← Product Code [LJT](/productcode/LJT) · K260916 # FLEXI-PORT™ Power Injectable Implantable Port (K260916) _Portal Access, Inc. · LJT · Jun 17, 2026 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260916 ## Device Facts - **Applicant:** Portal Access, Inc. - **Product Code:** [LJT](/productcode/LJT.md) - **Decision Date:** Jun 17, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5965 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The FLEXI-PORT Power Injectable Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medications (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for withdrawal of blood samples. When used with a power injectable needle, the FLEXI-PORT is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s. ## Device Story Totally implantable vascular access device; provides repeated central venous access. Consists of radiopaque injection port with self-sealing silicone septum and titanium stem; single-lumen radiopaque polyurethane catheter; radiopaque PEEK catheter connection lock. Implanted in chest or upper arm; accessed percutaneously by clinician using non-coring (Huber) needle. Fluids delivered into central venous circulation; power injection of contrast media supported at 5 mL/s. Septum reseals upon needle removal. Radiopaque markers allow visualization via fluoroscopy to confirm power injectability. Benefits include reliable long-term vascular access for therapies like chemotherapy and parenteral nutrition. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing, including port system air leak, tensile strength, static burst pressure, power injection performance, septum durability, catheter collapse/kink resistance, and biocompatibility (ISO 10993-1). MR compatibility verified per ASTM F2052, F2213, F2182, and F2119. ## Technological Characteristics Subcutaneous port with self-sealing silicone septum, titanium stem, and PEEK body. Single-lumen radiopaque polyurethane catheter. Locking collar mechanism (PEEK). Sterilized via EtO (SAL 10^-6). MR Conditional. Dimensions: 31mm x 21.7mm x 10.5mm port; 5Fr or 6Fr catheter. Complies with ISO 10555-1 and ISO 10555-6. ## Regulatory 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. ## Special Controls *Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990. ## Predicate Devices - PowerPort™ ClearVUE™ Slim Implantable Port ([K242328](/device/K242328.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **FDA** **U.S. FOOD & DRUG** ADMINISTRATION June 17, 2026 Portal Access, Inc. Hila Ravid VP QA&RA 4201 Collins Ave. Apt. 601 Miami Beach, Florida 33140 Re: K260916 Trade/Device Name: FLEXI-PORT™ Power Injectable Implantable Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, implanted, intravascular infusion port and catheter Regulatory Class: Class II Product Code: LJT Dated: March 19, 2026 Received: March 19, 2026 Dear Hila Ravid: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled 'Deciding When to Submit a 510(k) for a Change to an Existing Device' U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 www.fda.gov {1} K260916 - Hila Ravid Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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). {2} K260916 - Hila Ravid Page 3 Sincerely, DAVID WOLLOSCHECK - S David Wolloscheck, Ph.D. 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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. # Indications for Use 510(k) Number (if known) K260916 Device Name FLEXI-PORT™ Power Injectable Implantable Port Indications for Use (Describe) The FLEXI-PORT Power Injectable Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medications (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for withdrawal of blood samples. When used with a power injectable needle, the FLEXI-PORT is indicated for power injection of contrast media. For power injection of contrast media, the maximum 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." FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} Portal Access Inc. FLEXI-PORT™ 510(k) Submission # **510K SUMMARY** # **Traditional Premarket Notification Submission – 510(k) Portal Access Inc - FLEXI-PORT™ Power Injectable Implantable Port** **510(k) Number K260916** **Date Prepared:** June 17, 2026 # **1. Submitter** Portal Access Inc. 4201 Collins Ave., Apt. 601, Miami Beach, FL 33140, USA Tel: +1.305.900.7352 E-mail: hila@portal-cath.com # **2. Contact Person** Hila Ravid VP Quality Assurance & Regulatory Affairs Tel: +972.50.697.5566 E-mail: hila@portal-cath.com # **3. Device** Trade Name: FLEXI-PORT™ Power Injectable Implantable Port Common or Usual Name: Subcutaneous Implanted Intravascular Port & Catheter Classification Name: 21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Classification Panel: General Hospital Product Code: LJT # **4. Predicate Device** 510(k) Number: K242328 Trade Name: Bard Access Systems, Inc., PowerPort™ ClearVUE™ Slim Implantable Port Common or Usual Name: Subcutaneous Implanted Intravascular Port & Catheter Classification Name: 21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Classification Panel: General Hospital Product Code: LJT # **5. Device Description** The FLEXI-PORT is a totally implantable vascular access device designed to provide repeated access to a patient’s vascular system. The FLEXI-PORT device consists of two primary components: 510K Summary Page 1 of 7 {5} Portal Access Inc. FLEXI-PORT™ 510(k) Submission (i) a radiopaque injection port with a self-sealing silicone septum and titanium stem (Port); (ii) a radiopaque single-lumen catheter (Catheter). The port-catheter connection is secured by a radiopaque catheter connection lock (Cathlock). The ports are available with either a 5 Fr or 6 Fr single-lumen catheter. The catheter may be pre-attached by the manufacturer or attached to the port by the practitioner during the implantation procedure. The FLEXI-PORT is supplied as a sterile, single-use, non-pyrogenic kit containing the implantable port, catheter, and associated procedural accessories required to facilitate implantation. The kit is sterilized using a validated ethylene oxide (EtO) process to achieve a sterility assurance level (SAL) of 10⁻⁶. The port reservoir is accessed percutaneously using a non-coring (Huber) needle inserted through the self-sealing septum. Fluids, including medications, intravenous solutions, blood products, parenteral nutrition and contrast media, are delivered through the port and catheter into the central venous circulation. Power injection of contrast media is performed using a power injectable needle, and the device can be identified as power injectable under radiographic imaging by its radiopaque marker. Upon needle removal, the septum reseals, maintaining a closed, sterile fluid pathway. ## 6. Indications For Use The FLEXI-PORT Power Injectable Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medications (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for withdrawal of blood samples. When used with a power injectable needle, the FLEXI-PORT is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s. ## 7. Comparison Of Technological Characteristics with the Predicate Device A substantial equivalence table, which summarizes the similarities and differences between the FLEXI-PORT, and the predicate device, is provided below. | Specification | Subject Device FLEXI-PORT™ Power Injectable Implantable Port | Predicate Device PowerPort™ ClearVUE™ Slim Implantable Port | SE Justification | | --- | --- | --- | --- | | **Device Identification** | | | | | **510K Number** | K260916 | K242328 | N/A | | **Manufacturer** | Portal Access Inc. | Bard Access Systems Inc. | N/A | | **Device Classification Name** | Port & Catheter, Implanted, Subcutaneous, Intravascular | Port & Catheter, Implanted, Subcutaneous, Intravascular | Same | | **Regulation Number** | 21 CFR §880.5965 | 21 CFR §880.5965 | Same | | **Product Code** | LJT | LJT | Same | | **Classification** | Class II | Class II | Same | 510K Summary Page 2 of 7 {6} Portal Access Inc. FLEXI-PORT™ 510(k) Submission | Specification | Subject Device FLEXI-PORT™ Power Injectable Implantable Port | Predicate Device PowerPort™ ClearVUE™ Slim Implantable Port | SE Justification | | --- | --- | --- | --- | | **Device Use** | | | | | **Intended Use** | The FLEXI-PORT™ Power Injectable Implantable Port is a totally implantable vascular access device designed to provide long-term, repeated access to the vascular system | The PowerPort™ Implantable Port is a totally implantable vascular access device designed to provide long-term, repeated access to the vascular system | Same | | **Indications for Use** | The FLEXI-PORT™ Power Injectable Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medications (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for withdrawal of blood samples. When used with a power injectable needle, the FLEXI-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 PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ Implantable Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s. | SE – Similar indications for use. Difference in accessory labeling for power injection (power injectable needle vs. specific branded infusion set). This difference does not alter the intended use or clinical function and does not raise new questions of safety or effectiveness. | | **Patient Population** | Patients requiring repeated access to the vascular system | Patients requiring repeated access to the vascular system | Same | | **Duration of Use** | Long term (>30 days) | Long term (>30 days) | Same | | **Principles of Operation** | The device operates as a totally implantable vascular access port consisting of a subcutaneous port with a self-sealing silicone septum connected to an intravascular catheter. The port is accessed percutaneously using a non-coring needle, allowing fluids to be delivered into the vascular system through the catheter. | The device operates as a totally implantable vascular access port consisting of a subcutaneous port with a self-sealing silicone septum connected to an intravascular catheter. The port is accessed percutaneously using a non-coring needle, allowing fluids to be delivered into the vascular system through the catheter. | Same | | **Insertion Site** | Chest or Upper arm | Chest or Upper arm | Same | | **Visualization Techniques** | Fluoroscopy | Fluoroscopy | Same | 510K Summary Page 3 of 7 {7} Portal Access Inc. FLEXI-PORT™ 510(k) Submission | Specification | Subject Device FLEXI-PORT™ Power Injectable Implantable Port | Predicate Device PowerPort™ ClearVUE™ Slim Implantable Port | SE Justification | | --- | --- | --- | --- | | **Catheter Tip Termination Location** | Central venous system – lower 1/3 of superior vena cava preferred | Central venous system – lower 1/3 of superior vena cava preferred | Same | | **Design Characteristics** | | | | | **Device Dimensions** | Port: Septum length: 12.2 mm Septum width: 7.2 mm Septum surface area: 0.74 cm2 Height: 10.5 mm Width: 21.7 mm Length: 31 mm Reservoir Volume: 0.4 mL | Port: Septum diameter: 10.5 mm Septum surface area: 0.86 cm2 Height: 10.4 mm Width: 21.6 mm Length: 25.5 mm Reservoir Volume: 0.4 mL | SE – Differences in port dimensions. These differences do not affect device function. Performance testing demonstrated no new questions of safety or effectiveness. | | | Catheter: 6 Fr x 46 cm 5 Fr x 51 cm | Catheter: 8 Fr x 46.4 cm 6 Fr x 46.4 cm | SE – Different catheter dimensions. These differences do not alter intended use, principle of operation, or clinical function. Performance testing demonstrated no new questions of safety or effectiveness. | | **Device Geometry & Materials** | Port: - Rhombus Silicone overmolded hard plastic Radiopaque barium sulfate PEEK port top and base, including titanium stem and grasping tab - One-piece oval silicone septum - Radiopaque bismuth trioxide (Bi2O3)/Delrin CT symbol captured between the top and base assembly | Port: - Triangular hard plastic PEEK port cap and base, including stem - One-piece round silicone septum with 3 raised palpation bumps - 3 suture holes with or without silicone suture plugs - Radiopaque bismuth trioxide (Bi2O3)/Delrin CT symbol captured between the cap and base assembly | SE – Differences in port geometry and materials. These differences do not alter device function. Biocompatibility and performance testing demonstrated no new questions of safety or effectiveness. | | | Catheter: Radiopaque Polyurethane tube Depth marking | Catheter: Radiopaque Polyurethane tube Depth marking | Same | | | Cathlock: Radiopaque PEEK with laser marking locking collar | Cathlock: Polycarbonate with radiopaque print locking collar | SE – different materials. Same locking mechanism and function. Successful biocompatibility and performance testing demonstrated no new questions of safety or effectiveness. | | **Port Configuration** | Single lumen port | Single lumen port | Same | | **Catheter Connection** | Locking collar mechanism | Locking collar mechanism | Same | 510K Summary Page 4 of 7 {8} Portal Access Inc. FLEXI-PORT™ 510(k) Submission | Specification | Subject Device FLEXI-PORT™ Power Injectable Implantable Port | Predicate Device PowerPort™ ClearVUE™ Slim Implantable Port | SE Justification | | --- | --- | --- | --- | | **Maximum Pressure of Power Injectors' Setting** | 300 psi | 300 psi | Same | | **Maximum Power Injection Flowrate** | 19/20 G needle = 5 mL/sec 22 G needle = 2 mL/sec | 19/20 G needle = 5 mL/sec 22 G needle = 2 mL/sec | Same | | **Biocompatibility** | ISO 10993-1 | ISO 10993-1 | Same | | **MR Compatibility** | MR Conditional | MR Safe | SE – Different MR labeling classification. MR safety evaluation and labeling demonstrated no new questions of safety or effectiveness. | | **Sterilization** | Sterilized by EtO, SAL 10^{-6} | Sterilized by EtO, SAL 10^{-6} | Same | | **Shelf Life** | Shelf life for this device was established by