(266 days)
The KSEA model 38320 20 Angiomat pump is designed to provide a clear field of view during percutaneous and intra-operative endoscopy of the peripheral vascular system. Please consult your angloscope manual for specific indications and contraindications for use.
The KSEA model 383320 20 Angiomat for endoscopy of the peripheral vascular system is a microprocessor-based infusion pump, with user adjustable flow rates and pressure adjustment. The unit incorporates a wide variety of safety features including: bubble detection, pressure monitoring, volume monitoring and flow control. The Angiomat has two operating modes and also incorporates a bolus infusion function.
This document is a 510(k) summary for a medical device submitted to the FDA in 1996. It describes an infusion pump and asserts its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, study data, sample sizes, expert involvement, or any of the other specific details requested in your prompt.
The document primarily focuses on:
- Applicant and contact information
- Device identification (Common Name: Infusion Pump, Trade Name: KSEA Model 383320 20 Angiomat)
- Indication for Use (to provide a clear field of view during percutaneous and intra-operative endoscopy of the peripheral vascular system)
- Device Description (microprocessor-based infusion pump with user-adjustable flow rates, pressure adjustment, safety features like bubble detection, pressure monitoring, volume monitoring, flow control, two operating modes, and bolus infusion function)
- A statement of Substantial Equivalence to predicate devices.
Therefore, I cannot fulfill your request as the provided text does not contain the necessary information.
To answer your prompt, I would need a different document that details the studies conducted, their methodology, results, and acceptance criteria for the KSEA Model 383320 20 Angiomat.
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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The "O" in STORZ is stylized as a target.
Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe Culver City, Ca ifornia 90230-7600 Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
OCT 2 5 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.
Applicant:
Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500
Contact:
Betty M. Johnson Manager, Regulatory Affairs
Device Identification:
Common Name Infusion Pump
Trade Name KSEA Model 383320 20 Angiomat
Indication: The KSEA model 38320 20 Angiomat pump is designed to provide a clear field of view during percutaneous and intra-operative endoscopy of the peripheral vascular system. Please consult your angloscope manual for specific indications and contraindications for use.
Device Description: The KSEA model 383320 20 Angiomat for endoscopy of the peripheral vascular system is a microprocessor-based infusion pump, with user adjustable flow rates and pressure adjustment. The unit incorporates a wide variety of safety features including: bubble detection, pressure monitoring, volume monitoring and flow control. The Angiomat has two operating modes and also incorporates a bolus infusion function.
Substantial Equivalence: The KSEA model 383320 20 Angiomat for endoscopy of the peripheral vascular system is substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences between the KSEA Angiomat and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
Renate A. MacLaren, Ph.D.
Regulatory Affairs Speciali
§ 870.1800 Withdrawal-infusion pump.
(a)
Identification. A withdrawal-infusion pump is a device designed to inject accurately drugs into the bloodstream and to withdraw blood samples for use in determining cardiac output.(b)
Classification. Class II (performance standards).