The Fidmi Low Profile Enteral Feeding Device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.

Fidmi Low Profile Enteral Feeding Device Measuring kit is indicated for measuring the length of the stoma prior to placement of a low-profile feeding tube.

The Fidmi Low Profile Enteral Feeding Device Replaceable Tube is intended for use only with the Fidmi Low Profile Enteral Feeding Device, for the replacement of an existing tube. It is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.

Device Description

The Fidmi Low Profile Enteral Feeding Device and its components kits allow for enteral nutrition and / or medication delivery directly into the stomach. The device and components are supplied sterile.

Fidmi Medical's Low-Profile Enteral Feeding Device includes kits for initial placement of the tube, and complete removal of the gastrostomy tubes.

Fidmi Low-Profile Enteral Feeding Device incorporates three major components:

The Stoma Measuring Device – The Fidmi Medical Stoma Measuring Device is a single use, sterile, disposable device designed for use in the selection of an appropriate length of the Feeding Device to be used exclusively with the Fidmi Low-Profile Enteral Feeding Device.

Low Profile Enteral Feeding Device - The Low Profile Enteral Feeding Device consists of a gastric port that on one side (on the skin surface) includes the flexible external bumper that stabilizes the stoma and keeps the site dry and allows ventilation. On the other side (the stomach side), it includes the bumper that is designed to stay in place and to be dismantled apart for removal when enteral feeding is no longer required.

The Replacement Feeding Tube – The replaceable tubing is designed to be easily replaced when needed. The replacement tube is designed as an internal component that may be retracted, disposed and replaced without any manipulation to the device itself, i.e., the gastrostomy tube implant. It is designed to be replaced by personnel at a medical facility or at a home setting. As depicted in the instructions for use document supplied with the device, it is recommended to replace the tube either upon accidental dislodgement, clogging or once a week.

AI/ML Overview

This document is a 510(k) premarket notification for the Fidmi Low Profile Enteral Feeding Device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way typically found for AI/ML-driven devices. Instead, it demonstrates substantial equivalence to existing predicate devices based on a comprehensive set of bench tests and animal testing.

Here's an analysis based on the provided text, focusing on what's available and what's missing in relation to your specific request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" values in a quantitative manner for a comparative study against a benchmark or ground truth.

Instead, it lists the types of performance data (bench tests and animal testing) conducted to demonstrate that the device performs as intended and is substantially equivalent to predicate devices. The implication is that meeting the standards referenced (e.g., BS EN 1618:1997, ASTM F2528-06(2014)) constitutes "acceptance."

The general studies performed are:

Back Flow and Liquid Leakage
Dimensional Attributes
Functional Evaluation
Replaceable Tube & Extension Tube Detachment Force
Flow Rate
Bond Strength
Feeding Device Pullout Force
Packaging Integrity and Shelf life Testing
Animal testing

For biological evaluation, the following ISO standards were cited, implying compliance with their requirements:

EN ISO 10993-1:2018 (Biological Evaluation)
EN ISO 10993-3:2014 (Genotoxicity, carcinogenicity, reproductive toxicity)
EN ISO 10993-5:2009 (in vitro Cytotoxicity)
EN ISO 10993-6:2016 (Local effects after implantation)
EN ISO 10993-10: 2010 (Irritation and Skin Sensitization)
EN ISO 10993-11:2017 (Systemic toxicity)
EN ISO 10993-12:2012 (Sample preparation and reference materials)
EN ISO 10993-7:2008:AC 2009 (Ethylene Oxide Sterilization Residuals)

The document concludes that "Bench testing of the Fidmi Low-Profile Enteral Feeding Device and components demonstrates that the device performs as intended and is substantially equivalent." This is the reported device performance in the context of a 510(k).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench testing" and "animal testing." It does not specify the sample sizes for these tests, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective nature) as it would for a clinical study involving human subjects and diagnostic outputs. The testing appears to be primarily laboratory-based and pre-market validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and hence not provided in the document. The device is a physical medical device (enteral feeding device), not an AI/ML diagnostic tool requiring expert consensus for ground truth establishment. The "ground truth" for this device would be established by measuring physical properties, mechanical performance, and biological compatibility against established scientific and engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies where disagreement among human readers or interpreters needs to be resolved, often for diagnostic image interpretation or similar qualitative assessments. The tests described are primarily quantitative engineering and biological tests.

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 device is not an AI/ML diagnostic or assistive device that would involve human readers or image interpretation. Therefore, an MRMC study is not relevant to its regulatory submission.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the bench tests and animal testing, the "ground truth" would be established by:

Engineering specifications and standards: For physical and mechanical properties (e.g., dimensional attributes, flow rate, bond strength, pullout force, back flow, leakage).
Biological evaluation standards: For biocompatibility (e.g., cytotoxicity, irritation, systemic toxicity, genotoxicity, local effects after implantation), as defined by the EN ISO 10993 series.
Animal physiology/pathology: For animal testing, assessing the device's performance and safety in a living system.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set."

