(24 days)
Not Found
No
The document describes a standard vital signs monitor and does not mention any AI or ML capabilities.
No.
The device's intended use is to monitor physiological parameters, not to treat or cure a disease or condition.
No
The device is a vital signs monitor designed to measure and monitor physiological parameters (NIBP, SpO2, pulse rate, temperature) for general patient monitoring, rather than to diagnose specific diseases or conditions.
No
The device description clearly outlines hardware components such as a monitor, battery, optional temperature and recorder modules, and an optional rolling stand. It is a vital signs monitor, which is a physical device.
Based on the provided information, the Accutorr V is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to monitor physiologic parameter data (NIBP, SpO2, pulse rate, temperature) directly from the patient. IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The description focuses on monitoring vital signs directly from the patient using sensors and probes applied to the body.
- Lack of Specimen Handling: There is no mention of collecting, processing, or analyzing biological specimens.
The Accutorr V is a vital signs monitor, which is a type of medical device used for direct patient monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonatal patients.
Intended User / Care Setting
a health care facility under the direct supervision of a licensed healthcare practitioner.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Accutorr V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Accutorr Plus Noninvasive Blood Pressure Monitor - K983575
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
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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 07430 | |
| Contact: Kathleen Kramer | |
| Manager, Clinical and Regulatory Affairs | |
| Telephone: 201-995-8169 | |
| 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 |
| 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. | |
| 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), pulse rate and | |
| temperature. | |
| Technological Comparison | |
| to Predicate Device: | The Accutorr V is substantially equivalent to the predicate device, |
| Accutorr Plus respecting the indications for use, basic | |
| operating, performance specifications, energy supply and | |
| materials (with the exception of the external housing material). | |
| Summary of | |
| Performance Testing: | The Accutorr V Monitor has been tested and found to be in |
| compliance with recognized safety, performance and | |
| electromagnetic compatibility standards. | |
| A risk analysis has been developed to identify potential hazards | |
| and document the mitigation of the hazards. The device's software | |
| has been verified and validated in accordance with the appropriate | |
| test requirements. | |
| Conclusion: | Based on the description, technological comparison, performance |
| testing and the supporting documentation it can be concluded that | |
| the Accutorr V Monitor is safe, effective and substantially | |
| equivalent 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 |