The SmartPort CT Port Access System is indicated for any adult patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.

The SmartPort CT Series ports are also indicated for power injection of CT contrast media.

The SmartPort CT Series Port Access System is indicated for any pationt requiring repeated access of the vascular system for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.

The SmartPort CT Series Port Access System is also indicated for power injection of contrast media at a maximum infusion rate of 3 ml/sec or 5 ml/sec when used with 20 Ga or 19 Ga power injectable infusion sets.

Device Description

The SmartPort CT Series ports are Titanium or plastic, single or dual ports with a self sealing silicone rubber septum designed to maintain integrity after punctures with a noncoring needle. The port has a hollow area, or reservoir, under the septum through which fluid passes during infusion or aspiration.

The Vortex design features a proprietary reservoir with rounded walls giving it a toroidal shape. The outlet stem is located tangential to the reservoir wall allows fluid to pass between the reservoir and the catheter.

The SmartPort CT Series port systems offers models with catheters from 6.6FR to 12FR. The catheters contain radiopacifiers and have depth markings.

AI/ML Overview

The provided text describes a 510(k) submission for the "SmartPort CT Series Port Access System," a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study in the same way a new drug or novel medical device might.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size and ground truth) are not applicable to this type of regulatory submission and are not present in the provided document.

The document primarily focuses on demonstrating equivalence to predicate devices through design comparison, intended use, and performance claims derived from the predicate devices or standard engineering tests.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the format of a clinical trial's primary or secondary endpoints. Instead, it highlights performance characteristics of the SmartPort CT Series Port Access System in comparison to predicate devices, particularly regarding power injection. The performance claims are typically based on engineering testing to demonstrate the device can withstand the specified pressures and flow rates for power injection.

Performance Characteristic	Acceptance Criteria (Implied by Predicate/Design)	Reported Device Performance (SmartPort CT Series Vortex Ports)
Intended Use: Power Injection	Maximum 3 ml/sec or 5 ml/sec injection rate of contrast dye injected at up to 300 psi (from predicates)	Maximum 3 ml/sec or 5 ml/sec injection rate of contrast dye injected at up to 300 psi
Pressure Withstand (Dynamic)	300 PSI (from predicates K072375, K062414)	300 PSI
Needles for Access	19 or 20 Ga power injectable infusion set (from predicates K072375, K062414)	19 or 20 Ga power injectable infusion set
Material (Port)	Titanium or Plastic (matches predicates)	Titanium or Plastic
Material (Catheter)	Polyurethane or Silicone (matches predicates)	Polyurethane or Silicone
Catheter Size	6.6-12 FR (matches predicate K905841, K953529, etc.)	6.6-12 FR
Septum Material	Silicone (matches all predicates)	Silicone

2. Sample size used for the test set and the data provenance:

Not applicable. This document describes a 510(k) submission for substantial equivalence based on device design and performance specifications, not a clinical study with a "test set" of patients in the typical sense. Data provenance would be from engineering bench testing if performed, but specific details are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical ground truth established by experts is mentioned for a test set.

4. Adjudication method for the test set:

Not applicable. No adjudication method is mentioned as it's not a clinical study.

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:

Not applicable. This device is a vascular access port, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant.

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

Not applicable. This device is a physical medical implant, not an algorithm.

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

Not applicable. For a device like this, "ground truth" would relate to its structural integrity, material compatibility, and ability to withstand specified pressures and flow rates, typically verified through engineering and biocompatibility testing, rather than clinical outcomes or pathology from a patient cohort for establishing "ground truth." The substantial equivalence is based on meeting the design and performance characteristics of predicate devices.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set" or associated ground truth establishment.

Summary of the Study/Evidence that Proves the Device Meets the (Implied) Acceptance Criteria:

The document leverages the Substantial Equivalence (SE) pathway for Class II medical devices. The primary "study" is the comparison to legally marketed predicate devices and the assertion that the SmartPort CT Series Port Access System is as safe and effective as those predicates.

Comparison of Technical Characteristics: The bulk of the justification is presented in the "Device comparison table" (Page 2). This table directly compares the new device's features (intended use for power injection, design, materials, catheter size, shape, septum material, pressure withstand, needles used) to several AngioDynamics SmartPort CT models (K072375, K062414) and Horizon Medical Vortex Ports (K905841, K953529, K010189, K032557).
Performance Claims based on Predicates: The ability to withstand 300 PSI and allow 3 ml/sec or 5 ml/sec injection rates of contrast media is directly aligned with the performance of the cited AngioDynamics SmartPort CT predicate devices. The assumption is that if the design and materials are equivalent, and the manufacturing process is controlled (Good Manufacturing Practices, GMP), then the performance will also be equivalent.
Non-Clinical Bench Testing (Implied): While not detailed in this summary, a 510(k) submission for a device like this would typically include non-clinical (bench) testing results to demonstrate that the device physically meets these performance claims (e.g., pressure resistance, flow rates, septum resealability, material compatibility, sterilization efficacy). These tests are performed to show that the device performs as intended and is equivalent to the predicate in these specific aspects. The claim of "300 PSI" pressure withstand and "3 ml/sec or 5 ml/sec" injection rates implicitly refers to the successful completion of such engineering tests.
Biocompatibility Testing (Implied): As an implanted device, biocompatibility testing (not detailed here but required for 510(k) submissions) would also be conducted to ensure the materials are safe for human contact.

