(164 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical valve component for IV sets and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
This device is a valve intended for use with solution administration sets for fluid administration or withdrawal, not a device that directly treats a medical condition.
No
The device is described as a valve for administering drugs and solutions, or for fluid withdrawal, within an administration set. It does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or health condition.
No
The device description clearly describes a physical component, a "capped luer activated valve," which is intended to be incorporated into existing hardware (solution sets). There is no mention of software as the primary or sole component of the 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 administration and withdrawal of drugs and solutions to and from a patient's vascular access device. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic purposes in vivo.
- Device Description: The device is a valve incorporated into solution administration sets, designed to connect to syringes or other sets for fluid transfer. This function is related to delivering or removing substances from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed for testing samples outside the body. This device is designed for use within the body's circulatory system.
N/A
Intended Use / Indications for Use
Baxter solution administration sets with capped luer activated valve are intended for use with a vascular access device for the administration of drugs and solutions. The capped luer activated valve will replace the Y-injection site on the set. The valve can be connected to standard male luer adapters (e.g., syringes or sets), for continuous or intermittent fluid administration or the withdrawal of fluids.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The subject of this submission is a capped luer activated valve which Baxter intends to incorporate into currently marketed solution sets. The capped luer activated valve will replace the Y-injection site on the set for continuous or intermittent fluid administration or the withdrawal of fluids. The normally closed valve is opened by removing the cap and inserting a standard male luer adapter such as on syringes or sets to the female end of the valve automatically closes when the male luer is disconnected. The valve is intended to be capped when not in use.
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)
Data regarding the functional performance of the proposed capped luer activated valve have been generated. A description of the functional testing along with test results has been provided. The data indicate that the proposed valve meets or exceed all functional requirements and support its suitability for use in Baxter solution administration sets.
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.
Abbott I.V. Sets with Capped Reflux Valve Port
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
K 974571
MAY 21 1998 510(k) SUMMARY
Solution Administration Sets with Capped Luer Activated Valve
Submitted by:
Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared:
December 5, 1997
Proposed Device:
Solution Administration Sets with Capped Luer Activated Valve
Predicate Device:
Abbott I.V. Sets with Capped Reflux Valve Port
Proposed Device Description:
The subject of this submission is a capped luer activated valve which Baxter intends to incorporate into currently marketed solution sets. The capped luer activated valve will replace the Y-injection site on the set for continuous or intermittent fluid administration or the withdrawal of fluids. The normally closed valve is opened by removing the cap and inserting a standard male luer adapter such as on syringes or sets to the female end of the valve automatically closes when the male luer is disconnected. The valve is intended to be capped when not in use.
Statement of Intended Use:
Baxter solution administration sets with capped luer activated valve are intended for use with a vascular access device for the administration of drugs and solutions. The capped luer activated valve will replace the Y-injection site on the set. The valve can be connected to standard male luer adapters (e.g., syringes or sets), for continuous or intermittent fluid administration or the withdrawal of fluids.
1
Summary of Technological Characteristics of New Device to Predicate Devices
Baxter sets with the proposed valve are identical to currently marketed Baxter sets except for the change from a Y-injection site to a capped T-shaped luer activated valve. All other components of the solution administration sets remain unchanged. The T-shaped valve is very similar to the Y-shaped valve contained in currently marketed Abbott IV solution sets. The main difference between the proposed Tshaped valve and the currently marketed Y-shaped valve are the material and geometry of the valve housing.
Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature
Data regarding the functional performance of the proposed capped luer activated valve have been generated. A description of the functional testing along with test results has been provided. The data indicate that the proposed valve meets or exceed all functional requirements and support its suitability for use in Baxter solution administration sets.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a series of abstract shapes resembling a bird or a stylized human figure. The text is in all caps.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Ellen Synder Requlatory Affairs Manager Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073
MAY 21 1998
K974571 Re : Solution Administration Set with Capped Luer Trade Name: Activated valve Regulatory Class: II Product Code: FPA Dated: May 12, 1998 May 13, 1998 Received:
Dear Ms. Synder:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Praction (requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Ms. Snyder
through 542 of the Act for devices under the Electronic chrough 542 or the not all provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA debtriaca in your six (x) puivalence of your device to a legally rinding of bubbeancear equite in a classification for your markets produce 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to ene regardon" (21CFR 807.97). 1 Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeation 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
Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure______
4
K 974571
510(k) Premarket Notification Solution Administration Sets with Capped Luer Activated Valve
Not Available 510(k) Number:
Solution Administration Sets with Capped Luer Activated Valve Device Name:
Indication for Use:
Baxter solution administration sets with capped luer activated valves are intended for use with a vascular access device for the administration of drugs and solutions. The capped luer activated valve will replace the Y-injection site on the set. The valve can be connected to standard male luer adapters (e.g., syringes or sets), for continuous or intermittent fluid administration or the withdrawal of fluids.
Patricio Escosete
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K974571
Prescription Use
(Per 21 CFR 801.109)
s:\510k\lavcov.doc