The Medline Quick Switch Valve with ENFit Connector is a multi-port connector/valve closed system indicated for controlling fluid flow (nutrition, medication and water) between ENFit compatible devices, while reducing the frequency of disconnections between the associated ENFit devices. The Medline Quick Switch Valve with ENFit Connector can be used in pediatric (infants over 10kg, children, and adolescents) and adult patients, for up to 30 days.

Device Description

The Medline Quick Switch Valve with ENFit Connector is a three-way stopcock valve intended to control fluid flow between ENFit enteral devices (i.e., Gastrostomy tubes, enteral syringes, extension sets, feeding sets) used for different enteral functions (i.e., liquid nutrition, water, or medication administration), reducing the frequency of disconnections between the associated enteral devices.

AI/ML Overview

The provided document describes the Medline Quick Switch Valve with ENFit Connector and its substantial equivalence to a predicate device, the ICU Medical Lopez Valve (K915171), rather than a study proving the device meets specific acceptance criteria with reported device performance. The testing performed is non-clinical verification and primarily focuses on demonstrating that the proposed device performs similarly to the predicate device and meets relevant ISO standards and biocompatibility requirements.

Therefore, many of the requested elements (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone algorithm performance, and specific acceptance criteria with reported device performance values) are not applicable or cannot be extracted from this type of regulatory submission. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence, not on providing detailed clinical study results or AI performance metrics.

However, I can extract information related to the performance characteristics, the type of testing performed, and the general conclusion of equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with numerical values and reported device performance against those criteria in the way envisioned for, for example, an AI diagnostic device. Instead, it refers to compliance with ISO standards and successful completion of various tests to demonstrate safety and performance equivalent to a predicate device.

The performance characteristics cited as being equivalent to the predicate device are:

Flow rate
ENFit connectors compliant with ISO 80369-3

The reported performance for these characteristics is stated as "equivalent to the predicate device" and compliance with a specific ISO standard. No specific numerical values for flow rate are provided, nor are specific numerical metrics for ENFit connector compliance beyond the reference to the standard itself.

2. Sample size used for the test set and the data provenance

Not applicable. The tests performed are non-clinical bench tests and biocompatibility tests on the device itself, not studies on a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a medical accessory, not a diagnostic tool requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a physical medical accessory (a valve), not an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is a physical medical accessory, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device's performance is compliance with international standards (e.g., ISO 80369-3 for metrology, leakage, stress cracking, resistance to separation, overriding, disconnection) and biocompatibility standards (e.g., ISO 10993-5, -10) as well as comparison to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. The device is a physical medical accessory, not an AI algorithm.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary of Testing Performed (Non-Clinical Verification):

The study (non-clinical verification) involved the following tests to demonstrate safety, performance, and functionality of the Medline Quick Switch Valve with ENFit Connector:

Biocompatibility Testing:
- E-MEM Elution Cytotoxicity Test (ISO 10993-5: 2009)
- Intracutaneous Irritation Test (ISO 10993-10: 2010)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010)
- Results: Device considered non-cytotoxic, non-sensitizing, and non-irritant.
Phthalates Testing: Confirmed device is not made with DEHP or BPA.
Bioburden Testing: Environmental controls and monitoring support safe bioburden levels.
Performance Testing (Bench) - with predicate device included for comparison:
- Metrology per ISO 80369-3
- Positive Pressure Liquid Leakage per ISO 80369-3 § 6.1.3
- Stress Cracking per ISO 80369-3 § 6.2
- Resistance to Separation from Axial Load per ISO 80369-3 § 6.3
- Resistance to Separation from Unscrewing per ISO 80369-3 § 6.4
- Resistance to Overriding per ISO 80369-3 § 6.5
- Disconnection by Unscrewing per ISO 80369-3 § 6.6
- Flow Rate
- Tensile testing
- Torque testing

Conclusion from Testing: The results demonstrated the overall safety of the proposed device and supported a substantial equivalence determination to the predicate, ICU Medical Lopez Valve (K915171).

Summary

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December 4, 2019

Medline Industries, Inc. Dinah Rincones Regulatory Affairs Specialist Three Lakes Drive Northfield, IL 60093

Re: K191759

Trade/Device Name: Medline Quick Switch Valve with ENFit Connector Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF Dated: November 5, 2019 Received: November 6, 2019

Dear Dinah Rincones:

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

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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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Shani P. Haugen, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices 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)

K191759

Device Name

Medline Quick Switch Valve with ENFit Connector

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 shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked on top of a white abstract star shape. The background is a solid dark blue color. The logo is simple and clean, and the colors are contrasting.

ledline Industries, Inc. Three Lakes Drive Northfield, II 60093

K191759 Page 1 of 8

K191759 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]

Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592

Contact Person

Dinah Rincones Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Phone: 847-949-2687 Fax: 224-931-1271 Email: DRincones@medline.com

Summary Preparation Date

November 26th, 2019

Type of 510(k) Submission

Traditional

Device Information

Type of 510(k) Submission: Traditional Device Common Name: Gastrointestinal tube valve Medline Quick Switch Valve with ENFit Connector Trade Name: Regulation Name: Gastrointestinal tube and accessories Regulation Number: 21 CFR §876.5980 Class: Class II Review Panel: Gastroenterology/Urology Product Code: PIF (Gastrointestinal tubes with enteral specific connectors)

Predicate Device

ICU Medical Lopez Valve K915171

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Image /page/4/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 white, bold sans-serif font, positioned to the left of a stylized white cross. The cross is oriented diagonally, with its arms extending outwards from the center, creating a dynamic and modern look. The overall design is clean and professional, reflecting the company's focus on healthcare solutions.

Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093

K191759 Page 2 of 8

Reference Device

Medline ENFit Syringe K160642

Dale Medical Products, Inc. Dale ACE Connector (Access Controller for Enteral) K082241

Medline ENFit Connectors K151628

Medline Enteral Feeding Sets K150286

Device Description

The Medline Quick Switch Valve with ENFit Connector is a three-way stopcock valve intended to contro

fluid flow between ENFit enteral devices (i.e., Gastrostomy tubes, enteral syringes, extension sets, feedin g sets) used for different enteral functions (i.e., liquid nutrition, water, or medication administration), reducing the frequency of disconnections between the associated enteral devices.

TABLE:1 Quick Switch Valve with ENFit Connector Offerings

Item	Description
ENFit9000S	Medline Quick Switch Valve with ENFit Connector sterile
ENFit9000NS	Medline Quick Switch Valve with ENFit Connector non-sterile

Indications for Use

Summary of Technological Characteristics

The Medline Quick Switch Valve with ENFit Connector is similar in design and technological characteristics to the predicate device cleared under K915171, ICU Medical Lopez Valve. Variations from the predicate device design are nonsignificant. The table below shows a side-by-side comparison of the key attributes associated with the proposed device and the predicate device.

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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in a bold, sans-serif font, stacked on top of a white, stylized symbol that resembles a cross or a stylized star. The logo is simple and clean, with a focus on the company name and a recognizable symbol.

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

TABLE 2: Comparison of the Proposed Device with the Predicate

Device Characteristic	Proposed Device	Predicate Device(K915171)	ComparisonAnalysis
Product Name	Medline Quick SwitchValve with ENFitConnector	ICU Medical Lopez Valve	N/A
Intended Use	Intended for use inproviding access toenteral systems withoutopening or breaking thefluid delivery lines.	Intended for use inproviding access to enteralsystems without openingor breaking the fluiddelivery lines.	Same
Indications for Use	The Medline QuickSwitch Valve with ENFitConnector is a multi-portconnector/valve closedsystem indicated forcontrolling fluid flow(nutrition, medication andwater) between ENFitcompatible devices, whilereducing the frequency ofdisconnections betweenthe associated ENFitdevices.	Note: The predicate'sdevice 510(k) Summary orIndications for UseStatement are not publiclyavailable.	N/A
Device Characteristic	Proposed Device	Predicate Device(K915171)	ComparisonAnalysis
RegulationName/Number	21 CFR §876.5980 -Gastrointestinal tube andaccessories	21 CFR §876.5980 -Gastrointestinal tube andaccessories	Same
Product Code	PIF	KNT	DifferentNote: Currently thisdevice's design hasbeen updated toinclude ENFitconnector. Refer to itspromotional materialin Appendix C.
Materials	Valve Body:PolycarbonateValve Knob: HighDensity PolyethyleneValve Plate: HighDensity PolyethyleneFemale/Mate ENFitConnector: PolycarbonateCap: PolycarbonateTether: PVC	Valve Body:Polycarbonate.Valve Core: Low lineardensity polyethylene.Cap: Polyethylene.	Similar
Design Features	Three-way stopcock.One female ENFitend/connector.	Three-way stopcock.One female ENFitend/connector.	Similar
Device Characteristic	Proposed Device	Predicate Device(K915171)	ComparisonAnalysis
	Two male ENFitends/connectors withtethered caps.On-Off 360° rotationhandle.	One male ENFitend/connector w/o cap.One male ENFitend/connector withtethered cap.On-Off 360° rotationhandle.
Product Configurations	Sterile and non-sterileconfigurations	Sterile and non-sterileconfigurations	Same
Packaging	Individually packaged ina soft poly film pouchwith Tyvek lid.	Individually packaged in asoft poly film pouch withTyvek lid.	Same
PerformanceCharacteristics	The followingperformancecharacteristics areequivalent to thepredicate device:• Flow rate• ENFit connectorscompliant withISO 80369-3	The followingperformancecharacteristics areequivalent to thepredicate device:• Flow rate• ENFit connectorscompliant withISO 80369-3	Same
Prescription vs. OTC	Prescription only	Prescription only	Same
Duration of Use	< 30 daysChange per institutionalprotocol	Acute care: < 7 days.Other care settings:May be used longer.	Different
Device Characteristic	Proposed Device	Predicate Device(K915171)	ComparisonAnalysis
	Not recommended for useover 30 days.	Note: Refer to thepredicate's promotionalmaterial in Appendix C.
Sterile vs. Non-Sterile	Sterile and non-sterileconfigurations	Sterile and non-sterileconfigurations	Same
Single Use vs. Reusable	Single use	Single use	Same
Shelf Life	Yes: 3 years	Not stated	N/A

