DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER

K042016 · Datascope Corp. · MSD · Sep 23, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K042016
• Device Name: DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
• Applicant: Datascope Corp.
• Product Code: MSD · Gastroenterology, Urology
• Decision Date: Sep 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Datascope Chronic Dialysis catheter is indicated for use in attaining longterm access for hemodialysis and apheresis. It may be implanted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein as required.

Device Story

Double-lumen polyurethane (Carbothane) catheter for long-term hemodialysis and apheresis access; provides dedicated arterial and venous lumens. Features thermo-sensitive material, rigid for insertion and softening at body temperature to reduce vessel trauma. Includes pre-loaded stylet for insertion; 'over-the-wire' design eliminates need for tear-away sheath. Hub molded from soft polyurethane for patient comfort; extensions color-coded for identification. Used by clinicians in clinical settings for percutaneous implantation, primarily in the internal jugular vein. Device facilitates blood access for dialysis/apheresis procedures.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated through in vitro bench testing comparing the device to the predicate.

Technological Characteristics

Double-lumen catheter; material: Carbothane (polyurethane); 14.5 French; lengths 24-40cm. Features: thermo-sensitive material, pre-loaded stylet, rotating suture wing, color-coded luer connectors. Sterilization method not specified.

Indications for Use

Indicated for long-term hemodialysis and apheresis access in adult patients. Primarily placed in the internal jugular vein; alternate site is the subclavian 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

• Medcomp Hemo-Flow™ Catheter (K994105)

Submission Summary (Full Text)

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#### A. Submitter Information:

Submitter:

Contact:

B.

Date Prepared:

Common Name:

Trade Name:

Classification: C.F.R. Section:

## SEP 2 3 2004

Datascope Interventional Products Division 1300 MacArthur Blvd. Mahwah, NJ 07430-0605 Phone: [phone] Fax: [phone] Patrice Napoda Manager, Regulatory Affairs July 26, 2004

Datascope Chronic Dialysis Catheter Hemodialysis Catheter, Implanted 78 MSD 876.5540

#### C. Predicate Device:

K994105 Medcomp Hemo-Flow™ Catheter

na 1 Mi

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#### D. Device Description:

The Datascope Chronic Dialysis Catheter is double lumen polyurethane catheter (Carbothane) that provides two dedicated (arterial/venous) access lumens. Both lumens are "D" shaped, open at the distal tip, with and without side holes. Each lumen is connected through an extension line with female luer connectors. The transition between lumen and extension is housed within a molded hub.

Product Features: The catheter lumen is composed of a soft, thermo sensitive, polyurethane material that is rigid upon insertion and once it reaches body temperature it becomes soft to reduce vessel trauma. The catheter assembly contains a pre-loaded stylet for ease of insertion. The Datascope Chronic Dialysis Catheter has a unique "over the wire" design that eliminates the need for a tear-away sheath during catheter insertion.

The catheter hub is molded from soft, pliable polyurethane to increase patient comfort.

The dialysis extensions are color coded with a red luer and a clamp for the arterial lumen, a blue luer and a clamp for the venous lumen for easy identification.

## Physical Dimensions: Lumen Outer Diameter:

Lumen Length: 24, 28, 32, 36 & 40cm Straight

Outer Diameter 0.193 +/- . 003 Lumen Dimensions: Inner Diameter 0.122 +.002/-.003

14.5 French

Lumen Side Holes: With and Without

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K04 2016 PJ 2of-2

#### Intended Use: E.

The Datascope Chronic Dialysis Catheter is indicated for use in attaining long-term rne Batacopo only is and apheresis. It may be implanted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein as required.

#### Comparison to Predicate Device: F.

The technological characteristics of the Datascope Chronic Dialysis Catheter are substantially equivalent to the predicate device in terms of intended use, insertion method, design, materials, performance, labeling, manufacturing process, and method of sterilization.

The modifications include:

- Pre-Loaded stylet .
- Without side hole design .
- Slightly different hub design .
- Different tip design .
- Rotating suture wing .

#### Performance Data: ુ.

In vitro performance data for the Datascope Chronic Dialysis Catheter includes force @ break, air/liquid leak, recirculation, flow vs. pressure, and gravity flow, all demonstrate that this device is substantially equivalent to the legally marketed predicate device.

Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized birds in flight, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2004

Ms. Patrice Napoda Manager, Regulatory Affairs Datascope Corporation Interventional Products Division 1300 MacArthur Blvd. MAHWAH NJ 07430-0605

Re: K042016

Trade/Device Name: Datascope ProGuide Chronic Hemodialysis Catheter, with accessories; Models 61124, -28, -32, -36, and -40, With Side Holes; and, Models 62124, -28, -32, -36, and -40, Without Side Holes Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: July 26, 2004 Received: July 27, 2004

Dear Ms. Napoda:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Ms. Patrice Napoda

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number [phone] or [phone], or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

David A. Syrom

fr

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 04 2016 pg 1 of 1

# INDICATIONS FOR USE

## 510(k) Number:

Device Name: DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER

## Indications for use:

The Datascope Chronic Dialysis catheter is indicated for use in attaining longterm access for hemodialysis and apheresis.

It may be implanted percutaneously and is primarily placed in the internal jugular vein of an adult patient.

Alternate insertion sites include the subclavian vein as required.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tami A. Lypson

uctive, Abdominal

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter

(Optional Format 1-2-96)