(188 days)
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No
The device description focuses on mechanical components and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is used for injecting contrast media, which aids in diagnostic imaging, not for treating a disease or condition.
No
Explanation: The device description states its intended use is for "hand injection of contrast media during angiography." This describes a role in the administration of a substance for imaging, not in the interpretation or diagnosis based on the imaging itself. It is an accessory for an imaging procedure, not a diagnostic tool.
No
The device description clearly details physical components like polycarbonate barrels, an elastomeric piston, and a polymeric plunger, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for hand injection of contrast media during angiography." This is a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a syringe for injecting substances into the body. This is a medical device used for direct patient care, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention anything related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is for delivering a substance into the body.
N/A
Intended Use / Indications for Use
This device is intended for hand injection of contrast media during angiography.
Product codes
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Device Description
The SDM Control Syringes consist of visibly clear high strength polycarbonate barrels, an elastomeric piston, and a high strength polymeric plunger terminating in a palm plate. The device is modeled in the European style in regard to the finger grips and palm plate. Each barrel is marked to 10cc's of volume in increments of 0.2cc and is very lightly coated with a medical grade silicone oil to enhance smootheness of operation. Two models will be available, one having a 0.5cc reservoir of internal volume remaining in the fully inserted position. The other model will leave no reservoir following full travel of plunger to the bottom of the barrel. These devices will be supplied single packaged and sterile. Packaging will consist of standard Tyvek/Poly pouches.
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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§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image shows a logo with the letters "sdm" inside of a circle. There are two curved lines above and below the circle. To the left of the circle are two horizontal lines.
scientific device manulac
8 AUG
999 Andersen Drive, Suile 110 San Rafael, California 94901 Phone 415-454-9370 Fax 415-454-9380
SUMMARY OF SAFETY AND AFFECTIVENESS
SDM CONTROL SYRINGES
510(k) Premarket Notification
| Trade Name: | SDM Control Syringes |
|---|---|
| Generic Name: | High Pressure Syringes |
| Manufacturer: | Scientific Device Manufacturer, Inc. |
| 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 Control Syringes consist of visibly clear high strength polycarbonate barrels, an elastomeric piston, and a high strength polymeric plunger terminating in a palm plate. The device is modeled in the European style in regard to the finger grips and palm plate. Each barrel is marked to 10cc's of volume in increments of 0.2cc and is very lightly coated with a medical grade silicone oil to enhance smootheness of operation. Two models will be available, one having a 0.5cc reservoir of internal volume remaining in the fully inserted position. The other model will leave no reservoir following full travel of plunger to the bottom of the barrel. These devices will be supplied single packaged and sterile. Packaging will consist of standard Tyvek/Poly pouches.
1
Image /page/1/Picture/0 description: The image shows a symbol that appears to be a stylized representation of an eye or a lens. The symbol consists of a circle with the letters 'sdm' inscribed inside. The circle is surrounded by two curved shapes that resemble eyelids or brackets, and there are horizontal lines on either side of the symbol, giving it a symmetrical appearance. The overall design is simple and graphic, with a focus on the central letters and the surrounding shapes.
999 Andersen Drive, Suite 110 San Rafael, California 94901 Phone 415-454-9370 Fax 415-454-9380
Intended Use:
This device is intended for hand injection of contrast media during angiography.
Rationale for Substantial Equivalence:
Scientific Device Manufacturer's Control Syringes are substantially equivalent to currently marketed "Control" and "Angiographic" syringes with regard to intended use, materials, and design. Predicate devices include those made by Medex, Namic, Becton Dickinson and Merit. No significant changes or modifications were made from those predicate devices. SDM therefore posits that its devices are equivalent in safety and effectiveness to those devices.
Biocompatability Evaluations:
Materials used in Scientific Device Manufacturer's Control Syringes were chosen to be generically of the same type and grade 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 requirements of ISO Standard 109993, Part I.
Summary:
Based upon the product description, its intended use, and comparative features of predicate devices, the Scientific Device Manufacturer's Control Syringes are substantially equivalent to other high pressure syringes currently approved for use.
Richard C. Ball
Richard C. Ball Vice President Regulatory Affairs and Quality Assurance