NIAGARA DUAL LUMEN CATHETER

K965178 · Vas-Cath, Inc. · MPB · Aug 19, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K965178
• Device Name: NIAGARA DUAL LUMEN CATHETER
• Applicant: Vas-Cath, Inc.
• Product Code: MPB · Gastroenterology, Urology
• Decision Date: Aug 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Niagara™ Dual Lumen Catheter is indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian or femoral vein.

Device Story

Polyurethane dual-lumen catheter; provides vascular access for hemodialysis, hemoperfusion, or apheresis. Features two round lumens within an oval shaft; arterial lumen bevelled with two side holes; venous lumen extends beyond arterial lumen with soft atraumatic black tip. Includes clamping extensions with luer connectors and suture wings for securement. Used by clinicians for short-term access via jugular, subclavian, or femoral veins. Device facilitates extracorporeal blood flow; performance metrics include flow rate, pressure, and vacuum maintenance. Benefits patient by enabling necessary blood-purification therapies.

Clinical Evidence

Bench testing only. In vitro performance data compared elongation, tensile strength of molded joints, leakage, recirculation, maximum pressure, and vacuum against the predicate. Flow rate of the Niagara™ catheter was determined to be greater than the predicate.

Technological Characteristics

Polyurethane body/extensions; PVC connectors. 13.5 French shaft diameter. Two round lumens. Straight (15, 20, 24 cm) or pre-curved (12.5, 15, 20 cm) configurations. Soft black tip. Injection molded bifurcation. One-piece construction.

Indications for Use

Indicated for patients requiring short-term vascular access for hemodialysis, hemoperfusion, or apheresis therapy via jugular, subclavian, or femoral vein.

Regulatory Classification

Identification

A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device. (2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).

Special Controls

*Classification.* (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided. (ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated. (B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided. (C) Priming volumes must be established. (D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use. (E) Air leakage testing and liquid leakage testing must be conducted. (F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage. (G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern. (H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established. (iii) Performance data must demonstrate the sterility of the device. (iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing. (v) Labeling of implanted blood access devices for hemodialysis must include the following: (A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated. (B) Labeling must specify the forward and reverse recirculation rates. (C) Labeling must provide the arterial and venous priming volumes. (D) Labeling must specify an expiration date. (E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device. (F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient. (G) Labeling must include a patient implant card. (H) The labeling must contain comprehensive instructions for the following: ( *1* ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;( *2* ) Proper care and maintenance of the device and device exit site;( *3* ) Removal of the device;( *4* ) Anticoagulation;( *5* ) Management of obstruction and thrombus formation; and( *6* ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following: (A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port. (B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device. (C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use. (vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following: (A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied. (B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties. (C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens. (D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness. (viii) The following must be included for A-V shunt cannulae (with vessel tips): (A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply. (B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation. (C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use. (2) Class II (performance standards) for the nonimplanted blood access device. (3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section. (4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Permanent Dual Lumen Catheter Soft-Cell™ (K871488)

Submission Summary (Full Text)

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K965178
Page 1 of 2

2380 Tedlo Street
Mississauga, Ontario
Canada, L5A 3V3

Tel. [phone]
Fax [phone]

# 510(k) SUMMARY of SAFETY AND EFFECTIVENESS FOR THE NIAGARA™ DUAL LUMEN CATHETER

## A. Submitter Information:

| Submitter’s Name: | Vas-Cath Incorporated |
| --- | --- |
| Address: | 2380 Tedlo Street
Mississauga, Ontario
Canada, L5A 3V3 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Dolores McGirr |
| Date of Preparation: | November 15, 1996 |

## B. Device Name:

| Trade Name: | Niagara™ Dual Lumen Catheter |
| --- | --- |
| Common/Usual Name: | Hemodialysis Catheter |
| Classification Name: | Subclavian Catheter |

## C. Predicate Device Name:

| Trade Name: | Permanent Dual Lumen Catheter
Soft-Cell™ |
| --- | --- |

## D. Device Description:

The Vas-Cath Niagara™ catheter is a polyurethane catheter which allows for dialysis, hemoperfusion or apheresis. The Niagara™ catheter contains two clear polyurethane clamping extensions with luer connectors at the ends and atraumatic nylon clamps. The arterial and venous extensions are identified with red and blue luer connectors. The two extensions merge into a tapered bifurcation joint or hub molded to the catheter body tubing. Both a fixed and a removable suture wing are provided for securing the catheter after initial placement.

