(88 days)
Not Found
No
The description details the use of the Oscillometric method and a microcomputer for signal processing and calculation, which are standard techniques for blood pressure monitors and do not inherently involve AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No
Explanation: This device is for measurement and monitoring of blood pressure and pulse rate, not for treatment or therapy.
Yes
The intended use explicitly states that the device is "intended to measure the systolic and diastolic blood pressures and pulse rate," which are measurements used in the diagnosis of various health conditions.
No
The device description explicitly mentions "inflatable cuff" and "closed air pipe system," indicating physical hardware components are essential to its function.
No, 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 HOSMAN USB Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the arm or wrist and using the oscillometric method. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
The description clearly states it's a "noninvasive blood pressure measurement system." This confirms it does not involve testing samples "in vitro" (in glass or outside the body).
N/A
Intended Use / Indications for Use
The HOSMAN USB Blood Pressure Monitor, Upper Arm Type: HM-500 and Wrist Type: HM-100, are noninvasive blood pressure measurement systems 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 inflat ridat, wrapped around the wrist or upper arm.
The cuff circumference is limited to be 5.3'7.7' (13.5 cm19.5 cm) for wrist type; and 8.7'14.6' (22 cm37 cm) for Upper Arm type.
Product codes
DXN
Device Description
HOSMAN USB Blood Pressure Monitor Upper Arm Type: HM-500 and Wrist Type: HM-100 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, 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 or upper arm
Indicated Patient Age Range
adult individual, 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)
Test Summary:
- ELECTRIC SAFETY, EMC and FCC test reports,
General safety IEC/EN 60601-1:1995 PASS
EMC conformity EN 60601-1-2: 2007 PASS
FCC conformity ANSI C63.4: 2003 PASS - WOVEN COTTON SHEETING:
Uses the 510K Blood-Pressure Cuff. - PERFORMANCE & CLINICAL TEST
AAMI / ANSI SP10
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
§ 870.1130 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
HOSMAN International Co., Ltd. No.10, Lane 209, Sec. 2, Kee-Lung Road, Taipei, 10675, Taiwan Tel:886-2-87327866 Fax:886-2-87325677
"510(k) Summary for K/03046"
JAN 1 0 2011
Submitter's Name: HOSMAN International Co., Ltd.
No.10, Lane 209, Sec. 2, Kee-Lung Road, Taipei, Address: 10675, Taiwan
Telephone: 886-2-87327866
FAX: 886-2-87325677
Contact Person: Dr. Jen, Ke-Min
Date Summary Prepared: September 28, 2010
Proprietary Name:
HOSMAN USB Blood Pressure Monitor Upper Arm Type: HM-500; Wrist Type: HM-100
Common Name: BLOOD PRESSURE MONITOR
Classification Name:
NON-INVASIVE BLOOD-PRESSURE MEASUREMENT SYSTEM
( per 21CFR section 870.1130)
Class II (performance standards)
Device Class:
Specialty: CARDIOVASCULAR
Product code: DXN
Legally Marketed ( Predicate ) Device :
YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB
510(k) No: K090058
1
HOSMAN International Co., Ltd. No.10, Lane 209, Sec. 2, Kee-Lung Road, Taipei, 10675, Taiwan Tel:886-2-87327866 Fax:886-2-87325677
Description of the new device: (Same as the predicate devices)
HOSMAN USB Blood Pressure Monitor Upper Arm Type: HM-500 and Wrist Type: HM-100 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, 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.
Technological Characteristics of our new device compared to the predicate device:
The technological characteristics of HOSMAN USB Blood Pressure Monitor Upper Arm Type: HM-500 and Wrist Type: HM-100 are substantially equivalent to YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700B, BP-700TB, BP-700UB, and BP-700TUB (K090058). There are the same design specifications, the same form and intended to be used in the same manner that means the new devices are same as the predicate devices. Especially, HOSMAN USB Blood Pressure Monitor and the BP-700U, BP-700UB, and BP-700TUB of the predicate devices are also through USB to connect the PC for monitoring, record archiving, and printing purposes.
The mainly different are:
-
- The new devices are different vision appearance and specifications for the predicate devices.
2
HOSMAN International Co., Ltd. No.10, Lane 209, Sec. 2, Kee-Lung Road, Taipei, 10675, Taiwan Tel:886-2-87327866 Fax:886-2-87325677
-
- The predicate devices just for the general upper arm use and the new devices are either for the general upper arm (HM-500) or wrist use (HM-100).
-
- The new devices are through USB to connect PC for monitoring; and the predicate devices BP-700 series are the identical device with the optional functions for the BP-700U, BP-700UB, and BP-700TUB which can connect to the PC, backlight, and the voice function for the general upper arm use.
Thus there are substantially equivalent.
Test Summary:
1. ELECTRIC SAFETY, EMC and FCC test reports,
| General safety | IEC/EN 60601-1:1995 | PASS |
|---|---|---|
| EMC conformity | EN 60601-1-2: 2007 | PASS |
| FCC conformity | ANSI C63.4: 2003 | PASS |
2. WOVEN COTTON SHEETING:
Uses the 510K Blood-Pressure Cuff.
3. PERFORMANCE & CLINICAL TEST
AAMI / ANSI SP10
HOSMAN Internation Co., Ltd. believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent to the predicate product and other products currently in distribution.
Ketrin Jenson
Dr. Jen, Ke-Min official correspondent HOSMAN Internation Co., Ltd.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is a stylized emblem consisting of three curved lines that resemble a human figure or a symbol representing health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
HOSMAN International Co., Ltd. c/o Dr. Jen. Ke-Min Official Correspondent ROC Chinese-European Industry Research Society No. 58, Fu Chiun Street, Hsin Chu City TAIWAN ROC 30067
and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi
JAN 1 0 201
Re: K103046
Trade/Device Name: HOSMAN USB Blood Pressure Monitor, Upper Arm Type: HM-500; and Wrist Type: HM-100 Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: December 4, 2010 Received: December 9, 2010
Dear Dr. Jen, 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 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. 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); medical device reporting (reporting of medical device-related adverse events) (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 v product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.gov/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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K/03046
- JAN 10 2011
Device Name: HOSMAN International Co., Ltd. HOSMAN USB Blood Pressure Monitor Upper Arm Type: HM-500; Wrist Type: HM-100
● Indications for use:
The HOSMAN USB Blood Pressure Monitor, Upper Arm Type: HM-500 and Wrist Type: HM-100, are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult inclividual, over age 18, at home by using a non-invasive technique in which an inflat ridat, wrapped around the wrist or upper arm.
The cuff circumference is limited to be 5.3'7.7' (13.5 cm19.5 cm) for wrist type; and 8.7'14.6' (22 cm37 cm) for Upper Arm type.
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)
W.P.W.S.A.
of Cardiovascular Devices
Page 1 of 1
CI
510(k) Numbe