(49 days)
The AESCULON®, AESCULON® CHF Clinic™, AESCULON® Hypertension Clinic® and AESCULON® Pacemaker Clinic Fare intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:
1. Acceptance Criteria and Reported Device Performance:
The 510(k) summary for the AESCULON® Version C2 does not explicitly state quantitative acceptance criteria or typical device performance metrics in a table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device (AESCULON® Version C1.1). The core of the claim is that the new device "is as safe, as effective, and performs as well as the predicate device."
Therefore, the "acceptance criteria" are implicitly tied to the performance of the predicate device, which is considered to meet established safety and effectiveness standards for impedance plethysmographs. The "reported device performance" is framed as being equivalent to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Device is safe for intended use. | The AESCULON® Version C2 is concluded to be "as safe" as the predicate device Version C1.1. |
| Effectiveness: Device effectively measures hemodynamic parameters. | The AESCULON® Version C2 is concluded to be "as effective" as the predicate device Version C1.1. It determines hemodynamic parameters with respect to blood flow, vascular system, contractility, and fluid status, using the same theoretical model and algorithms as the predicate. |
| Performance: Device performs similarly to the predicate device in terms of design, intended use, and principle of operation. | The AESCULON® Version C2 is substantially equivalent to the predicate device Version C1.1 in terms of design, intended use, and principal of operation. It uses the same fundamental relationship for stroke volume (SV) and derives the same key parameters from TEB measurements. |
| Stroke Volume (SV) Calculation: Uses the same general relationship as the predicate. | Uses the relationship $SV = V_{EPT} · \bar{V}_{FT} · FT$, identical to the predicate device. |
| Derivation of Parameters from TEB: Measures $Z_0$, $ | \frac{dZ(t)}{dt} |
| Contractility Index (ICON™) Derivation: Uses the same theoretical model as the predicate for $ | \frac{dZ(t)}{dt} |
2. Sample Size and Data Provenance for the Test Set:
- Sample Size: Not applicable.
- Data Provenance: Not applicable.
The submission explicitly states: "Summary Clinical testing not part of this submission." This indicates that no new clinical test set was used to directly evaluate the AESCULON® Version C2. The demonstration of substantial equivalence was based on non-clinical performance data and the similarity to the predicate device.
3. Number of Experts and Qualifications for Ground Truth:
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
Since no clinical testing was performed for this submission, there was no need for experts to establish ground truth for a new test set.
4. Adjudication Method:
- Adjudication method: Not applicable.
As no clinical testing was performed, there was no need for an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC study: No.
The submission does not mention any MRMC study. The device is a monitor, not an image interpretation or diagnostic aid that typically involves human readers.
6. Standalone (Algorithm Only) Performance Study:
- Standalone study: Yes, implicitly.
The statement "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" implies that the new device's core algorithms and engineering performance were evaluated in comparison to the predicate. While not a "standalone performance study" in the sense of a new clinical trial, the assessment of "non-clinical performance data" confirms the algorithm's behavior is consistent with the established predicate's performance characteristics. This is a form of demonstrating algorithmic functionality without human intervention in the loop of the assessment itself.
7. Type of Ground Truth Used:
- Ground Truth: For the purpose of this 510(k) submission, the "ground truth" for the new device's acceptable performance is its substantial equivalence to the predicate device (AESCULON® Version C1.1), which itself would have undergone its own studies to establish its ground truth against recognized physiological measurements or clinical outcomes. The equivalence is established by comparing design, intended use, and principal of operation, as well as the underlying mathematical models and derived parameters.
8. Sample Size for the Training Set:
- Sample Size: Not applicable.
The document does not describe the use of machine learning or AI that would require a distinct "training set" in the conventional sense. The device appears to be based on established biophysical principles and algorithms rather than trained models from a large dataset.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable.
As there is no mention of a dedicated training set, the question of how its ground truth was established is not relevant to this submission. The core "truth" being referred to is the established performance and safety profile of the predicate device, against which the new device is compared for equivalence.
