(267 days)
The Cedic F 00126 ENFit to Reverse Luer Transition Connector is intended to connect an enteral female ENFit giving set to the "g" port of the AbbVie PEG-J enteral male Luer catheter.
The Cedic F 00128 Luer to ENFit Transition Connector is intended to connect the AbbVie Duopa Medication Cassette Reservoir delivery system to an enteral male ENFit catheter.
The Cedic Enteral ENFit Transition Connectors are designed to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors. This submission describes the Cedic ENFit to Reverse Luer Transition Connector and the Cedic Luer to ENFit Transition Connector. These Cedic ENFit Transition Connectors are intended for prescription use only. The two transition connectors introduced by means of this submission are intended only for use with specific products commercialized in the US by Abbvie Inc., North Chicago, IL 60064-1802, USA, these being the AbbVie PEG-J enteral male Luer catheter (cleared under K142816) and the AbbVie Duopa Medication Cassette Reservoir (details available in DMF 26089) respectively.
The provided document describes Cedic Enteral ENFit Transition Connectors, which are medical devices designed to facilitate connections between new ISO 80369-3 compliant enteral connectors and older, non-compliant legacy enteral connectors. The document primarily focuses on demonstrating the substantial equivalence of these devices to a legally marketed predicate device (AMT Enteral Transition Adapters).
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document refers to FDA-recognized standards for the design and testing of the connectors. The acceptance criteria are implicitly those defined by these standards, and the device performance is stated to be in compliance.
| Acceptance Criteria (from referenced standards) | Reported Device Performance |
|---|---|
| Design in compliance with ISO 80369-3 (ENFit ends) | Complies: "The ENFit (PGLock) ends of the connectors are designed in compliance with FDA-recognized standard ISO 80369-3" |
| Design in compliance with ISO 594-2 (Luer ends) | Complies: "The Luer ends of the connectors are designed in compliance with ISO 594-2." |
| Testing in accordance with ISO 80369-20 (Common test methods) | Complies: "[ENFit ends] tested in accordance with FDA-recognized standard ISO 80369-20" |
| Enteral connector misconnection assessment | Bench tests carried out. (Results not explicitly quantified in tables but implied to be compliant for equivalence.) |
| Human factors | Bench tests carried out. |
| Fluid leakage | Bench tests carried out. |
| Stress cracking | Bench tests carried out. |
| Resistance to separation from axial load | Bench tests carried out. |
| Resistance to separation from unscrewing | Bench tests carried out. |
| Resistance to overriding | Bench tests carried out. |
| Disconnection by unscrewing | Bench tests carried out. |
| Biocompatibility (in accordance with ISO 10993) | Complies: "Established in accordance with ISO 10993" |
| Material properties (e.g., modulus of elasticity in tension meets requirements of relevant FDA-recognized standard) | Complies: "the modulus of elasticity in tension for all materials meets the requirements of the relevant FDA-recognised standard." |
2. Sample size used for the test set and the data provenance
The document states, "Bench tests have been carried out on samples of the Cedic Transition Connectors." However, it does not specify the sample size used for these tests. The data provenance is from Cedic S.r.l. in Italy, and the tests appear to be prospective bench tests performed on the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for these types of devices typically relies on adherence to engineering standards and test specifications, rather than expert clinical consensus in the same way an imaging AI algorithm would.
4. Adjudication method for the test set
This information is not provided and is generally not applicable to bench testing against engineering standards. The tests are objective measurements against defined criteria.
5. 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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that influence human interpretation. The Cedic device is a physical connector, not an AI algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not done. The device is a physical connector, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for performance assessment is primarily engineering specifications and test methods defined by FDA-recognized international standards (ISO 80369-3, ISO 594-2, ISO 80369-20, ISO 10993). This is based on objective, quantitative measurements and adherence to design requirements for medical device connectors, rather than human interpretation or clinical outcomes data in the usual sense.
8. The sample size for the training set
This information is not applicable as the device is a physical connector and does not involve AI or machine learning models that require training sets.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2017
Cedic S.r.1. % Roger Gray VP. Ouality And Regulatory Donawa Lifescience Consulting S.r.1. Piazza Albania, 10 Rome, 00153 Italy
Re: K162254
Trade/Device Name: Cedic Enteral ENFit Transition Connectors Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PIO Dated: March 29, 2017 Received: April 5, 2017
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.
