(49 days)
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No
The document describes a device that measures bioimpedance and calculates hemodynamic parameters. There is no mention of AI, ML, or related technologies in the intended use, device description, or performance studies sections.
No
The device is used for monitoring hemodynamic parameters, not for treating or preventing a disease or condition.
Yes
The device is used for "noninvasive continuous monitoring of hemodynamic parameters," which are measurements used by healthcare professionals to diagnose and assess a patient's cardiovascular status.
No
The device description explicitly states that it measures thoracic electrical bioimpedance (TEB) by applying an array of adhesive ECG type surface electrodes to the body. This indicates the use of hardware components (electrodes and a monitor) to acquire the physiological data, making it a hardware-based medical device with accompanying software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes monitoring hemodynamic parameters in vivo (within the living body) using surface electrodes. IVDs are designed to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
- Device Description: The device measures thoracic electrical bioimpedance by applying electrodes to the body. This is a direct measurement on the patient, not an analysis of a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the AESCULON® and its variations are considered in vivo diagnostic devices or monitoring devices, not IVDs.
N/A
Intended Use / Indications for Use
The AESCULON®, AESCULON® CHF Clinic™, AESCULON® Hypertension Clinic® and AESCULON® Pacemaker Clinic® are intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Product codes (comma separated list FDA assigned to the subject device)
DSB
Device Description
The AESCULON® Version C2, including the models CHF Clinic™, Hypertension Clinic™ and Pacemaker Clinic™, is a noninvasive comprehensive cardiovascular monitor, also known as a hemodynamic monitor.
By application of an array of adhesive ECG type surface electrode to the body, the AESCULON® measures thoracic electrical bioimpedance (TEB) and in particular the changes of bioimpedance related to the cardiac cycle.
The AESCULON® determines hemodynamic parameters with respect to blood flow, vascular system (if the NIBP option is incorporated), contractility and fluid status.
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
Body
Indicated Patient Age Range
adult, pediatric, and neonatal patients
Intended User / Care Setting
hospitals, hospital-type facilities, mobile, and home environments
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)
Summary Non-Clinical Testing: Demonstration of substantial equivalence between the AESCULON® Version C2 (new device) and the Version C1.1 (predicate device) was based on an assessment of non-clinical performance data.
Summary Clinical Testing: Clinical testing not part of this submission.
Conclusion: It is concluded that the AESCULON® Version C2 is as safe, as effective, and performs as well as the predicate device Version C1.1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
K081035/S1
P1/3
Image /page/0/Picture/1 description: The image shows the logo for OSYPKA MEDICAL. The logo consists of a black square with a white checkered circle inside, followed by the text "OSYPKA MEDICAL" in a large, sans-serif font. Below the company name is the text "Berlin, Germany • San Diego, California, USA" in a smaller font, indicating the company's locations.
510(k) Summary
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510(k) Summary
MAY 3 0 2008
| Date: | 8 April 2008 | |||
|---|---|---|---|---|
| Submitter: | Osypka Medical, Inc. | |||
| 7855 Ivanhoe Avenue, Suite 226, La Jolla, CA 92037 | ||||
| Contact Person: | Markus Osypka, Ph.D., President | |||
| Osypka Medical, Inc. | ||||
| 7855 Ivanhoe Avenue, Suite 226, La Jolla, California 92037 | ||||
| Phone: (858) 454 0021 Fax: (858) 454 0064 | ||||
| Device Trade | ||||
| Names: | CARDIOTRONIC™ | AESCULON® | CHF Clinic™ | |
| AESCULON® | Hypertension Clinic™ | |||
| AESCULON® | Pacemaker Clinic™ | |||
| OSYPKA MEDICAL® | AESCULON® | |||
| AESCULON® | CHF Clinic™ | |||
| AESCULON® | Hypertension Clinic™ | |||
| AESCULON® | Pacemaker Clinic™ | |||
| All of Version C2 | ||||
| Common / | ||||
| Usual Names: | Hemodynamic Monitor, Cardiac Output Monitor, Cardiovascular | |||
| Monitor | ||||
| Classification | ||||
| Names: | 21 CFR 870.2770 | Impedance Plethysmograph | ||
| Regulatory | ||||
| Class: | Class II | |||
| Product Code: | DSB | |||
| Predicate | ||||
| Device: | K070895 | AESCULON® Version C1.1 |
7855 Ivanhoe Avenue, Suite 226 • La Jolla, CA 92037
Phone (858) 454 0021 • Fax (858) 454 0064
www.osypkamed.com Osypka Medical, Inc.
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510(k) Summary
Page 2 of 3
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