The PORT-A-CATH® II Regional Arterial Portal System will be indicated when patient therapy requires prolonged or repeated intra-arterial access for injection or infusion regimes.

Device Description

A system consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, a single lumen silicone catheter, a hemostasis sy assembly, and a micro-catheter assembly

AI/ML Overview

The provided text describes a 510(k) submission for the PORT-A-CATH® II Regional Arterial System. However, it does not contain information typically associated with AI/ML device studies, such as:

Acceptance criteria and reported device performance in terms of metrics like sensitivity, specificity, or accuracy. The document focuses on functional and material equivalence to predicate devices.
Sample sizes for test sets, training sets, or data provenance relevant to AI model development.
Number and qualifications of experts or adjudication methods for ground truth establishment.
Details about multi-reader multi-case (MRMC) comparative effectiveness studies.
Information on standalone algorithm performance.
Specific types of ground truth (e.g., pathology, outcomes data) as they relate to AI model training/testing.

Therefore, I cannot populate the table or provide detailed answers to most of the requested points as they are not present in the provided document.

The study described is primarily a pre-market notification (510(k)) for a medical device, not an AI/ML diagnostic or therapeutic device study. The "studies" mentioned are largely functional, in-vitro, and in-vivo non-clinical tests to demonstrate the physical properties and performance of the device, along with biocompatibility testing. Clinical studies were not deemed necessary due to the similarity to existing predicate devices.

Here's what can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (General Areas)	Reported Device Performance (Summary)
Functional Performance	Functions according to specifications
Tensile Strength	Tested in accordance with FDA guidance
Flow-rate	Tested in accordance with FDA guidance
Catheter Stiffness	Tested in accordance with FDA guidance
Catheter Flexural Fatigue	Tested in accordance with FDA guidance
System Leakage	Tested in accordance with FDA guidance
Guidewire Removal Testing	Tested in accordance with FDA guidance
Long-Term Performance (Simulated Life Test)	Performance documented under simulated, accelerated conditions
Implantation Feasibility (In-vivo)	Feasible for implantation and immediate post-implant performance
Biocompatibility	Materials used are biocompatible

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not specified in terms of number of devices or clinical subjects, as the testing described is primarily in-vitro and in-vivo feasibility in a non-clinical context.
Data Provenance: Not applicable in the context of clinical data for AI/ML validation. The testing appears to be internal to Deltec, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth establishment by human experts for performance metrics (like accuracy for a diagnostic AI) is not relevant to the functional and material testing described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are not described as there are no expert evaluations of performance being evaluated in this manner.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This was not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This was not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device would be its ability to meet engineering specifications and material properties through various functional, mechanical, and biocompatibility tests. It's not a clinical diagnostic or AI-driven "ground truth."

8. The sample size for the training set:

Not applicable. This was not an AI/ML device that requires training data.

9. How the ground truth for the training set was established:

Not applicable. This was not an AI/ML device.

Summary

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JAN 2 3 2004

K033686

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

PORT-A-CATH® II Regional Arterial System

November 21, 2003

I. GENERAL INFORMATION

Applicant's Name and Address:	Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Patricia LaForteRegulatory Affairs Associate
Common/Usual Name:	Implantable Access System
Proprietary Name:	Regional Arterial Port/Catheter System forLocal/Regional Drug Delivery
Equivalence Device Comparison:	PORT-A-CATH® II Trans-Arterial PercutaneousSystemPORT-A-CATH® II Implantable Venous AccessSystem

II. DEVICE DESCRIPTION

III. INTENDED USE OF DEVICE

The PORT-A-CATH® II Regional Arterial Portal System is indicated when patient therapy requires prolonged or repeated intra-arterial access for injection or infusion regimes.

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510(k) Summary of Safety and Effectiveness Page 2 of 4

