(5 days)
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.
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 thread molded internally between the existing double to provide additional surface contact with the mating threads of the luer thread. The micro thread provides additional security of the connection.
This document describes a 510(k) submission for the InterLink® Threaded Lock Cannula (modified), aiming to demonstrate its substantial equivalence to an existing predicate device, the BD/Baxter InterLink® Blunt Cannula. The document focuses on comparing the modified device to a previous version of the Threaded Lock Cannula and concludes with an FDA approval letter based on this equivalence.
However, the provided text does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or any similar quantitative measures. The core of this submission is to demonstrate functional, design, and material equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and reported device performance in the context of diagnostic or efficacy outcomes.
Therefore, many of the requested sections (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be directly answered from the provided text, as this type of information is typically found in performance testing reports for medical devices that aim to demonstrate efficacy or safety against measurable criteria.
Here's an analysis based on the information that is present:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document focuses on demonstrating substantial equivalence based on design, materials, sterilization, and intended use, rather than presenting specific quantitative performance criteria and the results of a study designed to meet those. The tables compare characteristics, not performance metrics against acceptance criteria.
2. Sample sized used for the test set and the data provenance
This information is not provided. The document does not describe a clinical or performance test set with a specific sample size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. As there's no described test set or ground truth establishment, this is not applicable.
4. Adjudication method for the test set
This information is not provided. As there's no described test set, this is not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document describes a medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. No ground truth is established as there's no performance study described. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, which the modified device is being compared to.
8. The sample size for the training set
This information is not provided. This is not a machine learning or AI-based device, so the concept of a "training set" is not relevant here.
9. How the ground truth for the training set was established
This information is not provided. As above, this is not relevant for this type of device submission.
Summary of what the document does provide regarding equivalence:
The document demonstrates substantial equivalence of the modified InterLink® Threaded Lock Cannula to an existing, unmodified predicate device through a direct comparison of physical and functional characteristics.
Comparison Table for Equivalence (from the text):
| 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 |
The "study" in this context is the comparison and analysis of the modified device against the predicate device based on their technical specifications and intended use, as presented in the 510(k) submission. The FDA's letter (K011858) confirms that, based on this submission, they have determined the device to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. The "acceptance criteria" can be implied as meeting the FDA's requirements for substantial equivalence, which primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. This is achieved by showing similar intended use, technological characteristics, and performance (in a broad, qualitative sense based on design and materials).
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1 Recton Drive Franklin Lakes, New Jersey 07417 lel: 201.847.6800 www.bd.com
011858
JUN 1 9 2001
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Indispensable to human health
Summary of Safety and Effectiveness for InterLink® Threaded Lock Cannula
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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
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3 Predicate Device(s): BD/Baxter InterLink® Blunt Cannula, Modification 510(K) K911868, Date of Decision: 06/24/91
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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.
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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
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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 accessto IV Sites connected to aninjection site for continuousand intermittent IV Therapy. | Used for needleless access toIV Sites connected to aninjection site for continuousand intermittent IV Therapy. |
| Incorporates SameBasic Design | Yes | Yes |
| Utilizes SameOperating Principle | Yes, lubricated and shieldedcannula with standard femaleluer fitting hub. Injection sitethreads are enhanced withaddition of 'micro' thread foradded security for connectionto mating injection site body. | Lubricated and shieldedcannula with standard femaleluer fitting hub. Standardthreads provide for attachmentto mating injection site body. |
| Incorporates SameMaterial | 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.
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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:
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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
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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
§ 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.