(444 days)
Not Found
No
The summary describes a physical implantable device and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is used for the administration of fluids, including chemotherapy, analgesics, and nutritional therapy, which are forms of medical treatment.
No
This device is an implantable venous access device used for administering fluids and withdrawing blood specimens. It is not used to diagnose a medical condition.
No
The device description clearly states it is an "implantable venous access device" with physical components like a port body, reservoir, septum, and catheter. It is a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for accessing the central venous system for administering and withdrawing substances from the patient's body (fluids, chemotherapy, blood products, nuclear medicine, contrast media, blood specimens). This is a direct interaction with the patient's circulatory system.
- Device Description: The description details an implantable venous access device (a port and catheter) designed to be placed subcutaneously and accessed with a needle. This is a medical device used in vivo (within a living organism).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or function.
The device is a medical device used for patient treatment and access, not for analyzing biological samples outside the body.
N/A
Intended Use / Indications for Use
The ports are indicated for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, as well as the administration and adequate removal of nuclear medicine.
When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s with 19G or 20G non-coring power injectable needles or 2 mL/s with a 22G non-coring power injectable needle.
| Needle Size (G), non-coring power injectable | Catheter Size (F) | Maximum Recommended Flow Rate Setting (mL/s) | Maximum Recommended Pressure Setting (psi) |
|---|---|---|---|
| 19/20 | 5,6 and 8 | 5 | 300 |
| 22 | 5,6 and 8 | 2 | 300 |
Product codes
LJT
Device Description
The SmartPort* device with ENDEXO and Vortex Technology and the SmartPort Plastic device with Vortex Technology are implantable venous access devices designed for repeated access to the vascular system. The SmartPort* and SmartPort Plastic devices are subcutaneous implant devices with one reservoir. The ports are accessed using a Huber needle which is passed through the self-sealing silicone septum covering the reservoir. When used with power injectable needles, the port can be used for power injection of contrast media and contrast enhanced computed tomography (CECT).
Available in plastic and titanium port bodies, the SmartPort* device has standard, low profile, and mini Titanium port configurations and low-profile Plastic port configurations. The ports are offered with a 5F, 6F or 8F single lumen BioFlo catheter. The BioFlo catheter with ENDEXO technology is present in the previously cleared NMI Port II (K131694) for improved resistance to thrombus accumulation and/or formation on the catheter. The outlet of the vortex port chamber is set at a tangent rather than perpendicularly.
The SmartPort Plastic device is offered in a low-profile Plastic port body configuration with a 6F or 8F single lumen polyurethane catheter. Both the BioFlo and polyurethane catheters are radiopague.
When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate setting is 5 ml/s with 19G or 20G non-coring power injectable needles or 2 ml/s with a 22G non-coring power injectable needle.
The ports are available with either silicone filled suture fixation holes. If desired, the suture fixation holes can be used to anchor the port to the subcutaneous tissue. All port configurations have a radiopaque identifier (CT mark) as a power injectable port. The radiopaque catheter is marked at every centimeter and can be cut to the desired length.
The ports are packaged with procedural accessories in a kit to the end user
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
During use, the ports may be subjected to fluoroscopy, CT scout and x-ray imaging.
Anatomical Site
central venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Power injectable ports will be implanted in standard hospital/clinical/radiology suites.
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 performance evaluation of the SmartPort and SmartPort Plastic devices included testing conducting in accordance with the following FDA guidance documents and international standards:
- FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports dated October 1990.
