(110 days)
The HOSPIRA ® Enteral Feeding Sets is intended to deliver, via gravity or a pamp, liquid nuttition formulas to an enteral access device (a feeding tube).
The HOSPIRA ® Enteral Feeding Sets will consist of variations of the following components: non-DETIP Enteral feeding bags, non-DEHP plasticized polyvinyl tubing, fluid shut off devices, non-DEHP sight chambers, cassette technology and adapters for enteral feeding catheters.
1. Acceptance Criteria and Reported Device Performance
This 510(k) summary does not contain specific, quantifiable acceptance criteria or detailed performance data for the Hospira® Enteral Feeding Sets. Instead, it relies on a claim of substantial equivalence to previously cleared predicate devices (K810996, K052052, K865059, K052059).
The device's "performance" is implicitly deemed acceptable because it meets the "functional claims and intended use" and is similar in function and operating principles to the predicate devices. The primary differences highlighted are material composition (non-DEHP, non-PVC) rather than functional performance metrics.
Therefore, a table of acceptance criteria and reported device performance as typically understood for new, innovative devices with novel performance claims cannot be created from this document. The "acceptance criteria" here are essentially "demonstrated substantial equivalence to legally marketed predicate devices."
2. Sample Size and Data Provenance
This document does not describe a study involving a "test set" of data or patient samples in the way that AI/ML medical devices often do. The evaluation is based on comparison to existing device designs and their established safety and effectiveness.
- Sample Size: Not applicable in the context of this 510(k) submission, as no new clinical or performance data from a specific "test set" is presented.
- Data Provenance: Not applicable. The "data" here refers to the design specifications and materials of the proposed device, compared to those of predicate devices already marketed. This is not a study involving patient data from a specific country or design (retrospective/prospective).
3. Number of Experts and Qualifications
Not applicable. This type of submission relies on engineering and material science evaluations, and comparison to existing regulatory clearances, rather than expert consensus on diagnostic or clinical outcomes from a test set. The review and approval are conducted by FDA staff (e.g., Office of Device Evaluation), who are experts in medical device regulation and relevant scientific fields.
4. Adjudication Method
Not applicable. There is no test set or ground truth requiring expert adjudication described in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention or present any MRMC study. The device is an enteral feeding set, which is a physical medical device, not an AI-assisted diagnostic or therapeutic tool that would involve human readers interpreting cases.
6. Standalone Performance Study
No. This document does not describe a standalone performance study in the context of an algorithm's performance without human intervention. The "performance" assessment is based on design similarities and adherence to established regulatory requirements for similar devices. The core claim is substantial equivalence, not novel performance to be proven by a standalone study.
7. Type of Ground Truth Used
Not applicable in the typical sense of a diagnostic or predictive algorithm. For this device, the "ground truth" for demonstrating safety and effectiveness is implicitly the established safety and performance profile of the predicate devices, which have already been deemed safe and effective for their intended use by the FDA. The new device's design and materials are compared against this established benchmark.
8. Sample Size for the Training Set
Not applicable. This submission does not involve a "training set" as it would for an AI/ML device. There is no algorithm being trained.
9. How Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned or implied in this document.
§ 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.