(129 days)
Enteral Pump Syringe delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow.
Enteral Pump Syringe is intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump.
Enteral Pump Syringe is intended for neonatal, pediatric and adult use.
Enteral Pump Syringe is single use device.
The proposed device is modified device of K190502(ENFit Oral/Enteral Syringe,cleared July 2, 2019) according to 21CFR 820.30. The change is a operation mode change from manual use to use with infusion pump.
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml to 60ml. The ENFit enteral feeding syringe consists of moveable plunger, piston, calibrated hollow barrel and tip cap(not necessary). At the distal end of the barrel is a female connector, designed according to ISO 80369-3 (often referred to as an ENFit connection). The tip is designed to mate only with enteral administration devices and is incompatible with Luer connectors. The device is used to deliver fluids into the body enterally by connected to an enteral access device with male ENFit connector. The syringes (size 6ml to 60ml) incorporate a female Standard ENFit connector; the syringes (size 1ml and 6ml) incorporate a female low dosing ENFit connector.
There are 2 types of ENFit connector ENFit syringe and central connector ENFit syringe. The sizes of the Side connector ENFit syringe range from 12ml to 60ml; and The sizes of the central connector ENFit syringe range from 1ml to 60ml. The syringes are provided with transparent or amber color barrel.
The material used of deviec are Polypropylene. Polyisoprene rubber, Polydimethysiloxane(inside surface coating of barrel ). Amber additive(for used amber color barrel only), which are also patient-contacting materials for the proposed devices. The time of contact duration is less than 24 hours. The contact level is mucosal membrane, indirect.
The proposed device is sterile or non-sterile, single use. The sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
The proposed device intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals. The device has no energy in itself. But the syringe works with infusion pump and extension sets.The syringe is aspirated nutritional formula liquid, connected the extension set. Then user installed it on the infusion pump, and pump fluids into a body enterally in a controlled manner for administer enteral nutrition. The accuracy of graduations for enteral syringes is +/- 4% of expelled volume.
This document is a 510(k) Premarket Notification for an "Enteral Pump Syringe." It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical device meets specific performance acceptance criteria through the kind of study described in the prompt. This device is a syringe, not an AI or imaging device, so the requested information regarding AI performance metrics, expert adjudication, MRMC studies, and ground truth establishment is not applicable.
Therefore, I cannot provide the requested information for an AI/imaging device. However, I can extract the information relevant to the performance and testing of this specific medical device, the Enteral Pump Syringe, as presented in the document:
Device: Enteral Pump Syringe
Context: This document is an FDA 510(k) submission, aiming to demonstrate "substantial equivalence" of the proposed device to an already legally marketed predicate device. It is not a clinical study report for an AI or imaging device.
Information that can be extracted from the provided text regarding this device's performance and testing:
1. A table of acceptance criteria and the reported device performance:
The document primarily refers to compliance with established international standards rather than specific quantitative acceptance criteria and reported performance values in a table format. The "acceptance criteria" here are the requirements of these standards.
| Standard / Characteristic | Acceptance Criteria (implied by standard compliance) | Reported Device Performance (as stated in document) |
|---|---|---|
| ISO 80369-3:2016 (Small-Bore Connectors for Enteral Applications) | Compliance with specifications for enteral connectors | "The proposed device complies with the following standards: ISO 80369-3:2016" and "These product models were tested according to ISO 80369-3." |
| ISO 80369-20:2015 (Common Test Methods for Small-Bore Connectors) | Compliance with common test methods | "The proposed device complies with the following standards: ISO 80369-20:2015" |
| ISO 7886-1:2017 (Syringes for Manual Use) | Compliance with specifications for sterile hypodermic syringes for manual use | "The proposed device complies with the following standards: ISO 7886-1:2017" and "These product models were tested according to ISO 7886-1." |
| ISO 7886-2:2020 (Syringes for use with power-driven syringe pumps) | Compliance with specifications for sterile hypodermic syringes for use with power-driven syringe pumps | "The proposed device complies with the following standards: ISO 7886-2:2020" and "These product models were tested according to ISO 7886-2." |
| ISO 10993-5:2009 (Biocompatibility - in Vitro Cytotoxicity) | No cytotoxicity | "Cytotoxicity: No Cytotoxicity" |
| ISO 10993-10:2010 (Biocompatibility - Irritation and Skin Sensitization) | No irritation, no sensitization | "Skin Irritation: No Irritation," "Sensitization: No Sensitization" |
| ISO 10993-7:2008 (Biocompatibility - Ethylene oxide sterilization residuals) | Compliance with residuals limits | "ISO 10993-7:2008" listed as a complied standard. |
| ISO 14971:2007 (Medical Devices - Application of Risk Management) | Application of risk management principles | "ISO 14971:2007" listed as a complied standard. |
| ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | Compliance with seal strength requirements | "ASTM F88/F88M-15" listed as a complied standard. |
| ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) | Compliance with seal leak detection | "ASTM F1929-15" listed as a complied standard. |
| ASTM F1886F1886M-16 (Determining Integrity of Seals for Flexible Packaging by Visual Inspection) | Compliance with visual inspection for seal integrity | "ASTM F1886F1886M-16" listed as a complied standard. |
| Graduation Accuracy (for enteral syringes) | +/- 4% of expelled volume | "The accuracy of graduations for enteral syringes is +/- 4% of expelled volume." (This is stated as a characteristic, implying it meets this.) |
| SAL (Sterility Assurance Level) | 10^-6 | "EO Sterilized to achieve a SAL of 10^-6" |
| Shelf Life | 5 years | "maintain the sterility of the device during the shelf life of five years." |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The document refers to "non-clinical tests" and "bench tests" to verify compliance with standards, but not the number of units tested.
- Data Provenance: Not specified, but likely from the manufacturer's internal testing facilities in China (Jiangsu Caina Medical Co., Ltd.). The tests are "non-clinical" (bench tests) and therefore not from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is a medical device (syringe) and not an AI or imaging device that requires expert-established ground truth from images or clinical data. The "ground truth" for this device's performance is adherence to engineering and biocompatibility standards measured through bench tests.
4. Adjudication method for the test set:
Not applicable. As above, this is not an AI/imaging device study requiring human reader 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:
Not applicable. This is not an AI-assisted device.
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.
7. The type of ground truth used:
The "ground truth" for this device's performance is established by the international and national standards it is required to meet (e.g., ISO and ASTM standards for sterility, biocompatibility, connector compatibility, and physical performance). Compliance is shown through bench tests and material characterization, not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic or prognostic devices.
8. The sample size for the training set:
Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
Not applicable. This device does not involve machine learning.
§ 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.