(5 days)
Not Found
No
The 510(k) summary describes a mechanical medical device (a cannula) with no mention of software, data processing, or any terms related to AI or ML. The modification described is purely mechanical.
No
The device is described as a component of an IV access system used for therapies and blood draws, which are medical procedures, but the cannula itself is a tool for delivery/access, not a therapeutic agent or device that directly treats a condition.
No
This device is described as a component of an IV access system used for continuous and intermittent IV therapy, vial access, and blood draws. Its function is to facilitate connections to IV lines, not to diagnose a condition.
No
The device description clearly outlines physical components made of polypropylene and polyethylene, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as part of an IV access system for delivering fluids and drawing blood. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic purposes in vivo (within the living body), not for testing samples in vitro (in a test tube or lab setting).
- Device Description: The description focuses on the physical components and function of a cannula for connecting to IV lines. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of IVD Indicators: The document does not contain any of the typical indicators of an IVD, such as:
- Mention of analyzing biological samples (blood, urine, tissue, etc.).
- Description of diagnostic tests or measurements.
- Reference to diagnostic parameters or results.
- Information about performance metrics relevant to diagnostic accuracy (sensitivity, specificity, etc.).
The device is a component of an IV access system, which is a medical device used for patient care, but it does not perform an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
The Threaded Lock Cannula is one of several needleless cannula components that are part of the InterLink® IV Access System that provide for continuous and intermittent IV Therapy, Vial Access, and Blood Draws. The system allows the user to make connections to any IV line using a mating injection site with a pre-slit septum safely without chance of needle stick injury to the user or patient. InterLink® Threaded Lock Cannula are specifically designed for use with InterLink® injection sites, identified by a white alert ring around the septum. Not compatible with conventional injection sites.
Product codes (comma separated list FDA assigned to the subject device)
FPA, FMI
Device Description
A product comparison between the modified InterLink® Threaded Lock Cannula and existing Threaded Lock Cannula is provided in the table below:
| Component/Characteristic | Threaded Lock (existing) | Threaded Lock (modified) |
|---|---|---|
| Cannula Body | Polypropylene | Polypropylene |
| Tip Shield (Cannula Stem) | Polyethylene | Polyethylene |
| Lubricant | Medical Grade Silicone | Medical Grade Silicone |
| Sterilization Process | Radiation | Radiation |
The Threaded Lock Cannulae are equivalent in product function, design, and manufacturing process with the only difference being the addition of 'micro' helical threads molded internally between the existing double helix and more of the luer thread. The 'micro threads' provide additional surface contact with the mating threads and improve the security of the connection.
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)
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.
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
1 Recton Drive Franklin Lakes, New Jersey 07417 lel: 201.847.6800 www.bd.com
011858
JUN 1 9 2001
Image /page/0/Picture/3 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a circular emblem on the left and the letters "BD" on the right. The emblem features a stylized sun rising over a smiling face, symbolizing hope and innovation. The letters "BD" are bold and sans-serif, representing the company's strength and modernity.
Indispensable to human health
Summary of Safety and Effectiveness for InterLink® Threaded Lock Cannula
-
1 BD Contact person:
Gregory W. Morgan Director, Regulatory Affairs BD Medical Surgical - Mail Code 226 1 Becton Drive Franklin Lakes, NJ 07417-1880 Phone (201) 847-4344 (201) 847-4855 Fax -
Device Name: InterLink® Threaded Lock Cannula 2
-
3 Predicate Device(s): BD/Baxter InterLink® Blunt Cannula, Modification 510(K) K911868, Date of Decision: 06/24/91
-
Intended Uses: (REVISED): The Threaded Lock Cannula is one of several प needleless cannula components that are part of the InterLink® IV Access System that provide for continuous and intermittent IV Therapy, Vial Access, and Blood Draws. The system allows the user to make connections to any IV line using a mating injection site with a pre-slit septum safely without chance of needle stick injury to the user or patient. InterLink® Threaded Lock Cannula are specifically designed for use with InterLink® injection sites, identified by a white alert ring around the septum. Not compatible with conventional injection sites.