In essence, the "study" is the comprehensive technical comparison and the regulatory assertion of substantial equivalence, supported by implied bench testing, rather than a clinical trial with patient-specific outcome data.

Summary

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SEP 2 3 2008

4081472

4.0 510(k) Summary

Date: May 19, 2008

Sponsor of the 510(k)

AngiodDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12801 Establishment Registration number 1319211 Contact: Brian Kunst, Vice President, Regulatory Affairs and Quality Assurance 518-798-1215, x1123

Device Identification:

Proprietary Name:	SmartPort CT Series Port Access Systems
Common Name:	Vascular access port
Classification Name:	Subcutaneous, implanted, intravascular infusion port &catheter
Classification Number:	21 CFR §880.5965
Classification Panel:	General Hospital
Product Code:	LJT
Regulatory Class:	II

Legally marketed device to which equivalence is claimed:

AngioDynamics SmartPort CT MP	510(k) K072375
AngioDynamics SmartPort CT	510(k) K062414
Horizon Medical Vortex Ports	510(k) K905841, K953529, K010189, K032557

Intended Use / Indications

The SmartPort CT Series ports are also indicated for power injection of CT contrast media.

Vortex CT 510(k)	Confidential	Page 11 of 39
May 19, 2008

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Device Description

The SmartPort CT Series port systems offers models with catheters from 6.6FR to 12FR. The catheters contain radiopacifiers and have depth markings.

Question	YES	NO
Is the device intended for prescription use (21 CFR 801 Subpart D)?A	X
Does the device contain components derived from a tissue or other biologicsource?		X
Is the device provided sterile?	X
Is the device intended for single use?	X
Is the device a reprocessed single use device?		X
Does the device contain a drug?		X
Does the device contain a biologic?		X
Does the device use software?		X
Does the submission include clinical information?		X
Is the device implanted?	X

Vortex CT 510(k)	Confidential	Page 12 of 39
May 19, 2008

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Device comparison table

	AngioDynamicsSmartPort CT SeriesVortex Ports	AngioDynamics SmartPortCT MP	AngioDynamics SmartPortCT	RITA Medical Systems(formerly Horizon MedicalProducts)
		K072375	K062414	K905841, K953529,K010189, K032557
Intended use, powerinjection	Maximum 3 ml/sec or 5 ml/secinjection rate of contrast dyeinjected at up to 300 psi	Maximum 3 ml/sec injection rateof contrast dye injected at up to300 psi.	Maximum 5 ml/sec injection rateof contrast dye injected at up to300 psi.	Not indicated for powerinjection
Design	Port system with attachablecatheter	Port system with attachablecatheter, single.	Port system with attachablecatheter, single.	Port system with attachablecatheter, single or dual.
Port Material	Titanium or Plastic	Titanium	Titanium	Titanium or Plastic
Catheter Material	Polyurethane or Silicone	Polyurethane	Polyurethane or Silicone	Polyurethane or Silicone
Catheter Size	6.6-12 FR	5 FR	7.5-9.6 FR	6.6-12 FR
Shape	Round port system withtangential outlet	Round port system with tangentialoutlet	Round port system with tangentialoutlet	Round port system withtangential outlet
Septum Material	Silicone	Silicone	Silicone	Silicone
Pressure withstand,dynamic	300 PSI	300 PSI	300 PSI	Not Rated
Needles used forAccess	19 or 20 Ga power injectableinfusion set	19 or 20 Ga power injectableinfusion set	19 or 20 Ga power injectableinfusion set	19 or 20 Ga infusion set

Confidential

Vortex CT 510(k)
May 19, 2008

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2008

Mr. Brian Kunst ANGIODYNAMICS, Incorporated 603 Queensbury Avenue Queensbury, New York 12804

Re: K081472

Trade/Device Name: SmartPort CT Series Port Access System Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: Il Product Code: LJT Dated: August 27, 2008 Received: August 29, 2008

Dear Mr. Kunst:

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 deviccs 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 either 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 -- Mr. Kunst

Please be advised that FDA's issuance of a substantial equivalence determination docs 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.

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 Center for Devices and Radiological Health's (CDRHI's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

QRS

Chiu S. Lin. Ph. D Division 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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Indications for Use

510(k) Number (if known):

Device Name:	SmartPort CT Series Port Access System		-----
		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications for Use:

X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807

Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amithen

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: __ < 415/4 22

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.