DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe

K170371 · Intervene Group Limited · PNR · Oct 20, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K170371
• Device Name: DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe
• Applicant: Intervene Group Limited
• Product Code: PNR · Gastroenterology, Urology
• Decision Date: Oct 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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 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).

Device Story

Single-use enteral syringes (1-100 mL) and caps; used for dispensing, measuring, and transferring fluids or nutritional formula into gastrointestinal systems. Features female ENFit connectors (ISO 80369-3) and low-dose tip designs (ISO 20695). Operated by clinicians or laypersons in clinical or home settings. Caps allow for advance preparation, storage, and transport of enteral feeds/medications. Device ensures secure connection to enteral access devices, preventing misconnections. Benefits include accurate delivery of nutrition and medication to patients unable to swallow.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility, sterilization validation, shipping/packaging, accelerated aging, and design verification (visual, dimensional, physical). Performance testing confirmed compliance with ISO 80369-3 (fluid leakage, stress cracking, axial load, unscrewing, overriding) and ISO 7886-1 (piston syringe requirements). Risk management included FMEA and enteral connector misconnection assessments.

Technological Characteristics

Single-use syringes (1-100 mL) with female ENFit connectors per ISO 80369-3. Low-dose tip design per ISO 20695. Materials verified via biocompatibility testing. Sterile packaging with 5-year shelf life for syringes and 3-5 years for accessories. Mechanical operation; no software or energy source.

Indications for Use

Indicated for patients of all ages physically unable to eat and swallow, requiring delivery of fluids or nutritional formula into the gastrointestinal system. Used by clinicians or laypersons under clinician supervision in clinical or home settings.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Monoject Enteral Feeding Syringe with ENFit Connector (K161963, K161045)
• NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps (K152857)

Reference Devices

• NeoConnect Oral/Enteral Syringes with ENFit Connectors (K161039)

Submission Summary (Full Text)

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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);

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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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#### 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.

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#### 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: [phone] E-mail: [e-mail] 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)<br>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. |

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#### Predicate Device/Reference devices in the market 5.3

#### 5.3.1 Predicate for Syringes

| | Primary Predicate:<br>Centered Tip Syringe<br>and Low Dose Tip<br>Syringe | Reference Device:<br>Eccentric Syringe Tip |
|---------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------|
| Trade Name: | Monoject Enteral<br>Feeding Syringe with<br>ENFit Connector | NeoConnect<br>Oral/Enteral Syringes<br>with ENFit Connectors |
| Manufacturer and<br>Clearance Number: | Covidien<br>K161963<br>K161045 | NeoMed, Inc.<br>K161039 |
| Product Code: | PNR | PNR |
| Classification Name: | Enteral Syringes with<br>Enteral Specific<br>Connectors | Enteral Syringes with<br>Enteral Specific<br>Connectors |

#### 5.3.2 Predicate/Reference for Accessories

| | Predicate: Syringe Cap | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------|--|
| Trade Name: | NeoMed NeoConnect™ Enteral<br>Syringes with ENFit™ Connector<br>and compatible NeoSecure™ Tip<br>Caps | |
| Manufacturer and<br>Clearance Number: | NeoMed, Inc.<br>K152857 | |
| Product Code: | PIF | |
| Classification<br>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).

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# 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

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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<br>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)

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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.