(263 days)
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 and funnel connections, used in enteral nutrition. A doctor, a nurse or the adult laypersons can do enteral feeding. The target population is adults.
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.
The provided text describes a medical device, the "Nutricair enteral ENFit adapter: ENFit male - stepped/Christmas tree connector," and its substantial equivalence to a predicate device. However, it does not include information about AI/ML device performance or a comparative effectiveness study with human readers. Therefore, I cannot provide details regarding:
- Sample size used for the test set and data provenance specific to an AI/ML study.
- Number of experts used to establish ground truth for an AI/ML test set.
- Adjudication method for an AI/ML test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
- Standalone AI algorithm performance.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on non-clinical performance criteria and demonstrates compliance with established international standards for medical device connectors and biocompatibility.
Here's the information about the device's acceptance criteria and how it was shown to meet them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Standard Reference) | Reported Device Performance (Met/Not Met) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5:2009 | Met |
| Guinea Pig Maximization Sens. | ISO 10993-10:2010 | Met |
| Irritation | ISO 10993-10:2010 | Met |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Met |
| Material-Mediated Pyrogenicity | ISO 10993-11:2017 | Met |
| Visual Inspections | Visual inspection for the aspect | Met |
| Enteral Device Performance | ||
| Leakage (air and liquids) | ISO 20695:2020 | Met |
| Enteral Connector Performance | ||
| Fluid leakage | ISO 80369-20:2019 (met 80369-3 standards) | Met |
| Stress cracking | ISO 80369-20:2019 (met 80369-3 standards) | Met |
| Resistance to separation (axial) | ISO 80369-20:2019 (met 80369-3 standards) | Met |
| Resistance to separation (unscrew) | ISO 80369-20:2019 (met 80369-3 standards) | Met |
| Resistance to overriding | ISO 80369-20:2019 (met 80369-3 standards) | Met |
| Disconnection by unscrewing | ISO 80369-20:2019 (met 80369-3 standards) | Met |
| ENFit dimensional verification | ISO 80369-3:2016 | Met |
| Risk Analysis | ISO 14971:2019 | Met |
| Usability Analysis | ISO 62366-1:2015 | Met |
2. Sample size used for the test set and the data provenance
The document does not specify general "test set" sample sizes or data provenance in terms of country of origin or retrospective/prospective for the non-clinical tests conducted. The tests refer to compliance with ISO standards, which typically specify the number of samples required for each test. The tests are non-clinical, involving physical and chemical properties of the device, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for the non-clinical performance tests is defined by the objective pass/fail criteria specified within the referenced ISO standards. Human expert interpretation of results is not described as part of establishing the 'truth' for these mechanical, chemical, and biological performance tests, though qualified personnel would be required to execute and analyze the tests according to the standards.
4. Adjudication method for the test set
Not applicable. The tests are objective and based on compliance with specific ISO standard criteria. No human adjudication process, such as 2+1 or 3+1, is mentioned or implied for determining the outcome of these physical and chemical tests.
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
Not applicable. This device is a physical medical adapter, not an AI/ML software device for diagnostic imaging or similar applications requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For the non-clinical performance tests, the "ground truth" is established by the specified pass/fail criteria and methodologies outlined in the referenced international standards (e.g., ISO 10993, ISO 20695, ISO 80369). These standards define acceptable limits for various physical, chemical, and biological properties.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML software device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML software device.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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TAB 5 510(k) Summary
l. Submitter
| Official Contact | Name: Anne-Marie FUENTESTitle: Regulatory Affairs ManagerEmail: afuentes@cairlgl.fr |
|---|---|
| CAIR LGLAddress: 1, Allée des Chevreuils69380 Lissieu, FRANCE | |
| Phone: +33 (0)4 78 43 77 44Fax: +33 (0)4 78 43 77 09 | |
| Date of Preparation | February 27, 2023 |
II. Device
| Trade Name: | Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmastree 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.
