NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX

K100163 · Vygon Corp. · FPD · Oct 13, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K100163
• Device Name: NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
• Applicant: Vygon Corp.
• Product Code: FPD · Gastroenterology, Urology
• Decision Date: Oct 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.

Device Story

Nutrisafe 2 Feeding Tube is a product line extension of existing enteral feeding tubes. Device features unique non-luer safety connectors designed to prevent accidental misconnection with intravenous systems; locking mechanism secures connection, while manual unscrewing allows for disconnection. Available in 14F, 16F, and 18F sizes. Used in clinical settings for enteral nutrition delivery. Device provides a physical barrier against hazardous misconnections, enhancing patient safety during feeding procedures.

Clinical Evidence

Bench testing only. In-vitro verification confirmed that the product line extension meets all specifications and intended use requirements.

Technological Characteristics

Enteral feeding tubes with non-luer safety connectors. Available in 14F, 16F, and 18F sizes. Materials and design are identical to the predicate device. Mechanical locking hub mechanism.

Indications for Use

Indicated for nasogastric or oralgastric enteral feeding in patients requiring such access. Incorporates safety connectors to prevent misconnection with intravenous lines.

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

• Nutrisafe 2 Feeding Tubes (K060944)

Submission Summary (Full Text)

{0}------------------------------------------------

| | PREMARKET NOTIFICATION<br>510(k) SUMMARY |
|----------------------|------------------------------------------------------------------------------------------------|
| | (As Required By 21 CFR §807.92) |
| 510k number: | K100163 |
| Applicant: | Vygon<br>103A Park Dr<br>Montgomeryville, PA 18936 |
| Contact Name: | Cindy Varughese<br>Sr. Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Trade Name: | Nutrisafe 2 Feeding Tube |
| Common Name: | Tubes, Feeding |
| Regulation Number: | 876.5980 |
| Product Code: | FPD |
| Classification Name: | Gastrointestinal tube and accessories devices, 21 CFR §876.5980 |
| Regulatory Class: | Class II |
| Predicate Device: | Nutrisafe 2 Feeding Tubes, K060944 |
| Date Prepared: | March 15, 2011 |

### Device Description:

The Nutrisafe 2 feeding tubes are a product line extension to the existing Nutrisafe 2 feeding tubes. The subject feeding tubes are available in several sizes and in two materials. The feeding system contains a unique connection that does not incorporate a luer, reducing the risk of inadvertently connecting to intravenous connectors. The locking connection reduces the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections.

#### Intended Use:

For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.

### Technology Characteristics:

The subject Nutrisafe 2 feeding tubes have the same technological characteristics of the predicate device with the exception of the size of the tubes. The subject devices are 14, 16, and 18F, while the predicate devices range from 4F-12F. The technological characteristics are substantially equivalent to the predicate device.

## Non-Clinical Summary:

Non-clinical verification of Nutrisafe 2 Feeding Tubes was conducted through in-vitro bench testing. Results of this testing indicate that the Nutrisafe 2 Feeding Tube product line extension meets all specifications and intended use.

15 March 2011

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Ms. Cindy Varughese Sr. Regulatory Affairs Manager Vygon 103A Park Drive MONTGOMERYVILLE PA 18936

OCT 1 3 2011

Re: K100163

Trade/Device Name: Nutrisafe 2 Feeding Tube Regulation Number: 21 CFR\$ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD Dated: September 20, 2011 Received: September 21, 2011

Dear Ms. Varughese:

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. 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

{2}------------------------------------------------

### Page 2

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lemmering

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known):

K100163

Device Name:

Indications For Use:

Nutrisafe 2 Feeding Tube

For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.

Prescription Use X

AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Avon M

(Division Sign Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Page 1 of