NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE

K151503 · Gbuk Enteral Limited · PIF · Apr 5, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K151503
• Device Name: NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
• Applicant: Gbuk Enteral Limited
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Apr 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube device is inserted into the stomach through the nasal cavity for the purpose of supplying a nutritional source for those patients who are unable to feed themselves.

Device Story

Enteral feeding tube for continuous or intermittent delivery of nutritional sources; inserted via nasal or oral cavity into stomach, duodenum, or small intestine. Comprises radio-opaque polyurethane tube, guide wire set, and ENFit connector. Practitioner inserts tube using guide wire; guide wire removed post-insertion. ENFit connector allows attachment of female ENFit enteral syringes. Used in clinical settings by healthcare practitioners. Provides nutritional access for patients unable to feed themselves. Design includes depth markings for insertion reference and dual distal openings for flow. Single-use, sterile device.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993), liquid leakage, stress cracking, tensile testing, corrosion testing, and flow rate testing per EN 1618:1997 and AAMI/CN3:2014(PS).

Technological Characteristics

Polyurethane tube; radio-opaque; 6Fr to 12Fr diameter; 50cm-120cm length. Features ENFit/ISO 80369-1 compliant connector. Includes metal guide wire. Sterile (Ethylene Oxide). Single-use. Biocompatibility per ISO 10993. Mechanical testing per AAMI/CN3:2014(PS).

Indications for Use

Indicated for patients unable to feed themselves requiring nutritional support via nasogastric tube insertion.

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

• CORFLO Anti-IV Enteral Feeding Tube Model Number 20-XXX (K083210)

Submission Summary (Full Text)

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

April 5, 2016

Gbuk Enteral Limited % Leeanne Baker Regulatory Consultant Advena Medical Pure Offices, Plato Close Warwick, CV34 6WE United Kingdom

Re: K151503

> Trade/Device Name: NUTRICARE - ISOSAF™ Naso-Gastric Feeding Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and accessories Regulatory Class: Class II Product Code: PIF Dated: February 2, 2016 Received: February 12, 2016

Dear Leeanne Baker,

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

**Herbert P. Lerner -S**

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) K151503

Device Name

Nutricare ISO-SAF Naso-Gastric Feeding Tube

Indications for Use (Describe)

The NUTRICARE ISO-SAF Naso-gastric Feeding Tube device is inserted into the stomach through the nasal cavity for the purpose of supplying a nutritional source for those patients who are unable to feed themselves.

| Type of Use (Select one or both, as applicable) | <table><tr><td><div> <span style="text-decoration: underline;">☑</span> Research Use (Per 21 CFR 201.66; Subject to Review) </div></td><td><div> ☐ Other Commercial Use (21 CFR 201.66) </div></td></tr></table> | <div> <span style="text-decoration: underline;">☑</span> Research Use (Per 21 CFR 201.66; Subject to Review) </div> | <div> ☐ Other Commercial Use (21 CFR 201.66) </div> |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| <div> <span style="text-decoration: underline;">☑</span> Research Use (Per 21 CFR 201.66; Subject to Review) </div> | <div> ☐ Other Commercial Use (21 CFR 201.66) </div> | | |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

## for

# NUTRICARE – ISOSAF™ NASO-GASTRIC FEEDING TUBE

#### 1. Submission Sponsor

- GBUK Enteral Limited Blackwood Hall Business Park North Duffield Selby North Yorkshire, YO8 5DD United Kingdom Phone: [phone] Contact: Mark Thompson, Managing Director
#### 2. Submission Correspondent

Advena Medical Pure Offices Plato Close Warwick CV34 6WE United Kingdom Cell Phone: [phone] Office Phone [phone] Contact: Leeanne Baker, Regulatory Consultant Email: [e-mail]

#### 3. Date Prepared

20th May 2015

## 4. Device Identification

| Trade/Proprietary Name: | NUTRICARE – ISOSAFTM NASO-GASTRIC FEEDING TUBI |
|----------------------------|------------------------------------------------|
| Common/Usual Name: | Tube, feeding |
| Classification Name: | Gastrointestinal tube and accessories |
| Classification Regulation: | 21 CFR 876.5980 |
| Product Code: | PIF |
| Device Class: | Class II |
| Classification Panel: | Gastroenterology/ Urology |

#### 5. Legally Marketed Predicate Device(s)

K083210 – CORFLO Anti-IV Enteral Feeding Tube Model Number 20-XXX

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## 6. Device Description

The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube is an enteral feeding tube designed for continuous or intermittent use. It comprises of radio-opaque polyurethane tube with guide wire set and ENFit connector.

The guide wire set is composed of a rigid guide wire and a male threaded connector, which is inserted into the polyurethane tube. They're depth marks printed on the tube in order to provide reference about the depth of insertion to the practitioner.

