(256 days)
No
The device description and performance studies focus on the physical characteristics and functionality of a syringe and its accessories, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a syringe used to deliver fluids or nutritional formula, acting as a dispenser, measuring device, and fluid transfer device, but it does not directly treat or cure a disease or condition.
No
Explanation: The device is described as a dispenser, measuring device, and fluid transfer device used to deliver fluids or nutritional formula. There is no mention of it being used for diagnostic purposes, such as identifying or monitoring a medical condition.
No
The device description clearly states it is a physical syringe and accessories, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "deliver fluids or nutritional formula into the gastrointestinal system." This is a direct delivery of substances into the body, not for testing samples taken from the body.
- Device Description: The description focuses on the physical characteristics of the syringe and its connectors for delivering fluids.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, providing diagnostic information, or any other activities typically associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to introduce substances into the body.
N/A
Intended Use / Indications for Use
The DASH 3TM ENFit Syringe is a sugle use syninge indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nututional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral synnges 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.
The DASH 3TM Eccentric ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syninges 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.
The DASH 3TM Low Volume Tip ENFit Syringe is a sungle use syringe indicated for use as a dispenser, a measuning device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syninges are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinicians, in all age groups.
The DASH 3TM ENFit Syringe Cap allows the advance preparation and secure storage and transport of medication/fluids or mutritional formula. The synnge cap will fit any size of the Single Use Synnges (DASH 3TM).
Product codes (comma separated list FDA assigned to the subject device)
PNR
Device Description
The DASH 3™ ENFit Syringe device family is a Single Use, in-hospital and home care (DASH 3™ ENFit Syringe, DASH 3™ Eccentric ENFit Syringe, DASH 3™ ENFit Low Dose Tip Syringe) device.
It is provided in sizes from 1 mL to 100 mL. The device incorporates a female ENFit connector for connection to an enteral access device with a male ENFit port specified in ISO 80369-3. The Low Dose Tip contains the low dose design feature specified in (Draft) ISO 20695.
The DASH 3™ ENFit accessories are designed to be compatible with ENFit connector devices. The DASH 3™ ENFit Syringe Caps fit any size of the Single Use ENFit Syringes (DASH 3™), which allows the advance preparation and secure storage and transport of medication/fluids or nutritional formula.
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)
All necessary bench testing was conducted on the DASH 3™ ENFit Syringe, DASH 3™ Eccentric ENFit Syringe, DASH 3™ ENFit Low Dose Tip Syringe and DASH 3™ ENFit Syringe Cap to support a determination of substantial equivalence to the (primary) predicate and reference devices. Testing included biocompatibility, sterilization validation, shipping and packaging, accelerated aging, and design verification testing. Design verification testing included the following:
- Visual inspection
- Dimensional verification
- Physical testing
Performance testing was conducted to confirm compliance to the design specifications of ISO 80369-3, and also with reference to Draft ISO 20695 for the low dose tip; all functions have been verified to operate as designed. The DASH 3™ Syringe device family, its female ENFit connector and its accessories (with male ENFit connectors) have met all acceptance criteria.
| Individual Test Defined in ISO 80369-3 | Test Method Defined in ISO 80369-20 |
|---|---|
| Fluid Leakage | Annex C |
| Stress Cracking | Annex E |
| Resistance to separation from axial load | Annex F |
| Resistance to separation from unscrewing | Annex G |
| Resistance to overriding | Annex H |
| Disconnection by unscrewing | Annex I |
Dimensional analysis was conducted for critical dimensions of the DASH 3™ ENFit Syringe device family and its accessories (with ENFit connectors), in accordance with the criteria in ISO 80369-3.
Device Verification Testing for the piston syringe was conducted in accordance with ISO 7886-1. This includes:
- Lubricant.
- Limits of extractable metals,
- Limits for acidity/alkalinity,
- Capacity Tolerance (Graduated Scale),
- Dead Space
- Air and liquid leakage Testing (Side Force/Axial Force.)
Biocompatibility testing has demonstrated that the DASH 3™ Syringe and its accessories meet the requirements for biocompatibility.
Stability testing evaluated the properties of the DASH 3™ Syringe and its accessories after accelerated aging to establish a 5-year shelf life for the syringes and a 3 to 5-year shelf life for the accessories and to confirm the strength and integrity characteristics of the sterile device packaging and the ability of the packaging to maintain a sterile barrier for the duration of the labeled shelf life.
