The Dignity® Dual Port is a power injectable implantable infusion port that is indicated for patient therapies requiring repeated access to the vascular system. The Dignity® Dual Port can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

When used with a power injectable needle, the Dignity® Dual Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.

Device Description

The Dignity® Dual power injectable implantable infusion port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a power injectable needle only. The Dignity® Dual Port device consists of two primary components: an injection port with a self-sealing septa and a radiopaque catheter. The Dignity® Dual Ports can be identified subcutaneously by feeling the top of the septum and the top rim of the port housing. Power Injectable Implantable Infusion Ports can be identified by the letters "CT" under radiographic imaging.

The Dignity® Dual Port will be marketed in four kit configurations, which are listed below:

9.5F Standard Port Kit (Catalog number MRDP95ADN)
9.5F Port Kit with Micro-Stick (Catalog number MIDP95ADN)
9.5F Standard Port Kit with Silicone Filled Suture Holes (Catalog number MRDP95ADS)
9.5F Port kit with Silicone Filled Suture Holes and with Micro-Stick (Catalog number MIDP95ADS)

AI/ML Overview

The provided text describes the "Dignity® Dual Port," a power injectable implantable infusion port. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to pre-existing devices. Therefore, the "study" referred to is a demonstration of equivalence through functional and material comparisons, rather than a traditional clinical study with human patients and outcomes data.

Here's the breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Predicate/Reference Devices & Standards)	Reported Device Performance (Dignity® Dual Port - K153238)
Design: Double lumen, dual reservoir, power injection	Equivalent: Double lumen, dual reservoir, power injection
Dimensions: Base fits within 29mm x 39mm; Internal Volume 0.6 ml each reservoir; Depth Marking every 1cm (Predicate: K090512)	Equivalent: Base fits within 41mm x 12mm; Internal Volume: 0.7ml and 0.6 ml; Depth Marking every 1cm (Note: Dimensions are different, but deemed "Equivalent" in the context of the 510(k) summary, likely indicating functional equivalence despite size variation).
Indications for Use: Infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, withdrawal of blood samples; Power injection of contrast media up to 5 ml/s. (Predicate: K090512)	Equivalent: Infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, withdrawal of blood samples; Power injection of contrast media: 5 ml/s (19 or 20 gauge non-coring needle), 2 ml/s (22 gauge non-coring needle). (Additional detail for 22 gauge, but generally equivalent)
Catheter Size: 9.5F Double Lumen ChronoFlex Polyurethane Catheter (Predicate: K090512)	Equivalent: 9.5F Double Lumen ChoronFlex Polyurethane Catheter
Sterilization: ETO (Predicate: K090512)	Equivalent: ETO, ANSI/AAMI/ISO 11135-1:2007 SAL 10-6
Power Injectable Rate: 5 ml/s (Predicate: K090512)	Equivalent: 5 ml/s
Materials: Plastic, Silicone, Polyurethane (Predicate: K090512)	Equivalent to Reference Devices (K070003, K120281): Thermoplastic Polymer, Silicone, Polyurethane, Titanium, Polycarbonate (Note: Uses different and additional materials compared to the predicate, but is deemed equivalent based on comparison to reference devices which use similar materials and have established biocompatibility.)
MRI Performance Testing: MRI Conditional; Power Injection (19Ga 4.9ml/s, 20Ga 4.9ml/s, 22Ga 1.9ml/s); Infusion Testing (1700ml/hr); Catheter Lock Disengagement (10 lbs); Needle Insertion (19Ga 2.88lb, 22Ga 2.05 lbs); Gravity Flow (1680 ml/hr). (Predicate: K090512)	Equivalent: MRI Conditional; Power Injection (19Ga 4.9ml/s, 20Ga 4.9ml/s, 22Ga 1.9ml/s); Infusion Testing: 1600ml/hr; Catheter Lock Disengagement: 6.9 lb; Needle Insertion: 19Ga 3.8lb, 22Ga 3.6 lbs; Gravity Flow: 1760 ml/hr. (Some values differ but are deemed equivalent by the submission.)
Biocompatibility: Meet ISO 10993-1 requirements for permanent implant with tissue and both indirect/direct blood contact (via reference devices K070003, K120281)	Met: Materials are equivalent to cleared reference devices (K070003, K120281) which performed biocompatibility per ISO 10993-1. Summary of prior testing confirms compliance.