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

Not applicable. As noted above, this is not an AI/ML device.

Summary in relation to your request:

The provided document describes a traditional 510(k) submission for a physical medical device. It focuses on demonstrating substantial equivalence to predicate devices through bench testing and animal testing, complying with various engineering and biological standards. It does not involve AI/ML technology, and therefore, many of the requested elements pertaining to acceptance criteria, ground truth, expert involvement, and study types (like MRMC or standalone algorithm performance) are not applicable to this type of device and submission. The "acceptance criteria" are intrinsically tied to meeting the requirements of the referenced standards and demonstrating performance comparable to the predicate device.

Summary

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 30, 2019

Fidmi Medical Ltd % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103

Re: K191844

Trade/Device Name: Fidmi Low Profile Enteral Feeding Device Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: II Product Code: KNT Dated: July 9, 2019 Received: July 9, 2019

Dear Janice Hogan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Martha W. Betz, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910–0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191844

Device Name Fidmi Low Profile Enteral Feeding Device

Indications for Use (Describe)

Fidmi Low Profile Enteral Feeding Device Measuring kit is indicated for measuring the length of the stoma prior to placement of a low-profile feeding tube.

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 (7/17)

PSC Publishing Services (301) 443-6740 FF

Confidential

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Traditional Premarket Notification Submission - 510(k) Fidmi Low Profile Enteral Feeding Device 510(k) Number K191844 September 27, 2019

1. SUBMITTER

Fidmi Medical Ltd. 5 Haeshsel Street Caesarea Business Park, Israel 3079500 Tel: +(972) 77-3628361 Fax: +(972) 77-3628362

2. DEVICE INFORMATION

Device Trade Name:	Fidmi Low Profile Enteral Feeding Device
Classification Name:	Gastrointestinal tube and accessories, 21 CFR 876.5980
Regulatory Class:	Class II
Product Code:	KNT

3. PREDICATE DEVICE

Fidmi Medical Ltd. believes that the Fidmi Low Profile Enteral Feeding Device is substantially equivalent to the following predicate device:

Boston Scientific Corporation "One Step Button, Low Profile Initial Placement PEG Kit" and the Low Profile Button Replacement Gastrostomy Tube Kit cleared under K161003

4. REFERENCE DEVICE

Kimberly-Clark MIC-KEY "Low Profile Gastrostomy Tube and Accessories" cleared under K122653

5. DEVICE DESCRIPTION

Fidmi Medical's Low-Profile Enteral Feeding Device includes kits for initial placement of the tube, and complete removal of the gastrostomy tubes.

Fidmi Low-Profile Enteral Feeding Device incorporates three major components:

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6. INDICATIONS FOR USE

Fidmi Low Profile Enteral Feeding Device Measuring kit is indicated for measuring the length of the stoma prior to placement of a low-profile feeding tube.

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Fidmi Low Profile Enteral Feeding Device (hereafter the Fidmi device) has the same product code and intended uses as the predicate and reference devices, and the Low-Profile Enteral Feeding Device's principles of operation, functionality and technological characteristics are similar to those of the predicate and reference devices. A comparison table is provided below.

