(69 days)
The EVA TPN container is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The EVA TPN container can be filled either by gravity or in conjunction with automated compounding equipment.
The EVA TPN container is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The EVA TPN container can be filled either by gravity or in conjunction with compounding equipment. The EVA TPN container is composed of Ethylene Vinyl Acetate copolymer (EVA). The containers will be available as a single chamber bag in two configurations. One configuration will be used for filling the container by gravity. The second configuration is for use with a B. Braun Medical Inc. compounder. The containers will range in volume capacity from 250mL - 4000mL. The gravity containers can be filled using standard admixture products (spikes, tubing), and clamped after filling. The container for use with the compounder will have an adapter unique to the compounder. The tubing is composed of a DEHP-free polyvinyl chloride material. Additional medications can be added to the gravity or compounder container using the medication port. After filling, the container can then be attached to an intravascular administration set via the set port.
The provided text is a 510(k) summary for the EVA TPN Container. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for a novel device. As such, several of the requested categories of information are not present in the document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or provide a table of performance metrics. It relies on the claim of "similar indications for use, materials of construction, labeling and sterilization methods as the predicate device" and that the "Mixing Container was tested in accordance with current international standards for containers for intravenous injections." No specific performance data or test results are provided.
2. Sample Size Used for the Test Set and Data Provenance:
Not specified. The document states "Mixing Container was tested in accordance with current international standards," but no details on sample size, test sets, or data provenance (country of origin, retrospective/prospective) are given for this testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a medical container, not an AI or diagnostic device that requires expert adjudication for ground truth.
4. Adjudication Method for the Test Set:
Not applicable for a medical container.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI/diagnostic device.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is not an AI/diagnostic device.
7. Type of Ground Truth Used:
Not applicable in the typical sense for a hardware device. The "ground truth" would be the performance against established international standards for containers for intravenous injections.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/model-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of available information related to acceptance and study:
The core of the submission for the EVA TPN Container is demonstrating substantial equivalence to a predicate device, the K983294 Baxter Healthcare Corporation; All-in-One Container. The "study" referenced is the testing of the "Mixing Container... in accordance with current international standards for containers for intravenous injections."
The acceptance criteria, in this context, are implicitly met by demonstrating that the new device is substantially equivalent to a legally marketed predicate device and complies with relevant international standards. The document explicitly states: "There are no differences between the B. Braun Medical Inc. EVA TPN Mixing Container and the predicate device that raise new issues of safety and effectiveness." This statement serves as the primary "proof" that the device meets the implied acceptance criteria for safety and effectiveness through substantial equivalence.
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AUG - 4 2004
510(k) Summary 7.0
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| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2597 |
|---|---|
| Contact: Amy Smith, RACRegulatory Affairs Specialist | |
| DEVICE NAME: | EVA TPN Container |
| COMMON OR USUALNAME: | TPN Bag |
| DEVICECLASSIFICATION: | I.V. Container, 21 CFR Part 880.5025, Product Code KPE |
| PREDICATE DEVICE: | K983294Baxter Healthcare Corporation; All-in-One Container |
| DESCRIPTION: | The EVA TPN container is for use in compounding andstorage of parenteral nutrition solutions prior to and duringadministration to a patient using an intravascularadministration set. The EVA TPN container can be filledeither by gravity or in conjunction with compoundingequipment. |
| The EVA TPN container is composed of Ethylene VinylAcetate copolymer (EVA). The containers will be availableas a single chamber bag in two configurations. Oneconfiguration will be used for filling the container bygravity. The second configuration is for use with a B.Braun Medical Inc. compounder. The containers will rangein volume capacity from 250mL - 4000mL. The gravitycontainers can be filled using standard admixture products(spikes, tubing), and clamped after filling. The containerfor use with the compounder will have an adapter unique tothe compounder. The tubing is composed of a DEHP-freepolyvinyl chloride material. Additional medications can beadded to the gravity or compounder container using the |
medication port. After filling, the container can then be
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attached to an intravascular administration set via the set port.
INTENDED USE:
The EVA TPN container is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.
SUBSTANTIAL EQUIVALENCE:
The B. Braun Medical Inc. EVA TPN Mixing Container has similar indications for use, materials of construction, labeling and sterilization methods as the predicate device, The EVA TPN Baxter All-in-One Mixing Container. Mixing Container was tested in accordance with current international standards for containers for intravenous injections.
There are no differences between the B. Braun Medical Inc. EVA TPN Mixing Container and the predicate device that raise new issues of safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three lines representing its wings and a wavy line below, possibly representing water or a ribbon.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 2004
Ms. Amy Smith, RAC Regulatory Affairs Specialist B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109
Re: K041415
Trade/Device Name: EVA TPN Container Regulation Number: 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: May 27, 2004 Received: May 27, 2004
Dear Ms. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinonens, or to as tround Cosmetic Act (Act) that do not require approval of a premarket the Federal I vou, Drag, das Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provinces or 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 (1 wr t), it may of our 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. Smith
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that 12 a determination that your device complies with other requirements mount that I DA nas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal butates and reguirements, including, but not limited to: registration 1 ou mast comply with an all the Process (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), labling (21 CFR Part 820) regulation (21 CFR Part 820); and if requirements as set form in are quartify ion 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) This letter will anow you to ough finding of substantial equivalence of your device to a promatics notification. - The PDF 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), If you desire specific at 100 los your we at (301) 594-4618. 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 may obtain 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 yours,
Q
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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Indications for Use Statement 2.0
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
EVA TPN Container Device Name:
Indications For Use:
The EVA TPN container is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The EVA 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)
Cintia D mo
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: كالة | الأوروب | الأوروب
§ 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).