NUTRICAIR™ enteral feeding syringes with ENFit® are disposable, sterile medical devices that are intended for the measurement, the preparation and enteral administration of solutions (hydration, feeding) or medications for neonatal, pediatric and adult patient populations. These devices are intended to be used in clinics and home care settings by: - health care professionals - adult laypersons (instructed by/or under the supervision of health care professionals).

Device Description

The Nutricair™ enteral syringe with ENFit is sterile, single use device. It is provided in size 10 ml. It consists in a body with ENfit connector in polypropylene, a plunger in polypropylene and a piston seal in isoprene. This device incorporates a female ENFit connection to enteral access device with a male ENFit connector that is compliant to ISO 80369-3. Graduations from 1 to 10 ml are printed on the body. The 10 mL syringe model number is NCE10SE.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Nutricair Enteral Syringe with ENFit," which functions as an enteral feeding syringe. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or conducting clinical trials.

As such, the information you're requesting regarding acceptance criteria and studies demonstrating a device meets acceptance criteria, an AI-driven system, ground truth establishment, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not applicable to this document.

This submission focuses on engineering and performance criteria to show the new device performs as safely and effectively as an existing one, usually through non-clinical bench testing and comparative analysis of design features.

Here's a breakdown of why your specific questions generally don't apply to a 510(k) for a physical medical device like a syringe, based on the provided text:

1. A table of acceptance criteria and the reported device performance:
- The document largely relies on meeting established international standards (e.g., ISO) for medical devices, particularly those related to syringes and enteral connectors. The "acceptance criteria" are these standard requirements, and the "reported device performance" is that the device met these standards.
- The table on pages 6-7 ("Table 5-1: Device comparison table") highlights comparisons to the predicate device and states "Equivalent" or "Similar" and "No impact on safety or performance" as the outcome, indicating that existing standards and comparative performance are the basis for acceptance.
- Section VIII, "Performance Testing," lists the types of tests performed (biocompatibility, visual inspections, enteral device performance tests, enteral connector performance tests, risk analysis, usability analysis) and the standards they comply with (e.g., ISO 10993, ISO 20695, ISO 7886-1, ISO 80369-20, ISO 80369-3, ISO 14971, ISO 62366-1). The acceptance criteria for each of these would be the specific quantitative or qualitative limits defined within those ISO standards. The document states that the device "met updated standard ISO 20695:2020" or "met the standards of 80369-3." However, specific numeric performance results are not typically included in these public 510(k) summaries unless a deviation from a standard is justified or an equivalence needs quantitative proof for a specific parameter.
2. Sample sizes used for the test set and the data provenance:
- For physical product testing as described (e.g., fluid leakage, stress cracking, barrel dimensions), sample sizes are typically defined by the test protocols within the relevant ISO standards (e.g., a certain number of syringes tested per batch). This information is generally not included in the 510(k) summary itself, as it's part of the detailed test reports provided to the FDA.
- Data provenance for such physical device testing is typically the manufacturer's internal testing labs or third-party accredited labs. Country of origin for testing is not specified, but the manufacturer is based in France. The testing is retrospective in the sense that it was completed before the submission to demonstrate compliance.
3. Number of experts used to establish the ground truth... and their qualifications:
- This is not applicable. There is no "ground truth" in the diagnostic AI or clinical outcome sense for a basic physical device like a syringe. The "truth" is whether it meets engineering specifications and safety standards defined by regulatory bodies and consensus standards. These are established through engineering principles, laboratory testing, and risk assessment by qualified engineers and scientists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to human review of diagnostic imaging or clinical findings for establishing ground truth, which is not relevant here.
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 is not an AI/software device that would involve human readers or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- As explained in #3, "ground truth" in the diagnostic sense is not applicable. The "truth" is whether the physical device meets its specified engineering performance parameters and safety requirements, as verified through standard laboratory tests and adherence to ISO standards.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved.

In summary: The provided document is an FDA 510(k) clearance summary for a disposable medical syringe. The "acceptance criteria" are the relevant ISO standards for medical device safety and performance, and the "study" is a series of non-clinical, bench-top engineering tests demonstrating compliance with these standards and substantial equivalence to a predicate device. Concepts related to AI/ML performance, diagnostic ground truth, or multi-reader studies are entirely outside the scope of this particular device and its regulatory submission.

Summary

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October 6, 2023

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

Re: K231300

Trade/Device Name: Nutricair Enteral Syringe with ENFit Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PNR Dated: September 1, 2023 Received: September 5, 2023

Dear Irving Wiesen, Esq .:

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

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Device" (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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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) K231300

Device Name Nutricair™ enteral syringe with ENFit®

Indications for Use (Describe)

adult laypersons (instructed by/or under the supervision of health care professionals).

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	September 29th, 2023

II. Device

Trade Name:	Nutricair™ enteral syringe with ENFit®
Common Name:	Enteral Syringe
Classification Name &Number:	Gastrointestinal Tubes and accessories21 CFR 876.5980Class IIProduct Code: PNR

III. Legally Marketed Predicate Device

Disposable Enteral Feeding Syringe with ENFit Connector Product name: 510(k) Number: K193657 Manufacturer: Shinva Ande Healthcare Apparatus Co., Ltd. Product Code: PNR Device Class: Class II

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Device Description IV.

