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 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.

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.

AI/ML Overview

The provided document (K181787) is a 510(k) premarket notification for Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes. This type of medical device is a physical tube used for nutritional support, not a software-based AI/ML device. Therefore, the questions related to AI/ML acceptance criteria, ground truth establishment, expert adjudication, MRMC studies, and training/test set data are not applicable to this document.

The document primarily relies on non-clinical performance testing to demonstrate substantial equivalence to predicate devices, as well as biocompatibility testing. No clinical performance testing, animal testing, or AI/ML specific studies were conducted or required for this device.

Here's a breakdown of the relevant information provided in the document regarding how the device meets acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" in the way one would for an AI/ML device with specific metrics like sensitivity or specificity. Instead, it demonstrates compliance with relevant international standards and performs specific mechanical and material tests.

Criteria/Test	Acceptance Method (Implicit)	Reported Device Performance (Implicit - Pass/Fail)
Biocompatibility	ISO 10993-1	Pass (Successfully evaluated per ISO 10993-1)
ISO 80369-3:2016 (Small-bore connectors)	Compliance with standard, including tests for:	Pass (Designed and constructed in compliance)
- Fluid leakage	Meet standard requirements	Met
- Stress cracking	Meet standard requirements	Met
- Resistance to separation from axial load	Meet standard requirements	Met
- Resistance to separation from unscrewing	Meet standard requirements	Met
- Resistance to overriding	Meet standard requirements	Met
- Disconnection by unscrewing	Meet standard requirements	Met
- Dimensional verification	Meet standard requirements	Met
EN 1615:2000 (Feeding Tubes)	Compliance with standard, including tests for:	Pass (Designed and constructed in compliance)
- Leakage	Meet standard requirements	Met
- Tensile Strength	Meet standard requirements	Met
- Flow Rate (with water and commercially available enteral nutrition)	Meet standard requirements	Met
ISO 11070 (Guidewire - if included)	Compliance with standard, including tests for:	Pass (Testing performed)
- Tensile Strength	Meet standard requirements	Met
- Fracture Resistance	Meet standard requirements	Met
- Flexion Resistance	Meet standard requirements	Met
Tubing Kink Resistance	EN 13868:2002	Pass (Testing performed)
Shelf Life	Accelerated aging conditioning	Substantiated
Substantial Equivalence	Comparison to predicate devices based on intended use, indications, clinical settings, target population, design characteristics, materials, and performance.	Determined as "Substantially Equivalent"

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated as "sample size" in the context of a "test set" for an algorithm. Instead, the tests refer to a sufficient number of manufactured units or materials to validate the design and manufacturing claims (e.g., "accelerated aging conditioning" implies a batch of devices).
Data Provenance: The testing was conducted by or for Cedic s.r.l., located in Peschiera Borromeo (MI), Italy. This is a manufacturer's internal testing or contracted testing to demonstrate compliance with standards. It is retrospective in the sense that it's done on manufactured products for regulatory submission, but not in the clinical data sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This is a physical device, not an AI/ML algorithm that requires expert-established ground truth from medical images/data. The "ground truth" for this device's performance is objective measurement against engineering standards and material properties.

4. Adjudication Method for the Test Set:

Not applicable. No human adjudication of clinical data is involved. Performance is determined by whether the device meets quantitative and qualitative engineering and material standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is not a study type relevant to an enteral feeding tube.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done:

Not applicable. This is not an algorithm. The "standalone" performance here refers to the device's ability to meet its specifications independently, which is what the non-clinical tests demonstrate (e.g., flow rate, tensile strength).

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on established engineering standards (ISO, EN), material specifications, and physical measurements (e.g., flow rate, tensile strength, leakage). It's objective, quantitative data derived from laboratory testing, not medical consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" for a traditional medical device like an enteral feeding tube.

9. How the Ground Truth for the Training Set was Established:

Not applicable. No training set exists.

In summary, this 510(k) clearance relied on demonstrating that the Cediflo Enteral Feeding Tubes meet established performance standards and are substantially equivalent to existing predicate devices through comprehensive non-clinical (laboratory and engineering) testing, rather than clinical trials or AI/ML performance studies.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

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, 63/920068 Peschiera Borromeo (MI)Italy
Phone:	+1-847-345-6920
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)
1. Corpak MedSystems Neonatal Nasogastric Feeding Tube (K831328)

Device Description

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Criteria for Comparison	Proposed Device Compared toPredicate #1 Aquarias NasalFeeding Tubes	Proposed Device Compared toPredicate #2 CorpakMedsystems NeonatalNasogastric Feeding Tubes
Intended Use
Indications	Similar and SE	Similar and SE
Clinical Settings	Same	Same
Target Population	Similar (predicate #1 is notintended for use in neonates)	Similar (predicate #2 is notintended for use in adults)
Design Characteristics
Outer Diameter:	Similar and SE (Predicate deviceshave 5 Fr to 16 Fr diameters).	Similar and SE (Predicatedevices have 5 Fr to 8 Frdiameters)
Length	Similar and SE, (Predicate devicesare 50 cm to 120 cm in length.)	Similar and SE (Predicatedevices are 22" to 36" in length.)
Sterility	Different but SE (Sterility ofpredicate device #1 is unknown)	Similar and SE (Predicatedevices are supplied sterile ornon-sterile)
Access Port	Same	Different (Predicate has flexibleY port funnel)
Caps	Same	Different (Predicate device hastethered, male friction fit plugs)
Tubing	Same	Same
Distal Tip	Similar and SE (Predicate devicedistal tips are weighted and non-weighted with hydrophiliccoating)	Similar and SE (Predicatedevices distal tips are singleopening, close ended, weightedor non-weighted withhydrophilic coating.)
Guidewire/Stylet	Similar and SE (Predicate devicesprovided with and without aguidewire/stylet.)	Similar and SE (Predicatedevices provided with orwithout 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 devicesconnect to legacy administrationsets and syringes
Theory of operation	Same	Same
Risk assessment	Same	Same
Mechanical	Same – both are designed andconstructed in compliance withEN1615:2000 and ISO 80369-3:2016	Different — Predicate devicedesign is not compliant with ISO80369-3:2016
Electrical	Same - not electrical devices	Same - not electrical devices
Radiation	Same - not radiation emittingdevices	Same - not radiation emittingdevices

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Indications for Use

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.

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
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).(b)
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.