Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes

K181787 · Cedic S.R.L. · PIF · Apr 25, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K181787
• Device Name: Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
• Applicant: Cedic S.R.L.
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Apr 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Cediflo Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for patients 2 years and above which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract. Maximum duration of use: 42 days. The Cediflo Junior Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for neonatal and pediatric patients which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract.

Device Story

Sterile, single-use nasoenteric feeding tubes; polyurethane tubing with radiopaque markings; distal tip closed/rounded with four side holes; proximal end bonded to rigid male ENFit connector (ISO 80369-3:2016) with tethered cap. Optional stainless-steel braided guidewire with lubricious coating and flow-through connector aids insertion. Used in acute care, long-term care, and home settings; operated by clinicians or caregivers. Tubes deliver nutrition, fluids, or medications directly to stomach or small intestine. ENFit connector design prevents misconnections to non-enteral devices. Benefits include reliable enteral access and reduced risk of administration errors.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical performance testing, including biocompatibility (ISO 10993-1), connector testing (ISO 80369-3:2016), tensile strength/leakage (EN 1615:2000), guidewire integrity (ISO 11070), and kink resistance (EN 13868:2002). Accelerated aging testing performed to substantiate shelf life.

Technological Characteristics

Polyurethane tubing; stainless-steel braided guidewire; rigid male ENFit connector (ISO 80369-3:2016). Lengths 50-120 cm; diameters 5-16 Fr. Distal tip closed/rounded with four side holes. Non-electrical, non-radiation emitting. Sterilization method not specified.

Indications for Use

Indicated for neonatal, pediatric, and adult patients (2 years+) requiring nutritional support, unable to meet requirements via oral intake, with functioning/accessible gastrointestinal tract.

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

• Degania Aquarius Nasal Feeding Tubes (K141753)
• Corpak MedSystems Neonatal Nasogastric Feeding Tube (K831328)

Submission Summary (Full Text)

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April 25, 2019

Cedic S.r.1. % Crystal Koelper President Koelper Consulting LLC 268 Baltimore Drive North Barrington, IL 60010

Re: K181787

> Trade/Device Name: Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PIF Dated: March 12, 2019 Received: March 14, 2019

Dear Crystal Koelper:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark J. Antonino -S

for

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) K181787

Device Name

Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes

#### Indications for Use (Describe)

The Cediflo Enteral Feeding Tubes are intended for the administration of enteral nutrition. fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for patients 2 years and above which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract.Maximum duration of use: 42 days.

The Cediflo Junior Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for neonatal and pediatric patients which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## Section 5: 510(k) Summary of Safety and Effectiveness

### Submitter / 510(k) Holder

| Company: | Cedic s.r.l. |
|-----------------|-----------------------------------------------------------------|
| Address: | Via Liberazione, 63/9<br>20068 Peschiera Borromeo (MI)<br>Italy |
| Phone: | [phone] |
| Contact Person: | Crystal Koelper |
| Date Prepared: | April 12, 2019 |

### Device Name and Classification

| Trade Name: | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes |
|----------------------|----------------------------------------------------------------------|
| Model Number(s): | N### |
| Classification Name: | Gastrointestinal Tube and Accessories (21 CFR 876.5980) |
| Product Code: | PIF |
| Class: | II |

### Predicate Device(s)

- 1) Degania Aquarius Nasal Feeding Tubes (K141753)
- 2) Corpak MedSystems Neonatal Nasogastric Feeding Tube (K831328)

### Device Description

The Cediflo and Cediflo Junior Enteral Feeding Tubes are sterile, single use devices intended for use in acute care facilities, long-term care facilities, and home. They are made from radiopaque polyurethane tubing printed with centimeter markings and bonded at the proximal end to a rigid male ENFit connector with a tethered cap. The proposed device is offered in lengths of 50 cm to 120 cm and diameters of 5 Fr (1.66 mm) to 16 Fr (5.33 mm). These tubes are supplied with or without a guidewire. The distal tip of the polyurethane tubing is closed and rounded with four side holes to allow for fluid flow.

The male ENFit connector of the proposed device is designed to comply with ISO 80369-3:2016 and allows for connection to enteral feeding specific sets and syringes while reducing the likelihood of misconnections to devices that are not intended for enteral administration. A twist on cap is tethered to the male ENFit connect via a strap.

