Low Profile Balloon Feeding Device

K161413 · Applied Medical Technology, Inc. · KNT · Feb 9, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K161413
• Device Name: Low Profile Balloon Feeding Device
• Applicant: Applied Medical Technology, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Feb 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Low Profile 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. The Low Profile Balloon Feeding Device is intended for all age groups.

Device Story

Low Profile Balloon Feeding Device provides enteral nutrition, medication delivery, and gastric decompression. Device consists of external bolster, feeding catheter, and internal retention balloon. Catheter inserted through stoma; internal balloon secures position. Available in 10Fr to 24Fr diameters and 0.5cm to 10.0cm stoma lengths. Features MR Conditional balloon fill-valve or MR Safe Invisi-Valve. Used in clinical settings for patients requiring long-term access. Healthcare providers manage placement and maintenance. Benefits include reliable gastric access for patients unable to tolerate oral intake.

Clinical Evidence

Bench testing only. Performance testing included stoma pullout, bond strength, fill valve integrity, balloon burst, leak testing, flow rate, and balloon integrity in simulated gastric fluid. Biocompatibility testing performed per ISO 10993-1, -3, -5, -6, -7, -10, -11, and -12 for permanent contact with mucosal membranes.

Technological Characteristics

External bolster, feeding catheter, internal retention balloon. Catheter diameters 10Fr-24Fr; stoma lengths 0.5cm-10.0cm. MR Conditional or MR Safe (with Invisi-Valve). Biocompatibility per ISO 10993 standards. Mechanical retention via balloon.

Indications for Use

Indicated for patients of all ages requiring long-term enteral feeding, gastric decompression, or medication delivery via a secured or formed stoma; patients must be unable to tolerate oral feeding and be at low risk for aspiration.

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

• Kimberly-Clark MIC-KEY SF Low Profile Gastrostomy (K122653)

Reference Devices

• Kimberly-Clark MIC-KEY Low Profile Gastrostomy Tube (K043114)
• Low Profile Balloon Feeding Device (K945618)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

February 9, 2017

Applied Medical Technology, Inc. Michelle Scott Regulatory/QA Specialist 8006 Katherine Boulevard Brecksville, OH 44141

Re: K161413

> Trade/Device Name: Low Profile Balloon Feeding Device Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: January 9, 2017 Received: January 10, 2017

Dear Michelle Scott:

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

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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 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 -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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# Indications for Use

510(k) Number (if known) K161413

Device Name Low Profile Balloon Feeding Device

#### Indications for Use (Describe)

The Low Profile 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. The Low Profile Balloon Feeding Device is intended for all age groups.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span></span> </div> |
|----------------------------------------------|----------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span></span> </div> |

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## SECTION - 5

## 510(k) Summary

### Low Profile Balloon Feeding Device

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| Date Prepared: | February 8, 2017 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Applied Medical Technology, Inc.<br>8006 Katherine Boulevard<br>Brecksville, OH 44141<br>Phone: [phone]<br>Fax: [phone]<br>Contact Person: Michelle Scott - Regulatory/QA Specialist<br>Email: [e-mail] |
| Device<br>Information: | Trade/Device Name: Low Profile Balloon Feeding Device<br>Common Name: Gastrointestinal Feeding Tubes<br>Classification Name: Tubes, Gastrointestinal (And Accessories) (21 CFR 876.5980)<br>Product Code: KNT<br>Regulatory Class: II<br>Review Panel: Gastroenterology and Urology |
| Predicate<br>Device: | Primary Predicate: Kimberly-Clark MIC-KEY SF Low Profile Gastrostomy (K122653)<br>Reference Device: Kimberly-Clark MIC-KEY Low Profile Gastrostomy Tube (K043114)<br>Reference Device: Low Profile Balloon Feeding Device (K945618) |
| Intended Use: | The Low Profile Balloon Feeding Device is indicated for use in patients who<br>require long term feeding, are unable to tolerate oral feeding, who are at low risk<br>for aspiration, require gastric decompression and/or medication delivered<br>directly into the stomach through a secured (initial placement) or formed<br>(replacement) stoma. The Low Profile Balloon Feeding Device is intended for<br>all age groups. |
| Device<br>Description: | The Low Profile Balloon Feeding Device is used to provide nutrition,<br>medication, and decompression access into the stomach through a secured<br>(initial placement) or formed (replacement) stoma. |
| Technological<br>Characteristics: | The Low Profile Balloon Feeding Device consists of an external bolster, feeding<br>catheter, and internal retention balloon, similar to the predicate devices. The<br>feeding catheter is inserted into the stomach through a stoma and is held in place<br>with an internal retention balloon. The device can have an MR Conditional<br>balloon fill-valve or will be MR Safe when assembled with the Invisi-Valve.<br>The devices are provided in a number of sizes to accommodate different stoma |
| | diameters and lengths and can have either a blunt or tapered tip balloon. The<br>catheter tubes range in diameter from 10Fr to 24Fr, which is the same as the<br>primary predicate. The stoma lengths are available in a wider range of options,<br>from 0.5cm to 10.0 cm. |
| Biocompatibility<br>Testing: | The Low Profile Balloon Feeding Device has been tested for biocompatibility<br>based on the applicable sections of the following standards:<br>ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and testing within a risk management process ISO 10993-3: 2003 Biological Evaluation of Medical Devices - Part 3:<br>Tests for genotoxicity, carcinogenicity, and reproductive toxicity. ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5:<br>Tests for in vitro cytotoxicity. ISO 10993-6: 2007 Biological Evaluation of Medical Devices - Part 6:<br>Test for local effects after implantation. ISO 10993-7: 2008 Biological Evaluation of Medical Devices - Part 7:<br>Ethylene Oxide Sterilization Residuals. ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part<br>10: Tests for irritation and skin sensitization. ISO 10993-11:2006 Biological Evaluation of Medical Devices – Part<br>11: Tests for systemic toxicity ISO 10993-12:2007 Biological Evaluation of Medical Devices – Part<br>12: Sample preparation and reference materials An independent risk assessment was completed on the patient contacting<br>materials and it was determined that the Low Profile Balloon Feeding Device<br>met the acceptance criteria for permanent contact (greater than 30 days) with<br>mucosal membrane and breached/compromised surfaces. |
| Performance<br>Testing: | AMT conducted various performance tests on the components contained within<br>the Low Profile Balloon Feeding Device. Testing found that all components and<br>materials met or exceeded design specifications established by AMT.<br>Bench tests have been carried out on samples of the Low Profile Balloon<br>Feeding Device. The tests carried out included:<br>Stoma Pullout Minimum Overmold Bond Strength Fill Valve Blow Out Fill Valve Pullout Fill Valve Cycle Test Balloon Assembly Bond Peel/Tear Strength Balloon Burst Assembled Balloon Size Interlock Pullout Leak Test |
| Balloon Concentricity Ratio Tubing Tensile Testing Flow Rate Balloon Volume Maintenance Balloon Integrity Balloon Integrity in Simulated Gastric Fluid Testing | |
| Conclusion: | The Low Profile Balloon Feeding Device is substantially equivalent to the predicate device cleared under K122653 in intended use, design, biocompatibility, performance, and principles of operation. |

Applied Medical Technology, Inc. – 510(k) Submission Low Profile Balloon Feeding Device Section 5 – Page 5.1

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## SECTION - 5

Applied Medical Technology, Inc. – 510(k) Submission Low Profile Balloon Feeding Device Section 5 – Page 5.2

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# SECTION - 5