Additive Cap

K190305 · International Medical Industries, Inc. · KPE · Apr 30, 2019 · General Hospital

Device Facts

• Record ID: K190305
• Device Name: Additive Cap
• Applicant: International Medical Industries, Inc.
• Product Code: KPE · General Hospital
• Decision Date: Apr 30, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5025
• Device Class: Class 2

Indications for Use

The Additive Port Cap is indicated for use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed.

Device Story

Additive Port Cap (APC) is a single-use, non-sterile, polypropylene cap designed to snap over medication ports of specific Baxter IV containers. Device provides visual indication of medication addition via bright red coloration; functions as tamper-evident seal once closed. If forced open or removed, device causes visible damage to IV container or cap, rendering it unusable. Used in clinical settings by healthcare personnel to secure medication ports after additive injection. Benefits include enhanced medication safety through visual confirmation and tamper deterrence.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included visual inspection, axial detachment force, opening/closing force, dimensional verification, leakage testing, packaging/labeling integrity, simulated transportation, shelf-life testing, and human factors/usability validation. All pre-determined acceptance criteria were met.

Technological Characteristics

Material: Polypropylene. Form factor: Snap-on cap. Energy source: None (mechanical). Connectivity: None. Sterilization: Non-sterile. Software: None.

Indications for Use

Indicated for use on medication ports of Baxter VIAFLEX, INTRAVIA, AVIVA, and ALL-IN-ONE EVA IV containers to provide visual confirmation of medication addition and tamper evidence.

Regulatory Classification

Identification

An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.

Predicate Devices

• Baxter Additive Cap for Viaflex Containers (K111217)

Submission Summary (Full Text)

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April 30, 2019

International Medical Industries, Inc. Peter Lehel Senior Manager Engineering 2981 Gateway Drive Pompano Beach, Florida 33069

Re: K190305

Trade/Device Name: Additive Cap Regulation Number: 21 CFR 880.5025 Regulation Name: IV Container Regulatory Class: Class II Product Code: KPE Dated: February 7, 2019 Received: February 12, 2019

Dear Peter Lehel:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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 (if known) K190305

Device Name Additive Port Cap

Indications for Use (Describe)

The Additive Port Cap is indicated for use on the medication port of Baxter VIAFLEX, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed.

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) |

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Image /page/3/Picture/1 description: The image shows the logo for IMI. The logo consists of a blue square with three curved white lines inside, followed by the letters "IMI" in black. There is a registered trademark symbol to the upper right of the last "I" in the logo.

# K190305 510(k) Summary

| Date Summary Prepared: | February 7, 2019 | |
|-------------------------|--------------------------------------------------|--|
| Manufacturing Company: | International Medical Industries, Inc. | |
| Manufacturing Address: | 2981 Gateway Drive, Pompano Beach, Florida 33069 | |
| Corresponding Official: | Peter Lehel | |
| | Senior Manager Engineering | |
| Telephone Number: | 954.917.9570 x 227 | |
| Fax Number: | 954.917.9244 | |
| Email Address: | [e-mail] | |
| Trade Name: | Additive Port Cap | |
| Device Common Name: | Additive Cap | |
| Regulation Number: | 21 CFR 880.5025 | |
| Regulation Name: | I.V. Container | |
| Product Class: | II | |
| Product Panel: | General Hospital | |
| Product Code: | KPE | |
| Predicate Device: | Baxter Additive Cap for Viaflex Containers | |
| | K111217 cleared June 14, 2011 | |

### 5.1 Device Description

The Additive Port Cap (APC) is a polypropylene, single use device designed to snap over the outside of the medication port of compatible Baxter IV container (Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA) after the addition of medication. Once closed, the device prevents the port from being accessed without causing visible damage to the IV container. The bright red coloration serves as a clear indicator that medication has been added. The APC device is non-fluid path and non-sterile. The APC device is marketed as a stand-alone device and packaged in bulk.

## 5.2 Indications for Use

| Device:<br>Additive Port Cap (APC) | Predicate:<br>Baxter Additive Cap for Viaflex<br>Containers K111217 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Additive Port Cap is indicated for use<br>on the medication port of Baxter<br>VIAFLEX, Baxter INTRAVIA, Baxter<br>AVIVA, and Baxter ALL-IN-ONE EVA<br>containers to provide both visual evidence<br>that medication has been added and<br>tamper evidence once the device is<br>closed. | Additive Cap is indicated for use on the<br>medication port of VIAFLEX and<br>AVIVA containers to provide visual<br>evidence that medication has been<br>added. |

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Image /page/4/Picture/0 description: The image shows the IMI logo. The logo consists of a blue square with three curved lines inside, followed by the letters "IMI" in black. The "I" on the right has a registered trademark symbol next to it. The logo is simple and modern.

