(444 days)
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.
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
The provided text does not contain information about the acceptance criteria and study proving device meets acceptance criteria for an AI/ML powered device. Instead, it is a 510(k) premarket notification for implantable infusion ports (SmartPort+ and SmartPort Plastic Implantable Ports), which are physical medical devices, not AI/ML software. Therefore, the requested information regarding acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance studies cannot be extracted from this document.
The document details non-clinical performance testing for the physical device, 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
It also includes a biocompatibility assessment and sterilization validation. However, these are for the physical properties and biological interaction of the implantable port, not for an AI/ML algorithm's performance.
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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
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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
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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 RecommendedFlow Rate Setting (mL/s) | Maximum RecommendedPressure 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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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
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| 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
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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 powerinjectable | Catheter Size (F) | MaximumRecommendedFlow Rate Setting (mL/s) | MaximumRecommendedPressure 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.
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| Device Characteristic | SmartPort+ and SmartPort Plastic ports510(k) number K190559 | PredicateSmart Port CT SeriesPort Access Systems510(k) number K101017 | PredicateNMI Port II510(k) numberK131694 | |||
|---|---|---|---|---|---|---|
| Indication for use | SmartPort+ and SmartPort Plastic ports are indicatedfor patients who require long-term access to thecentral venous system for blood specimen withdrawaland administration of fluids including but not limited tohydration fluids, chemotherapy, analgesics, nutritionaltherapy and blood products, as well as theadministration and adequate removal of nuclearmedicine.When used with power injectable needles, the ports areindicated for power injection of contrast media. Forpower injection of contrast media, the maximumrecommended infusion rate is 5 mL/s with 19G or 20Gnon-coring power injectable needles or 2 mL/s with a22G non-coring power injectable needle. | NeedleSize (G),non-coringpowerinjectable19/2022 | CatheterSize (F)5,6, and85,6, and8 | MaximumRecommendedFlow RateSetting (mL/s)52 | The Smart Port CT PortAccess System isindicated for anypatient requiringrepeated access of thevasculature system, fordelivery of medications,nutritionalsupplementation, fluids,blood, blood products,and sampling of blood.When used with non-Y-site LifeGuard Safetyinfusion sets in 20 Ga or19 Ga sizes, the SmartPort CT Access Systemis indicated for powerinjection of contrastmedia. For powerinjection of contrastmedia, at a maximum of300 psi, the maximumrecommended infusionrate is 5 mL/s. | NMI Port II is indicatedfor patients whorequire long-termaccess to the centralvenous system foradministration of fluidsincluding but notlimited to hydrationfluids, chemotherapy,analgesics, nutritionaltherapy and bloodproducts. The device isalso indicated for bloodspecimen withdrawal.When used with apower injectableneedle, the port isindicated for powerinjection of contrastmedia. The maximumrecommended infusionrate at a maximum of300 psi, is 5 mL/s witha 19G or 20G non-coring power injectableneedle or 2 mL/s with a22G non-coring powerinjectable needle. |
