MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES

K100700 · Benlan, Inc. · FPD · Dec 13, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K100700
• Device Name: MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
• Applicant: Benlan, Inc.
• Product Code: FPD · Gastroenterology, Urology
• Decision Date: Dec 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The MED-RX Pediatric Feeding Tube and Accessories are disposable, single use enteral feeding devices featuring non-luer enteral only connectors. The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric enteral feeding, as directed by a physician. The MED-RX Enteral Extension Set is an accessory to the MED-RX Pediatric Feeding Tube, to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tube and Accessories are for hospital use, pediatric patient use only, and are not intended for use beyond 30 days.

Device Story

The MED-RX Pediatric Feeding Tube and Accessories are sterile, single-use enteral feeding devices designed for hospital use in pediatric patients. The system consists of a feeding tube featuring an integral radiopaque line, depth markings, and a non-luer enteral-only slip-fit connector, alongside enteral extension sets. The device is used to deliver nutritional fluids from a source to the patient's stomach via nasogastric or oralgastric routes. The non-luer connector design is intended to prevent accidental misconnections with non-enteral medical devices. The device is operated by healthcare professionals. By providing a dedicated enteral-only connection, the device aims to reduce the risk of clinical errors associated with tubing misconnections, thereby improving patient safety during enteral nutrition therapy.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included tensile strength of bonded joints and tubes, resistance to liquid leakage under pressure (50 kPa) and vacuum, connector separation force (3.37 lbf), and device compatibility. Biocompatibility testing included ISO 10993-5 (cytotoxicity), ISO 10993-10 (intracutaneous reactivity), and Guinea Pig Maximization sensitization testing.

Technological Characteristics

Materials: PVC, polyurethane, medical grade plastics. Features: Radiopaque line, depth markings, non-luer enteral-only slip-fit connector. Sterilization: Ethylene oxide (EO) per ANSI/AAMI/ISO 11135:1994. Biocompatibility: ISO 10993-5, ISO 10993-10. Single-use, sterile, latex-free.

Indications for Use

Indicated for pediatric patients requiring nasogastric enteral feeding or fluid delivery via enteral extension sets in a hospital setting. Not for use beyond 30 days.

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)
• NeoChild SafeChild Infant Feeding Tube and Accessories (K082710)

Submission Summary (Full Text)

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K100700 Page 1 of 4

## SECTION 5 - 510(K) SUMMARY

DEC 1 3 2010

Date of Summary: November 26, 2010

Benlan Inc 2760 Brighton Road Oakville, ON L6H 5T4

Tel [phone] Fax [phone]

| Official Contact: | Cheryl Brown – QA / RA Manager |
|----------------------|-------------------------------------------------------------------------------------------------|
| Proprietary Name: | MED-RX Pediatric Feeding Tube and Accessories |
| Common Name: | Feeding Tube or NG/OG Tube |
| Classification Name: | Gastrointestinal tube and accessories |
| Class: | Class II |
| Product Code: | FPD |
| Predicate Devices: | Vygon Nutrisafe 2 (K060944)<br>NeoChild SafeChild Infant Feeding Tube and Accessories (K082710) |

#### Device Description

The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician. Accessories to be offered alongside the MED-RX Pediatric Feeding Tubes include MED-RX Enteral Extension Sets of various configurations. The MED-RX Enteral Extension Set is intended to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tubes and Enteral Extension Sets feature non-luer enteral only connectors to decrease the risk of accidental misconnection. All devices are sterile, single-use, and latex free. The MED-RX Pediatric Feeding Tube and Accessories are for pediatric use only. Accessories may be sold with MED-RX Pediatric Feeding Tubes or separately.

#### Indications for Use

The MED-RX Pediatric Feeding Tube and Accessories are disposable, single use enteral feeding devices featuring non-luer enteral only connectors. The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric enteral feeding, as directed by a physician. The MED-RX Enteral Extension Set is an accessory to the MED-RX Pediatric Feeding Tube, to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tube and Accessories are for hospital use, pediatric patient use only, and are not intended for use beyond 30 days.

