(43 days)
Not Found
No
The description focuses on the oscillometric method and standard signal processing techniques to derive blood pressure and pulse rate. There is no mention of AI or ML algorithms, training data, or performance metrics typically associated with such technologies.
No
The device is intended to measure blood pressure and pulse rate, not to treat any medical condition.
Yes
The device measures blood pressure and pulse rate to assess an individual's health status, which is a form of diagnosis.
No
The device description explicitly lists hardware components such as setting buttons, function buttons, LCD display, start/stop button, recall memory button, and an arm cuff, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The iDoc Upper Arm attached Blood Pressure and Pulse Rate Monitor measures blood pressure and pulse rate directly from the arm using a non-invasive method (oscillometric). It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate, which are physiological parameters, not to diagnose a condition based on analyzing a biological sample.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of iDoc™ iD-42A/ iD-43A Upper Arm Attached Blood Pressure and Pulse Rate Monitor is to measure human systolic, diastolic blood pressure and heart rate by using the oscillometric method. The measurement position of the device is the arm of the subject.
The iDoc Upper Arm attached Blood Pressure and Pulse Rate Monitor provide intended to use non-invasive measure the systolic and diastolic blood pressure and pulse rate or an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9"~14" (23cm ~ 36cm).
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The iDoc™ iD-42A/ iD-43A Upper Arm Attached Blood Pressure and Pulse Rate Monitors are arm blood pressure monitors and use the oscillometric method to measure the blood pressure. The device includes setting button, function button, LCD display, start/stop button, recall memory button, and arm cuff. The symbols display on LCD include month, date, hour, minute, systolic rate, diastolic rate, pulse rate, pulse symbol, blood pressure unit, battery display, error symbol, memory record.
Both devices determine values of blood pressure by using oscillometric method. In this method, pulse waves are detected by using pressure sensors. Then the diastolic blood pressure, mean average pressure, and pulse pressure are derived. Furthermore, the systolic blood pressure and pulse rate are computed based on the information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm
Indicated Patient Age Range
adult individual, over age 16
Intended User / Care Setting
at home
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)
Non-clinical Performance: The results for non-clinical trials as presented in this document demonstrated the conformance to the SP10 standard that is also the reference standard for the predicate device. Therefore, the substantial equivalence between the devices is determined.
Clinical Performance: As the predicate device, the clinical test results of the iD-42A/iD-43A showed the functions of the device met the criteria in the SP10 standard. Hence, it is reasonable to conclude the substantial equivalence between the devices.
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 3 2005
Submitter's Information
| Submitter's Name: | TaiDoc Technology Corporation |
|---|---|
| Contact person: | Sophia, Shu-Mei Wu, Ph.D. |
| Address: | 4F, No. 88, Sec. 1, Kwang-Fu Rd., |
| San-Chung, Taipei County, Taiwan | |
| Phone: | +886-2-66358080 |
| Fax: | +886-2-66355959 |
| E-mail: | shumei@taidoc.com.tw |
| Date Prepared: | October 05, 2005 |
1. Device
Trade Name/Proprietary Name: iDoc™ iD-42A/ iD-43A Upper Arm Attached Blood Pressure and Pulse Rate Monitor.
Common Name: Noninvasive Blood Pressure Measurement System
Classification Name: blood pressure monitor
Class II devices, 21 CFR 870.1130
Product Code: DXN
2. Predicate Device
Trade /Proprietary Name: HL888HA H&L Full Automatic (NIBP) Blood Pressure Monitor, (K030498)
Common Name: Noninvasive Blood Pressure Measurement System Classification Name: blood pressure monitor
Class II devices, 21 CFR 870.1130
Manufacturer: Health & Life, Inc.
510 (k) Number: K030498
3. Device Description
The iDoc™ iD-42A/ iD-43A Upper Arm Attached Blood Pressure and Pulse Rate
Page 1-of-3
1
Monitors are arm blood pressure monitors and use the oscillometric method to measure the blood pressure. The device includes setting button, function button, LCD display, start/stop button, recall memory button, and arm cuff. The symbols display on LCD include month, date, hour, minute, systolic rate, diastolic rate, pulse rate, pulse symbol, blood pressure unit, battery display, error symbol, memory record.
Both devices determine values of blood pressure by using oscillometric method. In this method, pulse waves are detected by using pressure sensors. Then the diastolic blood pressure, mean average pressure, and pulse pressure are derived. Furthermore, the systolic blood pressure and pulse rate are computed based on the information.
4. Intended Use
The intended use of iDoc™ iD-42A/ iD-43A Upper Arm Attached Blood Pressure and Pulse Rate Monitor is to measure human systolic, diastolic blood pressure and heart rate by using the oscillometric method. The measurement position of the device is the arm of the subject.
5. Technology Characteristics Comparison
Both devices determine values of blood pressure by using oscillometric method. In this method, pulse waves are detected by using pressure sensors. Then the diastolic blood pressure, mean average pressure, and pulse pressure are derived. Furthermore, the systolic blood pressure and pulse rate are computed based on the information.
6. Non-clinical Performance
The results for non-clinical trials as presented in this document demonstrated the conformance to the SP10 standard that is also the reference standard for the predicate device. Therefore, the substantial equivalence between the devices is determined.
Page 2-of-3
7. Clinical Performance
2
As the predicate device, the clinical test results of the iD-42A/iD-43A showed the functions of the device met the criteria in the SP10 standard. Hence, it is reasonable to conclude the substantial equivalence between the devices.
8. Conclusions
The iDoc™ Upper Arm Attached Blood Pressure and Pulse Rate Monitor demonstrates satisfactory performance and is suitable for its intended use.
Page 3-of-3
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing segments, representing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
NOV 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tai Doc Technology Corporation c/o Dr. Shu-Mei Wu Project Manager 4F No. 88, Sec. 1, Kwang-Fu Rd, San-Chung Taipei County TAIWAN
Re: K052872
Trade Name: iDoc™ iD-42A/iD-43A Upper Arm Attached Blood Pressure and Pulse Rate Monitor Regulation Number: 21 CFR 870. 1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 6, 2005 Received: October 11, 2005
Dear Dr. Wu:
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.
4
Page 2 - Dr. Shu-Mei Wu
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 Office of Compliance at (240) 276-0295. 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 Manufacturers, International 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. Bommima for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
K052872 510(k) Number:
Device Name: iDoc Upper Arm Attached Blood Pressure and Pulse Rate Monitor
Indications For Use:
The iDoc Upper Arm attached Blood Pressure and Pulse Rate Monitor provide intended to use non-invasive measure the systolic and diastolic blood pressure and pulse rate or an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9"~14" (23cm ~ 36cm).
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
Blammiamr
Page 1 of
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K052872