Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector

K231299 · Cair Lgl · PIO · Jan 22, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K231299
• Device Name: Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector
• Applicant: Cair Lgl
• Product Code: PIO · Gastroenterology, Urology
• Decision Date: Jan 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Indications for Use

The Nutricair enteral ENFit adapter: ENFit male- stepped/Christmas tree connector is a disposable, sterile medical device intended to be used as an adapter between ENFit connectors and funnel connections, used in enteral nutrition. A doctor, a nurse or the adult laypersons can do enteral feeding. The target population is adults.

Device Story

Disposable, sterile adapter for enteral nutrition; connects ENFit male connectors to funnel-style enteral access devices. Composed of ABS plastic with a PEHD female ENFit cap attached via a link. Used in hospital or home settings by physicians, nurses, or adult patients. Facilitates secure connection between incompatible enteral feeding components; ensures compliance with ISO 80369-3 standards for enteral connectors. No active components or software.

Clinical Evidence

No clinical data. Safety and performance demonstrated through bench testing, including biocompatibility (ISO 10993), enteral device performance (ISO 20695), and connector performance (ISO 80369-20, ISO 80369-3).

Technological Characteristics

Materials: ABS (connector), PEHD (cap). Design: Male ENFit to stepped/Christmas tree connector. Standards: ISO 80369-3 (ENFit), ISO 80369-20 (testing), ISO 20695 (enteral device performance), ISO 10993 (biocompatibility). Sterile, single-use, non-powered, mechanical device.

Indications for Use

Indicated for adults requiring enteral feeding, serving as an adapter between ENFit connectors and funnel connections.

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 Distal End ENFit Transition Connector (K140581)

Submission Summary (Full Text)

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January 22, 2024

Cair LG Irving Wiesen Regulatory Counsel 1. Allée des Chevreuls Lissieu, Rhône 69380 France

Re: K231299

Trade/Device Name: Nutricair enteral ENFit adapter: ENFit male - stepped/Christmas tree connector Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: PIO Dated: December 22, 2023 Received: December 22, 2023

Dear Irving Wiesen:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K231299

### Device Name

Nutricair enteral ENFit adapter: ENFit male - stepped/Christmas tree connector

Indications for Use (Describe)

The Nutricair enteral ENFit adapter: ENFit male - stepped/Christmas tree connector is a disposable, sterile medical device intended to be used as an adapter between ENFit connections, used in enteral nutrition. A dotor, a nurse or the adult laypersons can do enteral feeding. The target population is adults.

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

| <div>☑ Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|-----------------------------------------------------------|
| <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# TAB 5 510(k) Summary

### l. Submitter

| Official Contact | Name: Anne-Marie FUENTES<br>Title: Regulatory Affairs Manager<br>Email: [e-mail] |
|---------------------|---------------------------------------------------------------------------------------------|
| | CAIR LGL<br>Address: 1, Allée des Chevreuils<br>69380 Lissieu, FRANCE |
| | Phone: [phone]<br>Fax: [phone] |
| Date of Preparation | February 27, 2023 |

### II. Device

| Trade Name: | Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas<br>tree connector |
|-----------------------|------------------------------------------------------------------------------------|
| Common Name: | Enteral specific transition connector |
| Classification Name & | Gastrointestinal Tubes and accessories |
| Number: | 21 CFR 876.5980 |
| | Class II |
| | Product Code: PIO |

### III. Legally Marketed Predicate Device

Cedic Enteral Distal End ENFit Transition Connector Product name: 510(k) Number: K140581 Manufacturer: Cedic S.r.l Product Code: PIO Device Class: Class II

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### Device Description IV.

# General Description of Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector

The Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector is sterile single use device. The adapter presents a ENFit connection in ABS at one extremity and a notched connection (in ABS) at the other extremity. The device has also a female ENFit cap in PEHD attached to the adapter with a link. This device incorporates a male ENFit connection to enteral access device with a female ENFit connector that is compliant to ISO 80369-3. It is provided with a sterility protector.

Reference concerned is NCE104A.

#### V. Intended Use

The Nutricair enteral ENFit adapter: ENFit male- stepped/Christmas tree connector is a disposable, sterile medical device intended to be used as an adapter between ENFit connectors and funnel connections, used in enteral nutrition. A doctor, a nurse or the adult laypersons can do enteral feeding. The target population is adults.

### VI. Substantial Equivalence Discussion

The Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector is substantially equivalent to the currently marketed Cedic Enteral Distal End ENFit Transition Connector. Table 5-1 is a detailed comparison of the Cair adapter to the predicate devices regarding substantial equivalence.

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Table 5-1: Device comparison table for Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector and the predicate device.

