Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector

K150084 · Covidien · PIF · Jul 13, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150084
• Device Name: Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
• Applicant: Covidien
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Jul 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector are intended for enteral feeding to deliver enteral nutrition, liquid or medication to patient from an enteral feeding syringe or feeding set designed with a connector for enteral applications. The device is intended for pediatric patients who require enteral feeding.

Device Story

Sterile, disposable single-lumen feeding tubes; constructed of Polyvinyl Chloride (PVC) or Polyurethane (PU). Features proximal male ENFit small-bore connector compliant with ISO 80369-3. Used in clinical settings for pediatric patients unable to obtain nutrition orally. Device delivers enteral nutrition, liquids, or medications from a compatible syringe or feeding set. Healthcare providers operate the device to provide nutritional support. Benefits include safe, reliable enteral delivery and reduced risk of misconnection via standardized ENFit interface.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility, stability, dimensional analysis, and performance testing (fluid leakage, stress cracking, tensile strength) per ISO 80369-3 and ISO 80369-20. Human factors validation and FMEA risk assessment for ENFit misconnection were performed.

Technological Characteristics

Single-lumen PVC or PU tubes; proximal male ENFit small-bore connector. Dimensions and connector design conform to ISO 80369-3. Biocompatible materials. Sterile, disposable. No energy source. No software.

Indications for Use

Indicated for pediatric patients requiring enteral feeding due to illness preventing normal chewing or swallowing; used to deliver nutrition, liquids, or medications.

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

• Argyle Polyvinyl Chloride (PVC) Feeding Tubes (K820441)
• Argyle Indwell Polyurethane Feeding Tubes (K820442)

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

July 13, 2015

Covidien Sona Manickam Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048

Re: K150084

> Trade/Device Name: Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF Dated: June 12, 2015 Received: June 15, 2015

Dear Sona Manickam,

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.

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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 device-related 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -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) K150084

Device Name

Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector

#### Indications for Use (Describe)

The Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector are intended for enteral feeding to deliver enteral nutrition, liquid or medication to patient from an enteral feeding syringe or feeding set designed with a connector for enteral applications.

The device is intended for pediatric patients who require enteral feeding.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b>☑</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 2.0 510(k) Summary

Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit Connector

In accordance with section 513(i) of the SMDA and as defined in 21CFR Part 807.92 this summary is submitted by:

Covidien 15 Hampshire Street Mansfield, MA 02048 Date Prepared: July 09, 2015

a. Contact Person

Sona Manickam Senior Regulatory Affairs Specialist Covidien Telephone: [phone] Fax: [phone]

- b. Name of Medical Device
Common Name: tube, feeding

U.S. FDA Classification Product Code: PIF

U.S. Regulation Description: Gastrointestinal tube and accessories, 21 CFR 876.5980

Proprietary / Trade Name: Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit Small Bore Connector

- c. Identification of Legally Marketed Device(s)
Argyle Polyvinyl Chloride (PVC) Feeding Tubes, K820441 Argyle Indwell Polyurethane Feeding Tubes, K820442

d. Device Brief Description

The Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit Connector are sterile, disposable medical devices designed to deliver nutrition to patients who cannot obtain nutrition by mouth, are unable to chew or swallow safely, or need nutritional supplementation. The device is designed with a single lumen Polyvinyl Chloride (PVC) or Polyurethane (PU) tubes with ENFit male small bore connector at proximal end.

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## e. Device Intended Use

The Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector are intended for enteral feeding to deliver enteral nutrition, liquid or medication to patient from an enteral feeding syringe or feeding set designed with a connector for enteral applications.

The device is intended for pediatric patients who require enteral feeding.

- f. Product Comparison Summary
The proposed and predicate enteral feeding devices are all intended for pediatric patients who require enteral feeding due to illness which prevents normal chewing and swallowing. These products have the same intended use, the same function, and the same general technological characteristics. The majority of the parts for both the proposed and predicate feeding tubes are made with the same material. The variation of the materials for certain components has been proven biocompatible and effective. The major technological enhancement is the incorporation of new ENFit connector which is compliant to ISO 80369-3, in the proposed Feeding Tubes. A male ENFit connector is offered for the proposed feeding tubes. Other additions to the proposed products include additional Fr sizes in both PVC and Polyurethane feeding tubes and an added length to the Polyurethane feeding tubes. These variations do not alter the intended use of the device, nor impact the safety and effectiveness of the product.

- g. Nonclinical testing
- Biocompatibility testing has demonstrated the biological safety of parts of the proposed feeding tubes which directly contact the patient.
- . Stability testing evaluated the properties of the proposed Feeding Tubes after accelerated aging in support of the product expiration date.
- Dimensional analysis was conducted for critical dimensions of the proposed Feeding Tubes, in accordance with ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications. The testing demonstrates the proposed devices conform to the criteria in Table B.2 of ISO 80963-3.
- Study performed on the proposed Feeding Tubes with ENFit Connector included the ● tests listed below, in accordance with ISO 80369-3, Small- bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications, using the test methods provided in ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods. The testing demonstrates the proposed devices conform to the requirements of ISO 80963-3.

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| Individual Test Defined<br>in ISO 80369-3 | Requirement Defined<br>in ISO80369-3 | Test Method Defined<br>in ISO 80369-20 |
|---------------------------------------------|--------------------------------------|----------------------------------------|
| Fluid Leakage | Clause 6.2 | Annex C |
| Stress Cracking | Clause 6.3 | Annex E |
| Resistance to separation<br>from axial load | Clause 6.4 | Annex F |
| Resistance to separation<br>from unscrewing | Clause 6.5 | Annex G |
| Resistance to overriding | Clause 6.6 | Annex H |
| Disconnection by<br>unscrewing | Clause 6.7 | Annex I |

- Flow testing was conducted and has demonstrated that the proposed feeding tubes are ● substantially equivalent to the performance of of the predicate device.
- Liquid Leakage ●
- Tensile Strength ●
- The risk associated with the misconnection of the ENFit connector has been assessed.
- ENFit Misconnection Data with Failure Modes and Effects 트 Analysis (FMEA)
- l Enteral Connector Misconnection Assessment
- l Enteral Connection Risk Management Report
- I ENFit Misconnection Risk Assessment Report
- Human Factors Validation Study ●

## h. Clinical testing

Clinical evaluations were not relied upon for the determination of substantial equivalence to the predicate device based on the device classification, sufficient safety and functional performance information provided in the submission.

- i. Conclusions
This information provided within this pre-market notification demonstrates that the Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit Connector have no difference that would affect the safety or effectiveness of the devices as compared to the predicate devices and demonstrate substantial equivalency.

## End of Summary