(305 days)
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The description focuses on standard vital signs monitoring technology.
No
The device is a vital signs monitor, intended for monitoring physiologic parameters, not for treating any condition.
No
The device is described as a "Vital Signs Monitor" intended for "monitoring physiologic parameters." While monitoring vital signs is crucial for patient assessment, it is not explicitly stated or implied that the device is used for diagnosing diseases or conditions. The provided information focuses on parameter measurement and monitoring, not on generating a diagnosis.
No
The device description explicitly states it consists of a "main unit, parameters measurement accessories, peripheral equipments or accessories," indicating it includes hardware components beyond just software.
Based on the provided information, the Accutorr 7 Vital Signs Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to monitor physiological parameters (SpO2, PR, NIBP, TEMP) directly from the patient. IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The description focuses on a patient monitor with accessories for direct patient measurement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
The Accutorr 7 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 Accutorr 7 Vital Signs Monitor is intended for monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians
Product codes
MWI
Device Description
The Accutorr 7 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. This patient monitor consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.
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
clinical physicians or appropriate medical staff under the direction of physicians in healthcare facilities
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 7 Vital Signs Monitor comply with the recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. Mindray's product development process required that the following activities be completed during the development of those patient monitors:
Requirements specification review Hardware and Software testing Code design and code reviews Environmental EMC testing Wireless testing Safety testing Performance testing Hardware and Software validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
K132038 page 1 of 2
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K132038
| Submitter: | Shenzhen Mindray Bio-medical Electronics Co., LTD |
|---|---|
| Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, | |
| Nanshan, Shenzhen, 518057, P. R. China | |
| Tel: +86 755 2658 2888 | |
| Fax: +86 755 2658 2680 |
- Contact Person: Yanhong Bai Manager Regulatory Affairs SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan, Shenzhen 518057, P.R. China Tel: +86 755 81885635 Fax: +86 755 26582680 E-mail: baiyanhong@mindray.com
Date Prepared: March 25, 2014
Trade/Proprietary Name: Accutorr 7 Vital Signs Monitor
Common Name: Vital Signs Monitor
Classification:
| 21 CFR 870.2300 Cardiac monitor (including cardiotachometer and rate alarm) | Class II | |
|---|---|---|
| 21 CFR 870.1130 Non-Invasive blood pressure measurement System | Class II | |
| 21 CFR 880.2910 Clinical Electronic Thermometers-Temperature Monitor with Probe Class II | ||
| 21 CFR 870.2700 Oximeter, Pulse | Class II |
Legally Marketed Predicate Devices:
K072235, VS-800 Vital Signs Monitor, Shenzhen Mindray Bio-medical Electronics Co., LTD
Device Description:
The Accutorr 7 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. This patient monitor consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.
The Accutorr 7 Vital Signs Monitor is intended for monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
1
Statement of intended Use:
The Accutorr 7 Vital Signs Monitor is intended for monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians
Technology:
The Accutorr 7 Vital Signs Monitor is substantially equivalent to the predicate devices VS-800 Vital Signs Monitor (K072235).
Test Summarv:
The Accutorr 7 Vital Signs Monitor comply with the recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. Mindray's product development process required that the following activities be completed during the development of those patient monitors:
Requirements specification review Hardware and Software testing Code design and code reviews Environmental EMC testing Wireless testing Safety testing Performance testing Hardware and Software validation
Conclusion:
The results of all testing demonstrate that the Accutorr 7 Vital Signs Monitor is as safe, as effective, and perform as well as the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10003 New Hamnshire Avenue Document Control Center - WO66 CASA Silver Spring, MD 20993-0002
Image /page/2/Picture/3 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved, wing-like shapes above three wave-like shapes.
May 2, 2014
Mindray North America Russell Olsen 800 Macarthur Blvd Mahwah, NJ 07430 US
Re: K132038
Trade/Device Name: Accutorr 7 Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Regulatory Class: Class II Product Code: MWI Dated: April 1, 2014 Received: April 3, 2014
Dear Russell Olsen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your avriles to 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease be advised that I Driver 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); medical device reporting of medical device-related adverse labeling (21 CFR 803); 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.
3
Mr. Russell Olsen - Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Accutorr 7 Vital Signs Monitor
Indications for Use:
The Accutorr 7 Vital Signs Monitor is intended for monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians
Prescription Use_ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Picture/11 description: The image shows a signature and a date. The date is 2014.05.02 and the time is 15:01:43'04'00'. The signature is illegible.
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