ACCUTORR V MONITOR, MODEL 0998-00-2000

K091068 · Datascope Corp., Patient Monitoring Division · DXN · May 8, 2009 · Cardiovascular

Device Facts

• Record ID: K091068
• Device Name: ACCUTORR V MONITOR, MODEL 0998-00-2000
• Applicant: Datascope Corp., Patient Monitoring Division
• Product Code: DXN · Cardiovascular
• Decision Date: May 8, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the Accutorr V is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The physiologic parameters measured includes: noninvasive blood pressure (NIBP), pulse oximetry (SpO2), pulse rate and temperature.

Device Story

Accutorr V is a vital signs monitor for use in healthcare facilities under licensed practitioner supervision. It measures NIBP, SpO2, pulse rate, and temperature (via optional infrared or predictive modules). Device inputs include physiological signals from patient sensors; these are processed to provide real-time data and high/low alarm limit alerts for systolic, diastolic, mean arterial pressure, pulse rate, and SpO2. Powered by rechargeable Lithium-ion battery or line-power; features optional rolling stand for portability. Output displayed on monitor for clinician review to support clinical decision-making regarding patient status. Benefits include continuous, reliable monitoring of vital signs to facilitate timely clinical intervention.

Clinical Evidence

Bench testing only. The device was tested for compliance with recognized safety, performance, and electromagnetic compatibility standards. Software was verified and validated in accordance with test requirements. No clinical study data was provided.

Technological Characteristics

Vital signs monitor; measures NIBP, SpO2, pulse rate, temperature. Power: rechargeable Lithium-ion battery or line-power. Optional modules: infrared or predictive temperature, recorder. Form factor: portable, optional rolling stand. Software: verified and validated. Connectivity: not specified. Sterilization: not applicable.

Indications for Use

Indicated for monitoring physiologic parameters including NIBP, SpO2, pulse rate, and temperature in adult, pediatric, and neonatal patients in 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.

Predicate Devices

• Accutorr Plus Noninvasive Blood Pressure Monitor (K983575)

Submission Summary (Full Text)

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K091068

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## 510(k) Summary Accutorr V Monitor

MAY - 8 2009

This 510(K) Summary is provided in accordance with 21 CFR 807.92.

| Date: | April 10, 2009 |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Datascope Patient Monitoring, Mindray DS USA, Inc.<br>800 MacArthur Blvd.<br>Mahwah, NJ 07430<br>Contact: Kathleen Kramer<br>Manager, Clinical and Regulatory Affairs<br>Telephone: [phone]<br>Facsimile: 201-995-8605 |
| Device Trade Name: | Accutorr V Monitor |
| Common Name: | Noninvasive Blood Pressure Management System |
| Device Classification: | Cardiovascular, Class II, 21 CFR 870.1130, Product Code DXN. |
| Predicate Devices: | Accutorr Plus Noninvasive Blood Pressure Monitor - K983575 |
| Device description: | The Accutorr V Monitor is a vital signs monitor intended for use in<br>a health care facility under the direct supervision of a licensed<br>healthcare practitioner.<br>The Accutorr V provides high and low alarm limit settings for<br>systolic, diastolic, mean arterial pressure, pulse rate, and pulse<br>oximetry (SpO2). The Accutor V may be powered by a<br>rechargeable Lithium ion battery or through line-power. The<br>Accutorr V may be equipped with optional infrared or predictive<br>temperature and recorder modules and may be mounted on an<br>optional rolling stand for easy portability. |
| Indications for Use: | The intended use of the Accutorr V is to monitor physiologic<br>parameter data on adult, pediatric and neonatal patients. The<br>physiologic parameters measured includes: noninvasive blood<br>pressure (NIBP), pulse oximetry (SpO2), pulse rate and<br>temperature. |
| Technological Comparison<br>to Predicate Device: | The Accutorr V is substantially equivalent to the predicate device,<br>Accutorr Plus respecting the indications for use, basic<br>operating, performance specifications, energy supply and<br>materials (with the exception of the external housing material). |
| Summary of<br>Performance Testing: | The Accutorr V Monitor has been tested and found to be in<br>compliance with recognized safety, performance and<br>electromagnetic compatibility standards. |
| | A risk analysis has been developed to identify potential hazards<br>and document the mitigation of the hazards. The device's software<br>has been verified and validated in accordance with the appropriate |
| | test requirements. |
| Conclusion: | Based on the description, technological comparison, performance<br>testing and the supporting documentation it can be concluded that<br>the Accutorr V Monitor is safe, effective and substantially<br>equivalent to the predicate device. |

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Accutorr V Monitor
501(K) Summary

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Accutorr V Monitor 501(K) Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold design.

Public Health Service

MAY - 8 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Datascope Patient Monitoring, Mindray DS USA, Inc. c/o Ms. Kathleen Kramer Manager, Clinical and Regulatory Affairs 800 MacArthur Blvd. Mahwah, NJ 07430

K091068 Re:

> Trade/Device Name: ACCUTORR V MONITOR Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Codes: DXN Dated: April 17, 2009 Received: April 20, 2009

Dear Ms. Kramer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Kathleen Kramer

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name:

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ACCUTORR V

Indications For Use:

The intended use of the Accutorr V is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The physiologic parameters measured includes: noninvasive blood pressure (NIBP), pulse oximetry (SpO2), heart rate and temperature.

Prescription Use ਮ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------------------|
| | <i>for Zuckerman</i> |
| (Division Sign-Off) | 5/8/09 |
| Division of Cardiovascular Devices | |
| 510(k) Number | K09/068 |
| | Page 1 of 1 |