. Administrating nutrition, fluids and medications via the naso-gastro-enteric route
. Aspiration via the naso-gastroenteric route
. Transfers electrical activity (Edi signals) to compatible SERVO ventilator systems on which NAVA and NAVA NIV are available

Device Description

The Edi Catheter ENFit is a sterile, single use nasogastric feeding tube that carries electrode rings that record diaphragm electrical activity (Edi signal). The Edi Catheter ENFit is an accessory to be used with patients in the range of neonates, infants, and adults together with the SERVO ventilator system. The Edi signal is used as an additional detector to improve the synchrony between the patient and the ventilator and to give the patient corresponding ventilatory support in the ventilation modes NAVA and NIV NAVA.
As a nasogastric feeding tube, the Edi Catheter ENFit is used for administration of nutrition, fluids and medications, as well as and aspiration via the naso-gastroenteric route. For the 12 Fr and 16 Fr catheters, a sump lumen is available for air venting the feeding tube to the atmosphere.
The new ENFit connector which is compliant with ISO 80369-3 is introduced in order to avoid misconnections with small-bore connectors used for other healthcare applications than enteral feeding.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Edi Catheter ENFit." It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and a study demonstrating the device meets those criteria in the context of diagnostic performance or clinical effectiveness with human readers or AI.

The document focuses on engineering and material changes from a predicate device, primarily the adoption of a new ENFit connector, and verifies that these changes do not compromise the device's basic function or safety.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of evaluation (e.g., diagnostic accuracy, reader study) than what is presented here.

Here's what can be answered based on the provided text, and where gaps exist:

Table of acceptance criteria and the reported device performance
- Acceptance Criteria (as related to the changes in the device): The document outlines several non-clinical tests performed to ensure the new ENFit connector and other minor design changes meet safety and performance standards. These are implicit acceptance criteria related to engineering and material properties, not diagnostic performance.
  - Fluid Leakage
  - Stress Cracking
  - Resistance to separation from axial load
  - Resistance to separation from unscrewing
  - Resistance to overriding
  - Disconnection by unscrewing
  - Biocompatibility (conformance to ISO 10993-1:2009)
  - Stability after accelerated aging
  - Usability validation for the ENFit connector
- Reported Device Performance: The document states, "The testing demonstrates that the proposed device conform to all requirements of the Edi Catheter ENFit." It also notes that biocompatibility testing "demonstrated the biological safety of all parts of the proposed feeding tubes that have contact with the patient." Specific quantitative performance values for each of the listed tests are not provided in this summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this type of submission. The testing described is primarily non-clinical engineering and material testing, not a clinical study involving a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" establishment by medical experts described for this type of engineering and safety testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication process is described.
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
- No. This device is a nasogastric feeding tube with electrodes to transfer electrical activity of the diaphragm (Edi signals). It is not an imaging device or an AI-powered diagnostic tool, and no MRMC study or AI-related improvement is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for the non-clinical testing would be the engineering specifications and ISO standards themselves. Biological safety relies on conformance to ISO 10993-1.
The sample size for the training set
- Not applicable. No training set is mentioned as this device is not an AI/ML algorithm.
How the ground truth for the training set was established
- Not applicable. No training set is mentioned.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are designed with flowing lines, giving the impression of movement or wind. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

March 2, 2017

Maquet Critical Care Ab % Mark Dinger Senior Regulatory Affairs Specialist Maquet Medical System USA 45 Barbour Pond Drive Wayne, New Jersey 07470

Re: K153688

Trade/Device Name: Edi Catheter ENFit Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories. Regulatory Class: Class II Product Code: PIF, CBK Dated: January 30, 2017 Received: January 31, 2017

Dear Mark Dinger:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 yours,

Lori A. Wiggins -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153688

Device Name Edi Catheter ENFit

Indications for Use (Describe)

The Edi catheter ENFit is intended for:

. Administrating nutrition, fluids and medications via the naso-gastro-enteric route
. Aspiration via the naso-gastroenteric route
. Transfers electrical activity (Edi signals) to compatible SERVO ventilator systems on which NAVA and NAVA NIV are available

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)

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510(k) SUMMARY as required by section 21 CFR 807.92

Date prepared: March 1, 2017

Submitter Name & Address

Maquet Critical Care AB Röntgenvägen 2 SE-171 54 Solna, Sweden Tel: +46 10 335 73 00 Fax: +46 10 335 7838

Contact Persons for this submission:

Mirva Boothe Regulatory Affairs Manager Phone: +46 10 335 73 00 Email: mirva.boothe@getinge.com

Application Correspondent:

Mark Dinger Senior Regulatory Affairs Specialist Maquet Medical Systems USA 45 Barbour Pond Drive Wayne, NJ 07470 USA Email: mark.dinger@getinge.com Phone: 973-709-7691 Fax: 973-909-9954

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Trade name

Edi Catheter ENFit

Device Classification

Common Name	ClassificationProduct Code	Class	Regulation Number
Gastrointestinal tubes with enteralspecific connectors	PIF	II	21 CFR 876.5980
Ventilator, continuous, facility use	CBK	II	21 CFR 868.5895

Predicate Device Identification

Legally marketed devices to which equivalence is being claimed	510(k) #
SERVO-i Ventilator System	K123149

Device Description

As a nasogastric feeding tube, the Edi Catheter ENFit is used for administration of nutrition, fluids and medications, as well as and aspiration via the naso-gastroenteric route. For the 12 Fr and 16 Fr catheters, a sump lumen is available for air venting the feeding tube to the atmosphere.

The new ENFit connector which is compliant with ISO 80369-3 is introduced in order to avoid misconnections with small-bore connectors used for other healthcare applications than enteral feeding.

See table 1 below for a listing of the main components and characteristics of the device, compared to the predicate device.

	Predicate device	Current device	Comment
Technology
Device type	Nasogastric feeding tube	Nasogastric feeding tube	Identical
Measurement method	Monitor electricalsignal fromdiaphragm activity(Edi)	Monitor electricalsignal fromdiaphragmactivity (Edi)	Identical
Energy source	From NAVAmodule in SERVOVentilator System	From NAVAmodule inSERVOVentilator System	Identical
Patient group	Neonatal to adult	Neonatal to adult	Identical
Components/Parts
Total number of electrodes	10	10	Identical
Electrodes	Material: Stainlesssteel	Material:Stainless steel	Identical
Electrical connector	14 pole circularconnector	14 pole circularconnector	Identical
Feeding tube	Material: PUR	Material: PUR	Identical
Feeding connector	Funnel typeMaterial: PVC	ENFit typeMaterial: ABS	New type of connectorand new material forcurrent device
Sump lumen	For 12 and 16 Fr	For 12 and 16 Fr	Identical
Catheter dimensions	Length:49-125 cmDiameter:6 / 8 / 12 / 16 Fr	Length:49-125 cmDiameter:6 / 8 / 12 / 16 Fr	Identical size range.Additional feedingholes and one newdesign option forcurrent device:8 Fr 50 cm
Sterilization
Sterile barrier system	Preformed pouch	Preformed pouch	Identical
Sterilization	Gammasterilization	Gammasterilization	Identical
Accessories
Guidewire	For 6 Fr 49 and 50cmFor 8 Fr 100 cmFor 8 Fr 125 cm	For 6 Fr 49 and50 cmFor 8 Fr 100 cmFor 8 Fr 125 cm	Not part of device.Guidewire cleared inK153461, is not adevice component

Table 1. Comparison with predicate device catheter

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Indications for Use

The Edi catheter ENFit is intended for:

. Administrating nutrition, fluids and medications via the naso-gastro-enteric route
Aspiration via the naso-gastroenteric route
Transfers electrical activity (Edi signals) to compatible SERVO ventilator ● systems on which NAVA and NAVA NIV are available

Comparison of Indications for Use

The Indications for Use for the subject device is comparable to the Indications for Use for the predicate device Edi Catheter PHT Free, which is an accessory within the ventilator system SERVO-i (K123149).

