(301 days)
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.
Not Found
The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria. However, it does provide some information about the device and its claimed performance compared to a predicate device.
Here's an attempt to answer the questions based on the limited information provided, mostly inferring from the comparison to the predicate device:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state quantitative acceptance criteria or a formal performance report with specific metrics. Instead, it focuses on the theoretical differences in how the AESCULON® and its predicate device (BIOZ.COM®) interpret the impedance measurements. The "performance" here is implied by its claim of "substantial equivalence" and its different theoretical interpretation.
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Ability to measure base impedance ($Z_0$) | Measures $Z_0$ |
| Ability to measure maximum rate of change of impedance $\left(\frac{dZ(t)}{dt}\right)_{MIN}$ | Measures $\left(\frac{dZ(t)}{dt}\right)_{MIN}$, but interprets it as being related to peak aortic blood acceleration, deriving an index of contractility (ICON™). |
| Ability to measure left-ventricular flow time (FT) | Measures $FT$ |
| Substantial equivalence to predicate device's function as a hemodynamic monitor, cardiac output monitor, cardiovascular monitor | Deemed substantially equivalent to predicate device (BIOZ.COM®), despite differences in theoretical interpretation. |
2. Sample size used for the test set and the data provenance
This information is not provided in the document. There is no mention of a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. There is no mention of experts or ground truth establishment for a test set.
4. Adjudication method for the test set
This information is not provided in the document. The document does not describe any test set or adjudication process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This type of study is not applicable to this device. The AESCULON® is a hemodynamic monitoring device, not an AI-assisted diagnostic tool that would involve human readers interpreting images.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a standalone hemodynamic monitor. Its performance is based on its algorithms for interpreting bioelectrical impedance. There isn't a "human-in-the-loop" aspect described that would necessitate a standalone vs. assisted comparison in the typical sense of AI-driven diagnostic tools. The document describes the core algorithms and their theoretical interpretation of measurements.
7. The type of ground truth used
The document does not explicitly state the type of ground truth used for any validation study. Given the nature of a hemodynamic monitor, potential ground truths could involve:
- Invasive direct measurements of cardiac output (e.g., Swan-Ganz catheterization)
- Direct observation of physiological parameters
- Comparison to well-established, validated hemodynamic monitoring methods.
However, none of this is detailed in the provided text. The document primarily focuses on the theoretical interpretation of measurements and comparison to a predicate device.
8. The sample size for the training set
This information is not provided in the document. The document describes the algorithms and their theoretical basis, but not how they were developed or trained on specific datasets.
9. How the ground truth for the training set was established
This information is not provided in the document. As there is no mention of a training set, there is also no information on how its ground truth might have been established.
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Image /page/0/Picture/1 description: The image shows the logo for Osypka Medical. The logo consists of a black square with a white circle inside, followed by the text "OSYPKA MEDICAL" in a simple, sans-serif font. Below the company name, the text "Berlin, Germany • San Diego, California, USA" is written in a smaller font, indicating the company's locations.
510(k) Summary Page 1 of 4
FEB - 1 - 1 - 2002
| Date: | 1 April 2007 | ||
|---|---|---|---|
| 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®AESCULON®AESCULON®AESCULON®OSYPKA MEDICAL®AESCULON®AESCULON®AESCULON®AESCULON® | AESCULON® | CHF Clinic™Hypertension Clinic™Pacemaker Clinic™AESCULON®CHF Clinic™Hypertension Clinic™Pacemaker Clinic™ |
| Common /Usual Names: | Hemodynamic Monitor, Cardiac Output Monitor, CardiovascularMonitor | ||
| ClassificationNames: | 21 CFR 870.2770Impedance Plethysmograph | ||
| RegulatoryClass: | Class II | ||
| Product Code: | DSB | ||
| PredicateDevices: | K011439 | Cardiodynamics BIOZ.COM® Hemodynamic Monitor | |
| K033296 | Masimo SET® Rad 5 Pulse Oximeter | ||
| Both the AESCULON® and BIOZ.COM 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 / SV Algorithm | The AESCULON differs from the predicate device BIOZ.COM® with respect to the theoretical interpretation of the measurements, in particular of the magnitude of the maximum rate of change of impedance $\left(\frac{dZ(t)}{dt}\right)_{MIN}$ : | ||
| BIOZ.COM® (Predicate Device) | AESCULON® | ||
| ZMARC® | Electrical Velocimetry™ | ||
| The interpretation of $\left(\frac{dZ(t)}{dt}\right)_{MIN}$ is that it is related to peak blood velocity. The BioZ.COM® derives thereof a velocity index (VI). | The interpretation of $\left(\frac{dZ(t)}{dt}\right)_{MIN}$ is that it is related to peak aortic blood acceleration. The AESCULON® derives thereof an index of contractility (ICON™). | ||
| The BIOZ.COM® calculates the magnitude of the maximum of the second derivative of the change of impedance $\left(\frac{d^2Z(t)}{dt^2}\right)_{MIN}$ and derives thereof an acceleration index (ACI). | Because the magnitude of the maximum rate of change of impedance $\left(\frac{dZ(t)}{dt}\right)_{MIN}$ is interpreted as being related to acceleration, no additional index is derived. |
510(k) Summary
7855 Ivanhoe Avenue, Suite 226 • La Jolla, CA 92037 Osypka Medical, Inc. Phone (858) 454 0021 • Fax (858) 454 0064 www.osypkamed.com
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Image /page/1/Picture/1 description: The image shows the logo for Osypka Medical. The logo consists of a black square with a white circle inside, followed by the text "OSYPKA MEDICAL" in a sans-serif font. Below the company name, the text "Berlin, Germany • San Diego, California, USA" is written in a smaller font, indicating the company's locations.
510(k) Summary
Page 3 of 4
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB - 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Markus J. Osypka, Ph.D. President Osypka Medical, Inc. 7855 Ivanhoe Avenue, Suite 226 La Jolla, CA 92037
Re: K070985
Trade/Device Name: CARDIOTRONICTM AESCULON® Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: January 20, 2007 Received: January 23, 2007
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 J. Osypka, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
B. Simmon Jr.
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 (if known):
Device Name:
AESCULON® AESCULON® CHF Clinic™ AESCULON® Hypertension Clinic™ AESCULON® Pacemaker Clinic™
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.
Prescription Use (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.Zimmerman
Division of Chilovascular Devices
§ 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.