(29 days)
No
The device description and performance studies focus on mechanical and material properties of fluid administration components, with no mention of AI or ML. The basis for the notification is a design standardization, not a technological advancement involving AI/ML.
No
The device is used to administer fluids, but it does not directly treat or prevent a medical condition.
No
The device is described as administering or withdrawing fluids, which is a therapeutic or administrative function, not a diagnostic one that involves detecting or identifying a medical condition.
No
The device description clearly outlines physical components such as stopcocks, manifolds, and administration sets, which are hardware. The performance studies also focus on bench tests for physical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To administer fluids from a container into the patient's vascular system through a vascular access device." This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose a condition.
- Device Description: The description details components like stopcocks, administration sets, and extension sets, all of which are used for controlling and delivering fluids intravenously. There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes
- Reagents or assays
The device is clearly intended for therapeutic or supportive purposes (fluid administration), not for diagnostic testing.
N/A
Intended Use / Indications for Use
To administer fluids from a container into the patient's vascular system through a vascular access device.
Product codes (comma separated list FDA assigned to the subject device)
FMG, FPA
Device Description
The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of a stand-alone stopcock, stopcock manifold gangs, Intravenous (I.V.) administration sets with stopcock(s), and I.V. extension sets with stopcock(s). They are single use disposable devices intended for use for continuous or intermittent fluid administration or withdrawal of fluids. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K962581 (cleared August 28, 1996), K961225 (cleared June 21, 1996) and K022895 (Elcam Plastic, cleared October 18, 2002).
The stand-alone stopcock is an in-line access site and can be connected to male Luer adapters (e.g., syringes or sets) to allow needleless access to the fluid or vascular path. It is used to control the fluid flow pathway by rotating the flow control handle.
The stopcock manifold gangs consist of individual stopcocks assembled in series through common Luer fittings to form a manifold or gang. These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for the administration of drugs and solutions. The Luer connectors on either end of the stopcock gang allow connection to an administration or extension set for fluid administration through an indwelling intravascular catheter.
The I.V. administration sets with stopcock(s) (i.e. solution sets, secondary medication sets, Continu-Flo sets) are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They contain the stopcock(s) that can be used for the administration of secondary medication.
The I.V. extension sets with stopcock(s) are used for the administration and withdrawal of fluids. They consist of the stopcock connected to the extension set.
Currently, Baxter uses three stopcock designs in the stopcock system. The basis for this premarket notification is the standardization to one stopcock design. No new materials of construction are being introduced into Baxter's stopcock system as part of this change. This change does not impact the intended use or the fundamental scientific technology of the device. The product labels are also being updated to add the indications for use statement of the device and clarify their use to comply with Baxter's labeling standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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 the intended use. The following bench tests were conducted to evaluate the effect of the design modification on the functional performance of the Stopcock and I.V. Solution Administration Sets with Stopcock(s):
- Visual inspection
- Inner diameter assessment
- High pressure test
- Long duration pressure test
- ISO Luer tests on female and male Luer lock connectors
- Plug torque test
- Lipid resistance test
- Rigid bond flex test
- Rigid bond water pressure test
- Rigid bond air pressure test
- Rigid bond torque test
- Tubing bond pressure test
- Tubing bond tensile test
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.
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.
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Section 5, 510(k) Summary Page 1 of 4
5. 510(K) SUMMARY
February 8, 2013
Owner:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
Contact Person:
Nanette Hedden Associate Director, Global Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073 Telephone: (224) 270-4871 Fax: (224) 270-4119
Device name:
Stopcock and I.V. Solution Administration Sets with Stopcocks
Table 5-1.