-
5 Device Description and Comparison: (REVISED)
A product comparison between the modified InterLink® Threaded Lock Cannula and existing Threaded Lock Cannula is provided in the table below:
| Component/Characteristic | Threaded Lock (existing) | Threaded Lock (modified) |
|---|---|---|
| Cannula Body | Polypropylene | Polypropylene |
| Tip Shield (Cannula Stem) | Polyethylene | Polyethylene |
| Lubricant | Medical Grade Silicone | Medical Grade Silicone |
| Sterilization Process | Radiation | Radiation |
Summary of Safety and Fiffectivencss
Becton, Dickinson and Company
1 of 2
1
The Threaded Lock Cannulae are equivalent in product function, design, and The Threaded Lock Cannulae are equiffactin in product andition of 'micro' helical thread
manufacturing process with the only difference being the lucr thread manufacturing process with the only annovelses and and more of the luer thread. molded internally belween the existing double to surface contact with the mating threads The Thicro thread provideos adultional surfity of the connection.
Equivalence determination: 6
The BD 'modified' InterLink® Threaded Lock Cannula is substantially equivalent in The BD Thoullied ThierLink® Throuded Look Look Lose to the existing "unmodified" predicate device product function and intended use to the oxleding "anno one illusing similarities as detailed in the table below:
| | Threaded Lock Cannula
(modified) | Threaded Lock Cannula
(existing) |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used for needleless access
to IV Sites connected to an
injection site for continuous
and intermittent IV Therapy. | Used for needleless access to
IV Sites connected to an
injection site for continuous
and intermittent IV Therapy. |
| Incorporates Same
Basic Design | Yes | Yes |
| Utilizes Same
Operating Principle | Yes, lubricated and shielded
cannula with standard female
luer fitting hub. Injection site
threads are enhanced with
addition of 'micro' thread for
added security for connection
to mating injection site body. | Lubricated and shielded
cannula with standard female
luer fitting hub. Standard
threads provide for attachment
to mating injection site body. |
| Incorporates Same
Material | Yes - Polypropylene Resin | Yes - Polypropylene Resin |
| Sterility | Sterile 10 -6 SAL | Sterile 10 -6 SAL |
| Sterilization Process | Gamma Radiation | Gamma Radiation |
| Toxicity | Non-Toxic | Non-Toxic |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Product Size | .915" x .500" Diameter | .915" x .500" Diameter |
In summary the 'modified' InterLink® Threaded Lock Cannula described in this in ourmision is, in our opinion, substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three distinct head profiles overlapping each other. The bird is oriented towards the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2001
Mr. Gregory W. Morgan Head of Requlatory Compliance BD Medical Surqical 1 Becton Drive MC 226 Franklin Lakes, New Jersey 07417
Re : K011858 Interlink Threaded Lock Cannula Trade/Device Name: Regulation Number: 880.5440 Regulatory Class: II Product Code: FPA and FMI Dated: June 13, 2001 Received: June 14, 2001
Dear Mr. Morgan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
3
Page 2 - Mr. Morgan
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Attachment 5
Indications for Use Statement
510(k) Number: not known at this time
Device Name: InterLink® Threaded Lock Cannula
Indications for Use: The Threaded Lock Cannula is one of several needleless cannula manations for Obe. The The InterLink® IV Access System that provide for continuous components that are part of the more ess, and Blood Draws. The system allows the user allo internations to any IV line using a mating injection site with a pre-slit septum to make bonne chance of needle stick injury to the user or patient. InterLink® Threaded Safely while are specifically designed for use with InterLink® injection sites, identified 1.00% Callian are operiisms as special. Not compatible with conventional injection sites.
Tile Hubbard for Pat Circuit.
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 1510k) Number K0118