(212 days)
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)
The target populations are adult, pediatric and neonate populations. The monitor is intended for use within the health care facility setting.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Datascope Accutorr® Plus Non Invasive Blood Pressure Monitor. It confirms the device's substantial equivalence to a predicate device but does not contain the detailed acceptance criteria or a study proving the device meets those criteria.
The letter mentions "indications for use stated in the enclosure," but the enclosure itself (which would contain such information) is not provided in the text. The only "Indications for Use Statement" present briefly lists the vital signs the device monitors and the target populations/setting but does not include any performance metrics or acceptance criteria.
Therefore,Based on the information provided, it is not possible to complete the requested table and study details. The document is an FDA clearance letter and does not contain the technical performance specifications or details of a study that would demonstrate the device meets acceptance criteria.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.
MAY 1 3 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Russell Olsen Director of Quality Assurance and Requlatory Affairs Datascope Corporation Patient Monitoring Division 580 Winters Avenue Paramus, NJ 07652
Re : K983575 Accutorr® Plus Non Invasive Blood Pressure Monitor Regulatory Class: II (Two) 74 DXN Product Code: February 12, 1999 Dated: February 16, 1999 Received:
Dear Mr. Olsen:
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 legally 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, 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 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 Requlation (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. Russell Olsen
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding acberized in your device 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" (21CFR 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.qov/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 Radiological Health
Enclosure
{2}------------------------------------------------
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name: Jotascope Accutor Plus
Indications For Use:
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 .
- Temperature measurement
- Non Invasive Blood Pressure (NIBP) measurement .
- Heart Rate derived from selected source (SpO2, NIBP)
The target populations are adult, pediatric and neonate populations. The monitor is intended for use within the health care facility setting.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ben K. Kynsele
(Division Sign-Off)
Division of Cardiovascular, Respiratory and Neurological Devices
510(k) Number K983575
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).