Representative Product Codes for Stopcock and I.V. Solution Administration Sets with Stopcocks
| Code number | Name |
|---|---|
| 2C6204 | Large Bore Stopcock with Rotating Male Luer Lock |
| STP5604 | Large Bore Stopcock with Extension Set |
| 2C6218 | Three Gang Large Bore Stopcock Manifold |
| 2C6255 | Clearlink System Continu-Flo Solution Set Large Bore Stopcock |
| Extension Set | |
| 2C6607 | Interlink System Extension Set Large Bore Stopcock with Rotating |
| Male Luer Lock | |
| STP0142 | Interlink System Continu-Flo Solution Set Large Bore Stopcock |
| Manifold Large Bore Stopcock with Rotating Male Luer Lock | |
| Extension Set |
Common name:
Stopcock and I.V. Solution Administration Sets with Stopcocks
MAR 0 1 2013
1
Classification name:
IV Administration Set (21 CFR 880.5440, Product Code FMG, FPA)
Predicate Device :
| Device | Company | Previous
510(k) | Clearance date |
|---------------------------------------------------------|-------------------------|--------------------|-----------------|
| Stopcock Manifold Gangs | Baxter Healthcare Corp. | K962581 | August 28, 1996 |
| Continu-Flo Solution
Set/Secondary Medication
Set | Baxter Healthcare Corp. | K961225 | June 21, 1996 |
Table 5-2. Previous 510(k)s
Device Description:
The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of a stand-alone stopcock, stopcock manifold gangs, Intravenous (I.V.) administration sets with stopcock(s), and I.V. extension sets with stopcock(s). They are single use disposable devices intended for use for continuous or intermittent fluid administration or withdrawal of fluids. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K962581 (cleared August 28, 1996), K961225 (cleared June 21, 1996) and K022895 (Elcam Plastic, cleared October 18, 2002).
The stand-alone stopcock is an in-line access site and can be connected to male Luer adapters (e.g., syringes or sets) to allow needleless access to the fluid or vascular path. It is used to control the fluid flow pathway by rotating the flow control handle.
The stopcock manifold gangs consist of individual stopcocks assembled in series through common Luer fittings to form a manifold or gang. These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for the administration of drugs and solutions. The Luer connectors on either end of the stopcock gang allow connection to an administration or extension set for fluid administration through an indwelling intravascular catheter.
The I.V. administration sets with stopcock(s) (i.e. solution sets, secondary medication sets, Continu-Flo sets) are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They contain the stopcock(s) that can be used for the administration of secondary medication.
2
The I.V. extension sets with stopcock(s) are used for the administration and withdrawal of fluids. They consist of the stopcock connected to the extension set.
Currently, Baxter uses three stopcock designs in the stopcock system. The basis for this premarket notification is the standardization to one stopcock design. No new materials of construction are being introduced into Baxter's stopcock system as part of this change. This change does not impact the intended use or the fundamental scientific technology of the device. The product labels are also being updated to add the indications for use statement of the device and clarify their use to comply with Baxter's labeling standards.
Statement of Intended Use:
To administer fluids from a container into the patient's vascular system through a vascular access device.
Technological Characteristics and Substantial Equivalence:
The proposed devices are equivalent to Baxter's currently legally marketed Stopcock Manifold Gangs cleared August 28, 1996 (K962581) and Continu-Flo Solution Set/Secondary Medication Set cleared June 21, 1996 (K961225). See Table 5-2. This modification will standardize the stopcock design to one design. The intended use, basic design and the materials for the proposed devices are equivalent to the predicate device.
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 the intended use. The following bench tests were conducted to evaluate the effect of the design modification on the functional performance of the Stopcock and I.V. Solution Administration Sets with Stopcock(s):
- · Visual inspection
- · Inner diameter assessment
- · High pressure test
- · Long duration pressure test
- · ISO Luer tests on female and male Luer lock connectors
- · Plug torque test
- · Lipid resistance test
- · Rigid bond flex test
- · Rigid bond water pressure test
3
- Rigid bond air pressure test
- Rigid bond torque test
- Tubing bond pressure test
- · Tubing bond tensile test
Conclusion:
The proposed devices are substantially equivalent to the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
March 1. 2013
Ms. Nanette Hedden Associate Director, Global Regulatory Affairs Baxter Healthcare Corporation 32650 North Wilson Road ROUND LAKE IL 60073
Re: K130245
.
Trade/Device Name: Stopcock and I.V. Solution Administration Sets with Stopcocks Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG, FPA Dated: January 25, 2013 Received: January 31, 2013
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.
5
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 (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.
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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: &
Stopcock and I.V. Solution Administration Sets with Stopcocks
Indications for Use:
To administer fluids from a container into the patient's vascular system through a vascular access device.
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)
| Sajjad H Syed | Digitally signed by Sajjad H. Syed DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Sajjad H. Syed, 0.9.2342.19200300.100.1.1=2000601742 Date: 2013.02.28 11:02:12 -05'00' |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K130245 |
36