← Product Code [KNT](/productcode/KNT) · K170319 # Low Profile Non-Balloon Feeding Device (K170319) _Applied Medical Technology, Inc. · KNT · Oct 6, 2017 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K170319 ## Device Facts - **Applicant:** Applied Medical Technology, Inc. - **Product Code:** [KNT](/productcode/KNT.md) - **Decision Date:** Oct 6, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5980 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The Low Profile Non-Balloon Feeding Device is indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma. ## Device Story Device provides gastric access for nutrition, medication, and decompression. Consists of external bolster, feeding catheter, and internal retention bolster. Two insertion methods: 'capsule' (water-dissolvable capsule encasing internal bolster, deployed via pull-tab/suture) and 'obturator' (T-handle/ratcheting rod assembly to elongate internal dome for insertion). Removal uses specialized tool assembly to elongate bolster for easier extraction. Used in clinical settings; operated by healthcare professionals. Device features anti-reflux valve and feeding port interlock. Benefits include low-profile design and controlled insertion/removal process. Output is direct gastric access; provider uses device to manage patient nutritional/medication needs. ## Clinical Evidence Bench testing only. No clinical data. Performance testing included stoma pullout force, tip poke-through force, snap arm/T-handle engagement, interlock pullout, capsule rupture time, suture deployment force, ripcord tensile strength, pull tab-to-suture bond strength, liquid leakage, flow rate (water/viscous), tube tensile test, obturator bond strength, duckbill flow/backflow, and obturator push-through force. ## Technological Characteristics Medical-grade silicone construction. Non-balloon retention bolster. Two insertion mechanisms: water-dissolvable capsule or T-handle/ratcheting obturator rod. Includes anti-reflux valve and feeding port interlock. Available in 14, 18, 20, 24 Fr diameters; lengths 1.0 cm to 4.4 cm. Sterile, single-use. No electronic components or software. ## Regulatory 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 - AMT Button Replacement Gastrostomy Device ([K980305](/device/K980305.md)) - Capsule Monarch Trans shaping Gastrostomy Tube ([K043027](/device/K043027.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 6, 2017 Applied Medical Technology, Inc. Shraddha Saini Regulatory Affairs Specialist 8006 Katherine Boulevard Brecksville, OH 44141 Re: K170319 > Trade/Device Name: Low Profile Non-Balloon Feeding Device Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: September 12, 2017 Received: September 13, 2017 Dear Shraddha Saini: 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. {1}------------------------------------------------ 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 of medical device-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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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, # 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170319 #### Device Name Low Profile Non-Balloon Feeding Device. #### Indications for Use (Describe) The Low Profile Non-Balloon Feeding Device is indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma. | 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." {3}------------------------------------------------ ## SECTION - 5 # 510(k) Summary ## Low Profile Non-Balloon Feeding Device I | Date Prepared: | September 12, 2017 | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Applied Medical Technology, Inc.
8006 Katherine Boulevard
Brecksville, OH 44141
Phone: 440-717-4000
Fax: 440-717-4200
Contact Person: Shraddha Saini - Regulatory Affairs Specialist
Email: Shraddha.Saini@appliedmedical.net | | Device
Information: | Trade Name: Low Profile Non-Balloon Feeding Device
Common Name: Gastrointestinal Feeding Tubes
Classification Name: Gastrointestinal Tube and Accessories (21 CFR
876.5980)
Product Code: KNT
Regulatory Class: II
Review Panel: Gastroenterology and Urology | | Predicate
Device: | AMT Button Replacement Gastrostomy Device (K980305)
Capsule Monarch Trans shaping Gastrostomy Tube (K043027) | | Intended Use: | The Low Profile Non-Balloon Feeding Device is indicated for use in patients
who require long term feeding, are unable to tolerate oral feeding, who are at
low risk for aspiration, require gastric decompression and/or medication
delivered directly into the stomach through a secured (initial placement) or
formed (replacement) stoma. | | Device
Description: | The Low Profile Non-Balloon Feeding Device is used to provide nutrition,
medication, and decompression access into the stomach through a secured
(initial placement) or formed (replacement) stoma. The device may be placed
using one of two insertion methods including an 'obturator' insertion method
and a 'capsule' insertion method.
Capsule Insertion Method: The internal bolster of the device is encased by water
dissolvable capsule. The capsule technology provides a low-profile option that
is delivered by lubricating the capsule with lubricant, inserting the device
through the stoma site, and pulling on a pull tab that pulls a suture through the
capsule and deploys the internal dome. Once the capsule is deployed, the
internal dome returns to its uncompressed shape and the device is held in place.
Obturator Insertion Method: A T-Handle and ratcheting obturator rod (Snap
Arm Assembly) is used to extend the internal dome, decreasing the outer profile
of the dome. When the dome is fully elongated, the internal dome maintains a | | | narrow profile that can easily be inserted into the stoma site with proper
lubrication. Once inserted into the stoma site, the ratcheting rod and T-handle
are removed and device is held in place by the internal bolster.
Once placed, both devices provide access to nutrition, medication, and
decompression into the stomach via a Mini ONE® feeding port. Both devices
are identical after placement regardless of the insertion method chosen.
