INTERLINK THREADED LOCK CANNULA

K011858 · Bd · FPA · Jun 19, 2001 · General Hospital

Device Facts

• Record ID: K011858
• Device Name: INTERLINK THREADED LOCK CANNULA
• Applicant: Bd
• Product Code: FPA · General Hospital
• Decision Date: Jun 19, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

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.

Device Story

The InterLink® Threaded Lock Cannula is a needleless component of the InterLink® IV Access System used for IV therapy, vial access, and blood draws. It functions as a connector between an IV line and a mating injection site featuring a pre-slit septum. The device is a lubricated, shielded cannula with a standard female luer fitting hub. The modified version incorporates a 'micro' helical thread molded internally between existing double threads to increase surface contact with the mating injection site, providing enhanced connection security. It is intended for use by healthcare professionals in clinical settings. The device eliminates the risk of needle stick injuries associated with conventional needles. It is not compatible with standard, non-InterLink injection sites.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Polypropylene (cannula body), Polyethylene (tip shield), Medical Grade Silicone (lubricant). Design: Shielded cannula with female luer hub and internal 'micro' helical threads. Sterilization: Gamma radiation (10^-6 SAL). Dimensions: 0.915" x 0.500" diameter.

Indications for Use

Indicated for patients requiring continuous or intermittent IV therapy, vial access, or blood draws via the InterLink® IV Access System. Designed for use with InterLink® injection sites (identified by white alert ring); not for use with conventional injection sites.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BD/Baxter InterLink® Blunt Cannula, Modification 510(K) K911868

Submission Summary (Full Text)

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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

- 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 [phone] [phone] 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

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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<br>(modified) | Threaded Lock Cannula<br>(existing) |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used for needleless access<br>to IV Sites connected to an<br>injection site for continuous<br>and intermittent IV Therapy. | Used for needleless access to<br>IV Sites connected to an<br>injection site for continuous<br>and intermittent IV Therapy. |
| Incorporates Same<br>Basic Design | Yes | Yes |
| Utilizes Same<br>Operating Principle | Yes, lubricated and shielded<br>cannula with standard female<br>luer fitting hub. Injection site<br>threads are enhanced with<br>addition of 'micro' thread for<br>added security for connection<br>to mating injection site body. | Lubricated and shielded<br>cannula with standard female<br>luer fitting hub. Standard<br>threads provide for attachment<br>to mating injection site body. |
| Incorporates Same<br>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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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