COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER

K983830 · Mallinckroot, Inc. · LIT · Apr 16, 1999 · Cardiovascular

Device Facts

• Record ID: K983830
• Device Name: COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER
• Applicant: Mallinckroot, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Apr 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mallinckrodt Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature system, such as the renal, iliac, femoral, popliteal, peroneal, and profunda arteries.

Device Story

Disposable, sterile, coaxial double-lumen catheter; balloon mounted at distal tip. Used for percutaneous transluminal angioplasty (PTA) in peripheral arteries. Physician advances catheter over guidewire to stenosis site; inflates balloon with fluid to specific pressure/diameter to dilate vessel. Inner lumen allows guidewire passage and contrast media administration; outer lumen manages balloon inflation. Radiopaque markers delineate balloon working length; soft atraumatic tip facilitates navigation. Available in 4 Fr (Finch) and 5 Fr (Copperhead) sizes with optional hydrophilic coating. Device enables mechanical vessel dilation, improving blood flow in stenotic peripheral arteries.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included balloon burst strength, distensibility, fatigue, bond strength, catheter profile, torque strength/response, and contrast flow rates. Biocompatibility testing performed per ISO 10993, including sensitization, irritation, cytotoxicity, systemic toxicity, hemocompatibility, hemolysis, pyrogenicity, and implantation tests. All results were acceptable.

Technological Characteristics

Coaxial double-lumen catheter; 4 Fr and 5 Fr shaft diameters. Materials: Nylon shaft, PET (polyethyleneterephthalate) balloon, platinum marker bands. Features: hydrophilic coating option, radiopaque tip. Energy source: manual fluid inflation. Sterilization: sterile/non-pyrogenic. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty of the peripheral vasculature, including renal, iliac, femoral, popliteal, peroneal, and profunda arteries.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Advanced Cardiovascular (ACS) Vantage Dilatation Catheter (K965183)
• Bard Tru-Trac Peripheral Balloon Dilatation Catheter (K960517)
• MediTech Ultra-Thin Balloon Dilatation Catheter (K924320)
• Peripheral Systems (PSG) Advance 418 Dilatation Catheter (K904984)
• MediTech Symmetry Balloon Dilatation Catheter (K953602)
• MediTech Sub-4 Balloon Dilatation Catheter (K924047)

Submission Summary (Full Text)

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MAR. 18. 1999 MMI MED REG

4/16/95
MALLINCKRODT

NO. 295

K 983830

Mallinckroot Inc 675 McDonnell Boylevard PO Box 5840 St. Louis MO 63134 Phone: 314,654.2000

# 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted as required by SMDA of 1990.

| Date: | March 17, 1999 | |
|-------------------------------------------|-----------------------------------------------------------|--|
| Applicant: | Mallinckrodt Inc. | |
| Address: | 675 McDonnell Blvd. | |
| | PO Box 5840 | |
| | St. Louis, MO 63134 | |
| Owner/Operator No: | 1925021 | |
| Contact Person: | Teresa O'Shea | |
| Title: | Regulatory Affairs Associate | |
| Telephone: | [phone] | |
| Telefax: | [phone] | |
| a. Trade Name: | 4 Fr. = Finch | |
| | 5 Fr. = Copperhead | |
| b. Common Name: | Peripheral Percutaneous Transluminal Angioplasty Catheter | |
| c. Classification of Device: | Surgical Vessel Dilator | |
| | CV (74) LIT | |
| | Class II (performance standards) | |
| | 21 CFR 870,4475 | |
| d. Identification of Predicate Device(s): | 510(k) # | |

| Advanced Cardiovascular (ACS) Vantage Dilatation Catheter | K965183 |
|-----------------------------------------------------------|---------|
| Bard Tru-Trac Peripheral Balloon Dilatation Catheter | K960517 |
| MediTech Ultra-Thin Balloon Dilatation Catheter | K924320 |
| Peripheral Systems (PSG) Advance 418 Dilatation Catheter | K904984 |
| MediTech Symmetry Balloon Dilatation Catheter | K953602 |
| MediTech Sub-4 Balloon Dilatation Catheter | K924047 |

## e. Intended use:

The Mallinckrodt Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature system, such as the renal, iliac, femoral, popliteal, peroneal, and profunda arteries.

Percutaneous Transluminal Angioplasty (PTA) Catheter 510(k) Summary of Safery and Effectiveness MALLINCKRODT INC.