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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized starburst symbol behind it. The starburst is white, and the background is a solid blue color. The logo is simple and modern, and it is easily recognizable.

Medline Industries, Inc. Three Lakes Drive
Northfield, IL 60093

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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, bold, sans-serif font, stacked on top of a white, stylized starburst shape. The background is a solid dark blue color. The logo is contained within a square frame.

Medline Industries, Inc. Three Lakes Drive
Northfield, IL 60093

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Image /page/8/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, stacked on top of a white symbol that resembles a stylized cross or star. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a recognizable symbol.

Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093

Summary of Testing and Supporting Information

Non-clinical verification of The Medline Quick Switch Valve with ENFit Connector has been conducted to evaluate its safety, performance and functionality. The results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination of Medline Quick Switch Valve with ENFit Connector to the predicate, ICU Medical Lopez Valve (K915171). A summary of testing is presented below.

Biocompatibility Testing

The biological evaluation for the Medline Quick Switch Valve with ENFit Connector was conducted in accordance with FDA guidance document, "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1 Biological Evaluation of the Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process."

Based on the indications for use, the proposed device has been classified as follows: Per nature of body contact Surface device, indirectly contacting mucosal membrane (gastrointestinal). Per contact duration Prolonged (>24 hours to 30 days)

Based on the proposed device indications for use, its categorization, and its material composition the following biocompatibility tests were performed on the final finished sterilized device:

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Image /page/9/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue square background. The word "MEDLINE" is written in white, bold sans-serif font. A white, stylized cross-like symbol is positioned behind the text, with its center aligned with the middle of the word "MEDLINE."

Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093

1. E-MEM Elution Cytotoxicity Test per ISO 10993-5: 2009 "Biological Evaluation of Medical Devices, Part 5: Tests for in vitro Cytotoxicity."
1. Intracutaneous Irritation Test per ISO 10993-10: 2010: "Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization."
1. Guinea Pig Maximization Sensitization Test per ISO 10993-10: 2010: "Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization."

The biocompatibility test results indicate that the Medline Quick Switch Valve with ENFit Connector is considered to be non-cytotoxic, non-sensitizing, and a non-irritant. Collectively, the test results indicate that the product meets the biocompatibility requirements and is considered safe for its intended use.

Phthalates Testing

Phthalates testing supports that the Medline Quick Switch Valve with ENFit Connector is not made with DEHP or BPA.

Bioburden Testing

The environmental controls and bioburden monitoring supports safe bioburden levels for the indications for use.

Performance Testing (Bench)

To evaluate the performance of the proposed device, the Medline Quick Switch Valve with ENFit Connector was subjected to:

Metrology per ISO 80369-3 ●
Positive Pressure Liquid Leakage per ISO 80369-3 § 6.1.3
Stress Cracking per ISO 80369-3 § 6.2
Resistance to Separation from Axial Load per ISO 80369-3 § 6.3
Resistance to Separation from Unscrewing per ISO 80369-3 § 6.4
Resistance to Overriding per ISO 80369-3 § 6.5
Disconnection by Unscrewing per ISO 80369-3 § 6.6 ●
Flow Rate* ●
. Tensile testing
o Torque testing

*Predicate device included for comparison in testing.

Performance Testing (Animal)

This section does not apply. No animal testing was performed.

Performance Testing (Clinical)

This section does not apply. No clinical testing was performed.

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Image /page/10/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked on top of a white symbol that resembles a stylized cross or star. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a recognizable symbol.

Medline Industries, Inc Three Lakes Drive Northfield, IL 60093

K191759 Page 8 of 8

Conclusion

In accordance with 21 CFR Part 807, and based on a comparison of 'Indications for Use,' technological characteristics and performance data, Medline Industries, Inc. concludes that the proposed Medline Quick Switch Valve with ENFit Connector is substantially equivalent to the predicate device, ICU Medical Lopez Valve (K915171).

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.