The Vortex® CT 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 the sampling of blood.

When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19Ga sizes, the Vortex® CT Port Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

The LifeGuard® Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with the Vortex® CT Port Access System, the LifeGuard® Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, only models LG-19-75, LG-19-100, LG-20-75, LG-20-100, and LG-20-150 may be used at a maximum infusion rate of Sml/sec.

Device Description

The Vortex® CT Port is a Titanium port with a self sealing silicone rubber septum designed to maintain integrity after punctures with a non-coring 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 Vortex® Port Access systems offer models with single lumen 7.5 French to 9.6 French catheters made from either polyurethane or silicone. The catheters all contain radiopacifiers, and depth markings.

The LifeGuard safety infusion set is a port access needle set with an integrated proprietary safety feature to prevent re-bound injury. The safety infusion set includes a huber needle, a winged housing, non-DEHP PVC extension legs, and a luer standard connector.

AI/ML Overview

This document describes the non-clinical performance data for the Vortex® CT Port Access System and LifeGuard® Safety Infusion Set, which is a medical device for vascular access and power injection of contrast media.

Here's the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific "reported device performance" values for each test, but rather indicates that the tests were performed to establish substantial equivalence, safety, and effectiveness. The "Required Results" column from the provided table serves as the acceptance criteria.

Test Description	Sample Size	Required Results (Acceptance Criteria)	Reported Device Performance
Sterilization exposure	All	All samples must be capable of withstanding a 2X sterilization cycle	Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance.
Physiological exposure	All	All samples must be capable of withstanding physiological conditioning	Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance.
Power injection Performance Test	18	Maximum Pressure: $(U-X)/s \geq k$ where k = 1.96 for an AQL level of 0.65; Catheter material failure: no bursts, leaks, / plastic deformations allowed	Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance.
Simulated Power Injection	30	All samples must meet expected flow rate and pressure withstand requirements	Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance.
Dynamic Failure Test	18	Data shall be gathered to support label claims and determine the operational safety factor.	Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance.
Static Burst Test	18	Data shall be gathered to support label claims.	Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance.
Life Cycle Power Injection Test	10	Catheter material failure: no bursts, leaks, / plastic deformations allowed	Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance.
Cyclic testing	30, 10 cycles per port	All samples must withstand 10 cycles without leaking or bursting. The expected maximum number of power injection cycles is 5.	Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance.
Port Patency Verification	5	Blood return must be easily and empirically verifiable to establish safety of power injection	Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance.
Port Occlusion Test	10	Data shall be gathered to support label claims.	Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance.
Puncture Life	2	Establish label claim for largest needle likely to be used during power injection	Not explicitly stated; "non-clinical tests demonstrate that the device is as safe, as effective" implies compliance.

The study concludes that "The non-clinical tests demonstrate that the device is as safe, as effective for the modified intended use." This statement implies that the device met all the required results set as acceptance criteria for the non-clinical tests.

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

Test Set Sample Sizes:
- Sterilization exposure: All
- Physiological exposure: All
- Power injection Performance Test: 18
- Simulated Power Injection: 30
- Dynamic Failure Test: 18
- Static Burst Test: 18
- Life Cycle Power Injection Test: 10
- Cyclic testing: 30, 10 cycles per port
- Port Patency Verification: 5
- Port Occlusion Test: 10
- Puncture Life: 2
Data Provenance: The data is from non-clinical testing. There is no mention of country of origin for the data (as it's laboratory-based testing, not human patient data) and it is inherently prospective as it involves conducting specific tests on the devices.

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

Not applicable. This is a submission for a physical medical device (Vortex® CT Port Access System and LifeGuard® Safety Infusion Set) and the testing performed is non-clinical/pre-clinical (laboratory-based physical and performance testing), not involving human interpretative tasks or diagnostic assessment. Therefore, no experts were used to establish ground truth in the context of diagnostic accuracy, and no qualifications of such experts are relevant.

