AQUARIUS Gastrostomy Replacement Tube

K143378 · Degania Silicone , Ltd. · KNT · Dec 29, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K143378
• Device Name: AQUARIUS Gastrostomy Replacement Tube
• Applicant: Degania Silicone , Ltd.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Dec 29, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AQUARIUS™ Gastrostomy Replacement Tube is intended for use in a well-established gastrostomy tract for feeding and/or administration of medications. May be used for gastric decompression.

Device Story

AQUARIUS™ Gastrostomy Replacement Tube is a silicone feeding tube designed for placement in established gastrostomy tracts. The device features a double-lumen design, an external retention disk, an internal retention balloon, and a distal open flow-through tip. It includes external centimeter graduations and a radiopaque marker for positioning. The device incorporates ENFit safety access ports to prevent misconnections. It is used by clinicians to deliver nutrition or medication directly to the stomach or to perform gastric decompression. The device is manufactured without natural latex, BPA, or phthalates. It is a replacement device intended for long-term access through an existing stoma.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including positive pressure liquid leak, stress cracking, resistance to separation (axial load/unscrewing), resistance to overriding, flow rate, dimension verification, tensile strength, simulated gastric fluid exposure, balloon burst volume, and biocompatibility evaluation per ISO 14971:2012.

Technological Characteristics

Silicone construction; double-lumen tube; ENFit safety access ports; radiopaque distal marker; external retention disk; internal balloon. Materials are free of natural latex, BPA, and phthalates. Testing conducted per ISO 14971:2012. Dimensions include 10Fr size. Connectivity via standardized ENFit enteral connectors.

Indications for Use

Indicated for patients requiring enteral feeding, medication administration, or gastric decompression via a well-established gastrostomy tract.

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

• K070124

Reference Devices

• K141753

Submission Summary (Full Text)

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

December 29, 2014

Degania Silicone, Ltd. Zoya Lee RA CO Degania Bet Emek Hayarden, 151300 Israel

Re: K143378

> Trade/Device Name: AQUARIUS™ Gastrostomy Replacement Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: PIF Dated: November 12, 2014 Received: November 25, 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. 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 device

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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 [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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -A

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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## Indications for Use

510(k) Number (if known) K143378

Device Name AQUARIUSTM Gastrostomy Replacement Tube

#### Indications for Use (Describe)

AQUARIUS™ Gastrostomy Replacement Tube is intended for use in a well-established gastrostomy tract for feeding and/or administration of medications. May be used for gastric decompression.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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### Premarket Notification Summary under 21 CFR § 807.92

- a) Type of 510(k) submission: Special
- b) Common name: Gastrostomy Replacement Tube
- c) Device trade name: AQUARIUSi Gastrostomy Replacement Tube
- d) Classification Panel: 21 CFR 876.5980
- e) Classification Name: Gastrointestinal tube and accessories
- f) Class: Il
- g) Product code: PIF
- h) Predicate / Unmodified device: 510(k) K070124
- i) Reference device: 510(k) K141753
- j) 510(k) submitter/holder: Degania Silicone Ltd
- k) FDA Registration Number: 8030107
- Contact person: Zoya Lee, Regulatory Affairs, e-mail: [e-mail], fax: [phone] I) 5155, tel: [phone]
- m) Device Description: Aquariusi Gastrostomy Replacement Tube is a silicone feeding tube comprised of a double lumen tube with external proximal specific ENFit safety access port/s, external retention disk, balloon, and distal open flow-through tip. The tube is with external graduations (cm) and radiopaque marker at the distal end. The tube size and balloon capacity are clearly indicated on the shaft and pouch of each device. The tube is made without use of natural latex, BPA, or phthalates plasticizers.
- n) Indication of Use. Aquariusi Gastrostomy Replacement Tube is indicated for use in a well-established gastrostomy tract for feeding and/or administration of medications. May be used for gastric decompression.
- o) Technological Characteristic. Aquariusi Gastrostomy Replacement Tube is a substantially equivalent to the predicate unmodified device, 510(k) K070124. The difference between modified and unmodified/ predicate device is in the specific ENFit access port/s attached to the funnel of the unmodified device and an addition of the 10Fr size device. The design, materials, performance and safety characteristic of this specific ENFit port/s are the same as the enteral specific connection access port of the reference device 510(k) K141753.

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- p) Non- clinical Summary. Non- clinical verification of Aquariusï Gastrostomy Replacement Tube was conducted through the risk management process According to ISO 14971:2012 and performance functionality testing. The following performance testing was conducted on the Gastrostomy Replacement Tube:
- > Positive pressure liquid leak
- > Stress Cracking
- > Resistance to separation from axial load
- > Resistance to separation from unscrewing
- > Resistance to overriding
- > Disconnection by unscrewing
- > Flow rate
- > Dimension verification
- ✔ Tensile strength
- > Tensile strength of the connections of G-tube 10Fr
- > Leak Test for G-tube 10F
- ✔ Simulated Gastric fluids for G-tube 10Fr
- > Balloon burst volume for G-tube 10Fr
- > Biocompatibility evaluation
- ✔ Shelf . life (3 years).