The i-port Advance™ injection port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple drug injections without the discomfort of additional needle sticks. The i-port Advance™ may be used on a wide range of patients, including adults and children. Model numbers for the device include 020110, 020210, 020102 and 020202.

Device Description

The i-port Advance™ injection port was designed and developed through a technological collaboration between Unomedical A/S and Patton Medical Devices and modifies the Patton Medical Device i-port@ injection port (K052389) to include the automated insertion component ("Inserter") of the Unomedical Inset™ Infusion Sct (K032854).

The Injection Port component is a prescription only, sterile, single use, non-pyrogenic, external, disposable injection port with an indwelling catheter through which physician-prescribed medications can be injected subcutaneously from a standard syringe and needle, pen or alternative manual injection device. The indwelling catheter is installed using the integrated Inserter, a manually-operated springloaded catheter insertion tool that introduces the indwelling catheter into the subcutaneous tissue by automatically inserting the prefixed introducer needle to a predetermined depth below the skin surface.

Once applied, the insertion needle is removed, and only the soft cannula remains under the skin, acting as a gateway to the subcutaneous tissue. The user injects medicines directly through the resealable septum at the top of the device. The needle of the syringe or insulin pen remains above the surface of the skin, while the medication is delivered through the soft cannula and into the subcutaneous tissue. The device, which may be worn for up to 72 hours and receive up to 75 injections, is designed to reduce the hardships of multiple daily subcutaneous injections.

AI/ML Overview

The Unomedical A/S i-port Advance™ injection port is indicated for patients requiring multiple daily subcutaneous injections of physician-prescribed medications, including insulin. The device can remain in place for up to 72 hours, accommodating multiple injections without additional needle sticks. This device is suitable for both adults and children.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria with specific numerical thresholds for each test, but rather confirms that the device "meets all applicable design and performance requirements." The performance tests conducted are standard for this type of medical device and are designed to ensure safety and effectiveness.

Criteria (Type of Test)	Reported Device Performance
Flow Testing (before & after maximum punctures)	Confirmed to meet internal Unomedical protocols. (Ensures proper medication delivery)
Leak Testing (before & after maximum punctures)	Confirmed to meet internal Unomedical protocols. (Ensures no leakage of medication or bodily fluids)
Catheter Tension Testing (per ISO 10555)	Confirmed to meet standard requirements. (Evaluates the catheter's ability to withstand tensile forces)
Introducer Needle Pull Testing (per ISO 10555 & ISO 11070)	Confirmed to meet standard requirements. (Assesses the securement and removal forces of the introducer needle)
Adhesive Weld Strength Test (internal protocol)	Confirmed to meet internal Unomedical protocols. (Ensures the integrity of adhesive bonds)
Injection Port Disconnection Strength Testing (internal protocol)	Confirmed to meet internal Unomedical protocols. (Ensures the injection port remains securely connected)
Spring Loading Force Testing (internal protocol)	Confirmed to meet internal Unomedical protocols. (Ensures the automated inserter functions correctly)
Insertion Depth Testing (internal protocol)	Confirmed to meet internal Unomedical protocols. (Verifies consistent and appropriate insertion depth of the cannula)
Biocompatibility (AAMI/ANSI/ISO 10993-1:2009)	Materials are biocompatible and safe; drug/patient contact materials are the same as cleared predicate devices. (Ensures materials do not cause adverse biological reactions)
Sterilization (AAMI/ANSI/ISO 11135-1:2007)	Sterilized with Ethylene Oxide (EtO) to a Sterility Assurance Level (SAL) of 10⁻⁶; EtO residuals comply with AAMI/ANSI/ISO 10993-7:2008. (Ensures product sterility and safety from residual chemicals)
Pyrogenicity (LAL Testing)	Fluid path confirmed to be Pyrogen-free. (Ensures absence of fever-inducing substances)
Packaging Integrity	Tested to applicable standards to ensure integrity and durability. (Ensures product remains sterile and intact until use)
Risk Management (ISO 14971:2007)	Risk Management Plan established; risks identified, evaluated, and mitigated using FMECA and FTA. Overall risks determined to be within "As Low as Reasonably Practicable" (ALARP) and "Broadly Acceptable" regions. (Ensures potential risks are identified, assessed, and controlled)

