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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medline ENFit Syringe, structured according to your request. However, it's important to note that this document is a 510(k) summary, not a detailed study report. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria with detailed study designs and outcomes. Therefore, some of your requested information (like specific effect sizes for MRMC studies, sample sizes for training sets, and detailed expert qualifications) is not present in this type of FDA submission document.

Acceptance Criteria and Study for Medline ENFit Syringe (K160642)

The Medline ENFit Syringe's acceptance criteria and performance are primarily evaluated through its substantial equivalence to predicate devices, demonstrating its safety and effectiveness through adherence to established standards (ISO 80369-20 and ISO 7886-1) and general non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary, explicit numerical acceptance criteria with precise performance outcomes are generally not provided in this format. Instead, the document states that tests were conducted according to specified ISO standards and that the results "demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination." The performance is implied to have met the requirements of these standards.

Test / Acceptance Criteria (Implied by Standard)	Reported Device Performance (Implied)
ISO 80369-20 Testing (Syringe Tip / ENFit female connector)	(Implied to meet standard requirements for)
Positive Pressure Liquid Leakage	Satisfactory (meets standard)
Stress Cracking	Satisfactory (meets standard)
Resistance to Separation from Axial Load	Satisfactory (meets standard)
Resistance to Separation from Unscrewing	Satisfactory (meets standard)
Resistance to Overriding	Satisfactory (meets standard)
Disconnection by Unscrewing	Satisfactory (meets standard)
ISO 7886-1 Testing (Syringe)	(Implied to meet standard requirements for)
Tolerance on Graduated Capacity	Satisfactory (meets standard)
Graduated Scale (Scale, Numbering, Overall Length, Position)	Satisfactory (meets standard)
Barrel Finger Grips	Satisfactory (meets standard)
Piston / Plunger Assembly Design	Satisfactory (meets standard)
Fit of Piston in Barrel	Satisfactory (meets standard)
Fiducial line Dead Space	Satisfactory (meets standard)
Freedom from Air / Liquid Leakage	Satisfactory (meets standard)
Other Non-Clinical Testing	(Implied to pass, supporting substantial equivalence)
Enteral Connector Misconnection Assessment Study	Acceptable
Human Factors Validation Study: Enteral Connectors Final Report	Acceptable
PG-Lock Misconnection Data with Failure Modes and Effects Analysis (FMEA)	Acceptable
Internal Risk Analysis	Acceptable
Bioburden Testing	Acceptable
Metrology Testing	Acceptable
Stability (Shelf-Life) Testing	Acceptable
Biocompatibility Testing (Cytotoxicity, Irritation, Delayed-Type Hypersensitivity)	Acceptable (per ISO 10993-5 and ISO 10993-10)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated in this 510(k) summary. The summary only lists the types of tests performed (e.g., ISO 80369-20, ISO 7886-1, Biocompatibility). The sample sizes would have been determined by the requirements of the specific ISO standards or internal protocols for each test.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given that these are non-clinical (laboratory and engineering) tests, the data would generally be prospective from controlled test environments.

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

This information is not applicable as the studies described are non-clinical engineering and laboratory tests (e.g., liquid leakage, stress cracking, biocompatibility), not studies requiring expert interpretation of medical images or patient data to establish "ground truth." The "truth" for these tests is determined by adherence to physical performance metrics defined by international standards.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective interpretations (e.g., by experts) where disagreements need resolution. These are objective engineering and biological tests.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence."
Effect size of human reader improvement: Not applicable, as no such study was performed.

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

Yes, standalone performance was assessed through non-clinical testing. The summarized studies (ISO compliance, misconnection assessment, human factors validation, risk analysis, bioburden, metrology, stability, biocompatibility) evaluate the device's intrinsic characteristics and performance independent of a human operator's variable performance in a clinical diagnostic or interpretive context. For example, liquid leakage and stress cracking tests evaluate the device's physical integrity directly.

