(764 days)
Not Found.
Not Found.
No
The provided text does not contain any keywords or descriptions that explicitly mention or imply the use of AI or ML technology.
No
The provided information describes a "Hemodynamic and Oxygen Transport Monitoring and Managing System," which implies a diagnostic or monitoring function rather than a direct therapeutic intervention.
No
The provided information does not contain an "Intended Use / Indications for Use" section, which is crucial for determining if a device is diagnostic. The "Device Description" only states its name and what it monitors ("Hemodynamic and Oxygen Transport Monitoring and Managing System") but doesn't specify if it diagnoses conditions or only monitors parameters.
Unknown
The provided text only gives the device name and acronym. It lacks any description of the device's function, components, or how it interacts with the user or other systems. Without this information, it's impossible to determine if it's software-only or includes hardware.
Based on the provided information, it is not possible to determine if the HOTMAN device is an IVD (In Vitro Diagnostic).
Here's why:
- The provided text lacks the crucial information needed to classify a device as an IVD. An IVD is a medical device used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- The description "Hemodynamic and Oxygen Transport Monitoring and Manaqing System" suggests a device that monitors physiological parameters within the body. This is more typical of a device used in vivo (within a living organism) rather than in vitro (in a test tube or laboratory setting).
- None of the sections that would typically indicate an IVD are present or contain relevant information. For example, there's no mention of:
- Analyzing biological specimens.
- Specific analytes being measured.
- Laboratory use.
In conclusion, the provided description of the HOTMAN device does not contain any information that would classify it as an In Vitro Diagnostic. It appears to be a system for monitoring physiological parameters directly from a patient.
N/A
Intended Use / Indications for Use
Not Found.
Product codes
74 KFR
Device Description
Not Found.
Mentions image processing
Not Found.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
Not Found.
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Not Found.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
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.
Not Found.
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.
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a flowing design that suggests movement or progress. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 100 1997
B. Bo Sramek, Ph.D. Hemo Sapiens®, Inc. ...... 19211 Edgehill Drive Irvine, California 92715
Re: * K952172 HOTMAN (Hemodynamic and Oxygen Transport Monitoring and Manaqing System) Regulatory Class: II (two) Product Code: 74 KFR Dated: March 8, 1997 Received: March 13, 1997
Dear Dr. Sramek:
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 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 qeneral 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 regulations.
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Page 2 - B. Bo Sramek, Ph.D.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health