2. Sample Size for the Test Set and Data Provenance

The document provided does not specify the sample sizes used for each performance test. The data provenance is "internal Unomedical protocols" and adherence to international standards (ISO, AAMI/ANSI). It is implied these are prospective tests conducted during the device development and validation phases, likely conducted in various Unomedical facilities. The country of origin of the data is implied to be relevant to Unomedical A/S (Denmark) and potentially Patton Medical Devices (USA), given the collaboration.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The provided text does not indicate the use of experts to establish ground truth for a test set. The studies conducted are performance and safety tests against engineering specifications and international standards, rather than clinical studies requiring expert interpretation of results (e.g., image analysis by radiologists). The "ground truth" for these engineering tests is derived directly from the test methodologies and metrics defined by the standards and internal protocols.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as the tests are for device performance against predefined specifications, not for interpretation by multiple human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or mentioned. This device is a physical medical device (an injection port), not an AI algorithm or diagnostic tool. Therefore, a study comparing human readers with and without AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone algorithm study was done or mentioned. As stated, this is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for the performance tests conducted (Flow, Leak, Tension, Pull, Weld Strength, Disconnection Strength, Spring Loading Force, Insertion Depth, Biocompatibility, Sterility, Pyrogenicity, Packaging Integrity) is based on engineering specifications, international consensus standards (e.g., ISO, AAMI/ANSI), and internal Unomedical protocols. This means the device's performance was measured against established benchmarks for safety and functionality. For instance:

Biocompatibility: Conformance to AAMI/ANSI/ISO 10993-1:2009.
Sterility: Conformance to AAMI/ANSI/ISO 11135-1:2007 to a SAL of 10⁻⁶.
Ethylene Oxide Residuals: Compliance with AAMI/ANSI/ISO 10993-7:2008.

8. Sample Size for the Training Set

No training set is mentioned or applicable as this is a physical medical device, not an AI/machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no training set for this type of device.

Summary

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Unomedical A/S i-port Advance™ injection port Abbreviated 510(k) Submission

FEB 1 6 2012 K120337

Image /page/0/Picture/2 description: The image shows the logo for Unomedical. The logo consists of a circular symbol on the left and the word "Unomedical" on the right. The circular symbol is divided into four sections, each containing a different shape. The word "Unomedical" is written in a bold, sans-serif font. Below the word "Unomedical" is the phrase "A Convatec Company".

Section 5 510(K) Summary

5.1 Administrative Information

Date of Submission .................. September 16, 2011

Submitter .................................................................................................................................................................... Aaholmvei 1 - 3 Osted, Lejre, Denmark 4320 Søren Melsted, Director, Head of RA and QA T: +45 4816 7000/F: +45 4642 7865 E: soren.melsted@convatec.com

Correspondent .................................... Cody Floch, Director of Operations Patton Medical Devices 3108 N. Lamar Blvd. Austin, TX 78705 T: (512) 279-4545/F: (512) 279-0372 E: cfloch@pattonmd.com

5.2 Device Identification

Proprietary Name ................. i-port Advance™ injection port Common Name .................................................................................................................................................................. Classification Name ........ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Classification ...............................................................................................................................................................

5.3 Indications for Use

These are the same indications previously cleared for the predicate i-port® injection port (K052389)

5.4 Predicate Devices

The i-port Advance™ is substantially equivalent to: Patton Medical Devices i-port® injection port (K052389) Unomedical A/S Inset™ Infusion Sct (K032854)

ર્સ્ડ Device Description

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Image /page/1/Picture/1 description: The image shows the logo for Unomedical, a ConvaTec Company. The logo consists of a circular symbol with four petal-like shapes surrounding a central circle, followed by the word "Unomedical" in bold, sans-serif font. A horizontal line underlines the word "Unomedical", and below that, the text "A ConvaTec Company" is written in a smaller font size.

