(263 days)
Not Found
No
The device description and intended use clearly define a simple mechanical adapter for enteral feeding, with no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
This device is an adapter for enteral nutrition, facilitating connection between different tubing types, and does not directly provide therapy or affect a body function.
No
The device is described as an adapter for enteral nutrition, connecting ENFit and funnel connections. Its purpose is for feeding, not for diagnosis.
No
The device description clearly states it is a physical, disposable medical device made of ABS and PEHD, intended for use as an adapter in enteral nutrition. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an adapter for enteral nutrition, which involves delivering food or nutrients directly into the stomach or small intestine. This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The description details a physical adapter with connectors for enteral feeding systems. It doesn't mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Language: The document does not use any language typically associated with IVDs, such as "diagnosis," "detection," "measurement of analytes," "in vitro," or "specimen."
- Performance Studies: The performance studies focus on verification and validation of the physical adapter's design and performance requirements, not on the accuracy or reliability of diagnostic results.
- Predicate Device: The predicate device (K140581 Cedic Enteral Distal End ENFit Transition Connector) is also an enteral feeding accessory, further supporting that this device falls under the category of medical devices for delivery/administration, not diagnosis.
In summary, the device's purpose is to facilitate the physical connection for delivering enteral nutrition, which is a medical treatment/support, not a diagnostic process performed outside the body on biological samples.
N/A
Intended Use / 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 connections, used in enteral nutrition. A dotor, a nurse or the adult laypersons can do enteral feeding. The target population is adults.
Product codes
PIO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
A doctor, a nurse or the adult laypersons can do enteral feeding. Hospital - Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
- Biocompatibility:
a. Cytotoxicity per ISO 10993-5:2009
b. Guinea Pig Maximization Sensitization per ISO 10993-10:2010
c. Irritation per ISO 10993-10:2010
d. Acute Systemic Toxicity per ISO 10993-11:2017
e. Material-Mediated Pyrogenicity per 10993-11:2017 - Visual Inspections
a. Visual inspection for the aspect - Enteral Device Performance test
a. Leakage (air and liquids) testing in accordance with ISO 20695:2020 - Enteral Connector Performance Tests
a. Fluid leakage per ISO 80369-20:2019
b. Stress cracking per ISO 80369-20:2019
c. Resistance to separation from axial load per ISO 80369-20:2019
d. Resistance to separation from unscrewing per ISO 80369-20:2019
e. Resistance to overriding per ISO 80369-20:2019
f. Disconnection by unscrewing per ISO 80369-20:2019
g. ENFit dimensional verification per ISO 80369-3:2016 - Risk Analysis per ISO 14971:2019.
a. Design Failure Modes and Effects Analysis (DFMEA). - Usability Analysis per ISO 62366-1:2015.
Key Results: It was found that enteral adapter is in compliance with the design and performance requirements when tested per the standards listed.
Clinical Tests: Clinical tests were not required.
Animal Tests: Animal tests were not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
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
3
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
TAB 5 510(k) Summary
l. Submitter
| Official Contact | Name: Anne-Marie FUENTES
Title: Regulatory Affairs Manager
Email: afuentes@cairlgl.fr |
|---------------------|---------------------------------------------------------------------------------------------|
| | CAIR LGL
Address: 1, Allée des Chevreuils
69380 Lissieu, FRANCE |
| | Phone: +33 (0)4 78 43 77 44
Fax: +33 (0)4 78 43 77 09 |
| Date of Preparation | February 27, 2023 |
II. Device
| Trade Name: | Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas
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
5
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.
