(90 days)
Not Found
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is a monitor that measures physiological parameters. It does not provide treatment or facilitate a therapeutic action.
No
Explanation: The device measures blood pressure and pulse rate, which are physiological parameters. While these measurements can be used in diagnosis, the device itself is a monitor that determines (measures) these values, not a device that makes a diagnosis based on those values.
No
The device description explicitly states it is a "Non-invasive Blood Pressure Monitor" and mentions the use of an "occluding cuff" and the "Oscillometric measurement technique," which are hardware components and physical measurement methods, not solely software functions.
Based on the provided information, the Oscillornate 9001 Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Oscillornate 9001 Function: The description clearly states that the Oscillornate 9001 Monitor non-invasively measures blood pressure. This means it takes measurements from the outside of the body, without requiring a sample to be taken.
- Measurement Technique: The Oscillometric measurement technique is a non-invasive method.
Therefore, the Oscillornate 9001 Monitor falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Oscillornate 9001 Monitor non-invasively measures the blood pressure of adult , and pediatric patients primarily in the emergency care environment. The monitor automatically inflates an occluding cuff and, using the Oscillometric measurement technique, determines systolic, diastolic, mean arterial pressure and pulse rate.
Product codes
DXN
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
Not Found
Indicated Patient Age Range
adult, and pediatric patients
Intended User / Care Setting
emergency care environment
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
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.
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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.
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized representation of three human profiles facing right, arranged in a stacked formation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the seal's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 1998
Mr. Ron Jeffrey QA Manager CAS Medical Systems, Inc. Technology Applied To Medicine 21 Business Park Drive Branford, CT 06405
Re : K982135 Oscillomate EMS NIBP Monitor Model 9001 Requlatory Class: II Product Code: DXN Dated: June 16, 1998 Received: June 17, 1998
Dear Mr. Jeffrey:
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 leqally 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, Druq, 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 aqainst 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 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.
1
Page 2 - Mr. Ron Jeffrey
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) 594-4648. 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/dsma/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 Radioloqical Health
2
Page of of
510(k) Number (if known):
Device Name: Qscillomate 9001 Non-invasive Blood Pressure Monitor
STATEMENT OF INDICATIONS FOR USE
The Oscillornate 9001 Monitor non-invasively measures the blood pressure of adult , and pediatric patients primarily in the emergency care environment. The monitor automatically inflates an occluding cuff and, using the Oscillometric measurement technique, determines systolic, diastolic, mean arterial pressure and pulse rate.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dee Campese li
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K982135
510(k) Number __
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)