7. Type of Ground Truth Used

The "ground truth" for these non-clinical tests is established by:

International Standards: The requirements and methodologies laid out in ISO 80369-20 (Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods) and ISO 7886-1 (Sterile hypodermic syringes for single use — Part 1: Syringes for manual use).
Engineering Specifications: Internal design specifications and performance limits for metrology, stability, and other functional tests.
Biological Endpoints: For biocompatibility, the ground truth is the absence of cytotoxicity, irritation, or sensitization as defined by ISO 10993 standards.

8. Sample Size for the Training Set

This information is not applicable because the device itself (Medline ENFit Syringe) is a physical medical device, not an AI algorithm or software that requires a training set. The term "training set" typically refers to data used to train machine learning models.

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

This information is not applicable for the same reason as point 8.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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/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: 847-643-3690 Email: SAugsburg@medline.com

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

Indications for Use

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.

DeviceCharacteristic	Proposed Device	Predicate Device	Predicate Device	ComparisonAnalysis
Product Name	Medline ENFit Syringe	NeoMed NeoConnectTMEnteral Syringes withENFitTM Connector andcompatible tip caps	Covidien KangarooTMEnteral Feeding Syringeswith ENFit	Similar
Product Owner	Medline Industries, Inc.	NeoMed	Covidien	Different
Product Code	PIF	PIF	PIF	Same
Intended Use	The Medline ENFit Syringeis intended to be used inclinical or home care	NeoMed NeoConnectTMEnteral Syringes withENFitTM Connector and	The KangarooTM EnteralFeeding Syringe withENFit Connector delivers	Same

	settings by users rangingfrom clinicians tolaypersons (under thesupervision of a clinician) tomeasure and administerenteral nutrition.	compatible tip caps areindicated for use as adispenser, a measuringdevice and a fluid transferdevice intended to be usedin clinical or home caresettings by users rangingfrom clinicians tolaypersons (under thesupervision of a clinician)in all age groups.	nutritional formulato the gastrointestinalsystem of a patient who isphysically unable to eatand swallow. Thefeeding syringes areintended to be used inclinical or home caresettings by users rangingfrom laypersons toclinicians (under thesupervision of aclinician), to administerenteral nutrition. Thesyringe is intended for allage groups.
RegulationNumber	21 CFR 876.5980	21 CFR 876.5980	21 CFR 876.5980	Same
Design Features	3 piece design syringe withcap	3 piece design syringewith or without cap	3 piece design syringe	Similar
DesignConfigurations	60 ml non-sterile	0.5 - 100 mL	Not specified in 510(k)summary	Similar
Materials	Polypropylene translucentbarrel and plunger rod	Translucent barrel	Not specified in 510(k)summary	Similar
Prescription vs.OTC	Prescription	Prescription	Prescription	Same
ContactDurations	≤ 24 hours	≤ 24 hours	≤ 24 hours	Same
Sterile vs. Non-Sterile	Non-Sterile	Non-Sterile and Sterile	Not specified in 510(k)summary	Similar
Single Use vs.Reusable	Single Use	Single Use	Single Use	Same
Disposable vs.Non-Disposable	Disposable	Disposable	Disposable	Same
Syringe Tip(ISO 80369-3ENFit) femaleconnector	Liquid Leakage TestingStress CrackingResistance to separationfrom axial loadResistance to separationfrom unscrewingResistance to overriding	Liquid Leakage TestingStress CrackingResistance to separationfrom axial loadResistance to separationfrom unscrewingResistance to overriding	Fluid LeakageStress CrackingResistance to separationfrom axial loadResistance to separationfrom unscrewingResistance to overriding	Same
	Disconnection byunscrewing	Disconnection byunscrewing	Disconnection byunscrewing
ISO 7886Syringe Testing	Tolerance on GraduatedCapacityGraduated Scale: Scale,Numbering of Scale,Overall Length of Scale,Position of ScaleBarrel Finger GripsPiston / Plunger AssemblyDesignFit of Piston in BarrelFiducial line Dead SpaceFreedom from Air / LiquidLeakage	Capacity ToleranceGraduated ScalePiston Fit in BarrelAir and Liquid LeakageTesting	Not specified in 510(k)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

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
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).(b)
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.