The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood, and blood products.

The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for power injection of contrast media. For power injection of contrast media, the maximium recommended infusion rate is 5 mL/s.

Device Description

The TidalPort-AP™ has one port size (Standard) and one catheter size (9.6F Polyurethane). It is designed to provide repeated access to the vascular system without the need for repeated venipuncture or the daily care of an external catheter. The TidalPort-APTM is available as a standard profile totally implantable, titanium port-based design and is accessed perpendicularly to the skin like a typical, conventional access port. For the purpose of apheresis, high-flow procedures, it is accessed with using the FDA Cleared 16G or 18G high-flow, non-coring needle Tidal High-Flow Non-coring Needle (K151341).

The TidalPort-APTM can also be used for routine vascular access infusion or withdrawal using Huber point needle. For power injection infusion procedures, the subject device can be accessed with a power injection rated needle to create a power-injectable system.

The design of the TidalPort-AP™ utilizes a spherical reservoir and an elongated radius contoured septum to achieve the design purpose of creating a port with a smaller reservoir and less clearance volume. The TidalPort-APTM comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The TidalPort-AP™ and necessary kit components are provided sterile (EtO).

The overall implanted port system consists of three primary components: the titanium port body with a silicone septum, an attachable radiopaque polyurethane catheter, and a catheter lock which secures the catheter to the port body stem. Once implanted, the method of accessing the subject TidalPort-APTM device is the exact same as the predicate TidalPort™ device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped port. Once the port is palpated, providing the location of the septum, the 16G or 18G high-flow needle (K151341) is inserted into the reservoir for apheresis procedure use. After the reservoir floor is reached, the stylet is unlocked and pulled back slightly, and the needle is once again advanced forward until contacting the reservoir floor again. The stylet is then completely removed, leaving the hollow cannula with luer lock fitting in place. After stylet removal, the cannula is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TidalPort-AP™ Implantable Apheresis Vascular Access Port. This document details the device's indications for use, technological characteristics, and non-clinical tests performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment in a format typically used for evaluating the performance of AI/ML-driven devices.

The document focuses on engineering and material performance testing of a physical medical device, not a diagnostic or prognostic AI/ML algorithm. Therefore, many of the requested fields are not applicable in this context.

Here's an attempt to extract the relevant information based on the provided text, while acknowledging the limitations:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests but does not explicitly state quantitative "acceptance criteria" and "reported performance" in a structured table for each test. It states that "The TidalPort-AP™ Implantable Apheresis Vascular Access Port has met all predetermined acceptance criteria of design verification evaluations through testing examination." This implies that the device did meet the criteria for each performed test.

Key Performance Tests Mentioned:

Catheter to Port Connection
Catheter Tensile Strength
Radiopacity
Gravity Flow Rate
Port System Burst under Power Injection
Stem Tensile Strength
Corrosion Resistance
Septum Puncture / Port Leak (w/both Huber point and 2-part large bore needles)
Port Clearance Volume
Power Injection / Multi-Power Injection
Simulated Apheresis Testing- comparison to predicate (PowerFlow)
Recirculation, Forward and Reverse Flow- comparison to predicate (PowerFlow)
Hemolysis, Forward and Reverse Flow- comparison to predicate (PowerFlow)
MRI Safety Testing
Packaging Ship Testing
Pyrogenicity Testing

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

Not applicable. The document describes bench testing and biocompatibility assessments of a physical device, not a test set of medical images or patient data.

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. This is not an AI/ML diagnostic or prognostic device requiring expert-established ground truth from a test set of data.

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

Not applicable.

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 is not an AI-assisted diagnostic or prognostic device.

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

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

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

Not applicable in the context of AI/ML ground truth. For this physical device, the "ground truth" would be established by validated engineering specifications, accepted international standards (ISO, ASTM), and FDA guidance documents (e.g., FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, standards listed in the document). Performance was evaluated against these predefined physical and functional requirements.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that undergoes a "training set."

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

August 20, 2020

Norfolk Medical Products, Inc. Natan Pheil Product Development Manager 7350 N. Ridgeway Avenue Skokie, Illinois 60076

Re: K192291

Trade/Device Name: TidalPort-AP Implantable Apheresis Vascular Access Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port And Catheter Regulatory Class: Class II Product Code: PTD Dated: July 17, 2020 Received: July 20, 2020

Dear Natan Pheil:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192291

Device Name

TidalPort-APTM Implantable Apheresis Vascular Access Port

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
✖ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Norfolk Medical. The logo consists of the word "Norfolk" in large, bold font, followed by a red heart-shaped symbol, and then the word "Medical" in the same font as "Norfolk". Below the logo is the address "7350 N. Ridgeway • Skokie, IL, USA • 847-674-7075".

