The Gabriel 3-way EnFit valve is a three-way closed system valve with three ports for control of fluid flow (nutrition, medication and water) between devices with EnFit connectors and catheter tip syringe. It can be used in pediatric, adult and elderly patients, for up to 7 days.

Device Description

The Gabriel 3-way EnFit Valve is a three-way stopcock valve that is intended to control fluid flow between enteral devices (feeding tubes and feeding lines) with EnFit compatible connectors in a closed system fashion that reduces the need for frequent connection of the EnFit ports. It has one male EnFit port, one female EnFit port and one catheter tip port. The catheter tip port can be used for flushing and administration of medication using a catheter tip syringe. The male EnFit port is provided with a tethered cap and the catheter tip port is provided with a tethered cap. The ability to use a catheter tip syringe for flushing and administration of medicine in health care facilities that do not carry EnFit syringes, may facilitate adoption of feeding tubes and feeding lines with EnFit connectors.

AI/ML Overview

The provided text describes a medical device, the "Gabriel 3-Way EnFit Valve," and its 510(k) submission to the FDA. However, this document does not contain information about an AI/ML-enabled device or its acceptance criteria and study results for such a device.

The document primarily focuses on demonstrating substantial equivalence of a physical medical device (a 3-way valve) to a predicate device based on design, materials, intended use, and bench testing for mechanical performance and biocompatibility.

Therefore, I cannot answer the questions related to AI/ML acceptance criteria, performance studies (like MRMC or standalone performance), ground truth establishment, sample sizes for training/test sets, or expert qualifications/adjudication. These concepts are not discussed in the provided text.

The closest information provided is the summary of bench testing for the physical valve. Below is a table of the acceptance criteria (stated as "PASS" for each test) and the reported device performance from the document.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied by "PASS")	Reported Device Performance
Male EnFit Measurement Verification Test	Meets specified measurements for male EnFit connectors	PASS
Female EnFit Measurements Verification Test	Meets specified measurements for female EnFit connectors	PASS
Catheter Tip Port Measurement Verification Test	Meets specified measurements for catheter tip ports	PASS
Tensile Test	Withstands specified tensile forces	PASS
Cytotoxicity test	Non-cytotoxic	PASS
Sensitization Test	Non-sensitizing	PASS
Irritation Test	Non-irritant	PASS
Leakage by Pressure Decay Test	No leakage under pressure decay conditions	PASS
Positive Pressure Liquid Leakage Test	No leakage under positive pressure liquid conditions	PASS
Stress Cracking Test	Resistant to stress cracking	PASS
Resistance to Separation from Axial Load Test	Resists separation from axial load	PASS
Resistance to Separation from Unscrewing Test	Resists separation from unscrewing	PASS
Thread Overriding Resistance Test	Resistant to thread overriding	PASS
Disconnection by Unscrewing Test	Resists disconnection by unscrewing	PASS
Flexure modulus	Above 700 Mpa	PASS
Feeding Formula Flow Rate Test	Achieves specified feeding formula flow rate	PASS

The following information is NOT available in the provided text, as it pertains to AI/ML device studies, which this document does not describe:

Sample sizes used for the test set and the data provenance: Not applicable, no AI/ML test set described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no ground truth for image/data interpretation described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 versus without AI assistance: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 5, 2020

Syncro Medical Innovations, Inc. Sabry Gabriel MD. President 515 Mulberry Street Macon, GA 31201-6308

Re: K201741 Trade/Device Name: Gabriel 3 Way EnFit Valve Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF Dated: October 26, 2020 Received: October 30, 2020

Dear Sabry Gabriel:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

Shanil P. Haugen, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K201741

Device Name

Gabriel 3-Way EnFit Valve

Indications for Use (Describe)

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

V | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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5. 510(k) Summary

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

5.1 Submitter Information

Company:	Sabry GabrielMD, PresidentSyncro Medical Innovations, Inc.515 Mulberry StreetMacon, GA 31201-6308 USATelephone: (478)-335-8311Fax: (716)-809-3504sabrygabriel@syncromedical.com
Contact:	Sabry GabrielMD, PresidentSyncro Medical Innovations, Inc.515 Mulberry StreetMacon, GA 31201-6308 USATelephone: (478)-335-8311Fax: (716)-809-3504sabrygabriel@syncromedical.com
Date Summary Prepared:	October 26, 2020

5.2 Name of the Device

Trade Name:	Gabriel 3-Way EnFit Valve (K201741)
Common Name:	Stopcock, 3-way valve. Gastrointestinal Tubes With Enteral Specific Connector andAccessories
ClassificationName:	Gastrointestinal tube and accessories
Review Panel:	Gastroenterology & Urology (GU)
Regulation:	876.5980
Class:	Class II
Product Code:	PIF

5.3 Equivalence Claimed to Predicate Device

The Gabriel 3-Way EnFit Valve (K201741) is equivalent to the LOPEZ VALVE TM II (K915171), manufactured by ICU MEDICAL, INC..

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5.4 Basis for Substantial Equivalence

The device has identical intended use, intended population, material and functionality as the predicate device "Lopez Valve" (K915171), cleared on 02/07/1992 and its' updated version with EnFit ports.

It is intended to control fluid flow (nutrition, medication and water) between EnFit compatible devices and catheter tip syringe, without frequent connection and disconnection of the associated devices.

The device passed all mechanical and biocompatibility tests listed in subsequent sections.

