Medela Low Dose Enteral Syringe

K161811 · Medela, Inc. · PNR · Feb 15, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K161811
• Device Name: Medela Low Dose Enteral Syringe
• Applicant: Medela, Inc.
• Product Code: PNR · Gastroenterology, Urology
• Decision Date: Feb 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Medela Low Dose 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 enterally, into the gastrointestinal system of patients in all age groups. The enteral syringes are intended to be used in clinical settings by clinicians.

Device Story

Medela Low Dose Enteral Syringe is a manual fluid delivery device consisting of a calibrated hollow cylindrical body and movable plunger. It features a low-dose tip designed to interface with ENFit connectors for enteral feeding applications. Available in 1mL and 3mL sizes; used by clinicians in clinical settings to measure, dispense, and transfer fluids into a patient's feeding tube. The device ensures accurate fluid delivery within +/-10% tolerance. It functions as a mechanical tool for enteral nutrition or medication administration, providing a secure connection to feeding tubes to prevent misconnections.

Clinical Evidence

No clinical data. Bench testing only. Verification included syringe design testing per ISO 7886-1 (cleanliness, lubricant, dead space, piston fit, slide force, leakage, alkalinity/acidity, extractable metals), ENFit connector dimensional analysis and performance testing per AAMI/CN3 (PS):2014 and AAMI/CN20 (PS):2014 (leakage, stress cracking, separation resistance, unscrewing, overriding), biocompatibility (cytotoxicity, irritation, sensitization), toxicological risk assessment, dosing accuracy verification, and shelf-life study.

Technological Characteristics

Manual enteral syringe with low-dose tip and ENFit connector. Design conforms to ISO 7886-1 and AAMI/CN3 (PS):2014. Available in 1mL and 3mL volumes. Materials evaluated for biocompatibility per ISO 10993 standards. Mechanical operation; no energy source or software.

Indications for Use

Indicated for enteral fluid delivery into the gastrointestinal system for patients of all age groups. Intended for use by clinicians in clinical 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 Syringe with ENFit Connector (K161963)

Submission Summary (Full Text)

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 15, 2017

Medela, Inc. Fergie Ferguson Sr. Director Quality Assurance 785 Challenger Street Brea, CA 92821

Re: K161811

> Trade/Device Name: Medela Low Dose Enteral Syringe Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: January 11, 2017 Received: January 12, 2017

Dear Fergie Ferguson:

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.

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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 [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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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| Form Approved: OMB No. 0910-0120 | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-----------------------------------|-----------------------------------------|--|
| Expiration Date: January 31, 2017 | Food and Drug Administration | |
| See PRA Statement below. | <b>Indications for Use</b> | |

| 510(k) Number (if known) | K161811 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Medela Low Dose Enteral Syringe |
| Indications for Use (Describe) | The Medela Low Dose 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 enterally, into the gastrointestinal system of patients in all age groups. The enteral syringes are intended to be used in clinical settings by clinicians. |

| Type of Use (Select one or both, as applicable) | <div> <span> <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> </div> <div> <span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> </div> |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# Section 5 - 510(k) Summary of safety and effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT: | Medela, Inc. |
|------------------------|----------------------------------------------------------------------------------------------|
| TRADE NAME: | Medela Low Dose Enteral Syringe |
| COMMON NAME: | Low Dose Tip ENFit Syringe |
| CLASSIFICATION NAME: | Gastrointestinal Tube and Accessories - Enteral Syringes with<br>Enteral Specific Connectors |
| DEVICE CLASSIFICATION: | Class II |
| PRODUCT CODE | PNR |
| PREDICATE DEVICES: | Monoject™ Enteral Syringe with ENFit Connector (K161963) |

#### Substantially Equivalent To:

The Medela Low Dose Enteral Syringe is substantially equivalent in intended use, principal of operation and technological characteristics to the Monoject™ Enteral Syringe with ENFit Connector (K161963).

#### Description of the Device Subject to Premarket Notification:

The Medela Low Dose Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is a low dose tip designed to allow for the delivery of fluid to a patient's feeding tube within +/-10%.

The Medela Low Dose Enteral Syringe is offered in 1mL and 3mL sizes and intended to connect with devices equipped with ENFit connectors.

## Indications for Use:

The Medela Low Dose Enteral Svringe with ENFit Connector is indicated for use as a dispenser. a measuring device, and a fluid transfer device. It is used to deliver fluids enterally, into the gastrointestinal system of patients in all age groups. The enteral syringes are intended to be used in clinical settings by clinicians.

## Technical Characteristics:

The Medela Low Dose Syringe has similar physical and technical characteristics to the predicate device based on the design per ISO 7886-1 and AAMI/CN3 (PS):2014 and as demonstrated by the nonclinical tests performed for the subject syringe.

## Nonclinical Testing:

The following nonclinical testing was performed:

- . Syringe Design Verification per ISO 7886-1.
- o Cleanliness
- Lubricant o
- Dead Space O
- Fit of Piston in Barrel O
- Slide Force Test O
- Freedom from Air and Liquid Leakage O
- Limits of Alkalinity/Acidity O
- Limits of Extractable Metals O
- 0 ENFit Connector Dimensional Analysis per AAMI/CN3 (PS):2014.

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- Additional Connector Testing per AAMI/CN3 (PS):2014 Using test methods provided in o AAMI/CN20 (PS):2014.
- Fluid Leakage o
- o Stress Cracking
- Resistance to Separation from Axial Load O
- Resistance to Separation from Unscrewing O
- Resistance to Overriding o
- Disconnection by Unscrewing O
- Biocompatibility Testing. o
- o Cytotoxicity
- Intracutaneous Irritation o
- Sensitization o
- o Toxicological Risk Assessment.
- Verification demonstrating dosing accuracy of the Low Dose syringe. 0
- Shelf Life Study. o
- o The Low-Dose ENFit connector design has been evaluated for risk of misconnection and usability.

#### Performance Data:

All necessary verification and validation testing has been performed for the Medela Low Dose Syringe to assure substantial equivalence to the predicate device.

#### Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Medela Low Dose Syringe is determined by Medela, Inc., to be substantially equivalent to the existing legally marketed device.

End of Summary