(247 days)
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.
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.
The provided text describes the 510(k) summary for the "Low Profile Non-Balloon Feeding Device." It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, supported by performance testing. However, the document does not contain the level of detail typically found in a study description for an AI/ML device, especially regarding acceptance criteria directly linked to a specific study with statistical results.
The document discusses performance testing in general terms for a medical device (a feeding tube), but not for an AI/ML component. Therefore, much of the requested information regarding AI/ML study specifics (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this text.
Here's a breakdown of what can and cannot be extracted based on your request and the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text lists various performance tests conducted for the device. It states, "Testing found that all components and materials met or exceeded design specifications established by AMT." However, it does not explicitly state quantitative acceptance criteria for each test, nor does it provide the specific numerical results for each test. Instead, it offers a general statement of compliance.
| Acceptance Criteria (Not explicitly stated quantitatively in the document) | Reported Device Performance (Summary statement) |
|---|---|
| Design specifications established by AMT (specifics not provided) | All components and materials met or exceeded design specifications. |
| (Implicitly, the device must function as intended without leakage, with appropriate flow rates, and withstand various forces) | - Stoma Pullout Force: Met specifications. - Tip Poke-Through Force: Met specifications. - Snap Arm Body to Rod Attachment Force: Met specifications. - Snap Arm to T-Handle Snap Engagement Force: Met specifications. - T-Handle Tooth Shear Strength: Met specifications. - Interlock Pullout: Met specifications. - Time to Capsule Rupture: Met specifications. - Suture Deployment Force: Met specifications. - Ripcord Tensile Strength: Met specifications. - Pull Tab-to-Suture Bond Strength: Met specifications. - Liquid Leakage Test: Met specifications. - Flow Rate Test (Water and Viscous Fluid): Met specifications. - Tube Tensile Test: Met specifications. - Obturator Bond Strength Test: Met specifications. - Duckbill Flow and Backflow Test: Met specifications. - Obturator Poke-Through Evaluation: Met specifications. - Obturator Push-Through Force Test: Met specifications. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "samples of the Low Profile Non-Balloon Feeding Device" were used for bench tests, but no specific number of samples is provided for any test.
- Data Provenance: Not applicable in the context of clinical data. These are bench tests conducted on physical device samples. The company conducting the tests is Applied Medical Technology, Inc. (AMT), based in Brecksville, OH, USA. The tests are prospective in the sense that they were conducted for the purpose of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the performance testing described is for a physical medical device (feeding tube) through bench testing, not for an AI/ML algorithm requiring expert interpretation of data for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable for physical bench testing. The results would be based on direct measurement or observation against predetermined specifications by test engineers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the bench tests, the "ground truth" would be the engineering design specifications and expected physical properties and performance characteristics of each component and the assembled device. These are objective measurements rather than expert consensus on clinical data.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device. While presumably, some prototypes or earlier versions of the device would have been tested during development, the concept of a "training set" for an algorithm does not apply.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
In summary, the provided document details the regulatory submission for a physical medical device. It confidently states that the device met its design specifications through various bench tests, but it does not delve into the specifics of AI/ML performance evaluation as requested in the prompts.
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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.
