HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE

K103046 · Hosman International Co., Ltd. · DXN · Jan 10, 2011 · Cardiovascular

Device Facts

• Record ID: K103046
• Device Name: HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE
• Applicant: Hosman International Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended 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 cm~19.5 cm) for wrist type; and 8.7'~14.6' (22 cm~37 cm) for Upper Arm type.

Device Story

Device uses oscillometric method to measure blood pressure and pulse rate; senses vibrating signals via closed air pipe system; microcomputer automatically senses pulse signal characteristics; systolic pressure defined as pressure when cuff oscillating amplitude begins to increase; diastolic pressure defined as pressure when cuff oscillating amplitude stops decreasing. Device used at home by patients; connects to PC via USB for monitoring, record archiving, and printing. Benefits include non-invasive, automated blood pressure monitoring without need for stethoscope or manual Korotkoff sound detection.

Clinical Evidence

Bench testing only. Compliance with AAMI/ANSI SP10 performance standards for non-invasive blood pressure measurement systems. Electrical safety and EMC testing per IEC/EN 60601-1 and EN 60601-1-2. FCC conformity per ANSI C63.4.

Technological Characteristics

Oscillometric measurement principle; microcomputer-based signal processing; USB connectivity for PC interface; cuff materials include woven cotton sheeting; wrist cuff (13.5-19.5 cm) and upper arm cuff (22-37 cm) sizes; powered by internal electronics; software-based automated calculation of systolic/diastolic pressure.

Indications for Use

Indicated for adults over age 18 for non-invasive measurement of systolic/diastolic blood pressure and pulse rate at home using an inflatable cuff on the wrist or upper arm.

Regulatory Classification

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.

Predicate Devices

• YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB (K090058)

Submission Summary (Full Text)

{0}------------------------------------------------

HOSMAN International Co., Ltd. No.10, Lane 209, Sec. 2, Kee-Lung Road, Taipei, 10675, Taiwan Tel:[phone] Fax:[phone]

"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: [phone]

> FAX: [phone]

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:[phone] Fax:[phone]

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:

- 1. 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:[phone] Fax:[phone]

- 2. 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).
- 3. 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 [phone] or [phone] 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 cm~19.5 cm) for wrist type; and 8.7'~14.6' (22 cm~37 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