Model No.	Catheter Length	Quantity.
020110	6 mm	10x
020210	9 mm	10x
020102	6 mm	2x
020202	9 mm	2x

The device will be marketed under four (4) model numbers:

ર્સ્વ Comparison of Technological Characteristics

The new device modifies the Patton Medical Device i-port® injection port (K052389) to include the same integrated Inserter found in the Unomedical Insct™ Infusion Set (K032854). Both functional components of the device remain largely unchanged and have the same technological characteristics as their respective predicate devices. The Injection Port component of the i-port Advance™ has the same design, materials composition, operating principles and performance characteristics as the i-port® injection port (K052389), and the automated Inserter component of the new device has the same design, materials composition, operating principles and performance characteristics as the automated Inserter component in the Inset™ Infusion Set (K032854). Although some minor dimensional changes have been made to some of the individual components to accommodate the integration of the Inserter with the Injection Port components, none of these modifications alter the intended use or impact the safety and effectiveness of the device.

5.7 Non-Clinical Performance and Safety Data

Performance testing was conducted in accordance with consensus standards and design control requirements. Results from testing confirm that the i-port Advance™ meets all applicable design and performance requirements. No new issues of safety and effectiveness were raised with the testing performed. Testing performed includes:

. Flow Testing (before and after maximum punctures) per internal Unomedical protocols
프 Leak Testing (before and after maximum punctures) per internal Unomedical protocols
트 Catheter Tension Testing per ISO 10555
그 Introducer Needle Pull Testing per ISO 10555 and ISO 11070
에 Adhesive Weld Strength Test per internal Unomedical protocols
트 Injection Port Disconnection Strength Testing per internal Unomedical protocols
트 Spring Loading Force Testing per internal Unomedical protocols
l Insertion Depth Testing per internal Unomedical protocols

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Image /page/2/Picture/1 description: The image shows the logo for Unomedical, a ConvaTec Company. The logo consists of a stylized eye symbol on the left, followed by the word "Unomedical" in a bold, sans-serif font. Underneath "Unomedical" is the text "A ConvaTec Company" in a smaller font size.

A Risk Management Plan and a Risk Management File were established for the i-port Advance™ project. The Risk Management Plan is modeled after ISO 14971:2007, Medical devices - Application of risk management to medical devices. Risks were identified and through the use of Failure Modes, Effects, and Criticality Analysis (FMECA) and Fault Tree Analysis (FTA) risks were evaluated, and where possible, were mitigated. It was determined that the overall risks of the device are within the As Low as Reasonably Practicable (ALARP) and Broadly Acceptable regions for this type of device.

The materials used to fabricate the i-port Advance™ are biocompatible and safe for their intended use. The patient and drug contact materials on the i-port Advance™ are the same as those on the currently marketed predicate devices and meet the requirements of AAMVANSI/ISO 10993-1:2009. Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process for permanent body contact, external communicating device with indirect blood contact. The drug contact materials are the same as those used in the currently marketed predicate devices. The device contains no PVC and as such no DEHP plasticizers.

The i-port Advance™ is sterilized with Ethylene Oxide (EtO), and sterility is assured by using a validated sterilization method qualified in accordance with AAMI/ANSI/ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices to a sterility assurance level (SAL) of 10°. Ethylene oxide residual levels resulting from EtO sterilization will comply with AAMI/ANSV/ISO 10993-7:2008, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. The fluid path will be Pyrogen free as tested by limulus amebocyte lysate (LAL), and the packaging will be tested to applicable standards to ensure integrity and durability.

5.8 Statement of Substantial Equivalence

By definition, a new device is substantially equivalent to a predicate device when the new device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise any new questions regarding its safety and effectiveness when compared to the predicate device.

The i-port Advance™ has the same intended use as the Patton Medical Devices i-port® injection port, (K052389). The i-port Advance™ has the same technological characteristics as the predicate devices in terms of functional design, components and materials, principals of operation, sterilization method and performance characteristics. On this basis, Unomedical A/S concludes that the i-port Advance™ injection port is substantially equivalent to the Patton Medical Devices i-port® injection port, (K052389) and the Unomedical A/S Inset™ Infusion Set (K032854) and does not raise any new questions regarding safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Unomedical A/S C/O Mr. William Sammons Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

FEB 1 6 2012

Re: K120337

Trade/Device Name: i-port Advance™ injection port Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: February 2, 2012 Received: February 3, 2012 .

Dear Mr. Sammons:

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. 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 Eederal Register.

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Page 2 - Mr. Sammons

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:

i-port Advance™ injection port Device Name:

n/a

Indications for Use:

Prescription Use X (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Wht Chayman 2/15/12

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K12033t

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).