Churchill Medical Dual Chamber Empty Container is intended for indiodions For Society, and administration of total parenteral nutrition ( TPN ) solutions.

Device Description

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.

AI/ML Overview

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.

Summary

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K041038
1 of 4

DEC 21 2004

Abbreviated 510(k): Device modification Vitalmix empty container Rev. 1 June 25, 2004

510(k) Summary

Submitted by:

Keith Paluch Consultant Churchill Medical Systems 87 Venture Drive Dover, NH 03820

Proposed Device:

Dual Chamber Empty Container

Product Classification:

C.F.R. 880.5025 Product code: KPE Class II

FDA registration number:

1223004

Predicate Devices:

510(k)	Name	Manufacturer
K960581	Dual Chamber Empty Container	Secure Medical Products
K911567	Dual Chamber Empty Container	Stedim Inc.
K020485	Two Chamber Container	Baxter Healthcare Corp.
K072464	Vitamix Container1	Pacific Device

Device Description:

Churchill Medical Systems Abbreviated 510(k) submission Device modification K972464 Rev1 June 25, 2004

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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.

Image /page/1/Picture/3 description: The image shows a close-up of a container with a cylindrical rod and a "U" shaped piece over it. The container is captured between a divider or seal. The cylindrical rod is positioned on top of the container, and the "U" shaped piece is placed over the rod. The image provides a detailed view of the container's components and their arrangement.

Image /page/1/Figure/4 description: The image shows the text "Fig. 1" in a simple, sans-serif font. The text is black and appears to be against a white background. The text is likely a figure label from a document or publication.

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.

Churchill Medical Systems Abbreviated 510(k) submission Device modification K972464 Rev1 June 25, 2004

1(041035

2.84

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Image /page/2/Figure/0 description: This image shows a proposed medical device. The device is labeled as a "Dual Chamber Empty Container" by Churchill Medical Systems. The image also shows labels for the "Pharmacy fill port", "Additive Injection site", "Divider/seal", "Patient connection", and "Clamp".

Churchill Medical Systems Abbreviated 510(k) submission Device modification K972464 Rev1 June 25, 2004

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Information On the Device Specifications:

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 container must not leak either internally or externally when filled with fluid r ne ountainer mas ompressive force of 20 pounds for a minimum of 10 minutes.

The container must mix freely when the divider/seal is removed.

The device is ETO sterilized. ETO residuals specified as less than 2mg (AAMI TIR 19) ETO residual ECH is less than 25ppm. EG is less than 500ppm.

Non- pyrogenic fluid path way.

Comparison to predicate device:

Similarities3

Proposed and all predicate devices have the same indications for use.

Proposed and predicate devices are manufactured from non-DEHP vinyl extruded roll stock.

All devices use familiar and interchangeable pharmacy connectors and needle access injection sites.

Proposed and predicate device are ETO sterilized.

Proposed and predicate devices are 1500 ml in total volume.

Proposed and predicate have similar divider/seal and are

manufactured in HDPE and Kraton rubber.

Instructions for use are similar.

Proposed and predicate devices are sterile and non-pyrogenic.

Differences 4: K972464 is a single chamber device.

Churchill Medical Systems Abbreviated 510(k) submission Device modification K972464 Rev1 June 25, 2004

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes extending from its head, all enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2004

Mr. Keith Paluch Consultant Churchill Medical Systems, Incorporated 87 Venture Drive Enterprise Park Dover. New Hampshire 03820

Re: K041038

Trade/Device Name: Churchill Medical Dual Chamber Empty Container Regulation Number: 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: November 24, 2004 Received: December 8, 2004

Dear Mr. Paluch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Paluch

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Carls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K041038

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__Churchill Medical Dual Chamber Empty Container

Indications For Use: Churchill Medical Dual Chamber Empty Container is intended for indiodions For Society, and administration of total parenteral nutrition ( TPN ) solutions.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

inting D.h.

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Ocentral, Dental Devices Division of Anesthesions of Anestion Control.

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Kay 438 510(k) Number:_

Regulation Number and Section

§ 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).