ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER

K962577 · Arrow Intl., Inc. · FOZ · Aug 21, 1997 · General Hospital

Device Facts

• Record ID: K962577
• Device Name: ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
• Applicant: Arrow Intl., Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Aug 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The multiple-lumen catheter permits venous access to the central circulation. The Arrow antiseptic surface catheter is intended to help provide protection against catheter related infections. The catheter is not intended to be used as a treatment for existing infections nor is it indicated for longterm use.

Device Story

The ARROWgard Blue™ Quad-Lumen Central Venous Catheter is a multi-lumen device designed for central venous access. It features an antiseptic surface treatment intended to reduce the risk of catheter-related infections. The device is intended for short-term use in clinical settings, operated by healthcare professionals. It is supplied as part of a kit that may include various components such as sutures, Povidone-Iodine swabsticks, Povidone-Iodine ointment, and Lidocaine hydrochloride. The catheter provides a pathway for fluid administration, medication delivery, or blood sampling within the central circulation. It is not a treatment for existing infections.

Clinical Evidence

No clinical data provided. The submission relies on the determination of substantial equivalence to legally marketed devices and compliance with general controls and GMP regulations.

Technological Characteristics

Multi-lumen central venous catheter with an antiseptic surface treatment. Kit components include sutures, Povidone-Iodine swabsticks, Povidone-Iodine ointment, and Lidocaine hydrochloride. Sterilization process is validated to ensure suture characteristics are not altered.

Indications for Use

Indicated for patients requiring venous access to the central circulation. Intended to provide protection against catheter-related infections. Not indicated for treatment of existing infections or long-term use.

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.

Submission Summary (Full Text)

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

Thomas D. Nickel
Vice President, Regulatory Affairs and Quality Assurance
Arrow International, Incorporated
3000 Bernville Road
Reading, Pennsylvania 19605

AUG 21 1997

Re: K962577
Trade Name: ARROWgard Blue™ Quad-Lumen Central Venous Catheter
Regulatory Class: II
Product Code: FOZ
Dated: September 24, 1996
Received: September 30, 1996

Dear Mr. Nickel:

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

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Page 2 - Mr. Nickel

Manufacturing Practice for Medical Devices: General (GMP) 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 the following components which are subject to regulation as drugs:

1. Povidone-Iodine swabsticks,
2. Povidone-Iodine ointment, 1 qm., and
3. Lidocaine hydrochloride, 5 ml., 1%, ampule.

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]

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Page 3 - Mr. Nickel

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 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
Acting 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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Page 1 of 1

510(k) Number (if known): K962577

Device Name: ARROWARD Blue™ Quad-Lumen Central Venous Catheter

Indications For Use:

The multiple-lumen catheter permits venous access to the central circulation.
The Arrow antiseptic surface catheter is intended to help provide protection against catheter related infections. The catheter is not intended to be used as a treatment for existing infections nor is it indicated for longterm use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Peticor Cessate
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K962577

Prescription Use ☑
r 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)