K960431 · Scientific Device Manufacturer, LLC · FPA · Oct 29, 1996 · General Hospital
Device Facts
Record ID
K960431
Device Name
PRESSURE STOPCOCK/MANIFOLD
Applicant
Scientific Device Manufacturer, LLC
Product Code
FPA · General Hospital
Decision Date
Oct 29, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5440
Device Class
Class 2
Indications for Use
This device provides additional access ports into a standard angiographic fluid delivery system and can be used in conjunction with syringes and other accessories where angiographic injection is indicated. This product’s medium/high pressure designation does not preclude its use for low pressure modalities.
Device Story
SDM Angiographic Manifold consists of one or more stopcocks connected in-line; some models include high-pressure extension lines. Device provides additional access ports for angiographic fluid delivery systems; used with syringes and accessories. Operated by clinicians in clinical settings. Polycarbonate body; polyethylene handle plugs; lightly siliconized for rotation. Supplied sterile in Tyvek/Poly pouches. Facilitates fluid delivery during angiography; enables multi-port access for contrast or saline injection.
Clinical Evidence
Bench testing only. Biocompatibility testing performed per ISO 10993, Part I for externally communicating, blood path indirect devices.
Indicated for use as an access port in angiographic fluid delivery systems for patients requiring angiographic injection procedures.
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
Namic stopcock/manifold devices
Medex stopcock/manifold devices
Spectra Medical stopcock/manifold devices
Submission Summary (Full Text)
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scientific device manufacturer, L.L.C.
Sdm
OCT 29 1996
999 Andersen Drive, Suite 120
San Rafael, California 94901
Phone 415-454-9370 Fax 415-454-9380
# SUMMARY OF SAFETY AND EFFECTIVENESS
K960431
SDM Angiographic Manifold with Extension Lines
510(k) Premarket Notification
**Trade Name:** SDM Angiographic Manifold
**Generic Name:** Stopcock and Manifold
**Manufacturer:** Scientific Device Manufacturer, LLC.
999 Andersen Drive, Suite 110
San Rafael, CA 94901
Establishment Registration Number: TBD
## Classification:
In preparation of this PreMarket Notification, it was determined that devices of this generic type have been previously classified as Class II devices. No performance standards have yet been established for these products.
## Product Description:
The SDM Angiographic Manifold consists of one or more stopcocks, where the multiple stopcock configurations are connected in line to form a manifold, with some models of each also having a high pressure extension line attached. These devices have bodies made of polycarbonate and handle plugs made of polyethylene. The plugs are lightly siliconized for smooth rotation. Each of the devices will be supplied single packaged and sterile. Packaging will consist of a standard Tyvek/Poly pouch.
## Intended Use:
This device provides additional access ports into a standard angiographic fluid delivery system and can be used in conjunction with syringes and other accessories where angiographic injection is indicated. This product’s medium/high pressure designation does not preclude its use for low pressure modalities.
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## Rationale for Substantial Equivalence:
Scientific Device Manufacturer's Stopcock / Manifolds are substantially equivalent to currently marketed medium and high pressure stopcock / manifold devices with regards to intended use, materials, and design. Dimensions, materials, and functionality have been chosen to replicate several of the predicate devices, including those made by Namic, Medex, and Spectra Medical. No significant changes or modifications were made from those devices. SDM therefore posits that its devices are equivalent in safety and effectiveness to those devices.
## Biocompatibility Evaluation:
Materials used in Scientific Device Manufacturer's Angiographic Manifolds were chosen to be generically the same as those present in the substantially equivalent devices. Testing performed by SDM for this externally communicating device (blood path indirect) shows this device to be biocompatible per the requirements of ISO Standard 10993, Part I.
## Summary:
Based upon the product description, its intended use, and comparative features of predicate devices, the Scientific Device Manufacturer's Angiographic Manifold is substantially equivalent to other medium and high pressure manifolds currently in use.
Richard C. Ball
Vice President Regulatory Affairs and Quality Assurance
