SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER

K971085 · B.Braun Medical, Inc. · LJS · Jun 2, 1997 · General Hospital

Device Facts

• Record ID: K971085
• Device Name: SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER
• Applicant: B.Braun Medical, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Jun 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The soft Tip Multi-Lumen Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids or drugs.

Device Story

Soft Tip Multi-Lumen Central Venous Catheter; inserted into venous system for administration of blood products, parenteral nutrition, IV fluids, or drugs. Device consists of multi-lumen catheter; includes sutures, lidocaine, and povidone iodine ointment as components. Used in hospital settings; operated by healthcare professionals. Provides venous access for therapeutic fluid/drug delivery; benefits patient by enabling long-term or multi-pathway intravenous therapy.

Clinical Evidence

No clinical data. Bench testing only; physical testing and visual examination performed to meet release specifications.

Technological Characteristics

Multi-lumen catheter design. Materials tested per ISO 10993. Includes accessory components (sutures, lidocaine, povidone iodine).

Indications for Use

Indicated for patients requiring venous access for administration of blood products, parenteral nutrition, IV fluids, or drugs.

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

• Accuguide Multi-Lumen Central Venous Catheter Kit (K834473A)

Submission Summary (Full Text)

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K971085
June 2, 1997

# II 510(k) Summary of Safety and Effectiveness In Accordance with SMDA'90

March 7, 1997

B. Braun Medical, Inc
824 Twelfth Avenue
Bethlehem, PA 18018
[phone]

Contact: Mark S. Alsberge, Regulatory Affairs Manager

Product Name: Soft Tip Multi-Lumen Central Venous Catheter

Trade Name: Catheter, Percutaneous Intravascular, Long term

Classification name:

Hospital
Unclassified, 80LJS
21 CFR

SUBSTANTIAL EQUIVALENCE¹ TO:

| K834473A | Accuguide Multi-Lumen Central Venous Catheter Kit | B. Braun Medical Inc. |
| --- | --- | --- |

## Device Description:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Soft Tip Multi-Lumen Central Venous Catheter. A Soft Tip Multi-Lumen Central Venous Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids or drugs.

¹ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

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# Material:

The Soft Tip Multi-Lumen Central Venous Catheter is composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.

# Substantial equivalence:

The Soft Tip Multi-Lumen Central Venous Catheter is similar in materials, form, and intended use to the Accuguide Multi-Lumen Central Venous Catheter Kit cleared by B. Braun Medical Inc. There are no new issues of safety or effectiveness raised by The Soft Tip Multi-Lumen Central Venous Catheter.

# Safety And Effectiveness:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.

The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's.

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

Mark S. Alsberge
Manager, Regulatory Affairs
B. Braun Medical, Incorporated
824 Twelfth Avenue
Bethlehem, Pennsylvania 18018

JUN - 2 1997

Re: K971085
Trade Name: Soft Tip Multi-Lumen Central Venous Catheter
Regulatory Class: Unclassified
Product Code: LJS
Dated: March 11, 1997
Received: March 25, 1997

Dear Mr. Alsberge:

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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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 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)

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Page 2 - Mr. Alsberge

regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.

FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization process used for the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:

1. The labeling, packaging and method of sterilization of the suture cannot be changed without prior notification, review and clearance by FDA.
2. The supplier of the sutures used in your device cannot be changed without prior notification, review and clearance by FDA.

In addition, we have determined that your device kit contains a 5 ml. ampul of lidocaine and povidone iodine ointment which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310)
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
[phone]

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

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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 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 at [phone].

Sincerely yours,

Timothy A. Ulatowski
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 (if known): K971085

Device Name: Soft Tip Multi-Lumen Central Venous Catheter

Indications For Use:
The soft Tip Multi-Lumen Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids or drugs.

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

Counselor of CDRH, Office of Device Evaluation (ODE)

(Division of CDRH, Infection Control, and General Hospital Devices
510(h) Number) K971085

Description Use
or 21 CFR 801.100

OR

Over-The-Counter Use

(Optional Format 1-2-96)