(62 days)
The ICON® is intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments under the care of a physician, nurse or medical technician.
The ICON® is a noninvasive cardiac output monitor, also known as a hemodynamic monitor. By application of an array of adhesive ECG type surface electrode to the body, the ICON® measures thoracic electrical bioimpedance (TEB) and in particular the changes of bioimpedance related to the cardiac cycle. The ICON® determines hemodynamic parameters related to blood flow, contractility and fluid status.
The provided text is a 510(k) Summary for the DSYPKA MEDICAL 510(k) K082242 submission, introducing the CARDIOTRONIC® ICON® (also known as OSYPKA MEDICAL® ICON®) hemodynamic monitor. This document explicitly states that the submission is based on demonstrating substantial equivalence to a predicate device, the AESCULON® Type (Version) C2 (K081035).
Here's an analysis of the acceptance criteria and supporting study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the traditional sense of a clinical trial where specific numerical thresholds are met by the new device. Instead, the entire submission hinges on demonstrating substantial equivalence to a predicate device.
The "acceptance criteria" here are implicitly that the ICON® device performs "as well as" the predicate device, the AESCULON®. The "reported device performance" is a qualitative assessment of equivalence rather than quantitative measurements against predefined targets.
Implicit Acceptance Criteria and Performance (based on Substantial Equivalence):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety equivalent to predicate device | Concluded to be "as safe" as the AESCULON® |
| Effectiveness equivalent to predicate device | Concluded to be "as effective" as the AESCULON® |
| Performance equivalent to predicate device | Concluded to perform "as well as" the AESCULON® |
| Design, intended use, and principal of operation are substantially equivalent to predicate device | Stated to be "substantially equivalent" to the predicate device in these aspects |
| Provides hemodynamic parameters related to blood flow, contractility, and fluid status | Confirmed by device description and technology overview |
| Measurement of thoracic electrical bioimpedance (TEB) and recording of ECG | Confirmed by device description and technology overview |
| Derives $Z_0$, $\left (\frac{dZ(t)}{dt} \right )_{MIN}$, and $FT$ from TEB measurement | Confirmed by technology overview |
| Uses the same theoretical model for $\left (\frac{dZ(t)}{dt} \right )_{MIN}$ and relates it to peak aortic blood acceleration | Confirmed by "Theory / SV Algorithm" section |
| Estimates stroke volume (SV) using the formula $SV=V_{EPT} \cdot \overline{V}_{FT} \cdot FT$ | Confirmed by technology overview |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/Not reported. The document explicitly states: "Clinical testing not part of this submission." The demonstration of substantial equivalence was based on non-clinical performance data and a comparison to the predicate device.
- Data Provenance: The document explicitly states: "Demonstration of substantial equivalence between the ICON® (new device) and the AESCULON® (predicate device) was based on an assessment of non-clinical performance data." No specific country of origin for this non-clinical data is provided, nor is it specified if it's retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts and Qualifications: Not applicable/Not reported. Since clinical testing was not part of the submission and the approach was substantial equivalence based on non-clinical data, there would be no "ground truth" established by experts in the context of clinical performance evaluation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not reported. As no clinical "test set" was used for performance evaluation (only non-clinical data for substantial equivalence), no adjudication method is relevant or described.
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
- MRMC Study: No. This device is a hemodynamic monitor, not an AI-assisted diagnostic imaging tool with human readers. The concept of an MRMC study and "human readers" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: The document focuses on demonstrating that the device itself (the ICON® monitor) is substantially equivalent to the predicate device (AESCULON®). It's a medical device, not an AI algorithm in the typical sense that would have "human-in-the-loop performance" as a separate consideration. The comparison is between two complete physical devices. While the device contains algorithms for hemodynamic parameter calculation, a separate "standalone algorithm only" performance study, distinct from the device's overall performance, is not mentioned or implied.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Type of Ground Truth: Not applicable/Not reported for a clinical test set. Given that clinical testing was "not part of this submission," there was no clinical ground truth established for the new device's performance against actual patient conditions. The ground truth, in the context of this 510(k), is implicitly the established safety and effectiveness of the predicate device (AESCULON®), against which the new device (ICON®) is being compared for substantial equivalence using non-clinical data.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not reported. This document does not describe the development or training of a new algorithm where a "training set" would be used in the AI sense. It compares a new medical device to a legally marketed predicate device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable/Not reported. As there's no mention of a "training set" for an AI algorithm, this information is not relevant to the provided text.