- . EN ISO 10555-1:2013, Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements
- . EN ISO 10555-3:2013, Intravascular catheters – Sterile and single-use catheters – Part 3: Central Venous Catheters
- EN ISO 10555-6:2015, Intravascular catheters Sterile and single-use catheters Part 6: ● Subcutaneous Implanted Ports
The proposed ports successfully passed relevant testing per the above Guidance, standards, and preestablished acceptance criteria and internal product specification requirements, including:
- Multiple Power Injections
- Port Septum Testing
- Chemical / Vesicant Compatibility
- Nuclear Medicine Compatibility
- Off-Axial Connection
- Power Injection Flow Rate
- Assembly Leak Strength
- Static Burst Strength
- Port Maximum Operating Pressure, Dynamic
- Catheter Kink Resistance
- Catheter Flex Life Strength
- Catheter Freedom from Leakage
- Catheter Burst Strength
- Catheter Peak Tensile Force
- · Catheter Radiopacity
- Catheter Distance Marking
- Catheter Print Integrity
- Catheter Tip Dimensions
- Aspiration Strength Open Ended
- Aspiration Strength Closed Ended
- Tunneler to Catheter Compatibility
- · 17G Blunt Needle to Catheter Compatibility
- · Guidewire to Catheter Compatibility
- · Introducer to Catheter Compatibility
- Gravity Flow Rate
- Distribution Simulation
- Surface Finish
- Hyperbaric Chamber Environment
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Puncture Life and Septum Coring tests were done to demonstrate puncture life. The ports may be subjected up to 1,500 sticks with a 22G needle or 1000 sticks with a 19G or 20G needle.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 22, 2020
AngioDynamics, Inc. Vidyalakshmi Jayaraman Specialist, Global Regulatory Affairs 26 Forest Street Marlborough, Massachusetts 01752
Re: K190559
Trade/Device Name: SmartPort+ and SmartPort Plastic Implantable Ports Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: Class II Product Code: LJT Dated: March 20, 2020 Received: March 23, 2020
Dear Vidyalakshmi Jayaraman:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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,
Sapana Patel -S
for Tina Kiang, Ph.D. 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) K190559
Device Name
SmartPort+ and SmartPort Plastic Implantable Ports
Indications for Use (Describe)
The ports are indicated for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, as well as the administration and adequate removal of nuclear medicine.
When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s with 19G or 20G non-coring power injectable needles or 2 mL/s with a 22G non-coring power injectable needle.
| Needle Size (G),
non-coring power injectable | Catheter Size (F) | Maximum Recommended
Flow Rate Setting (mL/s) | Maximum Recommended
Pressure Setting (psi) |
|-------------------------------------------------|-------------------|-------------------------------------------------|-----------------------------------------------|
| 19/20 | 5,6 and 8 | 5 | 300 |
| 22 | 5,6 and 8 | 2 | 300 |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary - K190559
Date Prepared: May 22, 2020
A.SPONSOR
AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752
B.CONTACT
Vidyalakshmi Jayaraman Specialist, Global Regulatory Affairs T: 1-508-658-7925 F: 1-508-658-7976 E: vjayaraman@angiodynamics.com
OR
Robin Fuller Senior Manager, Global Regulatory Affairs T: 1-508-658-7986 F: 1-508-658-7976 E:rfuller@angiodynamics.com
C. DEVICE NAME
| Trade Name: | SmartPort+ and SmartPort Plastic Implantable Ports |
|---|---|
| Common/Usual Name: | Implanted Port Catheter, Subcutaneous |
| Classification Name: | Implanted, Intravascular Infusion Port and Catheter |
| Classification Panel: | General Hospital |
| Product code: | LJT |
| Regulation number: | 880.5965 |
D. PREDICATE DEVICE(S)
- 510(k) Number Trade Name:
Common/Usual Name: Classification Name: Classification Panel: Product code: Regulation number:
AngioDynamics Inc. Smart Port CT Series Port Access Systems Implanted Port Catheter, Subcutaneous Implanted, Intravascular Infusion Port and Catheter General Hospital LJT 880.5965
4
| 2. 510(k) Number | K131694 |
|---|---|
| Trade Name: | NMI Port II |
| Common/Usual Name: | Implanted Port Catheter, Subcutaneous |
| Classification Name: | Implanted, Intravascular Infusion Port and Catheter |
| Classification Panel: | General Hospital |
| Product code: | LJT |
| Regulation number: | 880.5965 |
E. DEVICE DESCRIPTION
The SmartPort* device with ENDEXO and Vortex Technology and the SmartPort Plastic device with Vortex Technology are implantable venous access devices designed for repeated access to the vascular system. The SmartPort* and SmartPort Plastic devices are subcutaneous implant devices with one reservoir. The ports are accessed using a Huber needle which is passed through the self-sealing silicone septum covering the reservoir. When used with power injectable needles, the port can be used for power injection of contrast media and contrast enhanced computed tomography (CECT).
