The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) for patients in all age groups.

Device Description

The Enteral Syringe with ENFit Connector (10 ml to 60 ml) and the Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) are both sterile, standard piston style enteral syringes with an integrated female ENFit compatible connector compliant to the requirements of ISO DIS 80369-3, First Edition, Small-bore Connectors for Liquids and Gases in Healthcare Applications – Part 3: Connectors for Enteral Applications and designed to be compatible with male ENFit connectors.

The Enteral Syringe with ENFit Connector has capacities of 10, 20, 30 and 60 ml and is available in two different connector confiqurations: Centerline and Offset.

The Enteral Syringe with ENFit Low Dose Tip is a low dose syringe and has capacities of 1. 3 and 5 ml. The ENFit Lose Dose tip is a modification of the ENFit connector designed for the delivery of low doses of fluids for enteral feeding.

AI/ML Overview

The document describes the VR Medical Technology's Enteral Syringe with ENFit® Connector and Enteral Syringe with ENFit® Low Dose Tip. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria in the context of an effectiveness study for an AI/ML device.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of device submission. This document focuses on demonstrating compliance with recognized standards and biocompatibility.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table comparing acceptance criteria to device performance in the way typically seen for AI/ML device effectiveness studies. Instead, it lists various performance tests conducted according to international standards (ISO). The "acceptance criteria" are implied by compliance with these standards, and the "reported device performance" is indicated by the statement that these tests were "conducted" and supported a conclusion of substantial equivalence.

Performance Test (as per ISO standard)	Implied Acceptance Criteria	Reported Device Performance
Biocompatibility Testing
Cytotoxicity (ISO 10993-5)	Pass ISO 10993-5	Conducted, met standard
Sensitization (ISO 10993-10)	Pass ISO 10993-10	Conducted, met standard
Irritation (ISO 10993-10)	Pass ISO 10993-10	Conducted, met standard
Tests per ISO 7886-1
Cleanliness	Pass ISO 7886-1	Conducted, met standard
Lubricant	Pass ISO 7886-1	Conducted, met standard
Position of scale	Pass ISO 7886-1	Conducted, met standard
Tolerance on graduated capacity	Pass ISO 7886-1	Conducted, met standard
Dead space	Pass ISO 7886-1	Conducted, met standard
Fit of piston in barrel	Pass ISO 7886-1	Conducted, met standard
Slide force test	Pass ISO 7886-1	Conducted, met standard
Freedom from air and liquid leakage	Pass ISO 7886-1	Conducted, met standard
Limits for acidity or alkalinity	Pass ISO 7886-1	Conducted, met standard
Limits of extractable metals	Pass ISO 7886-1	Conducted, met standard
Printing Firmness	Pass ISO 7886-1	Conducted, met standard
Tests per ISO DIS 80369-3
Dimensional verification	Pass ISO DIS 80369-3	Conducted, met standard
Positive pressure liquid leakage	Pass ISO DIS 80369-3	Conducted, met standard
Stress cracking	Pass ISO DIS 80369-3	Conducted, met standard
Resistance to separation from axial load	Pass ISO DIS 80369-3	Conducted, met standard
Resistance to separation from unscrewing	Pass ISO DIS 80369-3	Conducted, met standard
Resistance to overriding	Pass ISO DIS 80369-3	Conducted, met standard
Disconnection by unscrewing	Pass ISO DIS 80369-3	Conducted, met standard
For ENFit Connector
Risk Assessment (ISO 14971)	Compliant with ISO 14971	Conducted, compliant
For ENFit Low Dose Tip
Low Dose Tip Misconnection Risk Management Reports	Addressed misconnection risks	Conducted, addressed risks
Usability Study for Low Dose Tip Design Feature	Usability validated	Conducted, validated

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. For physical device testing against standards, specific sample sizes are typically defined within the test protocols associated with the ISO standards, but these details are not presented here. Data provenance is also not relevant in the context of these physical performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this is a physical device, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth on patient data. The "ground truth" here is compliance with engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as this is a physical device, not an AI/ML diagnostic or prognostic tool.

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

This information is not applicable as this device is a physical enteral syringe, not an AI/ML system or a medical imaging device that would involve human readers.

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

This information is not applicable as this device is a physical enteral syringe, not an algorithm.

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

The "ground truth" in this context is the predefined requirements and specifications within the referenced ISO standards (ISO 10993-5, ISO 10993-10, ISO 7886-1, ISO DIS 80369-3, ISO 14971) and demonstrated through the physical performance and biocompatibility testing. In the case of the Usability Study, the "ground truth" would be the successful and safe use of the device by representative users.

8. The sample size for the training set

This information is not applicable as this is a physical device, not an AI/ML system that requires a "training set."

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

This information is not applicable as this is a physical device, not an AI/ML system.

Summary

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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

September 22, 2016

VR Medical Technology Company % Korina A. Akhondzadeh Regulatory Consultant to VR Medical Technology KARA & Associates 6965 El Camino Real, Suite 105-428 Carlsbad. CA 92009

Re: K162188

Trade/Device Name: Enteral Syringe with ENFit® Connector (10 ml to 60 ml), Enteral Syringe with ENFit® Low Dose Tip (1 ml To 5 ml) Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: August 1, 2016 Received: August 4, 2016

Dear Korina A. Akhondzadeh:

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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Page 2 - Korina A. Akhondzadeh

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,

Joyce M. Whang -S

for 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K162188

Device Name

Enteral Syringe with ENFit® Connector (10 ml to 60 ml) Enteral Syringe with ENFit® Low Dose Tip (1 ml to 5 ml)

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)

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 PRAStaff(@fda.hhs.gov

"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."