| Intended use | Power injectable ports will be implanted in standardhospital/clinical/radiology suites. During use, the portsare implanted, and will reside in a subcutaneousenvironment and the catheter will reside in the patient'svenous system.Ports are intended to interact with Huber needles,infusion sets, introducers, guidewires, dilators, andsheaths during implantation. During use, the ports maybe subjected to fluoroscopy, CT scout and x-ray imaging.The ports are designed to be used with power injectionequipment.During the implant life, the ports may be subjected upto 1,500 sticks with a 22G needle or 1000 sticks with a19G or 20G needle.Puncture Life and Septum Coring tests were done todemonstrate puncture life. | Same as proposed portswith the exception ofpuncture limits. TheStandard port may besubjected up to 1,000sticks with a 20G or 22Gneedle or 500 stickswith a 19G needle. TheMini and Low-Profileports may be subjectedup to 300 sticks with a19G/20G/22G needle. | Same as proposedports with theexception of puncturelimits. The ports maybe subjected up to1,334 sticks with a 22Gneedle or 667 stickswith a 19G or 20Gneedle. |
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| Device Characteristic | SmartPort+ and SmartPort Plastic ports510(k) number K190559 | PredicateSmart Port CT SeriesPort Access Systems510(k) number K101017 | PredicateNMI Port II510(k) numberK131694 |
|---|---|---|---|
| Catheter ShaftMaterial | SmartPort+: Radiopaque Carbothane 85A with 30%Barium Sulfate, 2% Endexo and 0.2% teal colorantSmartPort Plastic: Carbothane 85A 30% Barium Sulfate | Carbothane PC-3585A-B40 and Silicone | RadiopaqueCarbothane 85A with30% Barium Sulfate,2% Endexo and 0.2%teal colorant |
| Catheter PrimingVolume (ml/10 cmlength) | 8F - 0.216F - 0.135F - 0.11 | 6.6F - 0.167.5F - 0.158F - 0.189.6 F - 0.19 | 8 F - 0.216 F - 0.14 |
| Catheter ShaftNumber of Lumens | Single Lumen (SL) | Single Lumen (SL) | Single Lumen (SL) |
| Catheter Lumen SizeID (mm) | 8F - 1.576F - 1.275F - 1.07 | 6.6F - 1.427.5F - 1.378F - 1.529.6 F - 1.57 | 8 F - 1.576 F - 1.27 |
| Catheter French Size | SmartPort+: 8F, 6F, 5FSmartPort Plastic: 8F, 6F | 6.6F, 7.5F, 8F, 9.6F | 8F, 6F |
| Catheter Length(cm) | 63 | 55, 66 | 63 |
| Port Body Material | SmartPort+: Titanium, PlasticSmartPort Plastic: Plastic | Titanium | Titanium, Plastic |
| Maximum Port BaseDiameter (mm) | 28.6 | 28.6 | 25.4 |
| Port Height (mm) | Standard Titanium - 13.0Low Profile Titanium - 11.5Mini Titanium - 10.8Low Profile Plastic - 12.1 | Standard Titanium - 13.0Low Profile Titanium -11.5Mini Titanium - 10.8 | Titanium - 11.0Plastic - 13.3 |
| Port Weight (g) | Standard Titanium ≤ 13Low Profile Titanium ≤ 10Mini Titanium ≤ 8Low Profile Plastic ≤ 5 | Standard Titanium ≤ 13Low Profile Titanium ≤10Mini Titanium ≤ 8 | Titanium - 12Plastic - 6 |
| Port SeptumDiameter (mm) | Standard Titanium - 11.9Low Profile Titanium - 10.2Mini Titanium - 10.2Low Profile Plastic - 12.7 | Standard Titanium -11.9Low Profile Titanium -10.2Mini Titanium - 10.2 | 13 |
| Device Characteristic | SmartPort* and SmartPort Plastic ports510(k) number K190559 | PredicateSmart Port CT SeriesPort Access Systems510(k) number K101017 | PredicateNMI Port II510(k) numberK131694 |
| Port Internal Volume(mL) | Less than 1 mL | Less than 1 mL | Less than 1 mL |
| Port SeptumMaterial | Mini /Low Profile Titanium - NUSIL SILICONE MED-4750Standard Titanium - NUSIL SILICONE MED-4840Low Profile Plastic - NUSIL SILICONE MED-4850 | NUSIL SILICONE MED-4750 | Silopren LSR 4050Silicone |
| Maximum pressureof power injectors'setting | 300 psi | 300 psi | 300 psi |
| Maximum powerinjection flowrate | 5F,6F,8F catheter with 19/20 G needle = 5 mL/sec5F,6F,8F catheter with 22 G needle = 2 mL/sec | All French sizes with19/20 G needle = 5mL/sec | 6F,8F catheter with19/20 G needle = 5mL/sec6F,8F catheter with 22G needle = 2 mL/sec |
| Attachment Feature(catheter to port) | Plastic and Titanium collars | Titanium collarSilicone collar (blueboot) | Snap Lock connector |
| PASV ValveTechnology | No | No | Yes (valved versionsoffered) |
| Incrementalmarkings | Every 1 cm | Every 1 cm | Every 1 cm |
| MR Conditional | Yes | Yes | Yes |
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The substantial equivalence discussion table below compares key features of the predicate and subject devices.
