Medline ENFit Syringe

K160642 · Medline Industries, Inc. · PIF · Nov 29, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K160642
• Device Name: Medline ENFit Syringe
• Applicant: Medline Industries, Inc.
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Nov 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Medline ENFit Syringe is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) to measure and administer enteral nutrition.

Device Story

Medline ENFit Syringe is a 3-piece manual piston syringe; consists of polypropylene barrel/plunger and polyisoprene stopper; incorporates female ENFit connector (ISO 80369-3) to mate with enteral feeding extension sets. Used in clinical or home settings by clinicians or laypersons to measure and administer enteral nutrition. Device is non-sterile, single-use, and disposable. Design mitigates misconnection risks with small-bore connectors. Healthcare providers use the syringe to deliver nutritional formula to patients physically unable to swallow. Benefits include standardized, secure connection to enteral access devices, reducing risk of accidental misconnection to non-enteral systems.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including enteral connector misconnection assessment, human factors validation, biocompatibility (ISO 10993-5, -10), shelf-life, and mechanical performance testing per ISO 80369-3 and ISO 7886-1.

Technological Characteristics

Materials: Polypropylene (barrel/plunger), polyisoprene (stopper). Design: 3-piece piston syringe with female ENFit connector (ISO 80369-3). Non-sterile, single-use, disposable. Dimensions: 60 mL configuration. Connectivity: Mechanical interface only. No software or energy source.

Indications for Use

Indicated for patients of all age groups requiring enteral nutrition administration via gastrointestinal tube. Intended for use by clinicians or laypersons under clinician supervision in clinical or home settings.

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

• Covidien Kangaroo™ Enteral Feeding Syringes with ENFit connector (K142128)
• NeoMed NeoConnect™ Enteral Syringes with ENFit™ Connector and compatible NeoSecure™ Tip Caps (K152857)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a central emblem. The emblem features a stylized representation of three human profiles facing to the right, stacked one behind the other.

Public Health Service

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

November 29, 2016

Medline Industries, Inc. Stephanie Blair Regulatory Affairs Manager One Medline Place Mundelein, IL 60060

Re: K160642

Trade/Device Name: Medline ENFit Syringe Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PIF Dated: November 29, 2016 Received: November 29, 2016

Dear Stephanie Blair:

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.

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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

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# Indications for Use

510(k) Number (if known) K160642

Device Name Medline ENFit Syringe

Indications for Use (Describe)

The Medline ENFit Syringe is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) to measure and administer enteral nutrition.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 14px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue background and consists of the word "MEDLINE" in bold, sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst is composed of four elongated triangles converging at a central point, creating a dynamic and modern visual element.

ledline Industries, Inc. One Medline Place Mundelein. IL 60060

# SECTION 5 510(k) SUMMARY

Summary Preparation Date November 17th, 2016

# Submitter / 510(k) Sponsor

Medline Industries, Inc. One Medline Place Mundelein, IL 60060 Registration Number: 1417592

#### Submission Correspondent

Stephanie Augsburg Manager, Regulatory Affairs Phone: [phone] Email: [e-mail]

#### Type of 510(k) Submission

Traditional

#### Device Name / Classification

Proprietary Name: Medline ENFit Syringe Common Name: Gastrointestinal tubes with enteral specific connectors Regulation Name: Gastrointestinal Tube and Accessories Product Code: PIF Regulatory Class: II Classification Panel: Gastroenterology / Urology

#### Predicate Devices

- A. K142128 Covidien Kangaroo™ Enteral Feeding Syringes with ENFit connector
- B. K152857 NeoMed NeoConnect™ Enteral Syringes with ENFit™ Connector and compatible NeoSecure™ Tip Caps

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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a stylized white starburst symbol to the right of the text. The starburst has four points, resembling a compass rose.

dline Industries. ne Medline Place Mundelein. II 60060

#### Device Description

The Medline ENFit Syringe is a standard piston syringe which incorporates an ENFit connector. The device incorporates a female ENFit connector for connection to an enteral access device. The Medline ENFit Syringe is designed to mate with a range of enteral feeding extension sets. The 3-piece design syringe consists of a polypropylene barrel and plunger rod and a polyisoprene stopper. The Medline ENFit syringe comes with a cap as other predicate devices seen below. The Medline ENFit syringe will be sold as non-sterile. The performance of the Medline ENFit Syringe is equivalent to the predicate devices.

