(89 days)
Not Found
No
The summary describes a mechanical luer-activated device with an antimicrobial coating. There is no mention of AI, ML, or any software-driven functionality that would suggest the use of these technologies.
No
The device is used for the administration of drugs and solutions, and to reduce microbial growth on its surface, not to treat a disease or medical condition.
No
The device is an in-line injection site for administering drugs and solutions, designed to prevent microbial growth on its surfaces, not to diagnose diseases or conditions.
No
The device description clearly outlines physical components (housing, gland, center post) and a physical coating (silver technology). It is a hardware device with an antimicrobial feature.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration and withdrawal of fluids in conjunction with a vascular access device. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic purposes in vivo, not for examining specimens in vitro.
- Device Description: The description focuses on the mechanical function of the valve and the antimicrobial coating on the device surfaces. It does not describe any components or processes related to analyzing biological specimens outside of the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
The antimicrobial aspect is related to reducing microbial growth on the device itself, not for diagnosing or treating infections through in vitro testing.
N/A
Intended Use / Indications for Use
Intended for use with a vascular access device for the administration of drugs and solutions. The V-Link Antimicrobial Luer Activated Device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.
The V-Link Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may reduce the growth of microorganisms on the coated surfaces of the V-Link device. The antimicrobial agent is not intended to be used as a treatment for existing infections.
Product codes
FPA, FMG
Device Description
No design changes have been made to the V-Link Antimicrobial Luer Activated Device which was cleared on November 6, 2007. This submission adds supplemental data on the efficacy and durability of the antimicrobial coating.
The V-Link Antimicrobial Luer Activated Device consists of a clear housing encasing a gland and center post. The gland functions as the valve that provides a seal against the syringe/luer connector when the device is being used. The gland has a slit that opens when activated by the syringe/Luer connector. The gland also provides a surface that can be easily swabbed with antiseptic before each connection.
The hard surfaces of the V-Link Antimicrobial Luer Activated Device are coated with a proprietary silver technology that may reduce the growth of microorganisms on the coated surfaces of the V-Link device.
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
Not Found
Key Metrics
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
KOR 1289 1 of 3
Section 5, 510(k) Summary
5. 510(k) SUMMARY
July 28, 2008
OWNER:
:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Nanette Hedden Manager, Global Regulatory Affairs 1620 Waukegan Rd. MPGR-AL McGaw Park, IL 60085 Telephone: (847) 270-4871 Fax: (847) 785-5116
DEVICE NAME:
Trade name:
V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device
| 6N8399 | V-Link Luer Activated Device with VitalShield |
|---|---|
| 6N8378 | Non-DEHP Catheter Extension Set with |
| V-Link Luer Activated Device with VitalShield | |
| 6N8374 | Non-DEHP Catheter Extension Set with |
| V-Link Luer Activated Device with VitalShield | |
| 6N8377 | Non-DEHP Y-Type Catheter Extension Set with |
| V-Link Luer Activated Device with VitalShield | |
| 6N8371 | Non-DEHP Y-Type Catheter Extension Set with |
| V-Link Luer Activated Device with VitalShield |
Table 5-1. Product Codes for V-Link Antimicrobial Luer Activated Device
AUG - 4 2008
1
K081287 29
Section 5, 510(k) Summary
Common name: IV Administration Set
Classification name:
IV Administration Set (21 CFR 880.5440, Product Code FPA)
PREDICATE DEVICE:
Table 5-2. Previous 510(k)s
| Device | Company | Previous 510(k) | Clearance date |
|---|---|---|---|
| CLEARLINK Antimicrobial Luer | |||
| Activated Device and Extension Sets | |||
| with CLEARLINK Antimicrobial Luer | |||
| Activated Device | Baxter | ||
| Healthcare | K072576 | November 6, | |
| 2007 |
DESCRIPTION OF THE DEVICE:
No design changes have been made to the V-Link Antimicrobial Luer Activated Device which was cleared on November 6, 2007. This submission adds supplemental data on the efficacy and durability of the antimicrobial coating.
The V-Link Antimicrobial Luer Activated Device consists of a clear housing encasing a gland and center post. The gland functions as the valve that provides a seal against the syringe/luer connector when the device is being used. The gland has a slit that opens when activated by the syringe/Luer connector. The gland also provides a surface that can be easily swabbed with antiseptic before each connection.
The hard surfaces of the V-Link Antimicrobial Luer Activated Device are coated with a proprietary silver technology that may reduce the growth of microorganisms on the coated surfaces of the V-Link device.
STATEMENT OF INTENDED USE:
Intended for use with a vascular access device for the administration of drugs and solutions. The V-Link Antimicrobial Luer Activated Device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.
2
K081289 3 of 3
Section 5, 510(k) Summary
Special 510(k) Premarket Notification V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device
The V-Link Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may reduce the growth of microorganisms on the coated surfaces of the V-Link device. The antimicrobial agent is not intended to be used as a treatment for existing infections.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The Baxter V-Link Antimicrobial Luer Activated Device is substantially equivalent to Baxter's current legally marketed V-Link Antimicrobial Luer Activated Device cleared November 6, 2007 (K072576).
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 V-Link Antimicrobial Luer Activated Device is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 2008
Ms. Nanette Hedden Manager, Global Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085
Re: K081289
Trade/Device Name: V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, FMG Dated: May 6, 2008 Received: May 7, 2008
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.
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.
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); 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 vours.
Quts
Chiu Lin, Ph.D. 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): K081289
Device Name:
V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device
Indications for Use:
Intended for use with a vascular access device for the administration of drugs and solutions. The V-Link Antimicrobial Luer Activated Device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.
The V-Link Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may reduce the growth of microorganisms on the coated surfaces of the V-Link device. The antimicrobial agent is not intended to be used as a treatment for existing infections.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR AND/OR 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)
Sidn-Um) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KO8/289 510(k) Number: _