(62 days)
For percutaneous placement of a long-term replacement gastrostomy feeding and/or decompression device into an established stoma.
The Ponsky* Non-Balloon Replacement Gastrostomy Tube is a 20 French soft, silicone gastrostomy tube and internal retention dome with pre-attached external bolster and dual port feeding adaptor, packaged sterile with procedural aids. The Ponsky* Non-Balloon Replacement Gastrostomy Tube has a pocket in the dome that fits the obturator in order to assist in placement of the device through an established stoma. The Ponsky* Non-Balloon Replacement Gastrostomy Tube has a feeding port to administer nutrition, and a medication port.
The provided text describes a Special 510(k) Premarket Notification for the Ponsky Non-Balloon Replacement Gastrostomy Tube. This type of submission is for modifications to a legally marketed device that do not affect the intended use or alter fundamental scientific technology. Therefore, the study presented here focuses on demonstrating that the modified device meets specified performance criteria and remains substantially equivalent to the predicate device. It does not involve a comparative effectiveness study with human readers (MRMC) or a standalone AI algorithm performance study.
Here's an breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present specific quantitative acceptance criteria or a detailed table of device performance results for each criterion in the typical format of a clinical study. Instead, it references a series of recognized and national standards that were used to develop in-house test protocols. The general statement is that the device "met all pre-determined acceptance criteria."
| Acceptance Criteria (Referenced Standards) | Reported Device Performance |
|---|---|
| AAMI / ANSI / ISO 10993-1:2003 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding biological safety. |
| EN 1615:2000 (Enteral Feeding Catheters and Enteral Giving Sets for Single Use and Their Connectors) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding performance as an enteral feeding catheter. |
| EN 1618:1997 (Catheters other than Intravascular Catheters - Test Methods for Common Properties) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding common catheter properties. |
| JIS T 3213:2005 (Enteral Feeding Catheters and Enteral Giving Sets) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding performance as an enteral feeding catheter. |
| ASTM F 640:2007 (Standard Test Methods for Determining Radiopacity for Medical Use) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding radiopacity. |
| ISO 14971:2009 (Medical devices - Application of risk management to medical devices) | Risk management processes were applied, leading to the conclusion that no new questions regarding safety or effectiveness are raised. Device met all pre-determined acceptance criteria. |
| AAMI / ANSI / ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding packaging and maintenance of sterility. |
| ANSI / AAMI / ISO 11135:2007 (Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding sterilization efficacy and control. |
| AAMI / ANSI / ISO 10993-7:1995 (R) 2001 (Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence to the predicate device regarding biocompatibility in relation to ethylene oxide residuals. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for particular tests. The tests performed are in-house design verification and validation activities, which would typically involve testing of device prototypes or production samples. The data provenance is "in-house test protocols" developed based on recognized standards. The country of origin of the data is implied to be within Bard Access Systems, Inc. (Salt Lake City, Utah, USA), given the submitter information. It is a retrospective analysis of device performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a device modification submission based on engineering and material performance standards rather than clinical evaluation, there's no mention of experts establishing a "ground truth" for a test set in the clinical sense (e.g., radiologists interpreting images). The "ground truth" for these engineering tests are the specifications and requirements defined by the referenced international and national standards.
4. Adjudication Method for the Test Set
Not applicable. The tests are based on objective measurements and established standards, rather than expert interpretation requiring adjudication.
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
No, an MRMC comparative effectiveness study was not done. This device is a gastrostomy tube, not an AI-powered diagnostic tool, and the submission is for a device modification (Special 510(k)) that focuses on engineering and material performance, not clinical efficacy through human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used for performance assessment is based on the requirements and specifications embedded within the referenced international and national consensus standards (e.g., ISO, AAMI, EN, JIS, ASTM). These standards define acceptable levels of biological safety, material properties, sterility, radiopacity, and other performance characteristics for medical devices of this type.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
§ 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.