(69 days)
No
The device description and intended use focus solely on the physical characteristics and function of a container for parenteral nutrition solutions, with no mention of AI or ML capabilities.
No
The device is a container for holding parenteral nutrition solutions and does not directly provide therapeutic benefit.
No
Explanation: The device is described as a container for compounding and storing parenteral nutrition solutions, and its function involves physical containment and material composition, not the diagnosis of a medical condition.
No
The device description clearly describes a physical container made of Ethylene Vinyl Acetate copolymer (EVA) with tubing and ports, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the compounding and storage of parenteral nutrition solutions for administration to a patient using an intravascular administration set. This is a device used in vivo (within the body) for delivering substances, not for testing samples in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description details a container for holding and delivering solutions, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is clearly intended for the preparation and delivery of therapeutic solutions, which falls under the category of medical devices used for treatment or support, not diagnosis.
N/A
Intended Use / 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.
Product codes
KPE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mixing Container was tested in accordance with current international standards for containers for intravenous injections.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
AUG - 4 2004
510(k) Summary 7.0
: 上
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
(610) 266-0500, ext. 2597 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Amy Smith, RAC
Regulatory Affairs Specialist |
| DEVICE NAME: | EVA TPN Container |
| COMMON OR USUAL
NAME: | TPN Bag |
| DEVICE
CLASSIFICATION: | I.V. Container, 21 CFR Part 880.5025, Product Code KPE |
| PREDICATE DEVICE: | K983294
Baxter Healthcare Corporation; All-in-One Container |
| DESCRIPTION: | 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
1
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.
2
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.
3
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
4
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