full Text)

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#### LUTHER MEDICAL PRODUCTS, INC.

14332 CHAMBERS ROAD TUSTIN, CALIFORNIA 92780-6912

[phone] FAX [phone]

K9800090

# MAR 2 4 1998

### 510(k) SUMMAR Y

#### GENERAL INFORMATION:

Applicant's Name and Address

Luther Medical Products, Inc. 14332 Chambers Road Tustin, CA 92780-6912 Phone: [phone] [phone] FAX:

September 4, 1997

Contact Person:

George Brdlik Voice Mail: [phone] Ext. 224 FAX: [phone]

Date of Summary:

Peripherally Inserted Catheter

Common/Usual Name:

Proprietary Name:

Classification Name:

ONECATH® Catheter System an L-Cath® Catheter, Intravascular, Long Term 80FOZ Classification Number: E880.5200 Class II Catheter, Long Term, Implanted 80LJS Classification Number: None

## COMPARISON TO A LEGALLY MARKETED DEVICE;

ONECATH (K930743)

The ONECATH Catheter System consists of a SafeSide DEVICE DESCRIPTION: II® introducer and a radiopaque single lumen polyurethane catheter with a clear tip. The SafeSideII introducer consists of a stainless steel needle and a two-part locking needle protection device with a flashback chamber and introducer protector. The 60, 50 and 20 cm catheters are marked in 5cm increments, in a linear tear protective sleeve. For the

Luther Medical Products, Inc. 510(k) Substantially Equivalent Catheter 09/04/97 Page 1 of 4

Class II

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60, 50 and 20 cm catheters a stylet is pre-inserted through the Y-site injection port that is connected to the catheter. A vent plug is inserted in the side port of the Y-site. The SafeSide II introducer is pre-inserted in the catheter through an aperture approximately 2cm from the tip. The ONECATH catheter system is available in various lengths of 60. 50 and 20 cm and is packaged in a two-part tray in a pouch. The ONECATH 5cm catheter is packaged in a pouch with a hemostasis valve. The product contains no DEHP or latex. The female luer is lipid resistant. Non serrated forceps are included.

The basic device is essentially the same as the original SUMMARY: ONECATH with a minor change in tip configuration. There is no change in intended use.

SUBSTANTIAL EQUIVALENCE: The ONECATH has been marketed since 1994 with no reported adverse effects.

> The modification poses no additional risks or potential questions of efficacy.

The results of use of this catheter system indicates that it is acceptable for human implant.

Based on the proposed modification and the device similarity to the original in material, design and intended use the device is considered to be substantially equivalent.

Extensive studies are available in the scientific literature to POTENTIAL COMPLICATIONS: address the known complications from the insertion of The types and causes of safety and/or catheters. effectiveness problems that have been reported in use of infusion catheters are well known.

> The potential exists for serious complications, some of which are as follows:

AIR EMBOLUS ARRHYTHMA

HYDROTHORAX INFECTION AND CATHETER RELATED SEPSIS

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### POTENTIAL COMPLICATIONS:

ARTERIAL PUNCTURE BLEEDING CARDIAC TAMPONADE CATHETER FRAGMENT EMBOLUS CATHETER OCCLUSION DAMAGE TO CATHETER DRUG EXTRAVASATION EROSION/PERFORATIO N OF VESSEL/HEART HEMATOMA HEMOTHORAX

IMPLANT REJECTION MIGRATION OF CATHETER MYOCARDIAL DAMAGE NERVE DAMAGE

PHLEBITIS, CHEMICAL AND MECHANICAL PNEUMOTHORAX

PULMONARY ARTERY RUPTURE THROMBOEMBOLISM

THROMBOSIS VALVULAR DAMAGE ALONG VEIN

## CONCLUSION:

Based on the evidence presented the device is manufactured using essentially the same materials.

The intended use is the same and therefore the device is considered substantially equivalent.

A comparison of the subject device to the claimed device follows on the next page.