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 (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,
Image /page/1/Picture/8 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible and well-defined.
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) K162254
Device Name
Cedic Enteral ENFit Transition Connectors
Indications for Use (Describe)
The Cedic F 00126 ENFit to Reverse Luer Transition Connect an enteral female ENFit giving set to the "g" port of the AbbVie PEG-J enteral male Luer catheter.
The Cedic F 00128 Luer to ENFit Transition Connect the AbbVie Duopa Medication Cassette Reservoir delivery system to an enteral male ENFit catheter.
| 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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Image /page/3/Picture/0 description: The image features the word "Cedic" in a stylized, cursive font. The word is white and has a subtle shadow effect, giving it a three-dimensional appearance. Above the "i" in "Cedic" is a small, stylized "e" symbol, which appears to be part of the logo. The background is a gradient of blue and teal, with the darker shade at the top and the lighter shade at the bottom.
510(k) Summary
| Device Name: | Cedic F 00126 ENFit to Reverse Luer Transition Connector, andCedic F 00128 Luer to ENFit Transition Connector |
|---|---|
| Type of 510(k) submission: | Traditional |
| Date of Submission: | 8 August 2016 |
| Manufacturer: | Cedic S.r.l.Biomedical DivisionVia Liberazione, 63/920068 Peschiera Borromeo (MI)Italy |
| 510(k) Owner and Submitter: | Cedic S.r.l.Biomedical DivisionVia Liberazione, 63/920068 Peschiera Borromeo (MI)Italy |
| Phone:Fax:Contact: | +39 02 5530 0174+39 02 5530 1487Ms Tiziana MelisRegulatory Affairs Manager |
| Email: | tiziana.melis@cedicbio.com |
| FDA Registration Number: | 3003593728 |
| Owner/Operator Number: | 9063446 |
| 510(k) Application Correspondent: | 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 |
| FDA Identification: | Facilitates enteral specific connections between ENFitconnectors and non 80369-3 compliant enteral connectors. |
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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 80369 series of standards.
Cedic Enteral ENFit Transition Connectors are designed to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
This submission describes the Cedic ENFit to Reverse Luer Transition Connector and the Cedic Luer to ENFit Transition Connector. These Cedic ENFit Transition Connectors are intended for prescription use only.
The two transition connectors introduced by means of this submission are intended only for use with specific products commercialized in the US by Abbvie Inc., North Chicago, IL 60064-1802, USA, these being the AbbVie PEG-J enteral male Luer catheter (cleared under K142816) and the AbbVie Duopa Medication Cassette Reservoir (details available in DMF 26089) respectively.
Indications for Use
The Cedic F 00126 ENFit to Reverse Luer Transition Connector is intended to connect an enteral female ENFit giving set to the "g" port of the AbbVie PEG-J enteral male Luer catheter.
The Cedic F 00128 Luer to ENFit Transition Connector is intended to connect the AbbVie Duopa Medication Cassette Reservoir delivery system to an enteral male ENFit catheter.
Principle of operation, mechanism of action, and interaction with the patient
The Cedic Enteral ENFit Transition Connectors operate by providing a means of interconnecting incompatible enteral feeding device end fittings together, so that patient connection can take place when 'new generation' end fittings in accordance with ISO 80369-3 need to be connected to previous 'legacy' designs of end fitting.
The Cedic Enteral ENFit Transition Connectors are not intended to come into contact with the patient, but accidental contact may occur. The Cedic Enteral ENFit Transition Connectors have a central fluid path through which fluids flow into the patient during use.
Cedic ENFit Transition Connectors are not intended for a specific patient population: they can be used for any patients who need to use the Abbvie products to which they will be connected..
Device Specification
The ENFit (PGLock) ends of the connectors are designed in compliance with FDA-recognized standard ISO 80369-3 "Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications", and tested in accordance with FDA-recognized standard ISO 80369-20 " Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods". The Luer ends of the connectors are designed in compliance with ISO 594-2.