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### a. Device Description:

The Mallinckrodt PTA Catheter is intended for single patient use and is disposable, sterile and non-pyrogenic. This dilatation catheter is a coaxial double lumen catheter with a balloon mounted near the distal tip. The balloon is designed to inflate to a known diameter and length at pressures stated on the label (nominal inflation). The outer lumen is used for inflation of the balloon while the inner lumen permits (1) the use of a guide wire to facilitate catheter advancement to and through the stenosis to be dilated, and (2) low flow administration of contrast media to aid in correct positioning of the balloon. The lumens bifurcate from the catheter shaft to two molded hubs (proximal end of catheter), one for the inflation lumen and one for the guide wire lumen. The hubs are labeled for easy identification. The bifurcation is supported by a strain relief sleeve at the catheter end. Two radiopaque markers, within the balloon segment of the catheter, delineate the working length of the balloon for proper balloon orientation within a stenosis. The catheter tip is a highly radiopaque, soft, atraumatic material.

The Mallinckrodt PTA Catheter is available in two shaft diameters (4 and 5 Fr) and several shaft lengths (4 Fr - 90, 135 cm and S Fr - 45, 75, 125 cm). The catheter has a range of balloon sizes from 3 mm to 12 mm in inflated diameter and from 2 to 10 cm in length. (Note: Neither the 4 nor 5 Fr catheter with 12 min balloon is available in 8 and 10 cm length.) The catheters will be available with or without a hydrophilic coating.

#### Technological Characteristics and Rationale for Substantial Equivalence: g.

The Mallinckrodt PTA Catheter is substantially equivalent to the predicate devices listed above in terms of intended use, functionality, performance and safety. All of the predicate devices listed have been found to be substantially equivalent to devices which were in commercial distribution prior to May 28, 1976.

The Mallinckrodt PTA Catheter is inserted percutaneously, generally through an introducer and over a guidewire. The catheter is advanced within the vessel to the point of lesion and inflated with fluid to a recommended pressure and known diameter for dilatation of the vessel.

The Mallinckrodt PTA Catheter is constructed of biocompatible materials. The shaft is constructed of Nylon. The balloon is constructed of PET (polyethyleneterephthalate), the marker bands are platinum.

Percutaneous Transluminal Angioplasty (PTA) Catheter 510(k) Summary of Safety and Effectiveness MALLINCKRODT INC.

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### h. Safety and Performance Studies:

There are no significant changes to the Mallinckrodt PTA catheter from the predicate device(s) which could affect safety, effectiveness or intended use. Bench testing was conducted for the following characteristics:

- balloon minimum burst strength .
- balloon distensibility t
- balloon inflation/deflation performance .
- balloon fatigue (repeat balloon inflation) .
- bond strength ●
- catheter diameter and balloon profile ●
- over-the-arch torque strength .
- over-the-arch torque response ●
- balloon preparation ●
- catheter body burst testing ●
- contrast medium flow rate .

The results of each test were found to be acceptable.

Finished PTA Catheters including both 4 and 5 Fr catheters with hydrophilic coating were tested, in accordance with ISO 10993 for the following biocompatibility tests:

- Sensitization Assay ●
- . Irritation Tests
- Cytotoxicity
- Systemic Toxicity (acute) ♪
- Hemocompatibility (Thromboresistance, C3a Complement Activation, ● Plasma Recalcification)
- Hemolysis .
- Pyrogenicity .
- Implantation Tests .

The results of each test were found to be acceptable.

#### Conclusions: g.

Based upon the indications for use, technological characteristics, and safety and performance studies, the Mallinckrodt PTA Catheter has been shown to be safe and effective for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three horizontal lines above it, representing the department's mission to enhance the health and well-being of Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 16 1999

Ms. Teresa O'Shea Requlatory Affairs Associate Mallinckrodt Inc. 675 McDonnell Blvd. P.O. Box 5840 St. Louis, MO 63134

Re : K983830 Finch (4 Fr.) and Copperhead (5 Fr.) Percutaneous Trade Name: Transluminal Angioplasy (PTA) Catheters Requlatory Class: II Product Code: LIT Dated: February 26, 1999 February 26, 1999 Received:

Dear Ms. O'Shea:

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 (Special, Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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,

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Paqe 2 - Ms. Teresa O'Shea

your premarket notification submission 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,

Thomas J. Callahon

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K983830

Device Name: _ Peripheral Dilatation Catheter

Indications for Use:

ﺗﺮﺗ

The Mallinckrodt Peripheral Dilatation Catheter is intended for use in Percutaneous The Manniella of I confineral vasculature system, such as the renal, iliac, femoral, popliteal, peroneal, and profunda arteries.

Christopher M. H. for TTC

(Division Sign-Off) Division of Carciovascular, Respiratory, Division of Carchovascular, Respira
S10(k) Number 510(k) Number .

(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_ OR