K192291

510(k) Summary 21 CFR 807.92

TidalPort-AP™ Implantable Apheresis Vascular Access Port

August 17, 2020

Submitter/Sponsor Information 5.1

Submitter Name:FDA Establishment	Norfolk Medical Products, Inc.
Registration Number:	1450392
Address:	7350 N. RidgewaySkokie, IL 60076
Telephone Number:	(847) 674-7075
Fax Number:	(847) 674-7066
Contact Person:	Natan Pheil, Product Development Manager

5.2 Device Name

5.3

Trade Name:	TidalPort-APT™ Implantable Apheresis VascularAccess Port
Common Name:	Subcutaneous implanted apheresis port
Classification Panel:	80 General Hospital
Regulation:	21 CFR 880.5965
Regulation Name:	Subcutaneous, Implanted, Intravascular Infusion Port andCatheter
Class:	Class II
Product Code:	PTD
Predicate Device
Device Name:	PowerFlow™ Implantable Apheresis IV Port with9.6 Fr. ChronoFlex Catheter
Premarket Notification:	K163001
Product Code:	PTD

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Image /page/4/Picture/0 description: The image shows the logo for Norfolk Medical. The logo consists of the word "Norfolk" in large, bold letters, followed by a red heart symbol, and then the word "Medical" in the same font as "Norfolk". Below the logo is the address "7350 N. Ridgeway • Skokie, IL, USA • 847-674-7075".

Predicate Device
Device Name:	Norfolk Medical SportPort™ (now TidalPort™) Family of Vascular Access Ports
Premarket Notification:	K112713
Product Code:	LJT

5.4 Device Description

The kit components provided to aid in the implantation procedure and/or access of the device once implanted include:

Implantation Placement Kit:

1 x TidalPort-APTM Implantable Apheresis Vascular Access Port .

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Image /page/5/Picture/0 description: The image shows the logo for Norfolk Medical. The logo consists of the word "Norfolk" in a serif font, followed by a red heart-shaped symbol with a white outline and a small drop at the bottom. To the right of the heart is the word "Medical" in the same serif font as "Norfolk."

7350 N. Ridgeway · Skokie, IL, USA · 847-674-7075

1 x Radiopaque Polyurethane Catheter (9.6F) .
2 x Catheter Securement Boot .
1 x Syringe, 5cc with Luer Lock .
1 x Barbed Malleable Tunneler .
. 1 x Vein Pick
1 x Blunt Flushing Cannula .
. 1 x Needleless Injection Site
1 x 22G Straight Huber Point Needle w/Luer Lock Connector .
. 1 x Safety Scalpel with #11 Blade

Standard Introducer Kit (optional, pouched separately):

1 x Syringe, 10cc with Luer Slip .
1 x 18G x 2.75" Introducer Needle with Echogenic Tip .
. 1 x J-Tip Guidewire with Straightener, 0.035-inch OD x 45 cm length
1 x Standard Introducer, Peel-Apart Sheath, with VesselDilator o

Valved Introducer Kit (optional, pouched separately):

1 x Syringe, 10cc with Luer Slip .
1 x 18G x 2.75" Introducer Needle, Echogenic ●
1 x J-Tip Guidewire with Straightener, 0.035-inch OD x 45 cm length .
. 1 x Valved Introducer, Peel-Apart Sheath, with VesselDilator
Tidal High-Flow Needle (pouched separately):
o 1 x 16G x 1" Tidal High-Flow Non-coring Needle

న్.న Indications for Use Statement

The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.

5.6 Technological Characteristics Summary

The proposed device is substantially equivalent to Bard's PowerFlow Implantable Apheresis Port cleared under 510(k) premarket notification K163001 and Norfolk Medical's TidalPort cleared under 510(k) premarket notification K112713. The subject device is designed to be accessed with a 16G or 18G High-Flow, Non-coring Needle (K151341) for apheresis procedures and has a 9.6F catheter intended to provide optimal flow rates for patients requiring therapeutic apheresis.

An Implantable Port System with a silicone septum for access is the primary technological principle for both the subject and predicate devices. Both port systems have the same primary components: a titanium port w/silicone septum, a radiopaque polyurethane catheter securement mechanism that secures the catheter to the port pin.

