(423 days)
These devices are intended for various non-permanent intravascular applications including pressure monitoring, fluid administration, and blood sampling.
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.
This document describes the Safe-Cath Single- and Multi-Lumen Intravascular Catheter. However, it is a 510(k) Summary of Safety and Effectiveness for a medical device and does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
A 510(k) premarket notification is submitted to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This typically involves demonstrating "substantial equivalence" rather than presenting original clinical studies with detailed acceptance criteria and performance data in the way an AI/ML device submission would.
Therefore, I cannot provide the requested information from this document. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance data for an algorithm.
- Type of ground truth used (as it's not an AI/ML device).
- Sample size for a training set (as it's not an AI/ML device).
- How ground truth for a training set was established (as it's not an AI/ML device).
The document focuses on comparing the Safe-Cath catheter to predicate devices based on intended use, materials, dimensions, and mechanical properties, to argue for substantial equivalence, not to present a study demonstrating performance against specific acceptance criteria.
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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 120San 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.
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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:
§ 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).