The risk associated with misconnection of the ENFit connector has been assessed and the process captured in the following documents:
- FMEA (Design, User, Process)
- Risk Management Report
- Enteral Connector Misconnection Assessment (As recommended in FDA Enteral Connector Guidance)
Additional testing for the Low Dose Syringe tip design includes:
- Low Dose Enteral Connector Misconnection Assessment (As recommended in FDA Enteral Connector Guidance)
- Usability Assessment for the Low Dose Syringe Tip Design
- Low Dose Syringe Design Dose Accuracy Testing
The collective results of the testing demonstrate that the DASH 3™ ENFit Syringe device family and accessories meet specifications and perform as intended. In addition, the collective bench testing demonstrates that the DASH 3™ ENFit Syringe device family and accessories do not raise new questions of safety or effectiveness as compared to the predicate or reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 20, 2017
Intervene Group Limited Homer Trieu Regulatory Affairs Manager Russell Building, Brunel Science Park, Kingston Lane Uxbridge, UB8 3PQ GB
Re: K170371
Trade/Device Name: Dash 3 ENFit Syringe, Dash 3 Eccentric ENFit Syringe, Dash 3 ENFit Low Dose Tip Syringe, Dash 3 ENFit Syringe Cap. Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: PNR Dated: September 11, 2017 Received: September 25, 2017
Dear Homer Trieu:
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. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 (DICE) 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 (DICE) 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.
Joyce M. Whang -S
Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170371
Device Name
DASH 374 ENFit Syringe, DASH 374 Eccentric ENFit Low Dose Tip Syninge, DASH 374 ENFit Syringe Cap
Indications for Use (Describe)
The DASH 3TM ENFit Syringe is a sugle use syninge indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nututional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral synnges 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.
The DASH 3TM Eccentric ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syninges 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.
The DASH 3TM Low Volume Tip ENFit Syringe is a sungle use syringe indicated for use as a dispenser, a measuning device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syninges are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinicians, in all age groups.
Accessories
The DASH 3M ENFit Syringe Cap allows the advance preparation and secure storage and transport of medication fluids or mutritional formula. The synnge cap will fit any size of the Single Use Synnges (DASH 3TM)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
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| time to review instructions, search existing data sources, gather and maintain the data needed and complete | |
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| of this information collection, including suggestions for reducing this burden, to: |
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
SECTION 5 510(K) SUMMARY
This summary of the 510(k) premarket notification for the DASH 3™ is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
4
5.1 General Information
Applicant:
INTERVENE Group Ltd. Russell Building Brunel Science Park Kingston Lane Uxbridge, Middlesex UB8 3PQ UK Tel: + 44 (0)207 841 2734
Contact Person:
Homer Trieu Regulatory Affairs Manager, INTERVENE Group Limited Phone: +44 (0) 0207 841 2735 E-mail: htrieu@ivltd.co.uk Date Prepared: February 6, 2017
5.2 Device Information
Trade/Proprietary Name:
DASH 3™ ENFit Syringe, DASH 3™ Eccentric ENFit Syringe, DASH 3™ ENFit Low Dose Tip Syringe, DASH 3TM ENFit Syringe Cap.
| Generic/Common Name: | Enteral syringes with enteral specific connectors (syringes)
Gastrointestinal tubes with enteral specific connectors (accessories) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | PNR (syringes) |
| Device Class and Panel: | Class II, Gastroenterology and Urology |
| Classification Regulation: | 21 CFR§876.5980 - Gastrointestinal tube and accessories. |
5
Predicate Device/Reference devices in the market 5.3
5.3.1 Predicate for Syringes
| | Primary Predicate:
Centered Tip Syringe
and Low Dose Tip
Syringe | Reference Device:
Eccentric Syringe Tip |
|---------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------|
| Trade Name: | Monoject Enteral
Feeding Syringe with
ENFit Connector | NeoConnect
Oral/Enteral Syringes
with ENFit Connectors |
| Manufacturer and
Clearance Number: | Covidien
K161963
K161045 | NeoMed, Inc.
K161039 |
| Product Code: | PNR | PNR |
| Classification Name: | Enteral Syringes with
Enteral Specific
Connectors | Enteral Syringes with
Enteral Specific
Connectors |
5.3.2 Predicate/Reference for Accessories
| Predicate: Syringe Cap | ||
|---|---|---|
| Trade Name: | NeoMed NeoConnect™ Enteral | |
| Syringes with ENFit™ Connector | ||
| and compatible NeoSecure™ Tip | ||
| Caps | ||
| Manufacturer and | ||
| Clearance Number: | NeoMed, Inc. | |
| K152857 | ||
| Product Code: | PIF | |
| Classification | ||
| Name: | Gastrointestinal Tube and accessories |
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5.4 Indications for Use
Svringes
The DASH 3TM ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula 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.
The DASH 3TM Eccentric ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system 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.
The DASH 3™ Low Dose Tip ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula 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.
Accessories
The DASH 3TM ENFit Syringe Cap allows the advance preparation and secure storage and transport of medication/fluids or nutritional formula. The syringe cap will fit any size of the Single Use Syringes (DASH 3TM).
7
5.5 Product Description
The DASH 3™ ENFit Syringe device family is a Single Use, in-hospital and home care (DASH 3TM ENFit Syringe, DASH 3TM Eccentric ENFit Syringe, DASH 3TM ENFit Low Dose Tip Syringe) device.