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Image /page/6/Picture/0 description: The image shows the logo for Norfolk Medical. The logo consists of the words "Norfolk Medical" in a serif font, with a red heart-shaped symbol in between the two words. Below the logo is the address "7350 N. Ridgeway • Skokie, IL, USA" and the phone number "847-674-7075".

Technological Characteristics:

Feature	Subject Device(TidalPort-AP™)	Predicate(PowerFlow)	Predicate(SportPort)	Comparison –same/different
510(k) Number	K192291	K163001	K112713
Indications For Use	The TidalPort-AP™ImplantableApheresisVascular AccessPort is indicatedfor therapiesrequiringrepeated accessto the vascularsystem. The portsystem can beused for long-term therapeuticapheresis,withdrawal ofblood, andinfusion ofmedications, I.V.fluids, parenteralnutritionsolutions, blood,and bloodproducts.The TidalPort-AP™ImplantableApheresisVascular AccessPort is indicatedfor powerinjection ofcontrast media.For powerinjection ofcontrast media,the maximumrecommendedinfusion rate is 5mL/s.	The BardPowerFlow™Implantable ApheresisIV Port is indicatedfor patient therapiesrequiring repeatedaccess to thevascular system. Theport system can beused for long-termtherapeutic apheresis,withdrawal of blood,and infusion ofmedications, I.V.fluids, parenteralnutrition solutions,blood and bloodproducts.The BardPowerFlow™Implantable ApheresisIV Port is indicatedfor power injection ofcontrast media. Forpowerinjection of contrastmedia, the maximumrecommendedinfusion rate is 5mL/s.	The SportPort™ isindicated for usewhen the patientrequires thefollowing: repeatedaccess to thevascular system forinjections, infusionof drugs,administration ofblood or bloodproducts, and/orwithdrawal ofblood as part of thetherapy regimen.When used with apower injectableneedle infusion set,the SportPort™ isindicated for powerinjection of contrastmedia. For powerinjection of contrastmedia, themaximumrecommendedinfusion rate is5ml/s with a 19 or20 gauge non-coring powerinjectable needleand 2ml/s with a 22gauge non-coringpower injectableneedle.	1. Same except fordevice name2. Different
Port Catheter Size	9.6F Polyurethane	9.6F Polyurethane	9.6F Polyurethane	Same
Port Access Device	22, 20, 19, 18, or16-Gauge Needle	16- or 14-Gauge IVCatheter	22, 20, 19, 18, or16-Gauge Needle	1. Different2. Same
Septum	Silicone Septum	Single Layer Valve	Silicone Septum	1. Different2. Same
7350 N. Ridgeway • Skokie, IL, USA • 847-674-7075
Port Entry	Perpendicularwith non-coringneedle	Angle entry funnelwith an introducerneedle stop featurefor port systemaccess	Perpendicular withnon-coring needle	1. Different2. Same
Long-term Durationof Use	Repeated access tovascular system	Repeated access tovascular system	Repeated access tovascular system	Same
SubcutaneousImplantation	Tunneled andinserted into bloodvessel	Tunneled andinserted into bloodvessel	Tunneled andinserted into bloodvessel	Same
Catheter InsertionSite	External jugular,internal jugular, orsubclavian veins	External jugular,internal jugular, orsubclavian veins	External jugular,internal jugular, orsubclavian veins	Same
Catheter TipPlacement	Lower 1/3 ofsuperior vena cava	Lower 1/3 ofsuperior vena cava	Lower 1/3 ofsuperior vena cava	Same
Catheter Tip	Open ended tip	Open ended tip	Open ended tip	Same
Port Body Materials	Titanium andSilicone	Titanium Coveredwith Silicone	Titanium andSilicone	Same
Method ofSterilization	EO Gas	EO Gas	EO Gas	Same

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Image /page/7/Picture/0 description: The image shows the logo for Norfolk Medical. The logo consists of the word "Norfolk" in a serif font, followed by a stylized red heart shape. To the right of the heart is the word "Medical" in the same serif font as "Norfolk". The heart has a small "TM" symbol at the bottom.

7350 N. Ridgeway • Skokie, IL, USA • 847-674-7075

The Indication For Use statements between the TidalPort-AP™ and PowerFlow are the same. It differs from the SportPort™ in that the TidalPort-AP™ adds an indication for therapeutic apheresis, and as such, is limited to one port size and one catheter size.