Available in plastic and titanium port bodies, the SmartPort* device has standard, low profile, and mini Titanium port configurations and low-profile Plastic port configurations. The ports are offered with a 5F, 6F or 8F single lumen BioFlo catheter. The BioFlo catheter with ENDEXO technology is present in the previously cleared NMI Port II (K131694) for improved resistance to thrombus accumulation and/or formation on the catheter. The outlet of the vortex port chamber is set at a tangent rather than perpendicularly.
The SmartPort Plastic device is offered in a low-profile Plastic port body configuration with a 6F or 8F single lumen polyurethane catheter. Both the BioFlo and polyurethane catheters are radiopague.
When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate setting is 5 ml/s with 19G or 20G non-coring power injectable needles or 2 ml/s with a 22G non-coring power injectable needle.
The ports are available with either silicone filled suture fixation holes. If desired, the suture fixation holes can be used to anchor the port to the subcutaneous tissue. All port configurations have a radiopaque identifier (CT mark) as a power injectable port. The radiopaque catheter is marked at every centimeter and can be cut to the desired length.
The ports are packaged with procedural accessories in a kit to the end user
5
F.INTENDED USE/INDICATIONS FOR USE
The ports are indicated for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, as well as the administration and adequate removal of nuclear medicine.
When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with 19G or 20G non-coring power injectable needles or 2 mL/s with a 22G non-coring power injectable needle.
| Needle Size (G),
non-coring power
injectable | Catheter Size (F) | Maximum
Recommended
Flow Rate Setting (mL/s) | Maximum
Recommended
Pressure Setting (psi) |
|----------------------------------------------------|-------------------|----------------------------------------------------|--------------------------------------------------|
| 19/20 | 5,6, and 8 | 5 | 300 |
| 22 | 5,6, and 8 | 2 | 300 |
G.SUMMARY OF SIMILARITIES AND DIFFERENCES IN TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE
The proposed devices have similar materials, design and components as the predicate devices. Both the proposed devices and predicate ports are, in brief, intended for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products; available in single lumen configurations and plastic or titanium port bodies; rated for maximum power injector settings up to 300 psi with maximum power injection flow rate up to 5 ml/second based on model; and available kitted with a variety of procedural accessories.
The table below described key similarities and differences between predicate and proposed ports.
6
| Device Characteristic | SmartPort+ and SmartPort Plastic ports
510(k) number K190559 | | | | Predicate
Smart Port CT Series
Port Access Systems
510(k) number K101017 | Predicate
NMI Port II
510(k) number
K131694 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | SmartPort+ and SmartPort Plastic ports are indicated
for patients who require long-term access to the
central venous system for blood specimen withdrawal
and administration of fluids including but not limited to
hydration fluids, chemotherapy, analgesics, nutritional
therapy and blood products, as well as the
administration and adequate removal of nuclear
medicine.
When used with power injectable needles, the ports are
indicated for power injection of contrast media. For
power injection of contrast media, the maximum
recommended infusion rate is 5 mL/s with 19G or 20G
non-coring power injectable needles or 2 mL/s with a
22G non-coring power injectable needle. | Needle
Size (G),
non-
coring
power
injectable
19/20
22 | Catheter
Size (F)
5,6, and
8
5,6, and
8 | Maximum
Recommended
Flow Rate
Setting (mL/s)
5
2 | The Smart Port CT Port
Access System is
indicated for any
patient requiring
repeated access of the
vasculature system, for
delivery of medications,
nutritional
supplementation, fluids,
blood, blood products,
and sampling of blood.