4. Adjudication Method for the Test Set

Not applicable, for the same reasons as point 3. The tests are objective physical and performance measurements with defined pass/fail criteria, not subjective assessments requiring adjudication.

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 physical medical port and infusion set, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

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

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

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

The "ground truth" for the non-clinical tests is based on pre-defined engineering specifications and performance requirements. These are objective, measurable outcomes (e.g., "no bursts, leaks, / plastic deformations allowed," "meet expected flow rate and pressure withstand requirements," "withstand 10 cycles").

8. The sample size for the training set

Not applicable. Since this is a physical medical device and not an AI/machine learning model, there is no "training set."

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

Not applicable, for the same reason as point 8.

Summary

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5.0 510(k) Summary

Manufacturer and sponsor of the 510(k)

RITA Medical Systems, Inc. One Horizon Way Manchester, Georgia 31816 800-472-5221 Phone 706-846-5226 fax Establishment registration number: 1056436

Device Identification:

Proprietary Name:	Vortex® CT Port Access System
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
Proprietary Name:	LifeGuard® Safety Infusion Set
Common Name:	Port Access Infusion set
Classification Name:	Set, administration, intravascular
Classification Number:	21 CFR §880.5440
Classification Panel:	General Hospital
Product Code:	FPA
Regulatory Class:	II

Legally marketed device to which equivalence is claimed:

C.R. Bard PowerPort 510(k) K060812

Primary contact for correspondence

David Smith Director of Engineering 800-472-5221 ext. 3085 voice 706-846-5226 fax dsmith@ritamed.com

Secondary contact

Karen Alexander Director of Regulatory Affairs 800-472-5221 ext. 3023 voice 706-846-5303 fax kalexander@ritamed.com

Page 13 of 78

Kd62414 Pg 1 of 8

1 2007

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K06 2414 Pg 2 of 8

Device Description

The legally marketed devices that form the basis for this 510(k) submission is Horizon Medical Products' Vortex® Access System (K010767 cleared April 10, 2001), and the LifeGuard safety infusion set K013871 cleared March 6, 2002).

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 Vortex® Port Access systems offer models with single lumen 7.5 French to 9.6 French catheters made from either polyurethane or silicone. The catheters all contain radiopacifiers, and depth markings.

A more detailed description of the components of the Vortex® Port Access System is as follows;

Port Body: The body of the port is crafted of Titanium. Suture sites are incorporated into the port base to facilitate anchoring to the underlying tissue.

Reservoir: The reservoir is the hollow area under the septum, into which the non-coring needle is inserted for administration or withdrawal of fluids. The toroidal wall shape and a tangential outlet stem interface to facilitate flushing of the system.

Outlet stem: The port outlet stem is made from Titanium. Connection to the stem is accomplished through barbed connectors. The stem is located tangentially to the reservoir. The catheter is placed over stem, and locked into place. This creates a fluid connection with the reservoir.

Port septum: The port septum is the component through which the non-coring needle is inserted. The septum is self sealing, designed to maintain integrity after repeated punctures and is constructed from silicone (NuSil MED 4850).

Catheter: The available catheters are 7.5 or 9.6 French made from silicone (NuSil MED 4765) impregnated with a 15% BaSO4 in the cannula. The catheters include a blue stripe and tip loaded 25% BaSO4 for improved radiopacity. All catheters have depth markings to 65 cm to allow for precise placement.

Locking Mechanism: The cylindrical locking mechanism is made from silicone. The lock is advanced over the catheter until it positively locks onto the port stem, thereby compressing the catheter onto the stem and sealing the system.

Page 14 of 78

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Implantation: The Vortex® Port Access System is totally implanted in the body. The catheter is placed by percutaneous puncture technique with the distal tip at the juncture of the superior vena cava and right atrium via the jugular or subclavian vein. A subcutaneous pocket is prepared for placement of the port. The appropriate catheter length is determined, and the excess is trimmed by cutting straight across the proximal end. The catheter is marked up to 65 cm to allow more precise placement in the desired location. The catheter is attached to the port using the locking mechanism. The port body is secured by suturing through the base to the underlying fascia prior to wound closure.