However, since the proposed device is submitted as a product of its own right instead of an accessory within the ventilator system, the Indications for Use is not the same as the Indications for Use for the entire ventilator system.

The predicate device Edi Catheter PHT Free has been cleared with the ventilators Indications for Use. The Indication for Use for the Edi catheter ENFit has been clarified compared to the Edi catheter PHT Free. The following information has been updated, which is also relevant for the predicate device Edi catheter PHT Free.

Added: ●
o Aspiration via the naso-gastroenteric route
. Clarified:
- o Transfers electrical activity (Edi signals) to compatible SERVO ventilator systems on which NAVA and NAVA NIV are available

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Summary of Technological characteristics

The technological characteristics of the subject device Edi catheter ENFit with respect to design, material and energy source are similar to the Edi catheter PHT free included in the predicate device (K123149), see summary and comparison below. Note that the differences listed here are the only differences between the catheter variants.

Design

The design of the catheters and methodology used for fulfilling its intended use is the same between the subject and predicate device. The only differences include:

A new male ENFit connector on the feeding tube, in order to avoid misconnections with other small-bore connectors used for other applications than enteral feeding. This update is done according to the Standard requirements, ISO 80369-3:2016: Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications
Addition of a new size option within the current size range (Edi Catheter -ENFit 8Fr/50cm). This particular size combination is new, although the predicate device includes catheters 8Fr/X cm and XFr/50 cm. The design of of the catheter is therefore considered the same.
-Additional feeding holes to facilitate feeding and aspiration.

Material

The catheter material remains identical between the catheters, except from:

The new ENFit connector contains a new material compared to the predicate device (ABS in ENFit connecter and PVC in predicate device). The new material has been tested for biocompatibility according to applicable sub-standards of ISO 10993-1:2009.
However, the material coming in direct contact with the patient is identical between the subject and predicate device.

Energy source

Identical. From NAVA module in SERVO Ventilator System.

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Non-clinical Testing

· Biocompatibility testing in conformance to "ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and applicable sub-standards has demonstrated the biological safety of all parts of the proposed feeding tubes that have contact with the patient.
· Stability testing evaluated the properties of the proposed feeding tubes after accelerated aging in support of the product expiration date.
· The risks associated with the misconnection of the ENFit connector and feeding/aspiration have been assessed.
· Verification of the proposed ENFit Connector includes the tests listed below, in accordance with ISO 80369-3, 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.
- Fluid Leakage ●
- Stress Cracking
- . Resistance to separation from axial load
- Resistance to separation from unscrewing .
- . Resistance to overriding
- . Disconnection by unscrewing
Evaluation of the Usability validation for the new ENFit connector. .

Verification activities have been performed for all changes that have been updated due to the changes performed in this submission. The testing demonstrates that the proposed device conform to all requirements of the Edi Catheter ENFit.

Animal Testing

Animal testing was not relied upon for the determination of substantial equivalence to the predicate device.

Clinical Investigation

Clinical evaluations were not relied upon for the determination of substantial equivalence to the predicate device based on the device classification, sufficient data and functional performance information provided in the submission.

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Conclusion

There are no different questions regarding safety and effectiveness for the Edi Catheter ENFit compared to the predicate device Edi Catheter PHT Free within the SERVO-i ventilator system (K123149).

MAQUET has conducted the risk analysis and performed the necessary verification and validation activities to demonstrate that the design outputs meet the design input requirements and the appropriate product standards.

MAQUET has concluded that the subject device, Edi Catheter ENFit is substantially equivalent to the predicate device, Edi Catheter PHT Free which is an accessory within the SERVO-i ventilator system (K123149).

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.