AQUARIUS EXTENSION FEEDING SET

K141631 · Degania Silicone , Ltd. · KNT · Jul 28, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K141631
• Device Name: AQUARIUS EXTENSION FEEDING SET
• Applicant: Degania Silicone , Ltd.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jul 28, 2014
• Decision: SESK
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Intended 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.

Device Story

AQUARIUS™ Extension Feeding Set is a single-patient-use accessory for gastric feeding devices. It consists of a hollow tube with a funnel at one end for connection to a nutrition source and a connector at the other end for attachment to a gastrostomy button or similar gastric feeding device. The device incorporates safety connectors designed to prevent accidental misconnection between enteral and intravenous (IV) systems. The device is used in clinical or home settings by patients or caregivers to extend the reach of feeding tubes. By ensuring secure, non-luer compatible connections, it reduces the risk of medication or nutrition delivery errors, thereby enhancing patient safety during enteral feeding.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing (cytotoxicity, irritation, sensitization) per ISO 10993-5 and ISO 10993-10 confirmed toxicological safety. Performance testing included tensile strength, flow rate, and leakage tests. Mechanical testing per ISO 80369-1, Annex B and AAMI/ANSI ID54 verified non-compatibility with female luer connectors and intravenous sets.

Technological Characteristics

Device consists of a hollow tube, funnel, and connector. Tube and funnel are made of flexible medical-grade Polyurethane (PUR); connector is made of acrylonitrile butadiene styrene. Designed for enteral feeding with safety connectors to prevent IV misconnection. Complies with ISO 80369-1 and AAMI/ANSI ID54 for connector safety. Single-patient use.

Indications for Use

Indicated for use as an extension set for gastric feeding devices (e.g., AQUARIUS™ G-button) to facilitate enteral nutrition delivery while mitigating the risk of accidental IV-enteral system misconnections.

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

• K132686

Submission Summary (Full Text)

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

## 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: [e-mail], fax: [phone], tel: [phone]
- 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.

{1}------------------------------------------------

- 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.

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

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

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

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 [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/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 [phone] or [phone] 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

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

#### 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'

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 The builden inte for this concenter of internation to ocess, gather and maintain the data needed and complete time to rolledions, or 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 [e-mail]

"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."