When used with non-Y-
site LifeGuard Safety
infusion sets in 20 Ga or
19 Ga sizes, the Smart
Port CT Access System
is indicated for power
injection of contrast
media. For power
injection of contrast
media, at a maximum of
300 psi, the maximum
recommended infusion
rate is 5 mL/s. | NMI Port II is indicated
for patients who
require long-term
access to the central
venous system for
administration of fluids
including but not
limited to hydration
fluids, chemotherapy,
analgesics, nutritional
therapy and blood
products. The device is
also indicated for blood
specimen withdrawal.
When used with a
power injectable
needle, the port is
indicated for power
injection of contrast
media. The maximum
recommended infusion
rate at a maximum of
300 psi, is 5 mL/s with
a 19G or 20G non-
coring power injectable
needle or 2 mL/s with a
22G non-coring power
injectable needle. |
| Intended use | Power injectable ports will be implanted in standard
hospital/clinical/radiology suites. During use, the ports
are implanted, and will reside in a subcutaneous
environment and the catheter will reside in the patient's
venous system.
Ports are intended to interact with Huber needles,
infusion sets, introducers, guidewires, dilators, and
sheaths during implantation. During use, the ports may
be subjected to fluoroscopy, CT scout and x-ray imaging.
The ports are designed to be used with power injection
equipment.
During the implant life, the ports may be subjected up
to 1,500 sticks with a 22G needle or 1000 sticks with a
19G or 20G needle.
Puncture Life and Septum Coring tests were done to
demonstrate puncture life. | | | | Same as proposed ports
with the exception of
puncture limits. The
Standard port may be
subjected up to 1,000
sticks with a 20G or 22G
needle or 500 sticks
with a 19G needle. The
Mini and Low-Profile
ports may be subjected
up to 300 sticks with a
19G/20G/22G needle. | Same as proposed
ports with the
exception of puncture
limits. The ports may
be subjected up to
1,334 sticks with a 22G
needle or 667 sticks
with a 19G or 20G
needle. |
7
| Device Characteristic | SmartPort+ and SmartPort Plastic ports
510(k) number K190559 | Predicate
Smart Port CT Series
Port Access Systems
510(k) number K101017 | Predicate
NMI Port II
510(k) number
K131694 |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Catheter Shaft
Material | SmartPort+: Radiopaque Carbothane 85A with 30%
Barium Sulfate, 2% Endexo and 0.2% teal colorant
SmartPort Plastic: Carbothane 85A 30% Barium Sulfate | Carbothane PC-3585A-
B40 and Silicone | Radiopaque
Carbothane 85A with
30% Barium Sulfate,
2% Endexo and 0.2%
teal colorant |
| Catheter Priming
Volume (ml/10 cm
length) | 8F - 0.21
6F - 0.13
5F - 0.11 | 6.6F - 0.16
7.5F - 0.15
8F - 0.18
9.6 F - 0.19 | 8 F - 0.21
6 F - 0.14 |
| Catheter Shaft
Number of Lumens | Single Lumen (SL) | Single Lumen (SL) | Single Lumen (SL) |
| Catheter Lumen Size
ID (mm) | 8F - 1.57
6F - 1.27
5F - 1.07 | 6.6F - 1.42
7.5F - 1.37
8F - 1.52
9.6 F - 1.57 | 8 F - 1.57
6 F - 1.27 |
| Catheter French Size | SmartPort+: 8F, 6F, 5F
SmartPort Plastic: 8F, 6F | 6.6F, 7.5F, 8F, 9.6F | 8F, 6F |
| Catheter Length
(cm) | 63 | 55, 66 | 63 |
| Port Body Material | SmartPort+: Titanium, Plastic
SmartPort Plastic: Plastic | Titanium | Titanium, Plastic |
| Maximum Port Base
Diameter (mm) | 28.6 | 28.6 | 25.4 |
| Port Height (mm) | Standard Titanium - 13.0
Low Profile Titanium - 11.5
Mini Titanium - 10.8
Low Profile Plastic - 12.1 | Standard Titanium - 13.0
Low Profile Titanium -
11.5
Mini Titanium - 10.8 | Titanium - 11.0
Plastic - 13.3 |