The differences between the TidalPort-AP™ and the Predicate (PowerFlow) relate to the Port Access Device, Septum, and Port Entry. The differences do not impact the safety and effectiveness of the Port Access Device, 16-Gauge and 18-Gauge needles are used for apheresis today. The silicone septum creates a selfsealing unit and is easy to identify. Finally, the port entry, being perpendicular to the skin, is well-established which makes the TidalPort-AP™ access technique familiar to clinicians. The performance tests conducted below demonstrate that the differences do not raise new or different questions of safety or effectiveness.

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Image /page/8/Picture/0 description: The image shows the logo for Norfolk Medical. The logo consists of the words "Norfolk" and "Medical" in a serif font, with a red heart-shaped symbol in between. Below the logo is the address "7350 N. Ridgeway • Skokie, IL, USA" and the phone number "847-674-7075".

5.7 Discussion of Non-clinical Tests

Norfolk Medical develops product specifications based on design input and risk analysis activities related to the intended use of the product. These product specifications are used to create appropriate design verification tests with reference/guidance to established standards (listed below). For this application, the tests conducted were based on the following standards, specifically in reference to septum puncture / port leak information:

FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, dated October 1990 was ● used as a reference for the performance testing.
FDA Guidance on Implanted Blood Access Devices for Hemodialysis
FDA Guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Device Labeled as Sterile
FDA Guidance Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance Environment
FDA Guidance Use of International Standard ISO 10993, Biological evaluation of medical ● devices - Part 1: Evaluation and testing within a risk management process

•	EN ISO 10555-1:2013	Sterile, single-use intravascular catheters - Part 1: Generalrequirements
•	EN ISO 10555-6:2015	Intravascular catheters - Sterile, single use catheters - Part 6:Subcutaneous implanted ports
•	BS EN ISO 10993-1:2010	Biological evaluation of medical devices -- Part 1: Evaluation andtesting within a risk management process
•	BS EN ISO 10993-7:2008	Biological evaluation of medical devices -- Part 7: Ethylene oxidesterilization residuals
•	BS ENISO 11135:2014	Sterilization of health care products - Ethylene oxide - Part 1:Requirements for development, validation and routine controlof a sterilization process for medical devices
•	BS EN ISO 14971:2012	The application of risk management to medical devices
•	ISO 11607-1:2010	Packaging for terminally sterilized medical devices Part 1:Materials, sterile barrier systems and packaging systems
•	BS ENISO 14937:2009	Sterilization of health care products - General requirements forcharacterization of a sterilizing agent and the development,validation, and routine control of a sterilization process for medicadevices
•	ASTM F67-13(2017)	Standard Specification for Unalloyed Titanium, for SurgicalImplant Applications
•	ASTM F86-13	Standard practice for surface preparation and marking of metallicsurgical implants
•	ASTM F640-12	Standard test methods for determining radiopacity for medical use

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Image /page/9/Picture/0 description: The image shows the logo for Norfolk Medical. The logo consists of the words "Norfolk Medical" in a serif font, with a red heart-shaped symbol in between the two words. Below the logo is the address "7350 N. Ridgeway · Skokie, IL, USA · 847-674-7075".

Performance Data:

The following bench tests were performed to evaluate the performance of the TidalPort-APTM Implantable Apheresis Vascular Access Port:

1. Catheter to Port Connection
1. Catheter Tensile Strength
1. Radiopacity
1. Gravity Flow Rate
1. Port System Burst under Power Injection
1. Stem Tensile Strength
1. Corrosion Resistance
1. Septum Puncture / Port Leak (w/both Huber point and 2-part large bore needles)
1. Port Clearance Volume
1. Power Injection / Multi-Power Injection
1. Simulated Apheresis Testing- comparison to predicate (PowerFlow)
1. Recirculation, Forward and Reverse Flow- comparison to predicate (PowerFlow)
1. Hemolysis, Forward and Reverse Flow- comparison to predicate (PowerFlow)
1. MRI Safety Testing
1. Packaging Ship Testing
1. Pyrogenicity Testing

Biocompatibility:

The biocompatibility assessment was completed and appropriate endpoints conducted in compliance to ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1 - Evaluation and Testing within a Risk Management Process and the FDA Guidance for Industry - Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".

5.8 Conclusion

The TidalPort-AP™ Implantable Apheresis Vascular Access Port has met all predetermined acceptance criteria of design verification evaluations through testing examination. Based on the FDA's decision tree, it is concluded through performance testing that the TidalPort-APTM Implantable Apheresis Vascular Access Port is substantially equivalent to the predicate device.

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.