evaluating the performance of port systems and packaging after accelerated or real time aging for 1 year | Shelf life for this device was established by evaluating the performance of port systems and packaging after accelerated or real time aging for 2 years | SE – Different labeled shelf life. Aging and performance testing demonstrated no new questions of safety or effectiveness. | | **Packaging** | This device is packaged as a convenience kit in a blister tray covered with tray insert and sealed with Tyvek lid. | Triple tray packaging; two sterile barriers in the form of nested, sealed trays | SE – Different packaging configurations. Packaging validation demonstrated maintenance of the sterile barrier and no new questions of safety or effectiveness. | ## 8. Non-Clinical Performance Testing Comprehensive non-clinical performance testing was conducted to evaluate the safety and performance of the FLEXI-PORT device and to demonstrate substantial equivalence to the predicate device. Testing was performed in accordance with applicable FDA guidance documents and recognized international standards: - FDA's Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990 - FDA's Guidance on Premarket Notification 510(K) Submission for Short-Term and Long-Term Intravascular Catheters, March 1995 - ISO 10555-6:2015 AMD 2019, Intravascular catheters – Sterile and single-use catheters – Part 6: Subcutaneous Implanted Ports - ISO 10555-1:2023, Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements ### 8.1. Performance Bench Testing The proposed FLEXI-PORT device successfully passed relevant testing per the above Guidance, standards, and pre-established acceptance criteria and internal product specification requirements, including: - Port System Air Leak - Port System Tensile - Port System Static Burst Pressure - Power injection Performance Testing 510K Summary Page 5 of 7 {9} Portal Access Inc. FLEXI-PORT™ 510(k) Submission - Septum Performance (Durability and Puncture Life) - Catheter Air Leak - Catheter Tensile - Catheter Collapse - Catheter Kink - Catheter Static Burst Pressure - Catheter Hydratability - Gravity Flow Rate - Flushing Volume - Priming Volume - Tunneler-Catheter Tensile - Simulated Use and Accessory Compatibility Testing - Radiopacity - Visual & Dimensional - Corrosion Resistance - MR Compatibility Testing (ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119); MR labeling established in accordance with ASTM F2503 All testing met predefined acceptance criteria. The results demonstrate that the subject device performs as intended and is substantially equivalent in safety and performance to the predicate device. ## 8.2. Biocompatibility Biocompatibility testing for the proposed FLEXI-PORT device was performed in accordance with the FDA Guidance document “Use of International Standard ISO 10993-1:2018, 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 - Irritation - Acute Systemic Toxicity - Material Mediated Pyrogenicity - Muscle Implantation - Subacute Toxicity - Subchronic Toxicity - Chronic Toxicity - Genotoxicity (Bacterial Reverse Mutation Study, Mouse Lymphoma Assay) - Hemocompatibility (Hemolysis - Extract and Direct Contact Method, Complement Activation, Partial Thromboplastic Time, Heparinized Blood Platelet and Leukocyte Count Assay) - Particulate Analysis - Light Obscuration Method In addition, Biological Risk Assessment was performed. The overall biological safety profile supports that the FLEXI-PORT device is biocompatible for its intended use. ## 8.3. Sterilization, Packaging and Shelf Life Testing The sterilization validation process conforms to 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 1x10⁻⁶. In addition, shelf life 510K Summary Page 6 of 7 {10} Portal Access Inc. FLEXI-PORT™ 510(k) Submission and packaging testing were performed to support the labeled shelf life. All tests, including packaging integrity and device performance, were performed after environmental conditioning and distribution simulation. Based on the completed sterilization validation, packaging qualification, and shelf-life testing, the FLEXI-PORT device has been demonstrated to maintain sterility, packaging integrity, and functional performance throughout the labeled shelf life. ## **9. Conclusion** Based on the intended use, technological characteristics, and performance data, the FLEXI-PORT Power Injectable Implantable Port is substantially equivalent to the identified predicate device. 510K Summary Page 7 of 7 --- **Source:** [https://fda.innolitics.com/device/K260916](https://fda.innolitics.com/device/K260916) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com