(78 days)
Not Found
No
The device description and performance studies focus on mechanical, biocompatibility, and microbial ingress testing of a fluid administration/withdrawal set, with no mention of AI or ML technologies.
No
This device is an extension set for administering or withdrawing fluids and aiding in needlestick prevention, not a device directly used for therapy.
No
The device is described as an extension set for administration or withdrawal of fluids, and there is no mention of it being used to collect or analyze data for diagnostic purposes.
No
The device description clearly outlines physical components like an injection site, T-Housing, female adapter, tubing, and slide clamp, indicating it is a hardware device. The performance studies also mention mechanical and biocompatibility testing, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration or withdrawal of fluids using an indwelling catheter in neonatal patients. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo, not for testing samples in vitro.
- Device Description: The description details a set of components for connecting to a catheter and facilitating fluid flow. This aligns with a medical device used for patient care, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
The device is clearly intended for direct patient use for fluid management, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use in neonatal population only. To be used with an indwelling catheter for the administration or withdrawal of fluids. This device may aid in the prevention of needlestick injuries.
Product codes
FPA
Device Description
The Interlink T-Connector Extension Set consists of an Interlink injection site integrated into a T-Housing on one end of the extension set with a female adapter connected to the other end. A slide clamp is also included on the tubing. This extension set is connected to an indwelling catheter in order to administer or withdraw fluids. The injection site is accessed by a blunt plastic cannula; this allows fluid flow while aiding in the prevention of needlestick injuries.
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
neonatal population only
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 conducts risk analyses using procedures based on ISO 14971 (2000) "Medical Devices - Application of Risk Management to Medical Devices". The risk analysis method used to assess the impact of these modifications was Failure Modes and Effects Analysis (FMEA). Design verification tests based on the results of risk analysis and design input were performed to verify those modifications. Testing of the set and components included mechanical, biocompatibility, and microbial ingress testing. All test results met the acceptance criteria.
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
MAR 2 9 2006
1 c+2
1. 510(K) SUMMARY
Submitter:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
Preparer/Contact:
Nanette Hedden Global Regulatory Affairs 1620 Waukegan Rd. McGaw Park, IL 60085 Telephone: (847) 473-6281 Fax: (847) 784-5116
Date Summary was Prepared:
January 3, 2006
Device Name:
Trade name: Interlink T-Connector Extension Sct Common name: IV Administration Set Classification name: Intravascular Administration Set (21 CFR 880.5440, Product Code FPA)
Predicate Device(s):
Baxter Interlink T-Connector Extension Set cleared under premarket notification K921899, cleared April 20, 1993.
Device Description:
The Interlink T-Connector Extension Set consists of an Interlink injection site integrated into a T-Housing on one end of the extension set with a female adapter connected to the other end. A slide clamp is also included on the tubing. This extension set is connected to an indwelling catheter in order to administer or withdraw fluids. The injection site is accessed by a blunt plastic cannula; this allows fluid flow while aiding in the prevention of needlestick injuries.
1
1(0)000074 2. 2013
Statement of Intended Use:
For use in neonatal population only. To be used with an indwelling catheter for the administration or withdrawal of fluids. This device may aid in the prevention of needlestick injuries.
Summary of Technological Characteristics of New Device to Predicate Devices:
The technological characteristics of the Interlink T-Connector Extension Set do not differ significantly from the currently marketed Baxter Interlink Administration Sets. The T-Connector design allows for easy access to the catheter and easier tubing connection to the patient compared to standard extension sets. The slip connection provides an attachment method that is less likely to direct the forces of IV line attachment to the patient's sensitive catheter injection site as compared to locking collar type Luer devices. Also key to the intended population is the priming/residual volume and the flush clearance efficiency for infused drugs and for clearing blood from the device post blood sampling. Because the patient is small and commonly fluid restricted, control of the amount of fluid administered may be important. This includes medication as well as flushing or clearing the lines after medication administration.
Discussion of Nonclinical Tests:
Baxter Healthcare conducts risk analyses using procedures based on ISO 14971 (2000) "Medical Devices - Application of Risk Management to Medical Devices". The risk analysis method used to assess the impact of these modifications was Failure Modes and Effects Analysis (FMEA). Design verification tests based on the results of risk analysis and design input were performed to verify those modifications. Testing of the set and components included mechanical, biocompatibility, and microbial ingress testing. All test results met the acceptance criteria.
Conclusion:
The Interlink T-Connector Extension Set is substantially equivalent to the currently cleared Interlink T-Connector Extension Set.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular fashion around the emblem. The text is in all capital letters and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2006
Baxter Healthcare Corporation C70 Ms. Nanette Hedden Specialist Global Regulatory Affairs Medication Delivery 1620 Waukegan Road McGaw Park, Illinois 60085
Re: K060074
Trade/Device Name: Interlink T-Connector Extension Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 9, 2006 Received: January 10, 2006
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 approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 Eederal Register.
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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 and insting (s a set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
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K 06007 4 ા ર્વ ( )
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Interlink T-Connector Extension Set
Indications For Use: For use in neonatal population only. To be used with an indwelling catheter for the administration or withdrawal of fluids. This device may aid in the prevention of needlestick injuries.
Prescription Use X ___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
" nu, Ganeral Hus "