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K100700 Page

Page 2 of 4

#### Substantial Equivalence:

The information provided in the premarket notification demonstrates that the proposed device is substantially equivalent to legally marketed devices. The proposed MED-RX Pediatric Feeding Tube and Accessories is substantially equivalent to the Vygon Nutrisafe 2 (K060944) and the NeoChild SafeChild Infant Feeding Tubes and Accessories (K082710). Both the proposed and the predicate devices have the same intended use for nasogastric enteral feeding as directed by a physician. A comparison of features and principles of operation between the proposed device and predicate devices is provided in Table 1.

Table 1: Comparison between MED-RX Pediatric Feeding Tube, Vygon Nutrisafe 2 (K060944), and NeoChild SafeChild Infant Feeding Tube and Accessories (K082710)

| Attribute | Proposed Device:<br>MED-RX Pediatric Feeding<br>Tube and Accessories | Predicate Device:<br>Vygon Nutrisafe 2<br>(K060944) | Predicate Device:<br>NeoChild SafeChild<br>(K082710) |
|-----------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------------------------|
| Indications for Use | For nasogastric/oralgastric<br>enteral feeding as directed<br>by a physician | Same | Same |
| Intended<br>Population | Pediatrics | Same | Same |
| Intended<br>Environment of<br>Use | Hospital | Same | Hospital, home, or<br>environments where<br>feeding tube is<br>required |
| System<br>Configuration | Tube with integral<br>radiopaque line, depth<br>markings, and non-luer<br>enteral only connector | Same | Same |
| Materials | PVC, polyurethane, various<br>medical grade plastics | Same | Same |
| Connector | Non-luer enteral only slip fit<br>connector | Non-luer enteral<br>only threaded<br>connector | Non-IV enteral<br>connector |
| Packaging | Pouch, sealed | Same | Same |
| Sterility | EO | EO | EO |
| Single Use | Yes | Yes | Yes |

#### Summary of Differences

There are no significant differences between the proposed MED-RX Pediatric Feeding Tube and Accessories and the predicate devices, Vygon Nutrisafe 2 (K060944) and NeoChild SafeChild Infant Feeding Tube and Accessories (K082710). Similarities between the proposed device and the predicate devices include identical indications for use and intended populations. Both the proposed device and the predicate device feature non-luer enteral only connectors and are manufactured from equivalent materials. The MED-RX Pediatric Feeding Tube and Accessories, the Vygon Nutrisafe 2, and the NeoChild SafeChild Infant Feeding Tube and Accessories are single-use, sterile devices, packaged in peelable paper/poly pouches. All devices are sterilized using ethylene oxide. Any minor differences between the proposed device and the predicate

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K10 0700 Page 3 of 4

have been evaluated to have no impact on safety or effectiveness of the MED-RX Pediatric Feeding Tube and Accessories, and therefore the devices can be considered equivalent.

#### Non-Clinical Test Summary

Verification of functional performance of the MED-RX Pediatric Feeding Tubes and Accessories has been performed and successfully completed. The MED-RX Pediatric Feeding Tubes and MED-RX Enteral Extension Sets were subject to numerous performance tests including tensile strength of the bonded joints and of the tubes, and resistance to liquid leakage under pressure and under vacuum. The MED-RX Pediatric Feeding Tube and Accessories were also tested for connector separation, device compatibility with other non-luer medical devices, and for determination of flow rate. The MED-RX Pediatric Feeding Tubes and MED-RX Enteral Extension Sets have successfully completed all required performance testing, as summarized in Table 2.

