MODIFICATION TO VAXCEL DIALYSIS CATHETER

K012948 · Boston Scientific/Medi-Tech · MSD · Oct 3, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012948
• Device Name: MODIFICATION TO VAXCEL DIALYSIS CATHETER
• Applicant: Boston Scientific/Medi-Tech
• Product Code: MSD · Gastroenterology, Urology
• Decision Date: Oct 3, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vaxcel™ Dialysis Catheter is designed for chronic hemodialysis and apheresis.

Device Story

Vaxcel Dialysis Catheter is a medical device designed for chronic hemodialysis and apheresis procedures. The device consists of a dual lumen catheter, a hub, an injection cap, an introducer sheath/dilator, and a metal tunneler with a protective sheath. It is intended for use by healthcare professionals in a clinical setting to provide vascular access for blood purification therapies. By facilitating access to the circulatory system, the catheter enables the removal and return of blood during dialysis or apheresis, supporting patient treatment for renal failure or other conditions requiring blood processing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dual lumen catheter, hub, injection cap, introducer sheath/dilator, and metal tunneler with protective sheath. Class III device.

Indications for Use

Indicated for patients requiring chronic hemodialysis and apheresis.

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

• Vaxcel™ Dialysis Catheter

Submission Summary (Full Text)

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K012948
Page 1 of 1

## OCT = 3 2001

## Summary of Safety and Effectiveness

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR \$807.92.

| General Information | Submitter: Boston Scientific<br>480 Pleasant Street<br>Watertown, MA 02172<br>617-923-1720 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Nicholas Condakes |
| General Provisions | Trade Name: Vaxcel™ Dialysis Catheter<br>Classification Name: Catheter, Hemodialysis |
| Name of<br>Predicate<br>Devices | Vaxcel™ Dialysis Catheter |
| Classification | Class III |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514<br>of the Food, Drug and Cosmetic Act |
| Intended Use<br>and Device<br>Description | The Vaxcel™ Dialysis Catheter is designed for chronic hemodialysis and<br>apheresis. The major components of the Vaxcel™ Dialysis Catheter are the<br>dual lumen catheter, hub, injection cap, introducer sheath/dilator and metal<br>tunneler with protective sheath. |
| Summary of<br>Substantial<br>Equivalence | The Vaxcel Dialysis catheters have been tested and compared to the predicate<br>device. All data gathered demonstrate this device as substantially equivalent.<br>No new issues of safety or efficacy have been raised. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized symbol that resembles a bird or a human figure with outstretched arms.

- OCT 3 2001
Mr. Nicholas Condakes Regulatory Affairs Specialist Boston Scientific Corporation Medi-Tech® One Boston Scientific Place NATICK MA 01760-1537

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K012948

Trade/Device Name: Vaxcel™ Dialysis Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: August 31, 2001 Received: September 4, 2001

Dear Mr. Condakes:

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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 (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.

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 and 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.

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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 nothication. The FDA inding of successification 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), please If you desire specific advice at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on and promote of the regulation entitled, "Misbranding Office of Compilance at (301) 62 mm (21 CFR Part 807.97). Other general information on by relection to promative nothers and be obtained from the Division of Small Manufacturers, your responsibilities and revealer & its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

. ..

Sincerely yours,

Nancy C Brogdon

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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## Indications For Use

210(k) Number (if known)

X012948

Vaxcel™ Dialysis Catheter Device Name:

The Vaxcel™ Dialysis Catheter is dcsigned for chronic hemodialysis and Indications for Use apheresis.

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

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

Nancy Brogdon

**(Division Sign-Off)**
Division of Reproductive, Abdominal,

Pivision of Reproductive, Abdoming
and Radiological Devices
10(k) Number. K012948

000012