(209 days)
The device is indicated for use as a dispenser, measuring device, and fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) to in all age groups.
The device is an enteral feeding syringe for single use. The devices are piston-style syringes consisting of a syringe barrel, syringe plunger, syringe gasket, and syringe cap. The device incorporates a female ENFit connector designed to be compatible only with enteral access devices or accessories. It has ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.
The device is a disposable syringe made of the following components:
- Plunger: The Plunger is a piston having a longitudinal shaft that is mechanically received into the proximal syringe barrel aperture. It is made of polypropylene and uncoated. The proximal end of the plunger is flat to allow the device user to apply uniform pressure to the plunger shaft, thereby initiating the plunger into the syringe barrel.
- Barrel: The Barrel is a single, clear molded plastic hollow barrel made of polypropylene. This is the identical material used to manufacture the barrel of the predicate device. The distal end of the barrel possesses an integrally molded syringe tip. The barrel is marked on the exterior with non-toxic, biocompatible ink to create gradient volume graduation markings. The barrel is translucent to allow visualization of fluid contents and volume. The barrel is designed at an appropriate length to accommodate the nominal volume of each syringe size as labeled.
- Gasket: The gasket is attached to the distal end of the syringe plunger in an o-ring orientation. It is attached to the plunger via a mechanical interference fit. The purpose of the gasket is to engage the syringe barrel to form a low-pressure seal, which is impervious to fluids.
- Tip cap: The tip cap is an ENFit compatible closure cap for the syringe. The syringe tip cap is designed to be compatible with the ENFit female syringe tip of the syringe. The syringe tip cap is made of polypropylene and purple colorant.
This document primarily discusses the substantial equivalence of a medical device (Enteral Feeding Syringes with ENFit connector) to a predicate device, focusing on non-clinical performance testing, biocompatibility, and sterility. It does not present a study proving a device meets acceptance criteria in the context of an AI/ML medical device, clinical efficacy, or human reader performance. The document explicitly states "No clinical study is included in this submission."
Therefore, based on the provided text, I cannot answer the questions related to clinical studies, human readers, AI assistance, ground truth establishment for AI/ML models, or sample sizes for training sets.
However, I can extract the acceptance criteria and performance data for the non-clinical aspects of the device.
Here's the information gleaned from the document regarding the acceptance criteria and device performance for the physical device itself:
1. A table of acceptance criteria and the reported device performance
The document defines acceptance criteria by referencing compliance with specific international standards and then states that the device "met all requirements" or that "All of the pre-determined acceptance criteria were met." Specific numerical performance data is provided for sterility residuals and bioburden.
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance | Compliance with: |
- ISO 7886-1: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- ISO 80369-3: Small-bore connectors for liquids and gases in health care applications Part 3: Connectors for enteral applications
- ISO 80369-20: Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods | "For the finished device, it meets the defined performance requirements through bench testing." (Implies compliance with the listed ISO standards). |
| Biocompatibility | Compliance with ISO 10993-1 for indirectly contacting patients, contact duration ≤24h.
Specific tests: - In Vitro Cytotoxicity (ISO10993-5: 2009)
- Skin Sensitization (ISO10993-10: 2010)
- Intracutaneous Reactivity Test (ISO10993-10: 2010) | "The new device complies with the biocompatibility requirement defined in ISO10993-1. The verification test shows that the new devices comply with the biocompatibility requirement defined in ISO10993-1, the same as the predicate device. All of the pre-determined acceptance criteria were met." |
| Sterility | Sterilization conducted per ISO 11135-1, ISO 11737-1, ISO 11737-2, ISO 10993-7, ANSI/AAMI ST72.
Sterility Assurance Level (SAL): 10-6.
Residuals: - EO Residual: ≤ 4.0 mg/device
- ECH Residuals: ≤ 9.0 mg/device
Sterility Test Result: 0 Positives
Pyrogenicity Test: Temperature rise must meet standard
Endotoxin Test (Gel-Clot Limit Test):
§ 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.