| DesignFeatures/Function | Cedic Enteral DistalEnd ENFit TransitionConnector | Nutricair™ enteral ENFit adapter:ENFit male – stepped/Christmas treeconnector | SubstantiallyEquivalent? | Impact on Safetyand Performance |
|---|---|---|---|---|
| Indications for Use | The Cedic EnteralDistal End ENFitTransition Connectoris intended forconnecting an enteralgiving set with anENFit connector to anenteral catheter withfunnel. | The Nutricair™ enteral ENFitadapter: ENFit male –stepped/Christmas tree connector isa disposable, sterile medical deviceintended to be used as an adapterbetween ENFit connectors andfunnel connections, used in enteralnutrition. A doctor, a nurse or thepatient himself can do enteralfeeding. The target population isadults | Yes | Equivalent toK140581. Thereare no differencesin indications foruse that wouldimpact the safetyand performanceof the device. |
| Intended Use | The Cedic EnteralDistal End ENFitTransition Connectoris intended forconnecting an enteralgiving set with anENFit connector to anenteral catheter withfunnel. | The Nutricair™ enteral ENFitadapter: ENFit male –stepped/Christmas tree connector isa disposable, sterile medical deviceintended to be used as an adapterbetween ENFit connectors andfunnel connections, used in enteralnutrition. A doctor, a nurse or thepatient himself can do enteralfeeding. The target population isadults. | Yes | Equivalent toK140581. Thereare no differencesin intended usethat would impactthe safety andperformance ofthe device. |
| Environment ofUse | Hospital - Home | Hospital - Home | Yes | Equivalent toK140581. Thereare no differencesin environment ofuse that wouldimpact the safetyand performanceof the device. |
| Intended Users | A doctor, a nurse orthe patient himselfcan do enteralfeeding | A doctor, a nurse or the patienthimself can do enteral feeding | Yes | Equivalent toK140581. Noimpact on safetyor performance |
| Patient Population | Pediatric and adult | Adult | Yes | Equivalent toK140581. No |
| impact on safetyor performance | ||||
| Single Use | Yes | Yes | Yes | Equivalent toK140581. Noimpact on safetyor performance |
| Sterility Condition | Non sterile | Sterile | Yes | Equivalent toK140581. Noimpact on safetyor performance |
| ENFit Connector | Yes; compliant withISO 80369-3 | Yes; compliant with ISO 80369-3 | Yes | Equivalent toK140581. Noimpact on safetyor performance |
| Marking measures | Yes | Yes | Yes | Equivalent toK140581. Noimpact on safetyor performance |
| Fluid Leakage:Connector | Tested per ISO 80369-20 and met thestandards of 80369-3for fluid leakage. | Tested per ISO 80369-20 and met thestandards of 80369-3 for fluidleakage. | Yes | Equivalent toK140581. Noimpact on safetyor performance |
| Stress Cracking:Connector | Tested per ISO 80369-20 and met thestandards of 80369-3for stress cracking. | Tested per ISO 80369-20 and met thestandards of ISO 80369-3 for stresscracking. | Yes | Equivalent toK140581. Noimpact on safetyor performance |
| Resistance toseparation fromaxial load:connector | Tested per ISO 80369-20 and met thestandards of 80369-3for resistance toseparation from axialload. | Tested per ISO 80369-20 and met thestandards of ISO 80369-3 forresistance to separation from axialload. | Yes | Equivalent toK140581. Noimpact on safetyor performance |
| Resistance toseparation fromunscrewing:connector | Tested per ISO 80369-20 and met thestandards of 80369-3for separation fromunscrewing. | Tested per ISO 80369-20 and met thestandards of ISO 80369-3 forseparation from unscrewing. | Yes | Equivalent toK140581. Noimpact on safetyor performance |
| Resistance tooverriding:connector | Tested per ISO 80369-20 and met thestandards of 80369-3for resistance tooverriding. | Tested per ISO 80369-20 and met thestandards of ISO 80369-3 forresistance to overriding. | Yes | Equivalent toK140581. Noimpact on safetyor performance |
| Disconnection byunscrewing:connector | Tested per ISO 80369-20 and met thestandards of 80369-3for disconnection byunscrewing. | Tested per ISO 80369-20 and met thestandards of ISO 80369-3 fordisconnection by unscrewing. | Yes | Equivalent toK140581. Noimpact on safetyor 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.
-
- 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
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-
- 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.
(End of 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.