(86 days)
The Dual Chamber TPN Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The Dual Chamber TPN Container can be filled either by gravity or in conjunction with automated compounding equipment.
The Dual Chamber TPN (Total Parenteral Nutrition) Container is an empty, sterile pharmacy compounding container composed of ethylene vinyl acetate (EVA). The container is divided into two chambers separated by a flexible tube and rigid separator bar. Both chambers are designed to be filled via the tubing set attached to each chamber. The upper chamber is used for filling lipid emulsion. The lower chamber is used for filling other solutions such as dextrose, amino acids, and electrolytes. Additives may be introduced via the latex-free injection/medication port present on each chamber. Once both chambers are filled, the container is stored with the flexible tube and rigid separator bar in place until the time of administration to the patient. At the time of patient use, the flexible tube and rigid separator bar are removed and the contents of the two chambers are combined. The contents are then administered to the patient using an intravascular administration set which is connected via the set port located on the lower chamber. The Dual Chamber TPN Container will be offered in three sizes: 1500 mL, 3000 mL, and 4000 mL.
This document is a 510(k) summary for the B. Braun Medical Inc. Dual Chamber TPN Container. It describes the device, its intended use, and substantial equivalence to predicate devices. It also states that the device was subjected to various tests, but it does not provide acceptance criteria or detailed study results.
Therefore, I cannot provide the requested information regarding acceptance criteria, specific device performance against those criteria, or details of a study that proves the device meets such criteria because this information is not present in the provided text.
Here's a breakdown of what can be extracted or deduced:
1. A table of acceptance criteria and the reported device performance
- Information Not Found: The document states that "The Dual Chamber TPN Container was subjected to a variety of tests to demonstrate substantial equivalence... The following tests were conducted: biocompatibility, functional performance, package integrity, shipping, impermeability to microorganisms, and chemical testing." However, it does not list specific acceptance criteria for these tests, nor does it report the device's performance against any such criteria.
2. Sample sized used for the test set and the data provenance
- Information Not Found: The document mentions that tests were conducted but does not specify sample sizes or data provenance (e.g., country of origin of data, retrospective or prospective nature of studies).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Information Not Found: This information is not relevant to the type of device (a medical container) or the type of evaluations described (biocompatibility, functional performance, etc.), which do not typically involve expert readers for ground truth establishment.
4. Adjudication method for the test set
- Information Not Found: Adjudication methods are not applicable to the types of engineering and materials tests described for this device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- Information Not Found: An MRMC comparative effectiveness study is not applicable to an empty medical container. These studies are typically used for diagnostic devices with human interpretation of images or other data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Not Found: This device is a passive medical container; there is no "algorithm" or standalone performance in the sense of AI.
7. The type of ground truth used
- Information Not Found: The concept of "ground truth" as typically used in the context of diagnostic device evaluation (e.g., pathology, outcomes data) does not apply to the evaluation of a medical container. The evaluations performed (biocompatibility, functional performance, etc.) rely on established scientific and engineering standards and methods.
8. The sample size for the training set
- Information Not Found: This concept is not applicable as there is no "training set" for an empty medical container.
9. How the ground truth for the training set was established
- Information Not Found: This concept is not applicable for the reasons mentioned above.
In summary: The provided 510(k) summary indicates that tests were conducted for the Dual Chamber TPN Container to demonstrate substantial equivalence and safety/effectiveness (biocompatibility, functional performance, package integrity, shipping, impermeability to microorganisms, and chemical testing). However, it does not provide the detailed results, acceptance criteria, or methodological specifics (like sample sizes or the involvement of human experts/ground truth establishment) that would be needed to answer your questions comprehensively. These details are typically contained in the full 510(k) submission, not the public summary.
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K07-3538
ge 1 of 2
MAR 1 2 2008
510(k) Summary 5.
SUBMITTER:
B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341
Contact: Tracy Maddock, RAC Regulatory Affairs Analyst Phone (610) 596-2240 Fax (610) 266-4962 E-mail: tracy.maddock(@bbraun.com
DEVICE NAME:
Dual Chamber TPN Container
TPN Bag
COMMON OR USUAL NAME:
DEVICE CLASSIFICATION:
PREDICATE DEVICE:
DESCRIPTION:
I.V. Container Class II, CFR Title 21 § 880.5025
B. Braun EVA TPN Container (K041415) Churchill Medical Dual Chamber Empty Container (K041038)
The Dual Chamber TPN (Total Parenteral Nutrition) Container is an empty, sterile pharmacy compounding container composed of ethylene vinyl acetate (EVA). The container is divided into two chambers separated by a flexible tube and rigid separator bar. Both chambers are designed to be filled via the tubing set attached to each chamber. The upper chamber is used for filling lipid emulsion. The lower chamber is used for filling other solutions such as dextrose, amino acids, and electrolytes. Additives may be introduced via the latex-free injection/medication port present on each chamber. Once both chambers are filled, the container is stored with the flexible tube and rigid separator bar in place until the time of administration to the patient.
At the time of patient use, the flexible tube and rigid separator bar are removed and the contents of the two chambers are combined. The contents are then administered to the patient using an intravascular administration set which is connected via the set port
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K073538 page 2 of 2
located on the lower chamber. The Dual Chamber TPN Container will be offered in three sizes: 1500 mL, 3000 mL, and 4000 mL.
INTENDED USE:
SUBSTANTIAL EQUIVALENCE:
The Dual Chamber TPN Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The Dual Chamber TPN Container can be filled either by gravity or in conjunction with automated compounding equipment.
The B. Braun Medical Inc. Dual Chamber TPN Container has the same indications for use, similar materials of construction and similar manufacturing processes as the B. Braun EVA TPN Container, covered under K041415.
The B. Braun Medical Inc. Dual Chamber TPN Container has similar indications for use and is similar in design to the predicate device, the Churchill Medical Dual Chamber Empty Container, covered under K041038.
The Dual Chamber TPN Container was subjected to a variety of tests to demonstrate substantial equivalence with the two predicate devices and to demonstrate the safety and effectiveness of the proposed device. The following tests were conducted: biocompatibility, functional performance, package integrity, shipping, impermeability to microorganisms, and chemical testing.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with outstretched arms, representing care and protection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tracy Maddock Regulatory Affairs Analyst B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109
MAR 12 2008
Re: K073538
Trade/Device Name: Dual Chamber TPN Container Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: December 14, 2007 Received: December 17, 2007
Dear Ms. Maddock:
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 - Ms. Maddock
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/industry/support/index.html.
Sincerely yours,
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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K0 73538
Indications for Use Statement 4.
| Page | 1 of 1 |
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510(k) Number (if known):
Device Name:
Dual Chamber TPN Container
Indications For Use:
The Dual Chamber TPN Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The Dual Chamber TPN Container can be filled either by gravity or in conjunction with automated compounding equipment.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony D. m
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k-973538
11
§ 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).