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ComparedAttribute	Fidmi Low Profile Enteral FeedingDevice	EndoVive™ One-Step Button™and replacement tube (PrimaryPredicate)	Kimberly-Clark MIC-KEY SF LowProfile Gastrostomy Tube(Reference Device)
510(k) number	K	K161003	K122653
Product Code	KNT	KGC and KNT	KNT
CFR	21 CFR§ 876.5980	21 CFR§ 876.5980	21 CFR§ 876.5980
Indications forUse	The Fidmi Low Profile EnteralFeeding Device is intended toprovide nutrition to a patientdirectly into the stomach througha stoma. It is indicated for use onpatients who are unable toconsume nutrition byconventional means.	The One Step Button device isintended to provide nutrition to apatient directly into the stomachthrough a stoma. It is indicated foruse on patients who are unable toconsume nutrition byconventional means.	The Kimberly-Clark MIC-KEY SFLow Profile Gastrostomy Tube andAccessories are indicated for usein patients who require long termfeeding, are unable to tolerateoral feeding, who are at low riskfor aspiration, require gastricdecompression and/or medicationdelivered directly into thestomach through a secured (initialplacement) or formed(replacement) stoma.
	Fidmi Low Profile Enteral FeedingDevice Measuring kit is indicatedfor measuring the length of thestoma prior to placement of a low-profile feeding tube.	The Percutaneous StomaMeasuring Device is intended tobe used to measure the mucosallayers of the stoma prior toplacement of the EndoVive OneStep Button. The device isindicated for direct feeding	Kimberly-Clark MIC-KEY SF Overthe Wire Stoma Measuring Deviceis indicated for measuring thelength of the stoma prior toplacement of a low-profile feedingtube.
	The Fidmi Low Profile EnteralFeeding Device Replaceable Tubeis intended for use only with theFidmi Low Profile Enteral FeedingDevice, for the replacement of anexisting tube. It is intended toprovide nutrition to a patientdirectly into the stomach througha stoma. It is indicated for use onpatients who are unable toconsume nutrition byconventional means.	The EndoVive Low ProfileReplacement Button Gastrostomydevice is intended to providenutrition to a patient directly intothe stomach through a stoma. It isindicated for use on patients whoare unable to consume nutritionby conventional means.
Kit contents	Stoma Measuring DevicePlacement KitReplacement Kit	One-Step Button KitStoma Measuring DevicePatient Care Kit (replacement kit)	Stoma MeasuringPlacement KitReplacement Kit
Size	Feeding catheter outer diameter20Fr.Feeding tube length per color	Feeding catheter outer diameter18Fr. / 24 Fr. (color coded)Low profile Button - 1.2 cm - 4.4	Feeding catheter outer diameter10Fr. to 24 Fr.Feeding tube length 0.8cm to 6.0cm to fit different stoma
ComparedAttribute	Fidmi Low Profile Enteral FeedingDevice	EndoVive™ One-Step Button™and replacement tube (PrimaryPredicate)	Kimberly-Clark MIC-KEY SF LowProfile Gastrostomy Tube(Reference Device)
	code:	cm to fit different stomadiameters and lengths.	diameters and lengths (sizesshown below are for the 20Fr.Device)
	Orange	1.2cm	0.8cm
	Pink	1.7cm	1.0cm
	Blue	2.4cm	1.2cm
	Green	3.4cm	1.5cm
	Yellow	4.4cm	2.5cm
	1.8-2.5cm	Supplied withdesignated ButtonSpacers available in1,2,3,4, and 5mm disksthat may be used asspacers between thestoma and the externalflange of the device.	3.5cm
	2.5-3.2cm		4.0cm
	3.2-4.0cm		4.5cm
	4.0-4.7cm
	4.7-5.5cm
Sterilization	Sterile device by EtO	Sterile device by EtO / GammaIrradiation	Sterile device by EtO

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8. PERFORMANCE DATA

The Fidmi Low-Profile Enteral feeding Device and components have been tested according to the following standards:

-BS EN 1618:1997 – Catheters other than Intravascular Catheters – Test Methods for Common Properties
-BS EN 1615:2000 – Enteral Feeding Catheters and Enteral Giving Sets for Single Use and Their Connectors – Design and Testing
-ASTM F2528-06(2014) – Standard Test Methods for Enteral Feeding Devices with a Retention Balloon; Procedure A.
-EN ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process.
-EN ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
-EN ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests for in vitro Cytotoxicity.
-EN ISO 10993-6:2016 Biological evaluation of medical devices - Biological evaluation of medical devices Part 6: Tests for local effects after implantation.
-EN ISO 10993-10: 2010 Biological Evaluation of Medical Devices – Part 10: Tests for irritation and Skin Sensitization.
-EN ISO 10993-11:2017 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
-EN ISO 10993-12:2012 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials.
EN ISO 10993-7:2008:AC 2009 Biological evaluation of medical devices Part 7: Ethylene Oxide Sterilization Residuals.

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The information presented in this submission to support substantial equivalence of the Fidmi Low-Profile Enteral Feeding Device and components to the legally marketed predicate device include device description, indications for use, technological and material comparison, as well as labeling. Bench testing of the Fidmi Low-Profile Enteral Feeding Device and components demonstrates that the device performs as intended and is substantially equivalent. Specifically, the following bench tests were used to establish substantial equivalence:

Back Flow and Liquid Leakage,
Dimensional Attributes,
Functional Evaluation,
Replaceable Tube & Extension Tube Detachment Force,
Flow Rate,
. Bond Strength,
. Feeding Device Pullout Force,
. Packaging Integrity and Shelf life Testing, and
Animal testing.

Fidmi Medical Ltd. has assessed the similarities between the proposed Fidmi Medical Low-Profile Enteral Feeding Device and components, its predicate and reference devices in terms of intended use and technological characteristics while demonstrating the device to be safe and effective as the predicate and reference device(s). The differences in the technological characteristics were found to be minor and do not present any new issues of safety or effectiveness. This evidence supports substantial equivalence between the subject and predicate device, as well as the reference device.

9. CONCLUSION

Fidmi Medical Ltd. has demonstrated that the proposed Fidmi Medical Enteral Feeding Device and components are substantially equivalent to the currently marketed EndoVive™ One-Step Button™ and replacement tube cleared under K161003.

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.