ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)

K970061 · Datascope Corp. · DQA · Sep 25, 1997 · Cardiovascular

Device Facts

• Record ID: K970061
• Device Name: ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)
• Applicant: Datascope Corp.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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) The target populations are the adult and pediatric populations. The monitor is intended for use within the health care facility setting.

Device Story

Accutorr Plus is a multi-parameter patient monitor; inputs include SpO2, temperature, and NIBP sensors. Device processes physiological signals to derive heart rate and vital sign measurements. Output is displayed on monitor for clinical staff in healthcare facilities. Used for continuous or spot-check patient monitoring; assists clinicians in assessing patient status and making diagnostic or therapeutic decisions. Benefits include real-time physiological data tracking.

Clinical Evidence

No clinical data provided; device cleared based on substantial equivalence to existing marketed devices.

Technological Characteristics

Multi-parameter monitor for SpO2, temperature, and NIBP. Includes embedded firmware for signal processing and data display. Designed for clinical healthcare facility environments.

Indications for Use

Indicated for monitoring vital signs (SpO2, temperature, NIBP, heart rate) in adult and pediatric patients within healthcare facilities.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
SEP 25 1997

Mr. Frank J. Casamassina
Datascope Corp.
Patient Monitoring Division
580 Winters Avenue
Paramus, New Jersey 07652

Re: K970061
Accutorr Plus and Accutorr Plus with SpO2
Regulatory Class: II (two)
Product Code: 74 DQA
Dated: August 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 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 regulations.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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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01/03/1996 17:45 0000177
PAGE 02
K970061

# 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 the adult and pediatric populations. The monitor is intended for use within the health care facility setting.

[Signature]
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970061

PRESCRIPTION JSG ☑