Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port

K150010 · Cedic S.R.L. · PIO · Apr 2, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150010
• Device Name: Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port
• Applicant: Cedic S.R.L.
• Product Code: PIO · Gastroenterology, Urology
• Decision Date: Apr 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Indications for 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.

Device Story

Transition connector facilitating interconnection between legacy enteral feeding device fittings and new ISO/IEC 80369-3 compliant ENFit fittings. Device features mating components at each end: one side connects to male oral tip or Luer slip tip syringes; other side connects to ENFit medication ports on enteral sets/catheters. Used in clinical settings to enable enteral feeding when incompatible connector generations coexist. Not intended for patient contact, though accidental contact possible. Central fluid path allows flow during feeding. Operated by clinicians/healthcare staff. Benefits patient by ensuring compatibility between diverse enteral feeding components, preventing misconnections, and maintaining continuity of care during transition to new standards.

Clinical Evidence

Bench testing only. No clinical data. Testing included enteral connector misconnection assessment, human factors, fluid leakage, stress cracking, resistance to separation (axial load/unscrewing), and resistance to overriding. Luer components tested for compliance with ISO 594-1. Risk analysis provided per ISO 14971:2007.

Technological Characteristics

Injection-molded ABS HF 380; end cap colored with Remafin Violet PE43076356-ZT. Rigid/semi-rigid material construction. Complies with ISO 80369-1:2010 and ISO/IEC AAMI/CN3 (PS):2014. Mechanical interface for enteral fluid path. No software or electronics.

Indications for Use

Indicated for connecting male oral tip or male Luer slip tip syringes to enteral giving sets or catheters featuring ENFit medication ports. Intended for prescription use.

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

• Cedic Enteral ENFit Transition Connector for Medication Port (K140581)

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 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 [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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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)

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.

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

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# 510(k) Summary

| Device Name: | Cedic Oral/Luer Enteral ENFit Transition Connector for<br>Medication Port |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k) submission: | Traditional |
| Date of Submission: | 29 December 2014 |
| Manufacturer: | Cedic S.r.l.<br>Biomedical Division<br>Via Liberazione, 63/9<br>20068 Peschiera Borromeo (MI)<br>Italy |
| 510(k) Owner and Contact: | Ms Tiziana Melis<br>Regulatory Affairs Manager<br>Cedic S.r.l.<br>Biomedical Division<br>Via Liberazione, 63/9<br>20068 Peschiera Borromeo (MI)<br>Italy |
| Phone:<br>Fax:<br>Email: | [phone]<br>[phone]<br>[e-mail] |
| FDA Registration Number: | 3003593728 |
| Owner/Operator Number: | 9063446 |
| 510(k) Submitter and Contact: | Mr Roger Gray<br>VP Quality and Regulatory<br>Donawa Lifescience Consulting<br>Piazza Albania 10<br>00153 Rome<br>Italy |
| Phone:<br>Fax:<br>Email: | [phone]<br>[phone]<br>[e-mail] |
| 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.