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

This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical trial with a distinct human "test set."

Test Set: No independent human "test set" in the context of a clinical trial is described. The "testing" involves bench testing, material comparisons, and a comparison matrix against a predicate and reference devices.
Data Provenance: The data provenance is primarily from bench/performance data and comparison to previously FDA-cleared devices (predicate K090512, reference K070003, K120281). This is not data from human subjects or from a specific country of origin in the way a clinical trial would generate it. All data would be generated in a lab setting by Medcomp® or its contracted testing facilities.

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

Ground Truth Establishment: Not applicable in the context of this 510(k) summary. The "ground truth" for the current device's acceptability is established by demonstrating its equivalence to predicate devices that have already been determined safe and effective by the FDA. The performance standards are derived from established industry standards (e.g., ISO, ASTM) and the performance characteristics of the predicate device.
Experts: No external experts are described as establishing "ground truth" for the test set. The submission itself is prepared by Medcomp®'s regulatory associate, Ms. Courtney Nix, and reviewed internally by Medcomp® and externally by the FDA (specifically the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices).

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "test set" of patient data requiring adjudication. The assessment is a comparison of design, materials, and performance data against established standards and predicate device specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic imaging devices where human readers interpret results with and without AI assistance. The Dignity® Dual Port is an implantable infusion port, a physical medical device, not an imaging or diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. The device is a physical implantable infusion port, not an algorithm or AI system.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the submission is the established safety and effectiveness of the legally marketed predicate device (C.R. Bard PowerPort©, K090512) and reference devices (Medcomp® Pro-Fuse®, K070003; Medcomp® Dignity® Power Injectable Titanium Port, K120281), as interpreted through FDA regulations and consensus standards (ISO, ASTM). The equivalence is demonstrated through comparative analysis of specifications, materials, and bench test results against these established benchmarks.

8. The Sample Size for the Training Set

Training Set: Not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 15, 2016

Medcomp (Medical Components) Ms. Courtney Nix Regulatory Associate 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K153238

Trade/Device Name: Dignity Dual Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, implanted, intravascular infusion port and catheter Regulatory Class: II Product Code: LJT Dated: February 9, 2016 Received: February 12, 2016

Dear Ms. Nix:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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)

K153238

Device Name Dignity® Dual Port

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Preconstruction Use (Text CA SB 255, 2015, Statute)	Interim Use
------------------------------------------------------------------------------------------------------------	-----------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

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

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1499 Delp Drive Harleysville, PA 19438 Tel: 215-256-4201 Fax. 215-256-1787 www.medcompnet.com

Section 5		510(k) SUMMARYK153238
A.	Submitter Information:
	Submitter:	MEDCOMP®1499 Delp DriveHarleysville, PA 19438Tel: (215) 256-4201, x2244Fax: (215) 256-9191
	Contact:	Courtney NixRegulatory AssociateCnix@medcompnet.com
	Date Prepared:	March 11, 2016
B.	Trade Name:	Dignity® Dual Port
	Common Name:	Power Injectable, Implantable, Infusion Port
	Product Code :	LJT - Subcutaneous, Implanted, Intravascular InfusionPort and Catheter
	C.F.R. Section:	21 CFR 880.5965, Class II
	Classification Panel:	General Hospital
C.	Predicate Devices:	K090512 C.R. Bard, Inc. PowerPort© duo M.R.I.TMImplanted Port with 9.5 Fr, Dual Lumen ChronoFlex®Catheter, class II 880.5956
D.	Reference Devices:	K070003 Medcomp®, Power Injectable ImplantableInfusion Port; Pro-Fuse®, class II 880.5965
		K120281 Medcomp®, Dignity® Power InjectableTitanium Port, class II 880.5965
E.	Purpose for Submission:	Expansion of Medcomp®'s Dignity® product line toinclude an in-line dual reservoir point with injectioncapabilities.

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Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

housing. Power Injectable Implantable Infusion Ports can be identified by the letters "CT" under radiographic imaging.

