(155 days)
Not Found
No
The device description and intended use are for a standard enteral feeding syringe, and there is no mention of AI or ML in the provided text.
No
Explanation: This device is described as an enteral feeding syringe used for the measurement, preparation, and administration of solutions or medications, not for therapeutic treatment itself. While it facilitates the delivery of substances, it does not perform a direct therapeutic function.
No
Explanation: The device is described as an "enteral feeding syringe" intended for "measurement, preparation and enteral administration of solutions" like hydration, feeding, or medications. It does not mention diagnosis.
No
The device description clearly outlines physical components (body, plunger, piston seal) and mentions it is a sterile, single-use device, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "measurement, the preparation and enteral administration of solutions (hydration, feeding) or medications". This involves delivering substances into the body, not analyzing samples from the body to diagnose or monitor a condition.
- Device Description: The description details a syringe with an ENFit connector, designed for administering liquids. This aligns with a delivery device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for the delivery of substances.
N/A
Intended Use / Indications for 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 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).
Product codes
PNR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal system
Indicated Patient Age Range
neonatal, pediatric and adult patient populations.
Intended User / Care Setting
clinics and home care settings by: - health care professionals - adult laypersons (instructed by/or under the supervision of health care professionals).
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: 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.
- Biocompatibility: Cytotoxicity per ISO 10993-5:2009, Guinea Pig Maximization Sensitization per ISO 10993-10:2010, Irritation per ISO 10993-10:2010, Acute Systemic Toxicity per ISO 10993-11:2017, Material-Mediated Pyrogenicity per 10993-11:2017
- Visual Inspections: Visual inspection for sharp points or edges
- Enteral Device Performance test: Graduated capacity in accordance with ISO 20695:2020 and ISO 7886-1:2017, Barrel dimensions in accordance with ISO 20695:2020 and ISO 7886-1:2017, Collar dimensions in accordance with ISO 20695:2020 and ISO 7886-1:2017, Cap-Piston/Piston assembly in accordance with ISO 20695:2020 and ISO 7886-1:2017 (partially), 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 7886-1:2017, Graduations in accordance with ISO 20695:2020 and ISO 7886-1:2017, 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 7886-1:2017, Piston operating force testing in accordance with ISO 20695:2020 and ISO 7886-1:2017, Marking resistance testing in accordance with internal specifications and ISO 7886-1:2017
- Enteral Connector Performance Tests: Fluid leakage per ISO 80369-20:2019, Stress cracking per ISO 80369-20:2019, Resistance to separation from axial load per ISO 80369-20:2019, Resistance to separation from unscrewing per ISO 80369-20:2019, Resistance to overriding per ISO 80369-20:2019, Disconnection by unscrewing per ISO 80369-20:2019, ENFit dimensional verification per ISO 80369-3:2016
- Risk Analysis per ISO 14971:2019: 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 syringe with ENFit. 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 syringe with ENFit. Product functionality has been adequately assessed by non-animal tests.
Key results: 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.
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.
0
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
1
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).
2
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
3
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)
| ☑ 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 | September 29th, 2023 |
II. Device
| Trade Name: | Nutricair™ enteral syringe with ENFit® |
|---|---|
| Common Name: | Enteral Syringe |
| Classification Name & | |
| Number: | Gastrointestinal Tubes and accessories |
| 21 CFR 876.5980 | |
| Class II | |
| 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
5
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.
