(423 days)
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No
The device description focuses on the physical components and intended uses of a standard central venous catheter, with no mention of AI or ML capabilities.
No
The intended uses are for diagnostics (pressure monitoring, blood sampling) and administration (fluid administration), not for treating a disease or condition.
Yes
The intended use includes "pressure monitoring" and "blood sampling", which are diagnostic applications.
No
The device description clearly outlines physical components such as polyurethane bodies, extension tubes, luers, clamps, and various kit components like guidewires, dilators, syringes, etc. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "non-permanent intravascular applications including pressure monitoring, fluid administration, and blood sampling." These are procedures performed on the patient's body, not tests performed on samples taken from the patient's body.
- Device Description: The description details a catheter designed for insertion into blood vessels. This is a medical device used for direct patient care, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological samples (like blood, urine, etc.), or any other components or processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device is used within the body for direct medical intervention and monitoring.
N/A
Intended Use / Indications for Use
These devices are intended for various non-permanent intravascular applications including pressure monitoring, fluid administration, and blood sampling.
Product codes
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Device Description
The various SDM Central Venous Catheters consist of polyurethane bodies with zero to five polyurethane extension tubes. Except for the smallest French sizes of the single lumen devices, the catheters all contain an additional flexible polyurethane distal tip. The proximal end(s) of each catheter terminate in molded-on, fixed, female locking luers. Where present, the extension tubes are joined to the catheter body by insertmolded polyurethane and contain clamps for occluding the tubes. Many configurations are marked with centimeter markings to indicate insertion depth. Catheters will be offered in "kits" which will include some or all of the following depending on configuration: Catheter, guidewire in dispenser, dilator, syringe, scalpel, suture wing, and introducer needle. The makeup of specific sets can be seen in the Appendix D of this 510(k) submission. These kits will be packaged in semi-rigid vacuum formed trays containing a heat-sealed, ethylene oxide permeable lids, or in standard Tyvek/Poly pouches, depending on the product configuration.
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
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Key Metrics
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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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§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a logo with the letters 'sdm' inside of a circle. The circle is surrounded by two horizontal lines on either side. The circle is also surrounded by two curved lines that form an oval shape.
X946764
999 Andersen Drive, Suite 120 San Rafael, California 94901 Phone 415-454-9370 Fax 415-454-9380
APR 2 4 1997
Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K960764
Applicant Information:
| Date Prepared: | January 20, 1997 |
|---|---|
| Name: | Scientific Device Manufacturer, LLC. |
| Address: | 999 Andersen Drive, Suite 120 |
| San Rafael, California 94901 |
| Contact Person: | Richard C. Ball |
|---|---|
| Phone Number: | 415-454-9370 |
| Fax Number: | 415-454-9380 |
Device Information:
Trade Name: Common Name: Classification Name:
Safe-Cath Single- and Multi-Lumen Intravascular Catheter Intravascular Catheter
Equivalent Device:
Central Venous Multi-Lumen Catheter with flexible tip (Arrow International). Temporary Dual and Triple Lumen Catheters (Vas-Cath Incorporated).
Device Description:
The various SDM Central Venous Catheters consist of polyurethane bodies with zero to five polyurethane extension tubes. Except for the smallest French sizes of the single lumen devices, the catheters all contain an additional flexible polyurethane distal tip. The proximal end(s) of each catheter terminate in molded-on, fixed, female locking luers. Where present, the extension tubes are joined to the catheter body by insertmolded polyurethane and contain clamps for occluding the tubes. Many configurations are marked with centimeter markings to indicate insertion depth.
Catheters will be offered in "kits" which will include some or all of the following depending on configuration: Catheter, guidewire in dispenser, dilator, syringe, scalpel, suture wing, and introducer needle. The makeup of specific sets can be seen in the Appendix D of this 510(k) submission. These kits will be packaged in semi-rigid vacuum formed trays containing a heat-sealed, ethylene oxide permeable lids, or in standard Tyvek/Poly pouches, depending on the product configuration.
1
Image /page/1/Picture/1 description: The image shows a symbol that appears to be related to a specific concept or entity. The symbol consists of a circle with the letters 'sdm' inside it. The circle is surrounded by a double-lined oval shape, which gives the symbol a distinct and recognizable appearance. The symbol is presented in black and white, with bold lines that make it stand out.
999 Andersen Drive, Suite 120 San Rafael, California 94901 Phone 415-454-9370 Fax 415-454-9380
SDM,LLC 510(k) Submittal Central Venous Catheters, Standard
Intended Use:
These devices are intended for various non-permanent intravascular applications including pressure monitoring, fluid administration, and blood sampling.
Comparison To Predicate Device:
Scientific Device Manufacturer's Vascular Access Catheters are substantially equivalent to currently marketed vascular access catheters will regard to intended use, materials, dimensions and mechanical properties. Predicate devices include those made by Arrow International and Vas-Cath Incorporated. No significant changes or modifications were made from those predicate devices other than the addition of two 8.5FR 5-Lumen versions. With the exception of slightly smaller lumen sizes, the 5-Lumen catheters are constructed in the same manner as the other SDM devices. SDM, L.L.C., therefore posits that its devices are equivalent in safety, effectiveness and intended use to those devices.
Signed:
Q. Ball
Name:
Richard C. Ball
VP Regulatory Affairs and Quality Assurance Position:
January 20, 1997 Date: