K Number
K960431
Device Name
PRESSURE STOPCOCK/MANIFOLD
Date Cleared
1996-10-29

(272 days)

Product Code
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 nressure designation does not preclude its use for low pressure modalities.
Device Description
The SDM Angiographic Manifold consist 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 nolvearbonate and handle plugs made of polyethylene. The plugs are lightlv siliconized for smooth rotation. Each of the devices will be supplied single packaged and sterile. Packaging will consist of a standard Tyvek/Poly pouch.
More Information

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Not Found

No
The description focuses on the mechanical components and intended use of a fluid delivery system accessory, with no mention of software, algorithms, or data processing that would indicate AI/ML.

No
The device provides additional access ports for an angiographic fluid delivery system and is used with syringes and other accessories for angiographic injection, not for treating a disease or condition.

No

Explanation: The device description clearly states its purpose is to provide additional access ports for fluid delivery and can be used with syringes and other accessories for angiographic injection. It is a physical manifold with stopcocks, facilitating the delivery of substances, not diagnosing conditions or diseases.

No

The device description clearly outlines physical components made of polycarbonate and polyethylene, indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device as providing access ports into an angiographic fluid delivery system for use with syringes and other accessories where angiographic injection is indicated. This is a device used for delivering substances into the body, not for testing samples from the body.
  • Device Description: The description details the physical components of a manifold used in fluid delivery systems. There is no mention of reagents, samples (like blood, urine, etc.), or any process related to analyzing biological specimens.
  • Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples.
    • Detecting or measuring substances in samples.
    • Providing diagnostic information based on sample analysis.
    • Mentions of assays, tests, or laboratory procedures.

The device is clearly intended for use in a clinical setting for delivering fluids during angiographic procedures, which is a therapeutic or interventional process, not a diagnostic one in the sense of an IVD.

N/A

Intended Use / 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 nressure designation does not preclude its use for low pressure modalities.

Product codes

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Device Description

The SDM Angiographic Manifold consist 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 nolvearbonate and handle plugs made of polyethylene. The plugs are lightlv siliconized for smooth rotation. Each of the devices will be supplied single packaged and sterile. Packaging will consist of a standard Tyvek/Poly pouch.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 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

Image /page/0/Picture/0 description: The image shows a symbol that appears to be a stylized representation of an eye. The central element is a circle with the letters 'sdm' inside. The circle is surrounded by two curved lines that resemble eyelids, and there are two horizontal lines on the left side and a filled circle on the left side of the symbol.

scientific device manufacturer, L.L.C.

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

  • SDM Angiographic Manifold Trade Name:
  • Generic Name: Stopcock and Manifold

Scientific Device Manufacturer, LLC. Manufacturer: 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 consist 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 nolvearbonate and handle plugs made of polyethylene. The plugs are lightlv 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 nressure designation does not preclude its use for low pressure modalities.

1

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.

Biocompatability 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.

Riland C. Ball

Richard C. Ball Vice President Regulatory Affairs and Quality Assurance