(43 days)
No
The device description and performance studies focus on the physical properties and compatibility of a cap, with no mention of AI or ML.
No
Explanation: The device is an additive cap used to provide visual evidence that medication has been added to containers, not for treating a disease or condition.
No
Explanation: The device, an "Additive Cap," is described as providing "visual evidence that medication has been added" to IV containers. Its function is to visually indicate an action (medication addition), rather than to diagnose a medical condition or disease. The performance data focuses on mechanical aspects like removal force, not diagnostic accuracy.
No
The device description clearly states it is a physical "Additive Cap" made of material with a specific design, intended to be placed on a medication port. This is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide visual evidence that medication has been added to IV containers. This is a physical function related to the administration of medication, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a cap for a medication port. It is non-fluid path and non-sterile. This aligns with a device used in the process of administering medication, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device's function is purely mechanical and visual, serving as an indicator during medication preparation. This falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Additive Cap is indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added.
Product codes
KPE
Device Description
The subject of this submission is an Additive Cap which will be indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added. The material and design of the cap are not changing. The proposed Additive Cap will continue to be non-fluid path and non-sterile. The only change is a label modification to expand the indications for use statement to identify compatibility with an additional I.V. container (AVIVA). The device is marketed as a stand-alone device and is packaged in bulk.
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
A protocol was conducted to evaluate the force to remove the Additive Cap from the medication port when used with AVIVA and VIAFLEX containers.
Key Metrics
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
JUN 1 4 2011
5. 510(k) SUMMARY
March 25, 2010
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Nanette Hedden Senior Manager, Global Regulatory Affairs 1620 Waukegan Road McGaw Park, IL, 60085 Telephone: (847) 270-4871 Fax: (847) 785-5116
DEVICE NAME:
Trade name: Additive Cap
Common name: Additive Cap
Classification name: Container I.V., 21 CFR 880.5025, KPE, Class II
PREDICATE DEVICE:
Table 5-1. Previous 510(k)s
| Device | Company | Previous 510(k) | Clearance date |
|---|---|---|---|
| Additive Cap | Baxter Healthcare | K760880 | December 30, 1976 |
1
DESCRIPTION OF THE DEVICE:
The subject of this submission is an Additive Cap which will be indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added. The material and design of the cap are not changing. The proposed Additive Cap will continue to be non-fluid path and non-sterile. The only change is a label modification to expand the indications for use statement to identify compatibility with an additional I.V. container (AVIVA). The device is marketed as a stand-alone device and is packaged in bulk.
STATEMENT OF INTENDED USE:
Additive Cap is indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The Additive Cap is an injection molded, polypropylene component. The intended use and function of the proposed Additive Cap is identical to the predicate device. The material and design of the cap are not changing. The proposed Additive Cap will continue to be non-fluid path and non-sterile. The only change is a label modification to expand the indications for use statement by adding compatibility with the AVIVA container.
Performance Data: A protocol was conducted to evaluate the force to remove the Additive Cap from the medication port when used with AVIVA and VIAFLEX containers.
Biocompatibility: The subject device does not contact the patient's body directly or indirectly. Baxter assessed the biocompatibility testing requirements for the device based on FDA Blue Book Memorandum G-95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and internal Baxter procedures. Based on this assessment, a biocompatibility assay for the Additive Cap was performed per test method described in Biological Evaluation of Medical Devices ISO 10993-5: Tests for cytotoxicity: in vitro methods. The polypropylene material used to mold the Additive Cap was determined to be biocompatible and appropriate for its intended use.
2
DISCUSSION OF NONCLINICAL TESTS:
All test results meet the acceptance criteria and support that the device is appropriately designed for the intended use.
CONCLUSION:
The Additive Cap is substantially equivalent to Baxter's current legally marketed Additive Cap, cleared December 30, 1976 (K760880).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a wavy line forming the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 4 2011
Ms. Nanette Hedden Senior Manager Baxter Healthcare Corporation Medical Products 1620 Waukegan Road McGaw Park, Illinois 60085
Re: K111217
Trade/Device Name: Additive Cap Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. Container Regulatory Class: II Product Code: KPE Dated: June 6, 2011 Received: June 8, 2011
Dear Ms. Hedden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Ms. Hedden
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
An Thuong, D. Nhatban
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): ¥ | | 乙 | 7
Device Name: Additive Cap
Indications for Use:
Additive Cap is indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Acting for
RICHARD CHAPMAN
(Division Sign-Off) (Division ച്ചുറ-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Infection Control, Dental Devices
510(k) Number: K111217