#### Indications for Use

The Medline ENFit Syringe is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) to measure and administer enteral nutrition.

### Summary of Technological Characteristics

Medline ENFit Syringes are made of polypropylene and are non-sterile, single-use devices. In addition, the ENFit Syringe is made of semi-rigid materials to reduce the likelihood of forced fits between flexible connectors that are not intended to connect with each other, as recommended in FDA Final Guidance for Industry: Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications (February 11, 2015).

In addition, Medline ENFit Syringes are similar in design, intended use, function and internal and external characteristics to the predicate device cleared under K142128. Covidien Kangaroo™ Enteral Feeding Syringes with ENFit connector, as well as K152857, NeoMed NeoConnect™ Enteral Syringes with ENFit™ Connector and compatible NeoSecure™ Tip Caps.

| Device<br>Characteristic | Proposed Device | Predicate Device | Predicate Device | Comparison<br>Analysis |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline ENFit Syringe | NeoMed NeoConnectTM<br>Enteral Syringes with<br>ENFitTM Connector and<br>compatible tip caps | Covidien KangarooTM<br>Enteral Feeding Syringes<br>with ENFit | Similar |
| Product Owner | Medline Industries, Inc. | NeoMed | Covidien | Different |
| Product Code | PIF | PIF | PIF | Same |
| Intended Use | The Medline ENFit Syringe<br>is intended to be used in<br>clinical or home care | NeoMed NeoConnectTM<br>Enteral Syringes with<br>ENFitTM Connector and | The KangarooTM Enteral<br>Feeding Syringe with<br>ENFit Connector delivers | Same |
| | | | | |
| | settings by users ranging<br>from clinicians to<br>laypersons (under the<br>supervision of a clinician) to<br>measure and administer<br>enteral nutrition. | compatible tip caps are<br>indicated for use as a<br>dispenser, a measuring<br>device and a fluid transfer<br>device intended to be used<br>in clinical or home care<br>settings by users ranging<br>from clinicians to<br>laypersons (under the<br>supervision of a clinician)<br>in all age groups. | nutritional formula<br>to the gastrointestinal<br>system of a patient who is<br>physically unable to eat<br>and swallow. The<br>feeding syringes are<br>intended to be used in<br>clinical or home care<br>settings by users ranging<br>from laypersons to<br>clinicians (under the<br>supervision of a<br>clinician), to administer<br>enteral nutrition. The<br>syringe is intended for all<br>age groups. | |
| Regulation<br>Number | 21 CFR 876.5980 | 21 CFR 876.5980 | 21 CFR 876.5980 | Same |
| Design Features | 3 piece design syringe with<br>cap | 3 piece design syringe<br>with or without cap | 3 piece design syringe | Similar |
| Design<br>Configurations | 60 ml non-sterile | 0.5 - 100 mL | Not specified in 510(k)<br>summary | Similar |
| Materials | Polypropylene translucent<br>barrel and plunger rod | Translucent barrel | Not specified in 510(k)<br>summary | Similar |
| Prescription vs.<br>OTC | Prescription | Prescription | Prescription | Same |
| Contact<br>Durations | ≤ 24 hours | ≤ 24 hours | ≤ 24 hours | Same |
| Sterile vs. Non-<br>Sterile | Non-Sterile | Non-Sterile and Sterile | Not specified in 510(k)<br>summary | Similar |
| Single Use vs.<br>Reusable | Single Use | Single Use | Single Use | Same |
| Disposable vs.<br>Non-Disposable | Disposable | Disposable | Disposable | Same |
| Syringe Tip<br>(ISO 80369-3<br>ENFit) female<br>connector | Liquid Leakage Testing<br>Stress Cracking<br>Resistance to separation<br>from axial load<br>Resistance to separation<br>from unscrewing<br>Resistance to overriding | Liquid Leakage Testing<br>Stress Cracking<br>Resistance to separation<br>from axial load<br>Resistance to separation<br>from unscrewing<br>Resistance to overriding | Fluid Leakage<br>Stress Cracking<br>Resistance to separation<br>from axial load<br>Resistance to separation<br>from unscrewing<br>Resistance to overriding | Same |
| | Disconnection by<br>unscrewing | Disconnection by<br>unscrewing | Disconnection by<br>unscrewing | |
| ISO 7886<br>Syringe Testing | Tolerance on Graduated<br>Capacity<br>Graduated Scale: Scale,<br>Numbering of Scale,<br>Overall Length of Scale,<br>Position of Scale<br>Barrel Finger Grips<br>Piston / Plunger Assembly<br>Design<br>Fit of Piston in Barrel<br>Fiducial line Dead Space<br>Freedom from Air / Liquid<br>Leakage | Capacity Tolerance<br>Graduated Scale<br>Piston Fit in Barrel<br>Air and Liquid Leakage<br>Testing | Not specified in 510(k)<br>summary | Similar |