The Vortex® port has significant physical and performance characteristics that make it an ideal candidate for indication for power injection. These characteristics include; All Titanium construction for maximum strength, barbed outlet stems for ease and simplicity of catheter connection, and maximum connection strength, combination locking mechanism / strain relief for simple locking, and maximum catheter protection.

It has come to RITA's attention that ports have and are being used for power injection studies. RITA currently makes no claims, and provides no instructions for this procedure. The purpose of this 510(k), and the studies which have been conducted, is to establish a safe and effective way to conduct a power injection study through ports which are deemed to be appropriate for this type of use.

When used for power injection, the port is accessed, using qualified infusion sets, in the standard fashion, per the standard instructions. The supplemental instructions will then be followed for power injection. Power injection involves the use of a power syringe to inject contrast media in order to complete a study.

Intended Use / Indications

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

The Vortex® CT ports can accommodate a 5 ml/see injection rate of contrast dye. This should only be attempted using a 20 gauge or 19 gauge non-Y site LifeGuard® in Ision set model #'s LG-19-XXX, and LG-20-XXX.

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။ အိမ္း အသိန္းမွန္းမွာေရးမွာ ျပန္မားမာေတာင္းမွာ များမွန္မွာ ျပန္မာျဖစ္မွ ျပန္မာျဖစ္ေျပာင္း ေျခင္း

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Pre-market Notification -510(k) RITA Medical Systems, Inc. Vortex® CT Power Injectable Port Access System - August 14, 2006

Summary of the technological characteristics of your device compared to the predicate device

The following table summarizes the technological comparison between the Vortex® CT and Bard PowerPort:

Technological Characteristic	RITA Vortex™ CT	C.R. Bard PowerPort (K060812)
Intended use, power injection	Accommodates a 5 ml/secinjection rate of contrast dye. Thisshould only be attempted using a20 gauge or larger non-Y siteLifeGuard* CT infusion set.	Accommodates a 5 ml/secinjection rate of contrast dyeinjected at up to 300 psi withoutdamaging the port or catheter.
Design	Port system with attachablecatheter.	Port system with attachablecatheter.
Material	Titanium Grade 2	Titanium
Shape	Round port system with tangentialoutlet	Triangular port system with centraloutlet
Included labeling	Instructions for use (General)Instructions for use powerinjectionVortex™ CT poster for CT officesPatient information bookletPatient ID card with key fobPatient chart labelingProduct label	Educational booklet for patients,nurses, placers, and CT departmentWall charts for CT department andplacersDischarge kits for patients(includes Patient ID card with keyfob and bracelet)
Needles used for Access	LifeGuard non-Y site safetyinfusion sets in 19 or 20 Ga	LiftLock non-Y site safety infusionsets in 19 or 20 Ga

ი ინტერნეტში

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K062414 Pg 5 of 8

Summary of the non-clinical performance data

The following non-clinical tests were performed as the basis for establishing substantial equivalence to the predicate device, as well as safety and effectiveness of the indication for use:

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Pre-market Notification -510(k)

RITA Medical Systems, Inc.
Vortex® CT Power Injectable
Portex® CT Power Injectable
Port Access System -- August 14, 2006

