Nutricair Enteral Syringe with ENFit

K231300 · Cair Lgl · PNR · Oct 6, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K231300
• Device Name: Nutricair Enteral Syringe with ENFit
• Applicant: Cair Lgl
• Product Code: PNR · Gastroenterology, Urology
• Decision Date: Oct 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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).

Device Story

Nutricair enteral syringe is a sterile, single-use 10 mL syringe; consists of polypropylene body and plunger with isoprene piston seal; features female ENFit connector compliant with ISO 80369-3. Used in clinics and home care settings by healthcare professionals or supervised laypersons for measuring, preparing, and administering enteral nutrition or medications. Device connects to enteral access devices with male ENFit connectors. Provides visual volume measurement via printed graduations. Benefits patient by ensuring secure, standardized enteral delivery, reducing risk of misconnection.

Clinical Evidence

No clinical data. Safety and performance were established through non-clinical bench testing, including biocompatibility (ISO 10993), enteral device performance (ISO 20695:2020, ISO 7886-1:2017), and connector performance (ISO 80369-20:2019, ISO 80369-3:2016).

Technological Characteristics

Materials: Polypropylene (body/plunger), isoprene (piston seal). Connector: Female ENFit (ISO 80369-3). Dimensions: 10 mL capacity with printed graduations. Energy: None (manual). Sterilization: Sterile. Testing standards: ISO 20695:2020, ISO 7886-1:2017, ISO 80369-20:2019, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 14971:2019, ISO 62366-1:2015.

Indications for Use

Indicated for neonatal, pediatric, and adult patient populations requiring enteral administration of hydration, feeding solutions, or medications. Intended for use in clinical or home settings by healthcare professionals or supervised laypersons.

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

• Disposable Enteral Feeding Syringe with ENFit Connector (K193657)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 ([e-mail]) or phone [phone] 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)

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).

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

| <span style="font-size: 16px;">☑</span> 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 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 | September 29th, 2023 |

### II. Device

| Trade Name: | Nutricair™ enteral syringe with ENFit® |
|----------------------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Enteral Syringe |
| Classification Name &<br>Number: | Gastrointestinal Tubes and accessories<br>21 CFR 876.5980<br>Class II<br>Product 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

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.

