(266 days)
Not Found
Not Found
No
The description mentions a "microprocessor-based infusion pump" with standard safety features and adjustable parameters, but there is no mention of AI, ML, image processing, or any learning capabilities.
No
The device is an infusion pump designed to provide a clear field of view during endoscopy, not to treat a specific medical condition.
No
Explanation: The device is described as an "infusion pump" designed to "provide a clear field of view during percutaneous and intra-operative endoscopy of the peripheral vascular system." Its function is to facilitate a procedure (endoscopy) rather than to diagnose a condition. It provides support during a medical intervention.
No
The device description clearly states it is a "microprocessor-based infusion pump," indicating it is a hardware device with embedded software, not a standalone software-only medical device.
Based on the provided information, the KSEA model 38320 20 Angiomat pump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a clear field of view during percutaneous and intra-operative endoscopy of the peripheral vascular system." This describes a device used in vivo (within the body) to facilitate a medical procedure (endoscopy).
- Device Description: The description details an "infusion pump" that delivers fluids. This is consistent with a device used to irrigate or infuse fluids directly into the body during a procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. The Angiomat pump's function is to support a surgical/endoscopic procedure, not to analyze biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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