The Vortex® EZ Port Access System is indicated for any 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.

Device Description

The Vortex® EZ Port Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex® EZ Port is available in a Delrin port body configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The port base is crafted of silicone so that the port can be sutured to the underlying tissue anywhere around this base. A pre-attached or a detached/attachable catheter is offered in either polyurethane or silicone models with or without a highly radiopaque tip molded on. The products are packaged in sterile trays with introduction components.

AI/ML Overview

The provided text is a 510(k) summary for the Vortex® EZ Port Access System. This type of document focuses on establishing substantial equivalence to a legally marketed predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for novel device performance.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, number and qualifications of experts for ground truth, adjudication methods, MRMC study, standalone performance, type of ground truth used, how ground truth for training set was established) are not applicable or not present in the provided document.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance:

Not applicable/Not present. The document states, "The Vortex® EZ Port Access System design was evaluated through risk analysis and qualified through design verification testing following established Design Control procedures." However, it does not provide specific acceptance criteria or the reported performance data against those criteria. It relies on substantial equivalence to predicate devices (LifePort® VTX® Access System (K010767) and LifePort® LPS 7013 (K905852)).

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

Not applicable/Not present. As this is a 510(k) for a device modification, clinical studies with test sets in the context of AI/imaging are not required or detailed here. The premarket notification focuses on design verification testing, which would involve engineering tests rather than patient data.

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

Not applicable/Not present. No ground truth established by experts is mentioned, as this is not an AI/imaging device.

4. Adjudication method for the test set:

Not applicable/Not present. No adjudication method is mentioned.

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/Not present. This device is a vascular access system, not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant.

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

Not applicable/Not present. This is not an algorithm-based device.

7. The type of ground truth used:

Not applicable/Not present. No ground truth in the context of clinical outcomes or pathology is used for this type of device submission. The "ground truth" for a medical device in a 510(k) context often relates to demonstrating that the device performs as intended and is safe and effective when compared to existing legally marketed devices, usually through engineering testing, biocompatibility testing, and sometimes bench or animal studies, not typically through clinical "ground truth" in the AI/diagnostics sense.

8. The sample size for the training set:

Not applicable/Not present. This device is a physical medical device, not an AI model requiring a "training set."

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

Not applicable/Not present. As above, no training set or ground truth in this context.

Summary

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K050176

Premarket Notification - Special 510(k): Device Modification 510(k) Summary RITA Medical Systems, Inc. Vortex® EZ Port Access System

January 2005

Page 17 of 23

510(k) Summary [as required by 21 CFR 807.92(c)]

FEB 2 5 2005

Submitter's Name / Contact Person

Manufacturer	Contact
RITA Medical Systems, Inc.	Mary Gossard, M.S.
One Horizon Way	Manager, Regulatory Affairs
Manchester, Georgia 31816

General Information

Trade Name	Vortex® EZ Port Access System
Common Name	Vascular access port
Classification Name	Subcutaneous, implanted, intravascular infusion port and catheter
	Classification Number:
	Classification Panel:
	Product Code:
Modified Devices	LifePort® VTX® Access System (K010767)
	LifePort® LPS 7013 (K905852)

Device Description

Intended Use / Indications

Substantial Equivalence Comparison

The Vortex® EZ Port Access System and the modified devices, LifePort® VTX® Access System and the LPS 7013 model of the LifePort® ports with silicone and polyurethane catheters share identical intended uses and fundamental scientific technology. The subject and modified devices are substantially similar in configuration, dimensions, and materials. The Vortex® EZ Port Access System design was evaluated through risk analysis and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness were raised for the Vortex® EZ Port Access System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings, symbolizing health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

FEB 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Gossard Manager, Regulatory Affairs RITA Medical Systems One Horizon Way Manchester. Georgia 31816

Re: K050176

Trade/Device Name: Vortex® EZ Port Access System Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: January 25, 2005 Received: January 26, 2005

Dear Ms. Gossard:

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 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 - Ms. Gossard

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 (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 vour 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 (240) 276-0115. 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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clint Little, 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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Indications for Use

510(k) Number (if known): ¥050176

Vortex® EZ Port Access System Device Name:

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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.