NUTRISAFE 2

K060944 · Vygon Corp. · FPD · Sep 15, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060944
• Device Name: NUTRISAFE 2
• Applicant: Vygon Corp.
• Product Code: FPD · Gastroenterology, Urology
• Decision Date: Sep 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.

Device Story

Nutrisafe 2 is a system of enteral feeding tubes, syringes, and accessories designed to prevent accidental IV administration. The device features a unique, non-luer locking connection mechanism that prevents involuntary disconnection and eliminates the risk of misconnection to IV systems. The system is used for nasogastric or oralgastric feeding in clinical settings. It does not require specialized training as it maintains standard end-user techniques. The locking hub is secured by screwing and released by unscrewing. The device benefits patients by mitigating risks associated with medication/nutrition delivery errors.

Clinical Evidence

Bench testing only. Biocompatibility testing confirmed materials are non-irritant and non-toxic. Performance testing verified that design changes do not adversely affect safety or efficacy. Risk assessment performed per ISO 14971.

Technological Characteristics

Materials: DEHP-free PVC, Polyurethane, and Silicone. Connection: Unique non-luer locking hub. Form factor: Feeding tubes, syringes, and accessories. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients requiring nasogastric or oralgastric enteral feeding.

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 (K991918/ K003311)
• Vygon Enteral Nutrition Tube (K820176)

Submission Summary (Full Text)

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## 510K Summary

SEP 1 5 2006

### Date of Preparation: March 28, 2006

| Applicant: | Vygon Corporation<br>2495 General Armistead Ave.<br>Norristown, PA 19403 |
|------------------------|--------------------------------------------------------------------------|
| Contact Individual: | Courtney Smith, Regulatory Affairs Manager<br>610-539-9300 Ext. 110 |
| Trade Name: | Nutrisafe 2 |
| Common Name: | Feeding tube |
| Regulation Number: | 876.5980 |
| Product Code: | FPD |
| Classification Name: | Gastrointestinal tube and accessories devices |
| Classification: | Class II |
| Predicate Device Name: | Nutrisafe (K991918/ K003311), Vygon Enteral Nutrition Tube (K820176) |

The Nutrisafe 2 is a complete system of feeding tubes and accessories. Device Description: The feeding tubes are available in several configurations and in three materials: DEHP-free PVC, Polyurethane, and Silicone. A recent report in the FDA Patient Safety News: Show #46, December 2005, discussed the risks associated with health care personnel mistakenly connecting the wrong devices to the wrong luer connection. Often, this kind of error can result in fatal results. One of the benefits of the Nutrisafe 2 is that the connection does not incorporate a luer, and thus eliminating the risk of inadvertently connecting the system to an IV system. The Nutrisafe 2 feeding tube features a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections. Another benefit of the Nutrisafe 2 is that it does not change the technique of the end-user, and therefore it does not require any special training.

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K060944
page 2 of 2

The Nutrisafe 2 consists of the following:

| Description | Reference |
|-------------------------------------|------------------------------------------------------------------------------|
| Feeding Tubes | 361.xxx, 362.xxx, 363.xxx, 1361.xxx, 1362.xxx,<br>1363.xxx, 2332.xxx2395.xxx |
| Syringes and Syringe<br>Accessories | 1015.xxx, 818.xxx, 828.xxx |
| Accessories | 368.xxx, 5802.xx |
| Sampling Devices | 821.xxx, 817.xxx |

For nasogastric/oralgastric enteral feeding, incorporating safety connectors Intended Use: which eliminates the risk of IV administration through the feeding tube

Technology Characteristics: The Nutrisafe 2 feeding tubes are available in several configurations and in three materials: DEHP-free PVC, Polyurethane, and Silicone. Additional the feeding system contains a unique connection does not incorporate a luer. The locking connection eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections.

### Summary of Design Control Activities:

Biocompatibility testing of the material demonstrates that it is non-irritant and non-toxic. Performance testing demonstrates that the changes do not affect safety or efficacy. Risk Assessment was conducted in compliance with ISO 14971.

Conclusion:

The only changes between the predicate device (Nutrisafe K003311 / K991918) and the Nutrisafe 2 is the use of DEHP-free PVC and the unique non-luer connection. The only difference between the predicate device (Enteral Nutrition Tube K820176) is the additional sizes and the unique non-luer connection. Biocompatibility testing, performance testing and risk assessment demonstrate that the Nutrisafe 2 meets manufacturers specifications.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Courtney Smith Regulatory Affairs Manager Vygon Corporation 2495 General Armistead Avenue NORRISTOWN PA 19403

SEP 1 6 2006

Re: K060944

Trade/Device Name: Nutrisafe 2 Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Dated: September 8, 2006 Received: September 8, 2006

Dear Ms. Smith:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health". The logo is circular in shape and contains the letters FDA in the center. The text is written in a decorative font.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/edrh/industry/support/index.html.

Sincerely yours.

Nancy Chogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

K060944

Device Name:

Nutrisafe 2

Indications For Use:

For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rat. A. Pearson
(Division Sign Off)

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

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