The Dignity® Dual Port will be marketed in four kit configurations, which are listed below:

9.5F Standard Port Kit (Catalog number MRDP95ADN)
9.5F Port Kit with Micro-Stick (Catalog number MIDP95ADN)
9.5F Standard Port Kit with Silicone Filled Suture Holes (Catalog number MRDP95ADS)
9.5F Port kit with Silicone Filled Suture Holes and with Micro-Stick (Catalog number MIDP95ADS)

Indications for Use: G.

H. Comparison to Predicate Devices:

The Dignity® Dual Port is substantially equivalent to the predicate device, C.R. Bard PowerPort© (K090512), in terms of intended use, anatomical location, basic design, performance, labeling, manufacturing process and method of sterilization.

The Dignity® Dual power injectable implantable infusion port, is equivalent to the Medcomp® references devices, Medcomp® Pro-Fuse® (K070003) and Medcomp® Dignity® Power Injectable Titanium Port (K120281), in materials.

The difference between the reference device, Dignity® Power Injectable Titanium Port (K120281), and the Dignity® Dual Port assembly is that the Dignity® Dual Port has a polysulfone cap, base, two silicone septa and a titanium insert, while the titanium port is comprised of a one piece titanium housing and silicone septum. The Dignity® Dual Port utilizes a titanium insert to connect the distal reservoir to the catheter. Both ports use the same grade of titanium.

The difference between the Dignity® Dual Port and the predicate, Bard Access Systems, PowerPort™ duo M.R.I™ Implanted Port (K090512), is that the PowerPort™ duo M.R.I™ is a side-by-side reservoir design, whereas the Dignity® Dual Port has an in-line reservoir design.

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Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Table 1: 510(K) Summary: Design Comparison Matrix

Device	Proposed Dignity® Dual Port(K153238)	C.R. Bard PowerPort®(K090512)	SubstantiallyEquivalentComparison
Design	Double lumen open endedDual reservoirPower injection	Double LumenDual reservoirPower Injection	Equivalent
Dimensions	Bases Fits within:41mm x 12mmInternal Volume:0.7ml and 0.6 mlDepth Marking every 1cm	Bases Fits within:29mm x 39mmInternal Volume:0.6 ml each reservoirDepth Marking every 1cm	Equivalent
Indicationsfor use	The Dignity® Dual Port is apower injectable implantableinfusion port that is indicated forpatient therapies requiringrepeated access to the vascularsystem. The Dignity® Dual Portcan be used for infusion ofmedications, I.V. fluids,parenteral nutrition solutions,blood products, and for thewithdrawal of blood samples.When used with a powerinjectable needle, the Dignity®Dual Port is indicated for powerinjection of contrast media. Forpower injection of contrastmedia, the maximumrecommended infusion rate is 5ml/s with a 19 or 20 gauge non-coring power injectable needle.The maximum recommendedinfusion rate is 2 ml/s with a 22gauge non-coring powerinjectable needle.	PowerPort™ Implanted Port isindicated for patient therapiesrequiring repeated access to thevascular system. The portsystem can be used for infusionof medications, I.V. fluids,parenteral nutrition soltuions,blood products, and for thewithdrawal of blood samples.When used with a PowerLoc™Safety Infusion Set, ThePowerPort™ device is indicatedfor power injection of contrastmedia. For power injection ofcontrast media, the maximumrecommended infusion rate is 5ml/s.(From 510(k) SummaryK090512)	Equivalent
CatheterSize	9.5F Double Lumen ChoronFlexPolyurethane Catheter	9.5F Double Lumen ChoronFlexPolyurethane Catheter	Equivalent
Sterilization	ETOANSI/AAMI/ISO 11135-1:2007SAL 10-6	ETOReference Not Sited inpublished 510(k) Summary	Equivalent
PowerInjectable	Power InjectableRate: 5 ml/s	Power InjectableRate: 5 ml/s	Equivalent
Materials	Thermoplastic PolymerSiliconePolyurethaneTitaniumPolycarbonate	PlasticSiliconePolyurethane	Equivalent toReferencesDevices;Medcomp®Pro-Fuse®(K070003)andMedcomp ®Dignity®

