(132 days)
The ECSL is a low profile balloon gastrostomy tube indicated for use as a replacement tube in an established stoma tract for pediatric, adult and elderly patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients who require long term feeding support. Indicated for patients in whom malnutrition already exists or may result. This may include patients for diseases resulting in an abnormality in swallowing; tumors secondary to head/neck or upper airway diseases or oropharyngeal trauma on the head, neck or overlying swallowing. Some patients who require chronic use of supplemental fluids are also candidates for gastrostomy tube use.
The EntraCare Skin Level Gastrostomy Tube Kit (ECSL) is used as a replacement tube in an established stoma tract for patients who cannot consume an adequate diet orally. The kit consists of: Gastrostomy Tube, Elbow Connector Extension Set, Bolus Connector Extension set, Stoma Measuring Device, Universal Adapter Subassembly. Items within the kit that are supplied by an outside source: 35 ml Catheter Tipped Syringe, 6 ml Slip Luer Syringe, 4" X 4" Gauze. Item sold separately: Stoma Measuring Device. The Gastrostomy Tube consists of a Feeding Port Valve Subassembly that contains a valve used to open the fluid pathway allowing enteral feeding solutions to enter into the stomach. An inflatable balloon at the distal end secures the tube in the stomach through a stoma. The Gastrostomy Tube size variations include 14-24 French sizes and 0.8-4.5 cm length sizes. There are two slightly different valve designs available, Version 1 and Version 2. The design concept for the Gastrostomy Tube valve Version 1 utilizes a specially designed rubber mechanism that opens the fluid pathway when a bolus or elbow connector is inserted into the device. This specially designed rubber valve will seal around the connectors preventing leakage and allow unrestricted access into the fluid pathway. When the connections are removed, the valve will reseal immediately preventing leakage of fluids. The design concept for the Gastrostomy Tube valve Version 2 utilizes a specially designed silicone mechanism that opens the fluid pathway when a bolus or elbow connector is inserted into the device. This specially designed valve will seal around the connectors preventing leakage and allow unrestricted access into the fluid pathway. The Gastrostomy Tube also consists of an Inflation Valve Subassembly that contains a valve and spring mechanism. When the syringe is inserted into the Inflation Valve Subassembly, the tip pushes against the valve, which compresses the spring and opens the fluid path to inflate the balloon. The Skin Level Gastrostomy Tube Kit contains all delivery items (accessories) necessary for enteral feeding applications. The accessories provided in the kit are two Extension Sets; one that allows continuous feeding from a pump, and the other that allows feeding from a catheter tip syringe. Two syringes are supplied (which have either been previously cleared for marketing by the FDA or are pre amendment devices); the 6 ml syringe is used to inflate the balloon of the gastrostomy tube and the 35 ml catheter tip syringe is used for bolus feeding. Sterile gauze is provided for absorbency. A universal luer adapter is included for mating connections that require a female luer.
The provided text describes a 510(k) premarket notification for the EntraCare Skin Level Gastrostomy Tube Kit (ECSL). This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Mic-Key® "G" Low Profile Gastrostomy Tube, K993138), rather than a de novo clinical study with robust statistical analysis of device performance against primary endpoints. Therefore, the information typically associated with acceptance criteria and a detailed study proving performance against those criteria (such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not available in the given document.
