(29 days)
Not Found
No
The document describes a mechanical fluid administration set with a check valve and does not mention any AI or ML components or functionalities.
No.
The device is used for the administration of fluids into the vascular system, not for preventing, diagnosing, treating, or rehabilitating disease or injury.
No
The device is described as an administration set for fluids, not for diagnosing conditions. Its function is to prevent backflow during fluid administration.
No
The device description clearly details physical components (solution sets, check valve, tubing, Y-injection site housing) and materials (polyisoprene). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "the administration of fluids from a container to the patient's vascular system." This describes a device used in vivo (within the body) for delivering substances, not a device used in vitro (outside the body) for examining specimens from the body to diagnose or monitor conditions.
- Device Description: The description focuses on the mechanical function of a check valve within an infusion set, designed to control fluid flow within the administration system. This is consistent with an in vivo administration device.
- Anatomical Site: The anatomical site is the "patient's vascular system," which is an in vivo location.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a medical device used for fluid administration in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"Continu-Flo® solution sets with the proposed check valve have the same intended use as the currently marketed sets. The intended use of these sets is the administration of fluids from a container to the patient's vascular system. Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during the administration of secondary medication."
Product codes
FPA
Device Description
"The proposed Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during administration of secondary medication. The current check valve is a disc valve and is positioned in the set tubing between the drip chamber and Y-injection site. The new check valve is a duck bill valve and is positioned inside the Y-injection site housing of the set.
There is one material in the proposed check valve design which is new to Baxter devices. The valve itself will be formulated from a new polyisoprene material. The materials used on the proposed check valve cap and housing, are the same as those in use on the current check valve body and Y-injection site housing on Continu-Flo® solution sets. All other materials in the solution sets remain unchanged."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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)
"The biological and chemical reactivity of the new polyisoprene material have been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use.
Data regarding the functional performance of the proposed check valve have been generated. A description of the functional testing along with test results is provided. The data indicate that the proposed check valve meets or exceeds all functional requirements and support its suitability for use in Continu-Flo® sets."
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
§ 880.5440 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 971701
JUN - 6 1997
510(k) SUMMARY
Continu-Flo® Solution Sets with Modified Check Valve
Submitted by:
Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared:
May 7, 1997
Proposed Device:
Continu-Flo® Solution Sets with Modified Check Valve
Predicate Devices:
Continu-Flo® Solution Sets with Check Valve
Proposed Device Description:
The proposed Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during administration of secondary medication. The current check valve is a disc valve and is positioned in the set tubing between the drip chamber and Y-injection site. The new check valve is a duck bill valve and is positioned inside the Y-injection site housing of the set.
There is one material in the proposed check valve design which is new to Baxter devices. The valve itself will be formulated from a new polyisoprene material. The materials used on the proposed check valve cap and housing, are the same as those in use on the current check valve body and Y-injection site housing on Continu-Flo® solution sets. All other materials in the solution sets remain unchanged.
Statement of Intended Use:
Continu-Flo® solution sets with the proposed check valve the same intended use as the currently marketed sets. The intended use of these sets is the administration of fluids from a container to the patient's vascular system. Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during the administration of secondary medication.
MAY 0 7 1997
1
Summary of Technological Characteristics of New Device to Predicate Devices
The proposed solution sets are identical to currently marketed Continu-Flo® Solution Sets with Check Valve, previously cleared under K881052, except for the design and location change of the check valve component. The current check valve is a disc valve and is positioned in the set tubing between the drip chamber and Y-injection site. The proposed check valve is a duck bill valve and is positioned inside the Y-injection site housing of the set. All other components of the solution administration sets remain unchanged.
Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature
The biological and chemical reactivity of the new polyisoprene material have been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use.
Data regarding the functional performance of the proposed check valve have been generated. A description of the functional testing along with test results is provided. The data indicate that the proposed check valve meets or exceeds all functional requirements and support its suitability for use in Continu-Flo® sets.
2
Image /page/2/Picture/1 description: The image is a seal for 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 a stylized image of a human figure. The figure is composed of three curved lines that form the head, body, and legs. The figure is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 1997
Ms. Mary Ellen Snyder ·Manager, Regulatory Affairs Baxter Healthcare Corporation Route 120 And Wilson Road Round Lake, Illinois 60073
Re : K971701 Continu-Flo® Solution Sets with Modified Trade Name: Check Valve Requlatory Class: II Product Code: FPA Dated: May 07, 1997 Received: May 08, 1997
Dear Ms. Snyder:
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ನ್ನ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation
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Fage 2 - Ms. Snyder
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Smapl Manufacturers Assistance at its toll-free number (800) 638/2041 or at (301) 443-6597.
Sincerely yours
Claturd
Timoth A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
510(k) Number: Not Available
Continu-Flo® Solution Sets with Modified Check Valve Device Name:
Indication for Use:
Continu-Flo® solution sets with the proposed check valve have the same intended use as the currently marketed sets. The intended use of these sets is the administration of fluids from a
container to the for a contrise vascular system. Continu-Floor sets contain a prevents backflow of solution from the secondary medication container into the primary ontainer during the administration of secondary medication.
(Division Sign-Off) Fabricia Encontr
Division of Dental, Infection Control,
Division of Dental, ENT,
and General Hospital Devices
§10(k) Number K971701
Prescription Use
(Per 21 CFR 801.109)
MAY 0 7 1997
50