The cross-section of the oval shaft contains two round arterial and venous lumens. The arterial lumen exit is bevelled and is perforated with two holes. The venous lumen extends beyond the arterial lumen and ends with a soft atraumatic black tip. The Niagara™ catheters are available in a straight configuration with 15 cm, 20 cm, and 24 cm insertion lengths; as well as in a pre-curved configuration with 12.5 cm, 15 cm and 20 cm insertion lengths.

## E. Intended Use:

The Niagara™ Dual Lumen Catheter is indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian or femoral vein.

Niagara™ 510(k) Submission Page 6.1

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K965178
Page 2 of 2
vas-cath. INCORPORATED

## F. Technological Characteristics:

| Characteristic | Niagara™ Catheter | Vas-Cath Soft-Cell™ Catheter (K871488) |
| --- | --- | --- |
| Shaft Diameter | 13.5 French | 12.5 French |
| Materials | Polyurethane body and extensions,
PVC connectors | Polyurethane body and extensions,
PVC connectors |
| Priming Volume (arterial lumen) | 15cm: 1.3cc
20cm: 1.5cc
24cm: 1.6cc | 12cm: 1.3cc
19cm: 1.5cc
23cm: 1.7cc |
| Priming Volume (venous lumen) | 15cm: 1.4cc
20cm: 1.6cc
24cm: 1.7cc | 12cm: 1.4cc
19cm: 1.6cc
23cm: 1.8cc |
| Shape of arterial/venous lumens | two round lumens | “Double-D” lumens |
| Indications | hemodialysis, hemoperfusion,
apheresis, | hemodialysis, hemoperfusion,
apheresis |
| Catheter Insertion lengths | 15cm, 20cm, and 24cm | 12 cm, 19 cm, 23 cm |
| Tip Characteristic | soft black tip | 45° bevelled tip |
| Manufacturing Process | Injection Molded bifurcation onto
Body and Extensions.
Catheter is one piece | Injection Molded bifurcation onto
Body and Extensions.
Catheter is one piece |

## G. Performance Data:

*In vitro* performance data shows the Niagara™ catheter to be substantially equivalent to the predicate catheter in regard to elongation, tensile strength of molded joints, leakage, recirculation, as well as maximum pressure and vacuum. The flow rate of the Niagara™ catheter is greater than the Soft-Cell™ catheter as determined by bench testing.

Niagara™ 510(k) Submission Page 6.2

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Dolores McGirr
Regulatory Affairs
Vas-Cath, Inc.
2380 Tedlo Street
Mississauga, Ontario L5A 3V3
CANADA

Re: K965178
Niagara™ Dual Lumen Catheter
Dated: July 2, 1997
Received: July 10, 1997
Regulatory class: II
21 CFR §876.5540
Product code: 78 MPB

AUG 19 1997

Dear Ms. McGirr:

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. 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 legally 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, and 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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:

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Page 2 - Ms. Dolores McGirr

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 1% xylocaine, povidone iodine swabsticks, and povidine 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 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 the 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 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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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# 1.D Indication(s) Statement

I state in my capacity as Manager of QA/RA of Vas-Cath that this 510(k) premarket notification for the Niagara™ Dual Lumen catheter is indicated for the following:

The Niagara™ Dual Lumen Catheter is indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular, subclavian or femoral vein.


Janet Shaw
Manager of Quality Assurance and Regulatory Affairs, (printed)
96/12/20
Date

Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the code of Federal Regulations, Title 21.

# CONCURRENCE OF OFFICE OF DEVICE EVALUATION

510(K) Number


Division Sign-Off
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K96.5178

Division Sign-Off, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use

Niagara™ 510(k) Submission Page 1.6