| Port Weight (g) | Standard Titanium ≤ 13
Low Profile Titanium ≤ 10
Mini Titanium ≤ 8
Low Profile Plastic ≤ 5 | Standard Titanium ≤ 13
Low Profile Titanium ≤
10
Mini Titanium ≤ 8 | Titanium - 12
Plastic - 6 |
| Port Septum
Diameter (mm) | Standard Titanium - 11.9
Low Profile Titanium - 10.2
Mini Titanium - 10.2
Low Profile Plastic - 12.7 | Standard Titanium -
11.9
Low Profile Titanium -
10.2
Mini Titanium - 10.2 | 13 |
| Device Characteristic | SmartPort* and SmartPort Plastic ports
510(k) number K190559 | Predicate
Smart Port CT Series
Port Access Systems
510(k) number K101017 | Predicate
NMI Port II
510(k) number
K131694 |
| Port Internal Volume
(mL) | Less than 1 mL | Less than 1 mL | Less than 1 mL |
| Port Septum
Material | Mini /Low Profile Titanium - NUSIL SILICONE MED-4750
Standard Titanium - NUSIL SILICONE MED-4840
Low Profile Plastic - NUSIL SILICONE MED-4850 | NUSIL SILICONE MED-
4750 | Silopren LSR 4050
Silicone |
| Maximum pressure
of power injectors'
setting | 300 psi | 300 psi | 300 psi |
| Maximum power
injection flowrate | 5F,6F,8F catheter with 19/20 G needle = 5 mL/sec
5F,6F,8F catheter with 22 G needle = 2 mL/sec | All French sizes with
19/20 G needle = 5
mL/sec | 6F,8F catheter with
19/20 G needle = 5
mL/sec
6F,8F catheter with 22
G needle = 2 mL/sec |
| Attachment Feature
(catheter to port) | Plastic and Titanium collars | Titanium collar
Silicone collar (blue
boot) | Snap Lock connector |
| PASV Valve
Technology | No | No | Yes (valved versions
offered) |
| Incremental
markings | Every 1 cm | Every 1 cm | Every 1 cm |
| MR Conditional | Yes | Yes | Yes |
8
The substantial equivalence discussion table below compares key features of the predicate and subject devices.
| Feature | Summary of comparison |
|---|---|
| Are the predicate devices | |
| legally marketed? | Yes, the predicates Smart Port CT Series Port Access System and the |
| predicate, NMI Port II, have been cleared by the FDA 510(k) pathway. | |
| Their 510(k) numbers are K101017 and K131694 respectively. | |
| Do the proposed devices have | |
| the same intended use as the | |
| predicates? | Yes, the proposed and predicate devices are subcutaneous implanted |
| intravascular infusion ports that allow for repeated access to the | |
| vascular system for the infusion of fluids and medications and the | |
| sampling of blood per 21 CFR 880.5965. The proposed devices have | |
| the same intended use as their predicates. They are indicated for | |
| patients who require long-term access to the central venous system | |
| for blood specimen withdrawal and administration of fluids including | |
| but not limited to hydration fluids, chemotherapy, analgesics, | |
| nutritional therapy and blood products. When used with power |
9
| | injectable needles, the 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 19G or 20G non-coring
power injectable needles or 2 mL/s with a 22G non-coring power
injectable needle.
The additional indications for use for the proposed ports are that
they can be used to administer nuclear medicine. Necessary testing
to support this additional indication was completed - all port
assemblies tested passed tensile and burst requirements following
exposure and flushing of F-flurodeoxyglucose(FDG) and F-Sodium
Fluoride (NaF) contrast solutions. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Do the proposed devices have
the same technological
characteristics as their
predicates? | No, though the proposed devices have similar technological features
as the predicate devices there are slight differences.
