(86 days)
Not Found
No
The device description and intended use are for a simple mechanical syringe, and there is no mention of AI or ML in the provided text.
No
The device is described as a dispenser, measuring device, and fluid transfer device for delivering fluids into the gastrointestinal system, and it does not perform any therapeutic action itself.
No
Explanation: The device is described as a dispenser, measuring device, and fluid transfer device used to deliver fluids into the gastrointestinal system. There is no mention of it being used to diagnose conditions or process diagnostic data.
No
The device description clearly indicates a physical, disposable syringe with a connector, not a software application.
Based on the provided information, the Monoject™ Enteral Feeding Syringe with ENFit Connector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use of this syringe is to deliver fluids into the gastrointestinal system of a patient. It is not used to analyze blood, urine, tissue, or any other bodily fluid or substance outside the body to provide information about a patient's health.
- The description focuses on the physical function of the device. It describes it as a dispenser, measuring device, and fluid transfer device for enteral feeding.
- There is no mention of analyzing or testing any biological samples.
Therefore, this device falls under the category of a medical device used for patient care, specifically for enteral feeding, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Monoject™ 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 the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
Product codes
PNR
Device Description
The Monoject™ Enteral Feeding Syringe with ENFit Connector is a disposable enteral feeding syringe provided in a variety of sizes from 6mL to 60mL. The device incorporates a female ENFit connector for connection to an enteral access device with male ENFit connector.
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
all age groups
Intended User / Care Setting
clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians
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)
Nonclinical testing was performed including:
- Biocompatibility testing
- Stability testing
- Dimensional analysis in accordance with ISO 80369-3
- Testing in accordance with AAMI /CN3 (PS):2014, using test methods from ISO 80369-20, covering: Fluid Leakage, Stress Cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding, Disconnection by unscrewing.
- Risk assessment related to misconnection of the ENFit connector.
- Usability and human factors testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2016
Covidien Sona Manickam Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048
Re: K160419
Trade/Device Name: Monoject™ Enteral Feeding Syringe with ENFit Connector Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tubes and Accessories Regulatory Class: II Product Code: PNR Dated: February 12, 2016 Received: February 16, 2016
Dear Sona Manickam:
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 (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. 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.
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.
1
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1.0 Indications for Use Statement
Indications for Use
K160419 510(k) Number (if known):
Device Name:
Monoject™ Enteral Feeding Syringe with ENFit Connector
The Monoject™ 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 the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
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2.0 510(k) Summary
Monoject™ Enteral Feeding Syringe with ENFit Connector
In accordance with section 513(i) of the SMDA and as defined in 21CFR Part 807.92 this summary is submitted by:
Covidien 15 Hampshire Street Mansfield, MA 02048 Date Prepared: May 5, 2016
a. Contact Person
Sona Manickam Sr. Regulatory Affairs Specialist Covidien Telephone: (508) 261-8147 Fax: (508) 261-8461
- b. Name of Medical Device
Common Name: Enteral Syringes with Enteral Specific Connectors
U.S. FDA Classification Product Code: PNR
U.S. Regulation Description: Gastrointestinal tube and accessories, 21 CFR 876.5980
Proprietary / Trade Name: Monoject™ Enteral Feeding Syringe with ENFit Connector
c. Identification of Legally Marketed Device(s)
K142128 - Kangaroo™ Enteral Feeding Syringe with ENFit Connector K152857 - NeoMed NeoConnect™ Enteral Syringes with ENFit Connector and compatible NeoSecure™ Tip Caps
d. Device Brief Description
The Monoject™ Enteral Feeding Syringe with ENFit Connector is a disposable enteral feeding syringe provided in a variety of sizes from 6mL to 60mL. The device incorporates a female ENFit connector for connection to an enteral access device with male ENFit connector.
4
e. Indications for Use
The Monoject™ 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 the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians in all age groups.
Product Comparison Summary f.
The proposed and predicate enteral feeding syringes are intended for patients who require enteral nutrition due to illness or injury which prevents normal chewing and swallowing. These products are enteral syringes that have the same intended use, the same function, and the same general characteristics.
The design and materials of the proposed devices are identical to the predicate Kangaroo™ Enteral Feeding Syringe with ENFit Connector (K142128). The only difference between the cleared K142128 predicate and the proposed device is the expansion of the cleared indication to include enteral delivery of fluids in addition to the already cleared indication of delivery of enteral nutrition.
g. Nonclinical testing
- o Biocompatibility testing has demonstrated the biological safety of the proposed devices which may indirectly contact the patients
- Stability testing evaluated the properties of the enteral feeding syringes after accelerated aging in support of the labeling.
- o Dimensional analysis was conducted for critical dimensions of the Monoject Enteral Feeding Syringes with ENFit connector and the accessories, in accordance with ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications. The testing demonstrates the proposed devices conform to the criteria in Table B.2 of AAMI /CN3 (PS):2014.
- Testing performed on the Monoject™ Enteral Feeding Syringes with ENFit ● Connectors included the items listed below, in accordance with AAMI /CN3 (PS):2014, Small-bore connectors for liquids and gases in healthcare applications -Part 3: Connectors for enteral applications, using the test methods provided in ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications -Part 20: Common test methods. The testing demonstrates the proposed devices conform to the requirements of AAMI /CN3 (PS):2014.
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| Individual Test Defined
in ISO 80369-3 | Requirement Defined
in AAMI /CN3
(PS):2014 | Test Method Defined
in ISO 80369-20 |
|---------------------------------------------|--------------------------------------------------|----------------------------------------|
| Fluid Leakage | Clause 6.2 | Annex C |
| Stress Cracking | Clause 6.3 | Annex E |
| Resistance to separation
from axial load | Clause 6.4 | Annex F |
| Resistance to separation
from unscrewing | Clause 6.5 | Annex G |
| Resistance to overriding | Clause 6.6 | Annex H |
| Disconnection by
unscrewing | Clause 6.7 | Annex I |
- The risk associated the misconnection of the ENFit connector has been assessed at length and captured in the following documents..
- o PG Lock Misconnection Data with FMEA 2014-01-9
- o 3595-0501-04 Enteral Connector Misconnection Assessment
- o Enteral Connection Risk Management Report Rev 2.0
- o PG Lock Misconnection Risk Assessment Report 041513
- Usability and human factors testing was conducted as part of the design of the ENFit ● connector.
h. Clinical testing
Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence.
- i. Conclusions
The information provided within this pre-market notification demonstrates that the Monoject™ Enteral Feeding Syringe with ENFit Connector has no difference that would affect the safety or effectiveness of the devices as compared to the predicate device and provide reasonable assurance of the safety and effectiveness of the device to demonstrate substantial equivalency.
End of Summary