The tube is to be inserted through the nasal or oral area and feed down into the alimentary canal system (i.e. stomach area, duodenum or small intestine as intended). The guide wire with male connector is removed when the insertion is done leaving the tube and ENFit connector in situ. Only a female ENFit enteral syringe can be attached to the ENFit connector when in use.

# 7. Indication for Use Statement

The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube device is inserted into the stomach through the nasal cavity for the purpose of supplying a nutritional source for those patients who are unable to feed themselves.

# 8. Substantial Equivalence Discussion

The following table compares the NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

| Table 5A - Comparison of Characteristics | | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | GBUK ENTERAL LTD | CORPAC INC. |
| Trade Name | NUTRICARE ISO-SAF™ Naso-<br>gastric Feeding Tube | Corflo Anti IV Enteral Feeding<br>Tube |
| 510(k) Number | - | K083210 |
| Product Code | PIF | FPD |
| Regulation<br>Number | 21 CFR 876.5980 | 21 CFR 876.5980 |
| Regulation Name | Gastrointestinal tubes and<br>accessories | Gastrointestinal tubes and<br>accessories |
| Indications for<br>Use | The NUTRICARE ISO-SAF™ Naso-<br>gastric Feeding Tube device is<br>inserted into the stomach<br>through the nasal cavity for the<br>purpose of supplying a<br>nutritional source for those<br>patients who are unable to feed<br>themselves. | The CORFLO® ANTI IV Enteral<br>Feeding tube is intended for use<br>in those patients who require<br>intermittent or continuous tube<br>feedings via the nasogastric or<br>nasoenteric route |
| Material | Polyurethane | Polyurethane |

## Table 54 - Comnarison of Characteristics

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| Manufacturer | GBUK ENTERAL LTD | CORPAC INC. |
|------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Trade Name | NUTRICARE ISO-SAFT™ Naso-gastric Feeding Tube | Corflo Anti IV Enteral Feeding Tube |
| Sterile | Yes - Ethylene Oxide | Rest unknown<br>Yes - Ethylene Oxide |
| Overall Design | | |
| Proximal Connector | Single connector ENFit/ISO 80369-1 compliant | Luer slip two (2) ports |
| Distal feeding port | Dual openings on opposite sides of tube at offset levels | Single opening |
| Distal Tip | Continuous with diameter of rest of tube. Extra radiopaque tip | Contoured larger than diameter of rest of tube |
| Fully Radiopaque throughout length | Yes | Yes |
| Cm Markings | Numbered markings throughout the length of the tube | Markings through the length of the tube |
| Overall length | 50cm - 120cm | 55cm - 140cm |
| Guidewire | Twisted metal wire with sealed tip ends prior to the feeding port to prevent accidental emergence | Braided metal wire<br>Tip ends prior to the feeding port to prevent accidental emergence |
| Diameter | 6Fr to 12Fr | 5Fr to 12Fr |
| Duration of Use | Short term (up to 30 days) | Short term |
| Single-Use | Yes | Yes |
| Shelf Life | 3 years | 5 years |
| Latex Free | Yes | Yes |
| Complies with ISO 10993-1 | Cytotoxicity<br>Sensitization<br>Intracutaneous Reactivity | Unknown but assumed to comply as has 510k |
| ISO 80369-1 ENFIT compliant | Yes | Current product has luer slip connector |

#### 9. Non-Clinical Performance Data

The biocompatibility of the NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube has been demonstrated through appropriate in vitro tests on the device. The device has been assessed in accordance with ISO 10993 and does not introduce any additional safety risk over the predicate device.

The following testing has been performed (per AAMI/CN3:2014(PS) where applicable) to support substantial equivalence:

- Falling drop positive pressure liquid leakage pass ●
- . Stress Cracking - pass
- . Resistance to separation from axial load – pass
- Resistance to separation from unscrewing – pass
- . Resistance to overriding – pass
- Disconnection from unscrewing pass .

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- . Tensile testing of the catheter – pass
- . Tensile testing of the connectors – pass
- . Corrosion testing of guide wire – pass
- Liquid leakage - pass

A comparative study performed demonstrates that the NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube performs as intended and is safe for its intended use when compared with the predicate device.

A Risk Analysis including analysis of the risk of misconnection has been conducted in accordance with EN ISO 14971:2012

As part of demonstrating safety and effectiveness of NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, GBUK Enteral Limited completed a number of test as detailed below:

- . Flow Rate Testing in accordance with EN 1618:1997
- Mechanical Testing of the connector in accordance with AAMI/CN3:2014(PS) and AAMI/CN3:2014(PS), respectively
- Dimensional analysis in accordance with AAMI/CN3:2014(PS)

The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube passed all testing stated above as shown by the acceptable results obtained.

The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.

## 10. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

## 11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between the NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube and the predicate devices do not raise any questions regarding its safety and effectiveness. The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube, as designed and manufactured, is determined to be substantially equivalent to the

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referenced predicate devices.