(54 days)
Not Found
No
The description focuses on the mechanical function and antimicrobial coating of a luer activated device, with no mention of AI or ML technologies.
No.
The device's intended use is for the administration of drugs and solutions and to inhibit microbial growth on its surfaces, not to treat or cure a disease or condition.
No
The device is intended for the administration or withdrawal of fluids and contains an antimicrobial agent to inhibit microbial growth on its surfaces. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (housing, gland, center post) and a physical coating (silver technology), indicating it is a hardware device with an antimicrobial feature, not software.
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 therapeutic and procedural use, not a diagnostic one.
- Device Description: The description focuses on the mechanical function of the valve and the antimicrobial coating. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of Diagnostic Language: The text does not use any language typically associated with IVDs, such as "analyte," "sample," "detection," "measurement," "diagnosis," or "screening."
- Antimicrobial Function: The antimicrobial agent is intended to prevent microbial contamination of the device itself, not to diagnose an infection in a patient.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not perform such a function.
N/A
Intended Use / Indications for Use
Intended for use with a vascular access device for the administration of drugs and solutions. The CLEARLINK 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 CLEARLINK Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may inhibit the growth of microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The CLEARLINK 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 syringefluer 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 antiscptic before each connection.
The hard surfaces of the CLEARLINK Antimicrobial Luer Activated Device are coated with a proprietary silver technology that may destroy or inhibit the growth of microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially compromised.
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)
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.
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.
K003225, K973916, K051401, K053405
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
5. 510(k) SUMMARY
October 18, 2007
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
NOV 0 6 2007
CONTACT PERSON:
Nanette Hedden Manager, Global Regulatory Affairs 1620 Waukegan Rd. MPGR-AL McGaw Park. IL 60085 Telephone: (847) 473-6281 Fax: (847) 784-5116
DEVICE NAME:
Trade name:
CLEARLINK Antimicrobial Luer Activated Device and Extension Sets with CLEARLINK Antimicrobial Luer Activated Device
| 6N8399 | Luer Activated System1
Luer Activated Device with Silver for IV Access | |
|--------|---------------------------------------------------------------------------|--|
| 6N8378 | Luer Activated System
Non-DEHP Catheter Extension Set | |
| 6N8374 | Luer Activated System
Non-DEHP Catheter Extension Set | |
| 6N8377 | Luer Activated System
Non-DEHP Y-Type Catheter Extension Set | |
| 6N8371 | Luer Activated System
Non-DEHP Y-Type Catheter Extension Set | |
Table 5-1. Product Codes for CLEARLINK Antimicrobial Lucr Activated Device
' Clearlink is a trademark of Baxter, Intl., Inc.
Other trademarks are the properties of their respective owners.
1
1 Baxter Healthcare Corporation will be applying a brand name to replace Luer Activated System for the antimicrobial product prior to market release.
Common name: 1V Administration Set
Classification name:
1V Administration Set (21 CFR 880.5440. Product Code FPA)
PREDICATE DEVICE(S):
| Device | Company | Previous 510(k) | Clearance date |
|---|---|---|---|
| ON-Q Silver Soaker | |||
| Antimicrobial | |||
| Catheter (Coating) | I-Flow | K051401 | November 30, 2005 |
| Modification to | |||
| Solution | |||
| Administration Set | |||
| with Capped Luer | |||
| Activated Device | Baxter Healthcare | K003225 | October 19, 2000 |
| NP Medical Capless | |||
| Luer Activated | |||
| Valve | NP Medical | K973916 | March 9, 1998 |
| Elcam | |||
| Antimicrobial | |||
| Stopcock (or | |||
| Manifold) (Coating) | Elcam Medical | K053405 | May 11, 2006 |
Table 5-2. Previous 510(k)s
DESCRIPTION OF THE DEVICE:
The CLEARLINK 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 syringefluer 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 antiscptic before each connection.
The hard surfaces of the CLEARLINK Antimicrobial Luer Activated Device are coated with a proprietary silver technology that may destroy or inhibit the growth of
2
microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially compromised.
STATEMENT OF INTENDED USE:
The Mark Mark Home of Man Child States of Marin Home Andrew State Andrew State All All All All All All All All All All All All All All All All All All All All All All All A
Intended for use with a vascular access device for the administration of drugs and solutions. The CLEARLINK 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 CLEARLINK Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may inhibit the growth of microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The Baxter CLEARLINK Antimicrobial Luer Activated Device is substantially equivalent to Baxter's current legally marketed CLEARLINK Luer Activated Device cleared by 510(k) K003225 and NP Medical's 510(k) K973916. Baxter's current CLEARI.INK Luer Activated Device does not include the antimicrobial feature. The CLEARLINK Antimicrobial Luer Activated Device utilizes an antimicrobial agent equivalent to the coating in the 510(k) cleared on the I-Flow ON-Q SilverSoaker Catheter (K051401) and is similar to the antimicrobial agent (silver ions) used in Elcam Medical's Antimicrobial Stopcock (K053405).
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 CLEARLINK Antimicrobial Luer Activated Device is substantially equivalent to the predicate devices.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 6 2007
Ms. Nanette Hedden Manager, Global Regulatory Affairs Baxter Healthcare Corporation Medication Delivery 1620 Waukegan Road McGaw Park, Illinois 60085
Re: K072576
Trade/Device Name: CLEARLINK Antimicrobial Luer Activated Device and Extension Sets with CLEARLINK Antimicrobial Luer Activated Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 12, 2007 Received: September 14, 2007
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 (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.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,
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);
Device Name: CLEARLINK Antimicrobial Luer Activated Device and Extension Sets with CLEARLINK Antimicrobial Luer Activated Device
Indications for Use:
Intended for use with a vascular access device for the administration of drugs and solutions. The CLEARLINK 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 CLEARLINK Antimicrobial Luer Activated Device contains an antimicrobial agent (metallic silver) that may inhibit the growth of microorganisms on the coated surfaces of the CLEARLINK device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections.
Prescription Use __ X ________________________________________________________________________________________________________________________________________________________ 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K472516 |
|---|---|
| ---------------- | --------- |