(113 days)
Not Found
No
The device description and intended use focus on physical components for fluid administration and catheter stabilization, with no mention of AI or ML capabilities.
No.
The device facilitates the administration and withdrawal of fluids and secures catheters, but it does not directly treat a disease or condition.
No
The device is described as an IV extension tubing kit with components for fluid administration/withdrawal and catheter securement, and skin preparation. Its intended uses do not involve diagnosing any medical condition or disease.
No
The device description clearly outlines multiple physical components including tubing, a stabilization device, tape strips, and a skin prep pad. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device's purpose is for the administration and withdrawal of fluids, catheter stabilization, and skin preparation for dressing application. These are all procedures performed on the patient's body, not tests performed on samples from the body.
- Intended Use: The intended use focuses on facilitating intravenous procedures and securing medical lines. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, this device falls under the category of general medical devices used for patient care, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The IV extension tubing kits provide the user with a "ready-to-use" set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The kits are indicated for one-time use.
The IV extension tubing set is indicated for use with a vascular access device for administration and withdrawal of fluids.
The Vital-Hold catheter stabilization device and the foam tape strips are indicated to provide a method for catheter securement.
The APLICARE skin prep pad is indicated to prepare the skin prior to application of a dressing or bandage.
Product codes (comma separated list FDA assigned to the subject device)
2N8220, 2N8221, 2N8222, 2N8223, 2N8224, 2N8225, 2N8227, 6N8220, 6N8222, 6N8224
Device Description
The intravenous extension tubing kits will consist of an intravenous extension tubing set, a Vital-Hold catheter stabilization device, two foam tape strips and an APLICARE skin protectant prep pad. The intravenous extension sets may contain any of Baxter's cleared access ports (e.g., Interlink Injection Site, Clearlink Luer Activated Valve or V-Link Luer Activated Valve).
The IV extension tubing set is used with a vascular access device for administration and withdrawal of fluids.
The Vital-Hold catheter stabilization device is used to help anchor medical intravenous tubes and lines requiring mechanical stability while installed on the skin surface of a patient.
The two foam tape strips with release liners are used to assist with line stabilization.
The APLICARE skin protectant prep pad is a sterile pad saturated in skin prep solution. The prep solution prepares the skin prior to application of a dressing or bandage. When dry, the prep agent leaves a thin polymer film on the skin surface providing a clean surface for adhesion and a barrier to the natural body oils that can affect adhesion.
The IV extension tubing set, the Vital-Hold catheter stabilization device, the two foam tape strips and the APLICARE skin protectant prep pad will be integrated into one sterile unit blister package to provide the user with a "ready-to-use" set up avoiding the need to acquire/assemble components from various manufacturers) 4 home and comments and
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin surface
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)
Not Found
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.
K861557, K925126, K003225, K072576, K081289
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
Section 5, 510(k) Summary
MAR 2 5 2011
5. 510(k) SUMMARY
January 12, 2010
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Nanette Hedden Senior 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: Intravenous Extension Tubing Kits
Table 5-1.
Product Codes for Intercompany Extension Tuning & Use
| Code number | Name |
|---|---|
| 2N8220 | Clearlink System Non-DEHP Catheter Extension Set Kit, 7.7"(20.0 cm), Vol. 1.10 ml |
| 2N8221 | Interlink System Non-DEHP Catheter Extension Set Kit, 7.1"(18.0 cm), Vol. 0.85 ml |
| 2N8222 | Clearlink System Non-DEHP Catheter Extension Set Kit, 8.2"(21.0 cm), Vol. 0.57 ml |
| 2N8223 | Interlink System Non-DEHP Catheter Extension Set Kit, 7.7"(19.45 cm), Vol. 0.22 ml |
| 2N8224 | Clearlink System Non-DEHP Y-Type Catheter Extension Set Kit, 6.5"(16.45 cm), Vol. 1.2 ml |
| 2N8225 | Interlink System Non-DEHP Y-Type Catheter Extension Set Kit, 5.3"(13.4 cm), Vol. 1.21 ml |
| 2N8227 | Interlink System Non-DEHP Y-Type Catheter Extension Set Kit, 5.5"(13.9 cm), Vol. 0.85 ml |
| 6N8220 | V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Catheter Extension Set Kit, 7.6"(19.3 cm), Vol. 1.0 ml |
1
| Code number | Name |
|---|---|
| 6N8222 | V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP |
| Catheter Extension Set Kit, 8.2"(21.0 cm), Vol. 0.5 ml | |
| 6N8224 | V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Y- |
| Type Catheter Extension Set Kit, 5.3"(13.5 cm), Vol. 1.2 ml |
Table 5-1. Intravenous Extension Tubing Kits Product Codes
Common name: Intravenous Extension Tubing Kits
Classification name: IV Administration Set (21 CFR 880.5440, Product Code FPA), Intravenous Extension Tubing Set (21 CFR 880.5440, Product Code OJA), Intravascular Catheter Securement Device (21 CFR 880.5210, Product Code KMK), Bandage, Liquid, Skin Protectant (21 CFR 880.5090, Product Code NEC).
