(252 days)
Not Found
Not Found
No
The description details a mechanical valve and rigid plastic adapter with no mention of software, algorithms, or data processing.
No.
The "Intended Use" states it's for "needlefree access to IV infusion systems for injection of fluids or aspiration of blood samples," indicating it's an accessory to facilitate drug delivery or sample collection, not a device that directly performs a therapy.
No
Explanation: The device is described as a connector for IV infusion systems used for injecting fluids or aspirating blood samples. Its function is to facilitate access and control fluid flow, not to diagnose a medical condition or disease.
No
The device description clearly outlines a physical, rigid plastic adapter with a silicone rubber valve, indicating it is a hardware medical device, not software.
Based on the provided information, the BMW Needlefree Valved Connector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "needlefree access to IV infusion systems for injection of fluids or aspiration of blood samples." This describes a device used for administering substances to or collecting samples from a patient in vivo (within the living body).
- Device Description: The description details a connector that facilitates the flow of fluids and blood within the patient's circulatory system or for administering fluids into the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. The description of the BMW Needlefree Valved Connector does not mention any function related to analyzing or testing samples in vitro.
The device is clearly designed for direct interaction with the patient's circulatory system for infusion and aspiration, which are in vivo procedures, not in vitro diagnostic tests.
N/A
Intended Use / 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.
Product codes
FPA
Device Description
BMW's Needlefree Valued 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
BMW Medical, Inc's Clampless Valved Catheter, B. Braun's Safsite
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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- Contact Person
189
- Contact Person
Roger L. Richins V. P. RAJQA
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- Device Identification:
Trade Name: Common Name: Classification Name: to be determined Needlefree Valved Connector and Cap Intravascular Catheter Accessory
- Device Identification:
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- Predicate Device(s): BMW Medical, Inc's Clampless Valved Catheter and B. Braun's Safsite.
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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.
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.
1
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- 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.
2
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
3
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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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) |