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DSYPKA MEDICAL 510(k) Summary K082242
Berlin, Germany • San Diego, California, USA
Page 1 of 3
510(k) Summary
| Date: | 29 September 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 0021Fax: (858) 454 0064 |
| Device TradeNames: | CARDIOTRONIC® ICON®OSYPKA MEDICAL® ICON®All of Type (Version) C3 |
| Common /Usual Names: | Hemodynamic Monitor, Cardiac Output Monitor, Cardiovascular Monitor |
| ClassificationNames: | 21 CFR 870.2770 Impedance Plethysmograph |
| RegulatoryClass: | Class II |
| Product Code: | DSB |
| PredicateDevice: | K081035 AESCULON® Type (Version) C2, further referred to as the AESCULON® |
| DeviceDescription: | The ICON® is a noninvasive cardiac output monitor, also known as ahemodynamic monitor.By application of an array of adhesive ECG type surface electrode tothe body, the ICON® measures thoracic electrical bioimpedance(TEB) and in particular the changes of bioimpedance related to thecardiac cycle.The ICON® determines hemodynamic parameters related to bloodflow, contractility and fluid status. |
| Intended Use: | The ICON® is intended for noninvasive continuous monitoring ofhemodynamic parameters for adult, pediatric, and neonatal patients inhospitals, hospital-type facilities, mobile, and home environmentsunder the care of a physician, nurse or medical technician. |
| Technology: | The ICON®, including the option Pacemaker Clinic®, is substantiallyequivalent to the predicate device AESCULON® in terms of design,intended use and principal of operation. Measurement of thoracicelectrical 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 ICON® (new device) andAESCULON® (predicate device) use the general relationship$SV=V_{EPT} \cdot \overline{V}{FT} \cdot FT$with $V{EPT}$ being the volume of electrically participating tissue, $\overline{V}_{FT}$being the mean blood velocity during flow time, and $FT$ being the leftventricular flow time.Both the ICON® (new device) and the AESCULON® (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 /SV Algorithm | The ICON® (new device) and AESCULON® (predicate device) do notdiffer in the theoretical model applied to the measurement of themagnitude of the maximum rate of change of impedance$ \begin{pmatrix} \frac{dZ(t)}{dt} \end{pmatrix}_{MIN} $ , which relates this magnitude to peak aortic bloodacceleration. The ICON® (new device) and the AESCULON®(predicate device) derive thereof an index of contractility. |
| Options: | Unlike the AESCULON® (predicate device), the ICON® (new device)does not provide the options incorporating a module and accessoriesfor measurement of noninvasive blood pressure (NIBP) and pulseoximetry (SpO2). |
| Summary Non-Clinical Testing: | Demonstration of substantial equivalence between the ICON® (newdevice) and the AESCULON® (predicate device) was based on anassessment of non-clinical performance data. |
| SummaryClinical Testing: | Clinical testing not part of this submission. |
| Conclusion: | It is concluded that the ICON® is as safe, as effective, and performsas well as the AESCULON® (predicate device). |
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K082242 中文/3
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OSYPKA MEDICAL 510(k) Summary K082242
Berlin, Germany • San Diego, California, USA
Page 2 of 3
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OSYPKA MEDICAL 510(k) Summary K082242
Berlin, Germany · San Diego, California, USA
Page 3 of 3
OSYPKA MEDICAL, CARDIOTRONIC, the company logos, AESCULON, CHF CLINIC, ELECTRICAL
CARDIOMETRY, ELECTRICAL VELOCIMETRY, EV, ICON, and PACEMAKER CLINIC are trademarks Osypka Medical GmbH (Berlin, Germany), and Osypka Medical, Inc. (La Jolla, CA, USA). MASIMO and SET are trademarks of Masimo Corporation (Irvine, CA, USA).
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Public Health Service
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OCT 0 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Osypka Medical, Inc. c/o Markus Osypka, PhD President 7855 Ivanhoe Avenue, Suite 226 La Jolla, CA 92037
Re: K082242
Trade/Device Name: ICON Model C3 Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB Dated: September 19, 2008 Received: September 22, 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 – Markus Osypka, PhD
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 clectronic 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 Biometrics' (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,
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:
ICON®
Type C3
Indications for Use:
The ICON® is intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments under the care of a physician, nurse or medical technician.
x 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)
Atthlse for B Zuckerman
of Cardiovascular D
510(k) Number K082242
§ 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.