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The guidewire, when provided, of the proposed device is a stainless-steel braided wire with a rounded distal tip which is pre-loaded into the polyurethane feeding tube. The guidewire stiffens the polyurethane tubing to aide in insertion of the device. The guidewire has a lubricious coating that aids in removal of the guidewire from the feeding tube in situ. A flow through guidewire connector is attached to the proximal end of the guidewire which provides the connection between the wire and feeding tube.

| Criteria for Comparison | Proposed Device Compared to<br>Predicate #1 Aquarias Nasal<br>Feeding Tubes | Proposed Device Compared to<br>Predicate #2 Corpak<br>Medsystems Neonatal<br>Nasogastric Feeding Tubes |
|-------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | | |
| Indications | Similar and SE | Similar and SE |
| Clinical Settings | Same | Same |
| Target Population | Similar (predicate #1 is not<br>intended for use in neonates) | Similar (predicate #2 is not<br>intended for use in adults) |
| Design Characteristics | | |
| Outer Diameter: | Similar and SE (Predicate devices<br>have 5 Fr to 16 Fr diameters). | Similar and SE (Predicate<br>devices have 5 Fr to 8 Fr<br>diameters) |
| Length | Similar and SE, (Predicate devices<br>are 50 cm to 120 cm in length.) | Similar and SE (Predicate<br>devices are 22" to 36" in length.) |
| Sterility | Different but SE (Sterility of<br>predicate device #1 is unknown) | Similar and SE (Predicate<br>devices are supplied sterile or<br>non-sterile) |
| Access Port | Same | Different (Predicate has flexible<br>Y port funnel) |
| Caps | Same | Different (Predicate device has<br>tethered, male friction fit plugs) |
| Tubing | Same | Same |
| Distal Tip | Similar and SE (Predicate device<br>distal tips are weighted and non-<br>weighted with hydrophilic<br>coating) | Similar and SE (Predicate<br>devices distal tips are single<br>opening, close ended, weighted<br>or non-weighted with<br>hydrophilic coating.) |
| Guidewire/Stylet | Similar and SE (Predicate devices<br>provided with and without a<br>guidewire/stylet.) | Similar and SE (Predicate<br>devices provided with or<br>without a 2 strand twisted wire.) |
| Materials | | |
| Access Port | Different (Material is unknown) | Different (Flexible polyurethane) |
| Caps | Different (Material is unknown) | Different (Flexible polyurethane) |
| Tubing | Similar and SE | Similar and SE |
| Guidewire/Stylet | Different (Unknown) | Similar and SE |
| Performance | | |
| Use/Human Factors | Same | Different - Predicate devices<br>connect to legacy administration<br>sets and syringes |
| Theory of operation | Same | Same |
| Risk assessment | Same | Same |
| Mechanical | Same – both are designed and<br>constructed in compliance with<br>EN1615:2000 and ISO 80369-<br>3:2016 | Different — Predicate device<br>design is not compliant with ISO<br>80369-3:2016 |
| Electrical | Same - not electrical devices | Same - not electrical devices |
| Radiation | Same - not radiation emitting<br>devices | Same - not radiation emitting<br>devices |

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### Indications for Use

The Cediflo Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for patients 2 years and above which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract. Maximum duration of use: 42 days.

The Cediflo Junior Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for neonatal and pediatric patients which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract.

## Product Comparison Summary

The proposed and predicate enteral feeding devices are all intended for enteral administration of nutrients, fluids, and/or medications into the alimentary tract via the natural nasoenteric route for use in the same clinical settings. The combined populations of the predicate devices and the proposed device are intended for use in the same patient populations. The use and theory of operation of the proposed and predicate devices are the same regardless of the differences in size of tubes offered and design features. These differences do not alter the intended use of the devices or impact the safety and effectiveness of the devices. Material differences of the proposed device from the predicate device have been successfully evaluated for biocompatibility per ISO 10993-1. Refer to Table 1 below for a summary of the product comparison.

### Non-Clinical Performance Testing

Non-clinical performance testing was conducted to demonstrate that the Cediflo Enteral Feeding Tubes are substantially equivalent to the predicate device and effective for their intended use. In addition, Cediflo Enteral Feeding Tubes that underwent accelerated aging conditioning were tested to substantiate the product shelf life.

The following tests were performed:

●

- Biocompatibility testing per ISO 10993-1
- ISO 80369-3:2016 Testing, including:
- O Fluid leakage,
- Stress cracking, O

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K181787 Page 4 of 4

- Resistance to separation from axial load, O
- Resistance to separation from unscrewing, O
- Resistance to overriding, O
- O Disconnection by unscrewing, and
- Dimensional verification. O
- . EN 1615:2000 Testing, including:
- o Leakage
- o Tensile Strength
- Flow Rate with water and commercially available enteral nutrition o
- · ISO 11070 Testing on included guidewire, including:
- Tensile Strength, O
- Fracture Resistance, o
- o Flexion Resistance.
- Tubing Kink Resistance Testing per EN 13868:2002

#### Clinical Performance Testing

Clinical performance testing was not required to demonstrate the performance of the Cediflo Enteral Feeding Tubes. The Cediflo Enteral Feeding Tube performance has been adequately demonstrated by the completion of non-clinical performance testing.

#### Animal Testing

Animal testing was not required to demonstrate the performance of the Cediflo Enteral Feeding Tubes. The Cediflo Enteral Feeding Tube performance has been adequately demonstrated by the completion of non-clinical performance testing.

#### Conclusion

The results of the non-clinical performance testing demonstrate that the Cediflo Enteral Feeding Tubes are as safe and effective as the predicate device. Therefore, the proposed devices are substantially equivalent to the predicate devices.