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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
Page 1 of 3
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., PresidentOsypka Medical, Inc.7855 Ivanhoe Avenue, Suite 226, La Jolla, California 92037Phone: (858) 454 0021 Fax: (858) 454 0064 | |||
| Device TradeNames: | 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, CardiovascularMonitor | |||
| ClassificationNames: | 21 CFR 870.2770 | Impedance Plethysmograph | ||
| RegulatoryClass: | Class II | |||
| Product Code: | DSB | |||
| PredicateDevice: | 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
T
<081035151
| DeviceDescription: | The AESCULON® Version C2, including the models CHF Clinic™,Hypertension Clinic™ and Pacemaker Clinic™, is a noninvasivecomprehensive cardiovascular monitor, also known as ahemodynamic monitor. | |
|---|---|---|
| By application of an array of adhesive ECG type surface electrode tothe body, the AESCULON® measures thoracic electricalbioimpedance (TEB) and in particular the changes of bioimpedancerelated to the cardiac cycle. | ||
| The AESCULON® determines hemodynamic parameters with respectto blood flow, vascular system (if the NIBP option is incorporated),contractility and fluid status. | ||
| Intended Use: | The AESCULON®, AESCULON® CHF Clinic™, AESCULON®Hypertension Clinic® and AESCULON® Pacemaker Clinic® areintended for noninvasive continuous monitoring of hemodynamicparameters for adult, pediatric, and neonatal patients in hospitals,hospital-type facilities, mobile, and home environments. | |
| Technology: | The AESCULON® Version C2, including the models CHF Clinic™,Hypertension Clinic™ and Pacemaker Clinic™, is substantiallyequivalent to the predicate device AESCULON® Version C1.1 in termsof design, intended use and principal of operation. Measurement ofthoracic electrical bioimpedance (TEB) and recording of the ECG isaccomplished by attaching an array of ECG type surface electrodes tothe patient. A high frequency, low amplitude patient auxiliary current isapplied via the outer electrodes and the resulting voltage and theECG is recorded between the inner electrodes. | |
| For the estimation of stroke volume (SV) the AESCULON® Version C2(new device) and Version C1.1 (predicate device) use the generalrelationship | ||
| $SV = V_{EPT} · \bar{V}_{FT} · FT$ | ||
| with $V_{EPT}$ being the volume of electrically participating tissue, $\bar{V}_{FT}$being the mean blood velocity during flow time, and FT being the leftventricular flow time. |
Image /page/1/Picture/4 description: The image shows a black square with a white circle inside. The circle is filled with a checkerboard pattern of alternating black and white squares. The checkerboard pattern is slightly distorted, as if it were wrapped around a sphere.
OSYPKA MEDICAL
Berlin, Germany • San Diego, California, USA
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OSYPKA MEDICAL
Berlin, Germany • San Diego, California, USA
510(k) Summary
Page 3 of 3
Both the AESCULON® Version C2 (new device) and Version C1.1
(predicate device) derive from the measurement of TEB
- the base impedance
$$Z_0$$
, - the magnitude of the maximum rate of change of impedance
$$\left| \frac{dZ(t)}{dt} \right|_{MIN}$$
, and
- the left-ventricular flow time
$$FT$$
.
Theory / The AESCULON® Version C2 (new device) and Version C1.1
SV Algorithm (predicate device) do not differ in the theoretical model applied to the
measurement of the magnitude of the maximum rate of change of
impedance
$$\left| \frac{dZ(t)}{dt} \right|_{MIN}$$
, which relates this magnitude to peak aortic
blood acceleration. The AESCULON® Version C2 (new device) and
Version C1.1 derive thereof an index of contractility (ICON™).
Options: The AESCULON® Version C2 (new device) and Version C1.1
(predicate device) may incorporate a module and accessories for
measurement of noninvasive blood pressure (NIBP) manufactured or
supplied by SunTech Medical Instruments, Raleigh, NC (model
'Advantage').
The AESCULON® Version C2 (new device) and Version C1.1
(predicate device) may incorporate a module and accessories for
pulse oximetry (SpO2) manufactured or supplied by Masimo, Irvine,
CA (Model 'MS-11').
Summary Non- Demonstration of substantial equivalence between the AESCULON®
Clinical Testing: Version C2 (new device) and the Version C1.1 (predicate device) was
based on an assessment of non-clinical performance data.
Summary Clinical testing not part of this submission.
Clinical Testing:
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.
08/035/51
OSYPKA MEDICAL, CARDIOTRONIC, the company logos, AESCULON, CHF CLINIC, ELECTRICAL OSTPRA MEDICAL, CARDIOTHONG, the Company logo, HEBO SEVY ON. SELVE, ICON, CANDIOMETIT, ELEOTHIONE VEEGEMENT DAY DAY CORER and WINDOW TO THE CIRCULATION are r Hociminer - Oeline, "Total" (Berlin, Germany), and Osypka Medical, Inc. (La Jolla, CA, USA). trademarks of Coyparks of Masimo Corporation (Irvine, CA, USA).
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Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, along with the department's name encircling it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the emblem. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2008
Osypka Medical, Inc. c/o Mr. Markus Osypka, Ph.D. President 7855 Ivanhoe Ave., Suite 226 La Jolla, CA 92037
Re: K081035
Aesculon®, Aesculon® CHF Clinic™, Aesculon® Hypertension Clinic and Aesculon® Pacemaker Clinic® Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: May 7, 2008 Received: May 12, 2008
Dear Dr. Osypka:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Markus Osypka, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blommor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name:
AESCULON® AESCULON® CHF Clinic ™ AESCULON® Hypertension Clinic® AESCULON® Pacemaker Clinic®
Version C2
Indications for Use:
The AESCULON®, AESCULON® CHF Clinic™, AESCULON® Hypertension Clinic® and
AESCULON® Pacemaker Clinic Fare intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND / OR
Over-The-Counter-Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B.Brammer
(Division Sign Off)
on of Cardio 510fk) Nu
§ 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.