(30 days)
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No
The summary describes a device based on impedance cardiography and standard physiological measurements (HR, SV, CO, NIBP, CVP, SVR). There is no mention of AI, ML, or related concepts in the intended use, device description, or other sections.
No
The device is described as a "noninvasive hemodynamic monitor" that measures cardiac parameters and displays blood pressure and CVP. Its function is to monitor and display physiological data, not to treat a condition or restore a function.
Yes
The device is described as a "hemodynamic monitor" that "measures the following cardiac parameters: heart rate (HR); stroke volume (SV) and Cardiac Output (CO)." It also "displays with rate pressure product (RPP)" and calculates "systemic vascular resistance (SVR)." These actions relate to measuring and monitoring physiological parameters to assess the health status of a patient, which directly aligns with the function of a diagnostic device.
No
The device description explicitly states it is a "Non-Invasive Impedance Cardiograph," which is a hardware device that uses impedance technology to measure cardiac parameters. While it may have software components for data processing and display, the core technology is hardware-based.
Based on the provided information, the Steorra™ by SORBA is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body).
- The Steorra™ is described as a noninvasive hemodynamic monitor based on impedance cardiography. This technology measures electrical impedance changes on the body surface to assess cardiac function. It does not involve analyzing samples taken from the body.
Therefore, the Steorra™ operates in vivo (within the living body) and is not an IVD.
N/A
Intended Use / Indications for Use
The Steorra™ by SORBA is a noninvasive hemodynamic monitor based on the technology of impedance cardiography. The Steorra™ measures the following cardiac parameters: heart rate (HR); stroke volume (SV) and Cardiac Output (CO) The Steorra™ can be configured with optional noninvasive blood pressure (NIBP) technology. When blood pressure data are available (via the NIBP, analog input from an invasive monitor, or manual input), then systolic, diastolic and mean blood pressures are displayed with rate pressure product (RPP). If central venous pressure (CVP) is input as an analog signal from an invasive monitor, then CVP is displayed and systemic vascular resistance (SVR) is calculated and displayed.
Product codes
DSB
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three human profiles incorporated into its design, symbolizing the department's focus on health and human well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
Ms. Jill Barney President SORBA Medical Systems, Inc. 165 Bishops Way, Suite 152 Brookfield, WI 53005
Re: K014299
Trade Name: SORBA Steorra Non-Invasive Impedance Cardiograph Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: December 26, 2001 Received: December 31, 2001
Dear Ms. Barney:
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.
1
Page 2 - Ms. Jill Barney
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualied of a but enterest of the requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a determination that your active federal agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing (21 l comply with an the Act s requirements, morading practice requirements as set CFR Part 807); labeling (21 CFR Part 820); and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) i his letter will anow you to begin harkomig your as he equivalence of your device to a legally prematket notification. The PDA mainly of basification 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 and If you desire specific advice for your acvice diagnostic devices), please contact on one squartising and eductions additionally 21 CFC For 807.10 for in The Cragions on the promotion and advertising of Compliance at (301) 594-4640. Additionally, to: quested (301) 594-4639. Also, please note the Office Book 807 07 your device, prease connect the Chros of remarket notification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket in at triped from the It guilation entitled, "Misoranants of responsibilities under the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dolak Tule
ABram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KO14299 510K) Number (if known):
Device Name: SORBA Steorra Non-Invasive Impedance Cardiograph
Indications for Use: The Steorra™ by SORBA is a noninvasive hemodynamic monitor based on the technology of impedance cardiography. The Steorra™ measures the following cardiac parameters: heart rate (HR); stroke volume (SV) and Cardiac Output (CO) The Steonra™ can be configured vith optional noninvasive blood pressure (NIBP) technology. When blood pressure data are available (via the NIBP, analog input from an invasive monitor, or manual input), then systolic, diastolic and mean blood pressures are displayed with rate pressure product (RPP). If central venous pressure (CVP) is input as an analog signal from an invasive monitor, then CVP is displayed and systemic vascular resistance (SVR) is calculated and displayed.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Or
Over-The-Counter Use
Voleteh
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and
Neurological Devices
K014291
510(k)
N
Number