(363 days)
No
The summary describes a physical implantable device and its components, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a vascular access port, which facilitates therapies, but is not therapeutic itself. It is a tool for accessing the vascular system to administer or withdraw substances as part of a therapeutic process.
No
This device, the TidalPort-AP™ Implantable Apheresis Vascular Access Port, is an implantable access port for repeated access to the vascular system for therapies, withdrawal of blood, and infusion of various substances. It facilitates these "physical" functions and does not collect or interpret data to diagnose a condition.
No
The device description clearly details a physical, implantable medical device consisting of a titanium port body, silicone septum, polyurethane catheter, and catheter lock. The summary describes bench testing of physical properties and performance, not software validation.
Based on the provided text, the TidalPort-AP™ Implantable Apheresis Vascular Access Port is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for therapies requiring repeated access to the vascular system for procedures like apheresis, blood withdrawal, and infusion of various substances directly into the body. This is an in-vivo (within the living body) application.
- Device Description: The description details an implantable port system designed to be placed within the body for direct vascular access.
- Lack of IVD Characteristics: The description does not mention any components or functions related to examining specimens derived from the human body in vitro (outside the living body) for diagnostic purposes. There is no mention of analyzing blood, tissue, or other samples to provide information about a physiological state, health, or disease.
Therefore, the TidalPort-AP™ is a medical device used for therapeutic and access purposes within the body, not an IVD device used for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
PTD
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.
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 .
- 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following bench tests were performed to evaluate the performance of the TidalPort-APTM Implantable Apheresis Vascular Access Port:
-
- 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
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known) K192291
Device Name
TidalPort-APTM Implantable Apheresis Vascular Access Port
Indications for Use (Describe)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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. Ridgeway |
| Skokie, 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 Vascular
Access Port |
|-------------------------|------------------------------------------------------------------------------|
| Common Name: | Subcutaneous implanted apheresis port |
| Classification Panel: | 80 General Hospital |
| Regulation: | 21 CFR 880.5965 |
| Regulation Name: | Subcutaneous, Implanted, Intravascular Infusion Port and
Catheter |
| Class: | Class II |
| Product Code: | PTD |
| Predicate Device | |
| Device Name: | PowerFlow™ Implantable Apheresis IV Port with
9.6 Fr. ChronoFlex Catheter |
| Premarket Notification: | K163001 |
| Product Code: | PTD |
4
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 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.
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 .
5
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 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 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.
6
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™
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 maximum
recommended
infusion rate is 5
mL/s. | The Bard
PowerFlow™
Implantable Apheresis
IV Port is indicated
for patient 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 Bard
PowerFlow™
Implantable Apheresis
IV Port is indicated
for power injection of
contrast media. For
power
injection of contrast
media, the maximum
recommended
infusion rate is 5
mL/s. | The SportPort™ is
indicated for use
when the patient
requires the
following: repeated
access to the
vascular system for
injections, infusion
of drugs,
administration of
blood or blood
products, and/or
withdrawal of
blood as part of the
therapy regimen.
When used with a
power injectable
needle infusion set,
the SportPort™ is
indicated for power
injection of contrast
media. For power
injection of contrast
media, the
maximum
recommended
infusion rate is
5ml/s with a 19 or
20 gauge non-
coring power
injectable needle
and 2ml/s with a 22
gauge non-coring
power injectable
needle. | 1. Same except for
device name
2. Different |
| Port Catheter Size | 9.6F Polyurethane | 9.6F Polyurethane | 9.6F Polyurethane | Same |
| Port Access Device | 22, 20, 19, 18, or
16-Gauge Needle | 16- or 14-Gauge IV
Catheter | 22, 20, 19, 18, or
16-Gauge Needle | 1. Different
2. Same |
| Septum | Silicone Septum | Single Layer Valve | Silicone Septum | 1. Different
2. Same |
| 7350 N. Ridgeway • Skokie, IL, USA • 847-674-7075 | | | | |
| Port Entry | Perpendicular
with non-coring
needle | Angle entry funnel
with an introducer
needle stop feature
for port system
access | Perpendicular with
non-coring needle | 1. Different
2. Same |
| Long-term Duration
of Use | Repeated access to
vascular system | Repeated access to
vascular system | Repeated access to
vascular system | Same |
| Subcutaneous
Implantation | Tunneled and
inserted into blood
vessel | Tunneled and
inserted into blood
vessel | Tunneled and
inserted into blood
vessel | Same |
| Catheter Insertion
Site | External jugular,
internal jugular, or
subclavian veins | External jugular,
internal jugular, or
subclavian veins | External jugular,
internal jugular, or
subclavian veins | Same |
| Catheter Tip
Placement | Lower 1/3 of
superior vena cava | Lower 1/3 of
superior vena cava | Lower 1/3 of
superior vena cava | Same |
| Catheter Tip | Open ended tip | Open ended tip | Open ended tip | Same |
| Port Body Materials | Titanium and
Silicone | Titanium Covered
with Silicone | Titanium and
Silicone | Same |
| Method of
Sterilization | EO Gas | EO Gas | EO Gas | Same |
7
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.
8
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: General
requirements |
|---|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • | 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 and
testing within a risk management process |
| • | BS EN ISO 10993-7:2008 | Biological evaluation of medical devices -- Part 7: Ethylene oxide
sterilization residuals |
| • | BS ENISO 11135:2014 | Sterilization of health care products - Ethylene oxide - Part 1:
Requirements for development, validation and routine control
of 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 for
characterization of a sterilizing agent and the development,
validation, and routine control of a sterilization process for medica
devices |
| • | ASTM F67-13(2017) | Standard Specification for Unalloyed Titanium, for Surgical
Implant Applications |
| • | ASTM F86-13 | Standard practice for surface preparation and marking of metallic
surgical implants |
| • | ASTM F640-12 | Standard test methods for determining radiopacity for medical use |
9
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:
-
- 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
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.