ACUTE AND CHRONIC CATHETER REPAIR KIT

K092797 · Kendall · NFK · Nov 19, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K092797
• Device Name: ACUTE AND CHRONIC CATHETER REPAIR KIT
• Applicant: Kendall
• Product Code: NFK · Gastroenterology, Urology
• Decision Date: Nov 19, 2009
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Covidien Acute and Chronic Catheter Repair Kit is intended to repair the external extension tubing, luer adapter or clamp of a hemodialysis catheter manufactured by Covidien. Do not use this kit to repair a catheter if the damaged portion of the extension tubing is more than 0.5 cm away from the distal end of the luer adapter. Specific hemodialysis catheters that can be repaired using this kit include: Palindrome ™ Chronic Care Catheters; Palindrome TM Emerald™ Chronic Care Catheters; Palindrome ™ Ruby™ Chronic Care Catheters; Palindrome™ Sapphire™ Chronic Care Catheters; MAHURKAR™* Maxid™ Chronic Care Catheters; MAHURKAR™* 8 Fr. (2.67mm) Single Lumen Acute Care Catheters; MAHURKAR™* 8 Fr. (2.67mm) Dual Lumen Acute Care Catheters; MAHURKAR™* 10 Fr. (3.33mm) Dual Lumen Acute Care Catheters; MAHURKAR™* 11.5 Fr. (3.83mm) Dual Lumen Acute Care Catheters; MAHURKAR™* 13.5 Fr. (4.50mm) High Flow Dual Lumen Acute Care Catheters; MAHURKAR™* 12 Fr. (4.00mm) Triple Lumen Acute Care Catheters. (Note: do not use this kit to repair the infusion lumen.)

Device Story

Kit enables repair of damaged external components (luer adapter, clamp, or proximal 0.5cm of extension tubing) on existing Covidien hemodialysis catheters. Procedure involves clamping catheter with existing and provided slide clamp; cutting damaged extension tube; removing old clamp; installing threaded repair collar; inserting barbed connector into extension tube; securing collar to back end. Used in clinical settings by healthcare providers. Restores catheter function, avoiding need for complete catheter replacement; benefits patient by maintaining vascular access.

Clinical Evidence

Bench testing only. Performance evaluated via tensile strength, dynamic flow, leak, and burst testing in accordance with FDA and ISO guidance.

Technological Characteristics

Mechanical repair kit consisting of threaded repair collar, barbed connector, and slide clamp. Designed for specific Covidien hemodialysis catheter dimensions. No electronic or software components.

Indications for Use

Indicated for repair of external extension tubing, luer adapter, or clamp of specific Covidien hemodialysis catheters (Palindrome and MAHURKAR lines). Contraindicated for damage >0.5cm from distal end of luer adapter and for repair of infusion lumen on 12 Fr. Triple Lumen Acute Care Catheters.

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

• Bard Catheter Repair Kit with Replacement Connector (K063446)

Submission Summary (Full Text)

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K092797 Page 17

510(k) Summary of Safety and Effectiveness

| Date Summary Prepared: | August 31, 2009 | NOV 1 9 2009 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter's Information: | Kendall,<br>a Division of Tyco Healthcare Group LP<br>15 Hampshire Street<br>Mansfield, MA 02048<br>Phone: [phone]<br>Fax: [phone] | |
| Contact: | Daniel Campion<br>Senior Regulatory Affairs Specialist<br>Kendall,<br>a Division of Tyco Healthcare Group LP<br>Telephone: [phone]<br>Fax: [phone] | |
| Device Trade Name: | Acute and Chronic Catheter Repair Kit | |
| Device Common Name: | Kit, repair, catheter, hemodialysis | |
| Classification Panel: | Gastroenterology/Urology | |

# Legally Marketed Devices to Which Substantial Equivalence is Claimed:

The Covidien™ Acute and Chronic Catheter Repair kit is substantially equivalent to the Bard Catheter Repair Kit with Replacement Connector (K063446) in intended use, design, and repair methods.

## Device Description:

The Covidien™ Acute and Chronic Catheter Repair Kit is intended to be used for the repair of a broken luer adapter, clamp, or extension tubing (only the most proximal 0.5-cm of tubing) of an existing catheter. When one of these components is damaged the implanted catheter will be clamped off using the existing clamp and a slide clamp that will be provided as apart of the catheter repair kit. Then the damaged extension tube will be cut off and the existing clamp will be removed while the slide clamp will provide the stasis of the catheter. After removing the existing clamp a threaded repair collar will be placed over the remaining extension tube. The barbed connector will then be inserted barb end first into the extension tube. Once in place the repair collar will be threaded onto the new repaired back end to secure the placement

### Intended Use:

The Covidien™ Acute and Chronic Catheter repair kit is intended for the repair of the external extension tubing, luer adapter or clamp of a hemodialysis catheter manufactured by Covidien.

The repair kit is not intended to repair damaged extension tubing more than 0.5cm away from the distal end of the luer adapter.

### Performance Data:

Covidien Premarket Notification

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K092797 Page 2 of 2

Testing was performed to evaluate the performance of the repaired catheter based on Tensile Strength, Dynamic Flow, Leak and Burst in accordance with FDA and ISO guidance .

Covidien Premarket Notification

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Kendall, a division of Tyco Healthcare Group LP c/o Mr. Daniel Campion Senior Regulatory Affairs Specialist Patient Care and Safety Covidien 15 Hampshire Street MANSFIELD MA 02048

NOV 1 9 2009

Re: K092797

Trade/Device Name: Covidien™ Acute and Chronic Catheter Repair Kit Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: NFK Dated: November 4, 2009 Received: November 9, 2009

Dear Mr. Campion:

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 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 - Mr. Daniel Campion

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert Lemon

Janine M. Morris, Director (Acting) Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications For Use

510(k) Number (if known): k092797

#### Device Name: Covidien™ Acute and Chronic Catheter Repair Kit

Indications For Use:

The Covidien Acute and Chronic Catheter Repair Kit is intended to repair the external extension tubing, luer adapter or clamp of a hemodialysis catheter manufactured by Covidien. Do not use this kit to repair a catheter if the damaged portion of the extension tubing is more than 0.5 cm away from the distal end of the luer adapter. Specific hemodialysis catheters that can be repaired using this kit include:

Palindrome ™ Chronic Care Catheters 買

Palindrome TM Emerald™ Chronic Care Catheters E

Palindrome ™ Ruby™ Chronic Care Catheters 1

Palindrome™ Sapphire™ Chronic Care Catheters I

MAHURKAR™* Maxid™ Chronic Care Catheters I

MAHURKAR™* 8 Fr. (2.67mm) Single Lumen Acute Care Catheters l

MAHURKAR™* 8 Fr. (2.67mm) Dual Lumen Acute Care Catheters 트

MAHURKAR™* 10 Fr. (3.33mm) Dual Lumen Acute Care Catheters 트

MAHURKAR™* 11.5 Fr. (3.83mm) Dual Lumen Acute Care Catheters 트

MAHURKAR™* 13.5 Fr. (4.50mm) High Flow Dual Lumen Acute Care Catheters

MAHURKAR™* 12 Fr. (4.00mm) Triple Lumen Acute Care Catheters. (Note: do not use this kit to repair the infusion lumen.)

| Prescription Use | x |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) | |

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Covidien<br>Premarket Notification | (Division Sign-Off)<br>Division of Reproductive, Abdominal,<br>and Radiological Devices |
| 510(k) Number | K092797 |
| | Page 18<br>^TM Trademark |