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 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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Mallinckrodt PTA Catheter, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the nature of the tests conducted and the statement that "The results of each test were found to be acceptable." Since specific numerical targets for acceptability are not provided, we infer that the device's performance in these tests met internal specifications or industry standards for similar predicate devices.

Acceptance Criteria Category	Specific Test	Reported Device Performance
Mechanical Performance	Balloon minimum burst strength	Acceptable
	Balloon distensibility	Acceptable
	Balloon inflation/deflation performance	Acceptable
	Balloon fatigue (repeat balloon inflation)	Acceptable
	Bond strength	Acceptable
	Catheter diameter and balloon profile	Acceptable
	Over-the-arch torque strength	Acceptable
	Over-the-arch torque response	Acceptable
	Balloon preparation	Acceptable
	Catheter body burst testing	Acceptable
	Contrast medium flow rate	Acceptable
Biocompatibility	Sensitization Assay	Acceptable
	Irritation Tests	Acceptable
	Cytotoxicity	Acceptable
	Systemic Toxicity (acute)	Acceptable
	Hemocompatibility (Thromboresistance, C3a Complement Activation, Plasma Recalcification)	Acceptable
	Hemolysis	Acceptable
	Pyrogenicity	Acceptable
	Implantation Tests	Acceptable

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for each test. It states that "Finished PTA Catheters including both 4 and 5 Fr catheters with hydrophilic coating were tested" for biocompatibility and that "Bench testing was conducted for the following characteristics." This implies multiple units were tested, but the precise number is not given.
Data Provenance: The tests were conducted internally by Mallinckrodt Inc. as part of their 510(k) submission. Therefore, the data provenance is from internal bench testing and biocompatibility testing. The country of origin of the data is implicitly the USA, where Mallinckrodt Inc. is located. The data is prospective in the sense that the tests were specifically performed to support this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Number of Experts: Not applicable. The "ground truth" for these performance and biocompatibility tests is based on objective measurements and established scientific protocols (e.g., ISO 10993 for biocompatibility) rather than expert opinion on clinical findings.
Qualifications of Experts: Not applicable for establishing ground truth in this context. The experts involved would be technical staff, engineers, and scientists specialized in medical device testing and biocompatibility, whose qualifications are inherent in conducting such tests according to regulatory standards.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. As the tests are objective measurements of physical and chemical properties, there is no need for an adjudication method based on subjective expert review. The results are either within acceptance limits or not.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. This document describes bench testing and biocompatibility testing for a medical device (a PTA catheter). MRMC studies are typically used for diagnostic devices (e.g., AI in radiology) to evaluate the performance of human readers with and without AI assistance on various cases. This device is an interventional therapeutic device, not a diagnostic one.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Was a standalone study done? Yes, in a manner of speaking, but not in the context of an algorithm. The entire study described comprises standalone performance tests of the device itself (e.g., balloon burst strength, biocompatibility), independent of human operators beyond the standard operating procedures for such devices. There is no AI or algorithm involved in the device's function as described.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the performance tests consists of objective physical measurements (e.g., pressure, diameter, strength, flow rates) compared against predefined specifications. For biocompatibility, the ground truth is established by conformance to recognized standards (ISO 10993) and the absence of adverse biological reactions (e.g., sensitization, cytotoxicity, hemolysis) as measured by standard laboratory assays.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This refers to the training of an AI algorithm, which is not relevant to this device's testing. The device itself is a physical medical instrument, not a software algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no AI algorithm or training set involved.

Summary

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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:	(314) 654-3944
Telefax:	(314) 654-3344
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:

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

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a. Device Description:

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 (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).