KENDALL DUAL LUMEN CATHETER

K963446 · Kendall Healthcare Products Co. Div.Of Tyco Health · MPB · Mar 18, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963446
• Device Name: KENDALL DUAL LUMEN CATHETER
• Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
• Product Code: MPB · Gastroenterology, Urology
• Decision Date: Mar 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kendall Dual Lumen Catheters are intended for use as short-term vascular access for hemodialysis. The catheters can be inserted in the femoral, subclavian or jugular vein as required.

Device Story

Single-use, sterile, radiopaque dual-lumen cannula catheter; provides simultaneous arterial outflow and venous return for hemodialysis. Features two extension tubes with color-coded clamps (red/arterial, blue/venous) and luer lock adapters. Available in 8.5, 10.0, and 11.0 Fr sizes. Used by clinicians in clinical settings for short-term vascular access. Device facilitates hemodialysis procedure by providing necessary blood flow path; benefits patient by enabling essential renal replacement therapy.

Clinical Evidence

No clinical testing was performed. Evidence based on non-clinical comparative bench testing (flow rate, hemolysis, recirculation) and biocompatibility testing, demonstrating equivalence to predicate device.

Technological Characteristics

Single-cannula, dual-lumen catheter; radiopaque material; 8.5, 10.0, 11.0 Fr sizes; color-coded in-line clamps; luer lock adapters; sterile, single-use.

Indications for Use

Indicated for short-term vascular access for hemodialysis in patients requiring femoral, subclavian, or jugular vein catheterization.

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

• Neostar Dual Lumen Catheters (K941851)

Submission Summary (Full Text)

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MAR 18 1997
K963446

Exhibit 10

510(k) Summary

In accordance with section 513(l)(3) of the SMDA and as described in 21 CFR Part 807.92 interim rule dated April 28, 1992, this summary is submitted by:

Kendall Healthcare Products Company
15 Hampshire Street
Mansfield, MA 02048
Date: August 28, 1996

1. Contact Person

David A. Olson, Regulatory Affairs
Telephone: [phone]

2. Name of the Device

Classification Name: Hemodialysis System and Accessories
Common or Usual Name: Vascular Access Catheters
Proprietary Name: Kendall CURITY Dual Lumen Subclavian Catheters

3. Statement of Substantial Equivalence

The Kendall Dual Lumen Catheters are substantially equivalent in form, fit, function and intended use to the commercially available Neostar Dual Lumen Catheters, 510(k) No. K941851.

4. Description of Device

The Kendall Dual Lumen Catheters are single use, sterile devices. The single radiopaque cannula catheters have two distinct lumina which provide simultaneous "arterial" outflow and "venous" return. The catheters have two extension tubes, each with a color-coded in-line clamp (red for arterial outflow, blue for venous return) and luer lock adapter. The catheters are sold in 8.5, 10.0 and 11.0 Fr sizes.

5. Intended Use of the Device

The Kendall Dual Lumen Catheters are intended for use as short-term vascular access for hemodialysis. The catheters can be inserted in the femoral, subclavian or jugular vein as required.

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## 6. Product Comparison

The Kendall Dual Lumen catheters are equivalent to the referenced predicate device in that they are the same design (single cannula, dual lumen), fabricated from similar materials and have equivalent indications for use.

## 7. Performance Data

Non-Clinical Tests - Comparative testing of the Kendall Dual Lumen Catheters with the predicate device found similar physical and functional properties. Such criteria included flow rate, hemolysis and recirculation studies. Biocompatibility testing of the catheter components has also been performed.

Clinical Tests - No clinical testing was performed.

Test Conclusions - Biocompatibility testing of the Kendall Dual Lumen Catheters has demonstrated that they contain no bioactive components. Comparative testing of the Kendall product and predicate device have found them similar in design, physical and functional attributes.