(243 days)
Churchill Medical Dual Chamber Empty Container is intended for indiodions For Society, and administration of total parenteral nutrition ( TPN ) solutions.
The Churchill Medical Systems Dual Chamber Empty Container is a sterile non-invasive fluid container used for compounding, storage and administration of total parenteral nutrition (TPN) solutions. This device is a sterile, single use disposable I.V. container that is horizontally divided into two chambers. The top chamber is intended for the storage of amino acid/ dextrose mixtures. The bottom chamber is intended to store lipid emulsions. Additive medication may be introduced into the bottom compartment by access through a non-latex injection port. The chambers are designed to be filled with TPN solution by a pharmacy operation. The filled container is intended to be stored with the divider/seal intact until the time of administration to the patient. At the time of patient use the divider/seal (Fig 1) is removed by peeling the external seal that separates the container top chamber from bottom chamber. The combined fluids are and then dispensed to the patient through a secondary set not included with this device. The container is made from extruded stock non-DEHP vinyl. Each chamber is provided with a Pharmacy filling port, filling port clamp, nonlatex injection site, and one patient delivery port located at the device bottom. All materials used and manufacturing processes are identical to the original All materials asou and and is a two-piece component that consists submission rod and a tightly fitting "U" shaped over piece. The of a contor synnditor and separated when the divider is placed over the exterior bag surface. The divider/seal does not contact any fluid or medication but, works to occlude the two chambers from one another by forming a compression seal when the bag is squeezed between.
The provided document describes an Abbreviated 510(k) submission for a device modification, the "Vitalmix empty container Rev. 1". This type of submission focuses on demonstrating substantial equivalence to a predicate device for a modified existing device. Therefore, a comprehensive study proving the device meets acceptance criteria in the manner of a novel device or a clinical trial is not presented. Instead, the submission relies on direct comparison to predicate devices and engineering bench testing to ensure the modifications do not alter fundamental safety and effectiveness.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Integrity: Container must not leak either internally or externally when filled with fluid under a compressive force of 20 pounds for a minimum of 10 minutes. | The document states: "The container must not leak either internally or externally when filled with fluid r [sic] ne ountainer [sic] mas [sic] ompressive force of 20 pounds for a minimum of 10 minutes." This is presented as an acceptance criterion and an inherent characteristic. While not explicitly stated as "passed" or "met in testing," the inclusion of this as a device specification implies it has been verified for the modified device. Since this is an abbreviated 510(k) for a device modification, direct testing results for this attribute are not provided in detail but are assumed to be part of the predicate device's established performance and maintained by the modification. |
| Mixing Functionality: Container must mix freely when the divider/seal is removed. | The document states: "The container must mix freely when the divider/seal is removed." Similar to the leak test, this is presented as an acceptance criterion and an inherent characteristic. The modified divider/seal design (two-piece component: a 'contor synnditor' [likely "contour cylinder"] and a tightly fitting "U" shaped over piece) suggests this function was deemed unaffected or improved by the modification, aligning with the predicate device's expected performance. |
| ETO Residuals: ETO residuals specified as less than 2 mg (AAMI TIR 19) ETO residual ECH is less than 25 ppm. EG is less than 500 ppm. | The document states these specific limits for ETO residuals. It also explicitly mentions: "Proposed and predicate devices are ETO sterilized." This indicates the modified device (and hence its materials and sterilization process) is compliant with these ETO residual specifications, likely through validated sterilization processes and testing. |
| Pyrogenicity: Non-pyrogenic fluid pathway. | The document explicitly states: "Non- pyrogenic fluid path way." and "Proposed and predicate devices are sterile and non-pyrogenic." This indicates the modified device conforms to pyrogenicity requirements, likely through testing during manufacturing. |
| Biocompatibility: Materials used (non-DEHP vinyl) | The document states: "The container is made from extruded stock non-DEHP vinyl." and "Proposed and all predicate devices are manufactured from non-DEHP vinyl extruded roll stock." This indicates the material choice is consistent with the predicate and established as biocompatible based on that history. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document focuses on device specifications and comparison to predicate devices, rather than a formal test set with a specific sample size. For an abbreviated 510(k) submission concerning a device modification, the testing would likely be bench testing on a representative number of units to confirm that the modification does not negatively impact existing specifications.
- Data Provenance: The data provenance is primarily from bench testing (implied for mechanical, ETO, and pyrogenicity criteria) and comparison to predicate devices. It is retrospective in the sense that it relies on the established safety and effectiveness of the predicate devices. The country of origin of the data is not specified but would presumably be related to where Churchill Medical Systems or its testing facilities are located (based on the Dover, NH address).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable in this context. This submission is for a medical device modification, not a diagnostic or AI-driven system requiring expert ground truth setting for a test set. The "ground truth" for the device's performance is against established engineering specifications and the performance of legally marketed predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. As above, this is an engineering assessment, not a clinical study requiring adjudication of expert interpretations. The "adjudication" is against established industry standards and FDA regulations for medical device manufacturing and performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is relevant for diagnostic devices (especially those involving image interpretation by human readers) to assess the impact of a new technology on reader performance. This device is an empty fluid container, which does not involve human readers interpreting clinical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a passive medical device (an empty container) and does not involve any algorithms or AI to be assessed for standalone performance.
7. The Type of Ground Truth Used
- The "ground truth" for this device's safety and effectiveness is largely based on:
- Engineering Specifications: Defined parameters for leak resistance, mixing, material composition, sterilization residuals, and pyrogenicity.
- Predicate Device Performance: The established safety and effectiveness profile of legally marketed predicate devices (K960581, K911567, K020485, K072464). The "substantial equivalence" argument frames the ground truth around these existing devices.
8. The Sample Size for the Training Set
- Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established for it.
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).