K Number

Device Name

Manufacturer

BMW MEDICAL, INC.

Date Cleared

1997-07-16

(252 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The BMW Needlefree Valved Connector is designed for needlefree access to IV infusion systems for injection of fluids or aspiration of blood samples.

Device Description

BMW's Needlefree Valved Connector is a rigid plastic adapter with a male luer port on the distal end for attachment to I.V. access systems (e.g., catheters). The proximal end terminates in a female luer lock fitting which may be attached to any I.V. administration set terminating in a standard male luer. The female luer is capped when napt in use to minimize the potential for contamination.

The plastic adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve is normally closed when it is not in use. The valve opens towards the I.V. access system when fluids are infused into the patient and it opens away from the I.V. access system to permit aspiration of blood samples. The valve is captured (sandwiched) between the seating surfaces of the two-piece adapter. The seating surfaces of the adapter are held in position by a bond between the proximal and distal pieces of the adapter. The connector valve is packaged in a sterile blister pack with male luer cap(s). The caps will also be packaged and sold individually.

AI/ML Overview

This device is a physical medical device (Needlefree Valved Connector and Cap), not an AI/ML powered software, therefore, many of the requested categories are not applicable. The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with acceptance criteria typical for novel devices or software.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as might be expected for an AI/ML device or a device with new performance claims. Instead, the performance is described in terms of substantial equivalence to existing predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence: Device performs the same intended functions as predicate devices.	The valve remains closed when not in use. The valve opens toward the distal end of the I.V. administration system (catheter) when fluids are infused. The valve opens away from the I.V. device to permit aspiration of blood samples.
Physical Equivalence: Physical characteristics are substantially equivalent to a predicate device, with differences not raising new safety or efficacy questions.	Physical characteristics are substantially equivalent to the hub of BMW's Clampless Valued Catheter, except for attachment mechanisms (male luer lock vs. tapered barbed extension). The male luer lock attachment meets ANSI standards.
Safety and Efficacy: No new questions of safety and efficacy are raised compared to predicate devices.	The male luer lock attachment of the Needle Free Connector meets ANSI standards and "poses no new questions of safety and efficacy to the user." Offers the same needlefree access features as Braun's Safsite, reducing accidental stick risk. Both must be capped when not in use to minimize contamination.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. Given this is a physical device submission focused on substantial equivalence, the "test set" would likely refer to engineering verification and validation testing (e.g., flow rate, pressure, material compatibility, leak testing, functional cycling), rather than a clinical dataset in the AI/ML context. The document does not detail specific sample sizes for these tests or their provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/not provided. For a physical medical device like this, "ground truth" as typically defined for AI/ML (e.g., expert consensus on medical images) is not relevant. Performance is typically assessed against engineering specifications and predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are common in clinical studies where expert disagreement needs to be resolved for ground truth establishment. This type of submission relies on engineering testing and comparison with predicate devices.

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 information is not applicable. This is a physical medical device, not an AI/ML software, and therefore, an MRMC study related to human readers improving with AI assistance would not be performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on:

Engineering Specifications: Adherence to design requirements (e.g., luer lock meeting ANSI standards).
Functional Performance Comparison: Demonstrating that the device performs functionally identically to the predicate device (e.g., valve opening/closing as intended for infusion and aspiration).
Safety Profile: Assurance that design differences do not introduce new safety concerns, implicitly relying on established safety profiles of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device, not an AI/ML model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.

Summary

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K964439

JUL 16 1997

510 K SUMMARY Prepared: November 4, 1996

1. Submitted by:

Roger L. Richins V. P. RAIQA BMW Medical, Inc. 3598 West 1820 South Salt Lake City, UT 84107

Tel: (801) 954-8444 Fax: (801) 954-8484

1. Contact Person
  189

Roger L. Richins V. P. RAJQA

1. Device Identification:
  Trade Name: Common Name: Classification Name: to be determined Needlefree Valved Connector and Cap Intravascular Catheter Accessory
1. Predicate Device(s): BMW Medical, Inc's Clampless Valved Catheter and B. Braun's Safsite.
BMW's Needlefree Valved Connector is a rigid 5. Device Description: plastic adapter with a male luer port on the distal end for attachment to I.V. access systems (e.g., catheters). The proximal end terminates in a female luer lock fitting which may be attached to any I.V. administration set terminating in a standard male luer. The female luer is capped when napt in use to minimize the potential for contamination.

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1. Intended Use: The BMW Needlefree Valved Connector is designed for needlefree access to IV infusion systems for injection of fluids or aspiration of blood samples.

7. Summary of Technological Characteristics of Device in relation to Predicate Device(s):

A. Comparison of Physical Characteristics:

The physical characteristics of BMW's Needlefree Valved Connector are substantially equivalent to those of the hub of BMW's Clampless Valved Catheter except for the attachment mechanisms. The Needlefree Valved Connector has a male luer lock on the distal end of the adapter, permitting its direct, or indirect, attachment to a venous access system (catheter). The predicate device has a tapered barbed extension on the distal end of its plastic adapter which mechanically locks into and is integrally attached to BMW's Clampless Valved Catheter. The male luer lock attachment of the Needle Free Connector meets ANSI standards and poses no new questions of safety and efficacy to the user.

B Comparison of Performance Characteristics:

The Needlefree Valved Connector performs exactly the same as the hub of BMW's predicate device. The 2-piece adapters of both devices house a slitted disc of silicone rubber which serves as a three-way valve. The valve remains closed when the device is not in use. The valve opens toward the distal end of the I.V. administration system (catheter) when fluids are infused through it, and it opens away from the I.V. device to permit aspiration of blood samples. BMW's new connector offers the same needlefree access features as Braun's Safsite. Both reduce the risk of an accidental stick with a bloodcontaminated needle. Both must be capped when not in use to minimize the potential for contamination.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8. Conclusion:

BMW's Needlefree Connector and Cap are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Roger L. Richins Vice President Regulatory Affairs & Quality Assurance BMW Medical, Incorporated 3598 West 1820 South JUL 16 1997 Salt Lake City, Utah 84104-4959

K964439 Re : Needle-Free Valved Connector And Cap Trade Name: Requlatory Class: II Product Code: FPA Dated: June 26, 1997 Received: June 30, 1997

Dear Mr. Richins:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, 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 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 Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531

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Page 2 - Mr. Richins

through 542 of the Act for devices under the Electronic chrough Sra Crion 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 deborizon substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed preared overmits 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 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 general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeathou from one (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Tim Ulatowski v A. 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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K964439

Page 1 of _1

510(k) Number (If known): ____________________________________________________________________________________________________________________________________________________

Device Name: Needlefree Valved Connector and Cap

Indications For Use:

The BMW Needlefree Valved Connector is designed for needlefree access to IV infusion systems for

injection of fluids or aspiration of blood samples.

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

Concurrence of CDRH, Office of Evaluation (ODE)

(Division Sign-Off)	Palacea Cucenti
Division of Dental, Infection Control. and General Hospital Devices
510(k) Number	K964439

Prescription Use	OR	Over-The-Counter-Use
(Per 21 CFR 801.109)		(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.