(45 days)
Not Found
No
The document describes a physical medical device (syringe) and its intended use and testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as a dispenser, measuring device, and fluid transfer device used to deliver fluids into the gastrointestinal system; it does not explicitly state it treats or prevents a disease or condition.
No
The device is described as a "dispenser, a measuring device, and a fluid transfer device" used to "deliver fluids" into the gastrointestinal system. There is no mention of it being used to collect or analyze data for diagnosis.
No
The device description clearly outlines physical components (syringes of various sizes with connectors) and the performance studies focus on physical characteristics and functionality, not software performance.
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 "use as a dispenser, a measuring device, and a fluid transfer device" to "deliver fluids, either orally or enterally, into the gastrointestinal system of a patient." This describes a device used for administering substances to the body, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The description focuses on the physical characteristics of a syringe designed for enteral or oral delivery, including the connector type and sizes. 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.
- Performance Studies: The performance studies described focus on the physical and functional aspects of the syringe (biocompatibility, stability, connector integrity, dosing accuracy, usability), which are relevant to a delivery device, not a diagnostic device.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely in vivo (within the body) for the purpose of delivering fluids.
N/A
Intended Use / Indications for Use
The Monoject™ Enteral 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, either orally or enterally, into the gastrointestinal system of a patient. The oral/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 (comma separated list FDA assigned to the subject device)
PNR
Device Description
The Monoject™ Enteral Syringes with ENFit Connector are provided in sizes of 1mL to 60mL, sterile or non-sterile. The device (sizes 6mL to 60mL) incorporates a female ENFit connector for connection to an enteral access device with male ENFit connector. The device specific for low dose applications (sizes 1mL & 3mL) 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
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 syringes after accelerated aging in support of the labeling.
- Dimensional analysis of the ENFit and Low Dose Tip ENFit connector was conducted for critical dimensions, in accordance with AAMI /CN3 (PS):2014, Smallbore 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.
- Additional Testing performed on the Monoject™ Enteral Syringes with ENFit and ● Low Dose Tip ENFit Connector 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.
- Verification of the Enteral Syringes to demonstrate the direct oral administration Dosing ● Accuracy and Low Dose Syringe design Dosing Accuracy.
- o The risk associated with the misconnection of the ENFit tip and Low Dose Tip ENFit connector has been assessed.
- ENFit Syringe Tip and Low dose Tip Usability Testing. ●
Clinical testing: Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2016
Covidien Sona Manickam Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048
Re: K161963
Trade/Device Name: Monoject™ Enteral Syringe with ENFit Connector Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: July 15, 2016 Received: July 18, 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,
For Division
Douglas Silverstein -S 2016.09.01 12:36:01 -04'00'
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):
Device Name:
Monoject™ Enteral Syringe with ENFit Connector
The Monoject™ Enteral 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, either orally or enterally, into the gastrointestinal system of a patient. The oral/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 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: August 15, 2016
a. Contact Person
Sona Manickam Sr. Regulatory Affairs Specialist Covidien Telephone: (508) 261-8147
- 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 Syringe with ENFit Connector
Identification of Legally Marketed Device(s) C.
K160419 - Monoject™ Enteral Feeding Syringe with ENFit Connector (sizes 6-60mL) K161045 - Monoject™ Enteral Feeding Syringe with ENFit Connector (sizes 1 & 3mL) K161039 - NeoConnect Oral/Enteral Syringes With ENFit Connector (12 ML To 100 ML) And NeoConnect Low Dose Tip Oral/Enteral Syringes With ENFit Connector (0.5 ML To 6mL)
- d. Device Brief Description
The Monoject™ Enteral Syringes with ENFit Connector are provided in sizes of 1mL to 60mL, sterile or non-sterile. The device (sizes 6mL to 60mL) incorporates a female ENFit connector for connection to an enteral access device with male ENFit connector. The device specific for low dose applications (sizes 1mL & 3mL) 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 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, either orally or enterally, into the gastrointestinal system of a patient. The oral/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.
f. Product Comparison Summary
The proposed and the predicate syringes have the same intended use, the same function, and the same general characteristics. The primary difference between the predicate and the proposed Monoject™ Enteral Syringe with ENFit Connector is the intended route of administration and the packaging configuration. The proposed devices are identical in dimensions, materials, and function as the predicate Monoject™ Enteral Feeding Syringe with ENFit Connector (K160419 & K161045).
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 syringes after accelerated aging in support of the labeling.
- Dimensional analysis of the ENFit and Low Dose Tip ENFit connector was conducted for critical dimensions, in accordance with AAMI /CN3 (PS):2014, Smallbore 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.
- Additional Testing performed on the Monoject™ Enteral Syringes with ENFit and ● Low Dose Tip ENFit Connector 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 the Enteral Syringes to demonstrate the direct oral administration Dosing ● Accuracy and Low Dose Syringe design Dosing Accuracy.
- o The risk associated with the misconnection of the ENFit tip and Low Dose Tip ENFit connector has been assessed.
- ENFit Syringe Tip and Low dose Tip Usability Testing. ●
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 Syringe with ENFit Connector has no difference that would affect the safety or effectiveness of the devices as compared to the predicate devices and provides reasonable assurance of the safety and effectiveness of the device to demonstrate substantial equivalency.
End of Summary