NRFit® Caps, Male and Female Neuraxial Tip Caps

K201031 · International Medical Industries, Inc. · QEH · Dec 16, 2020 · General Hospital

Device Facts

• Record ID: K201031
• Device Name: NRFit® Caps, Male and Female Neuraxial Tip Caps
• Applicant: International Medical Industries, Inc.
• Product Code: QEH · General Hospital
• Decision Date: Dec 16, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections. The NRFit® cap is intended to be used for less than 24 hours on any single application.

Device Story

NRFit® Caps are sterile, single-use polypropylene caps designed to provide positive closure for neuraxial devices, CADD cassettes, or syringes featuring ISO 80369-6 compliant connections. Available in male and female configurations, the caps prevent fluid loss and contamination during clinical use. Operated by hospital or clinical personnel in general hospital settings, the caps are applied manually to the neuraxial device port. The device functions as a mechanical seal; it does not involve electronic processing or automated decision-making. By maintaining a secure connection, the caps support aseptic technique and prevent leakage, benefiting patients by ensuring the integrity of neuraxial delivery systems during short-term applications (less than 24 hours).

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including ISO 80369-6/20 performance testing, biocompatibility (cytotoxicity, sensitization, irritation, hemolysis, systemic toxicity, pyrogenicity), and packaging integrity (ASTM F1886).

Technological Characteristics

Medical grade polypropylene with yellow colorant. ISO 80369-6 compliant male/female neuraxial lock connections. Externally communicating, tissue/bone/dentin contacting. Sterilized via Ethylene Oxide. Single-use. Packaging integrity tested per ASTM F1886:2013.

Indications for Use

Indicated for use as a sterile, single-use closure for neuraxial devices, CADD cassettes, or syringes with NRFit® connections to prevent fluid loss and contamination for durations under 24 hours.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• DASH 6® NRFit Syringe Cap (K170900)

Submission Summary (Full Text)

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December 16, 2020

International Medical Industries, Inc. David Meily Director of Quality & Regulatory Affairs 2981 Gateway Drive Pompano Beach, Florida 33069

Re: K201031

Trade/Device Name: NRFit® Caps, Male and Female Neuraxial Tip Caps Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QEH Dated: November 18, 2020 Received: November 19, 2020

Dear David Meily:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Rumi Young Acting 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

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#### Indications for Use

510(k) Number (if known) K201031

#### Device Name

NRFit® Caps, Male and Female Neuraxial Tip Caps

Indications for Use (Describe)

The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections. The NRFit® cap is intended to be used for less than 24 hours on any single application.

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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# 510(k) Summary NRFit® Caps, Male and Female Neuraxial Tip Caps

## K201031

#### 1. Submission Sponsor

International Medical Industries, Inc.

2981 Gateway Drive.

Pompano Beach

FL, 33069

USA

Contact: David Meily

Title: Director of Quality & Regulatory Affairs

### 2. Submission Correspondent

No applicable

#### 3. Date Prepared

December 16, 2020

### 4. Device Identification

| Trade/Proprietary Name: | NRFit® Caps, Male and Female Neuraxial Tip Caps |
|-------------------------|-------------------------------------------------|
| Common/Usual Name: | syringe, piston |
| Classification Name: | syringe, piston |
| Regulation Number: | 21 CFR§880.5860 |
| Product Code: | QEH |
| Device Class: | Class II |
| Classification Panel: | General Hospital |

## 5. Legally Marketed Predicate Device(s)

#### Predicate Device

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#### K170900

| Trade/Proprietary Name: | DASH 6® NRFit Syringe Cap |
|-------------------------|---------------------------|
| Common/Usual Name: | syringe, Piston |
| Classification Name: | syringe, piston |
| Regulation Number: | 21 CFR 880.5860 |
| Product Code: | FMF |
| Device Class: | Class II |
| Classification Panel: | General Hospital |

## 6. Indication for Use Statement

The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections.

NRFit® cap is intended to be used for less than 24 hours on any single application.

### 7. Device Description

The NRFit® Caps (abbreviated as "NRFit") are ISO 80369-6 compliant caps designed to prevent fluid loss in Neuraxial devices. The NRFit cap is made from medical grade polypropylene with yellow colorant. The NRFit cap is available with either a male neuraxial lock connection or a female neuraxial lock connection. The NRFit cap is made of materials appropriate for a limited exposure duration, externally communicating, tissue/bone/dentin contacting medical device.

### 8. Substantial Equivalence Discussion

Based on the above information and FDA Guidance Document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications", the proposed NRFit caps is concluded to be substantially equivalent to its predicate, DASH 6 NRFit syringe caps.

