Tamper Evident Cap For use with ENFit Syringes

K170672 · International Medical Industries, Inc. · PNR · Oct 6, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K170672
• Device Name: Tamper Evident Cap For use with ENFit Syringes
• Applicant: International Medical Industries, Inc.
• Product Code: PNR · Gastroenterology, Urology
• Decision Date: Oct 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Indications for Use

Tamper Evident Cap For use with ENFit® Syringes is indicated for use to prevent fluid loss and contamination of syringe contents until ready for use with evidence of access.

Device Story

Sterile, single-use disposable closure cap for ENFit® enteral syringes; prevents fluid loss and contamination; features restrictive sleeve providing visual evidence of access (tampering); removal of sleeve indicates potential access; injection-molded assembly; polystyrene outer sleeve/bottom cover; acrylic syringe tip cap; used in clinical settings; operated by healthcare providers; provides physical barrier and visual indicator; ensures integrity of syringe contents until administration.

Clinical Evidence

Bench testing only. Compliance with AAMI/ISO 80369-3 (liquid leakage, stress cracking, axial load, unscrewing, overriding, disconnection). Additional internal testing: visual tamper indication, durability, compatibility, human factors, and dose accuracy. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity) for prolonged mucosal membrane contact.

Technological Characteristics

Injection-molded assembly; polystyrene outer sleeve/bottom cover; acrylic syringe tip cap; male ENFit® connector; ethylene oxide sterilization; single-use; biocompatible per ISO 10993-1 for prolonged mucosal contact; mechanical closure mechanism.

Indications for Use

Indicated for use with ENFit® enteral syringes to prevent fluid loss and contamination of contents while providing visual evidence of access.

Regulatory Classification

Identification

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Special Controls

*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Tamper Proof Cap with Luer Lock (K861276)

Reference Devices

• NeoMed NeoConnect™ Enteral Syringes with ENFit™ Connector and compatible NeoSecure™ Tip Caps (K152857)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the agency's acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 6, 2017

International Medical Industries, Inc. Brandon Hunt Vice President Operations 2981 Gateway Drive Pompano Beach, FL 33069

Re: K170672

> Trade/Device Name: Tamper Evident Cap For use with ENFit® Syringes Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: October 2, 2017 Received: October 3, 2017

Dear Brandon Hunt:

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 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.

{1}------------------------------------------------

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 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

#### Indications for Use

510(k) Number (if known) K170672

Device Name

Tamper Evident Cap For use with ENFit® Syringes

Indications for Use (Describe)

Tamper Evident Cap For use with ENFit® Syringes is indicated for use to prevent fluid loss and contamination of syringe contents until ready for use with evidence of access.

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 [e-mail]

"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."

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows a logo with the letters I, M, and I stacked vertically inside a white oval. The oval is surrounded by a series of concentric blue lines that create a visual effect of radiating waves. A small registered trademark symbol is visible at the bottom of the oval.

# Section 5 - 510(k) Summary

| Date Prepared: | October 5, 2017 |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | International Medical Industries, Inc. |
| Contact: | Brandon Hunt<br>Vice President Operations<br>International Medical Industries, Inc.<br>2981 Gateway Drive<br>Pompano Beach, Florida 33069<br>Phone [phone] Ext. 229<br>Fax [phone] |

| Trade Name: | Tamper Evident Cap For use with ENFit® Syringes |
|----------------------------|--------------------------------------------------------------------------------------------------------|
| Device Common Name: | ENFit Syringe Cap |
| Classification Regulation: | 21 CFR 876.5980 |
| Classification Name: | Gastrointestinal Tube and accessories |
| Class: | II |
| Panel: | Gastroenterology/Urology |
| Product Code: | PNR |
| Predicate Device: | International Medical Industries, Inc. Tamper Proof Cap with Luer Lock (K861276) |
| Reference Device: | NeoMed NeoConnect™ Enteral Syringes with ENFit™ Connector and compatible NeoSecure™ Tip Caps (K152857) |

{4}------------------------------------------------

# 5.1 Device Description

Tamper Evident Cap For use with ENFit® Syringes is a sterile, single use disposable device for use as a closure cap with evidence of access for Enteral Syringes with ENFit™ Connectors. Removal of the cap is achieved by removing a restrictive sleeve covering the ENFit™ Lock Cap. A damaged or missing restrictive sleeve indicates potential tampering. A non-sterile version of the device is also offered.

# 5.2 Indications for use

Tamper Evident Cap For use with ENFit® Syringes is indicated for use to prevent fluid loss and contamination of syringe contents until ready for use with evidence of access.

