NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES

K120182 · Neomed, Inc. · KNT · Apr 19, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120182
• Device Name: NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
• Applicant: Neomed, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Apr 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The NeoMed Gastrointestinal Tube and Accessories is intended for short-term use < 30 days in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement.

Device Story

NeoMed Gastrointestinal Tube and Accessories is a PVC single-lumen catheter for delivering liquid nutritional media to neonatal and pediatric patients. The device features a one-piece molded enteral-only connector hub with an integral tethered closure plug and a closed tip with side holes for flow and aspiration. An orange radiopaque barium sulfate stripe is embedded in the tubing wall for X-ray visualization of tip placement. The device is used in clinical settings for short-term gastric access. It is designed to connect with NeoMed extension tubing and oral syringes. By providing a secure, enteral-only connection, the device facilitates safe nutritional delivery, reducing the risk of misconnection and ensuring accurate placement via radiographic confirmation.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verification included biocompatibility testing per ISO 10993-1, tensile strength, dimensional analysis, non-interconnectability, and priming volume measurements.

Technological Characteristics

PVC single-lumen catheter; barium sulfate radiopaque stripe; one-piece molded enteral-only connector hub; tethered closure plug; closed tip with side holes. Biocompatibility per ISO 10993-1. Non-powered, mechanical device.

Indications for Use

Indicated for neonatal and pediatric patients requiring short-term (< 30 days) nutritional delivery via nasal or oral gastric placement.

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

• Vygon Nutrisafe 2 (K060944)
• Kendall Argyle PVC Feeding Tube (K820441)

Reference Devices

• NeoMed Silicone Feeding Tube (K072881)
• NeoMed Polyurethane Feeding Tube (K082238)
• NeoMed Extension tubing (K100288)
• NeoMed oral syringe (K092908)

Submission Summary (Full Text)

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K120/82

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APR 1 9 2012

# NeoMe

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

DATE:

April 11, 2012

APPLICANT:

NeoMed, Inc. 100 Londonderry Ct Suite 112 Woodstock, GA 30188 Tony Lair, President Tel: [phone] email: [e-mail]

Official Correspondent: Penny Northcutt, RAC, CQA Regulatory Consultant for NeoMed, Inc. REGSolutions, LLC Tel: [phone] Fax: [phone] email: [e-mail]

Trade Name:

NeoMed Gastrointestinal Tube and Accessories

Classification Tubes, Gastrointestinal (and accessories) Name:

| DEVICE | Class II per 21 CFR §876.5980 |
|--------------------|-------------------------------|
| CLASSIFICATION AND | Gastroenterology/Urology |
| PRODUCT CODE: | Product Code: KNT |

| PREDICATE DEVICE | Vygon Nutrisafe 2, KO60944 |
|------------------|-----------------------------------------------------|
| NAME: | Kendall Argyle PVC Feeding Tube, K820441 (Sherwood) |

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K12 0182

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### SUBSTANTIAL EQUIVALENCE:

The NeoMed Gastrointestinal Tube and Accessories is substantially equivalent to the legally marketed Vygon Nutrisafe 2 (K060944) and Kendall Argyle PVC Feeding Tube (K820441). In addition, the NeoMed PVC feeding tube device design is the same as previously cleared NeoMed Silicone (K072881) and Polyurethane (K082238) Feeding Tubes.

### TECNOLOGICAL CHARACTERISTICS:

The NeoMed Gastrointestinal Tube and Accessories have similar technological characteristics when compared to the predicate devices. They have similar indications for use, materials, product design, and principles of operation. Bench testing has demonstrated that the NeoMed Gastrointestinal Tube and Accessories is functionally equivalent to the proposed predicate feeding tubes. Any minor differences do not affect safety or effectiveness of the NeoMed Gastrointestinal Tube and Accessories.

#### DESCRIPTION OF THE DEVICE:

The NeoMed Gastrointestinal Tube and Accessories is a PVC single lumen catheter that is used to deliver liquid nutritional media. This NeoMed PVC feeding tube is designed to connect with other NeoMed accessories such as the NeoMed Extension tubing under FDA clearance K100288 and NeoMed oral syringe under FDA clearance K092908.

The device consists of the following main components: a feeding tube single lumen catheter and a one-piece molded enteral only connector hub with integral tethered connection closure plug. The catheter tubing has an orange radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The tip is closed. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration.

#### INTENDED USE/INDICATIONS FOR USE:

The NeoMed Gastrointestinal Tube and Accessories is intended for short-term use < 30 days in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement.

### PERFORMANCE DATA:

The NeoMed Gastrointestinal Tube and Accessories materials have a long history of use in feeding tube manufacturing and are biocompatible and have been evaluated in accordance with ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing and these tests pass.

Design verification functional test results including tensile strength, dimensions, noninterconnectability, and priming volume demonstrate that the NeoMed Gastrointestinal Tube and Accessories performs its intended use and is substantially equivalent to the predicate devices by Kendall and Vygon.

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K120182

## CONCLUSION:

Based on the performance testing, it can be concluded that the NeoMed Gastrointestinal Tube and Accessories is equivalent to the Vygon Nutrisafe 2 (KQ60944) and Kendall Argyle PVC Feeding Tube (K820441) predicts with respect to intended use, materials, design, and technological characteristics.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

#### Public Health Service

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

NeoMed, Inc. % Ms. Penny Northcutt President/CEO REGSolutions, LLC 717 Lakeglen Drive SUWANNEE GA 30024

APR 1 9 2012

Re: K120182

Trade/Device Name: NeoMed Gastrointestinal Tube and Accessories Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 19, 2012 Received: January 20, 2012

Dear Ms. Northcutt:

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 (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 1 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,

Sincerely yours,

Benjamin R. Fisher, Ph.D.

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

510(k) Number (if known):

Device Name: NeoMed Gastrointestinal Tube and Accessories

Indications For Use:

This product is intended for short-term use (< 30 days) in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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)

Huld Reimer

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120182

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Traditional 510(k) NeoMed, Inc. 1

NeoMed Gastrointestinal Tube and Accessories