Manufacture
The Cedic ENFit Transition Connectors are manufactured by injection molding from polypropylene.
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Performance Data
In relation to performance data for enteral transition connectors, the subject transition connectors follow the guidance provided in FDA publication 'Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications: Guidance for Industry and Food and Drug Administration Staff', February 11, 2015.
Bench tests have been carried out on samples of the Cedic Transition Connectors. 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 ●
Predicate device
The Predicate Device selected for comparison with the Cedic ENFit Transition Connectors is:
| Predicate Device: | AMT Enteral Transition Adapters |
|---|---|
| Sponsor: | Applied Medical Technology, Inc. |
| 510(k) Number: | K150034 |
| Clearance Date: | 9 June 2015 |
| FDA Product Code: | PIO |
| Classification Name: | Enteral specific transition connectors |
| Regulation No: | 876.5980 |
Substantial equivalence:
| Table 1: Predicate device comparison table | |||
|---|---|---|---|
| Item | Predicate device | Subject device | Similarity |
| Device description | The AMT Enteral Transition Adapters come in 5 configurations:• Male Enfit to Male Luer Adapter• Female Enfit to Female Luer Adapter• Female Enfit to Y-Port (Bolus/Luer) Adapter• Female Enfit to Bolus Adapter• Male Enfit to Christmas-tree Adapter | The Cedic Enteral ENFit Transition Connectors come in 2 configurations:• Male ENFit to Female Luer Transition Connector with Cap• Male Luer to Female ENFit Transition Connector with Cap | Very similar |
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Image /page/6/Picture/0 description: The image features the word "Cedic" in a stylized, cursive font. The word is rendered in a light color, possibly white or a very light shade of blue, which contrasts with the background. The background appears to be a solid color, possibly a shade of blue or teal, providing a clean and simple backdrop for the text. The overall design is clean and professional.
| Table 1: Predicate device comparison table | |||
|---|---|---|---|
| Item | Predicate device | Subject device | Similarity |
| Indications for Use | The AMT Enteral TransitionAdapters are intended tofacilitate enteral specificconnections betweenAAMI/CN3(PS) compliantconnectors and non ISO80369-1 compliant legacyenteral connectors. | The Cedic F 00126 ENFit toReverse Luer TransitionConnector is intended toconnect an enteral femaleENFit giving set to the "g" portof the AbbVie PEG-J enteralmale Luer catheter.The Cedic F 00128 Luer toENFit Transition Connector isintended to connect theAbbVie Duopa MedicationCassette Reservoir deliverysystem to an enteral maleENFit catheter. | Substantiallyequivalent |
| Geometry of ENFitconnecting portion | AAMI/CN3(PS) compliant | ISO 80369-3 compliant | The same |
| Geometry of Luerconnecting portion | ISO 594-2 compliant | ISO 594-2 compliant | The same |
| Materials | "DEHP and Latex freematerials" (from 510(k)Summary), no further materialdetails provided | DEHP and Latex freepolypropylene | The same |
| Biocompatibility | Established in accordancewith ISO 10993 | Established in accordancewith ISO 10993 | The same |
| Sterility | Not sterile | Not sterile | The same |
| Usage | Single use | Single use | The same |
| Manufacturing method | Injection molding | Injection molding | The same |
| Shelf life | Unknown | 3 years | N/A |
The Subject Device and the Predicate Device have many identical or similar properties and features. The only differences that exist are related to the exact end connection geometry, for example the predicate has a Male ENFit to Male Luer combination, whereas the subject device has a Male ENFit to Female Luer combination. Similarly, where the predicate has a Female ENFit combination, the subject device has a Male Luer to Female ENFit combination. In addition, although different materials may be used for the predicate and subject devices, the modulus of elasticity in tension for all materials meets the requirements of the relevant FDA-recognised standard. These differences do not have any significant effect on the safety or effectiveness of the subject device.
Conclusion:
Based on the information contained within this submission, it is concluded that the Cedic Enteral ENFit Transition Connectors are substantially equivalent to the identified predicate device already in interstate commerce within the USA.
§ 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.