DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

K031689 · Chf Solutions, Inc. · NQJ · Dec 23, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031689
• Device Name: DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
• Applicant: Chf Solutions, Inc.
• Product Code: NQJ · Gastroenterology, Urology
• Decision Date: Dec 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dual Lumen ELC catheters are peripheral venous access catheters, inserted preferably in the basilic vein (arm) and antecubital region respectively, and specifically for use with the System 100. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs. The System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

Device Story

6 French, polyurethane, dual-lumen extended-length catheter; provides peripheral venous access for blood removal and return during ultrafiltration. Features flexible hub with suture wings for skin securement; double-D lumen configuration in proximal shaft bonded to single-lumen distal tube. Connects directly to System 100 ultrafiltration circuit. Used in clinical settings by healthcare providers to manage fluid overload; facilitates extracorporeal blood circulation. Benefits patient by enabling temporary ultrafiltration treatment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

6 French, polyurethane, dual-lumen catheter. Double-D lumen configuration. Sterile, nonpyrogenic. Peripheral venous access device.

Indications for Use

Indicated for patients with fluid overload requiring temporary (up to 8 hours) ultrafiltration treatment. Peripheral venous access via basilic vein or antecubital region.

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

• B. Braun Accuguide (K971999)
• CHF Solutions System 100 (K013733)
• medComp VASCU-PICC (K030270)
• Duo-Flow (K974236)

Submission Summary (Full Text)

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K031689

Page / of /

## DEC 2 3 2003

## 510(k) Summary

Prepared on May 30, 2003

This 510(k) Summary is submitted in accordance with 21 CFR 807.92.

- Dual-Lumen Extended Length Catheter (dELC) Trade Name: CHF Solutions, Inc. Manufacturer: Suite 170 - 7601 Northland Drive Brooklyn Park, MN 55428 Telephone: [phone] Amv Peterson Official Fax: [phone] Vice President, RA/QA/CR Contact: Short-term/non-implanted blood access device Generic Name: Non-implanted Blood Access Device System 100 - Accessory Classification: Class: II (21 CFR 876.5540 (b)(2)) . Class: II (21 CFR 876.5860) . Panel: Gastroenterology-Urology Panel: Gastroenterology-Urology . . Product code: MPB . Product code: KDI . B. Braun Accuguide® (K971999) CHF Solutions, System 100, . . Predicate Extended Length Catheter (K013733) medComp® VASCU-PICC™ . Devices: (K030270) and Duo-Flow™ (K974236) The dELC is a 6 French, polyurethane, dual lumen extended-length catheter. It is Device intended to provide short-term peripheral venous access to facilitate blood removal Description: and return for the purposes of ultrafiltration. The catheter has a low profile, flexible hub with suture wings for securement to the skin. The dual lumen tubing in the proximal portion of the catheter shaft is a double-D configuration and is bonded to a single lumen tube for the distal portion. The blood is drawn up through the single lumen tubing, and infused back into the vessel through the short proximal section of the catheter shaft. The catheter will connect directly to the UF circuit of the System 100 to conduct blood to and from the patient for the purposes of ultrafiltration. The Dual Lumen ELC catheters are peripheral venous access catheters, inserted Indication preferably in the basilic vein (arm) and antecubital region respectively, and for Use: specifically for use with the System 100. The System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
The Dual-Lumen ELC and predicate devices are similar in materials of construction Safety & and identical for packaging and sterilization. The Dual-Lumen ELC is provided sterile Performance: and nonpyrogenic. Bench tests demonstrate the Dual-Lumen ELC is compatible with the System 100.

- Based on the intended use, technology characteristics and bench testing, the new Conclusion: access catheter has been shown to be safe and effective for its intended use. This product is substantially equivalent11 and considered acceptable for the intended use.
¹¹ This document uses the term "substantial equivalent" as intended in 21 CFR 807.87 and not as defined in Title 36 of the U.S. Code.

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Image /page/1/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 an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2003

Ms. Amy Peterson Official Correspondent Vice President RA/QA/CR CHF Solutions, Inc. Suite 170-7601 Northland Drive BROOKLYN PARK MN 55428

Re: K031689

Trade/Device Name: System 100 Dual Lumen Extended Length Catheter (dELC)/ A1557 Regulation Number: 21 CFR \$876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: 78 NQJ Dated: September 24, 2003 Received: September 25, 2003

Dear Ms. Peterson:

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 adultcration.

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 Section 510(k) I his letter will anow you to cognit.
premarket notification. The FDA finding of substantial equivalence of your device to a legally promance notication - caresults 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), please 11 you desire specific at Compliance at one of the following numbers, based on the regulation number at the top of the 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 Addistration of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding Other or Othphation at (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.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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Page 1 of 1

## INDICATIONS FOR USE STATEMENT

510(k) Number (if know): _____________________________________________________________________________________________________________________________________________________

Device Name: Dual Lumen Extended Length Catheter (dELC)

Indication For Use for device:

The Dual Lumen ELC catheters are peripheral venous access catheters, inserted The Dual Lumon EEO catherolo are porphenespectively, and specifically for use with the System 100.

The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.

The System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Daniel A. Leyva

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device

OR

510(k) Number K031689