(262 days)
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.
The Low Profile 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 Low Profile Balloon Feeding Device consists of an external bolster, feeding catheter, and internal retention balloon, similar to the predicate devices. The feeding catheter is inserted into the stomach through a stoma and is held in place with an internal retention balloon. The device can have an MR Conditional balloon fill-valve or will be MR Safe when assembled with the Invisi-Valve. 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 catheter tubes range in diameter from 10Fr to 24Fr, which is the same as the primary predicate. The stoma lengths are available in a wider range of options, from 0.5cm to 10.0 cm.
The provided text describes a 510(k) submission for a "Low Profile Balloon Feeding Device" and does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.
The document is a traditional medical device submission (K161413) to the FDA, demonstrating substantial equivalence to predicate devices, rather than an AI/ML device requiring performance evaluation against specific metrics like sensitivity, specificity, or AUC.
Therefore, I cannot extract the requested information (points 1-9) which are relevant to AI/ML device studies. The document focuses on:
- Device Description: What the device is and how it works.
- Intended Use: The medical purpose of the device.
- Technological Characteristics: Materials, sizes, and features.
- Biocompatibility Testing: Ensuring the materials are safe for patient contact, detailed with ISO standards used.
- Performance Testing: Bench tests to confirm the physical integrity and function of the device components, such as balloon burst strength, pullout strength, and flow rates.
- Substantial Equivalence: Comparison to existing devices on the market.
None of these sections discuss AI/ML models, algorithms, or their performance metrics.
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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 (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/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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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SECTION - 5
510(k) Summary
Low Profile Balloon Feeding Device
| Date Prepared: | February 8, 2017 |
|---|---|
| Submitter: | Applied Medical Technology, Inc.8006 Katherine BoulevardBrecksville, OH 44141Phone: 440-717-4000Fax: 440-717-4200Contact Person: Michelle Scott - Regulatory/QA SpecialistEmail: michelle.scott@appliedmedical.net |
| DeviceInformation: | Trade/Device Name: Low Profile Balloon Feeding DeviceCommon Name: Gastrointestinal Feeding TubesClassification Name: Tubes, Gastrointestinal (And Accessories) (21 CFR 876.5980)Product Code: KNTRegulatory Class: IIReview Panel: Gastroenterology and Urology |
| PredicateDevice: | Primary Predicate: Kimberly-Clark MIC-KEY SF Low Profile Gastrostomy (K122653)Reference Device: Kimberly-Clark MIC-KEY Low Profile Gastrostomy Tube (K043114)Reference Device: Low Profile Balloon Feeding Device (K945618) |
| Intended Use: | The Low Profile Balloon Feeding Device is indicated for use in patients whorequire long term feeding, are unable to tolerate oral feeding, who are at low riskfor aspiration, require gastric decompression and/or medication delivereddirectly into the stomach through a secured (initial placement) or formed(replacement) stoma. The Low Profile Balloon Feeding Device is intended forall age groups. |
| DeviceDescription: | The Low Profile Balloon Feeding Device is used to provide nutrition,medication, and decompression access into the stomach through a secured(initial placement) or formed (replacement) stoma. |
| TechnologicalCharacteristics: | The Low Profile Balloon Feeding Device consists of an external bolster, feedingcatheter, and internal retention balloon, similar to the predicate devices. Thefeeding catheter is inserted into the stomach through a stoma and is held in placewith an internal retention balloon. The device can have an MR Conditionalballoon fill-valve or will be MR Safe when assembled with the Invisi-Valve.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. Thecatheter tubes range in diameter from 10Fr to 24Fr, which is the same as theprimary predicate. The stoma lengths are available in a wider range of options,from 0.5cm to 10.0 cm. | |
| BiocompatibilityTesting: | The Low Profile Balloon Feeding Device has been tested for biocompatibilitybased on the applicable sections of the following standards:ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1:Evaluation and testing within a risk management process ISO 10993-3: 2003 Biological Evaluation of Medical Devices - Part 3:Tests for genotoxicity, carcinogenicity, and reproductive toxicity. ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5:Tests for in vitro cytotoxicity. ISO 10993-6: 2007 Biological Evaluation of Medical Devices - Part 6:Test for local effects after implantation. ISO 10993-7: 2008 Biological Evaluation of Medical Devices - Part 7:Ethylene Oxide Sterilization Residuals. ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part10: Tests for irritation and skin sensitization. ISO 10993-11:2006 Biological Evaluation of Medical Devices – Part11: Tests for systemic toxicity ISO 10993-12:2007 Biological Evaluation of Medical Devices – Part12: Sample preparation and reference materials An independent risk assessment was completed on the patient contactingmaterials and it was determined that the Low Profile Balloon Feeding Devicemet the acceptance criteria for permanent contact (greater than 30 days) withmucosal membrane and breached/compromised surfaces. |
| PerformanceTesting: | AMT conducted various performance tests on the components contained withinthe Low Profile Balloon Feeding Device. Testing found that all components andmaterials met or exceeded design specifications established by AMT.Bench tests have been carried out on samples of the Low Profile BalloonFeeding Device. The tests carried out included: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
§ 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.