(261 days)
Not Found
None
No
The provided 510(k) summary does not mention AI, ML, or any related technologies. The device description and performance study sections are also not available, which would be key areas to look for such information.
No
The device is described as monitoring physiological vital signs, which is a diagnostic function, not a therapeutic one. It gathers information rather than directly treating a condition.
No
The device monitors vital signs and does not mention diagnosing any conditions or diseases.
No
The 510(k) summary describes a device that monitors physiological vital signs (SpO2, Temperature, NIBP, Heart Rate). These measurements inherently require hardware sensors to acquire the data. The summary does not mention the device being software-only or relying on data from other devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- Device Function: The Accutorr Plus monitors physiological vital signs directly from the patient's body (SpO2, temperature, NIBP, heart rate). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states the monitoring of vital signs, which is a direct measurement of physiological parameters, not an analysis of biological samples.
Therefore, the Accutorr Plus falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use for the Accutorr Plus include the monitoring of the following human physiological vital signs:
- Blood Oxygenation (SpO2) measurement
- Temperature measurement
- Non Invasive Blood Pressure (NIBP) measurement
- Heart Rate derived from selected source (SpO2, NIBP)
Product codes
74 DQA
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
The target populations are the adult and pediatric populations.
Intended User / Care Setting
The monitor is intended for use within the health care facility setting.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 25
Mr. Frank J. Casamassina Datascope Corp. Patient Monitoring Division 580 Winters Avenue Paramus, New Jersey 07652
Re: K970061 Accutorr Plus and Accutorr Plus with Sp02 Requlatory Class: II (two) Product Code: 74 DQA Dated: Auqust 29, 1997 Received: September 3, 1997
Dear Mr. Casamassina:
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 requlations 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 Druq 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.
Image /page/0/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three overlapping profiles, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the figure.
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Page 2 - Mr. Frank J. Casamassina
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. Callehan
Thomas J. Callahan, 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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0178371986 - 171 45 이 대한민들 1917年12月
Indications for Use Statement
The indications for use for the Accutorr Plus include the monitoring of the following human physiological vital signs:
- Blood Oxygenation (SpO2) measurement 0
- O Temperature measurement
- ಂ Non Invasive Blood Pressure (NIBP) measurement
- Heart Rate derived from selected source (SpO2, NIBP) O
The target populations are the adult and pediatric populations. The monitor is intended for use within the health care facility setting.
Ar. A. Cizle.
(Division Sign-Off) (Division Sign-Oit)
Division of Cardiovascular, Respiratory, and Neurological Devices K970061 510(k) Number ________________________________________________________________________________________________________________________________________________________________
PRESCRIPTION USE