5.5 Legally Marketed Device to Which the proposed Device is Substantially Equivalent (Predicate Device):

ICU Medical Lopez Valve (K915171)

5.6 Device Description

5.7 Indication for use

5.8 Summary of Technologic Characteristics

The Gabriel 3-way EnFit valve 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.

Table 5.1: Table 1: Comparison of the proposed and Predicate Device
Attribute	Proposed Device (K201741)	Predicate Device(K915171)	ComparisonAnalysis
Product Name	Gabriel 3-way EnFit valve	ICU Medical Lopez Valve	N/A
Intended Use	Intended for use in providing access toenteral systems without opening or	Intended for use inproviding access to enteralsystems without opening or	Same
	disconnecting the fluid delivery lines.	disconnecting the fluid delivery lines.	K201Page

Indication forUse	The Gabriel 3-way EnFit valve is a three-way closed system valve with three ports for control of fluid flow (nutrition, medication and water) between devices with EnFit connectors and catheter tip syringe. It can be used in pediatric, adult and elderly patients, for up to 7 days.	Note: The predicate's device 510(k) Summary or Indications for Use Statement are not publicly available.	N/A
RegulationName/Number	21 CFR/876.5980- Gastrointestinal tube and accessories	21 CFR/876.5980- Gastrointestinal tube and accessories	Same
Product Code	PIF	KNT	DifferentNote: Currently the predicate device's design has been updated to include EnFit connector. Refer to its promotional material
Materials	Valve Body: CopolyesterValve Knob: High Density Polyethylene (HDPE)Valve Ports: Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS)Male EnFit Port Cap: ABSCatheter port Cap and Tether: PolyolefinMale EnFit Cap Tether: PVC	Valve Body: PolycarbonateValve Core: Low Linear density polyethylene.Cap: Polyethylene.	Similar
DesignFeatures	Three-way stopcock with:One rigid male EnFit port with tethered cap.One rigid female EnFit port.One rigid female catheter tip port with	Three way stopcock with:One rigid male catheter tip port, one rigid female catheter tip port, one flexible female catheter tip port and On-Off 360° rotation handle .Note: The updated three-way EnFit Lopez valve	Similar
	tethered cap.On-Off 360° rotation handle.	has: One male EnFit portwith tethered cap, onemale EnFit port withoutcap, one female EnFit portand On-Off 360° rotationhandle.	K201741Page 4 of
ProductConfiguration	Non-sterile	Sterile and non-sterileconfiguration	Different
Packaging	Individually packaged in s soft poly filmpouch.	Individually packaged insoft poly film pouch.	Same
PerformanceCharacteristics	The following performancecharacteristics are equivalent to thepredicate device:• Flow rate• EnFit connectors compliant withISO 80369-3• Dimensional verification test of themale EnFit port, female EnFit portand catheter tip port.• Tensile test	The following performancecharacteristicsare equivalent to theproposed device:• Flow rate• EnFit connectorscompliant with ISO80369-3	Same
Prescriptionvs. OTC	Prescription only	Prescription only	Same
Duration ofUse	Less than 7 daysChange valve per institutional protocoland as needed.	Acute care: less than 7daysOther care settings:May be used longer.	Same
Single Use vs.Reusable	Single use	Single use	Same
Shelf Life	One year	Not stated	N/A

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5.9 Summary of Testing (Bench)

Non-clinical verification of the Gabriel 3-way EnFit valve has been conducted on devices that were manufactured 12 months earlier 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 to the predicate , ICU Medical Lopez Valve (K915171). A summary of testing is presented below.

Male EnFit Measurement Verification Test (PASS)

Female EnFit Measurements Verification Test (PASS)

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Catheter Tip Port Measurement Verification Test (PASS)

Tensile Test (PASS)

Cytotoxicity test (PASS)

Sensitization Test (PASS)

Irritation Test(PASS)

Leakage by Pressure Decay Test (PASS)

Positive Pressure Liquid Leakage Test (PASS)

Stress Cracking Test (PASS)

Resistance to Separation from Axial Load Test (PASS)

Resistance to Separation from Unscrewing Test (PASS)

Thread Overriding Resistance Test (PASS)

Disconnection by Unscrewing Test (PASS)

Flexure modulus above 700 Mpa (PASS)

Feeding Formula Flow Rate Test (PASS)

5.10 Biocompatibility Testing

The following biocompatibility tests were conducted on the entire Gabriel 3-way EnFit valve per ISO 10993-1:

Cytotoxicity test (PASS).
Sensitization test(PASS)
Irritation test (PASS).

The biocompatibility test results indicates that the Gabriel 3-way EnFit Valve is considered to be non-cytotoxic. non-sensitizing, and non-irritant. Collectively, the test results indicate that the product meets the biocompatibility requirements and is considered safe for its intended use.

5.11 Conclusions Drawn from Non-Clinical Testing

The results of comparison of design, material, intended use, technological characteristics and bench tests demonstrate that the proposed device is as safe, as effective, and performs as the identified predicated legally marketed device (K915171) and supports a determination of substantial equivalence.

5.12 Performance Testing (Animal)

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

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5.13 Performance Testing (Clinical)

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

5.14 Conclusion

The Gabriel 3-way EnFit Valve is substantially equivalent to the predicate ICU Medical Lopez Valve (K915171). Based on the indication for use, principal of operation, performance characteristics, and technological characteristics, the proposed Gabriel 3-way EnFit valve is substantially equivalent to, and as safe, as effective, and performs as the legally marketed predicate device.

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.