The Cedic Oral/Luer Enteral ENFit Transition Connector for is intended for connecting a male oral tip syringe or a male Luer slip tip syringe to an enteral giving set or enteral catheter with an ENFit medication port.

Device Description

The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port is a transition connector intended for connecting a male oral tip syringe or a male Luer slip tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. This connector is available with and without end cap. It operates by providing a means of interconnecting incompatible enteral feeding device end fittings together. The PGLock end of the connector is designed in compliance with ISO 80369-1:2010 and ISO/IEC AAMI/CN3 (PS):2014. It is manufactured by injection molding from ABS HF 380.

AI/ML Overview

The provided document describes a medical device, the "Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port," and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study data, sample sizes for test or training sets, information on ground truth establishment, or multi-reader multi-case study results.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed de novo device study.

Therefore, much of the requested information cannot be extracted from this document. I will provide what is available and indicate where information is missing.

Acceptance Criteria and Device Performance:

The document refers to FDA recommendations for enteral connectors and the associated mechanical testing. It states that the device was tested to demonstrate compliance with these recommendations. Specific quantitative acceptance criteria (e.g., minimum force for separation) and the exact reported device performance values are not explicitly provided in a table format within this document. The document primarily states what types of tests were conducted and that the device "is made of the appropriate rigid or semi-rigid materials" and that "Bench tests have been carried out."

Acceptance Criteria (Referenced from FDA Draft Guidance)	Reported Device Performance (Summary from Document)
A. Connector Materials: Made of rigid or semi-rigid materials (as described in AAMI/ANS//ISO 80369-1, Clause 4, with testing according to ASTM D747 or ASTM D790, or equivalent) to reduce the likelihood of forced fits between flexible connectors not intended to connect.	The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port is manufactured by injection molding from ABS HF 380, which is stated to be an "appropriate rigid or semi-rigid material." The materials are identical to those used for the selected predicate device.
B. Mechanical Testing for Incompatibility: Mechanical force testing following AAMI/ANSVISO 80369-1, Clause 5.8, Annex B methods, or an equivalent alternative, to demonstrate that enteral connectors are non-interconnectable with connectors from other health care applications. Bench tests performed to assess: - Enteral connector misconnection - Human factors - Fluid leakage - Stress cracking - Resistance to separation from axial load - Resistance to separation from unscrewing - Resistance to overriding - Disconnection by unscrewing (Includes testing of the Luer part to demonstrate compliance with ISO 594-1).	"Bench tests have been carried out on samples of the Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port." The document implies these tests demonstrate compliance (e.g., "this 510(k) submission includes a copy of the risk analysis for the subject transition connector," suggesting risks were mitigated through such testing), but quantitative results are not presented.
C. Enteral Connector Risk Assessment: Provide a risk assessment to demonstrate effective mitigation of misconnection risks, with objective evidence that risks have been reduced to acceptable levels according to ISO 14971:2007 or equivalent.	"this 510(k) submission includes a copy of the risk analysis for the subject transition connector." This implies the risk assessment confirmed acceptable risk levels.

Detailed Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: The document states that "Bench tests have been carried out on samples" but does not specify the sample size used for these tests.
- Data Provenance: The tests were conducted internally by the manufacturer (Cedic S.r.l. Biomedical Division, Italy) or a contracted lab on behalf of the manufacturer. The data is retrospective in the sense that the tests were performed before the 510(k) submission. There is no mention of country of origin of the data beyond the manufacturer's location.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and study. This is a mechanical device, and "ground truth" would be established by objective physical measurements according to specified standards, not expert consensus on interpretations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks (e.g., image reading) where consensus among experts establishes ground truth. For mechanical tests, results are typically objective measurements against a standard.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. This document describes a mechanical connector device, not an AI-assisted diagnostic tool or an imaging system that would involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is a passive mechanical connector, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is objective measurement of its physical properties and mechanical behavior against established engineering standards (e.g., ISO 80369-1, ISO 594-1, ASTM D747, ASTM D790) and the FDA's draft guidance recommendations for misconnection mitigation. It's essentially compliance with predefined technical specifications.
The sample size for the training set:
- This is not applicable. This device is a mechanical product, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- This is not applicable as there is no training set.

Summary

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

April 2, 2015

Cedic S.r.1. % Roger Gray VP. Ouality and Regulatory Donawa Lifescience Consulting S.r.1. Piazza Albania, 10 Rome, 00153 Italy

Re: K150010 Trade/Device Name: Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIO Dated: December 29, 2014 Received: January 2, 2015

Dear Roger Gray,

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.

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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 (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K150010

Device Name

Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port

Indications for Use (Describe)

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

Device Name:	Cedic Oral/Luer Enteral ENFit Transition Connector forMedication Port
Type of 510(k) submission:	Traditional
Date of Submission:	29 December 2014
Manufacturer:	Cedic S.r.l.Biomedical DivisionVia Liberazione, 63/920068 Peschiera Borromeo (MI)Italy
510(k) Owner and Contact:	Ms Tiziana MelisRegulatory Affairs ManagerCedic S.r.l.Biomedical DivisionVia Liberazione, 63/920068 Peschiera Borromeo (MI)Italy
Phone:Fax:Email:	+39 02 5530 0174+39 02 5530 1487tiziana.melis@cedicbio.com
FDA Registration Number:	3003593728
Owner/Operator Number:	9063446
510(k) Submitter and Contact:	Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItaly
Phone:Fax:Email:	+39 06 578 2665+39 06 574 3786rgray@donawa.com
FDA Product Code:	PIO
FDA Regulation Number:	876.5980
FDA Classification Name:	Enteral Specific Transition Connectors
Classification Panel:	Gastroenterology and Urology
Common Name:	Transition Connectors for Enteral Applications
FDA Classification:	Class II

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Device Description

The introduction of new connectors to devices and accessories for enteral feeding applications, in order to help avoid misconnections with devices intended for other clinical applications, has resulted in the short-term need to connectors that will allow devices with existing ('legacy') end connectors to be connected with newer devices having end connectors meeting the relevant requirements of the ISO/IEC 80369 series of standards.