General Description of Nutricair™ enteral syringe with ENFit

V. Intended Use

NUTRICAIR™ enteral feeding syringes with ENFit® are disposable, sterile medical devices that are intended for the measurement, the preparation and enteral administration of solutions (hydration, feeding) or medications for neonatal, pediatric patient and adult patient populations. These devices are intended to be used in clinics and home care settings by:

health care professionals
adult laypersons (instructed by/or under supervision of health care professionals). -

Substantial Equivalence Discussion VI.

The Nutricair™ enteral syringe with ENFit is substantially equivalent to the currently marketed predicate Disposable Enteral Feeding Syringe with ENFit Connector. Table 5-1 is a detailed comparison of the Cair syringe to the predicate devices regarding substantial equivalence.

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Table 5-1: Device comparison table for Nutricair™ enteral syringe with ENFit and the predicate
	device.

DesignFeatures/Function	Disposable EnteralFeeding Syringewith ENFitConnector(Predicate)	NUTRICAIR™ enteralsyringe with ENFit®	SubstantiallyEquivalent?	Impact on Safetyand Performance
Indications for Use	The DisposableEnteral FeedingSyringe with ENFitConnector isindicated for use asa dispenser, ameasuring device,and a fluid transferdevice. It is used todeliver fluids intogastrointestinalsystem of a patientwho is physicallyunable to eat andswallow. The enteralfeeding syringes areintended to be usedin clinical or homecare setting by usersranging fromlaypersons (underthe supervision of aclinician) toclinicians, in allgroups.	NUTRICAIR™ enteralfeeding syringes withENFit® are disposable,sterile medical devicesthat are intended forthe measurement, thepreparation and enteraladministration ofsolutions (hydration,feeding) or medicationsfor neonatal, pediatricpatient and adultpatient populations.These devices areintended to be used inclinics and home caresettings by:- health careprofessionalsadult laypersons(instructed by/orunder supervision ofhealth careprofessionals).	Yes	Equivalent toK193657. There areno differences inindications for use thatwould impact thesafety andperformance of thedevice.
Intended Use	The DisposableEnteral FeedingSyringe with ENFitConnector isindicated for use asa dispenser, ameasuring device,and a fluid transferdevice. It is used todeliver fluids intogastrointestinalsystem of a patientwho is physicallyunable to eat andswallow. The enteralfeeding syringes areintended to be usedin clinical or homecare setting by usersranging fromlaypersons (underthe supervision of aclinician) toclinicians, in allgroups.	NUTRICAIR™ enteralfeeding syringes withENFit® are disposable,sterile medical devicesthat are intended forthe measurement, thepreparation and enteraladministration ofsolutions (hydration,feeding) or medicationsfor neonatal, pediatricpatient and adultpatient populations.These devices areintended to be used inclinics and home caresettings by:- health careprofessionalsadult laypersons(instructed by/orunder supervision ofhealth careprofessionals).	Yes	Equivalent toK193657. There areno differences inintended use thatwould impact thesafety andperformance of thedevice.
Environment of Use	Hospitals or Homeenvironment -Prescription only	Hospital or homeenvironment -Prescription Only	Yes	Equivalent toK193657. There areno differences inenvironment of usethat would impact thesafety andperformance of thedevice.
Intended Users	From Laypersons(under thesupervision of aclinician) toclinicians	- health careprofessionalsadult laypersons(instructed by/orunder supervision ofhealth careprofessionals).	Yes	Equivalent toK193657. No impacton safety orperformance
Patient Population	All groups	Neonatology, Pediatricand Adults	Yes	Equivalent toK193657. No impacton safety orperformance
Single Use	Yes	Yes	Yes	Equivalent toK193657. No impacton safety orperformance
Sterility Condition	Sterile	Sterile	Yes	Equivalent toK193657. No impacton safety orperformance
ENFit Connector	Yes; compliant withISO 80369-3	Yes; compliant withISO 80369-3	Yes	Equivalent toK193657. No impacton safety orperformance
Marking measures	Yes	Yes	Yes	Equivalent toK193657. No impacton safety orperformance
Size (mL)²	1; 2; 2,5; 3; 5; 10;20; 30; 50; 60	10	Yes	Similar to K193657.No impact on safety orproper performance
Biocompatibility	Compliant with Useof InternationalStandard ISO10993-1, "Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing within arisk managementprocess"	Compliant with Use ofInternational StandardISO 10993-1,"Biological evaluationof medical devices -Part 1: Evaluation andtesting within a riskmanagement process"	Yes	Equivalent toK193657. No impacton safety orperformance
Graduated scaletesting	Compliant with ISO7886-1:2017	Tested and metupdated standard ISO20695:2020 EnteralFeeding Systems -Design and Testing	Yes	Equivalent toK193657. No impacton safety orperformance
Barrel testing	Compliant with ISO7886-1:2017	Tested and metupdated standard ISO20695:2020 EnteralFeeding Systems -Design and Testing	Yes	Equivalent toK193657. No impacton safety orperformance
Plunger testing	Compliant with ISO7886-1:2017	Tested and metupdated standard ISO20695:2020 EnteralFeeding Systems -Design and Testing	Yes	Equivalent toK193657. No impacton safety orperformance
		Feeding Systems –Design and Testing		on safety orperformance
Air leakage testing	Compliant with ISO7886-1:2017	Tested and met updated standard ISO 20695:2020 Enteral Feeding Systems – Design and Testing	Yes	Equivalent toK193657. No impacton safety orperformance
Force to operatethe piston testing	Compliant with ISO7886-1:2017	Tested and met updated standard ISO 20695:2020 Enteral Feeding Systems – Design and Testing	Yes	Equivalent toK193657. No impacton safety orperformance
Fluid Leakage:Connector	Tested per ISO80369-20 and metthe standards of80369-3 for fluidleakage.	Tested per ISO 80369-20 and met thestandards of 80369-3 for fluid leakage.	Yes	Equivalent toK193657. No impacton safety orperformance
Stress Cracking:Connector	Tested per ISO80369-20 and metthe standards of80369-3 for stresscracking.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 for stresscracking.	Yes	Equivalent toK193657. No impacton safety orperformance
Resistance toseparation fromaxial load:connector	Tested per ISO80369-20 and metthe standards of80369-3 forresistance toseparation fromaxial load.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 for resistanceto separation from axialload.	Yes	Equivalent toK193657. No impacton safety orperformance
Resistance toseparation fromunscrewing:connector	Tested per ISO80369-20 and metthe standards of80369-3 forseparation fromunscrewing.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 for separationfrom unscrewing.	Yes	Equivalent toK193657. No impacton safety orperformance
Resistance tooverriding:connector	Tested per ISO80369-20 and metthe standards of80369-3 forresistance tooverriding.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 for resistanceto overriding.	Yes	Equivalent toK193657. No impacton safety orperformance
Disconnection byunscrewing:connector	Tested per ISO80369-20 and metthe standards of80369-3 fordisconnection byunscrewing.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 fordisconnection byunscrewing.	Yes	Equivalent toK193657. No impacton safety orperformance
ENFit DimensionalVerification	Evaluated per ISO80369-3 for ENFitdimensionalverification.	Evaluated per ISO80369-3 for ENFitdimensionalverification.	Yes	Equivalent toK193657. No impacton safety orperformance

