(24 days)
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.
The Accutorr V Monitor is a vital signs monitor intended for use in a health care facility under the direct supervision of a licensed healthcare practitioner. The Accutorr V provides high and low alarm limit settings for systolic, diastolic, mean arterial pressure, pulse rate, and pulse oximetry (SpO2). The Accutor V may be powered by a rechargeable Lithium ion battery or through line-power. The Accutorr V may be equipped with optional infrared or predictive temperature and recorder modules and may be mounted on an optional rolling stand for easy portability.
The provided text K091068 is a 510(k) Summary for the Accutorr V Monitor. This document does not contain the detailed study information regarding acceptance criteria and performance as requested. It states that "The Accutorr V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards" and that a "risk analysis has been developed... The device's software has been verified and validated in accordance with the appropriate test requirements." However, it does not provide the specific acceptance criteria, reported device performance metrics, study details such as sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot populate the requested table and answer the study-related questions based on the information provided in K091068. The document serves as a summary for regulatory submission, rather than a detailed report of the performance studies.
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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.800 MacArthur Blvd.Mahwah, NJ 07430Contact: Kathleen KramerManager, Clinical and Regulatory AffairsTelephone: 201-995-8169Facsimile: 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 ina health care facility under the direct supervision of a licensedhealthcare practitioner.The Accutorr V provides high and low alarm limit settings forsystolic, diastolic, mean arterial pressure, pulse rate, and pulseoximetry (SpO2). The Accutor V may be powered by arechargeable Lithium ion battery or through line-power. TheAccutorr V may be equipped with optional infrared or predictivetemperature and recorder modules and may be mounted on anoptional rolling stand for easy portability. |
| Indications for Use: | The intended use of the Accutorr V is to monitor physiologicparameter data on adult, pediatric and neonatal patients. Thephysiologic parameters measured includes: noninvasive bloodpressure (NIBP), pulse oximetry (SpO2), pulse rate andtemperature. |
| Technological Comparisonto Predicate Device: | The Accutorr V is substantially equivalent to the predicate device,Accutorr Plus respecting the indications for use, basicoperating, performance specifications, energy supply andmaterials (with the exception of the external housing material). |
| Summary ofPerformance Testing: | The Accutorr V Monitor has been tested and found to be incompliance with recognized safety, performance andelectromagnetic compatibility standards. |
| A risk analysis has been developed to identify potential hazardsand document the mitigation of the hazards. The device's softwarehas been verified and validated in accordance with the appropriate | |
| test requirements. | |
| Conclusion: | Based on the description, technological comparison, performancetesting and the supporting documentation it can be concluded thatthe Accutorr V Monitor is safe, effective and substantiallyequivalent to the predicate device. |
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Accutorr V Monitor
501(K) Summary
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K091068
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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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:
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) | |
|---|---|
| for Zuckerman | |
| (Division Sign-Off) | 5/8/09 |
| Division of Cardiovascular Devices | |
| 510(k) Number | K09/068 |
| Page 1 of 1 |
§ 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).