PREDICATE DEVICES:
| Device | Company | Previous
510(k) | Clearance date |
|------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------|------------------|
| APLICARE Skin Protectant Prep Pad | APLICARE,
Inc. | K861557 | July 11, 1986 |
| Modified Interlink Injection Site Septum | Baxter
Healthcare | K925126 | July 18, 1993 |
| Modification to Solution Administration Set
with Capped Luer Activated Device
(Clearlink). | Baxter
Healthcare | K003225 | October 19, 2000 |
| CLEARLINK Antimicrobial Luer Activated
Device and Extension Sets with
CLEARLINK Antimicrobial Luer Activated
Device | Baxter
Healthcare | K072576 | November 6, 2007 |
| V-LINK Antimicrobial Luer Activated
Device and Extension Sets with V-LINK
Antimicrobial Luer Activated Device | Baxter
Healthcare | K081289 | August 4, 2008 |
Table 5-2. Previous 510(k)s
2
DESCRIPTION OF THE DEVICE:
The intravenous extension tubing kits will consist of an intravenous extension tubing set, a Vital-Hold catheter stabilization device, two foam tape strips and an APLICARE skin protectant prep pad. The intravenous extension sets may contain any of Baxter's cleared access ports (e.g., Interlink Injection Site, Clearlink Luer Activated Valve or V-Link Luer Activated Valve).
The IV extension tubing set is used with a vascular access device for administration and withdrawal of fluids.
The Vital-Hold catheter stabilization device is used to help anchor medical intravenous tubes and lines requiring mechanical stability while installed on the skin surface of a patient.
The two foam tape strips with release liners are used to assist with line stabilization.
The APLICARE skin protectant prep pad is a sterile pad saturated in skin prep solution. The prep solution prepares the skin prior to application of a dressing or bandage. When dry, the prep agent leaves a thin polymer film on the skin surface providing a clean surface for adhesion and a barrier to the natural body oils that can affect adhesion.
The IV extension tubing set, the Vital-Hold catheter stabilization device, the two foam tape strips and the APLICARE skin protectant prep pad will be integrated into one sterile unit blister package to provide the user with a "ready-to-use" set up avoiding the need to acquire/assemble components from various manufacturers) 4 home and comments and
STATEMENT OF INTENDED USE:
The IV extension tubing kits provide the user with a "ready-to-use" set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The kits are indicated for one-time use.
The IV extension tubing set is indicated for use with a vascular access device for administration and withdrawal of fluids.
The Vital-Hold catheter stabilization device and the foam tape strips are indicated to provide a method for catheter securement.
The APLICARE skin prep pad is indicated to prepare the skin prior to application of a dressing or bandage.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
C/O Ms. Nanette Hedden Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085
APR - 5 2011
Re: K103551
Trade/Device Name: Intravenous Extension Tubing Kits Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 28, 2011 Received: March 1, 2011
Dear Ms. Hedden:
This letter corrects our substantially equivalent letter of March 25, 2011.
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 (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 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 sequirements of the Act or any Federal statutes and regulations administered by other Federal squareins. 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 (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.
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/ucm 115809.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-fire 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,
Howad Bolstead
for
FD
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
INDICATIONS FOR USE .
510(k) Number (if known): K103551
Device Name:
Intravenous Extension Tubing Kits
Indications for Use:
The IV extension tubing kits provide the user with a "ready-to-use" set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The kits are indicated for one-time use.
The IV extension tubing set is indicated for use with a vascular access device for administration and withdrawal of fluids.
The Vital-Hold catheter stabilization device and the foam tape strips are indicated to provide a method for catheter securement.
The APLICARE skin prep pad is indicated to prepare the skin prior to application of a dressing or bandage.
Prescription Use X AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3/24/4
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103551