Table 2: Summary of Performance Test Results

| Test | Pass/Fail Criteria | Result |
|-------------------------------------|-----------------------------------------------------------------------|--------------|
| Feeding Tube Tensile Strength Test | Withstand tensile force of:<br>2 lbf (OD ≤ 2 mm)<br>4 lbf (OD > 2 mm) | PASS<br>PASS |
| Extension Set Tensile Strength Test | Withstand tensile force of 4 lbf | PASS |
| Leakage under Pressure | No leakage or separation under 50 kPa | PASS |
| Leakage under Vacuum | No leakage or separation under vacuum | PASS |
| Connector Separation | Withstand tensile force of 3.37 lbf (15 N) | PASS |
| Device Compatibility | Incompatible with other recognized non-<br>luer medical devices | PASS |

#### Latex Content

The MED-RX Transfer Sets were tested for natural rubber latex content using a Modified Lowry Method. The devices were found to contain less than 0.04% latex and are therefore considered to not contain natural rubber latex. The testing was completed by Wuxi AppTec.

#### Summary of Sterilization

Each of the MED-RX Pediatric Feeding Tubes and Accessories is individually packaged using a medical grade peelable synthetic polymer reinforced paper with a film backing, and sterilized using ethylene oxide. Please see Table 3 for a summary.

| Table 3: Sterilization Summary | | | | |
|--------------------------------|--|--|--|--|
|--------------------------------|--|--|--|--|

| Test Description | Standard | Results |
|----------------------------|--------------------------|---------------------------------------------------------|
| Method of Validation | ANSI/AMMI/ISO 11135:1994 | Validated to a Sterility Assurance<br>Level of 1 x 10-6 |
| EO Sterilization Residuals | ISO 10993-7: 2008 | Pass |
| Bacterial Endotoxins | ANSI/AAMI ST72:2002 | Pass |

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K10 0700 Page 4 of 4

# Summary of Biocompatibility Tests

Biocompatibility testing was successfully completed on sterile finished devices. The MED-RX Pediatric Feeding Tubes and Accessories are classified as surface contacting devices with prolonged mucosal membrane contact. A summary of the testing completed and the relevant standards are listed in Table 4.

Table 4: Biocompatibility Test Summary

| Test Description | Standard | Results |
|-----------------------------------------------------------------------------------|--------------------|----------------------------------------------------------------------------------------------|
| ISO MEM Elution with<br>L-929 Mouse Fibroblast<br>Cells (Cytotoxicity) | ISO 10993-5: 2009 | Product code 54-3680RU, 54-8242RU, and 54-<br>7069U are considered non-toxic. |
| Intracutaneous Reactivity<br>Test | ISO 10993-10: 2010 | Product code 54-3680RU, 54-8242RU, and 54-<br>7069U are considered a non-irritant. |
| Guinea Pig Maximization<br>Sensitization Test (Method<br>of Biomaterial Extracts) | ISO 10993-10:2002 | Product code 54-3680RU, 54-8242RU, and 54-<br>7069U did not elicit a sensitization response. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Cheryl Brown QA/RA Manager Benlan, Inc. 2760 Brighton Road OAKVILLE ONTARIO · CANADA L6H 5T4

# DEC 1 3 2010

Re: K100700

Trade/Device Name: MED-RX Pediatric Feeding Tube and Accessories Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FDP Dated: December 10, 2010 Received: December 10, 2010

Dear Ms. Brown:

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

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#### 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 Lenoir MD

erbert 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

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# SECTION 4 -- INDICATIONS FOR USE

510(K) Number (If Known): K100700

DEC 1 3 2010

Device Name: MED-RX Pediatric Feeding Tube and Accessories

Indications For Use:

The MED-RX Pediatric Feeding Tube and Accessories are disposable, single use enteral feeding devices featuring non-luer enteral only connectors. The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric enteral feeding, as directed by a physician. The MED-RX Enteral Extension Set is an accessory to the MED-RX Pediatric Feeding Tube, to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tube and Accessories are for hospital use, pediatric patient use only, and are not intended for use beyond 30 days.

| Prescription Use: | <div> <span style="font-size: 2em;">✓</span> </div> |
|-----------------------------|-----------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-the-Counter Use | |
| (21 CFR 801 Subpart C) | |
| N/A | |

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------|----------|
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K 100700 |

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