ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER by BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES

The Needleless Vial Adapter is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Needleless Vial Adapter provides for the entry into a stoppered vial without the need of a sharp needle by allowing for the use of a blunt cannula.

Device Description

The B.E.C. Needleless Vial Adater consists of a Needleless Injection Site which is a tubular body with a male luer slip attachment at one end. This site is bonded to the female luer lock of the Medimop Vial Access device. The other end of the injection sites tubular body is provided with an enlarged section adapted to receive a cylindrical retaining ring which surrounds and compresses a pre-slit, natural rubber or polyisoprene septum. The septum retaining ring and enlarged section of the tubular body are adapted to receive and latch with the BEC. MED-NET or IMED shrouded plastic cannula. The pre-slit septum re-seals upon removal of the cannula.

AI/ML Overview

This 510(k) submission for the BEC Needleless Vial Adapter describes the device and its intended use, but it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested.

The document states that "Technological data and performance data for the injection site employed were submitted for the IMED predicate device in 510(k) #K944320." This implies that BEC is leveraging data from a previously cleared predicate device rather than conducting a new, separate study for this specific 510(k) submission to demonstrate substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of the specific questions about the study design.

However, based on the information provided, here's what can be extracted:

Device Name: Access Systems Needleless Vial Adapter (also referred to as Needleless Vial Access Device)
Intended Use: To provide additional protection against inadvertent "needlestick" injuries to healthcare providers during the administration of fluids and medications, by allowing entry into a stoppered vial without a sharp needle, using a blunt cannula.
Predicate Device: IMED predicate device in 510(k) #K944320.
Performance Data Source: The performance data for the injection site employed (which is a component of the BEC device) was submitted for the IMED predicate device (K944320). This indicates reliance on previously established performance, not a new study.

Absence of information regarding:

Table of acceptance criteria and reported device performance: Not present.
Sample size and data provenance for the test set: Not present, as no new test set study is detailed.
Number of experts and qualifications for ground truth: Not applicable, as no new clinical or expert-based ground truth establishment is described.
Adjudication method: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned and unlikely for this type of device.
Standalone algorithm performance: Not applicable, as this is a medical device, not an algorithm.
Type of ground truth used: Not applicable for a new study.
Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
How ground truth for the training set was established: Not applicable.

In essence, this 510(k) focuses on demonstrating substantial equivalence by referencing a predicate device and its established performance, rather than providing details of a new, standalone study with specific acceptance criteria.

Summary

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510(k) Summary

Headquarters/ Laboratory 705 front street toledo, ohio 43605 phone: (419) 693-5307 fax: (419) 691-0418

Environmental Laboratory 1632 enterprise parkway twinsburg, ohio 44087 phone: (216) 425-8200 fax: (216) 425-1349

Saies Office 129 dixie way south south bend, indiana 46637 phone: (219) 272-2200

Sales Office 77 west elmwood drive suite 123 dayton, ohio 45459 phone: (513) 438-1711

Medical Products Division

615 front street toledo, ohio 43605 phone: (419) 693-5307 fax: (419) 691-1227 Re: Trade Name: Common Name:

Access Systems Needleless Vial Adapter Needleless Vial Access Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection 75JKA

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 and DSMA 1995.

The Needleless Injection Site is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Needleless Vial Adapter provides for the entry into a stoppered vial without the need of a sharp needle by allowing for the use of a blunt cannula.

This needleless vial adapter is similar to those marketed by Baxter Healthcare, Abbott Laboratories, and McGaw, Inc. Technological data and performance data for the injection site employed were submitted for the IMED predicate device in 510(k) #K944320.

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510(k) Summary (Continued)

Packaging of the device is either performed in-house or under contract by a Sterilization is performed in-house using a registered device establishment. validated ethylene oxide process. Both packaging and sterilization procedures are consistent with those generally used by the medical device industry.

Contact Person:

James P. Kulla, President

4/22/97
Date Prepared

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1997

Mr. James P. Kulla President Biological & Environmental Control Laboratories 705 Front Street -----Toledo, Ohio 43605

Re : K971500 Trade Name: Access Systems Needleless Vial Adapter Regulatory Class: II Product Code: FPA Dated: Auqust 1, 1997 Received: August 4, 1997

Dear Mr. Kulla:

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 current Good Manufacturing Practice requirement, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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

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Page 2 - Mr. Kulla

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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) 594-4618. 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 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.fida.gov/cdrh/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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510(k) Number (if known):

Device Name: Needleless Vial Adapter

ations For Use:

The risk to health care providers of "needlestick" injuries has become a major public health and worker safety concern. The Needleless Vial Adapter is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Needleless Vial Adapter provides for the entry into a stoppered vial without the need of a sharp needle by allowing for the use of a blunt cannula.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cucente

(Division Sig Division of De and General Hoopita 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.