MEDCOMP ASH SPLIT

K011576 · Medical Components, Inc. · NFK · Jun 21, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K011576
• Device Name: MEDCOMP ASH SPLIT
• Applicant: Medical Components, Inc.
• Product Code: NFK · Gastroenterology, Urology
• Decision Date: Jun 21, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5540
• Device Class: Class 2

Indications for Use

The Medcomp Safety Slide Clamp is intended to provide a secondary extension tube clamp on the Medicomp Ash Split-Cath, Duo-Flow 400XL and Duo-Split Catheters to prevent leakage during connection or disconnection of the bloodlines.

Device Story

Device is a retrofit safety slide clamp for Medcomp hemodialysis catheters (Ash Split-Cath, Duo-Flow 400XL, Duo-Split). Original extension clamps (Halkey-Roberts) exhibited intermittent occlusion failure, risking blood loss. Safety slide clamp is an off-the-shelf component installed in the field by clinicians to provide secondary occlusion of extension tubing. Device prevents air or fluid communication between dialysis treatments. Output is mechanical occlusion of the catheter extension tube. Benefits include prevention of accidental blood loss and avoidance of surgical removal of implanted catheters.

Clinical Evidence

Bench testing only. 52-week simulated use testing (V-1026) performed to evaluate the safety and efficacy of the slide clamp retrofit. No clinical data provided.

Technological Characteristics

Standard off-the-shelf slide clamp designed for mechanical occlusion of medical tubing. Retrofit component for existing hemodialysis catheters. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a secondary extension tube clamp on Medcomp Ash Split-Cath, Duo-Flow 400XL, and Duo-Split catheters to prevent blood leakage during connection or disconnection of bloodlines in patients undergoing hemodialysis.

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 Ash Split-Cath (K972207)

Submission Summary (Full Text)

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KO11576

Page 1 of 2

JUN 2 1 2001

# 510(k) SUMMARY

#### Submitter Information: A.

Submitter:

MEDCOMP® 1499 Delp Drive Harlevsville, PA 19438 [phone] Telephone [phone] Fax

Establishment Registration #:

2518902

Contact:

Jeanne M. Cush Senior Regulatory Affairs Associate

Date Prepared:

May 14, 2001

#### Special 510(k) Corrective Action Being Affected B.

Product Affected: Product Modification: Classification: C.F.R. Section:

Medcomp Ash Split- Cath K972207 Addition of Safety Slide Clamp 78 MSD 876.5540

#### Description of Device Modification: C.

Medcomp has received (5) complaints (June 2000) concerning extension clamps. Mousemp has reported the clamp was not occluding the extension tube, or A ... the extension tube intermittently. The clamps are intended to occlude the extensions and prevent blood loss between dialysis treatments. Though injection caps taped to the luer connectors serve as a backup for blood loss between treatments, relying on the backup system increases the risk of accidental blood loss.

Medcomp confirmed the complaints and determined the root cause is use of Halkey-Roberts clamps manufactured from their new hot molding process.

Medcomp has determined that to prevent possible leakage in the field, a safety slide clamp would be provided for installation on the suspect catheters in the field. These safety slide clamps were provided to all dialysis units and affected hospitals as a preventive measure.

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Medcomp selected a standard "off the shelf" slide clamp designed to pinch or occlude a variety of medical tubing. This slide clamp is widely used throughout the medical device industry to prevent air or fluid communication. Medcomp clamp specifcation is included in Section 4.

This submission contains the following documentation associated with the Product Correction:

- Correction Report 2518902-10/12/00-001-C .
- Product Correction Notification (September 27, 2000) .
- Safety Slide Clamp Instructions for Installation ●
- Performance Data (Simulated Use Testing V-1026) .

Although this corrective action has already been implemented to prevent the surgical removal of implanted hemodialysis catheters, this submission is required in accordance with K95-1 Memorandum "510(k) Requirements for Proposed Fixes to Devices Undergoing Recall.

To date, only 1 complaint has been received concerning the failure of the safety slide clamp. The complaint stated that the extension tube was damaged by repeated application of the slide clamp. We have been unable to replicate this alleged failure, and this failure mode did not occur during the 52-week simulated use testing included in Section 5 of this submission. We therefore conclude that the retrofit of the safety slide clamp proves to be a safe and effective correction for implanted catheters in which the Halkey Roberts clamps do not fully occlude the extension tube.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 2001

Ms. Jean M. Cush Senior Regulatory Affairs Associate MEDCOMP®, Inc. 1499 Delp Drive HARLEYSVILLE PA 19438

Re: K011576

Addition of Safety Slide Clamp to MEDCOMP® Ash Split-Cath, Duo-FlowXL, and Duo-Split Catheters Dated: May 16, 2001 Received: May 22, 2001 Regulatory Class: II 21 CFR §876.5540/Procode: 78 NFK

Dear Ms. Cush:

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 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. 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 (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, the Food and Drug, Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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.

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 our 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours

Nancy Brogdon
Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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## INDICATIONS FOR USE

510(k) Number: Koll 676

Device Name: Medcomp Safety Slide Clamp

Indications for use;

The Medcomp Safety Slide Clamp is intended to provide a secondary extension tube clamp on the Medicomp Ash Split-Cath, Duo-Flow 400XL and Duo-Split Catheters to prevent leakage during connection or disconnection of the bloodlines.

(Please do not write below this line-continue on andther page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter_

(Optional Format 1-2-96)

David A. Segerson

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

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