(65 days)
Not Found
No
The document describes a simple mechanical device for fluid delivery and does not mention any AI/ML components or capabilities.
No.
The device is described as a dispenser, measuring device, and fluid transfer device for delivering fluids into the gastrointestinal system, not as a device that treats or diagnoses a disease or condition.
No
This device is described as a dispenser, a measuring device, and a fluid transfer device used to deliver fluids into the gastrointestinal system, not to diagnose a condition.
No
The device description clearly indicates a physical, disposable syringe, which is a hardware component. The performance studies also focus on physical properties and testing of the syringe itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an "Enteral Feeding Syringe" used to "deliver fluids into the gastrointestinal system of a patient." This is a device used on the patient for direct administration of substances, not for testing samples from the patient.
- Intended Use: The intended use is as a "dispenser, a measuring device, and a fluid transfer device" for delivering fluids for feeding. This aligns with a medical device used for patient care, not for diagnostic testing.
The information provided focuses on the physical characteristics, intended use, and performance testing related to the safe and accurate delivery of fluids, which are typical characteristics of a medical device used for treatment or support, not diagnosis.
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 sizes of 1mL and 3mL. The device specific for low dose applications incorporates a female ENFit Syringe tip with an internal tip lumen 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
users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
clinical or home care settings
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.
- 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.
- Testing performed on low dose Enteral Syringe design demonstrates the proposed devices conform to the requirements of ISO 7886-1 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use.
- Dimensional analysis of the low dose ENFit connector was conducted for critical dimensions, in accordance with AAMI /CN3 (PS):2014, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications. The analysis 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 low dose tip 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 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)
- Verification of low dose Enteral Syringe design to demonstrate the dosing Accuracy of the low dose tip ENFit connector.
- The risk associated with the misconnection of the ENFit low dose tip connector has been assessed.
- Low Dose Tip ENFit Syringe Tip Usability 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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2016
Covidien Sona Manickam Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048
Re: K161045
Trade/Device Name: Monoject™ Enteral Feeding Syringe with ENFit Connector Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: April 11, 2016 Received: April 13, 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 yours,
Benjamin R. Fisher -S
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
510(k) Number (if known): K161045
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: June 15, 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 sizes of 1mL and 3mL. The device specific for low dose applications incorporates a female ENFit Syringe tip with an internal tip lumen 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 except for the modification of the ENFit connector in compliance with AAMI /CN3 (PS):2014 to include an internal lumen tip to ensure dosing accuracy in low dose applications.
g. Nonclinical testing
- 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.
- Testing performed on low dose Enteral Syringe design demonstrates the proposed devices conform to the requirements of ISO 7886-1 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use
- Dimensional analysis of the low dose ENFit connector was conducted for critical dimensions, in accordance with AAMI /CN3 (PS):2014, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications. The analysis 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 low dose tip 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 ISO 80369-20.
5
| Individual Test Defined
in AAMI /CN3
(PS):2014 | 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 |
- Verification of low dose Enteral Syringe design to demonstrate the dosing Accuracy of ● the low dose tip ENFit connector
- The risk associated with the misconnection of the ENFit low dose tip connector has been assessed.
- Low Dose Tip ENFit Syringe Tip Usability Testing. ●
h. Clinical testing
Clinical evaluations were not relied upon for evidence of safety and 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 devices and is substantially equivalent.
End of Summary