(80 days)
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Not Found
No
The provided text does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing that would typically indicate the use of AI/ML in a medical device. The description focuses solely on monitoring hemodynamic parameters.
No
The device is designed to monitor hemodynamic parameters, not to treat a disease or condition. While monitoring can be part of a therapeutic process, the device itself is for measurement and not intervention.
Yes
The device monitors hemodynamic parameters, which are used to assess the physiological state of a patient and aid in diagnosing conditions related to their circulatory system.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the BioZ System is software-only or includes hardware components.
Based on the provided information, the BioZ System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes monitoring hemodynamic parameters of a patient. This involves measuring physiological signals directly from the patient's body (ECG, heart rate, etc.).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The BioZ System's function of monitoring parameters directly from the patient's body falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BioZ System was designed to monitor a patients hemodynamic parameters. These include ECG, HR, PEP, LVET, STR, SV, SI, CO, CI, SVR. SVRI, EDV, EDI, IC, ACI, LCW and TFC.
Product codes
74 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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 11 1997
Mr. James Barley CardioDynamics International Corporation 6155 Cornerstone Court East, Suite 125 92121 San Diego, California
K972320 Re : BioZ System (Models BZ-100, 101, and 102)) and BioZ Portable (Model BZ-125) Regulatory Class: II (two) Product Code: 74 DSB June 19, 1997 Dated: Received: June 23, 1997
Dear Mr. Barley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. James Barley
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Zallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): k 972320
· BioZ System Device Name:
Indications for Use:
ﻟﺴﻨﺔ
The BioZ System was designed to monitor a patients hemodynamic parameters. These include ECG, HR, PEP, LVET, STR, SV, SI, CO, CI, SVR. SVRI, EDV, EDI, IC, ACI, LCW and TFC.
LIST OF ABBREVIATIONS
| ECG HR | Heart Rate |
|---|---|
| PEP | Pre-Ejection Period |
| LVET | Left Ventricular Ejection Time |
| STR | Systolic Time Ratio |
| SV | Stroke Volume |
| SI | Stroke Index |
| CO | Cardiac Output |
| CI | Cardiac Index |
| SVR | Systemic Vascular Resistance |
| SVRI | Systemic Vascular Resistance Inde |
| EDV | End Diastolic Volume |
| EDI | End Diastolic Index |
| IC | Index of Contractility |
| ACI | Acceleration Index |
| LCW | Left Cardiac Work |
| LCWI | Left Cardiac Work Index |
| TFC | Thoracic Fluid Content |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mr. Puzer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number .
Prescription Use_ (per 21 CFR 801.109)
Over-The-Counter Use_
OR
(Optional Format 1-2-96)