(57 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is not available to infer such capabilities.
No
Explanation: The device is a blood pressure monitor, which is a diagnostic device used to measure physiological parameters, not a therapeutic device designed to treat a condition.
No
The device measures blood pressure and pulse rate, which are physiological parameters, not a diagnosis of a disease or condition. While these measurements can be used by a healthcare professional to assist in diagnosis, the device itself is a measurement tool.
No
The intended use describes a "Digital Blood Pressure Monitor Model RTW-8010A" which is a physical device for measuring blood pressure. The summary does not mention any software-only component or function.
Based on the provided information, the RTT Digital Blood Pressure Monitor Model RTW-8010A is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the non-invasive measurement of blood pressure and pulse rate from a user's wrist. This is a direct measurement of physiological parameters within the body, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This blood pressure monitor does not fit that description.
N/A
Intended Use / Indications for Use
RTT Digital Blood Pressure Monitor Model RTW-8010A is indicated for nonivasive measurement of systolic and diastolic blood pressure and determination of puslse rate from user's wrist .
Product codes
DXN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/1 description: The image shows the seal for the Department of Health and Human Services, USA. The seal is circular, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. In the center of the seal is a stylized emblem consisting of three curved lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 8
Real Tone Technology Corp. c/o Mr. Tom Wang 101 Room, NO 28, Lane 777 Xi Huang Road Xinzhuang Town, Shanghai
Re: K060077
K00007 /
Trade Name: Real Tone Digital Blood Pressure Monitor, Model RTW-8010A Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 12, 2006 Received: January 10, 2006
Dear Mr. Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device in diedic t we nave reviewed your becaon 310(x) premised is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 tise stated in the encrosule) to regard to the Medical Device Amendments, or to comments prices that have been reclassified in accordance with the provisions of the Federal Frod, DMA devices mat have been recuired in assee approval of a premarket approval application (PMA). and Costience Act (71ct) that the novice, subject to the general controls provisions of the Act. The I ou may, merciole, manot and act include requirements for annual registration, listing of general controls provisions of the rise, 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 may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Councements concerning your device in the Federal Register.
1
Page 2 - Mr. Tom Wang.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r read on 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 or any I odotal batates and states and the best mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI I rart 077, mooning (21 CFR Part 820); and if applicable, the electronic forth in the qualisy by by sions (Sections 531-542 of the Act); 21 CFR 1000-1050. product taxall allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and by of substantial equivalence of your device of your device to a legally premated predicated 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 if you dosire specific arrivaliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golferal micolinines and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B/mmumor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
KO60077 510(k) Number (if known):
RTT Digital Blood Pressure Monitor Model RTW-8010A Device Name:
Indications For Use:
RTT Digital Blood Pressure Monitor Model RTW-8010A is indicated for nonivasive measurement of systolic and diastolic blood pressure and determination of puslse rate from user's wrist .
Prescription Use (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)
B. Bimmima
ision Sign-Off
ion of Cardiovascular Devices
Number
Koo77