(27 days)
No
The device description focuses on the physical characteristics and function of a fluid container for TPN, with no mention of software, algorithms, or AI/ML capabilities.
No
This device is a container for compounding, storing, and administering total parenteral nutrition (TPN) solutions, not the therapeutic agent itself.
No
The device is described as a container for compounding, storage, and administration of TPN solutions, and its function involves holding and mixing fluids. It does not perform any disease diagnosis or patient monitoring functions.
No
The device description clearly indicates it is a physical container used for compounding, storage, and administration of TPN solutions, which is a hardware medical device.
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, storage, and administration of total parenteral nutrition (TPN) solutions." This describes a device used for preparing and delivering a medical treatment (nutrition) to a patient.
- Device Description: The description details a container for holding and mixing solutions that will be administered to a patient. It's a physical container for a therapeutic substance.
- Lack of Diagnostic Function: There is no mention of the device being used to test a sample from the human body to provide information about a physiological state, health, or disease. IVDs are used for diagnostic purposes, such as analyzing blood, urine, or tissue samples.
This device falls under the category of a medical device used for the preparation and delivery of a therapeutic substance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The All-In-One® Two Chamber Container is intended for the compounding, storage, and administration of total parenteral nutrition (TPN) solutions.
Product codes
KPE
Device Description
The All-In-One® Two Chamber Container is a sterile non-invasive fluid container used for compounding, storage and administration of total parenteral nutrition (TPN) solutions. It is an empty single use, disposable I.V. container that is vertically divided into two chambers. The left chamber is intended to store lipid emulsions. The right chamber is intended to store amino acid/dextrose admixtures. Additives may be added via the non-latex medication injection port located at the bottom of the left chamber. The chambers are designed to be filled with a total parenteral nutrition (TPN) solution by a pharmacy operation.
The contents of the container are intended to be stored with the seal intact (i.e., not broken) until the time of use (administration to the patient).
At the time of use, the contents of the two chambers are combined/mixed by opening the vertical peel-seal that runs along the inside of the container. The mixed contents of the container are then dispensed to the patient though a secondary administration set (i.e., a separate medical device that is not the subject of this submission).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
All-In-One® Two Chamber Container, cleared under premarket notification K945193
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
510(K) SUMMARY
Submitted by:
K 020485
Mary Konkowski Senior Regulatory Affairs Associate Baxter Healthcare Corporation Medication Delivery Division, Regulatory Affairs Route 120 and Wilson Road Round Lake, IL 60073
Proposed Device:
All-In-One® Two Chamber Container
Predicate Device:
All-In-One® Two Chamber Container, cleared under premarket notification K945193, May 12, 1995
Device Description and Statement of Intended Use:
The All-In-One® Two Chamber Container is intended for the compounding, storage, and administration of total parenteral nutrition (TPN) solutions.
The All-In-One® Two Chamber Container is a sterile non-invasive fluid container used for compounding, storage and administration of total parenteral nutrition (TPN) solutions. It is an empty single use, disposable I.V. container that is vertically divided into two chambers. The left chamber is intended to store lipid emulsions. The right chamber is intended to store amino acid/dextrose admixtures. Additives may be added via the non-latex medication injection port located at the bottom of the left chamber. The chambers are designed to be filled with a total parenteral nutrition (TPN) solution by a pharmacy operation.
The contents of the container are intended to be stored with the seal intact (i.e., not broken) until the time of use (administration to the patient).
At the time of use, the contents of the two chambers are combined/mixed by opening the vertical peel-seal that runs along the inside of the container. The mixed contents of the container are then dispensed to the patient though a secondary administration set (i.e., a separate medical device that is not the subject of this submission).
1
Summary of Technological Characteristics of New Device to Predicate Device
The technological characteristics of the modified All-In-One® Two Chamber Container do not differ significantly from the currently marketed All-In-One® Two Chamber Container. The devices utilize the same fundamental scientific technology and have the same intended use.
Discussion of Non-Clinical Tests; Conclusions Drawn from Nonclinical Tests
The results of testing conducted to verify the design modifications demonstrate acceptable performance of the device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2002
Ms. Mary Konkowski Senior Regulatory Affairs Associate Baxter Healthcare Corporation Rt. 120 & Wilson Road Round Lake, Illinois 60073
Re: K020485
Trade/Device Name: All-In-One® Two Chamber Container Regulation Number: 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: February 11, 2002 Received: February 13, 2002
Dear Ms. Konkowski:
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.
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.
3
Page 2 - Ms. Konkowski
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 and instills (2) Creating 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
Device Trade Name:
All-In-One® Two Chamber Container
Indication for Use:
The All-In-One® Two Chamber Container is intended for the compounding, storage, and administration of total parenteral nutrition (TPN) solutions.
Patrica Cuscente
(Division Sign-Off) (Division of Dental, Intection Control, Division Hospital Devices
510(k) Number K020485
S:\510K\TWOCHAMBAG\COVERLETTER.DOC
Baxter Confidential FEB. 1 1. 2002 *
038 .