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Image /page/3/Picture/0 description: The image shows a logo for VR Medical. The logo features the letters "VR" in a stylized font, with a green plus sign above the "V". A green and blue curved line is below the letters. The words "VR Medical" are printed in black below the logo.

510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

I.	SUBMITTER	VR Medical Technology90 Gao Xin Road, ZhouZhuangKunshan 215325CHINATel: +86 512 5720 0660 (China)
	Contact:Email:	Lee Pan, Ph.D., CEOlpan@vrmedical.net
	Official Correspondent	Korina A. AkhondzadehKARA & Associates - Regulatory Consultant to VRMedical Technology6965 El Camino Real, Suite 105-428Carlsbad, CA 92009Tel: 760-798-9642Fax: 760-798-9643
	Email	korina@karaandassociates.com
	Date Prepared:	August 1, 2016
II.	DEVICE
	Device Name:	Enteral Syringe with ENFit Connector (10 ml to 60 ml)and Enteral Syringe with ENFit Low Dose Tip (1 ml to ml)
	Common/Usual Name:	Enteral Syringe
	Classification Name:	Gastrointestinal tube and accessories
	Product Code:	PNR
	Class:	II

III. PREDICATE DEVICE

Predicate Device

Neoconnect Oral/Enteral Syringes with ENFit Connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit Connector (0.5 mL to 6 mL), K161039

This predicate device has not been subject to a recall.

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Image /page/4/Picture/0 description: The image shows a logo for VR Medical. The logo features the letters "VR" in a stylized font, with the "V" and "R" connected. The letters are in a dark blue color. A green medical cross is positioned above the "VR" letters. A green and blue curved line is below the letters, giving the impression of a horizon or base. The text "VR Medical" is written in black below the logo.

DEVICE DESCRIPTION IV.

The Enteral Syringe with ENFit Connector has capacities of 10, 20, 30 and 60 ml and is available in two different connector confiqurations: Centerline and Offset.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both the subject Enteral Syringe with ENFit Connector (10 ml to 60 ml) and Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) devices and predicate Oral/Enteral Syringes with ENFit Connector (12 ml to 100 ml) and Low Dose Tip Oral/Enteral Syringes with ENFit Connector (0.5 ml to 6 ml) devices are a standard piston-style syringe with an integral female ENFit Connector. The ENFit Connector for both the VR Medical and NeoMed devices were designed to be compliant with ISO DIS 80369-3, First Edition, Small-bore Connectors for Liquids and Gases in Healthcare Applications – Part 3: Connectors for Enteral Applications.

Both the Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) and predicate Low Dose Tip Oral/Enteral Syringes with ENFit Connector (0.5 ml to 6 ml) incorporate the same ENFit low dose tip design to ensure accuracy when dispensing small volumes.

The ENFit connectors on both the subject and predicate devices are compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to prevent misconnections to non-enteral devices. Both the subject and predicate devices are available in both sterile and non-sterile versions.

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Image /page/5/Picture/0 description: The image shows a logo for VR Medical. The logo features the letters "VR" in a stylized, interconnected design, with the "V" and "R" sharing a common vertical stroke. The letters are in a dark blue color. Above the "VR" is a green cross, commonly associated with medical services. Below the letters, the words "VR Medical" are written in a simple, sans-serif font.

VII. PERFORMANCE DATA

The following performance testing was conducted on the Enteral Syringe with ENFit Connector (10 ml to 60 ml) and the Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml).

Biocompatibility Testing

Cytotoxicity per ISO 10993-5 ●
Sensitization per ISO 10993-10 ●
Irritation per ISO 10993-10

Performance Testing

Tests per ISO 7886-1: Cleanliness Lubricant Position of scale Tolerance on graduated capacity Dead space Fit of piston in barrel Slide force test Freedom from air and liquid leakage Limits for acidity or alkalinity Limits of extractable metals

Tests per ISO DIS 80369-3:

Dimensional verification Positive pressure liquid leakage Stress cracking Resistance to separation from axial load Resistance to separaion from unscrewing Resistance to overriding Disconnection by unscrewing

Printing Firmness

For the Enteral Syringe with ENFit Connector

Risk Assessment per ISO 14971 ●
For the Enteral Syringe with ENFit Low Dose Tip
Low Dose Tip Misconnection Risk Management Reports ●
. Usability Study for Low Dose Tip Design Feature

VIII. CONCLUSIONS

The Enteral Syringe with ENFit Connector (10 to 60 ml) and the Enteral Syringe with ENFit Low Dose Tip (1 to 5 ml) are substantially equivalent to the predicate Oral/Enteral Syringes with ENFit Connector (12 ml to 100 ml) and Low Dose Tip Oral/Enteral Syringes with ENFit Connector (0.5 ml to 6 ml) devices.

VR Medical 510(k) for Enteral Syringe with ENFit/ENFit Low Dose Tip

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.