- Port design and material: The proposed ports have the same
port reservoir design as the predicate Smart Port CT series
(VORTEX technology, K101017). The predicate Smart Port CT
series K101017 port body is available only in titanium. The
predicate NMI Port II K131694 port bodies are available in
titanium and plastic. The proposed SmartPort+ port bodies
will be available in Titanium and Plastic, with standard, low
profile and mini configurations for Titanium ports and only
low profile for Plastic ports. The proposed SmartPort Plastic
will be available in a low-profile Plastic port body. |
| | 2. Catheter size: The predicate Smart Port CT series has 6.6F.
7.5F, 8F and 9.6F catheter sizes. The predicate NMI Port II
has 6F and 8F catheter sizes. The proposed SmartPort+ ports
will have 8F, 6F and 5F catheter sizes. The addition of a 5F
size catheter is due to clinical feedback for the need for a
catheter this size. The proposed SmartPort Plastic will have
8F and 6F catheter sizes. |
| | 3. Catheter material: The proposed SmartPort+ port will have a
BioFlo catheter made of Carbothane containing barium
sulfate and ENDEXO. The predicate NMI Port II also includes
the BioFlo catheter with Endexo. The proposed SmartPort
Plastic port will have a Carbothane catheter. The predicate
Smart Port CT series also contains a Carbothane catheter. - Port septum material: Both proposed ports and the predicates
have port septum made of silicone. The types of
silicone used in proposed ports are different from that in the
predicate devices. Predicate Smart Port CT series has NUSIL
SILICONE MED-4750 and predicate NMI Port II has Silopren
LSR 4050 Silicone. In the proposed ports, the Mini and Low-
Profile Titanium ports have NUSIL SILICONE MED-4750, the
Standard Titanium ports have NUSIL SILICONE MED-4840 and
the Low-Profile plastic ports have NUSIL SILICONE MED-4850. - MR Conditional: Both proposed ports and the predicates are
MR conditional. - Pressure for power injector setting: Both proposed ports and
the predicates are recommended to be used at a maximum
of 300 psi for power injection. - Internal port volume: Both proposed ports and predicates
have an internal port volume of less than 1 mL. |
| Do the different technological
characteristics of the devices
raise different questions of
safety and effectiveness? | No, the proposed devices and the predicate devices use similar
technology for access to the central venous system. All port
catheters address questions of biocompatibility and functional
performance characteristics. The new characteristics of the
proposed devices compared to the predicate devices do not raise
new types of safety or effectiveness questions. |
| Are the proposed scientific
methods to evaluate the effect
of new/different
characteristics in proposed
devices on their safety &
effectiveness acceptable? | Yes, the performance evaluation of the proposed ports included
testing based on FDA Guidance documents and Recognized
Standards. This included the FDA Guidance on Premarket
Notifications for Implanted Infusion Ports, October 1990. Please refer
to section Non-Clinical Performance Testing in this summary for
performance standards. |
| Does the evaluated
performance data
demonstrate substantial
equivalence? | Yes, the data summarized in the 510(k) demonstrate the substantial equivalence of the proposed ports to their predicate devices. |
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The following table lists the kit accessories included in the predicate and proposed port kits. The proposed ports are packaged with procedural accessories that are either legally marked pre-amendment devices or have been found to be substantially equivalent through the pre-market notification process. The accessories are identical to the accessories provided with the predicate devices.
