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 Description

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.

AI/ML Overview

The provided document describes the Medela Low Dose Enteral Syringe and its 510(k) submission for substantial equivalence. It is not a study proving device performance against acceptance criteria in the typical sense of a diagnostic or AI-driven medical device. Instead, it details the verification and validation testing performed to demonstrate that the device meets established standards and performs comparably to a predicate device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission, which focuses on physical and functional characteristics according to engineering standards rather than diagnostic accuracy or clinical outcomes.

Here's an interpretation of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various nonclinical tests and generally states that "All necessary verification and validation testing has been performed... to assure substantial equivalence." Specific numerical acceptance criteria and reported numerical performance values are not explicitly provided in this summary. However, the tests are based on recognized standards (ISO 7886-1 and AAMI/CN3 (PS):2014, AAMI/CN20 (PS):2014).

Acceptance Criteria Category (Based on Standards)	Reported Device Performance (Implied by Submission)
Syringe Design Verification (ISO 7886-1)	All tests performed; device found to perform satisfactorily, assuring substantial equivalence.
- Cleanliness	Pass (implied)
- Lubricant	Pass (implied)
- Dead Space	Pass (implied)
- Fit of Piston in Barrel	Pass (implied)
- Slide Force Test	Pass (implied)
- Freedom from Air and Liquid Leakage	Pass (implied)
- Limits of Alkalinity/Acidity	Pass (implied)
- Limits of Extractable Metals	Pass (implied)
ENFit Connector Dimensional Analysis (AAMI/CN3 (PS):2014)	All tests performed; device found to perform satisfactorily, assuring substantial equivalence.
Additional Connector Testing (AAMI/CN3 (PS):2014 & AAMI/CN20 (PS):2014)	All tests performed; device found to perform satisfactorily, assuring substantial equivalence.
- Fluid Leakage	Pass (implied)
- Stress Cracking	Pass (implied)
- Resistance to Separation from Axial Load	Pass (implied)
- Resistance to Separation from Unscrewing	Pass (implied)
- Resistance to Overriding	Pass (implied)
- Disconnection by Unscrewing	Pass (implied)
Biocompatibility Testing	All tests performed; device found to perform satisfactorily, assuring substantial equivalence.
- Cytotoxicity	Pass (implied)
- Intracutaneous Irritation	Pass (implied)
- Sensitization	Pass (implied)
Toxicological Risk Assessment	Assessment completed satisfactorily (implied).
Verification demonstrating dosing accuracy of the Low Dose syringe (within +/-10%)	Verified to meet the +/-10% accuracy target (implied).
Shelf Life Study	Study performed, implying acceptable shelf life confirmed.
Low-Dose ENFit connector usability/misconnection risk	Evaluated satisfactorily (implied).

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated. For engineering verification tests, sample sizes are typically determined by statistical methods for process validation (e.g., AQL, confidence levels) or as specified by the testing standards.
Data Provenance: The tests are nonclinical, usually conducted in a laboratory setting by the manufacturer, Medela, Inc. This is not clinical data from patients or specific countries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical medical instrument, not a diagnostic tool requiring expert interpretation of results to establish ground truth. "Ground truth" in this context refers to meeting engineering specifications.

4. Adjudication method for the test set

Not applicable. This isn't a clinical study requiring adjudication of diagnostic findings. Performance is measured against predetermined engineering specifications and standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device (syringe), not an AI-driven diagnostic tool or an imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (syringe), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device's performance is defined by the engineering specifications and established national/international standards (e.g., ISO 7886-1 for syringe design, AAMI/CN3 (PS):2014 for connectors, AAMI/CN20 (PS):2014 for connector testing methods) against which the device's physical and functional characteristics are measured. For dosing accuracy, the ground truth is the specified +/-10% deviation.

8. The sample size for the training set

Not applicable. The device is not learning from a training set. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

Summary

{0}------------------------------------------------

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.

{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,

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

{2}------------------------------------------------

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.	Indications for Use

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)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"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."

FORM FDA 3881 (8/14)	Page 1 of 1
----------------------	-------------

{3}------------------------------------------------

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 withEnteral 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 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.

{4}------------------------------------------------

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

Regulation Number and Section

§ 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.