#### 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. | | |

| Design<br>Features/Function | Disposable Enteral<br>Feeding Syringe<br>with ENFit<br>Connector<br>(Predicate) | NUTRICAIR™ enteral<br>syringe with ENFit® | Substantially<br>Equivalent? | Impact on Safety<br>and Performance |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Disposable<br>Enteral Feeding<br>Syringe with ENFit<br>Connector is<br>indicated for use as<br>a dispenser, a<br>measuring device,<br>and a fluid transfer<br>device. It is used to<br>deliver fluids into<br>gastrointestinal<br>system of a patient<br>who is physically<br>unable to eat and<br>swallow. The enteral<br>feeding syringes are<br>intended to be used<br>in clinical or home<br>care setting by users<br>ranging from<br>laypersons (under<br>the supervision of a<br>clinician) to<br>clinicians, in all<br>groups. | NUTRICAIR™ enteral<br>feeding syringes with<br>ENFit® are disposable,<br>sterile medical devices<br>that are intended for<br>the measurement, the<br>preparation and enteral<br>administration of<br>solutions (hydration,<br>feeding) or medications<br>for neonatal, pediatric<br>patient and adult<br>patient populations.<br>These devices are<br>intended to be used in<br>clinics and home care<br>settings by:<br>- health care<br>professionals<br>adult laypersons<br>(instructed by/or<br>under supervision of<br>health care<br>professionals). | Yes | Equivalent to<br>K193657. There are<br>no differences in<br>indications for use that<br>would impact the<br>safety and<br>performance of the<br>device. |
| Intended Use | The Disposable<br>Enteral Feeding<br>Syringe with ENFit<br>Connector is<br>indicated for use as<br>a dispenser, a<br>measuring device,<br>and a fluid transfer<br>device. It is used to<br>deliver fluids into<br>gastrointestinal<br>system of a patient<br>who is physically<br>unable to eat and<br>swallow. The enteral<br>feeding syringes are<br>intended to be used<br>in clinical or home<br>care setting by users<br>ranging from<br>laypersons (under<br>the supervision of a<br>clinician) to<br>clinicians, in all<br>groups. | NUTRICAIR™ enteral<br>feeding syringes with<br>ENFit® are disposable,<br>sterile medical devices<br>that are intended for<br>the measurement, the<br>preparation and enteral<br>administration of<br>solutions (hydration,<br>feeding) or medications<br>for neonatal, pediatric<br>patient and adult<br>patient populations.<br>These devices are<br>intended to be used in<br>clinics and home care<br>settings by:<br>- health care<br>professionals<br>adult laypersons<br>(instructed by/or<br>under supervision of<br>health care<br>professionals). | Yes | Equivalent to<br>K193657. There are<br>no differences in<br>intended use that<br>would impact the<br>safety and<br>performance of the<br>device. |
| Environment of Use | Hospitals or Home<br>environment -<br>Prescription only | Hospital or home<br>environment -<br>Prescription Only | Yes | Equivalent to<br>K193657. There are<br>no differences in<br>environment of use<br>that would impact the<br>safety and<br>performance of the<br>device. |
| Intended Users | From Laypersons<br>(under the<br>supervision of a<br>clinician) to<br>clinicians | - health care<br>professionals<br>adult laypersons<br>(instructed by/or<br>under supervision of<br>health care<br>professionals). | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Patient Population | All groups | Neonatology, Pediatric<br>and Adults | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Single Use | Yes | Yes | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Sterility Condition | Sterile | Sterile | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| ENFit Connector | Yes; compliant with<br>ISO 80369-3 | Yes; compliant with<br>ISO 80369-3 | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Marking measures | Yes | Yes | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Size (mL)² | 1; 2; 2,5; 3; 5; 10;<br>20; 30; 50; 60 | 10 | Yes | Similar to K193657.<br>No impact on safety or<br>proper performance |
| Biocompatibility | Compliant with Use<br>of International<br>Standard ISO<br>10993-1, "Biological<br>evaluation of<br>medical devices -<br>Part 1: Evaluation<br>and testing within a<br>risk management<br>process" | Compliant with Use of<br>International Standard<br>ISO 10993-1,<br>"Biological evaluation<br>of medical devices -<br>Part 1: Evaluation and<br>testing within a risk<br>management process" | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Graduated scale<br>testing | Compliant with ISO<br>7886-1:2017 | Tested and met<br>updated standard ISO<br>20695:2020 Enteral<br>Feeding Systems -<br>Design and Testing | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Barrel testing | Compliant with ISO<br>7886-1:2017 | Tested and met<br>updated standard ISO<br>20695:2020 Enteral<br>Feeding Systems -<br>Design and Testing | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Plunger testing | Compliant with ISO<br>7886-1:2017 | Tested and met<br>updated standard ISO<br>20695:2020 Enteral<br>Feeding Systems -<br>Design and Testing | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| | | Feeding Systems –<br>Design and Testing | | on safety or<br>performance |
| Air leakage testing | Compliant with ISO<br>7886-1:2017 | Tested and met updated standard ISO 20695:2020 Enteral Feeding Systems – Design and Testing | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Force to operate<br>the piston testing | Compliant with ISO<br>7886-1:2017 | Tested and met updated standard ISO 20695:2020 Enteral Feeding Systems – Design and Testing | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Fluid Leakage:<br>Connector | Tested per ISO<br>80369-20 and met<br>the standards of<br>80369-3 for fluid<br>leakage. | Tested per ISO 80369-20 and met the<br>standards of 80369-3 for fluid leakage. | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Stress Cracking:<br>Connector | Tested per ISO<br>80369-20 and met<br>the standards of<br>80369-3 for stress<br>cracking. | Tested per ISO 80369-20 and met the<br>standards of ISO<br>80369-3 for stress<br>cracking. | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Resistance to<br>separation from<br>axial load:<br>connector | Tested per ISO<br>80369-20 and met<br>the standards of<br>80369-3 for<br>resistance to<br>separation from<br>axial load. | Tested per ISO 80369-20 and met the<br>standards of ISO<br>80369-3 for resistance<br>to separation from axial<br>load. | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Resistance to<br>separation from<br>unscrewing:<br>connector | Tested per ISO<br>80369-20 and met<br>the standards of<br>80369-3 for<br>separation from<br>unscrewing. | Tested per ISO 80369-20 and met the<br>standards of ISO<br>80369-3 for separation<br>from unscrewing. | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Resistance to<br>overriding:<br>connector | Tested per ISO<br>80369-20 and met<br>the standards of<br>80369-3 for<br>resistance to<br>overriding. | Tested per ISO 80369-20 and met the<br>standards of ISO<br>80369-3 for resistance<br>to overriding. | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| Disconnection by<br>unscrewing:<br>connector | Tested per ISO<br>80369-20 and met<br>the standards of<br>80369-3 for<br>disconnection by<br>unscrewing. | Tested per ISO 80369-<br>20 and met the<br>standards of ISO<br>80369-3 for<br>disconnection by<br>unscrewing. | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |
| ENFit Dimensional<br>Verification | Evaluated per ISO<br>80369-3 for ENFit<br>dimensional<br>verification. | Evaluated per ISO<br>80369-3 for ENFit<br>dimensional<br>verification. | Yes | Equivalent to<br>K193657. No impact<br>on safety or<br>performance |

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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
- 2. Visual Inspections
- a. Visual inspection for sharp points or edges
- 3. 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
- 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.
- 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
- 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 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)