6
Table 5-1: Device comparison table for Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector and the predicate device.
| Design
Features/Function | Cedic Enteral Distal
End ENFit Transition
Connector | Nutricair™ enteral ENFit adapter:
ENFit male – stepped/Christmas tree
connector | Substantially
Equivalent? | Impact on Safety
and Performance |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Cedic Enteral
Distal End ENFit
Transition Connector
is intended for
connecting an enteral
giving set with an
ENFit connector to an
enteral catheter with
funnel. | 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
patient himself can do enteral
feeding. The target population is
adults | Yes | Equivalent to
K140581. There
are no differences
in indications for
use that would
impact the safety
and performance
of the device. |
| Intended Use | The Cedic Enteral
Distal End ENFit
Transition Connector
is intended for
connecting an enteral
giving set with an
ENFit connector to an
enteral catheter with
funnel. | 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
patient himself can do enteral
feeding. The target population is
adults. | Yes | Equivalent to
K140581. There
are no differences
in intended use
that would impact
the safety and
performance of
the device. |
| Environment of
Use | Hospital - Home | Hospital - Home | Yes | Equivalent to
K140581. There
are no differences
in environment of
use that would
impact the safety
and performance
of the device. |
| Intended Users | A doctor, a nurse or
the patient himself
can do enteral
feeding | A doctor, a nurse or the patient
himself can do enteral feeding | Yes | Equivalent to
K140581. No
impact on safety
or performance |
| Patient Population | Pediatric and adult | Adult | Yes | Equivalent to
K140581. No |
| | | | | impact on safety
or performance |
| Single Use | Yes | Yes | Yes | Equivalent to
K140581. No
impact on safety
or performance |
| Sterility Condition | Non sterile | Sterile | Yes | Equivalent to
K140581. No
impact on safety
or performance |
| ENFit Connector | Yes; compliant with
ISO 80369-3 | Yes; compliant with ISO 80369-3 | Yes | Equivalent to
K140581. No
impact on safety
or performance |
| Marking measures | Yes | Yes | Yes | Equivalent to
K140581. No
impact on safety
or performance |
| Fluid Leakage:
Connector | Tested per ISO 80369-
20 and met the
standards of 80369-3
for fluid leakage. | Tested per ISO 80369-20 and met the
standards of 80369-3 for fluid
leakage. | Yes | Equivalent to
K140581. No
impact on safety
or performance |
| Stress Cracking:
Connector | Tested per ISO 80369-
20 and met the
standards of 80369-3
for stress cracking. | Tested per ISO 80369-20 and met the
standards of ISO 80369-3 for stress
cracking. | Yes | Equivalent to
K140581. No
impact on safety
or performance |
| Resistance to
separation from
axial load:
connector | Tested per ISO 80369-
20 and met the
standards of 80369-3
for resistance to
separation from axial
load. | Tested per ISO 80369-20 and met the
standards of ISO 80369-3 for
resistance to separation from axial
load. | Yes | Equivalent to
K140581. No
impact on safety
or performance |
| Resistance to
separation from
unscrewing:
connector | Tested per ISO 80369-
20 and met the
standards of 80369-3
for separation from
unscrewing. | Tested per ISO 80369-20 and met the
standards of ISO 80369-3 for
separation from unscrewing. | Yes | Equivalent to
K140581. No
impact on safety
or performance |
| Resistance to
overriding:
connector | Tested per ISO 80369-
20 and met the
standards of 80369-3
for resistance to
overriding. | Tested per ISO 80369-20 and met the
standards of ISO 80369-3 for
resistance to overriding. | Yes | Equivalent to
K140581. No
impact on safety
or performance |
| Disconnection by
unscrewing:
connector | Tested per ISO 80369-
20 and met the
standards of 80369-3
for disconnection by
unscrewing. | Tested per ISO 80369-20 and met the
standards of ISO 80369-3 for
disconnection by unscrewing. | Yes | Equivalent to
K140581. No
impact on safety
or performance |
7
8
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.
-
- 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
-
- Visual Inspections
- a. Visual inspection for the aspect
-
- Enteral Device Performance test
- a. Leakage (air and liquids) testing in accordance with ISO 20695:2020
9
-
- 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.
-
- Risk Analysis per ISO 14971:2019.
- a. Design Failure Modes and Effects Analysis (DFMEA).
-
- 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.