| Design<br>Features/Function | Cedic Enteral Distal<br>End ENFit Transition<br>Connector | Nutricair™ enteral ENFit adapter:<br>ENFit male – stepped/Christmas tree<br>connector | Substantially<br>Equivalent? | Impact on Safety<br>and Performance |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Cedic Enteral<br>Distal End ENFit<br>Transition Connector<br>is intended for<br>connecting an enteral<br>giving set with an<br>ENFit connector to an<br>enteral catheter with<br>funnel. | The Nutricair™ enteral ENFit<br>adapter: ENFit male –<br>stepped/Christmas tree connector is<br>a disposable, sterile medical device<br>intended to be used as an adapter<br>between ENFit connectors and<br>funnel connections, used in enteral<br>nutrition. A doctor, a nurse or the<br>patient himself can do enteral<br>feeding. The target population is<br>adults | Yes | Equivalent to<br>K140581. There<br>are no differences<br>in indications for<br>use that would<br>impact the safety<br>and performance<br>of the device. |
| Intended Use | The Cedic Enteral<br>Distal End ENFit<br>Transition Connector<br>is intended for<br>connecting an enteral<br>giving set with an<br>ENFit connector to an<br>enteral catheter with<br>funnel. | The Nutricair™ enteral ENFit<br>adapter: ENFit male –<br>stepped/Christmas tree connector is<br>a disposable, sterile medical device<br>intended to be used as an adapter<br>between ENFit connectors and<br>funnel connections, used in enteral<br>nutrition. A doctor, a nurse or the<br>patient himself can do enteral<br>feeding. The target population is<br>adults. | Yes | Equivalent to<br>K140581. There<br>are no differences<br>in intended use<br>that would impact<br>the safety and<br>performance of<br>the device. |
| Environment of<br>Use | Hospital - Home | Hospital - Home | Yes | Equivalent to<br>K140581. There<br>are no differences<br>in environment of<br>use that would<br>impact the safety<br>and performance<br>of the device. |
| Intended Users | A doctor, a nurse or<br>the patient himself<br>can do enteral<br>feeding | A doctor, a nurse or the patient<br>himself can do enteral feeding | Yes | Equivalent to<br>K140581. No<br>impact on safety<br>or performance |
| Patient Population | Pediatric and adult | Adult | Yes | Equivalent to<br>K140581. No |
| | | | | impact on safety<br>or performance |
| Single Use | Yes | Yes | Yes | Equivalent to<br>K140581. No<br>impact on safety<br>or performance |
| Sterility Condition | Non sterile | Sterile | Yes | Equivalent to<br>K140581. No<br>impact on safety<br>or performance |
| ENFit Connector | Yes; compliant with<br>ISO 80369-3 | Yes; compliant with ISO 80369-3 | Yes | Equivalent to<br>K140581. No<br>impact on safety<br>or performance |
| Marking measures | Yes | Yes | Yes | Equivalent to<br>K140581. No<br>impact on safety<br>or performance |
| Fluid Leakage:<br>Connector | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for fluid leakage. | Tested per ISO 80369-20 and met the<br>standards of 80369-3 for fluid<br>leakage. | Yes | Equivalent to<br>K140581. No<br>impact on safety<br>or performance |
| Stress Cracking:<br>Connector | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for stress cracking. | Tested per ISO 80369-20 and met the<br>standards of ISO 80369-3 for stress<br>cracking. | Yes | Equivalent to<br>K140581. No<br>impact on safety<br>or performance |
| Resistance to<br>separation from<br>axial load:<br>connector | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for resistance to<br>separation from axial<br>load. | Tested per ISO 80369-20 and met the<br>standards of ISO 80369-3 for<br>resistance to separation from axial<br>load. | Yes | Equivalent to<br>K140581. No<br>impact on safety<br>or performance |
| Resistance to<br>separation from<br>unscrewing:<br>connector | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for separation from<br>unscrewing. | Tested per ISO 80369-20 and met the<br>standards of ISO 80369-3 for<br>separation from unscrewing. | Yes | Equivalent to<br>K140581. No<br>impact on safety<br>or performance |
| Resistance to<br>overriding:<br>connector | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for resistance to<br>overriding. | Tested per ISO 80369-20 and met the<br>standards of ISO 80369-3 for<br>resistance to overriding. | Yes | Equivalent to<br>K140581. No<br>impact on safety<br>or performance |
| Disconnection by<br>unscrewing:<br>connector | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for disconnection by<br>unscrewing. | Tested per ISO 80369-20 and met the<br>standards of ISO 80369-3 for<br>disconnection by unscrewing. | Yes | Equivalent to<br>K140581. No<br>impact on safety<br>or performance |

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### Discussion of Differences VII.

There are no substantial differences between the indications for use, use conditions, and use environment of the Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector and Cedic Enteral Distal End ENFit Transition Connector

# VIII. Performance Testing

# Non-Clinical Tests

Verification and validation testing was performed with the Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector. It was found that enteral adapter is in compliance with the design and performance requirements when tested per the standards listed below.

- 1. Biocompatibility:
- Cytotoxicity per ISO 10993-5:2009 a.
- Guinea Pig Maximization Sensitization per ISO 10993-10:2010 b.
- Irritation per ISO 10993-10:2010 C.
- d. Acute Systemic Toxicity per ISO 10993-11:2017
- e. Material-Mediated Pyrogenicity per 10993-11:2017
- 2. Visual Inspections
- a. Visual inspection for the aspect
- 3. Enteral Device Performance test
- a. Leakage (air and liquids) testing in accordance with ISO 20695:2020

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- 4. Enteral Connector Performance Tests
- a. Fluid leakage per ISO 80369-20:2019
- b. Stress cracking per ISO 80369-20:2019
- Resistance to separation from axial load per ISO 80369-20:2019 C.
- Resistance to separation from unscrewing per ISO 80369-20:2019 d.
- Resistance to overriding per ISO 80369-20:2019 e.
- f. Disconnection by unscrewing per ISO 80369-20:2019
- ENFit dimensional verification per ISO 80369-3:2016 g.
- 5. Risk Analysis per ISO 14971:2019.
- a. Design Failure Modes and Effects Analysis (DFMEA).
- 6. Usability Analysis per ISO 62366-1:2015.

## Clinical Tests

Clinical tests were not required to demonstrate the safety and performance of the Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector. Product functionality has been adequately assessed by non-clinical tests.

## Animal Tests

Animal tests were not required to demonstrate the safety and performance the Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector. Product functionality has been adequately assessed by non-animal tests.

#### IX. Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector are substantially equivalent in safety and effectiveness to the legally marketed devices identified in part III, "Legally Marketed Predicate Devices" of this section.

# (End of Section)