Removal of feeding device can be performed by using a removal tool assembly
(Snap Arm and T-handle with removal tool reinforcer). Removal is done by
elongating the internal bolster to reduce the outer diameter of the dome,
providing for an easier removal process. The Low Profile Non-Balloon Feeding
Device will be offered in several different diameters including14 Fr, 18 Fr, 20
Fr, and 24 Fr and will be available in stoma lengths ranging from 1.0 cm to 4.4
cm. | | | The Low Profile Non-Balloon Feeding Device is provided sterile for single use
only. The molded body of the Non-Balloon feeding device is made of medical
silicone. The Low Profile Non-Balloon Feeding Device consists of an external
bolster, feeding catheter, and internal retention bolster similar to the predicate
devices. The external bolster consists of a feeding port for access to the stomach
through the tubing of the device and a strap with a plug to close the feeding port
while not in use. In addition, an anti-reflux valve is included in the feeding port
area to prevent backflow of stomach contents while not in use. The feeding
catheter is inserted into the stomach through a stoma and is held in place with
the internal retention bolster. There are two different insertion methods for the
proposed device, the 'capsule' and the 'obturator' method. The 'capsule' version
includes a tapered capsule enclosing the internal bolster at one end that allows
ease of insertion and an obturator rod is pre-loaded in to the shaft prior to use.
The 'obturator' version uses a T-Handle and snap arm assembly for controlled
insertion and elongation through the device shaft. The Low Profile Non-Balloon
Feeding Device and the predicate devices are provided in a number of sizes to
accommodate different stoma diameters and lengths. | | Technological
Characteristics: | Design Differences:
Method of Insertion: The proposed devices provides two different methods of
insertion ('Capsule' or 'Obturator'), whereas the predicate devices are only
provided with a single method of insertion. The Capsule Monarch Trans
shaping Gastrostomy Tube uses the same Capsule technology of the proposed
device but does not offer a Snap arm assembly and T-handle method for
insertion. The AMT Button Replacement Gastrostomy Device uses an insertion
rod to insert the device, but does not offer the level of control and repeatability
for insertion that the proposed device offers with the Snap arm assembly and T-
handle components. Both predicate devices don't use removal tools, allowing
the proposed device to have a more comfortable means of removal by avoiding a
necessary retraction removal. | | | Interlock and Anti-Reflux Valve: The proposed device incorporates an
interlock for its feeding port, whereas the predicate devices do not have
interlocks. The proposed device incorporates an anti-reflux valve that is located
along the proximal end of the tubing along the external bolster. The Capsule
Monarch Trans shaping Gastrostomy Tube does not include an anti- reflux valve
and relies only on external plugs to prevent leakage. The AMT Button
Replacement Gastrostomy Device includes an anti-reflux valve along the distal | | | the proposed device. | | | The overall functionality and safety of the proposed Low Profile Non Balloon
Feeding Device remains substantially equivalent to the predicate devices. | | Biocompatibility
Testing: | The patient contacting components of the Low Profile Non-Balloon Feeding
Device are in contact with mucosal membrane and/or breached/compromised
surfaces for prolonged or permanent exposure. No additional biocompatibility
testing was conducted because the patient-contacting components in the final
finished device are identical to those in previously marketed devices (in terms
of formulation, processing, sterilization, geometry, nature of use, and duration
of exposure) and no chemicals were added (e.g., plasticizers, fillers, additives,
cleaning agents, mold release agents). | | Performance
Testing: | AMT conducted various performance tests on the components contained within
the Low Profile Non-Balloon Feeding Device. Testing found that all
components and materials met or exceeded design specifications established by
AMT.
Bench tests have been carried out on samples of the Low Profile Non-Balloon
Feeding Device. The tests carried out included:
• Stoma Pullout Force
• Tip Poke-Through Force
• Snap Arm Body to Rod Attachment Force
• Snap Arm to T-Handle Snap Engagement Force
• T-Handle Tooth Shear Strength
• Interlock Pullout
• Time to Capsule Rupture
• Suture Deployment Force
• Ripcord Tensile Strength
• Pull Tab-to-Suture Bond Strength
• Liquid Leakage Test
• Flow Rate Test (Water and Viscous Fluid)
• Tube Tensile Test
• Obturator Bond Strength Test
• Duckbill Flow and Backflow Test
• Obturator Poke-Through Evaluation
• Obturator Push-Through Force Test | | Conclusion: | The Low Profile Non-Balloon Feeding Device is substantially equivalent to the
predicate devices cleared under K980305 and K043027 in intended use, design,
biocompatibility, performance, and principles of operation. | Applied Medical Technology, Inc. - 510(k) Submission Low Profile Non Balloon Feeding Device Section 5 – Page 5.1 {4}------------------------------------------------ # SECTION - 5 Applied Medical Technology, Inc. - 510(k) Submission Low Profile Non Balloon Feeding Device Section 5 – Page 5.2 {5}------------------------------------------------ ## SECTION - 5 --- **Source:** [https://fda-staging.innolitics.com/device/K170319](https://fda-staging.innolitics.com/device/K170319) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com