6
| Table 5-1: Device comparison table for Nutricair™ enteral syringe with ENFit and the predicate | |||
|---|---|---|---|
| device. |
| Design
Features/Function | Disposable Enteral
Feeding Syringe
with ENFit
Connector
(Predicate) | NUTRICAIR™ enteral
syringe with ENFit® | Substantially
Equivalent? | Impact on Safety
and Performance |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Disposable
Enteral Feeding
Syringe with ENFit
Connector is
indicated for use as
a dispenser, a
measuring device,
and a fluid transfer
device. It is used to
deliver fluids into
gastrointestinal
system of a patient
who is physically
unable to eat and
swallow. The enteral
feeding syringes are
intended to be used
in clinical or home
care setting by users
ranging from
laypersons (under
the supervision of a
clinician) to
clinicians, in all
groups. | 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). | Yes | Equivalent to
K193657. There are
no differences in
indications for use that
would impact the
safety and
performance of the
device. |
| Intended Use | The Disposable
Enteral Feeding
Syringe with ENFit
Connector is
indicated for use as
a dispenser, a
measuring device,
and a fluid transfer
device. It is used to
deliver fluids into
gastrointestinal
system of a patient
who is physically
unable to eat and
swallow. The enteral
feeding syringes are
intended to be used
in clinical or home
care setting by users
ranging from
laypersons (under
the supervision of a
clinician) to
clinicians, in all
groups. | 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). | Yes | Equivalent to
K193657. There are
no differences in
intended use that
would impact the
safety and
performance of the
device. |
| Environment of Use | Hospitals or Home
environment -
Prescription only | Hospital or home
environment -
Prescription Only | Yes | Equivalent to
K193657. There are
no differences in
environment of use
that would impact the
safety and
performance of the
device. |
| Intended Users | From Laypersons
(under the
supervision of a
clinician) to
clinicians | - health care
professionals
adult laypersons
(instructed by/or
under supervision of
health care
professionals). | Yes | Equivalent to
K193657. No impact
on safety or
performance |
| Patient Population | All groups | Neonatology, Pediatric
and Adults | Yes | Equivalent to
K193657. No impact
on safety or
performance |
| Single Use | Yes | Yes | Yes | Equivalent to
K193657. No impact
on safety or
performance |
| Sterility Condition | Sterile | Sterile | Yes | Equivalent to
K193657. No impact
on safety or
performance |
| ENFit Connector | Yes; compliant with
ISO 80369-3 | Yes; compliant with
ISO 80369-3 | Yes | Equivalent to
K193657. No impact
on safety or
performance |
| Marking measures | Yes | Yes | Yes | Equivalent to
K193657. No impact
on safety or
performance |
| Size (mL)² | 1; 2; 2,5; 3; 5; 10;
20; 30; 50; 60 | 10 | Yes | Similar to K193657.
No impact on safety or
proper performance |
| Biocompatibility | Compliant with Use
of International
Standard ISO
10993-1, "Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within a
risk management
process" | Compliant with Use of
International Standard
ISO 10993-1,
"Biological evaluation
of medical devices -
Part 1: Evaluation and
testing within a risk
management process" | Yes | Equivalent to
K193657. No impact
on safety or
performance |
| Graduated scale
testing | Compliant with ISO
7886-1:2017 | Tested and met
updated standard ISO
20695:2020 Enteral
Feeding Systems -
Design and Testing | Yes | Equivalent to
K193657. No impact
on safety or
performance |
| Barrel testing | Compliant with ISO
7886-1:2017 | Tested and met
updated standard ISO
20695:2020 Enteral
Feeding Systems -
Design and Testing | Yes | Equivalent to
K193657. No impact
on safety or
performance |
| Plunger testing | Compliant with ISO
7886-1:2017 | Tested and met
updated standard ISO
20695:2020 Enteral
Feeding Systems -
Design and Testing | Yes | Equivalent to
K193657. No impact
on safety or
performance |
| | | Feeding Systems –
Design and Testing | | on safety or
performance |
| Air leakage testing | Compliant with ISO
7886-1:2017 | Tested and met updated standard ISO 20695:2020 Enteral Feeding Systems – Design and Testing | Yes | Equivalent to
K193657. No impact
on safety or
performance |
| Force to operate
the piston testing | Compliant with ISO
7886-1:2017 | Tested and met updated standard ISO 20695:2020 Enteral Feeding Systems – Design and Testing | Yes | Equivalent to
K193657. 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
K193657. 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
K193657. 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
K193657. 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
K193657. 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
K193657. 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
K193657. No impact
on safety or
performance |
| ENFit Dimensional
Verification | Evaluated per ISO
80369-3 for ENFit
dimensional
verification. | Evaluated per ISO
80369-3 for ENFit
dimensional
verification. | Yes | Equivalent to
K193657. No impact
on safety or
performance |
7
8
9
10
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.
-
- 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 sharp points or edges
-
- Enteral Device Performance test
- a. Graduated capacity in accordance with ISO 20695:2020 and ISO 7886-1:2017
11
- 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
-
- 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
-
- 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 syringe with ENFit. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests
12
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)