#### 5.3 Technological Characteristics and Basis for Substantial Equivalence

The APC is substantially equivalent to the predicate device, Baxter Additive Cap for VIAFLEX and AVIVA Containers (K111217). The devices are both indicated as non-fluid path caps which provide visual evidence that medication has been added to the specified IV containers. Both devices are injection molded polypropylene and are provided non-sterile.

| Parameter | Proposed Device | Predicate Device |
|---------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| Image | Image: Proposed Device Images: Injection port fit. and Installed. | Image: Predicate Device Images: Injection port fit. and Installed. |
| Proprietary Device<br>Name | Additive Port Cap (APC) | Additive Cap for Viaflex Containers |
| Company Name | International Medical Industries, Inc. | Baxter Healthcare Corporation |
| 510(k) # | K190305 | K111217 |
| Product Code | KPE | KPE |
| Regulation No. | 21 CFR 880.5025 | 21 CFR 880.5025 |
| Classification | Class II | Class II |
| Sterility | Non-Sterile | Non-Sterile |
| Number of Uses | Single Use | Single Use |
| Cap Material | Polypropylene | Polypropylene |
| Biocompatibility<br>Contact and<br>Duration | Device does not contact the patient's body<br>directly or indirectly. | Device does not contact the patient's body<br>directly or indirectly. |

#### Table 5.3.1 - Comparison Between APC and Predicate Devices

The label modification is to expand the indications for use statement by adding compatibility with the Baxter INTRAVIVA and Baxter ALL-IN-ONE EVA containers which are functionally equivalent to the VIAFLEX and AVIVA. The second label modification is to add tamper evidence to the indications for use. Performance testing to demonstrate tamper evidence was conducted. Once the Additive Port Cap is attached and closed, it cannot be opened manually. If a closed cap is opened (e.g. with a tool), it can cause damage to the bag or the cap making it unusable. Additionally, performance testing demonstrated that pulling on the cap in order to remove from the bag tears the bag.

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Image /page/5/Picture/0 description: The image shows the logo for IMI. The logo consists of a blue square with white curved lines inside, followed by the letters "IMI" in black. There is a registered trademark symbol to the right of the last "I".

| Feature of the Device | Proposed Device | Predicate Device | Discussion / Comment |
|------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------|------------------------------------------------------------------------------|
| Compatibility with Baxter<br>fluid containers. | Baxter VIAFLEX,<br>Baxter INTRAVIA,<br>Baxter AVIVA, and<br>Baxter ALL-IN-ONE<br>EVA containers | VIAFLEX and<br>AVIVA containers | The medication port are<br>equivalent for all the<br>containers. |
| Tamper Evidence | Includes tamper<br>evidence | Does not include<br>tamper evidence. | Performance testing was<br>conducted to support claim<br>of tamper evidence. |

#### Table 5.3.2 - Differences Between APC and Predicate Devices

The safety and effectiveness of the APC are adequately supported by the material information, comparison of design characteristics with the predicate device, testing rationale and data provided within this premarket notification. This testing supports the substantial equivalence of the APC to the predicate and shows that no different questions of safety and effectiveness have been introduced with this device.

### 5.4 Performance Data

Design verification and validation were performed to ensure that the APC device meets its performance specifications and demonstrates substantial equivalence to the predicate device. There are no known performance standards for this device. A summary of the performance testing conducted is presented below. All pre-determined acceptance criteria were met. The data demonstrates that the proposed cap device is substantially equivalent to the predicate device.

| Test Name | Test Description |
|--------------------------|---------------------------------------------------------------------------------|
| Visual Inspection | Visual Inspection to ensure no gross damage, coverage<br>of drug port etc. |
| Axial Detachment | Force required to remove the additive port cap from IV<br>container |
| Opening Force | Force required to open a properly installed cap |
| Closing Force | Force required to properly install product on injection<br>port of IV container |
| Dimensional Verification | Dimensional measurements of cap features |
| Leakage | Drug port freedom from leakage |

Table 5.4.1 - Summary of Performance Testing Conducted on APC Device

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Image /page/6/Picture/0 description: The image shows the logo for IMI. The logo consists of a blue square with white curved lines inside, followed by the letters "IMI" in black. There is a registered trademark symbol next to the last "I".

| Packaging and Labeling | Visual inspections to verify integrity of the packaging to<br>protect the device and of the label to be legible. |
|----------------------------|------------------------------------------------------------------------------------------------------------------|
| Transportation, Shelf Life | Simulated transportation conditions and shelf life<br>followed by design verification testing. |
| Product Validation | Human factors and Usability |

### 5.5 Biocompatibility Testing

The device does not contact the patient's body either directly. In accordance to 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; Guidance for Industry and Food and Drug Administration Staff" issued June 16, 2016, no biocompatibility testing is required for the APC device.

### Conclusion

Review of the performance test data as well as comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility demonstrate that the subject device, Additive Port Cap (APC) is substantially equivalent to the predicate cap Baxter Additive Cap for VIAFLEX and AVIVA Baxter containers K111217. Any differences between the subject and the predicate devices do not raise any different questions of safety or effectiveness.