MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE by DAVIS & GECK, INC.

Sherwood-Davis & Geck Monoject® BlunTip™ I.V. Access Cannula with Vial Access Pin Device is designed to provide needleless drug access. The sterile access pin is used to pre-pierce the rubber drug vial closure, facilitating direct medication access with the BlunTip* cannula. Only one access pin penetration is required to enable repeated BlunTip* cannula access. Once drawn , the medicaton can be delivered through any pre-pierced I.V. port compatible with the BlunTip* cannula.

Device Description

The Monoject® BlunTip™ I.V. Access Cannula with Vial Access Pin products combine a new access pin with the currently marketed BlunTip I.V. Access cannula. The access pin and cannula, in combination, perform the same function as a hollow-bore needle when used for accessing the contents of a drug vial. The Vial Access device has been designed to improve I.V. drug administration safety for both the clinician and the patient. This product has been extensively tested to ensure product safety and efficacy. The primary design goal of the Vial Access products is to eliminate the hazards associated with a sharp, hollow-bore hypodermic needle in I.V. drug administration. The brightly colored, sterile access pin enables users to prepierce the drug vial closure for subsequent access using a BlunTip cannula.

AI/ML Overview

This submission (K980062) for the Monoject® BlunTip™ I.V. Access Cannula with Vial Access Pin does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) premarket notification for a medical device. The core purpose of a 510(k) is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria in the manner you've described for an AI/algorithm-based device.

Here's a breakdown of why the requested information is absent and what the document does provide:

A table of acceptance criteria and the reported device performance: This is not present. The document states, "Although there are no performance standards associated with this device, the testing and design features have shown that there are no new issues with safety and effectiveness." This indicates that formal, objective performance metrics with acceptance criteria, common for AI/algorithm-based devices (e.g., sensitivity, specificity, AUC), were not established or reported in this submission for this type of mechanical device.
Sample size used for the test set and the data provenance: Not applicable. There is no mention of a "test set" in the context of an algorithm or diagnostic performance. The testing mentioned would have been primarily engineering and usability testing for a physical device, not data for an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic algorithms is not relevant here.
Adjudication method for the test set: Not applicable.
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: Not applicable. This is a physical device, not an AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What this 510(k) submission does discuss (related to performance and safety):

Design Goal: To eliminate hazards associated with sharp, hollow-bore hypodermic needles in I.V. drug administration.
Function: The access pin and cannula, in combination, perform the same function as a hollow-bore needle for accessing drug vial contents.
Testing: "This product has been extensively tested to ensure product safety and efficacy." (However, specifics of the tests and their results are not detailed in this public summary).
Substantial Equivalence: The primary argument for clearance is its substantial equivalence to:
- The Becton Dickinson 18 gauge Hypodermic needle.
- Monoject® gauge hypodermic needles manufactured by Sherwood Davis and Geck.
- Other products like Becton Dickenson Interlink Multi-Dose Access Cannula and Baxter/Becton Dickinson Interlink® Multi-Dose Vial Access System.
- The Monoject® BlunTip™ I.V. Access Cannula (marketed under K960982) is included with this product.

In summary, the provided document is for a mechanical medical device (a cannula and vial access pin system) seeking 510(k) clearance by demonstrating substantial equivalence, not an AI or algorithmic device subject to the performance metrics you've outlined. Therefore, the specific information requested in your prompt is not available in this filing.

Summary

{0}------------------------------------------------

K980062

MAR 20 1998

510(K) Summary of Safety and Effectiveness M.

Monoject® BlunTip™ I.V. Access Cannula with Vial Access Pin

Submitted by: Sherwood - Davis & Geck 444 McDonnell Blvd. Hazelwood, MO 63042

Stephen J. Tamsett, Contact: Regulatory Affairs Manager
Date of Summary: December 16, 1997, 2/4/98

The primary design goal of the Vial Access products is to eliminate the hazards associated with a sharp, hollow-bore hypodermic needle in I.V. drug administration. The brightly colored, sterile access pin enables users to prepierce the drug vial closure for subsequent access using a BlunTip cannula.

Hypodermic needles have been used for vial access for decades and are Pre-Amendment devices.

The Monoiect BlunTip™ I. V. Access Cannula included with the Vial Access product is currently marketed under 510(k) K960982.

The Monoject BlunTip™ I. V. Access Cannula is substantially equivalent to the Becton Dickinson 18 gauge Hypodermic needle, and the Monoject® gauge hypodermic needles manufactured by Sherwood Davis and Geck. There are other products such as the Becton Dickenson Interlink Multi-Dose Access Cannula and Baxter/Becton Dickinson Interlink* Multi-Dose Vial Access System.

{1}------------------------------------------------

The Monoject BlunTip™ I. V. Access Cannula with Vial Access Picc is designed to provide needleless drug vial access. The sterile device is used to pre-pierce the rubber drug vial closure facilitating medication Access with the BlunTip™ Cannula. Only one access pin penetration is required to enable Blun Tip™ Cannula access. Once drawn, the medication can be delivered through this prepierced I.V. port compatible with the BlunTip™ Cannula.

Although there are no performance standards associated with this device, the testing and design features have shown that there are no new issues with safety and effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 20 1998

Mr. Stephen J. Tamsett Regulatory Affairs Manager, USA Sherwood - Davis & Geck 444 McDonnell Boulevard Hazelwood, Missouri 63042-2516

Re: K980062 Monoject® BlunTip™ I.V. Access Cannula with Trade Name: Vial Access Pin Regulatory Class: II Product Code: FMI Dated: January 6, 1998 Received: January 7, 1998

Dear Mr. Tamsett:

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 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

{3}------------------------------------------------

Page 2 - Mr. Tamsett

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Directdr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

{4}------------------------------------------------

K 980062

Page 1 of 1

510(k) Number (if known)

Device Name: Sherwood-Davis & Geck Monoject® BlunTip™ I.V. Access Cannula with Vial Access Pin Device

Indications for Use: Sherwood-Davis & Geck Monoject® BlunTip™ I.V. Access Cannula with Vial Access Pin Device is designed to provide needleless drug access. The sterile access pin is used to pre-pierce the rubber drug vial closure, facilitating direct medication access with the BlunTip* cannula. Only one access pin penetration is required to enable repeated BlunTip* cannula access. Once drawn , the medicaton can be delivered through any pre-pierced I.V. port compatible with the BlunTip* cannula.

(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use (optional format 1-2-96)

(Division Sign-off)

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).