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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a white star-like symbol to the right of the text. The background of the logo is a solid dark blue color. The logo is simple and clean, and the colors are contrasting.

Medline Industries, Inc. One Medline Place Mundelein, IL 60060

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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a stylized white cross symbol placed to the right of the text. The cross symbol has a unique design, with the top and bottom points being longer than the side points.

edline Industries, Inc One Medline Place Mundelein. IL 60060

# Summary of Non-Clinical Testing

Non-clinical verification of Medline ENFit Syringes has been conducted to evaluate the safety, performance and functionality of Medline ENFit Syringes. The results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination. Specifically, the proposed device has been evaluated through the following tests:

- Enteral Connector Misconnection Assessment Study ●
- Human Factors Validation Study: Enteral Connectors Final Report .
- PG-Lock Misconnection Data with Failure Modes and Effects Analysis (FMEA) ●
- Internal Risk Analysis ●
- Bioburden Testing
- Metrology Testing
- Stability (Shelf-Life) Testing ●
- Biocompatibility Testing: ●
- Cytotoxicity MEM elution per ISO 10993-5 o
- Irritation Intracutaneous reactivity per ISO 10993-10 o
- Delayed-Type Hypersensitivity (Sensitization) Guinea Pig Maximization Test per ISO O 10993-10

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Image /page/7/Picture/0 description: The image features the Medline logo, which consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized white cross. The cross is formed by four lines converging at a central point, creating a star-like shape. The background is a solid dark blue color, providing a strong contrast to the white logo elements. A small portion of a gray rectangle is visible on the right side of the image.

dline Industries. ne Medline Place Mundelein. II 60060

# Summary of Non-Clinical Testing (continued)

- ISO 80369-20 Testing:
- Positive Pressure Liquid Leakage O
- Stress Cracking O
- Resistance to Separation from Axial Load O
- O Resistance to Separation from Unscrewing
- Resistance to Overriding O
- Disconnection by Unscrewing o
- ISO 7886-1 Testing: ●
- Tolerance on Graduated Capacity O
- Graduated Scale: Scale, Numbering of Scale, Overall Length of Scale, Position of Scale O
- Barrel Finger Grips o
- Piston / Plunger Assembly Design O
- Fit of Piston in Barrel o
- o Fiducial line Dead Space
- Freedom from Air / Liquid Leakage o

#### Summary of Clinical Testing

Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence.

#### Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline ENFit Syringes are substantially equivalent to the predicate devices, the Covidien Kangaroo™ Enteral Feeding Syringes with ENFit connector (K142128) and the NeoMed NeoConnect™ Enteral Syringes with ENFit™ Connector and compatible NeoSecure™ Tip Caps (K152857), as described herein.

Submitted by: Stephanie Augsburg Prepared by: Jessica Rivera-Montejo