(41 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as a blood pressure meter intended to measure blood pressure and pulse rate, which are diagnostic measurements rather than therapeutic interventions.
No
The device is intended to measure blood pressure and pulse rate, which are physiological parameters. While these measurements can contribute to a diagnosis, the device itself is not described as interpreting these measurements to diagnose a condition, nor does it identify disease states. It simply provides the raw data.
No
The device description explicitly mentions hardware components such as an inflated cuff, electrical air pump, mechanical valve, and LCD display, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device measures blood pressure and pulse rate directly from the patient's upper arm using a cuff and oscillometric method. It does not analyze any biological specimens.
The intended use and device description clearly indicate a non-invasive measurement of physiological parameters, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. The device is designed for adult patient population.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Quanta Blood Pressure Meter, Model no.: Cardiac Elite 1000 (or QH200) is designed to measure the systolic and diastolic blood pressure, and pulse rate (heart of an individual).
The device uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by an electrical air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff. The measurement results are displayed on the LCD.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult patient population
Intended User / Care Setting
Not Found
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)
In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
0
510(K) SUMMARY NOV 2 6 2008
R/ / 2
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1. Submitter's Name: | Quanta Computer Inc.
BG1 Medical Devices Department | | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Address: | 2F, No. 188, Wen Hwa 2nd Rd.,
Kuei Shan Hsiang, Tao Yuan Shien 33377, TAIWAN | | |
| Phone: | +886-3-327-2345 #18029 | | |
| Fax: | +886-3-327-2345 | | |
| Contact: | Jason Hung / Title: Specialist 1 | | |
| 2. Device Name : | | | |
| Trade Name: | Quanta Blood Pressure Meter ,
Model no.: Cardiac Elite 1000 (or QH200 ) | | |
| Common Name: | Non-Invasive Blood Pressure Monitor | | |
| Classification name | System , Measurement , Blood-Pressure , Non-Invasive | | |
| 3. DEVICE CLASS | The Quanta Blood Pressure Meter , Model no.: Cardiac
Elite 1000 (or QH200) has been classified as | | |
| | Regulatory Class: II | | |
| | Panel: 74 | | |
| | Product Code: DXN | | |
| | Regulation Number: 2ICFR 870.1130 | | |
| 4. Predicate Device: | • OMRON Automatic Blood Pressure Monitor, Model
HEM-711AC (K052154) marketed by Omron
Healthcare, Inc.. | | |
| | • A&D LifeSource Automatic Blood Pressure Monitor ,
Model#UA-767 (K982481) marketed by A & D
ENGINEERING, INC.. | | |
| 5. Intended Use: | The Quanta Blood Pressure Meter , Model no.: Cardiac
Elite 1000 (or QH200) is intended to measure the blood
pressure (systolic and diastolic) and pulse rate by
oscillometric method. The measurements are conducted by
using an cuff which is wrapped around the upper arm. The
device is designed for adult patient population. | | |
| | Product: Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) | | |
| 6. Device
Description: | The Quanta Blood Pressure Meter, Model no.: Cardiac
Elite 1000 (or QH200) is designed to measure the
systolic and diastolic blood pressure, and pulse rate (heart
of an individual). | | |
| | The device uses an inflated cuff which is wrapped around
the upper arm. The cuff is inflated by an electrical air pump.
The systolic and diastolic blood pressures are determined by
oscillometric method. The deflation rate is controlled by a
preset mechanical valve at a constant rate. At any moment
of measurement, the user can deflate the cuff. The
measurement results are displayed on the LCD. | | |
| 7. Performance
Summary: | In terms of operating specification, Safety & EMC
requirements, the device conforms to applicable standards
included EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC | | |
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Section 4 - 510(k) Summary
REV. [A]
1
60601-1 and IEC 60601-1-2 requirements.
083079
8. Conclusions:
The Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) has the same intended use and similar technological characteristics as the OMRON Automatic Blood Pressure Monitor, Model HEM-711AC (K052154) marketed by Omron Healthcare, Inc., and A&D LifeSource Automatic Blood Pressure Monitor , Model#UA-767 (K982481) marketed by A & D ENGINEERING, INC.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, The Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized depiction of a caduceus, a symbol often associated with healthcare, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2008
Quanta Computer Inc. c/o Ms. Jennifer Reich Harvest Consulting Corp. 2904 N. Boldt Drive Flagstaff, AZ 86001
Re: K083078
Trade/Device Name: Quanta Blood Pressure Meter, Cardiac Elite 1000 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 13, 2008 Received: October 16, 2008
Dear Ms. Reich:
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 intenstate 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 1 11The 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 devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, RDAouv 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 FDA has made a determination that your device complics with other requirements aft the Act
3
Page 2 - Ms. Jennifer Reich
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: registres. - Tournalisting (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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000. This letter will allow you to begin marketing your device as described in your Section 5.10(k) premarket notification. The FDA finding of substantial equivalence of your device to a logally 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of devices 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 Arth the Division of Small Manufacturers, International and Consumer Assistance an its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/indcx.html.
Sincerely yours,
[signature]
O Bram 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): 长oß3078
Device Name: Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) Quanta Computer Inc. BG1 Medical Devices Department
Indications For Use:
The Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. The device is designed for adult patient population.
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 807 Subpart C) | V |
| ------------------------------------------------- | -------- | ------------------------------------------------ | --- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K083078 |
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