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VII. Discussion of Differences

There are no substantial differences between the indications for use, use conditions, and use environment of the NUTRICAIR™ enteral syringe with ENFit and Disposable Enteral Feeding Syringe with ENFit Connector.

VIII. Performance Testing

Non-Clinical Tests

Verification and validation testing was performed with the NUTRICAIR™ enteral syringe with ENFit. It was found that enteral syringe is in compliance with the design and performance requirements when tested per the standards listed below.

1. 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
1. Visual Inspections
- a. Visual inspection for sharp points or edges
1. Enteral Device Performance test
- a. Graduated capacity in accordance with ISO 20695:2020 and ISO 7886-1:2017

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b. Barrel dimensions in accordance with ISO 20695:2020 and ISO 7886-1:2017
C. Collar dimensions in accordance with ISO 20695:2020 and ISO 7886-1:2017
d. Cap-Piston/Piston assembly in accordance with ISO 20695:2020 and ISO 7886-1:2017 (partially)
e. Cap-Piston/Piston fitting in accordance with ISO 20695:2020 and ISO 7886-1:2017 (partially)
Graduated scale testing in accordance with ISO 20695:2020 and ISO 7886f. 1:2017
g. Graduations in accordance with ISO 20695:2020 and ISO 7886-1:2017
h. Position of the ENFit connector in accordance with ISO 20695:2020 and ISO 7886-1:2017
Leakage (air and liquids) testing in accordance with ISO 20695:2020 and ISO i. 7886-1:2017
Piston operating force testing in accordance with ISO 20695:2020 and ISO 7886i. 1:2017
k. Marking resistance testing in accordance with internal specifications and ISO 7886-1:2017
1. 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.
- d. Resistance to separation from unscrewing per ISO 80369-20:2019
- e. Resistance to overriding per ISO 80369-20:2019
- Disconnection by unscrewing per ISO 80369-20:2019 f.
- g. ENFit dimensional verification per ISO 80369-3:2016
1. Risk Analysis per ISO 14971:2019.
- a. Design Failure Modes and Effects Analysis (DFMEA).
1. Usability Analysis per ISO 62366-1:2015.

Clinical Tests

Clinical tests were not required to demonstrate the safety and performance of the

NUTRICAIR™ enteral syringe with ENFit. Product functionality has been adequately assessed by non-clinical tests.

Animal Tests

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Animal tests were not required to demonstrate the safety and performance the NUTRICAIR™ enteral syringe with ENFit. 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 syringe with ENFit 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)

Regulation Number and 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.