(129 days)
Not Found
No
The description mentions a "microcomputer" and "simple calculation" based on the oscillometric method, which is a standard technique for blood pressure measurement and does not inherently involve AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is a blood pressure measurement system, which is a diagnostic tool, not intended for therapy.
No
The device is described as a blood pressure measurement system that determines systolic and diastolic blood pressures and pulse rate. While these measurements provide health information, the "Intended Use / Indications for Use" section does not state that the device interprets these measurements to diagnose a specific condition or disease, which is characteristic of a diagnostic device. It simply provides the measurements themselves.
No
The device description explicitly mentions an "inflatable cuff" and the use of the "Oscillometric method" which involves sensing "vibrating signal via the closed air pipe system," indicating the presence of hardware components beyond just software.
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. They are used to examine specimens outside of the body.
- Device Function: The description clearly states that this device is a "noninvasive blood pressure measurement system." It measures blood pressure and pulse rate by applying a cuff to the wrist and using the oscillometric method. This is a physical measurement taken on the body, not a test performed on a sample taken from the body.
- No Mention of Samples: There is no mention of collecting or analyzing any biological samples (blood, urine, etc.) in the intended use or device description.
Therefore, this device falls under the category of a non-invasive medical device for physiological measurement, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" - 7.75".
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
HOCA EZ-CARE BP108 and TENDER-CARE BP109 use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, clinically proven, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
over age 18
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)
Performance Testing:
Electric Safety Requirement Test Report of EN 60601-1:1990 and EMC test report of EN 60601-1-2 ( EN 55011:1991 and EN 61000-4-2:1995) ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers
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
FEB S 2006
K052671
71/2
HOCA Medical Microsystem, Inc.
No.336-2, Chien Kuo Road, Chu Nan Chen, Miaoli Shien, 35045, Taiwan Telephone (886) 37-481909 (886) 37- 484906 Fax # e-mail: neo@smarthoca.com Website : www.smarthoca.com
510(k) SUMMARY " દા
HOCA Medical Microsystem, Inc. Submitter's Name:
No.336-2, Chien Kuo Road, Miaoli Shien, 350, Taiwan Fax: 886-37-484906 Telephone: 886-37-481909 e-mail : neo@smarthoca.com
Date summary prepared:
Proprietary Name:
Device Name:
HOCA EZ-CARE BP108, TENDER-CARE BP109 NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM Common or Usual Name: Blood Pressure Monitor, Class II, Classification Name: 21 CFR 870.1130
September 19, 2005
Indications for Use:
The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" - 7.75".
Description of the device:
HOCA EZ-CARE BP108 and TENDER-CARE BP109 use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, clinically proven, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
1
F2/2
Image /page/1/Picture/1 description: The image shows a logo with a stylized leaf shape in black and white. Inside the leaf, there is a white square with a black plus sign in the center. To the right of the leaf, there is a cursive word that appears to be "foca".
HOCA Medical Microsystem, Inc.
No.336-2, Chien Kuo Road, Chu Nan Chen, Miaoli Shien, 35045, Taiwan (886) 37- 484906 Telephone (886) 37- 481909 Fax # e-mail: neo@smarthoca.com Website : www.smarthoca.com
Performance Testing:
Electric Safety Requirement Test Report of EN 60601-1:1990 and EMC test report of EN 60601-1-2 ( EN 55011:1991 and EN 61000-4-2:1995) ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers
Legally marketed device for substantial equivalence comparison:
Automatic Digital Blood Pressure Monitor, APM BP108A (K040159)
Summary for substantial equivalence comparison:
Same characteristics: intended use, technological characteristics, power supply, display, measuring range, accuracy, operating and storage environments. The new device HOCA BP108 are all the same as the predicate device APM BP108A.
Different characteristics: the new device HOCA BP109 has the different appearance for the "start key".
They are decided to be substantially equivalent.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 2006
HOCA Medical Microsystem, Inc. c/o Dr. Jen Ke-Min ROC Chinese-European Industrial Research Society No. 58 Fu-Chiun St. Hsin-Chu City Taiwan ROC
Re: K052671
Trade Name: HOCA Ez-Care BP108 and Tender-Care BP109 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: January 12, 2006 Received: January 18, 2006
Dear Dr. Ke-Min.
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.
3
Page 2 - Dr. Jen Ke-Min
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) 276-0210. 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,
Bhimimor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows a logo with a leaf-like shape on the left and the word "Coca" on the right. Inside the leaf shape, there is a plus sign. The leaf is shaded in black, and the word "Coca" is written in a cursive font.
HOCA Medical Microsystem, Inc.
No.336-2, Chien Kuo Road, Chu Nan Chen, Miaoli Shien, 35045, Taiwan Telephone (886) 37-481909 (886) 37- 484906 Fax # e-mail: neo@smarthoca.com Website : www.smarthoca.com
Indications for Use
510(k) Number:
Device Name: HOCA Medical Microsystem, Inc. HOCA EZ-CARE BP108 and TENDER-CARE BP109
. Indications for use:
The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" - 7.75".
Prescription Use
AND/OR
Over-The-Counter Use __
(Part 21 CFR 801 Subpart D)
(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)
Blummmmas
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K052671
Cl