It is provided in sizes from 1 mL to 100 mL. The device incorporates a female ENFit connector for connection to an enteral access device with a male ENFit port specified in ISO 80369-3. The Low Dose Tip contains the low dose design feature specified in (Draft) ISO 20695.
The DASH 3TM ENFit accessories are designed to be compatible with ENFit connector devices. The DASH 3TM ENFit Syringe Caps fit any size of the Single Use ENFit Syringes (DASH 3™), which allows the advance preparation and secure storage and transport of medication/fluids or nutritional formula.
5.6 Substantial Equivalence
The indications for use for the (primary) predicate and reference devices are substantially equivalent to the proposed indications for use for the DASH 3TM ENFit Syringe, DASH 3TM Eccentric ENFit Syringe, DASH 3TM ENFit Low Dose Tip Syringe and DASH 3TM ENFit Syringe Cap. Both device families have the same intended use and similar technological characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. These differences can be from non-critical dimensions (i.e. barrel wings, plunger dimension), additional sizes (i.e. 100ml Syringe), the color of the devices and packaging arrangements. Thus, the DASH 3TM ENFit Syringe device family and accessories are substantially equivalent to the predicate and reference devices.
5.7 Testing in Support of Substantial Equivalence Determination
All necessary bench testing was conducted on the DASH 3™ ENFit Syringe, DASH 3™ Eccentric ENFit Syringe, DASH 3™ ENFit Low Dose Tip Syringe and DASH 3™ ENFit Syringe Cap to support a determination of substantial equivalence to the (primary) predicate and reference devices. Testing included biocompatibility, sterilization validation, shipping and packaging, accelerated aging, and design verification testing. Design verification testing included the following:
- Visual inspection
- Dimensional verification
- Physical testing
Performance testing was conducted to confirm compliance to the design specifications of ISO 80369-3, and also with reference to Draft ISO 20695 for the low dose tip; all functions have been verified to operate as designed. The DASH 3TM Syringe device
8
family, its female ENFit connector and its accessories (with male ENFit connectors) have met all acceptance criteria, as described in Section 17.
| Individual Test Defined in ISO 80369-3 | Test Method Defined
in ISO 80369-20 |
|------------------------------------------|----------------------------------------|
| Fluid Leakage | Annex C |
| Stress Cracking | Annex E |
| Resistance to separation from axial load | Annex F |
| Resistance to separation from unscrewing | Annex G |
| Resistance to overriding | Annex H |
| Disconnection by unscrewing | Annex I |
Tests Defined in ISO 80369-3 and 80369-20 for ENFit Connectors
Dimensional analysis was conducted for critical dimensions of the DASH 3TM ENFit Syringe device family and its accessories (with ENFit connectors), in accordance with the criteria in ISO 80369-3.
Device Verification Testing for the piston syringe was conducted in accordance with ISO 7886-1. This includes:
- Lubricant. .
- . Limits of extractable metals,
- . Limits for acidity/alkalinity,
- . Capacity Tolerance (Graduated Scale),
- . Dead Space
- Air and liquid leakage Testing (Side Force/Axial Force.)
Biocompatibility testing has demonstrated that the DASH 3™ Syringe and its accessories meet the requirements for biocompatibility.
Stability testing evaluated the properties of the DASH 3™ Syringe and its accessories after accelerated aging to establish a 5-year shelf life for the syringes and a 3 to 5-year shelf life for the accessories and to confirm the strength and integrity characteristics of the sterile device packaging and the ability of the packaging to maintain a sterile barrier for the duration of the labeled shelf life.
The risk associated with misconnection of the ENFit connector has been assessed and the process captured in the following documents:
- FMEA (Design, User, Process)
- . Risk Management Report
- . Enteral Connector Misconnection Assessment (As recommended in FDA Enteral Connector Guidance)
9
Additional testing for the Low Dose Syringe tip design includes:
- . Low Dose Enteral Connector Misconnection Assessment (As recommended in FDA Enteral Connector Guidance)
- . Usability Assessment for the Low Dose Syringe Tip Design
- Low Dose Syringe Design Dose Accuracy Testing
The collective results of the testing demonstrate that the DASH 3™ ENFit Syringe device family and accessories meet specifications and perform as intended. In addition, the collective bench testing demonstrates that the DASH 3™ ENFit Syringe device family and accessories do not raise new questions of safety or effectiveness as compared to the predicate or reference devices.
5.8 Conclusion
The DASH 3™ ENFit Syringe family and accessories have the same intended use and similar technological characteristics as the predicate devices. The DASH 3TM ENFit Syringe family and accessories have been tested to ensure that they perform as intended and do not raise new questions of safety or effectiveness. As such, the DASH 3™ ENFit Syringe device family and accessories are substantially equivalent to the predicate and reference devices.