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

K162188 · Vr Medical Technology · PNR · Sep 22, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: 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)
• Applicant: Vr Medical Technology
• Product Code: PNR · Gastroenterology, Urology
• Decision Date: Sep 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Sterile, piston-style enteral syringes; capacities 1-60 ml; integrated female ENFit connector. Used for dispensing, measuring, and transferring enteral fluids. Operated by clinicians or laypersons in clinical/home settings. ENFit connector design prevents misconnections to non-enteral devices; low-dose tip variant ensures accuracy for small volumes. Output is manual fluid delivery; benefits include safe, accurate enteral administration and prevention of tubing misconnections.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5, -10), performance per ISO 7886-1 (cleanliness, scale tolerance, leakage, slide force), and ISO DIS 80369-3 (dimensional verification, pressure leakage, stress cracking, resistance to separation/overriding). Usability study conducted for low-dose tip design feature.

Technological Characteristics

Piston-style syringe; female ENFit connector compliant with ISO DIS 80369-3. Available in centerline/offset configurations. Materials biocompatibility per ISO 10993. Sterile and non-sterile versions. Manual operation; no energy source or software.

Indications for Use

Indicated for patients of all age groups requiring enteral fluid delivery; used 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

• 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)

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 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 [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,

# 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)

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.

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 Technology<br>90 Gao Xin Road, ZhouZhuang<br>Kunshan 215325<br>CHINA<br>Tel: [phone] (China) |
|-----|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact:<br>Email: | Lee Pan, Ph.D., CEO<br>[e-mail] |
| | Official Correspondent | Korina A. Akhondzadeh<br>KARA & Associates - Regulatory Consultant to VR<br>Medical Technology<br>6965 El Camino Real, Suite 105-428<br>Carlsbad, CA 92009<br>Tel: [phone]<br>Fax: [phone] |
| | Email | [e-mail] |
| | Date Prepared: | August 1, 2016 |
| II. | DEVICE | |
| | Device Name: | Enteral Syringe with ENFit Connector (10 ml to 60 ml)<br>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 (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.

#### V. INDICATIONS FOR USE

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.

#### 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