ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX

K983575 · Datascope Corp. · DXN · May 13, 1999 · Cardiovascular

Device Facts

• Record ID: K983575
• Device Name: ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
• Applicant: Datascope Corp.
• Product Code: DXN · Cardiovascular
• Decision Date: May 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• 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 adult, pediatric and neonate 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 sensors, temperature probes, and NIBP cuffs. Device processes physiological signals to derive vital sign measurements; displays data for clinician review. Used in healthcare facilities by medical professionals to monitor patient status; output facilitates clinical decision-making regarding patient stability and care. Benefits include continuous or periodic assessment of vital signs to detect physiological changes.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Multi-parameter monitor for SpO2, temperature, and NIBP. Includes signal processing for heart rate derivation. Designed for clinical facility use. Connectivity and specific hardware standards not detailed.

Indications for Use

Indicated for monitoring SpO2, temperature, NIBP, and heart rate in adult, pediatric, and neonate populations within healthcare facilities.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 [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" (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 [phone] or [phone] 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

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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)