# 5.3 Comparison of Technological Characteristics

The Tamper Evident Cap For use with ENFit® Syringes is an assembly of injection molded components with a polystyrene outer sleeve and bottom cover and acrylic Syringe Tip Cap. The intended use and function of the proposed Tamper Evident Cap For use with ENFit® Syringes is identical to the predicate device in design and operation. The primary difference between the proposed device and the predicate device is that the predicate device contains a female Luer lock with tamper evident features on the outer sleeve, whereas the proposed device contains a male ENFit® connector for use with a ENFit® syringe, with tamper evident features integrated into the cap.

The intended use and function of the proposed Tamper Evident Cap For use with ENFit® Syringes is identical to the reference device in design and operation. The primary difference between the proposed device and the reference device is that the proposed product contains evidence of access features also known as Tamper Evidence.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a logo with the letters I and M stacked vertically. The letter M is in the middle and is larger than the two I's. The logo is inside an oval shape with several concentric blue lines around it. The logo appears to be for a company or organization with the initials IMI.

| Parameter | Proposed Device | Predicate Device | Reference Device |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Image | Image: Purple cap (Multiple Colors) | Image: Red cap | Image: Purple cap |
| Proprietary Device<br>Name | Tamper Evident Cap For use<br>with ENFit® Syringes | Tamper Proof Cap with Luer<br>Lock | NeoMed NeoConnect™<br>Enteral Syringes with ENFit™<br>Connector and compatible<br>NeoSecure™ Tip Caps |
| Company Name | International Medical<br>Industries, Inc. | International Medical<br>Industries, Inc. | NeoMed, Inc. |
| 510(k) # | K170672 | K861276 | K152857 |
| Indications For<br>Use | Tamper Evident Cap For use<br>with ENFit® Syringes is<br>indicated for use to prevent<br>fluid loss and contamination<br>of syringe contents until<br>ready for use with evidence<br>of access. | Tamper Proof Caps provide<br>Evidence of Use and Positive<br>Closure for Luer Lock<br>Syringes | A NeoConnect TM Enteral<br>Syringe Accessory used to<br>prevent fluid loss and<br>contamination of syringe<br>contents until ready for use |
| Product Code | PNR | FMF | PNR |
| Regulation No. | 21 CFR 876.5980 | 21 CFR 880.5860 | 21 CFR 876.5980 |
| Classification | Class II | Class II | Class II |
| Sterilization<br>Method | Ethylene Oxide (for sterile<br>versions) | Ethylene Oxide | Ethylene Oxide |
| Number of Uses | Single Use, RX Only | Single Use, RX Only | Single Use, RX Only |
| Closure Cap<br>Material | Acrylic | Polypropylene | Polypropylene |
| Biocompatibility | Per ISO 10993-1 for<br>prolonged duration, surface<br>device, mucosal membrane | Unknown | Unknown |
| Connection | Male ENFit | Female Luer Lock | Male ENFit |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for the Institute of Makers of Machining. The logo is an oval shape with several blue lines that create the border. Inside the oval is the letters IMI in a vertical stack.

### 5.4 Performance Data

The Tamper Evident Cap For use with ENFit® Syringes meets the bench testing requirements per "AAMI/ISO 80369-3: Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications" for the following tests:

- Liquid Leakage
- Stress Cracking
- Resistance to Separation from Axial Load ●
- Resistance to Separation from Unscrewing ●
- Resistance to Overriding ●
- . Disconnection by Unscrewing

Additional performance bench tests were performed to verify that the Tamper Evident Cap For use with ENFit® Syringes meets internal specifications. The main performance data provided in support of the substantial equivalence determination included:

- Visual Indication of Tamper Evidence during Simulated Misuse Conditions
- Durability and Performance of Tamper Evidence during Installation and Removal ●
- Durability and Performance of Tamper Evidence during Simulated Misuse Conditions ●
- Compatibility with Use Environments during Simulated Installation and Removal
- Ease of Use / Human Factors of Tamper Evident Caps ●
- Impact on Dose Accuracy of Syringe

Compliance to AAMI/ISO 80369-3 and additional internal specifications, demonstrates that the proposed cap device is substantially equivalent to the predicate device.

### 5.5 Biocompatibility Testing

The device, Tamper Evident Cap For use with ENFit® Syringes, passed all biocompatibility tests. In accordance to 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." June 16, 2016, the following biocompatibility tests were performed: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Material-Mediated Pyrogen Testing, and Acute/Subacute Systemic ToxicityThe device is considered a device with mucosal membrane contact of prolonged duration.

### 5.6 Conclusions:

Tamper Evident Cap For use with ENFit® Syringes is substantially equivalent to the predicate device (Tamper Proof Cap, K861276). The devices have intended use, the sterilized versions are sterilized with acceptable methods, and the performance testing supports substantial equivalence in device performance.