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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
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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) |
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SECTION - 5
510(k) Summary
Low Profile Non-Balloon Feeding Device
I
| Date Prepared: | September 12, 2017 |
|---|---|
| Submitter: | Applied Medical Technology, Inc.8006 Katherine BoulevardBrecksville, OH 44141Phone: 440-717-4000Fax: 440-717-4200Contact Person: Shraddha Saini - Regulatory Affairs SpecialistEmail: Shraddha.Saini@appliedmedical.net |
| DeviceInformation: | Trade Name: Low Profile Non-Balloon Feeding DeviceCommon Name: Gastrointestinal Feeding TubesClassification Name: Gastrointestinal Tube and Accessories (21 CFR876.5980)Product Code: KNTRegulatory Class: IIReview Panel: Gastroenterology and Urology |
| PredicateDevice: | 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 patientswho require long term feeding, are unable to tolerate oral feeding, who are atlow risk for aspiration, require gastric decompression and/or medicationdelivered directly into the stomach through a secured (initial placement) orformed (replacement) stoma. |
| DeviceDescription: | 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 placedusing one of two insertion methods including an 'obturator' insertion methodand a 'capsule' insertion method.Capsule Insertion Method: The internal bolster of the device is encased by waterdissolvable capsule. The capsule technology provides a low-profile option thatis delivered by lubricating the capsule with lubricant, inserting the devicethrough the stoma site, and pulling on a pull tab that pulls a suture through thecapsule and deploys the internal dome. Once the capsule is deployed, theinternal dome returns to its uncompressed shape and the device is held in place.Obturator Insertion Method: A T-Handle and ratcheting obturator rod (SnapArm Assembly) is used to extend the internal dome, decreasing the outer profileof 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 properlubrication. Once inserted into the stoma site, the ratcheting rod and T-handleare removed and device is held in place by the internal bolster.Once placed, both devices provide access to nutrition, medication, anddecompression into the stomach via a Mini ONE® feeding port. Both devicesare 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 byelongating the internal bolster to reduce the outer diameter of the dome,providing for an easier removal process. The Low Profile Non-Balloon FeedingDevice will be offered in several different diameters including14 Fr, 18 Fr, 20Fr, and 24 Fr and will be available in stoma lengths ranging from 1.0 cm to 4.4cm. | |
| The Low Profile Non-Balloon Feeding Device is provided sterile for single useonly. The molded body of the Non-Balloon feeding device is made of medicalsilicone. The Low Profile Non-Balloon Feeding Device consists of an externalbolster, feeding catheter, and internal retention bolster similar to the predicatedevices. The external bolster consists of a feeding port for access to the stomachthrough the tubing of the device and a strap with a plug to close the feeding portwhile not in use. In addition, an anti-reflux valve is included in the feeding portarea to prevent backflow of stomach contents while not in use. The feedingcatheter is inserted into the stomach through a stoma and is held in place withthe internal retention bolster. There are two different insertion methods for theproposed device, the 'capsule' and the 'obturator' method. The 'capsule' versionincludes a tapered capsule enclosing the internal bolster at one end that allowsease 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 controlledinsertion and elongation through the device shaft. The Low Profile Non-BalloonFeeding Device and the predicate devices are provided in a number of sizes toaccommodate different stoma diameters and lengths. | |
| TechnologicalCharacteristics: | Design Differences:Method of Insertion: The proposed devices provides two different methods ofinsertion ('Capsule' or 'Obturator'), whereas the predicate devices are onlyprovided with a single method of insertion. The Capsule Monarch Transshaping Gastrostomy Tube uses the same Capsule technology of the proposeddevice but does not offer a Snap arm assembly and T-handle method forinsertion. The AMT Button Replacement Gastrostomy Device uses an insertionrod to insert the device, but does not offer the level of control and repeatabilityfor insertion that the proposed device offers with the Snap arm assembly and T-handle components. Both predicate devices don't use removal tools, allowingthe proposed device to have a more comfortable means of removal by avoiding anecessary retraction removal. |
| Interlock and Anti-Reflux Valve: The proposed device incorporates aninterlock for its feeding port, whereas the predicate devices do not haveinterlocks. The proposed device incorporates an anti-reflux valve that is locatedalong the proximal end of the tubing along the external bolster. The CapsuleMonarch Trans shaping Gastrostomy Tube does not include an anti- reflux valveand relies only on external plugs to prevent leakage. The AMT ButtonReplacement Gastrostomy Device includes an anti-reflux valve along the distal | |
| the proposed device. | |
| The overall functionality and safety of the proposed Low Profile Non BalloonFeeding Device remains substantially equivalent to the predicate devices. | |
| BiocompatibilityTesting: | The patient contacting components of the Low Profile Non-Balloon FeedingDevice are in contact with mucosal membrane and/or breached/compromisedsurfaces for prolonged or permanent exposure. No additional biocompatibilitytesting was conducted because the patient-contacting components in the finalfinished device are identical to those in previously marketed devices (in termsof formulation, processing, sterilization, geometry, nature of use, and durationof exposure) and no chemicals were added (e.g., plasticizers, fillers, additives,cleaning agents, mold release agents). |
| PerformanceTesting: | AMT conducted various performance tests on the components contained withinthe Low Profile Non-Balloon Feeding Device. Testing found that allcomponents and materials met or exceeded design specifications established byAMT.Bench tests have been carried out on samples of the Low Profile Non-BalloonFeeding 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 thepredicate 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
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SECTION - 5
Applied Medical Technology, Inc. - 510(k) Submission Low Profile Non 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.