AQUARIUS™ Extension Feeding Set is intended for use as an extension set for AQUARIUS™ G-button/ or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an IV system to the enteral system, or the enteral system to IV system.

Device Description

The Aquarius™ Extension Feeding Set comprise from the hollow Tube with Connector and Funnel at the ends. The Funnel connects to delivery source of nutrition and the Connector connects to a gastric feeding device. The Aquarius™ Extension Feeding Set is compatible with Aquarius™ Gastrostomy Button (G-Button) and any castric feeding device with Mc-Key™ connection ring. A device is for single patient use only.

AI/ML Overview

This document describes a Special 510(k) submission for the AQUARIUS™ Extension Feeding Set, focusing on its non-clinical summary. The submission asserts that the device is substantially equivalent to a predicate device (K132686).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Specification)	Reported Device Performance (Test Results)	Studied Device Component	Standard Reference
Biocompatibility:
Non-cytotoxic	Demonstrated toxicological safety	Proposed device	ISO 10993-5
Non-irritating	Demonstrated toxicological safety	Proposed device	ISO 10993-10
Non-sensitizing	Demonstrated toxicological safety	Proposed device	ISO 10993-10
Functional Performance:
Adequate Tensile Strength	Compliance with performance specification	Not specified (likely entire device)	Not specified
Adequate Flow Rate	Compliance with performance specification	Not specified (likely entire device)	Not specified
No Leakage	Compliance with performance specification	Not specified (likely entire device)	Not specified
Safety Connectors:
Non-compatibility with female luer connectors	Demonstrated non-compatibility	Proposed device	ISO 80369-1, Annex B
Non-compatibility with other intravenous sets	Demonstrated non-compatibility	Proposed device	AAMI/ANSI ID54

2. Sample Size and Data Provenance for Test Set

The document does not provide specific sample sizes for each test mentioned (e.g., number of devices tested for tensile strength, flow rate, leakage, or biocompatibility tests). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective. The non-clinical summary suggests these were laboratory-based tests conducted on the proposed device.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

This study involves non-clinical (laboratory) testing, not assessments that require human expert interpretation of results to establish ground truth in the way medical imaging or diagnostic tests do. Therefore, the concept of "experts used to establish ground truth" with specific qualifications (like radiologists) is not applicable here. The ground truth is established by the objective measurements and observations against pre-defined engineering and safety standards.

4. Adjudication Method for Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., when multiple readers assess images and their opinions need reconciliation). As this is a non-clinical, laboratory-based study focusing on device performance and safety, an adjudication method is not applicable. The results are based on direct measurements and adherence to specified standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted. This device is an extension feeding set, and the evaluation is based on its physical properties, biocompatibility, and functional performance, not on diagnostic accuracy requiring human interpretation or comparison with AI assistance.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was conducted. This is a medical device (hardware), not an algorithm or AI software. Therefore, this section is not applicable.

7. Type of Ground Truth Used

The ground truth used in these non-clinical studies is based on:

Standardized Test Methods and Criteria: These are established by international and national standards such as ISO 10993-5, ISO 10993-10, ISO 80369-1 Annex B, and AAMI/ANSI ID54.
Objective Measurements: Results are derived from quantitative and qualitative measurements (e.g., tensile strength values, flow rates, visual inspection for leakage, assays for cytotoxicity, irritation, sensitization, and physical connection tests for compatibility).
Compliance with Specifications: The device's performance is compared directly against pre-defined engineering and safety specifications derived from the predicate device and relevant standards.

8. Sample Size for the Training Set

This product is a physical medical device. The concept of a "training set" is typically associated with machine learning algorithms. Therefore, a training set as understood in that context is not applicable. The device's design and manufacturing processes are likely informed by prior engineering knowledge and predicate device characteristics, but there isn't a "training set" in the AI sense.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI algorithm, the method for establishing its ground truth is not applicable. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, regulatory requirements, and the performance characteristics of the predicate device.

Summary

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JUL 2 8 2014

Premarket Notification Summary under 21 CFR § 807.92

a) Type of 510(k) submission: Special
b) Common name: Feeding Extension Set
c) Device trade name: AQUARIUS™ Extension Feeding set
d) Classification Panel: 21 CFR 876.5980
e) Classification Name: Gastrointestinal tube and accessories
f) Class: Il
g) Product code: KNT
h) Unmodified/ Predicate device: 510(k) K132686
i} 510(k) submitter/holder: Degania Silicone Ltd
j) FDA Registration Number: 8030107
k) Contact person: Zoya Lee, Regulatory Affairs, e-mail: zoya@ds-il.com, fax: +972 4 675 5155, tel: +972 4 6755122
l) Device Description: The Aquarius™ Extension Feeding Set comprise from the hollow Tube with Connector and Funnel at the ends. The Funnel connects to delivery source of nutrition and the Connector connects to a gastric feeding device. The Aquarius™ Extension Feeding Set is compatible with Aquarius™ Gastrostomy Button (G-Button) and any castric feeding device with Mc-Key™ connection ring. A device is for single patient use only.
m) Indication of Use. AQUARIUS™ Extension Feeding Set is intended for use as an extension set for AQUARIUS™ G-button/ or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an IV system to the enteral system, or the enteral system to IV system ..
n) Technological Characteristic. AQUARIUS™ Extension Feeding Set is a substantially equivalent to the unmodified/ predicate device. The only difference between modified and unmodified/ predicate device is in constructive material of the tube and funnel of the device. The hollow tube and funnel of modified device are made of flexible medical grade Polyurethane (PUR) and not from PVC; connector is made from the same acrylonitrile butadiene styrene. No any change in Intention of Use, product design, specification, functional performance, labels and Instruction Of Use.

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o) Non- clinical Summary. Non- clinical verification of AQUARIUS™ Extension Feeding Set was conducted through biocompatibility and performance functionality testing. The results of Cytotoxicity, Irritation and Sensitization studies according to the standards ISO 10993-5 & ISO 10993-10 have demonstrated the toxicological safety of the proposed devices. The results of the tensile strength, flow rate, and leakage test have demonstrated the compliance with the performance and functionality specification of the device. The results of the mechanical tests according to ISO 80369-1, Annex B and AAMI/ANSI ID54 have demonstrated noncompatibility of the proposed device with female luer connectors and other intravenous sets.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

July 28, 2014

Degania Silicone, Ltd. % Zoya Lee Regulatory Affairs Kibbutz Degania Bet Emek Havarden 1513000 lsraci

Re: K141631

Trade/Device Name: AQUARIUSTM Extension Feeding Set Regulation Number: 21 CFRS 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: June 2 9. 2014 Received: July 1. 2014

Dear Zoya Lee.

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28. 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unlinished) and further process (e.g.. sterilize) you must submit a new 510(k) before including these components in your kit. 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 HI (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 - Zoya Lee

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 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/Safcty/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/Resourcesfor You/Industry/default.htm.

Sincerelv yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141631

Device Name

AQUARIUS™ Extension Feeding Set

Indications for Use (Describe)

nocations to Ose (Describe)
AQUARIUS™ Extension Feeding Set is intended for use as an extension set for AQUARIUS™ G-button/ or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an IV system to the enteral system, or the enteral system to IV system.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Benjamin R. Fisher -S 2014.07.28 16:37:16 -04'00'

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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.