| Manufacturer | International Medical Industries,<br>Inc. | INTERVENE Group Limited | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Proprietary Device<br>Name | NRFit® Caps, Male and Female<br>Neuraxial Tip Caps | DASH 6® NRFit™ Syringe Caps | Comparison |
| 510(k) # | K201031 | K170900 | N/A |
| Indications for Use | The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes | DASH 6® NRFit Syringe cap is intended to be used with ISO 80369-6 NRFit neuraxial syringes for sealing the tip of the syringe. | Similar, both are used with neuraxial devices |

| Table 5-A: NRFit Caps and Predicate Device Comparison | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | International Medical Industries,<br>Inc. | INTERVENE Group Limited | Comparison |
| Proprietary Device<br>Name | NRFit® Caps, Male and Female<br>Neuraxial Tip Caps | DASH 6® NRFit™ Syringe Caps | Comparison |
| Product Code | or Syringes utilizing NRFit®<br>connections. NRFit® cap is<br>intended to be used for less than<br>24 hours on any single<br>application. | FMF | New product<br>code for<br>neuraxial<br>devices |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Classification | Class II | Class II | Same |
| Device Description | The NRFit® Caps are ISO 80369-6<br>compliant caps designed to<br>prevent fluid loss in Neuraxial<br>devices. The NRFit® cap is made<br>from medical grade<br>polypropylene with yellow<br>colorant. The NRFit® cap is<br>available with either a male<br>neuraxial lock connection or a<br>female neuraxial lock connection.<br>The NRFit® cap is made of<br>materials appropriate for a<br>limited exposure duration,<br>externally communicating,<br>tissue/bone/dentin contacting<br>medical device < 24 contact<br>duration | DASH 6® NRFit Syringe Caps are<br>Single Use, In-Hospital devices. It<br>incorporates a female ISO 80369-6<br>NRFit connector to be connected<br>on an ISO 80369-6 compliant male<br>port. The device will be supplied as<br>individually packed (sterile) and the<br>bulk packed (non-sterile). The<br>sterile packed items will be<br>supplied directly to the user and<br>the bulk packed will be supplied to<br>Anesthetic Conduction Kit<br>manufacturers to be packaged into<br>kit. The devices packaging will<br>indicate it is a syringe cap and the<br>sterility/sterilization method the<br>device has undergone. | Similar.<br>IMI's<br>description is<br>based on<br>function,<br>material<br>composition<br>and patient<br>contact.<br>INTERVENE's<br>description is<br>of packaging<br>and sterility.<br>Both<br>companies<br>agree on<br>compliance to<br>ISO 80369-6 |
| Environment | General Hospital | General Hospital | Same |
| User | Hospital/clinical personnel | Hospital/clinical personnel | Same |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |
| Number of Uses | Single Use | Single Use | Same |
| Cap Material | Polypropylene (PP) | Polypropylene (PP) | Same |
| Biocompatibility<br>Contact and Duration | External communicating, blood<br>path (indirect) for a duration of<br><24 Hrs | External communicating, blood<br>path (indirect) for a duration of ≤24<br>Hrs | Same |

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The predicate device is a Syringe Family and Accessories. The NRFit® caps are substantially equivalent to the accessory- DASH 6® NRFit Syringe caps.

Note: Based on the comparison above, there are no new or different questions of safety or effectiveness.

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# 9. Non-Clinical Performance Data

| Table 5-B: Summary of NRFit® Caps Testing | | |
|-------------------------------------------|--|--|
|-------------------------------------------|--|--|

| Test Name | Test Description |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Falling Drop Liquid Leakage | NRFit® device shall show no signs of leakage sufficient to form a<br>falling drop of water |
| Sub-atmospheric-pressure air leakage | NRFit® Device shall not leak by more than 0.005 Pa (m^3)/s<br>during aspiration |
| Stress Cracking | NRFit® Device shall show no evidence of stress cracking (i.e.<br>visible cracks in the threads or taper of the connector) or<br>leakage after Stress Crack testing |
| Axial Separation | NRFit® Device shall not separate from a properly installed<br>reference connector while being subjected to at least 35N<br>disconnection tensile axial force |
| Resistance to Unscrewing | NRFit® Device shall not separate from a properly installed<br>reference connector |
| Resistance to Overriding | NRFit® device shall not override the threads or lugs of the<br>reference connector |
| Visual | NRFit® device shall be a similar yellow in color to other NRFit<br>products available on the open market |
| Visual Inspection | Device must be available in a primary package blister<br>configuration consisting of PETG film with Tyvek Lid. |
| Visual Inspection | Heat seals must meet ASTM F1886:2013 Standard test method<br>for determining integrity of seals for flexible packaging by visual<br>inspection |
| Wearing a set of disposable nitrile gloves,<br>run a finger along the outer edge of the<br>packaging and ensure glove does not catch<br>on any feature such that a hole or tear is<br>formed | Primary packaging must not expose the user to sharps that may<br>cause injury or a breach in aseptic technique |
| Visual Inspection | Product outer packaging must be free from gross cosmetic<br>defects, particulate, and foreign material |
| Transportation, Shelf Life | Simulated transportation conditions and shelf life followed by<br>design verification testing. |
| Product Validation | Human factors and Usability |
| Biocompatibility | Cytotoxicity, Intracutaneous Irritation testing, Sensitization<br>testing, Hemolysis testing direct/indirect, Acute systemic<br>toxicity, Pyrogenicity, Chemical Characterization, Extractables<br>and Leachables, Toxicological Risk assessment. |
| Performance | ISO 80369-6:2016 and ISO 80369-20:2015 |

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## 10. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device.

### 11. Statement of Substantial Equivalence

The male and female NRFit® caps have the same intended use, function, materials and patient contact as the predicate device. Both devices are compliant to ISO 80369-6. Minor technological differences do not raise new or different questions of safety and effectiveness.

The NRFit® caps, as designed and manufactured, are determined to be substantially equivalent to the referenced predicate device.