IV. DEVICE COMPARISON

	PORT-A-CATH® IIRegional ArterialDrug Delivery System	PORT-A-CATH® IITrans-ArterialPercutaneous System	PORT-A-CATH® IIImplantable VenousAccess System
MANUFACTURER	Deltec, Inc.	Deltec, Inc.	Deltec, Inc.
510(K) NUMBER	Subject Device	K992697	K932840
INDICATION FOR USE	A system is indicatedwhen patient therapyrequires prolonged orrepeated intra-arterialinfusions.	A system is indicatedwhen patient therapyrequires prolonged orrepeated intra-arterialinfusions.	A system is indicatedwhen patient therapyrequires repeated accessto the venous system forthe parenteral delivery ofmedications, fluids, andnutritional solutions, andfor the sampling ofvenous blood.
PORTAL ANDCONNECTORMATERIALS
Housing	Polysulfone/Titanium	Polysulfone/Titanium	Polysulfone/Titanium
Septum	Silicone	Silicone	Silicone
Connector	Polypropylene/Titanium	Polypropylene/Titanium	Polypropylene/Titanium
PORTAL DIMENSIONS(Nominal)
HeightPortal BaseSeptum Diameter	15.2 mm30.5 mm11.4 mm	11.5 mm25.0 mm9.5 mm	15.2 mm30.5 mm11.4 mm
PORTALCONNECTINGCATHETER
OD/ID	2.8mm/1.0mm	1.9mm/1.0mm	2.8mm/1.0mm
	PORT-A-CATH® IIRegional ArterialDrug Delivery System	PORT-A-CATH® IITrans-ArterialPercutaneous System	PORT-A-CATH® IIImplantable VenousAccess System
LENGTHMATERIAL	38cmSilicone	76cmPolyurethane	76cmSilicone
PORTAL TUBECONNECTOR	CATH-SHIELD®Connector	ULTRA-LOCK®Connector	CATH-SHIELD®Connector
INTRA-VASCULARCATHETEROD/IDLengthMaterial	1.0mm/0.72mm100cmPebax/PTFE/StainlessSteel	All same as above(same catheter connectsto portal and to vascularsystem)	All same as above(same catheter connectsto portal and to vascularsystem)
CATHETER TOCATHETERCONNECTOR	Boot- SiliconeClamp - AcetalSleeve - Tecoflex 93ABushing - Polyvinyl Chloride(TOTM plasticized)	n/a1	n/a
ACCESSORIESNeedles	1 blunt / 1 huber	1 blunt / 1 huber	1 blunt / 1 huber
Sharps Safety	1 Point Lok®	n/a	n/a
Portal Access	1 GRIPPER PLUS®	n/a	n/a
Other	n/a	Guidewire, introducerneedle, introducer,syringe	Vein Pick

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510(k) Summary of Safety and Effectiveness Page 3 of 4

DELTEC, INC.

Comparison Chart (Continued)

1 n/a = not applicable

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III. SUMMARY OF STUDIES

A. Functional Testing

In-vitro testing was conducted in accordance with the FDA "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters," dated March 16, 1995. The testing included tensile strength, flow-rate, catheter stiffness, catheter flexural fatigue, system leakage, and guidewire removal testing.

In-vitro Simulated Life Testing to document performance of the PORT-A-CATH® II Regional Arterial System under simulated, but accelerated, in-use conditions was performed.

In-vivo testing of the PORT-A-CATH® II Regional Arterial System to evaluate the feasibility of the implantation and immediate post-implant performance of an arterial port-catheter system into the hepatic or other target arteries using minimally invasive, image-guided techniques was conducted.

Biocompatibility testing was conducted on system components.

B. Clinical Studies

Clinical studies were not deemed necessary regarding PORT-A-CATH® II Regional Arterial System due to their similarity in materials, design and function to current Deltec systems.

C. Conclusions Drawn from the Studies

The results of the testing indicated that the PORT-A-CATH® II Regional Arterial Portal System functions according to specifications and the materials used in the system are biocompatible. Therefore, these systems are considered acceptable for human use.

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Image /page/4/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 words "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. The overall design is simple and conveys a sense of government authority and public service.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2004

Ms. Patricia LaForte Regulatory Affairs Associate Smiths Medical MD, Incorporated 1265 Grey Fox Road Saint Paul, Minnesota 55112

Re: K033686

Trade/Device Name: PORT-A-CATH® II Regional Arterial Portal System Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Codc: LJT Dated: November 21, 2003 Received: November 24, 2003

Dear Ms. LaForte:

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 adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. LaForte

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 (OS) 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) 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Cls
SG. Liu, Ph.D.

Chiu Lin, Ph., D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _____________________

Device Name: PORT-A-CATH® II Regional Arterial Portal System

Indications for Use:

"The PORT-A-CATH® II Regional Arterial Portal System will be indicated when patient therapy requires prolonged or repeated intra-arterial access for injection or infusion regimes."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Zork Dillard, Interim Branch Chief

(Division Sian-Off) Division of Anesthesiology, Ge Infection Control, Dental De

510(k) Number: K0331

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

000042

Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.