CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER

K041038 · Churchill Medical Systems, Inc. · KPE · Dec 21, 2004 · General Hospital

Device Facts

• Record ID: K041038
• Device Name: CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
• Applicant: Churchill Medical Systems, Inc.
• Product Code: KPE · General Hospital
• Decision Date: Dec 21, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5025
• Device Class: Class 2

Intended Use

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

Device Story

Sterile, single-use, non-invasive dual-chamber container for total parenteral nutrition (TPN) solutions; horizontally divided into two chambers for storage of amino acid/dextrose mixtures and lipid emulsions. Pharmacy fills chambers; additive medication introduced via non-latex injection port. Divider/seal (cylindrical rod with 'U' shaped piece) creates compression seal to keep chambers separate. At administration, user peels external seal to remove divider, allowing fluids to mix; combined solution dispensed to patient via secondary set. Used in pharmacy and clinical settings; operated by pharmacy staff and clinicians. Benefits include safe storage and controlled mixing of TPN components prior to patient delivery.

Clinical Evidence

Bench testing only. Testing included compression seal integrity (20 lbs for 10 minutes), leakage testing, and ETO residual analysis (AAMI TIR 19).

Technological Characteristics

Extruded non-DEHP vinyl container; HDPE and Kraton rubber divider/seal components. Compression seal mechanism. 1500 ml total volume. ETO sterilized (residuals: ETO <2mg, ECH <25ppm, EG <500ppm). Non-pyrogenic fluid pathway.

Indications for Use

Indicated for compounding, storage, and administration of total parenteral nutrition (TPN) solutions in patients requiring parenteral nutrition.

Regulatory Classification

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.

Predicate Devices

• Dual Chamber Empty Container (K960581)
• Dual Chamber Empty Container (K911567)
• Two Chamber Container (K020485)
• Vitamix Container (K072464)

Submission Summary (Full Text)

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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:

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

> 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

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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".

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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 [phone]. 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 [phone] or [phone] 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.

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