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| Element of Comparison | Subject Device<br>Modified ONECATH | Claimed Device<br>Legally Marketed ONECATH<br>K930473 |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter Type<br>FOZ – Intravascular<br>Catheter<br>And<br>LJS – Long-term<br>Intravascular Catheter | Long-Term Intravascular<br>Catheter, Adult and<br>Neonate/Pediatric<br>Peripheral, Midline, Midclavicular<br>and CVC (PICC) | Long-Term Intravascular<br>Catheter, Adult and<br>Neonate/Pediatric<br>Peripheral, Midline, Midclavicular<br>and CVC (PICC) |
| Intended Use | I.V. Administration<br>Blood Therapy<br>Blood Sampling | I.V. Administration<br>Blood Therapy<br>Blood Sampling |
| Mode of Operation | Catheter Insertion Over the Needle<br>Introducer with protected needle.<br>Recommended Site, Anticubital<br>Peripheral Vein. Additional site<br>selection may be at the direction of<br>the practitioner when used on the<br>neonatal and pediatric population. | Catheter Insertion Over the Needle<br>Introducer with protected needle.<br>Recommended Site, Anticubital<br>Peripheral Vein. Additional site<br>selection may be at the direction of<br>the practitioner when used on the<br>neonatal and pediatric population. |
| Intended Anatomical<br>Location of Distal End | Peripheral – Distal portion of the<br>extremity<br>Midline –Proximal portion of the<br>extremity<br>Midclavicular –<br>Proximal axillary or subclavian<br>veins.<br>Central – (PICC) within the<br>Superior Vena Cava<br>This is not a Right Atrium Catheter | Peripheral – Distal portion of the<br>extremity<br>Midline –Proximal portion of the<br>extremity<br>Midclavicular –<br>Proximal axillary or subclavian<br>veins.<br>Central – (PICC)<br>Superior Vena Cava<br>This is not a Right Atrium Catheter |
| Cannula Introducer | Stainless Steel Over the Needle | Stainless Steel Over the Needle |
| Catheter Markings | 5 cm intervals from distal end of<br>strain relief. | 5 cm intervals from distal end of<br>strain relief. |
| Catheter Material | Radiopaque Polyurethane | Radiopaque Polyurethane |
| Distal End Configuration | Tapered on Over the Needle<br>Cannula Introducer | Tapered on Over the Needle<br>Cannula Introducer |
| Proximal End<br>Configuration | Strain relief, standard luer lock,<br>with pre-inserted stylet through a<br>Y-site. | Strain relief, standard luer lock,<br>with pre-inserted stylet through a<br>Y-site. |
| Catheter Gauge Size | 16, 18, 20, 22 | 16, 18, 20, 24 |
| Catheter Length | 5 – 60 cm | 10 – 60 cm |

·

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 1998

Ms. Barbara C. Luther ·Requlatory Affairs Luther Medical Products, Incorporated 530 Kings Road Newport Beach, California 92663-5710

K980090 Re : Onecath®, L-Cath Catheter System, Model OC-Trade Name: (16-22 ga., 5cm - 60 cm) Regulatory Class: Unclassified Product Code: LJS Dated: January 4, 1998 Received: January 9 1998

Dear Ms. Luther:

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

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Page 2 - Ms. Luther

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 labelinq 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 qeneral 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.qov/cdrh/dsmamain.html".

Sincerely yours

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

Enclosure

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510(k) Number : _ | 980090

Name of Device: ONECATH CATHETER SYSTEM PERIPHERALLY INSERTED CATHETERS

INDICATIONS FOR USE:

## "Statement of Indications for Use"

The ONECATH Catheter System is designed for use when patient therapy

requires repeated venous access or prolonged intravenous administration of

fluids, medications, and/or nutritional solutions as prescribed. The catheter is

designed to be inserted in a peripheral vein. While any vessel suitable for

insertion may be used; the basilic vein is the most commonly used vein.

Note: This product may be used in pediatric as well as adult patients. Vascular cannulation is an important Procedure in the management of ill infants and children. The indications for use in children are the same as adults; however, insertion techniques are often modified according to the age and size of a child. If the practitioner is inexperienced in utilizing this product in a child, appropriate consultation should be sought.

Patricio Cucendie
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital, Intection of

\X Prescription Use

510(k) Number ________________________________________________________________________________________________________________________________________________________________