| Predicate Smart Port CT | Predicate NMI Port II | Proposed SmartPort+ and Plastic ports |
|---|---|---|
| 18 G Introducer Needle | 18 G Introducer Needle | 18 G Introducer Needle |
| 22 G Non-coring Needle | 0.038 in Guidewire (J-tipped) | 0.038 in Guidewire (J-tipped) |
| PTFE Introducer, 7 Fr x 14 cm | Peelable Sheath Introducer | |
| (Valved or Non-Valved) | Peelable Sheath Introducer | |
| (Valved or Non-Valved) | ||
| Guidewire, 0.035 in x 50 cm | 17 G Blunt Needle | 17 G Blunt Needle |
| LifeGuard Safety Infusion | ||
| Set, 20 G x 1 in | 12 mL Syringe (slip lock) | 12 mL Syringe (slip lock) |
| Tunneler | 22 G Huber Needle (straight) | 22 G Huber Needle (straight) |
| Two 10 cc Syringes | 22 G Huber Needle (90 degrees) | 22 G Huber Needle (90 degrees) |
| Blunt Needle | Tunneler | Malleable Tunneler (metal) |
| Vein Pick | Vein Pick | |
| 12 mL Syringe (luer lock) | 12 mL Syringe (luer lock) |
Non-Clinical Performance Testing
H. Performance Data
The performance evaluation of the SmartPort and SmartPort Plastic devices included testing conducting in accordance with the following FDA guidance documents and international standards:
- FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports dated October 1990.
- . EN ISO 10555-1:2013, Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements
- . EN ISO 10555-3:2013, Intravascular catheters – Sterile and single-use catheters – Part 3: Central Venous Catheters
- EN ISO 10555-6:2015, Intravascular catheters Sterile and single-use catheters Part 6: ● Subcutaneous Implanted Ports
The proposed ports successfully passed relevant testing per the above Guidance, standards, and preestablished acceptance criteria and internal product specification requirements, including:
- Multiple Power Injections
- Port Septum Testing
- Chemical / Vesicant Compatibility
- Nuclear Medicine Compatibility
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- Off-Axial Connection
- Power Injection Flow Rate
- Assembly Leak Strength
- Static Burst Strength
- Port Maximum Operating Pressure, Dynamic
- Catheter Kink Resistance
- Catheter Flex Life Strength
- Catheter Freedom from Leakage
- Catheter Burst Strength
- Catheter Peak Tensile Force
- · Catheter Radiopacity
- Catheter Distance Marking
- Catheter Print Integrity
- Catheter Tip Dimensions
- Aspiration Strength Open Ended
- Aspiration Strength Closed Ended
- Tunneler to Catheter Compatibility
- · 17G Blunt Needle to Catheter Compatibility
- · Guidewire to Catheter Compatibility
- · Introducer to Catheter Compatibility
- Gravity Flow Rate
- Distribution Simulation
- Surface Finish
- Hyperbaric Chamber Environment
I.Biocompatibility
Biocompatibility testing for the proposed SmartPort+ and SmartPort Plastic ports was performed in accordance with the FDA Guidance document "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
The following tests were performed on ports which were Ethylene Oxide (EtO) sterilized,
- Cytotoxicity
- · Sensitization
- Intracutaneous Irritation
- · Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- · Subacute Toxicity
- · Subchronic Toxicity
- Genotoxicity (Ames Assay, In Vitro Mouse Lymphoma, In Vivo Mouse Micronucleus)
- Implantation (Intramuscular)
- · Implantation (Subcutaneous)
- Hemocompatibility (Hemolysis Direct Contact and Extract method, Partial Thromboplastic Time, In-Vitro Hemocompatibility, Complement Activation)
- Carcinogenicity this was completed with a combination of an assessment of the raw materials and manufacturing process to determine the risk of introduction of carcinogenic and genotoxic materials.
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J.Sterilization
The sterilization validation process conforms to the following standard: AAMI/ANSI/ISO 11135:2014 Sterilization of health care products- Ethylene oxide-Requirements for development, validation and routine control of a sterilization process for medical devices. The sterility assurance level (SAL) for the proposed device is 1 X 10-6.
K.Conclusion
Based on intended use, technology/principle of operation, materials, and performance testing, the subject proposed devices are substantially equivalent when compared to the predicates. The test data supports that subject proposed devices is substantially equivalent to the legally marketed predicate devices.