However, the document does list several performance standards that the device is stated to meet. These can be interpreted as the acceptance criteria for the product's functional and material integrity. The text then states that "The product also meets the following," implying that internal testing or conformity assessments were conducted to prove compliance with these criteria.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| Industry Standards: | |
| Sterilization in conformance with ANSI/AAMI/ISO 11135:1994 and EN 550. | "The Skin Level Gastrostomy Tube Kit (ECSL) is sterilized by ETO… in conformance with ANSI/AAMI/ISO 11135:1994… and EN 550 Sterilization Standards." |
| Biocompatibility in conformance with ANSI/AAMI/ISO 10993-1:1997 (Class VI). | "The device complies with ANSI/AAMI/ISO 10993-1:1997; Class VI. Biocompatibility Standards Concerning Cytotoxicity, Sensitization, Intracutaneous, Systemic Toxicity, and Hemocompatibility." |
| Packaging in accordance with ANSI/AAMI/ISO 11607:1997. | "The device is packaged in accordance with the ANSI/AAMI/ISO 11607:1997, Packaging For Terminally Sterilized Devices Standard." |
| Specific Device Performance: | |
| Elbow and Bolus Connector withstands 20 inch ounces of torque when connected to the feeding port valve. | "The Elbow and Bolus Connector when connected to the feeding port valve withstands 20 inch ounces of torque." |
| Feeding port valve assembly bond to the skin level Gastrostomy Tube main body bond withstands 20 inch ounces of torque. | "The feeding port valve assembly bond to the skin level Gastrostomy Tube main body bond withstands 20 inch ounces of torque." |
| Device functions after 120 inflation valve flexes at 45 degrees from centerline. | "The device functions after 120 inflation valve flexes at 45 degrees from center line." |
| Gastrostomy Tube maintains an inflated balloon for up to seven days. | "The Gastrostomy Tube is able to maintain an inflated balloon for up to seven days." |
| Valve in the feeding port valve assembly withstands a low backpressure of 0.05 psig (3.5 cm H2O) after 360 insertions. | "The valve in the feeding port valve assembly withstands a low backpressure of 0.05 psig (3.5 cm H2O) after 360 insertions." |
| Valve closes at a low backpressure of 0.22 psig (15 cm H2O) after 7 days of continuous insertion. | "The valve closes at a low backpressure of 0.22 psig (15 cm H2O) after 7 days of continuous insertion." |
| Gastrostomy Tube fluid pathway and related elbow and bolus connections withstands a positive pressure of 15 psig after 360 insertions. | "The Gastrostomy Tube fluid pathway and related elbow and bolus connections withstands a positive pressure of 15 psig after 360 insertions." |
| Gastrostomy Tube fluid pathway and related elbow and bolus connections withstands a positive pressure of 15 psig after 7 days of continuous insertion. | "The Gastrostomy Tube fluid pathway and related elbow and bolus connections withstands a positive pressure of 15 psig after 7 days of continuous insertion." |
| Device is labeled in accordance with federal regulations. | "The device is labeled in accordance with federal regulations." |
| Device is Latex free. | "The device is Latex free." |
| Materials used are of FDA cleared medical grade materials. | "The Materials used to fabricate the Skin Level Gastrostomy Tube are of FDA cleared medical grade materials." |
| Acid balloon test. | "Acid balloon test." |
Additional Information Not Available or Applicable:
Given the nature of a 510(k) submission for a physical medical device, particularly from 2004, the following information is not typically part of such a submission or is not provided in the excerpt:
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Sample sizes used for the test set and the data provenance: Not specified in the document. The tests mentioned are likely bench or lab tests of component or assembled product integrity, not clinical trials with human subjects. Data provenance (country of origin, retrospective/prospective) is not applicable for these types of engineering tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context would be the objective measurement or predefined standard for the engineering performance criteria.
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Adjudication method for the test set: Not applicable. The tests are objective measurements against defined thresholds.
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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 device is a physical gastrostomy tube, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance criteria listed, "ground truth" refers to engineering specifications and objective measurements (e.g., torque values, pressure resistance, cycle counts) verified through laboratory testing.
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The sample size for the training set: Not applicable. There is no "training set" in the context of this type of device and performance testing.
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How the ground truth for the training set was established: Not applicable.
In summary: The provided document details the acceptance criteria as a series of specific engineering performance standards and industry compliance standards. It states that the device "meets" or "is in conformance with" these criteria, implying that internal testing was conducted to verify compliance. However, it does not provide details about the specific studies, sample sizes, or methodologies used for these internal verification tests, as would be expected for a detailed study report. The focus of this 510(k) submission is on demonstrating substantial equivalence, not conducting a novel performance study in the clinical sense.
§ 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.