(15 days)
Not Found
No
The summary describes a simple container for parenteral nutrition solutions and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
A therapeutic device actively treats or diagnoses a disease or condition. This device is an empty container for compounding and storing solutions, which is a supportive role in patient care rather than a direct therapeutic function.
No
The device is described as a container for compounding and storage of parenteral nutrition solutions. There is no indication that it is used to identify or analyze diseases or conditions, which are the functions of a diagnostic device.
No
The device description explicitly states it is an "empty EVA (Ethylene Vinyl Acetate) container," which is a physical hardware component.
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 intravascular administration to a patient. This is a process related to preparing and delivering medication directly into the bloodstream, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The device is an empty container for holding solutions. It doesn't perform any diagnostic testing or analysis of biological samples.
- Lack of IVD Characteristics: The description doesn't mention any features or functions typically associated with IVDs, such as analyzing blood, urine, tissue, or other bodily fluids, or using reagents for diagnostic purposes.
Therefore, the All-In-One Container falls outside the scope of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The All-In-One Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.
Product codes (comma separated list FDA assigned to the subject device)
KPE
Device Description
The All-In-One Container is an empty EVA (Ethylene Vinyl Acetate) container intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.
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)
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Traditional 510(k) Premarket Notification All-In-One Container
11:12 PM
Section 5, 510(k) Summary
న్నారు.
KORDAL 1822
5. 510(k) SUMMARY
December 12, 2008
OWNER:
باب تيان لا
i
JAN 3 0 2009
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Nanette Hedden Sr. Manager, Global Regulatory Affairs 1620 Waukegan Road McGaw Park, IL 60085 Telephone: (847) 270-4871 Fax: (847) 785-5116
DEVICE NAME:
Trade name: All-In-One Container Name
| Code number | Size | Name |
|---|---|---|
| 2B8114 | 1000 mL | All-In-One Empty Container, (Three Lead Transfer Set) |
| 2B8124 | 2000 mL | All-In-One Empty Container, (Three Lead Transfer Set) |
| 2B8134 | 3000 mL | All-In-One Empty Container, (Three Lead Transfer Set) |
| 2B8144 | 4000 mL | All-In-One Empty Container, (Three Lead Transfer Set) |
| 2B8112 | 1000 mL | All-In-One Empty Container, (Single Lead Transfer Set) |
| 2B8122 | 2000 mL | All-In-One Empty Container, (Single Lead Transfer Set) |
| 2B8132 | 3000 mL | All-In-One Empty Container, (Single Lead Transfer Set) |
| 2B8142 | 4000 mL | All-In-One Empty Container, (Single Lead Transfer Set) |
| 2B8152 | 500 mL | All-In-One Empty Container, (Single Lead Transfer Set) |
| 2B8172 | 250 mL | All-In-One Empty Container, (Single Lead Transfer Set) |
Table 5-1. Product Codes for All-In-One Container
2
1
۲۰۴ ﺗﺎ ۱۰۰
Image /page/1/Picture/2 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The top line seems to read 'K090096', while the bottom line reads '2011'. The handwriting is somewhat stylized, with some characters being more distinct than others.
Traditional 510(k) Premarket Notification All-In-One Container
Section 5, 510(k) Summary
Common Name: Compounding Container
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Classification Name: Intravenous Container (21 CFR 880.5025, Product Code KPE)
Predicate Device:
Table 5-2. Predicate Device
| Device | Company | Previous 510(k) | Clearance date |
|---|---|---|---|
| Modified All-In-One Container | Baxter | ||
| Healthcare | K983294 | November 3, | |
| 1998 |
DESCRIPTION OF THE DEVICE:
The All-In-One Container is an empty EVA (Ethylene Vinyl Acetate) container intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.
STATEMENT OF INTENDED USE:
The All-In-One Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The All-In-One Container is substantially equivalent to Baxter's current legally marketed All-In-One Container cleared November 3, 1998 (K983294).
DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use.
CONCLUSION:
The All-In-One Container is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Baxter Healthcare Corporation C/o Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
JAN 3 0 2009
Re: K090096
Trade/Device Name: All-In-One Container Regulation Number: 21 CFR 880.5025 Regulation Name; I.V. Container Regulatory Class: II Product Code: KPE Dated: January 15, 2009 Received: January 15, 2009
Dear Mr. Devine:
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.
3
Page 2 - Mr. Devine
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Anthony D. ask for
Ginette Y. Michaud, M.D. Acting 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
11:22:
510(k) Number (if known):
Device Name: All-In-One Container
Indications for Use:
1 / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /
The All-In-One Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
મન્તરમાન
1
.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K090090 510(k) Number: