(325 days)
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No
The description details a software package that performs calculations based on measured inputs and physical parameters using a tracer dilution method. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is a software package that calculates blood volume and reports on hyper/hypovolemia; it does not directly treat or alleviate a medical condition.
Yes.
The device calculates hyper- or hypovolemia, which provides diagnostic information about a patient's condition.
Yes
The device is described explicitly as a "software package" and its function is solely calculation and reporting based on data inputs from external sources (gamma counter, physical parameters). It does not include or control any hardware components for data acquisition or treatment.
Based on the provided information, the Daxor BVA-100 is an IVD (In Vitro Diagnostic) device.
Here's why:
- It is used to examine specimens derived from the human body: The software processes data from "patient blood samples" and "tracer calibration standards," which are derived from human blood.
- It is intended for use in the diagnosis of disease or other conditions: The software calculates blood volume and reports "Hyper- or hypovolemia, and associated red cell volumes," which are conditions related to blood volume abnormalities. This information is used to aid in diagnosis and management of these conditions.
- It is used to cure, mitigate, treat, or prevent disease or other conditions: While the software itself doesn't directly treat, the information it provides is crucial for guiding treatment decisions for conditions related to blood volume.
The fact that it's a software package that processes data from laboratory measurements of biological samples strongly aligns with the definition of an IVD device.
N/A
Intended Use / Indications for Use
The Daxor BVA-100 is a software package designed to calculate human blood volume, using the method of tracer dilution, utilizing tagged scrum albumin (a commonly used tag is I-131, resulting in "I-HSA"). Data inputs to the software come from the measured characteristics of patient blood samples (hematocrit and tracer concentration) and traccr calibration standards. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red ccll volumes, are reported, with statistics showing the quality of the results.
The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.
Product codes
JWO
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.5950 Blood volume measuring device.
(a)
Identification. A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass, plasma volume, and total blood volume.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines beneath them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ronald H. Baldry Vice President for Engineering Daxor Corporation 312 Trossachs Lane Knoxville, Tennessee
Re : K964406 Automated Multi-point Blood Volume Analyzer Requlatory Class: II Product Code: JWO Dated: July 3, 1997 Received: July 7, 1997
Dear Mr. Baldry:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 assumptions. Failure to comply with the GMP regulation may result in 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 requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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) 594-4588. 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,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number: : K964406
Device Name: Blood Volume Analyzer - BVA-100
Indications for Use:
The Daxor BVA-100 is a software package designed to calculate human blood volume, using the method of tracer dilution, utilizing tagged scrum albumin (a commonly used tag is I-131, resulting in "I-HSA"). Data inputs to the software come from the measured characteristics of patient blood samples (hematocrit and tracer concentration) and traccr calibration standards. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red ccll volumes, are reported, with statistics showing the quality of the results.
The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K964406
ASE DO NOT WRITE BBLOW THIS LINE - CONTINUE ON ANOTHER. PAGE IF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| CFR 801.109) |
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Over-The-Counter Use