MRIPerformanceTesting	MRI ConditionalPower Injection:19Ga 4.9ml/s20Ga 4.9ml/s22Ga 1.9ml/sInfusion Testing: 1600ml/hrCatheter Lock Disengagement:6.9 lbNeedle Insertion:19Ga 3.8lb22Ga 3.6 lbsGravity Flow:1760 ml/hr	MRI ConditionalPower Injection:19Ga 4.9ml/s20Ga 4.9ml/s22Ga 1.9ml/sInfusion Testing: 1700ml/hrCatheter LockDisengagement:10 lbsNeedle Insertion:19Ga 2.88lb22Ga 2.05 lbsGravity Flow:1680 ml/hr	InjectableTitanium Port(K120281)EquivalentEquivalent

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Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Bench / Performance Data / Non-Clinical Testing:

The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device is equivalent to the predicate devices. The performance testing was performed in accordance with the following standards:

BS EN ISO 10555-1: 2013: Intravascular Catheters Sterile and Single-use Catheters Part 1: General Requirements
ISO 10555-3: 2013; Intravascular Catheters Sterile and Single-Use -Catheters - Part 3: Central Venous Catheters (General Plastic Surgery/General Hospital)
BS EN ISO 10993-1; 2009: Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process (Biocompatibility)
BS EN ISO 11135; Second Edition 2014; Sterilization of health-care products - Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 10555-6: 2015; Intravascular Catheters Sterile and Single-use -Catheters - Part 6: Subcutaneous implanted ports
ASTM F2213-06: (Reapproved 2011), standard test method for , measurement of magnetically induced torque on medical devices in the magnetic resonance environment. (Materials)
ASTM F2129-08: Standard test method for conducting cyclic = potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices. (Materials)
ASTM F2052-14: standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment. (Materials)
ASTM F2503-13: standard practice for marking medical devices and other items for safety in the magnetic resonance environment. (Materials)

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Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Biocompatibility:

Materials of the Dignity® Dual Port are equivalent to the cleared, reference devices; Medcomp®, Power Injectable Implantable Infusion Port: Medcomp® Pro-Fuse® (K070003) and Medcomp ® Dignity® Power Iniectable Titanium Port (K120281). Biocompatibility on both reference devices we performed per ISO 10993-1, for a permanent implant device with tissue and both indirect and direct blood contact.

The Dignity® Dual Port is comprised of a polysulfone cap (with silicone filled suture holes, or open suture holes), two silicone septa, and a polysulfone base assembly with a titanium tube that provides a channel from the stem to the distal reservoir. The reservoir is plastic (polysulfone). The Dignity® Dual catheter locking assembly (makrolon/pellethane) locks the chronoflex lumen to the plastic stem of the Dignity® Dual Port. The materials that the Dignity® Dual Port is constructed of are the same as those cleared in the Power Injectable Implantable Infusion Port Pro-Fuse ™ (K070003), and the same formulation of titanium as cleared in the Dignity® Power Injectable Titanium Port (K120281). Therefore, as mentioned above, Medcomp® intends to use approved Medcomp® devices, Medcomp® Pro-Fuse® (K070003) and Medcomp® Dignity® Power Injectable Titanium Port (K120281), for biocompatibility testing results per ISO 10993-1, for a permanent implant device with tissue and both indirect and direct blood contact. Hence, all biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993-1 and a summary of prior testing is contained in section 15.

Summary of Substantial Equivalence: K.

In conclusion, the proposed device, The Dignity® Dual power injectable implantable infusion port, is equivalent to the predicate device, C.R. Bard PowerPort© (K090512), in intended use, design, function, and performance. The proposed device. The Dignity® Dual power injectable implantable infusion port, is equivalent to the Medcomp® references devices, Medcomp® Pro-Fuse® (K070003) and Medcomp® Dignity® Power Injectable Titanium Port (K120281), in materials.

The proposed device, The Dignity® Dual power injectable implantable infusion port, meets the performance criteria of design verification as specified by ISO standards. quidance documents and internal test protocols. The proposed device is substantially equivalent to the indicated legally marketed predicate and reference devices as defined in paragraph above.

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.