TestDescription	SampleSize	Test Description	Required Results
Sterilizationexposure	All	The samples shall be exposed to a 2x EtOsterilization cycle.	All samples must be capable ofwithstanding a 2X sterilization cycle
Physiologicalexposure	All	Maintain samples in a 0.9% saline bath at 37°C for24hrs prior to testing and between any tests.During the initial 24 hour preconditioning, thesamples shall be flushed and locked with aVancomycin solution (1g/1000cc of normalsaline).	All samples must be capable ofwithstanding physiologicalconditioning
Power injectionPerformanceTest	18	Inject 200 ml of an 11.8 cP solution through theport at 5ml/sec. Evaluate system for leaks anddamage	Maximum Pressure: $(U-X)/s ≥ k$where k = 1.96 for an AQL level of0.65Catheter material failure: no bursts.leaks, / plastic deformations allowed
SimulatedPower Injection	30	Inject 150 ml of an 11.8 cP solution through theport at 5ml/sec with 19 Ga and 20 Ga needles.Evaluate system for leaks and damage	All samples must meet expectedflow rate and pressure withstandrequirements
DynamicFailure Test	18	Inject 200 ml an 11.8 cP solution through the port atincreasing flow rates until failure occurs.	Data shall be gathered to supportlabel claims and determine theoperational safety factor.
Static BurstTest	18	Inject 100ml of a saline solution through the portwith the catheter occluded. Record the maximumpressure	Data shall be gathered to supportlabel claims.
Life CvclePower InjectionTest	10	Inject 200 ml of an 11.8 cP solution through theport at 5ml/sec. Evaluate system for leaks anddamage. Repeat the test 9 times	Catheter material failure: no bursts,leaks, / plastic deformations allowed
Cyclic testing	30, 10cycles perport	Inject 150 ml of an 11.8 cP solution through theport at 5ml/sec with 19 Ga needles. Repeat cycle10 times. Evaluate system for leaks and damage.	All samples must withstand 10cycles without leaking or bursting,The expected maximum number ofpower injection cycles is 5.
Port PatencyVerification	5	Withdraw simulated blood through port needlecombination to determine flow rate of fully patentsystem.	Blood return must be easily andempirically verifiable to establishsafety of power injection
Port OcclusionTest	10	Inject 100ml of a saline solution through the portwith the catheter occluded. Record the maximumpressure	Data shall be gathered to supportlabel claims.
Puncture Life	2	To test the durability of the septum with needlesexpected to be used in power injection.	Establish label claim for largestneedle likely to be used duringpower injection

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Kob 24/14 pg 7 of 8

Summary of the clinical performance data

No clinical tests were performed to determine substantial equivalence.

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K062414 pg 8of8

Conclusions drawn from the non-clinical performance data

The non-clinical tests demonstrate that the device is as safe, as effective for the modified intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Smith Director, of Vascular Products Engineering RITA Medical Systems, Incorporated One Horizon Way Manchester, Georgia 31816

FEB - 1 2007

Re: K062414

Trade/Device Name: Vortex® CT Port Access Systems and LifeGuard® Safety Infusion Set Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT, FPA Dated: January 24, 2007 Received: January 25, 2007

Dear Mr. Smith:

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 - Mr. Smith

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

Sincerely yours,

Clars

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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Pre-market Notification response -- 510(k) # K062414 RITA Medical Systems, Inc. Vortex® CT Power Injectable Port Access System

The LifeGuard® Safety Administration Set intended use has been reproduced below in the FDA's required format.

Indications for Use

510(k) Number (if known): K062414

LifeGuard® Safety Infusion Set Device Name:

Indications for Use:

The LifeGuard® Safety Infusion Sct is an administration set with a non-coring right angle needle and manually activated needle-stick prevention safety mechanism. The device is used to access surgically implanted vascular ports.

The LifeGuard® Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

Prescription Use AND/OR X (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)

Anthony D. Watson

K462414

Page 4 of 34

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Indications for Use Statement 4.0

The Vortex® CT Port Access System intended use has been reproduced below in the FDA`s required format.

Indications for Use

510(k) Number (if known): K062414

Vortex® CT Port Access System Device Name:

Indications for Use:

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

Over-The-Counter Use (21 CFR 807 Subpari C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

itz Lont

1462414

and and the britain and the comments of the first of the count

Page 11 of 78

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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.