14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH

K013162 · Medcomp · KNT · Oct 19, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K013162
• Device Name: 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH
• Applicant: Medcomp
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Oct 19, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medcomp Ash Split-Cath is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site is the subclavian vein as required.

Device Story

Medcomp Ash Split-Cath is a polyurethane, double-lumen catheter for long-term hemodialysis and apheresis. Device features two segregated 'D'-shaped lumens with tapered distal tips and six side holes; distal venous lumen extends beyond arterial lumen to minimize recirculation. Fixed polyester cuff facilitates tissue ingrowth for long-term placement. Lumens connect to extensions via soft pliable hub with suture wing; red/blue luer connectors and clamps identify arterial/venous lines. Clamps include I.D. rings for priming volume and site care info. Device is inserted percutaneously by clinicians, typically in the internal jugular or subclavian vein. Modifications from predicate include added strain relief at hub-to-cuff junction, pre-split lumens, and additional length options (24cm, 36cm, 40cm). Device provides vascular access for blood removal and return; clinical benefit is sustained, reliable access for dialysis/apheresis procedures.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via in vitro bench testing, including lumen-to-hub tensile strength, alcohol effects, air leakage, and liquid leakage testing.

Technological Characteristics

Polyurethane double-lumen catheter; 'D'-shaped lumen geometry; polyester cuff for tissue ingrowth; soft pliable hub with suture wing; luer connectors; strain relief at hub-to-cuff junction. Sterilization method not specified.

Indications for Use

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

Regulatory Classification

Identification

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Special Controls

*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Medcomp Ash Split-Cath (K972207)

Submission Summary (Full Text)

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K013162

Page 1 of 2

OCT 1 9 2001

# 510(k) SUMMARY

#### Submitter Information: A.

Submitter:

Contact: Date Prepared:

Trade Name: B. Common Name: Classification: ب ا C.F.R. Section:

MEDCOMP® 1499 Delo Drive Harleysville, PA 19438 [phone] Telephone [phone] Fax Jeanne M. Cush July 25, 2001

Medcomp Ash Split-Cath Hemodialysis Catheter, Implanted 78 MSD 876.5540

C. Predicate Device: K972207 Medcomp Ash Split-Cath

#### Device Description: D.

The Medcomp Ash Split-Cath is a polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, tapered at the distal tip, with six side holes. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement.

The lumens are connected to the extensions via a soft pliable hub with suture wing. Red and blue luer connectors and clamps identify the arterial and venous extensions. The clamps incorporate I.D. Rings which indicate priming volume and site care information.

#### E. Intended Use:

The Medcomp Ash Split-Cath is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site is the subclavian vein as required.

## 0 T l

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KOI 3162

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## Comparison to Predicate Device: F.

The technological characteristics of the Ash Split-Cath are substantially equivalent to the predicate in terms of intended use, insertion method, anatomical location, materials, design, performance, labeling, manufacturing process and method of sterilization.

The Ash Split-Cath modifications include:

- Addition of a strain relief to hub to cuff location .
- Pre-split lumens .
- Additional lengths of 24cm, 36cm and 40cm ●

The principles operation and basic design remain unchanged.

### Performance Data: G.

ﭘ

In Vitro performance data for the modified Ash Split-Cath includes:

- Lumen to hub tensile strength ●
- Alcohol affects testing ●
- Air leakage ●
- Liquid leakage ●

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2001

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

Re: K013162 Trade/Device Name: 14F x 24cm Ash Split-Cath, Model ASPC24 14F x 28cm Ash Split-Cath, Model ASPC28 14F x 32cm Ash Split-Cath, Model ASPC32 14F x 36cm Ash Split-Cath, Model ASPC36 14F x 40cm Ash Split-Cath, Model ASPC40 Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: September 20, 2001 Received: September 21, 2001

Dear Ms. Cush:

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

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Page 2 - Ms. Marion Gordon

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 that I Dr. I has haat a sona 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 nsmirements 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) I mo letter with are no to your finding of substantial equivalence of your device to a legally premaince noticated 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 (21 CFR Part 801 and additionally Part 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 (2017) 971 1059 Frainon''(21 CFR Part 807.97). Other general information on your responsibilities premation hourned from the Division of Small Manufacturers, International and ander the Possistance at its toll free number [phone] or [phone], or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy bogdon

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

510(k) Number: KO13/62

Device Name: Medcomp Ash Split-Cath

# Indications for use:

The Medcomp Ash Split-Cath is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site includes 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)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter______________________________________________________________________________________________________________________________________________________________

Nancy C. Brogdon

(Optional Format 1-2-96)

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