| Feature | Summary of comparison |
|---|---|
| Are the predicate deviceslegally marketed? | Yes, the predicates Smart Port CT Series Port Access System and thepredicate, 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 havethe same intended use as thepredicates? | Yes, the proposed and predicate devices are subcutaneous implantedintravascular infusion ports that allow for repeated access to thevascular system for the infusion of fluids and medications and thesampling of blood per 21 CFR 880.5965. The proposed devices havethe same intended use as their predicates. They are indicated forpatients who require long-term access to the central venous systemfor blood specimen withdrawal and administration of fluids includingbut not limited to hydration fluids, chemotherapy, analgesics,nutritional therapy and blood products. When used with power |
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| injectable needles, the port is indicated for power injection ofcontrast media. For power injection of contrast media, the maximumrecommended infusion rate is 5 mL/s with 19G or 20G non-coringpower injectable needles or 2 mL/s with a 22G non-coring powerinjectable needle.The additional indications for use for the proposed ports are thatthey can be used to administer nuclear medicine. Necessary testingto support this additional indication was completed - all portassemblies tested passed tensile and burst requirements followingexposure and flushing of F-flurodeoxyglucose(FDG) and F-SodiumFluoride (NaF) contrast solutions. | |
|---|---|
| Do the proposed devices havethe same technologicalcharacteristics as theirpredicates? | No, though the proposed devices have similar technological featuresas the predicate devices there are slight differences.1. Port design and material: The proposed ports have the sameport reservoir design as the predicate Smart Port CT series(VORTEX technology, K101017). The predicate Smart Port CTseries K101017 port body is available only in titanium. Thepredicate NMI Port II K131694 port bodies are available intitanium and plastic. The proposed SmartPort+ port bodieswill be available in Titanium and Plastic, with standard, lowprofile and mini configurations for Titanium ports and onlylow profile for Plastic ports. The proposed SmartPort Plasticwill 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 IIhas 6F and 8F catheter sizes. The proposed SmartPort+ portswill have 8F, 6F and 5F catheter sizes. The addition of a 5Fsize catheter is due to clinical feedback for the need for acatheter this size. The proposed SmartPort Plastic will have8F and 6F catheter sizes. | |
| 3. Catheter material: The proposed SmartPort+ port will have aBioFlo catheter made of Carbothane containing bariumsulfate and ENDEXO. The predicate NMI Port II also includesthe BioFlo catheter with Endexo. The proposed SmartPortPlastic port will have a Carbothane catheter. The predicateSmart Port CT series also contains a Carbothane catheter.4. Port septum material: Both proposed ports and the predicateshave port septum made of silicone. The types ofsilicone used in proposed ports are different from that in thepredicate devices. Predicate Smart Port CT series has NUSILSILICONE MED-4750 and predicate NMI Port II has SiloprenLSR 4050 Silicone. In the proposed ports, the Mini and Low-Profile Titanium ports have NUSIL SILICONE MED-4750, theStandard Titanium ports have NUSIL SILICONE MED-4840 andthe Low-Profile plastic ports have NUSIL SILICONE MED-4850.5. MR Conditional: Both proposed ports and the predicates areMR conditional.6. Pressure for power injector setting: Both proposed ports andthe predicates are recommended to be used at a maximumof 300 psi for power injection.7. Internal port volume: Both proposed ports and predicateshave an internal port volume of less than 1 mL. | |
| Do the different technologicalcharacteristics of the devicesraise different questions ofsafety and effectiveness? | No, the proposed devices and the predicate devices use similartechnology for access to the central venous system. All portcatheters address questions of biocompatibility and functionalperformance characteristics. The new characteristics of theproposed devices compared to the predicate devices do not raisenew types of safety or effectiveness questions. |
| Are the proposed scientificmethods to evaluate the effectof new/differentcharacteristics in proposeddevices on their safety &effectiveness acceptable? | Yes, the performance evaluation of the proposed ports includedtesting based on FDA Guidance documents and RecognizedStandards. This included the FDA Guidance on PremarketNotifications for Implanted Infusion Ports, October 1990. Please referto section Non-Clinical Performance Testing in this summary forperformance standards. |
| Does the evaluatedperformance datademonstrate substantialequivalence? | 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 InfusionSet, 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.
§ 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.