Cedic is already marketing the Enteral ENFit Transition Connector for Medication Port in the US following FDA clearance, this device being for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. This connector is available with and without end сар.

Cedic is now planning to introduce a very similar transition connector into the US market, this being the Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port, for connecting a male oral tip syringe or a male Luer slip tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. This connector is also available with and without end cap.

The Cedic ENFit Transition Connectors are intended for prescription use only.

Indications for Use/Intended Use

The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port is intended for connecting a male oral tip syringe or a male Luer slip tip syringe to an enteral giving set or enteral catheter with an ENFit medication port.

Principle of operation, mechanism of action, and interaction with the patient:

The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port operates by providing a means of interconnecting incompatible enteral feeding device end fittings together, so that patient enteral feeding can take place when 'new generation' end fittings in accordance with ISO/IEC 80369-3 need to be connected to previous designs of end fitting.

The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port provides the mating components at each end of the connector that allow connection with the 'new' end of the connector, and connection with 'old' end fittings at the other.

The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port will be used in combination with legally marketed enteral giving sets, enteral catheters, oral tip syringes or Luer slip tip syringes.

The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port is not intended to come into contact with the patient, but accidental contact may occur. The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port has a central fluid path through which flow during the feeding process.

Device Specification

The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port is for connecting a male oral tip syringe or a male Luer slip tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. This connector is available with and without end cap.

The PGLock end of the connector is designed in compliance with ISO 80369-1:2010 and ISO/IEC AAMI/CN3 (PS):2014.

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Image /page/5/Picture/0 description: The image shows the word "Cedic" in a stylized, cursive font. The word is white and has a slight glow around it, making it stand out against the teal background. The "e" in "Cedic" is stylized with a circle around it, giving it a unique look. The overall design is simple and modern.

Manufacture

The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port is manufactured by injection molding from ABS HF 380. Where fitted, the end cap is colored with Remafin Violet PE43076356-ZT (2%). These materials are identical to those used for the selected predicate device.

Performance Data:

In relation to performance data for such ENFit Transition Connectors, according to the FDA publication 'Draft Guidance for Industry and Food and Drug Administration Staff: Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications', July 27, 2012:

"Adapters are used to connect enteral devices and provide additional connection points where misconnection events can occur. To mitigate misconnection via adapters, the FDA recommends that adapters be treated similarly to enteral connectors, as described in Section VI.A, B, and C within this guidance. This means that they should be made of rigid or semi-rigid materials, and mechanical testing should be performed according to recommendations described in AAMI/ANSI/ISO 80369-1, or an equivalent alternative, to demonstrate that adapters are specific and compatible for enteral applications only and are non-interconnectable with the connectors of non-enteral devices."

The FDA draft guidance includes in Section VI. A, B and C the following recommendations:

A. Connector materials

"FDA recommends that enteral connectors be made of rigid or semi-rigid materials, as described in AAMI/ANS//ISO 80369-1, Clause 4, with testing according to ASTM D747 or ASTM D790, or equivalent. Use of rigid or semi-rigid materials will reduce the likelihood of forced fits between flexible connectors that are not intended to connect with each other."

In this respect, the Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port is made of the appropriate rigid or semi-rigid materials.

B. Mechanical testing of enteral connectors to assess incompatibility

"FDA recommends mechanical force testing of enteral connectors following AAMI/ANSVISO 80369-1, Clause 5.8, Annex B methods, or an equivalent alternative, to demonstrate that enteral connectors are non-interconnectable with connectors from other health care applications."

Bench tests have been carried out on samples of the Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port. The tests carried out include:

Enteral connector misconnection assessment ●
Human factors
. Fluid leakage
Stress cracking
. Resistance to separation from axial load
Resistance to separation from unscrewing
Resistance to overriding
. Disconnection by unscrewing

The above tests include testing of the Luer part of the transition connector to demonstrate compliance with the relevant clauses of ISO 594-1.

C. Enteral connector risk assessment

"When an applicant submits a new 510(k) application, they should provide a risk assessment to demonstrate they have effectively mitigated the risk of misconnection with their new product. There should be objective evidence that risks have been reduced to acceptable levels according to ISO

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14971:2007 or equivalent. For example, the applicant may provide evidence of selection of appropriate material (Section VI.A, above) and quantitative mechanical testing data to demonstrate that the proposed enteral connector has a reduced risk of forming stable attachments to connectors routing into non-enteral devices (Section VI.B, above)."

In this respect, this 510(k) submission includes a copy of the risk analysis for the subject transition connector.

Predicate device

The Predicate Device selected for comparison with the Subject Device is the Cedic Enteral ENFit Transition Connector for Medication Port

Sponsor:	Cedic Srl
510(k) Number:	K140581
Clearance Date:	17 October 2014
FDA Product Code:	PIO
Classification Name:	Enteral specific transition connectors
Regulation No:	876.5980

The Subject Device and the Predicate Device both share many identical or similar properties and features, and none of the differences have any significant effect on safety or effectiveness of the Subject Devices.

Conclusion:

Based on the information contained within this submission, it is concluded that the Cedic OrallLuer Enteral ENFit Transition Connector for Medication Port is substantially equivalent to the identified predicate device already in interstate commerce within the USA.

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.